2001-0143 Rev A - LEDISO · GSI Audera Additional copies Additional copies of this manual or other...

Part Number 2001-0143 Rev A

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Title: GSI Audera DPOAE User Manual

Date: 200

Copyright © 2007 Inc. All rights reserved. No part of this publication may be reproduced or transmitted in any form or by any means without the prior written permission of The information in this publication is proprietary to Inc.

Part number: 2001-0143 Rev 0

Printing history: 200 2001-0143 Rev 0 printing

Compliance

The CE0344 mark identifies compliance with the Medical Device Directive 93/42/EEC.

Grason-Stadler is an ISO 9001-certified corporation.

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European Authority Representative Grason-Stadler Kongebakken 9 2765 Smorum Denmark

0344

GSI Audera

Additional copies

Additional copies of this manual or other GSI literature may be obtained from:

Attention

The information in this document is subject to change without notice.

Grason-Stadler makes no warranty of any kind with regard to this material, including, but not limited to the implied warranties of merchantability and fitness for a particular purpose. GSI assumes no responsibility for any errors that may appear in this document. GSI makes no commitment to update nor to keep current the information contained in this document.

Trademarks

Microsoft, MS, Windows, Window XP and Windows NT are registered trademarks of Microsoft Corporation.

Pentium is a trademark of Intel Corporation.

Audera is a trademark of Grason-Stadler.

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System warranty

GSI warrants that each product we sell you shall conform to its product specifications as defined in the user documentation.

If the product does not function as warranted during the warranty period, we will repair or replace it without charge. If in our judgment we are unable to do so, you may return it to us and we will refund your money.

Warranty period The warranty period is stated in the product user documentation. If you install the product, the warranty period begins on the date of invoice. If we install the product, the warranty period begins on the date of installation but will begin no later than 30 days from the date of invoice.

The warranty period for products sold outside the U.S.A. and Canada is 12 months from the date of installation or 14 months from the date of shipment, whichever is less.

Limit of warranty Misuse, accident, modification, unsuitable physical or operating environment, improper maintenance, or damage caused by a product for which we are not responsible may void the warranty.

Certain components may have separate warranty periods as stated in the product user documentation. Consumables are not covered under warranty.

THIS WARRANTY REPLACES ALL OTHER WARRANTIES, EXPRESSED OR IMPLIED, INCLUDING THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE AND ANY OTHER OBLIGATIONS OR LIABILITIES ON THE PART OF GSI. WHETHER IN CONTRACT, WARRANTY, NEGLIGENCE OR OTHERWISE. GSI SHALL NOT BE LIABLE FOR AND DISCLAIMS ALL CONSEQUENTIAL, INCIDENTAL AND CONTINGENT DAMAGES.

Items not covered We do not warrant uninterrupted or error-free operation of a product.

by warranty We provide certain non-GSI products on an “as is” basis.

Non-GSI manufacturers or suppliers may provide their own warranties to you.

Separate software warranty is provided with software user documentation.

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GSI does not warrant that the software will operate uninterrupted or error-free.

GSI MAKES NO OTHER WARRANTIES, EITHER EXPRESSED OR IMPLIED, WITH RESPECT TO THIS SOFTWARE, INCLUDING WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE. GSI MAKES NO WARRANTY, EITHER EXPRESSED OR IMPLIED, WITH RESPECT TO THE QUALITY OR PERFORMANCE OF THIS SOFTWARE. GSI SHALL NOT BE LIABLE FOR CONSEQUENTIAL, INCIDENTAL OR CONTINGENT DAMAGES.

Some states do not allow the exclusion or limitation of implied warranties or limitation of liability for incidental or consequential damages, so the above limitation or exclusion may not apply to you.

This software is protected by state, U.S. and international copyright treaty provisions. These copyright provisions apply to your use of this software regardless of whether or not you agree to the following terms. Under law, copyright infringers may be liable for actual damages sustained by the copyright owner and for punitive damages of up to $100,000 per infringement. Unauthorized copying of computer software, and attempts to do so, are also criminal violations, with penalties that may exceed $100,000 in fines and 10 years in prison.

1. Unless restricted by an agreement with GSI, you are permitted to:

a. Use this software on only one computer and by one user at a time.

b. Make one copy of this software, provided that:

(i) the copy is created as an essential step in the utilization of this software in conjunction with your machine and that it is used in no other manner, or

(ii) that the copy is for archival purposes only and that all archival copies are destroyed in the event that your continued possession of this software should cease to be rightful.

c. Sell this software, and any archival copy, only as part of the sale of all of your rights in this software, except that adaptations so prepared may be transferred only with the authorization of GSI.

2. You are not permitted to:

a. Make copies of this software or documentation except as described above.

b. Alter, modify or adapt this software or documentation except as described above.

c. Distribute, lease, rent or sublicense this software or documentation.

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GSI Audera

Software warranty

GSI warrants that the physical media (e.g. CDs), shall be free of malfunction in labor and materials for a period of ninety (90) days from the invoice date. If the physical mediacontaining the software is defective, GSI will replace it without charge.

This is your sole remedy for product malfunctions. In no event will GSI' liability exceed the price paid for the software, regardless of the form of the claim.

Software copyright protection

iv

Customer responsibility

This product and its components will perform reliably only when operated and maintained in accordance with the instructions contained in this manual, accompanying labels, and/or inserts. A defective product should not be used. Parts which may be broken or missing or are plainly worn, distorted or contaminated should be replaced immediately with clean, genuine replacement parts manufactured by or available from GSI. The responsibility of GSI for a malfunctioning product is limited by the warranty set forth in this manual. Should repair or replacement of this product become necessary after the warranty period, the customer should seek advice from GSI Technical Support. prior to such repair or replacement. If this product is in need of repair it should not be used until all repairs have been made and the unit is functioning properly and ready for use. The owner of this product has sole responsibility for any malfunction resulting from improper use or maintenance, or repair by anyone other than GSI, and from any malfunction caused by parts that are damaged or modified by anyone other than GSI.

Regulatory standards

GSI Audera systems meet the following safety standards set by domestic and international regulatory agencies for Medical Electrical Equipment.

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•

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UL 60601-1 - American Standards for Medical Electrical Equipment General Requirements

CAN/CSAC 22.2 No. 601.1-M90 Canadian General Requirements for Medical Electrical Equipment

EC/EN 60601-1 - International Standards for Medical Electrical Equipment General Requirements

IEC/EN60601-2-40 Particular Requirements for the safety of Electromyographs and EvokedResponse Equipment

Federal law in the U.S.A. and Canada restricts the sale, distribution or useof this product to, by or on the order of a licensed medical practitioner.

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CAUTION

GSI Audera

About GSI Audera

The GSI Audera system provides all the functionality you need to perform the following auditory exams:

• Distortion Product Otoacoustic Emissions • Spontaneous Otoacoustic Emissions

Protective classification This system is intended for continuous operation and has a protective classification of Class I, Type BF and Type B applied parts, ordinary equipment, not suitable for use in the presence of flammable anesthetics.

Intended operator The system is intended as an aid for users trained and skilled in audiology.

User interface • A pointing device (mouse, touchpad, or track-ball). • Standard Windows™ toolbars with customized icons and sliders.

• Keyboard short cuts.

Output interface • Windows-supported printers.

Identifying the GSI Audera software version number

To locate which version of software is loaded on your system,

1. Open the GSI Audera application.

2. From the Menu Bar, click on Help.

3. Click on About GSI Audera. The software version number is displayed on the About GSI Audera panel.

Requirements

The GSI Audera package requires a GSI Audera hardware platform in order to operate.

Input requirements System Power: 115W, excluding printer

Frequency Range: 50-60Hz AC Voltage/Current: 100V-120V/11.5A-9.6A/250V 220V-240V/5.3A-4.8A/250V

Fuse: 5x20mm 100V-120V: T10AL 220V-240V: T5AL

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equipment or lose data.

The Note label helps identify areas of possible confusion and avoid potential problems during system operation.

IMPORTANT!

Please read and follow all WARNINGS, CAUTIONS and NOTES provided in this guide. To avoid the possibility of injury, damage to your system or lost data, observe these safety precautions during system operation.

vii

This section describes the types of safety symbols used in this guide and lists the Warnings andCautions found in this manual.

Safety summary

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to the patient and/or user.

WARNING The WARNING label identifies conditions or practices that may present danger!

CAUTION The CAUTION label identifies conditions or practices that could damage the

!

FAILURE TO OBSERVE THESE REQUIREMENTS COULD RESULT IN SERIOUS INJURY OR DEATH.

This device should only be used by hearing health care professionals such as an audiologist, otolaryngologist, researcher or a technician under the direct supervision by the fore mentioned specialists. Users should use their professional skills when interpreting the results and this should be done in conjunction with other testing as deemed appropriate given their professional skills.

This device is rated “Type BF.” This means the device is not insulated sufficiently to be considered totally isolated electrically and dangerous leakage currents can occur. In particular, the OAE probe could leak current to the eartip connected to the patient if a mains power cable comes in close contact or in direct contact with OAE probe parts.

Users should take the necessary precautions for environments or situations that require “Type BF or Type CF” protection. Contact your hospital’s Bio-medical engineering department or call GSI for clarification as required.

Ensure that the earth connection at the mains electrical power outlet is properly earthed.

Standard clinical precautions must be taken when testing sedated or anesthetized patients.

Do NOT use in the presence of flammable gaseous mixtures. Users should consider the possibility of explosions or fire when using this device in close proximity to flammable anaesthetic gases. Discuss with your anesthetist.

Installation of third party software packages can affect the functionality of the software and may cause malfunctions.

Do not use extension cords for the Isolation Box. Extension cords can cause ground integrity and impedance problems.

Using an OAE probe without its corresponding calibration file loaded will adversely affect testing.

For optimal DPOAE results, the patient should be asleep.

GSI Audera

Safety precautions The following safety precautions must be observed at all times.

! CAUTION

The Audera system is designed to operate in an air-conditioned environment. The maximum temperature at which the system should be used is 30 degrees Celsius.

The unit should be placed in a position that allows adequate ventilation.

Avoid placing it in the proximity of other equipment that may also produce heat.

Operation at temperatures above 30 degrees Celsius could damage the GSI Audera system.

Do not stack any item of equipment on top of the GSI Audera system unit (other than a laptop computer when appropriate).

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WARNING !

The modulation frequencies need to be selected carefully when making your own DPOAE test sets. Avoid modulation frequencies that have a fundamental or harmonic relationship to the frequency used in your country’s mains power supply (50 or 60 Hz), and its harmonics. Using these frequencies can give erroneous results as the power supply’s voltage could be imposed on them.

Other frequencies such as the refresh frequencies used by computer monitors (typically 60 to 100 Hz) can also cause erroneous results. Refer to the manual supplied with your computer monitor if in doubt.

Proper use of this software depends on careful reading of all instructions and labels.

Federal law in the U.S.A. and Canada restricts the sale, distribution or use of this device to, by or on the order of a licensed medical practitioner.

Do not attempt to reinstall the software without consulting a qualified GSI Service Representative first. You can destroy all your data. Follow the steps provided only under the direction of a qualified Service Representative.

Follow the Shutdown sequence described in your system's User manual to turn off the system to ensure the integrity of your data files.

Use this device in humidity controlled medical use rooms with an anticipated humidity range of 20 to 80%.

All nonmedical equipment connected to this device, such as printers, must comply with IEC 950 and/or appropriate European Directives. Connect all nonmedical equipment to the GSI Isolated Power Supply.

Turn OFF system power before cleaning. Prevent detergent solution or cold sterilization agents from seeping into the electronics of the instrument. Be especially careful around controls, connectors and panel edges. Do not use abrasives.

If the system is not functioning properly, do not operate it until all necessary repairs are made and unit is tested for proper functioning in accordance with GSI published specifications. It is recommended that all repairs be performed by a qualified Service Representative only.

Inspect the power cord often for fraying or other damage. Do not operate the apparatus with a dam-

aged power cord or plug.

The AC power outlets on the iso-power box are intended for use with GSI approved components only. Use of any other equipment may result in damage to the power unit.

Follow all safety standards set by your place of employment.

Do not over tighten the connector securing screws.

The customer is responsible for maintaining all system software in a safe, secure location.

