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Top of FormJournal of Otolaryngology-Head & Neck SurgeryVolume 39, Issue 03, June 2010, Pages 259-268

Simple Mass Loading of the Tympanic Membrane to Alleviate Symptoms of Patulous Eustachian Tube

Clark Bartlett MD, Ronald Pennings MD, PhD, Allan Ho MBBS, MRCS, FRCS, David Kirkpatrick MD, FRCS, Rene van Wijhe, Manohar Bance MB, MSc, FRCS.

Clark Bartlett, Ronald Pennings, David Kirkpatrick,andManohar Bance:Division of Otolaryngology, Department of Surgery, andRene van Wijhe:E.A.R. Lab, Dalhousie University, Halifax, Nova Scotia; andAllan Ho:Department of Otolaryngology, University of Alberta, Edmonton, Alberta.

ABSTRACT

BACKGROUND:Patulous eustachian tube (PET) has a major impact on a patient's quality of life. The purpose of this study was to understand mechanisms behind the symptoms, develop treatments based on these, and develop and use a questionnaire to measure changes in PET symptoms with a novel intervention. Our hypothesis is that PET symptoms can be addressed at the level of the eardrum more easily than at the level of the eustachian tube.METHODS:In a population of 14 PET subjects and 6 fresh temporal bones, several investigations were performed. Nasal audiometry was used to measure frequencies preferentially transmitted to the ear in PET subjects. An intervention consisting of mass loading of the eardrum was devised in the temporal bones to damp these frequencies. This was then applied to subjects with PET. A questionnaire was developed and administered to measure the response to this intervention. This questionnaire included the more common symptoms associated with PET, such as echoing sounds, increased environmental sounds, and a plugging sensation in the ear. Mass loading of the eardrum was performed with Blu Tack, a clay-like, nontoxic substance.RESULTS/CONCLUSION:Low frequencies are preferentially transmitted in PET, and eardrum vibrations to these can be mitigated with mass loading. Mass loading in human subjects significantly reduced major symptoms of PET, although temporarily.

Translated AbstractSommaireCONTEXTE:La bance tubaire (BT), ou trompe d'Eustache bante, se rpercute grandement sur la qualit de vie des personnes atteintes. La prsente tude avait pour buts de comprendre les mcanismes sous-jacents aux symptmes, de concevoir des traitements fonds sur ces mcanismes ainsi que d'laborer et d'utiliser un questionnaire visant mesurer les changements de symptmes attribuables une nouvelle intervention. Selon notre hypothse, il est plus facile de traiter les symptmes de la BT la hauteur de la caisse du tympan qu' la hauteur de la trompe d'Eustache.MTHODE:Plusieurs examens ont t effectus chez 14 sujets atteints de BT et sur 6 os temporaux frais. Nous avons procd une audiomtrie nasale afin de mesurer les frquences transmises le plus souvent dans l'oreille des sujets. Une intervention consistant en la mise en place d'une charge dans la caisse du tympan a t pratique dans les temporaux afin d'amortir ces frquences. On a ensuite appliqu le traitement aux sujets. Nous avons labor un questionnaire, puis nous l'avons soumis aux participants afin de mesurer la raction l'intervention. Le questionnaire portait, entre autres, sur