IMPORTANT! Do not attempt any procedures requiring specialized test equipment or access to the interior of the instrument.

Switch off all power to the system before attempting any service and maintenance.

The USB cable and connectors are delicate. Be careful not to kink or sharply bend the cable. It should not be coiled to a diameter less than 15 cm. Do not use excessive force or use force delivered at an angle when unplugging the probe connectors. Damage to the probe or connectors is not covered by warranty.

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GSI Audera

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Table of Contents

Additional copies i-ii

Attention i-ii

Trademarks i-ii

System warranty i-iii Warranty period i-iii Limit of warranty i-iii Items not covered by warranty i-iii

Software warranty i-iv Software copyright protection i-iv

Customer responsibility i-v

Regulatory standards i-v

About GSI Audera i-vi Protective classification i-vi Intended operator i-vi User interface i-vi Output interface i-vi

Identifying the GSI Audera software version number i-vi

Requirements i-vi Input requirements i-vi

Safety summary i-vii

Safety precautions i-viii

DPOAE Introduction

Overview 1-3

Electromagnetic compatibility guide 1-3

GSI Audera DPOAE Application Software 1-4 OAE Probe Design 1-4 Customizable Software 1-4

How it works 1-5 Distortion Product Otoacoustic Emissions 1-5 Spontaneous Emissions Measurements 1-5 Anatomical Influences 1-5 Repeatability Check 1-6

DPOAE Screens

Introduction 2-3

DPOAE Acquisition screen 2-4 1. Acquisition Screen Control Panel 2-5 2. Microphone Display Window 2-8 3. Current Acquisition Display (FFT Spectrum) 2-9 4. Results Display 2-10 5. Communication Status 2-12 6. Cursor Display 2-12 7. Test Status Area 2-12

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GSI Audera

DPOAE Review screen 2-14 1. Menu bar 2-15 2. Toolbar buttons 2-18 3. Cursor Display 2-20 4. Left and Right Charting Panels 2-20 5. Review Screen Control Panel 2-21 6. Hierarchical Tree 2-21

Performing DPOAE Tests

Performing an Earprobe Check 3-3

Quick Start DPOAE Testing Sequential Trial 3-4

Running DPOAE Tests – Individual Trials 3-5

Running a Spontaneous OAE Test (SOAE) 3-6

Creating your own DPOAE Test Sets 3-7 1. Test Set List 3-8 2. Test Item details 3-9 3. Test Item Wizard 3-14

Analyzing DPOAE Tests

Reviewing and Analyzing Previous Results (DPGram or I/OGram) 4-3

Reviewing and Analyzing Previous Results (Spontaneous OAE) 4-5 To Review a Spontaneous OAE Result 4-5

Compare Tests 4-6 1. Trial Display Area 4-7 2. Toolbar Buttons 4-7 3. Status Display Boxes 4-7 4. Hierarchical Tree 4-8

DPOAE Reference Data 4-10 To Create New Reference Data Sets 4-10

Editing Existing Reference Data Set 4-14

Deleting Existing Reference Data 4-14

Importing Reference Data 4-15

Adding Notes to a Session 4-16

Printing DPOAE Reports 4-17

Printing a DPOAE Chart 4-18

Appendix

DPOAE selected bibliography 5-3

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DPOAE Introduction

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DPOAE Introduction

Overview GSI NeuroCare, a division of GSI proudly continues the tradition of equipment excellence with Grason-Stadler instruments, a world leader in screening and diagnostic audiological equipment for over 50 years. The GSI Audera DPOAE is part of a platform of products for diagnostic evaluation of cochlear and retrocochlear impairment. The GSI Audera DPOAE provides test capabilities for Distortion Product Otoacoustic Emission (DPOAE) and Spontaneous Otoacoustic Emissions (SOAE) in a computer-based system available in two versions: a portable and a desktop systems.

The GSI Audera DPOAE system consists of a USB interface between the GSI Audera base unit, an OAE probe assembly with a microphone located near the probe tip and two stimulus speakers; and software application installed on the computer. A test cavity, serialized to the OAE probe, is provided along with a calibration file saved to a CD.

NOTE: You must ensure that the calibration file assigned matches the serial number of the probe.

IMPORTANT: You must use the GSI Audera isolation transformer when a laser printer or external monitor is attached to the portable version of the system, or when using the desktop system.

Electromagnetic compatibility guide Please refer to the Electromagnetic Compatibility Reference Guide on CD (part number 269-

5962xx) for information concerning your GSI Audera DPOAE System.

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The GSI Audera DPOAE Application Software operates within the Microsoft Windows environment on the XP Pro operating system. It uses the Microsoft Access Database engine to store patient information on the hard drive and allows you to retrieve patient data by name, session, test type, etc.

Grason-Stadler gave special attention to the OAE probe design to make it easy to use on patients of all ages and very easy to clean. The microphone capsule and the two tubes that carry the primary tones to the ear canal are removable from the probe tip, and can be cleaned using the special cleaning kit included with the system. The GSI Audera DPOAE also includes a full range of standard and special sized eartips to seal most ear canals, as well as a sample kit of disposable eartips for use with infants.

At the beginning of each test, the GSI Audera DPOAE checks to ensure that the probe is sealed in the ear canal. In addition, it checks the intensity levels for F1 and F2 at the beginning of each primary tone pair presentation.

Because the amplitude of the otoacoustic emissions are quite low, the noise floor within the OAE probe and the DSP board are also low to provide a broad dynamic range of 85 dB SPL (typical).

The flexible nature of the software allows users to develop libraries of test protocols that are appropriate for the populations being tested. Simply selecting the name of the protocol (which the user assigns) sets up the equipment for testing that population. Default Test Sets for screening and diagnostic protocols are also provided.

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GSI Audera

GSI Audera DPOAE Application Software

OAE Probe Design

Customizable Software

1-4

DPOAE Introduction

During distortion product measurements, the probe assembly presents two pure tones simultaneously to the ear canal e.g. primary tone pair labeled F1 and F2, where F2 is a higher frequency than F1. These primary tones travel through the middle ear to the cochlea which generates a number of distortion products at the outer hair cell level. These distortion products or intermodulation distortions are predictable, based upon the frequencies of the primary tones, by formulas such as 2F1-F2, 3F1-2F2, 2F2-F1. The most commonly measured distortion product is 2F1-F2, due to its robustness in all age groups; this is the distortion product that the GSI Audera DPOAE System measures. The distortion products travel from the cochlea through the middle ear to the outer ear canal where they are detected by the microphone in the probe assembly. After analysis, the results are plotted on a graph called a DPgram. This graph can be plotted using the amplitude of the distortion product as a function of the geometric mean frequency; the distortion product frequency 2F1-F2, the mean frequency (F1+F2)/2, the lower tone F1, or the higher primary tone F2. When the intensity of the F1 and F2 primary tones are the same, the geometric mean frequency better represents the region of the distortion product generation. If the intensity of F1 is greater than F2, then the F2 frequency better represents the region of the distortion product generation. Each plots the DP result at a frequency closest to the true frequency site of the emission.

The GSI Audera DPOAE system provides frequencies between 500 - 12,000 Hz for the primary tone pairs with a fixed sampling rate of 48 kHz in 4096 bins. The bandwidth of each bin is 11.72 Hz. The intensity range available for these primary tones is -10 to 90 dBSPL in 5 dB steps.

You may select the number of distortion product results plotted per octave, the intensity of F1 (i.e., L1), the intensity of F2 (i.e., L2) relative to or independent of F1, and the ratio of F2 to F1 frequency.

During Spontaneous Otoacoustic Emissions Measurement (SOAE), the OAE probe speakers do not present a stimulus. The probe microphone simply captures all frequencies naturally present within the ear canal. The Test Set selected determines the number of samples of data that the microphone captures. The default SOAE Test Set will collect data for a maximum of 90 seconds or until the user stops the collection of data manually. In this test mode, the GSI Audera displays the frequency spectrum while it collects and averages the data. Once the software reaches the number of accepted frames defined in the Test Set, collection will stop. Move the crosshair cursor to select any frequency value along the spectrum. The frequency and amplitude of the selected point will be displayed in the Cursor Position Display Boxes on the menu bar.

Since the microphone measures the otoacoustic emission within the ear canal rather than at its site of generation (the cochlea), the anatomy along its return path (i.e. the ossicular chain, the tympanic membrane and/or the middle ear space) can influence the amplitude of the response. Therefore, to account for these effects, GSI highly recommends measuring the status of the middle ear by tympanometry in conjunction with distortion product measurements.

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How it works Distortion Product Otoacoustic Emissions

Spontaneous Emissions Measurements

Anatomical Influences

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When using otoacoustic emission measurements as a test for cochlear function, consider both internal and external environmental factors, which may influence the accuracy of the test results. A second test is recommended to determine the repeatability of the response. If the results across the frequency range do not correspond closely, you may need to use a more rigorous protocol with respect to the number of averages performed and the amplitude of the signal-to-noise or you may need to reduce the environmental noise. Individuals who fail a particular test protocol should be retested and/or referred for more diagnostic testing to determine the cause of the abnormality.

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GSI Audera

Repeatability Check

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DPOAE Screens

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DPOAE Screens

Introduction

The GSI Audera Main Screen includes the Patient Database as well as access to the Global Options that apply to all applications within the GSI Audera program.

Database features include Search Criteria for existing patients, New Patient button, Patient List, and Session Details with the Examiner name. Database backup, archive, restore, import and export patient records are all accessed through the Database menu on the Main GSI Audera screen.

See the GSI Audera Reference Manual for system setup instructions prior to beginning testing in any application and for a detailed description of the items listed above.

The GSI Audera Main Screen also contains the Application buttons to provide access to all licensed software applications. Application buttons become active after a patient has been selected from the database or new patient information has been entered and saved. The following application buttons will appear at the bottom of the GSI Audera Main Screen: AEP, Cortical AEP, ASSR and DPOAE. Only those buttons for which a software license has been purchased will be displayed.

The DPOAE application consists of two screens: The Review Screen and the Acquisition Screen.

Depending on the options selected on the GSI Audera Main Screen (Options > Main Options), either the Review Screen or the Acquisition Screen will be the first screen displayed when starting the DPOAE application for a new patient. If DPOAE data exists for a selected patient, the Review Screen will be opened.

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If the DPOAE Acquisition Screen is not the first screen displayed, click the Acquisition Screen button on the control panel of the Review Screen to go to the Acquisition Screen.

The DPOAE Acquisition Screen is divided into seven areas.

1. Acquisition Screen Control Panel

2. Microphone Display Window

3. Current Acquisition Display (FFT Spectrum)

4. Results Display (DPgram or IOgram)

5. Cursor Display

6. Communication Status

7. Test Status Area

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DPOAE Acquisition screen

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DPOAE Screens

This panel provides control of the testing procedure allowing selection of the Test Set, Test Items, and the Test Ear. Starting and stopping a test are also accomplished here. The options and messages displayed on the control panel are listed below.

Test Set

Click the drop-down arrow to reveal a list of available Test Sets. Several default Test Sets are included with the application; however, you may create an unlimited number of customized Test Sets to meet your needs.

NOTE: When you exit the DPOAE Application by returning to the GSI Audera Main Screen, the last Test Set used will be displayed the next time the DPOAE Application is accessed from the Main Screen.

Test Item

Click the drop-down arrow to reveal a list of available items within the selected Test Set.

NOTE: When Pause is selected during a trial, the test item list will remain on the item that was active when the trial was Paused. When Continue is selected the trial will begin with a seal check and then resume testing at the current test item.

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1. Acquisition Screen Control Panel

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GSI Audera

Details

Click to display full acquisition details for the currently selected Test Item. Changes to Test Items must be made in the Test Set Editor, which is accessed from the DPOAE Review and Acquisition screens.

To display details for other items in the Test Set:

1. Leave the Details window open (do not click Close).

2. Use the left and right arrow buttons on the Control Panel to display details for the next or previous item in the Test Set list. Alternately, click the drop-down arrow on the Test Item list to display the test items within the Test Set.

3. Click on an item to display the details for that item.

4. Click Close to close the Test Details window.

Click to select the next Test Item in the Test Set.

Click to select the previous Test Item in the Test Set.

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DPOAE Screens

Click to select the test ear. Only one ear may be tested at a time.

NOTE: Testing one ear and then selecting the button to test the other ear will result in the automatic creation of a new chart. The chart containing the data for the first ear tested will be saved automatically and transferred to the Review Screen. The Acquisition Screen DPgram or IOgram, and FFT Spectrum displays will be cleared.

NOTE: It is possible to view the results for both ears in the same chart on the Review Screen. See the section on Analyzing DPOAE Results.

Start One Test

Click to start a test using the currently selected test item ONLY. When the stopping and scoring criteria are met for the item, the DP symbol (and F1, F2 and/or NF, if selected) is plotted and two buttons appear in the control panel in place of the Back to Review Screen Button

•Accept Plots the DP and NF symbols and saves the results to the patient file. •Discard Does not plot the points nor save it to the patient file.

NOTE: Saved results may be deleted from the patient file on the Review Screen. Discarded results cannot be retrieved at any time.

Back to Review Screen

Closes the DPOAE Acquisition Screen and returns to the Review Screen.

Start Auto Test

Click to start a test using all items in the Test Set. All items will be presented automatically in the order in which they appear in the test set, starting with item 1 if the previous test set was completed.

When Start Auto Test is selected to start a test, the DPOAE data points (i.e. DP and NF) are plotted automatically on the DPgram or IOgram once the scoring rule criteria and stopping criteria for each Test Item are met.

To plot additional results for the same ear in the current chart, do one of the following:

a. To repeat all items within the Test Set, click the Start Auto Test button.

b. To select a single item in the same Test Set, click on the Next or Prev button, or select an item from the drop-down list and click the Start One Test button.

To test the other ear, select the Left Ear or Right Ear button. A new chart will be started automatically.

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GSI Audera

Changes to Acquisition Screen Control Panel buttons

When the Start One Test button is selected this button and the two buttons below it change designation.

•Start One Test is renamed to Stop •Start Auto Test is renamed to Pause

When the Start Auto Test button is selected this button and the two buttons above it change designation.

•Start One Test is renamed to Stop, but is grayed out •Start Auto Test is renamed to Pause

2. Microphone The following panel contains the ongoing microphone display.

Display Window

The microphone up and down arrows change the y axis on the ongoing microphone status display window.

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DPOAE Screens

3. Current The following section displays the FFT spectrum while a test is in progress.

Acquisition Display (FFT Spectrum)

The x-axis displays frequency. The range of frequencies shown will vary depending on the frequency of F1. The display frequency range is determined by the formula 2F1. This insures the F1 frequency is displayed in the center of the FFT spectrum. When Start Auto Test is selected, the frequency range of the spectrum changes as each new test item begins.

The y-axis displays intensity. The maximum range that can be displayed is –20 to 90 dB SPL. The vertical scaling of the display may be changed by using the up and down arrow buttons in the upper right corner of the spectrum panel. Clicking the up arrow increases the range of displayed dB SPL values and clicking the down arrow decreases the range of displayed dB SPL values. Data acquisition parameters are not affected by changing the displayed intensity range.

A label appears at the top of the FFT Spectrum window to identify the current display.

Prior to and after data acquisition the label displays “SELECTED TEST”, the Test Ear, L1 and L2 levels and the target DP Frequency for the current test item. This is the first item that will be tested when Start One Test or Start Auto Test is selected.

During acquisition the label displays the word ”ACQUIRING”, the Test Ear, L1 and L2 levels and the target DP Frequency for the current test item. When the Test is started, the FFT spectrum corresponding to the current test item is displayed.

While the Seal Check is being presented the FFT spectrum is colored green. Once F1 and F2 are started, the FFT Spectrum turns blue if testing the left ear, or red when testing the right ear. Upon Test Item completion the FFT resets ready for the next signal presentation.

The FFT spectrum for a previously acquired result may be displayed in a separate window on either the Acquisition Screen or the Review Screen. To accomplish this:

1. Place the crosshair cursor position over the DP point on the DPgram.

2. Click the right mouse button.

3. Select Show FFT Data from the menu. A separate FFT Spectrum window appears displaying the saved FFT spectrum for that data point.

4. Use the crosshair cursor to help view the intensity and frequency points along the FFT spectrum. These can be viewed in the Cursor Position Display at the top of this window.

5. Click CLOSE to close the FFT Spectrum window and return to the Acquisition Screen.

Only one FFT Spectrum may be viewed at a time. It is not possible to view multiple FFT spectrums simultaneously.

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4. Results Display This panel displays the DPgram, IOgram or SOAE for ongoing tests, or previously acquired tests, depending on the test type.

If the options for “Show F1 & F2” or “Show Noise Floor” are selected under the Review Screen menu item Options > DPOAE Options the symbols for the selected items are displayed simultaneously with the corresponding test result.

If these items are not selected in the Options menu only the point corresponding to the DP Target frequency is displayed. To show these items, right-click on a DP symbol and place a check next to the desired item.

The following symbols may appear on the DPgram or IOgram Previous Results window depending on the options selected.

Left ear DP symbol designates the frequency and amplitude for the target frequency when the left ear is selected as the Test Ear.

Right ear DP symbol designates the frequency and amplitude for the target frequency when the right ear is selected as the Test Ear.

F1 and F2 frequency and intensity when a single Test Item is used.

NOTE: See the next section Review Screen > Options > Show F1 F2 by default to always display F1 F2 symbols when a new chart is created.

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DPOAE Screens

NOTE: See the next section Review Screen > Hierarchical Tree and Toolbar Buttons to change the F1 and F2 display options for a chart that already contains data.

F1 and F2 frequency and intensity when multiple Test Items are used.

Designates the Noise Floor (NF) for a left ear DP.

Designates the Noise Floor (NF) for a right ear DP.

NOTE: See the next section Review Screen > Options > DPOAE Options > Show Noise Floor by default to always display the NF when a new chart is created.

NOTE: See the next section Review Screen > Hierarchical Tree and Toolbar Functions > Turn Noise Floor on/off to change Noise Floor display settings for a chart that already contains data.

This example shows the measured DP points for the right ear plotted with the Noise Floor option selected.

This example shows the measured DP points for the left ear plotted with the NF option selected.

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5. Communication This area displays communication information during data acquisition by means of the symbol.

Status During data acquisition this symbol will appear in the upper left corner of the menu bar and indicates motion to show that data acquisition is in progress.

6. Cursor Display Located above the Previous Results display, the current crosshair position values for frequency, amplitude and signal-to-noise difference are shown denoted by Hz, amplitude and S/N dB respectively. Move the cursor to one data point to view the values of the currently selected point. The display remains blank if the crosshair cursor is not on a test result data point.

If the dB SPL of the target DP frequency is equal to or less than the noise floor (4 bins on each side of the target frequency) —- will be displayed in the S/N dB box.

If the cursor crosshair is positioned on a symbol denoting F1 or F2 the frequency and intensity for the selected symbol is displayed, but the dB S/N value will be blank. This feature enables the user to easily determine F1 and F2 frequency and intensity values as measured at the microphone of the probe.

7. Test Status Area Displays real time information regarding the DP point that is currently being acquired.

The acquisition information is continually updated until the stopping and scoring criteria are reached for each point.

Test State - Displays one of the following messages:

Ready Prior to starting a test.

Checking Seal System is testing the probe microphone to ensure a good seal.

Earprobe Bad Seal Indicates improper seal of the probe. Try repositioning the eartip in the ear canal or use a different size probe tip.

Level Calibration Presents the stimulus and adjusts the L1 (F1 intensity) and L2 (F2 intensity) to ensure that the intensity measured at the microphone is equivalent to that defined in the Test Set for each Test Item.

Testing Displayed during acquisition.

Dwell Paused System is switching to the next Test Item during an Auto Test Run.

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DPOAE Screens

When a trial is completed, the scored result will be displayed. Default Test Sets will display one of the following scoring results:

Complete - Pass If both the Stopping Rules and the Scoring Rules are met as defined in the Test Set Editor for the Test Set used. This label (Pass) is defined in the Test Set Editor.

Complete - Refer If either the Stopping Rules or Scoring Rules are not met as defined in the Test Set Editor for this Test Set. This label (Refer) is defined in the Test Set Editor.

Incomplete If the testing could not be completed as defined in the Stopping Rules during auto testing. During a single test, this information is discarded.

NOTE: User defined Test Sets will display the results as defined in the Tests > Edit DPOAE Test Sets > Test Set Definition panel > Scoring Rules. Any text may be entered into the Scoring Text boxes.

Test Time Displays the estimated time remaining in the trial.

Reject % The percentage of data points rejected because they did not meet the stopping criteria defined in the Test Set.

Acc. Frames Accepted Test Frames or the total number of data points accepted because they met the stopping criteria defined in the Test Set.

Rej. Frames The number of data points rejected because they did not meet the stopping criteria defined in the Test Set.

DP S/N Displays the ongoing average of the difference between the measured DPOAE and the measured noise levels.

NOTE: To view the criteria defined in the Test Set use the Details button as described previously for each item in the test set. Changes to the criteria must be made under the Test Sets > Edit DPOAE Test Sets menu item from either the Review screen or the Acquisition screen.

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DPOAE Review screen

The DPOAE Review screen displays previously acquired DPgrams, IOgrams or SOAE for data analysis and reporting.

If the option is selected from the Main GSI Audera Screen > Options > Main Options > Go to Acq if no existing results, the DPOAE Review screen must be selected by using the Back to Review screen button on the Acquisition screen.

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The DPOAE Review screen is divided into 6 areas:

1. Menu Bar

2. Toolbar

3. Cursor Display

4. Left and Right Chart Panels

5. Review Screen Control Panel

6. Hierarchical Tree

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DPOAE Screens

1. Menu bar Provides access to perform such housekeeping functions as editing patient information, comparing results, printing reports, listing and editing Test Set information, selecting DPOAE application options and accessing the Help files.

Patient menu

Patient > Edit

Opens the Patient Details dialog box for the current patient for viewing or editing details.

•Select Save to save any changes and close the Patient Details dialog box. •Select Cancel to close the dialog box without saving changes.

Patient > Print Current Chart

Opens the Print Preview window for the currently selected chart containing OAE data and allows printing.

Prior to selecting this option, select the desired chart from the Hierarchical Tree or click on the chart in the panel.

NOTE: The Print Current Chart option does not include information on testing criteria used.

Patient > Print DPOAE Report

Opens the DPOAE Report Selection dialog box, which lists all saved charts containing OAE data for both ears and allows the creation of customized reports.

NOTE: See Printing DPOAE Reports in Chapter 4 for details on creating and printing customized DPOAE reports using the DPOAE Report Selection Window.

Patient > Compare Tests

Allows comparison of OAE data obtained in different charts or on different dates. Only similar test result types are viewed in the Compare Test window.

NOTE: See the section Analyzing DPOAE Results for details on using this feature.

Patient > Back to Main Screen

This option will return to the GSI Audera Main Screen.

Tests menu

Tests > Edit DPOAE Test Sets

Opens the Test Set Editor for making changes to existing Test Sets and creating new Test Sets. Creating and Editing Test Sets is described in Chapter 3.

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Options menu

Options > DPOAE Options

The options selected in this dialog box may apply to all charts or only to newly created charts.

Graph Options for all charts

•Grid on charts – Check this box to display grid lines on all charts on the Review Screen. •Grid on acquisition window – Check this box to display grid lines on the FFT area of the

acquisition window •Charts to fit vertically – Select the number of charts to be stacked vertically on each panel on

the Review Screen. The default is set to 3, a value from 2 to 50 can be selected. If the number of charts displayed on a panel exceeds the specified number, a scroll bar will be provided in the panel to view all charts. Alternately, charts may be resized for viewing by clicking and dragging the lower border of each chart.

Graph Options for New Charts ONLY

NOTE: The following display options apply to newly created charts only.

NOTE: Changing the display options of previously acquired results is not possible using the Options menu. See each section below for instructions on changing Display Options for previously acquired data.

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DPOAE Screens

•Show F1 F2 by default – Check this box to display the F1 and F2 symbols and values on the active chart during a test.

NOTE: The F1 F2 symbols are indicated on the DPgram or I/O Plot only during a test; they are not automatically displayed on data that has been previously recorded and recalled at a later time. To display the noise floor for previously acquired data you must right click on the chart or DPgram in the hierarchical tree on the Review Screen and select Show F1&F2 from the pop up menu. Alternatively, select the chart or DPgram and select the Show F1&F2 icon in the toolbar.

•Show NF by default – Check this box to display the measured noise floor during a test. The Noise Floor is calculated on 4 bins of data above and 4 bins of data below the target frequency.

NOTE: The noise floor is indicated on the DPgram or I/O Plot only during a test; it is not automatically displayed on data that has been previously recorded and recalled at a later time. To display the noise floor for previously acquired data you must right-click on the chart or DPgram in the hierarchical tree on the Review Screen and select Show Noise Floor from the pop up menu. Alternatively, select the chart or DPgram and select the Show Noise Floor icon in the toolbar

•Use Red/Blue - Check this box to display the DP symbols as a red O for the right ear and blue X for the left ear. No checkmark in this box will remove color-coding.

•Beep at trial end - Select this option to enable an audible beep at the completion of a test. This option requires that your computer contain a sound card and speaker.

NOTE: Loudness of the keyboard bell may vary with computer model and settings.

•DP Auto-filter - Placing a check in this box will turn on an automated filter. The filter will remove low frequency energy starting at 85% of the expected DP frequency.

Click OK to apply changes to DPOAE Options.

Options > Edit Reference Data

Displays reference data sets that may be used to interpret DPOAE results. The use of Reference Data is at the user’s discretion and it is not the responsibility of GSI to ensure that appropriate Reference Data is used.

This option is also used to create new Reference Data sets.

See DPOAE Reference Data in Chapter 4 – Analyzing DPOAE Data for more details on this feature.

Help menu

Help > About Audera provides information about the software, including the version number.

Help > Contacting GSI provides information on how to contact GSI.

Help > View Manual provides an electronic version of this manual as well as the Reference Guide which can be opened and minimized while testing without having to exit the GSI Audera software.

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2. Toolbar buttons There are several ways to review and analyze data on the Review Screen. The Hierarchical Tree right-click menu, the corresponding keyboard Function keys, and the Toolbar buttons can all be used for data manipulation.

The item selected on the Hierarchical Tree determines which Toolbar buttons, Function keys and right-click menu items are available. Only the applicable functions will be active. Inactive buttons and items will be grayed.

The Toolbar Buttons provide functions affecting the selected panel, chart, or individual test result. The same functions are available by using the Hierarchical Tree right-click menu, or by using the keystrokes listed on the right-click menu.

Hide

Temporarily hides the selected chart or result within a chart. Alternatively, press the Insert key on the keyboard to achieve the same result. If all results in a chart are hidden, the empty chart will no longer be displayed. You must click on a blank area of the chart or on the name of the chart in the hierarchical tree and then click the toolbar button or insert key again to restore the chart and selected results to the screen.

It is not possible to retrieve individual results once the chart has been hidden without first displaying the associated chart.

Hidden results or charts are preceded by the designator (h) on the Hierarchical Tree.

Delete

PERMANENTLY removes an individual result, a chart or all the charts in a panel from the patient’s file. Deleted results cannot be retrieved.

Copy

Copies a chart or individual trial. The result of the copy will be labeled in the Hierarchical Tree as “T# copy…” If the entire chart is copied, a duplicate chart, with a new chart number, will appear on the Review Screen and the trials within the chart will be given new T #’s and labeled as copies.

Rename

Renames the selected item. The new name will appear in the Hierarchical Tree, along with the designation indicating its position within the tree (i.e. T# for a trial that is renamed).

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DPOAE Screens

Print

Opens the Print Preview dialog box and allows printing of the selected chart. The site name, patient name, examiner and date of the test will print at the top of the page. The testing parameters will not be printed when this option to print is selected.

Color

Changes the color of all results within a chart or an individual trial. If a single trial is selected a Color dialog box appears. Select the new color for the DP symbol and click OK to close the color selection window and apply the color change. The colors for other symbols within the chart (F1/F2 or NF) do not change and a legend appears at the bottom of the chart for the differently colored trials.

If a chart is selected the Chart Colors Option window will appear. Select Blue/Red to Match Left/ Right or Multi-Colored for results that are not color-coded to the test ear.

Reset

Resets the size and display parameters of the selected item to the values used during acquisition.

Measurement Table

Displays the scoring criteria, if any, used for automatic interpretation of the trial. Scoring criteria

are defined at the time the Test Set is created.

Show F1 & F2

This button toggles the display of F1 and F2 symbols for all trials within the panel or a chart.

Show Noise Floor

This button toggles the display of the Noise Floor symbols for all trials in the panel or a chart.

Patient History

Displays the Patient History dialog box, which is used to review, add, copy or print notes in a patient file.

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Add Notes

Displays the Enter Note dialog box. The header of the application or “History”, the date, and time of the note appears indicating that the note pertains to a particular application test results or the Patient File.

To add an application Note to the patient’s file:

1. Click the Add Notes icon.

2. Type a note.

3. Select Save to save the text to the patient’s file or Cancel to return to the last screen without saving.

NOTE: You may view all notes in the Patient’s file by clicking the Patient History icon from any application screen within the GSI Audera software (AEP/CAEP/ASSR/DPOAE). Select the Test Type(s) at the top of the screen to display the notes relevant to each application. This feature allows for the inclusion or exclusion of specific notes when customizing reports.

NOTE: Once a note has been saved to the patient file it cannot be deleted.

3. Cursor Display Displays the current crosshair position (frequency, amplitude and signal-to-noise difference between the test frequency and the noise floor) for a selected point on the OAE result. Move the cursor from one data point to another to view the data for the currently selected point. If no symbol is located at the intersection of the cursor crosshair position, the boxes will be blank. If the cursor crosshair is positioned on a symbol for F1 or F2 the frequency and intensity are displayed, but the dB S/N value will be blank.

4. Left and Right Clicking on the Left or Right Panel places the next set of acquisitions in a chart on that panel.

Charting Panels In the Audera DPOAE application, clicking on the Left Panel of the Review Screen automatically selects the Left Ear as the Test Ear on the Acquisition Screen. Clicking on the Right Panel of the Review Screen automatically selects the Right Ear as the Test Ear on the Acquisition Screen.

It is, therefore not possible to collect data for the Right Ear on the Left Panel or for the Left Ear on the Right Panel in the DPOAE Application.

It is also not possible to collect data for both ears in the same chart in the DPOAE Acquisition Screen.

It is possible to View data for both ears in the same chart on the Review Screen by relocating charts or results within charts. This is accomplished by clicking and dragging items from within the Hierarchical Tree.

See Reviewing and Analyzing Acquired Data for details on repositioning results on the Review Screen.

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DPOAE Screens

5. Review Screen Control Panel

Back to Main Screen

This button returns you to the Main Screen, automatically saving any tests performed.

Acquisition Screen

Click this button to display the DPOAE Acquisition Screen. (This screen is detailed in the earlier pages of this section.)

6. Hierarchical Tree Displays a list of the data that has been acquired in a session and provides several options for manipulation of data.

The Hierarchical Tree (shown above) represents all the data acquired and is displayed in a structured manner. By double-clicking on the white background, the tree enlarges allowing easier viewing of the display.

As explained above, a hierarchy is displayed within this tree, each panel contains charts and each chart contains OAE results (DPgram).

Each result is given a unique T Number to identify the trial in the hierarchical tree. T numbers are assigned sequentially as data is acquired and/or manipulated. If a result is Copied, the resulting copy will be assigned a new T Number and the word “Copy” will appear in the description on the Hierarchical Tree.

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A prior to a result on the Hierarchical Tree denotes that F1 and F2 are displayed on the DPgram or IOgram for the associated trial.

A prior to a result on the Hierarchical Tree denotes that the Noise Floor is displayed on the DPgram or IOgram for the associated trial.

It is possible to simultaneously toggle the display of F1/F2 and the NF Noise Floor on and off by double-clicking on the name of the Trial in the list.

The symbol prior to a result indicates that both the F1/F2 and the Noise Floor symbols are displayed along with the corresponding DP symbol.

The symbol prior to a result indicates that the F1/F2 and the Noise Floor symbols are not displayed with the DP symbols.

To display only F1/F2 or the Noise Floor for all items in a test, either Right-click on the name of the Trial and select Show Noise Floor or Show F1/F2 from the right-click menu options or Left- click on the trial in the hierarchical tree list or click on an individual trial within a chart and click the Show Noise Floor or Show F1/F2 toolbar buttons.

NOTE: If a trial contains multiple data points the Noise Floor symbol is displayed for all points collected during the trial. It is not possible to display the Noise Floor symbol for only one point on the DPgram of a multi-item test.

However, it is possible to view the FFT spectrum and surrounding noise floor for one point at a time in a separate window. Select a DP or NF point in the DPgram with the crosshair of the cursor, Right-click with the mouse and select Show FFT from the options.

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The options provided by the Hierarchical Tree are shown below and detailed in the section Analyzing DPOAE Results.

It is possible to view and/or modify the properties of the displayed items (panel, chart or individual result) by Right-clicking on that item in the hierarchical tree. This displays a list of options with their corresponding keyboard function keys. You may select an option by clicking on it or by using the designated keyboard key.

Not all functions are enabled at all levels of the hierarchical tree. Those that are gray are not available at the selected level. For example, there are only 5 functions available for Panel modifications/analysis, but most functions are available to modify/analyze a chart and even more for a DPgram, IOgram or SOAE.

The functions provided by the right-click menu above are also possible by left clicking on the panel, chart or result to be modified/analyzed, then using the Toolbar Shortcut Buttons (as discussed under Review Screen > Toolbar buttons).

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This section details how to perform Otoacoustic Emission tests as a sequential series of Test Items or each item individually. Either type of test is considered a “trial”. Otoacoustic Emission testing requires the OAE probe is sealed in the ear canal with an appropriately sized ear tip. These test procedures also assume testing is done in an environment where the patient is comfortable and relaxed. Prior to running tests you should be familiar with the safety precautions. Refer to Precautions in the GSI Audera Reference Guide.

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Performing an Earprobe Check

GSI recommends checking the OAE probe on a regular basis to ensure that it remains within calibration and is working properly. An Earprobe Check utilizes the serialized test cavity to test the output of the two speakers and the microphone in the OAE probe assembly. The measured levels are compared to the measurements made in the same test cavity when the OAE probe was calibrated (baseline values).

Depending on the results of the Earprobe Check, messages appear on the Earprobe Check dialog box explaining the results. If the OAE probe is not functioning properly, the message contains possible problems and solutions to repair the problems.

An automatic Earprobe Check reminder is found on the Options > Main Options menu on the GSI Audera Main Screen. If this option is checked, a message appears every 14 days to remind you to perform an Earprobe Check. However, you may perform an earprobe check at any time.

Prior to performing an earprobe check complete the following steps to ensure that the probe calibration is being compared to the appropriate calibration file:

1. Verify that the serial number of the probe matches the serial number on the OAE test cavity.

2. Verify that the serial number on the probe matches the serial number of the calibration file that is assigned in the software. To check the serial number of the assigned calibration file go to the GSI Audera Main Screen > Options > Assign Calibration Information. A dialog box appears which details the assigned transducers for the GSI Audera system. The Earprobe selection box displays an 8 digit serial number in brackets ( ). Ensure that the serial number in brackets matches the serial number of the OAE probe you are using. If the serial numbers do not match, click the button Load File… and follow the on-screen instructions to load the calibration file for the OAE probe you are using.

To Perform an Earprobe Check:

1. On the GSI Audera Main Screen select Options > Earprobe Check.

2. Insert the Earprobe tip into the OAE Test Cavity as instructed and click OK.

The Earprobe Check screen opens. The system checks the left transducer and then the right plotting the results on the graph. After results are plotted for both transducers a message appears indicating the result of the Earprobe Check.

Possible results for the Earprobe Check may include the following:

1. If the OAE probe is functioning properly the following message will be displayed: “The earprobe is within tolerance and may be used for patient trials.”

2. If the Earprobe Check detects microphone, F1 or F2 levels not within tolerance, one of the following messages may be displayed. Perform the suggested solution and re-check the probe. If you receive this message a second time contact your local GSI representative for assistance.

a. “The earprobe is reading higher than it should. You should minimize the amount of background noise and rerun the calibration check in a quieter environment. Verify earprobe and test cavity serial numbers both equal AUxx-xxxx.”

b. Possible microphone blockage or F1 F2 blockage. Possible microphone damage or bad seal in test cavity. Clean earprobe. Check connections. Check test cavity seal and test cavity grommet condition. Verify earprobe and test cavity serial numbers both equal AUxx-xxxx.”

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Quick Start DPOAE Testing Sequential Trial

Testing DPOAE using default test sets

1. Select a patient or enter and save new patient information on the Main GSI Audera Screen.

2. Select DPOAE.

3. Select an Examiner Name, if prompted. The Acquisition Screen is displayed.

4. Select Left or Right radio buttons to choose the Test Ear.

5. Select a Test Set on the Control Panel.

6. Click the Start Auto Test button.

• While the test is in progress an icon appears in the upper left corner of the screen indicating communication between the GSI Audera base unit and the computer.

• The FFT spectrum area at the bottom of the Acquisition screen displays an ongoing frequency analysis of the activity recorded at the microphone.

• As the trial proceeds, the results are progressively displayed in the DPgram area. Results are displayed as pairs of symbols as each test item is completed. The distortion product result appears as either a circle (0) or an (X) for right or left ear; the Noise Floor is noted by a triangle or square, respectively.

7. Wait until the test has finished automatically or click Stop to stop the test prematurely.

• Click Pause to pause the acquisition. Click Continue to continue the test at the beginning of the test item at which the trial was paused

8. If automatic scoring is enabled, the message “Complete - Pass” or "Complete - Refer" appears in the upper right corner of the screen after all items in the Test Set are completed. If automatic scoring is not enabled, the message “Complete” appears in the upper right corner of the Control Panel.

9. Select Start Auto Test to repeat the test and assess repeatability of the results. The second set of results will be plotted in the same chart.

10. Choose the Left or Right radio buttons to select the other ear for testing. The results for the first ear are saved to the Review Screen and a new chart is created to store the results for the next test.

NOTE: During an Acquisition the Noise Floor and F1/F2 symbols will be plotted on the DPgram or IOgram along with the DP symbol ONLY when the DPOAE Main Option to Show Noise Floor and/or Show F1/F2 are selected. The Noise Floor and F1 F2 data are saved with the DP point regardless of whether they are displayed. It is possible to turn the display of these values on and off at any time by using the right-click menu on the Review Screen. During the trial, if the noise level exceeds the criteria defined in the Test Set, the following message appears: “The Testing was stopped. The acoustic noise level was too high.” It may be necessary to use a larger ear tip or repeat the test in a quieter environment.

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Running DPOAE Tests – Individual Trials

Occasionally, it may be desirable to test only one or a few items within a Test Set rather than running a complete trial using all items. For instance, if during automatic testing one or more Test Items displays an unfavorable results, those Test Items may be re-tested individually rather than repeating the entire sequential trial.

Manual testing allows for maximum clinician control over the Test Items presented and the order of presentation. Results for manual testing may be displayed in the same chart as the results obtained during automatic testing or in a new chart.

1. On the Acquisition screen, select a Test Set and Test Item for this individual trial.

2. Click on the Left or Right radio button to select the ear to test.

3. Click the Start One Test button to begin testing. The testing begins at the selected Test Item and stops automatically when the stopping and scoring criteria for that point is met.

4. When the test completes, click Accept to accept the results and move them to the Previous Results screen, or click Discard to delete the results and clear the screen.

Select another Test Item, if desired, and repeat the steps above. Continue testing until the test is complete or until you want to test the other ear or create a new chart for the current ear.

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Running a Spontaneous OAE Test (SOAE)

The amplitudes being measured during a spontaneous emissions test are quite small. To obtain the best results, it is advisable to run the test in a sound room. Select an eartip that will tightly seal the ear canal to obtain the lowest possible noise floor.

When performing the SOAE test no stimulus is presented. The microphone collects all frequencies present within the ear canal and displays a frequency spectrum plot. During testing the spectrum is displayed in the lower portion of the Acquisition Screen. The test runs until the maximum number of frames defined in the Test Set has been collected. At the end of the trial, if the result is accepted, the spectrum is transferred to the Previous Results section in the upper portion of the Acquisition Screen. DP points and Noise Floor symbols are not plotted for spontaneous results.

1. On the Acquisition Screen, select an SOAE Test Set.

2. Click Start One Test.

3. When the test completes, click Accept to accept the test results and move them to the Previous Results screen, or Discard to delete the results and clear the screen.

4. Click Back to Review to analyze the results.

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1. Test Set List

2. Test Item Details

3. Test Set Wizard

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Creating your own DPOAE Test Sets

The Test Set Definition Window is accessed from the Tests > Edit DPOAE Test Sets menu item on both the Review screen and Acquisition screen. It is used to create a new Test Set or edit an existing Test Set.

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The Test Set Definition window is divided into 3 main areas:

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1. Test Set List The Test Set List displays the names of all Test Sets stored within the system. Default Test Sets supplied with the GSI Audera cannot be deleted or modified, but they may be copied and edited for

customization by the user. Default Test Sets are denoted by the symbol prior to the name of

the Test Set. User defined Test Sets are denoted by the symbol . There is no limit to the number of Test Sets that can be created.

Buttons to the right of the Test Set List allow the user to perform the following functions:

Add New

Creates a new Test Set. A Test Set dialog box appears.

1. Enter a name for the new Test Set.

2. Select the type of test from the drop down list Type.

a. DPgram – Select this test type to define a DPOAE Test set. Results will be plotted on a DPgram. The x-axis will be displayed in frequency (Hz) and the y-axis will be displayed in intensity (dBSPL).

b. IOgram uPa – Select this option to define an input/output graph, with the x-axis displayed in uP and the y-axis displayed in intensity (dB SPL).

c. IOgram dB SPL - Select this option to define an input/output graph, with the x-axis and y-axis displayed in intensity (dB SPL).

NOTE: Data collected as one of the above types may be displayed in any of the other above formats after the test is completed. To view data as a different chart type, go to the Review Screen, right click on a symbol within the result or on the name of the file in the hierarchical tree and select Set Chart Type from the pop up menu. Then click on the chart type in the list to display the data in that format.

d. SOAE – Select this test type to define a Spontaneous OAE Test Set. During recording of spontaneous OAE’s no stimulus is presented; therefore, it is not necessary to define parameters for test set items. If the SOAE option is selected, the following message will appear in the Test Items window “Test Set items do not apply to spontaneous emissions tests”. It is still necessary to define the stopping rules for SOAE tests. Scoring Rules also do not apply to SOAE tests and cannot be defined. The following message will appear in the Scoring Rules window: “Scoring rules do not apply to spontaneous emissions tests.”

Delete

Deletes a user-define Test Set. It is not possible to delete default test sets - denoted by .

Copy and Edit

Copies and edits a default or user created Test Set for the purpose of creating a new Test Set. A Test Set dialog box appears. Enter the name and type (DP gram, IOgram or SOAE) of the new Test Set.

NOTE: If Copy and Edit is selected a default name will appear in the Test Set Name dialog box and the selection box for Test Type will be grayed out. If Add New is selected you must enter a name for the new test set and select Test Type.

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Rename

Renames a user-defined Test Set.

Lock

Permanently prevents changes to a user-defined Test Set.

NOTE: Once a test set is locked, no further changes can be made.

NOTE: All default Test Sets are locked and cannot be modified.

Move Up

Moves the Test Set to an earlier position in the Test Set List.

Move Down

Moves the Test Set to a later position in the Test Set List.

Select a Test Set to activate these buttons. Inaccessible buttons are grayed out. For instance, when a default test set is highlighted the Delete, Rename and Lock buttons are unavailable. When the user elects to create a new test set all buttons are accessible.

2. Test Item details Tab 1: Test Items

The bottom area of the Test Set Editor displays the details for each item within the currently selected Test Set.

Test Items

List all items and details for each item within the currently selected Test Set. The following acquisition parameters are displayed for each item:

a. Seq # - indicates the relative position within the Test Set

b. F1 Level (dB SPL) – the target intensity level for the F1 primary tone

c. F2 Level (dB SPL) – the target intensity level for the F2 primary tone

d. Freq. (Hz) – the Test Item frequency

e. Test Freq. – as defined in the test set as F2, arithmetic mean, geometric mean or F1

f. F2/F1 Ratio – the target ratio

g. Noise Rejection (dB) - this level defines the maximum acceptable noise for that frequency. The noise is measured from 4 bins of data on each side of the target DP frequency. If the absolute intensity of the background noise exceeds the defined level, the test sample will be rejected. We recommend adjusting this level up if the DP results look too noisy. You can adjust the level down if the test time is too long due to too many rejects.

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The following buttons are also included in the Test Item Details section of the screen:

• Add New - Adds a new test item to the currently selected Test Set. The stimulus and acquisition parameters of the new item will be copied from the preceding item in the list. The parameters for the new test item may be edited by clicking on the item and selecting the Edit button (see below).

• Delete - Deletes the highlighted item in the list. Note: It is not possible to delete ALL items within the test set; there must always be at least one item in the test item list. If only one item remains in the test set list this button will be grayed.

• Review/Edit - The label on this button changes depending on whether the selected test set is Read Only or editable.

If the test set is Read Only the button label will be Review. Select a test item and click this button to open a Details window, which displays the parameters for the selected item; however, parameter changes are not possible.

If the test set is editable the button label will be Edit. Select a test item and click this button to open a Details window, which displays the parameters for the selected item. It is possible to edit the parameters for an item by making changes in the Details Window. Changes will only apply to the currently selected item.

• Move Up - Moves the selected item to an earlier position in the test sequence.

• Move Down - Moves the selected item to a later position in the test sequence.

NOTE: The Delete, Move Up and Move Down buttons are active ONLY when more than one item appears in the test set list.

Tab 2: Stopping Rules

The Stopping Rules define the criteria used for determining when to stop data acquisition for a trial. The determination to stop a test is based first on the defined criteria for discarding a test. If the test is not discarded based on these criteria then the criteria for when to accept a test is applied.

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Test Discard Criteria - Two criteria are used for determining when to Discard a test:

• Check that the background acoustic noise level isn’t too high

Set the maximum percentage of allowable rejects. If the maximum level has been reached, the system will stop testing and move to the next test item. The dBSPL reject level is defined in Test Items.

• Check that the F1 and F2 levels are what they should be.

Measured SPL values for F1 and F2 during the in-ear calibration must be within tolerance. A fixed tolerance of +/- 3 dB is applied to this criterion. The intensity measured in the ear canal are compared to the targeted intensity level defined in the Test Set. For example, if F1 is targeted to be 65 dB SPL and F2 is targeted to be 55 dB SPL, then the actual measured values must be within +/- 3 dB for the test to continue.

NOTE: A test will be discarded if either of the above conditions are met.

Test Acceptance Criteria - Two criteria are used to determine when to Accept a test:

• When does a test time out?

Maximum Number of Frames to Acquire - Testing will stop and move to the next test item when the maximum number of frames has been accepted. This number does not include rejected frames.

• When is a test accepted?

Minimum accepted frame count - This defines the number of frames to be collected before testing is timed out after meeting the stopping rules.

Check whether the DP level is significantly above the noise floor

DP-Average Noise Level: This level defines the minimum DP level required above the noise level.

And Average Noise Level: This level defines the maximum acceptable noise level.

When both boxes are checked, the response will need to meet both requirements for the testing to be stopped.

Check for low average noise level

Average Noise Level: This setting will stop the session if the average noise level is lower than selected.

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Tab 3: Scoring Rules

The Scoring Rules define the criteria that are used to generate an automatic scoring result (i.e. pass/ refer) for the test. The use of Scoring is optional. When developing the scoring criteria, care should be taken so that the criteria properly matches the particular Test Set.

The Scoring Rule Criteria, Scoring Text and Overall Scoring Method are defined on this panel. The Scoring Rule Criteria applies to each Test Item while the Overall Scoring Method applies to all items as a group. The Scoring Text is the text that appears on the DPgram at the completion of all items within the test set. The Scoring Text also appears on the DPOAE printout.

Scoring Rule Criteria - This section contains two different criteria, one of which must be selected.

• Check the level of each DP point relative to its Noise Floor - Compares the intensity of the target DP to the surrounding Noise Floor. With this option, enter the signal-to-noise ratio required for this point to be scored. If the intensity of the target DP is higher than the surrounding Noise Floor by at least the defined value, the result will be scored as a Pass for that individual point.

• Check the absolute level of each DP Point - Assesses the absolute intensity of the target DP for scoring purposes for each point. When this option is selected, enter the amplitude value required for this point to be scored.

• Scoring Text - This section allows the user to specify the text to be used when the test results meet and do not meet the scoring criteria. Type in the preferred text to appear on the DPgram for a Pass or Refer result.

Overall scoring method - Defines the number of points per octave that must match the Scoring Rule Criteria to be considered a “pass”. Care must be taken when defining the points per octave to ensure that there is agreement between the autoscoring criteria and the actual number of DP points tested in the Test Set. The overall scoring method may be defined by the number of points in each frequency range or on all tested points combined.

• Score by dividing the results into frequency ranges, then check each one – Check this option to apply the Scoring Criteria to each frequency range separately. It is possible to apply a different scoring criterion to each octave, keeping in mind the total number of points in each octave.

• Score by evaluating all points within the result – Check this option to score the total number of points in the test set. For instance if 3 octaves and 3 points per octave are selected in the test set the total number of points in the test set is 10 a subset of the total points may be entered as the definitive scoring method.

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Tab 4: Miscellaneous

Miscellaneous - Provides random presentation of items within a Test Set. This option is useful when performing research studies where it is desirable to use the same Test Set for all subjects. When this option is selected, the items in the test set will be presented in a random order. The presentation varies each time the Start Auto Test button is clicked. This option is not applicable for manual testing when only one item within the Test Set is selected by you.

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3. Test Item Wizard The Test Item Wizard is provided as a way to create a new Test Set or add items to an existing Test Set with just a few clicks of the mouse.

The Test Item Wizard becomes accessible when the Add New or Copy and Edit buttons are selected and after a name and test type is entered for the New Test Set.

1. After naming a new Test Set or copying and editing an existing one, click Run Wizard to start the Test Item Wizard. The Test Item Wizard window appears.

2. Range of Required Frequencies

a. Select the test frequencies:

i. Standard - Choose the octave ranges to include in the Test Set.

ii. Custom - Choose the lowest and highest frequencies to be included in the test set; the allowable frequency is between 500-12,000 Hz.

b. Points per Octave - Choose the number of points per octave (1-12) to include in the Test Set.

NOTE: When a custom stimulus is selected, the octaves included in the test set will depend on the frequencies selected. For example, if the lowest frequency selected is 2000 Hz, the highest frequency selected is 4000 Hz and points per octave is set to 3, the resulting test set will contain 4 items. The first octave is defined as 2000 – 3999 Hz and will result in three test set items (for the 3 points per octave) and the fourth test item will be for the octave beginning at 4000 Hz.

c. Sort Order -

i. Lowest to Highest - Arranges items in the Test Set from the lowest to the highest frequency.

ii. Highest to Lowest - Arranges items in the Test Set from the highest to the lowest frequency.

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3. Range of F2 Level - This section of the Test Set Wizard is used to specify the intensity level of F2.

a. To set the F2 level at a constant level for all items in the test set (i.e., 55dB SPL), set both the highest and lowest values to the same level (i.e. 55 dB SPL). The allowable F2 level may range from –10 to 90 dB SPL. In this instance, it is not necessary to select the step size or sort order fields.

b. To set the F2 level as a variable intensity (i.e., when recording an input/output function):

i. Set the upper and lower limits of the F2 intensity to correspond to the highest and lowest F2 levels to be presented during the Test Set. After selecting the upper and lower intensity limits for F2.

ii. Select the step size in dB to specify the incremental change in F2 level for each Test Item in the Test Set.

iii. Select the sort order to specify whether the F2 intensity level will start at the highest or the lowest intensity specified

4. F1 Level as a function of F2 level - F1 intensity is specified relative to the F2 level defined in the previous item. For options that include a “k” value, “k” must be defined in addition to selecting the option.

a. L1 = L2 – F1 level (L1) is set to the same intensity level as L2 for all items in the test set.

b. L1 = L2 + k – F1 Level (L1) is determined by adding the defined “k” value to the intensity level of L2.

c. L1 = m.L2 + k – F1 level (L1) is determined by adding the defined “k” value to the geometric mean of the L2 level. A box appears indicating the calculated mean (“m”) value. The software automatically calculates the “m” value.

5. Test Item Details - The items in this group include:

a. Test Frequency can be defined as:

i. F2 ii. Arithmetic Mean iii. Geometric Mean iv. F1

b. Target F2/F1 ratio – Select the target F2/F1 ratio – the values range from 1.1 to 1.8.

c. Noise Rejection Level – select the intensity level for the noise rejection. Any input at the microphone above this level will be rejected and, therefore, not included in the analysis.

6. Grouping Options – defines the order of items within the Test Set. This option is provided for defining Input/Output test types.

a. Group by Frequency – Select this option to sort the test set items according the F1 frequency.

b. Group by Level – Select this option to sort the test set items according to the intensity level of F1 from highest to lowest.

NOTE: If the intensity of F1 and F2 are the same for all items in the Test Set the items will be grouped by frequency regardless of the grouping option selected.

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7. Test Set Update Options

a. Replace all existing test items in Test Set - This option will put all new items in the Test Set based on choices made in the Wizard.

b. Add to end of existing items in Test Set - This option will add the items selected in the Wizard to the other items if you have done a Copy and Edit of an existing Test Set.

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This chapter contains information for reviewing, analyzing, and printing previous results.

After a Test Set is completed it is possible to review data on either the Acquisition screen or on the Review screen.

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Reviewing and Analyzing Previous Results (DPGram or I/OGram)

The Acquisition screen Previous Results window may be viewed in normal mode or expanded to full screen.

The Review screen may be viewed in its entirety with all charts visible or a single chart (the active chart) may be expanded and viewed in full screen mode. All manipulation of data (deleting data, moving data between charts, etc.) must be done from the Review screen in the standard view mode.

Full Screen (Zoom In) Mode - If you choose, you may expand the previous results window on the Acquisition screen or the active chart on the Review screen to view the DPGram, IOGram or SOAE spectrum in a larger window. The active chart is identified by the Zoom In

button located in the upper right corner of the chart. Only one chart is active at a given time.

1. On the Acquisition screen, the active chart is displayed in the upper portion of the window.

or

From the Review screen click on any chart to designate it as the active chart.

2. Click the Zoom In button located in the upper right corner of the Acquisition screen active chart or double-click anywhere within the chart. A full screen window will open allowing for easier viewing of the results.

3. Click the Zoom Out button in the upper right corner of the expanded chart or double-click anywhere within the expanded chart to return to the normal view.

The following options are available when Reviewing OAE Data. To access these options right- click on a point within a DPGram or IOGram. When a trial is selected the corresponding text markers in the chart will be colored pink and the name of the trial will be highlighted in the Hierarchical Tree.

The options available on the right-click menu will vary depending on whether Reference Data has been applied to a trial.

•If Reference Data has not been applied, the right-click menu will include an option to Apply Reference Data as shown in Figure 1.

•If Reference Data has been applied the right click-menu will include options to view reference data protocol and Clear reference data as shown in Figure 2.

Figure 2

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Figure 1

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To review the data for each DP or IO point, right-click on either the symbol or the corresponding NF symbol and select an option from the right-click menu.

1. Set Chart type – For DPGram and IOGram tests the data may be viewed in either DPGram format or in IOGram format, regardless of how it was collected. See Chapter 3 - Creating Test Sets for a discussion of the different chart types.

2. Apply Reference Data – Reference Data may be applied to DPOAE results provided that Reference Data has been collected and is applicable to the result being analyzed. See the section in the following pages for directions on collecting and using Reference Data. After this option has been selected two new options will appear on the right-click menu:

a. View reference data protocol – Select this option to view the parameters for the reference data that has already been applied to the result.

b. Clear reference data – Select this option to remove the reference data from the result.

3. Result Score – Select this option to display the Scoring text window for the selected trial. This option is only available when automatic scoring has been enabled for Test Set that was used to acquire the data.

4. Show F1 & F2 – Select this option to display or turn off the display of the F1 and F2 symbols in the DPGram or IOGram for all test items in a trial. The presence of a checkmark next to this item indicates that the F1 & F2 symbols are displayed. The absence of a checkmark next to this item indicates that the F1 & F2 symbols are not displayed.

5. Show Noise Floor – Select this option to display or turn off the display of the noise floor symbols in the DPGram or IOGram for all test items in a trial. The presence of a checkmark next to this item indicates that the NF symbols are displayed. The absence of a checkmark next to this item indicates that the NF symbols are not displayed.

6. Show FFT Data – Select this option to open a separate window to display the FFT spectrum for the selected point on the DPGram or IOGram. When finished, click the red X in the upper right corner of the window to close the FFT spectrum display window and return to the data.

7. Trial Details – Select this option to open a separate window to display the acquisition details for the selected point on the DPGram or IOGram. When finished, click the Close button at the bottom of the window to close the Trial Details window and return to the data.

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1. Place the cursor crosshair at any point along the spectrum. The frequency (Hz) and intensity (dB SPL) of the cursor location will be displayed in the boxes on the menu bar.

2. Use the left and right keyboard arrow keys to move along the spectrum and analyze selected points.

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Reviewing and Analyzing Previous Results (Spontaneous OAE)

Spontaneous OAE tests may only be viewed in the Spontaneous FFT Spectrum mode. Results collected with a Spontaneous OAE Test Set cannot be viewed as a DPGram or IOGram.

To Review a Spontaneous OAE Result

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Compare Tests

The Compare Tests feature allows you to compare tests from a single patient that were acquired in different sessions to monitor changes over time. It is possible to simultaneously display test results of similar types that were acquired for the same patient in different sessions on the same date and also to compare test results from different dates.

It is not possible to simultaneously display results for different types of tests. For example, you cannot display a spontaneous OAE test result or IOGram on the same screen with a DPGram.

To Access the Compare Tests Window in the DPOAE Application:

1. Select an existing patient from the Main Audera Database by using the Database search feature or selecting a patient from the Database list.

2. Click on a session that contains DPOAE results.

3. Click the DPOAE application button to start the DPOAE application. The Review Screen,containing all charts from the currently selected session, will be displayed.

4. Select the Review Screen menu item Patient > Compare Tests. The Compare Tests for Patient: window will appear. The Compare Results window shown in Figure 1 is displayedwith the Hierarchical Tree expanded for demonstration.

The name of the selected patient will also be displayed at the top of the window.

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2

1 4

The Compare Test window has 4 sections.

1. Trial Display Area 2. Toolbar 3. Status Display Boxes 4. Hierarchical Tree

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a. Clear All Selections – Select to clear all displayed results from the screen.

b. Select All Left and Select All Right – To select all trials of the same type for the Left ear or Right Ear from all sessions. When one of these buttons is selected, the Select Result Type window will be displayed as shown below. Click on a radio button to select the type of results to be displayed. Only 1 radio button may be selected. It is not possible to display different types of results in the same window.

c. Print Screen – Select to print the Compare Results window.

d. Show F1 & F2 – Select to display or remove the F1 and F2 symbols for all displayed DPGrams or IOGrams that are selected for comparison.

e. Show Noise Floor – Select to display or remove the Noise Floor symbols for all displayed DPGrams or IOGrams that are selected for comparison.

f. Patient History – Select to display the Patient History Screen and select the notes to be displayed and/or printed.

g. Add Note – Select to enter a DPOAE note to the Patient History.

This area of the Compare Results window is used to display the frequency (HZ), intensity (dB SPL) and, for DPGrams and IOGrams, the difference in dB between the target DP point and the corresponding noise floor (S/N dB) for a selected point on the display.

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1. Trial Display This area is used to display all selected trials.

Area

2. Toolbar Buttons

3. Status Display Boxes

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4. Hierarchical Tree This area of the screen lists all DPOAE test results for that patient in chronological order. Each session is identified by a folder icon followed by the date and time of the session. Each session contains charts and each chart contains trials.

To Compare Tests for a Selected Patient:

1. Select the existing patient from the Main Audera Database.

2. Click on any session.

3. Click the DPOAE application button to start the DPOAE application. The Review screen will be displayed.

4. Select the Review Screen Menu item Patient > Compare Tests. The Compare Tests for Patient: window will appear.

5. Click on “Plus symbol” preceding a folder or double-click on the folder or date to expand the Hierarchical Tree and view the charts in each session.

6. Click on “Plus symbol” preceding a chart to expand the tree further and view the trials in each chart. Each trial is preceded by a selection box.

Click to place a checkmark in the selection box for each trial to be displayed.

Click the selection box again to remove the checkmark and remove a trial from the display.

NOTE: Alternatively, you may select all trials saved for the left ear or right ear in all sessions by clicking the Select All Left or Select All Right button at the top of the screen. When one of these buttons is selected, the Select Result Type window as discussed above will be displayed. Select the type of results to display by clicking on a radio button. The Clear All Selection button may be used to clear all trials from the Compare Tests screen.

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7. After a trial has been selected for display, all trials of the same type (DPGram or IOGram) will be preceded by a selection box indicating that they are available for adding to the

display. All trials of different types will be preceded with a , indicating that they are not available for adding to the display.

8. Click the Print button to display the Print Preview window. Select Print from the Preview Window to print the Compare Tests window.

9. Click the Patient History button to display all notes that have been saved to the patient file. Select any notes to be printed from the Patient History window. Notes will print on a separate page.

10. If you wish to Save the comparison for future viewing select the Save Layout button at the bottom of the window. The next time you go to Options > Compare Results, the saved layout will be displayed.

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On the DPOAE Review Screen, click on Options > Edit Reference Data. The window shown below will be displayed.

The Reference Data window has two sections:

a. The top portion of the window is used to display, add and edit the patient groups and test sets that were used to collect reference data. Each group of reference data will be displayed as a separate entry in the list. For example, the patient group “infants” may be listed more than one time if this group was used to collect reference data for more than one test set (i.e. Screening and Diagnostic test sets). The name of the test set and protocol that was used to collect the reference data should be shown to the right of the group designation.

b. The bottom section of the window is used to display and edit the reference data values for the group that is highlighted in the top portion of the window.

Select the tab for either DP Reference Data or IO Reference Data to view existing reference data sets, edit existing reference data, or to enter new reference data for the appropriate test type.

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DPOAE Reference Data

NOTE: The use of Reference Data is optional. Special attention is required when using referencedata. Each set of reference data should only be applied to test results that were collected with thesame Test Set used to collect the reference data. Care should also be taken that the same test conditions apply during collection of reference data values and the use of the test set.

To Create New 1.

Reference Data Sets

2.

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3. Click the Add button in the upper portion of the window to add a new patient group. The DPOAE Reference Group window will be displayed.

a. Type in a name for the Reference Group

b. Type in the Protocol details to define the patients included in the Reference Group and the details of the Test Set used to collect the reference data. This information is useful for determining which test results can be compared to the reference data set. Edit the text in the window to include as much information as possible on how the reference data was collected. Typically the following information is required to completely specify any protocol used to acquire the reference data for a reference group:

• Who collected the data and who compiled it.

• A version number or date for this reference data.

• Number of subjects tested, their age and sex.

• Results from other hearing tests.

• Ambient noise level controlled.

DP Stimulus:

• Frequencies tested. Typically in points per octave.

• Test frequency is: F2, arithmetic or geometric mean or F1.

• F2/F1 ratio.

• L1 and L2 levels in dB SPL.

Stopping conditions:

• Maximum test time.

• DP signal to noise in dB.

• L1 or L2 out of tolerance by +/-3 dB.

Rejection conditions:

• Maximum percentage of FFTs rejected.

• Absolute average noise level in dB.

Hardware used, i.e., GSI Audera in this case.

Application software version number.

NOTE: It is essential that all the above criteria remain constant throughout reference data collection to ensure validity of the reference data collected.

c. Click the Add button at the bottom of the Reference Group window to save the protocol details and return to the DPOAE Reference Data Screen or click Cancel to close the window without saving changes.

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4. Click the Add button in the lower left portion of the DPOAE Reference Data Screen to add the frequency reference data for each test set item. The Distortion Product Range window will be displayed.

a. Type in the frequency for the first test set item in the test set that was used to collect the reference data.

b. Type in the upper limit for the normative range as calculated from the reference data subjects

c. Type in the lower limit for the normative range as calculated from the reference data subjects.

d. Click the Add button to save the entry or the Cancel button to leave the window without saving changes.

5. Repeat steps 4a through 4d above for all frequencies included in the Test Set. As each frequency is added, the lower portion of the window will become progressively populated with the reference data criteria.

6. When all frequencies have been entered, click the Close button in the Distortion Product Range window to close the window and return to the DPOAE Reference Data screen.

7. Click the Add button on the bottom right of the DPOAE Reference Data Screen to define the Noise Floor criteria reference data for each frequency entered. The Noise Floor Range window will be displayed as shown below.

a. Type in the frequency for the first test set item of the test set that was used to collect the reference data.

b. Type in the upper limit for the normative range of the noise floor as calculated from the data obtained from reference subjects.

c. Type in the lower limit for the normative range of the noise floor as calculated from the data obtained from reference subjects.

d. Click the Add button to save the entry or the Cancel button to leave the window without saving changes.

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8. Repeat steps 4a through 4d for all frequencies included in the Test Set. As the noise floor for each frequency is added the lower portion of the window will become progressively populated with the reference data criteria.

9. When all frequencies have been entered click the Close button in the Noise Floor Range window to close the window and return to the DPOAE Reference Data screen.

10. If desired, click the Lock button in the upper portion of the DPOAE Reference Data screen to prevent any future changes to the Reference Data set or it’s contents.

NOTE: Once a Reference Data set has been locked it cannot be unlocked; however, locked reference data sets can be deleted.

11. When all data for the reference set has been completed click the Save button at the bottom of the DPOAE Reference Data window to save the reference data set and return to the DPOAE Review Screen.

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Editing Existing Reference Data Set 1. On the DPOAE Review screen click on Options > Edit Reference Data. The DPOAE

Reference Data window shown in Figure 1 above will be displayed.

2. To Edit the Reference Group Name or Protocol information

a. Click on the name of a reference group in the upper portion of the window to highlight a reference group for editing.

b. Click the Edit button. The DPOAE Reference Group window will open. Type in a new name or make changes to the proforma text in the protocol text box.

c. Click the Save button to save the changes and return to the DPOAE Reference Data Window or click Cancel to exit the window without saving changes.

3. To edit values in the DP Range or NF Range areas of the reference data screen.

a. Click on an item in the list to select it

b. Click the Edit button below the corresponding item. The DP Range or NF Range definition box will be displayed.

c. Type in the new values for Frequency, Upper Limit and/or Lower limit.

d. Click the Save button to save the changes and return to the DPOAE Reference Data Window or click Cancel to exit the window without saving changes.

Deleting Existing Reference Data It is possible to delete either an entire set of reference data for a patient group or to selectively delete items within the reference data set.

1. On the DPOAE Review Screen click on Options > Edit Reference Data. The DPOAE Reference Data window shown in Figure 1 above will be displayed.

2. To delete an entire Reference Group and the associated data:

a. Click on the Reference Group to be deleted in the upper portion of the DPOAE Reference Data window. The reference data associated with that group will be displayed in the lower portion of the window.

b. Click on the Delete button in the upper portion of the window to delete the Reference group and all associated data displayed below. A message will be displayed asking if you are sure you want to delete the reference group and all it’s range data.

c. Click Yes to delete the reference group and data or click No to cancel the operation and return to the Reference Data screen without deleting data.

3. To Delete Reference Data for selected items in a Reference Data set:

a. Click on a Reference Group in the upper portion of the DPOAE Reference Data window. The reference data associated with that group will be displayed in the lower portion of the window.

b. Click on the item in the DP Range or NF Range area of the screen to select an item to delete from the Reference Group data.

NOTE: If a DP Range item is deleted you should also delete the associated NF range item.

c. Click on the Delete button under the corresponding highlighted item. A message will be displayed asking if you are sure you want to delete the reference range.

d. Click Yes to delete the range and No to cancel the operation without deleting the item and return to the Reference Data window.

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Importing Reference Data

When the GSI Audera system is upgraded to include the DPOAE application, the normative data needs to be imported. During the software upgrade, the normative data file is installed on the hard drive for importing purposes.

To import normative Reference Data:

1. On the DPOAE Review Screen, select Options > Edit Reference Data.

2. Click the Import button at the bottom of the DPOAE Reference Data dialog box.

3. Select the following hard drive directory C:\Grason Stadler\GSI Audera\Utility. Highlight the dpoae_ref.dat file.

4. Click Open, the reference data and proforma will be imported and ready for use.

5. Click Save on the DPOAE Reference Data dialog box. This saves the normative data and returns you to the DPOAE Review Screen.

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Adding Notes to a Session

Prior to printing reports you may wish to add notes to a patient file. Notes may be added to a session before, during or after a test. In the DPOAE application notes there are 2 ways to add notes to a patient file. The first procedure below will allow you to add notes that are specific to the DPOAE test. The second procedure will allow you to add notes to the Patient History section of the file.

To Enter a Session Specific Note:

1. On the Review Screen:

a. Click the Add Notes icon from the toolbar shortcut buttons. The Enter Note dialogue box will be displayed with the date and time of the note entry at the top of the window.

b. Type a note specific to the session.

c. Click the Save button to save the note and return to the Review Screen or click Cancel to exit the window without saving changes.

To Add a Patient History Note:

1. On the Review Screen:

a. Select the Menu item Patient > Edit. The Patient Details window will be displayed.

b. Click the Patient History icon at the bottom of the window. The Patient Details window will open allowing you to review all notes that have been entered into the patient file in all applications.

c. Click the Add Note icon at the bottom of the Patient Details window to display the Enter Note dialogue box.

d. Type a note to add to the Patient History

e. Click the Save button to save the note and return to the Review Screen or click Cancel to Exit the window without saving changes.

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Printing DPOAE Reports 1. From the Main Audera Screen, select the Patient from the Database.

2. Highlight the Session that contains the results the report will be based on.

3. Click the DPOAE application button. The Review Screen will be displayed with the test results from the selected session.

4. Select Patient > Print DPOAE Report from the Review Screen menu bar. The DPOAE Report Selection window will be displayed as shown below.

5. The left panel charts will be displayed at the top of the window and the right panel charts will be displayed at the bottom of the window. The first chart in each panel will be selected by default for inclusion in the report. The following items may also be included in the report.

a. Patient History Notes – Click to place a checkmark in the selection box at the top of the screen to include Patient History notes in the report.

b. Session Notes – Click to place a checkmark in the selection box at the top of the screen to include Session Notes in the report.

6. For each chart it is possible to print any or all of the following items for each chart. Click in the selection box to select each item to include in the report.

To include All items for all charts, click the Select All button located at the bottom of the screen. To Clear all items for all charts click the Clear All button located at the bottom of the screen.

a. Chart – Includes all results displayed in the chart.

b. Summary – Includes the result and scoring, if enabled.

NOTE: Summary information is only available for test types DPGram and IOGram. Summary information is not available for the Spontaneous OAE test type.

c. Details – Includes trial details for all trials displayed in the chart

7. To include other charts in the report:

a. Click on the selection box to place a checkmark for each item to include in report.

b. Click on a selection box to remove a checkmark for each item you do not wish to include.

8. Click on Preview Report.

9. Click Next Page to preview the entire report.

10. Click Print to print the report as outlined in the Preview.

11. Click Close to return to the Report Selection window if changes need to be made prior to printing.

2001-0143 Rev. A 4-17

GSI Audera

Printing a DPOAE Chart 1. From the Main Audera Screen, select the Patient from the Database.

2. Highlight the Session that contains the results the report will be based on.

3. Click the DPOAE application button. The Review Screen will be displayed with the test results from the selected session.

4. Click on a chart to select it for printing.

5. Select Patient > Print Current Chart from the Review Screen menu bar.

6. A preview of the chart will be displayed.

7. Select Print then select OK to print the chart or Cancel to return to cancel printing and return to the review screen.

8. Select Close to cancel printing and return to the Review Screen.

The printout will include the chart with title, the patient’s name, examiner’s name, site and date of test.

4-18 2001-0143 Rev. A

Appendix

5-1

5

2001-0143 Rev. A

GSI Audera

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5-2 2001-0143 Rev. A

Appendix: Selected Bibliography

DPOAE selected bibliography 1. Beattie, RC (2003): Distortion product otoacoustic emissions: comparison of sequential

versus simultaneous presentation of primary-tone pairs, J Am Acad Audiol. 14 (9): 471- 482.

2. Beattie RC, Kenworthy OT, Luna CA (2003): Immediate and short-term reliability of distortion-product otoacoustic emissions, Int J Audiol 42(6): 348-354.

3. Boege P, Janssen T. (2002): Pure-tone threshold estimation from extrapolated distortion product otoacoustic emission I/O-functions in normal and cochlear hearing loss ears, J Acoust Soc Am 111(4):1810-1818.

4. Cilento BW, Norton SJ, Gates GA (2003): The effects of aging and hearing loss on distortion product otoacoustic emissions, Otolaryngol Head Neck Surg. 129(4): 382-389.

5. Davis B, Qiu W, Hamernik RP (2004): The use of distortion product otoacoustic emissions in the estimation of hearing and sensory cell loss in noise-damaged cochleas, Hear Res. 187 (1-2): 12-24.

6. Dorn PA, Konrad-Martin D, Neely ST, Keefe DH, Cyr E, Gorga MP. (2001): Distortion product otoacoustic emission input/output functions in normal-hearing and hearing- impaired human ears, J Acoust Soc Am 110(6):3119-3131.

7. Franz B, Altidis P, Altidis B. (2000): Spontaneous otoacoustic emissions in neonates and effect of contralateral white noise stimulation, Int Tinnitus J 6(2): 168-171.

8. Gorga MP, Neely ST, Dorn PA, Hoover BM. (2003): Further efforts to predict pure-tone thresholds from distortion product otoacoustic emission input/output functions, J Acoust Soc Am 113(6) 3275-3284.

9. Hall, James W. III (2000), Handbook of Otoacoustic Emissions, Singular Publishing Group, San Diego.

10. Keogh T, Kei J, Driscoll C, Smyth V. (2001): Distortion-product otoacoustic emissions in schoolchildren: effects of ear asymmetry, handedness, and gender, J Am Acad Audiol 12(10): 506-513.

11. Lonsbury-Martin BL, Martin GK (2003): Otoacoustic emissions, Curr Opin Otolaryngol Head Neck Surg 11(5): 361-366.

12. Muller J, Janssen T. (2004): Similarity in loudness and distortion product otoacoustic emission input/output functions: implications for an objective hearing aid adjustment, J Acoust Soc Am. 115(6): 3081-3091.

13. Parthasarathy TK, Klostermann B. (2001): Similarities and differences in distortion- product otoacoustic emissions among four FDA-approved devices, J Am Acad Audiol 12(8): 397-405.

14. Robinette, M. & Glattke, T. (1997), Otoacoustic Emissions: Clinical Applications, Thieme, New York.

15. Shaffer LA, Withnell RH, Dhar S, Lilly DJ, Goodman SS, Harmon KM. (2003): Sources and mechanisms of DPOAE generation: implications for the prediction of auditory sensitivity, Ear Hear 24(5): 367-379.

16. Toral-Martinon R, Shkurovich-Bialik P, Collado-Corona MA, Mora-Magana I, Goldgrub- Listopad S, Shkurovich-Zaslavsky M (2003): Distortion product otoacoustic emissions test is useful in children undergoing cisplatin treatment, Arch Med Res 34(3): 205-208.

17. Torre P 3rd, Cruickshanks KJ, Nondahl DM, Wiley TL. (2003): Distortion product otoacoustic emission response characteristics in older adults, Ear Hear 24(1): 20-29.

18. Vento BA, Durrant JD, Sabo DL, Boston JR (2004): Development of f2/f1 ratio functions in humans, J Acoust Soc Am 115(5 Pt 1): 2138-2147.

2001-0143 Rev. A 5-3

GSI Audera

Blank page.

5-4 2001-0143 Rev. A

A About Audera 2-17 Acc. Frames 2-13 Acquisition Screen 2-21 Acquisition screen control panel 2-5 Add a Patient History Note 4-16 Add New 3-8, 3-10 Add Note 2-20, 4-7 Add to end of existing items in Test Set 3-16 Adding Notes to a Session 4-16 Additional copies i-ii Analyzing DPOAE Tests 4-1 Analyzing Previous Results 4-3 Analyzing Previous Results (Spontaneous OAE) 4-5 Anatomical Influences 1-5 And Average Noise Level 3-11 Appendix 5-1 Apply Reference Data 4-4 Average Noise Level 3-11

B Back to Main Screen 2-15, 2-21 Back to Review Screen 2-7 Beep at trial end 2-17 bibliography 5-3

C CAUTION label i-vii Cautions i-vii Changes to Acquisition Screen Control Panel buttons 2-7 Chart 4-17 Charts to fit vertically 2-16 Check for low average noise level 3-11 Check that the background acoustic noise level isn’t too

high 3-11 Check that the F1 and F2 levels are what they should be. 3-11 Check the absolute level of each DP Point 3-12 Check the level of each DP point relative to its Noise Floor 3-

12 Check whether the DP level is significantly above the noise

floor 3-11 Checking Seal 2-12 cleaning kit 1-4 Clear reference data 4-4 cochlear function 1-6 Color 2-19 Communication Status 2-12 Compare Tests 2-15, 4-6 Complete 3-4 Complete - Pass 2-13, 3-4 Complete - Refer 2-13, 3-4 Compliance i-i Contacting GSI 2-17 Copy 2-18 Copy and Edit 3-8 Create New Reference Data Sets 4-10

2001-0143 Rev. A

Index

Creating your own DPOAE Test Sets 3-7 Current Acquisition Display (FFT Spectrum) 2-9 Cursor Display 2-20 Cursor Position 2-12 Custom 3-14 Customer responsibility i-v Customizable Software 1-4

D Delete 2-18, 3-8 Deleting Existing Reference Data 4-14 Details 2-6, 4-17 Distortion Product Otoacoustic Emissions 1-5 DP Auto-filter 2-17 DP S/N 2-13 DP-Average Noise Level 3-11 DPgram 3-8 DPOAE Acquisition screen 2-4 DPOAE Application Software 1-4 DPOAE Options 2-16 DPOAE Reference Data 4-10 DPOAE Review Screen 2-13 DPOAE Review screen 2-14 DPOAE Screens 2-1 DPOAE selected bibliography 5-3

E Earprobe Bad Seal 2-12 Earprobe Check 3-3 Edit DPOAE Test Sets 2-15 Edit Reference Data 2-17 Editing Existing Reference Data Set 4-14 Electromagnetic compatibility guide 1-3 Enter a Session Specific Note 4-16 environmental factors 1-6

F F1 Level as a function of F2 level 3-15 Full Screen (Zoom In) Mode 4-3

G Graph Options for all charts 2-16 Graph Options for New Charts ONLY 2-16 Grid on acquisition window 2-16 Grid on charts 2-16 Group by Frequency 3-15 Group by Level 3-15 GSI Audera DPOAE Application Software 1-4

H Help i-vi Help > About Audera 2-17 Help > Contacting GSI 2-17 Help > View Manual 2-17

i

GSI Audera

Help menu 2-17 Hide 2-18 Hierarchical Tree 2-21, 4-8 Highest to Lowest 3-14 How it works 1-5

I Identifying the GSI Audera software version number i-vi Importing Reference Data 4-15 Incomplete 2-13 Individual Trials 3-5 Input requirements i-vi Intended operator i-vi IOgram dB SPL 3-8 IOgram uPa 3-8 Items not covered by warranty i-iii

L Left and Right Charting Panels 2-20 Left ear DP symbol 2-10 Level Calibration 2-12 Limit of warranty i-iii Lock 3-9 Lowest to Highest 3-14

M Measurement Table 2-19 Menu bar 2-15 Microphone Display Window 2-8 Miscellaneous 3-13 Move Down 3-9 Move Up 3-9

N Noise Rejection Level 3-15 Note label i-vii

O OAE Probe Design 1-4 Options > DPOAE Options 2-16 Options > Edit Reference Data 2-17 Output interface i-vi Overall scoring method 3-12

P Pass 2-13, 3-4 Patient > Back to Main Screen 2-15 Patient > Compare Tests 2-15, 4-6 Patient > Edit 2-15 Patient > Print Current Chart 2-15, 4-18 Patient > Print DPOAE Report 2-15, 4-17 Patient History 2-19, 4-7

ii

Patient History Notes 4-17 Patient menu 2-15 Performing an Earprobe Check 3-3 Performing DPOAE Tests 3-1 Plus symbol 4-8 Points per Octave 3-14 primary tone 1-5 Print 2-19 Print Current Chart 2-15, 4-18 Print DPOAE Report 2-15, 4-17 Print Screen 4-7 Printing a DPOAE Chart 4-18 Printing DPOAE Reports 4-17 Probe Design 1-4 Protective classification i-vi pure tones 1-5

Q Quick Start DPOAE Testing Sequential Trial 3-4

R Range of F2 Leve 3-15 Range of Required Frequencies 3-14 Ready 2-12 Refer 2-13, 3-4 Regulatory standards i-v Rej. Frames 2-13 Reject % 2-13 Rename 2-18, 3-9 Repeatability Check 1-6 Replace all existing test items in Test Set 3-16 Requirements i-vi Reset 2-19 Result Score 4-4 Results Display 2-10 Review screen 2-14 Review Screen Control Panel 2-21 Review/Edit 3-10 Reviewing and Analyzing Previous Results 4-3 Reviewing and Analyzing Previous Results (Spontaneous

OAE) 4-5 Right ear DP symbol 2-10 Run Wizard 3-14 Running a Spontaneous OAE Test (SOAE) 3-6 Running DPOAE Tests – Individual Trials 3-5

S Safety precautions i-viii Safety summary i-vii safety symbols i-vii Score by dividing the results into frequency ranges, then check

each one 3-12 Score by evaluating all points within the result 3-12 Scoring Rule Criteria 3-12 Scoring Rules 2-13, 3-12

2001-0143 Rev. A

Index

W WARNING label i-vii Warnings i-vii warranty i-iii Warranty Period i-iii When does a test time out? 3-11 When is a test accepted? 3-11

iii

Scoring Text 3-12 Session Notes 4-17 Set Chart type 4-4 Show F1 & F2 2-19, 4-4, 4-7 Show F1 F2 by default 2-17 Show FFT Data 4-4 Show NF by default 2-17 Show Noise Floo 2-19 Show Noise Floor 4-4, 4-7 SOAE 1-5, 3-8 Software copyright protection i-iv Software warranty i-iv Sort Order 3-14 Spontaneous Emissions Measurements 1-5 Spontaneous OAE Test (SOAE) 3-6 Standard 3-14 Start Auto Test 2-7 Start One Test 2-7 Start One Trial 2-8 Status Display Boxes 4-7 Stopping Rules 3-10 Summary 4-17 System warranty i-iii

T Target F2/F1 ratio 3-15 Test Acceptance Criteria 3-11 Test Discard Criteria 3-11 Test Item 2-5 Test Item Details 3-15 Test Item details 3-9 Test Item Wizard 3-14 Test Set 2-5 Test Set List 3-8 Test Set Update Options 3-16 Test State 2-12 Test Status Area 2-12 Test Time 2-13 Testing 2-12 Tests > Edit DPOAE Test Sets 2-15 Tests menu 2-15 Toolbar Buttons 4-7 Toolbar buttons 2-18 Trademarks i-ii Trial Details 4-4 Trial Display Area 4-7

U USB interface 1-3 Use Red/Blue 2-17 User interface i-vi

V View Manual 2-17 View reference data protocol 4-4

2001-0143 Rev. A

GSI Audera

iv 2001-0143 Rev. A

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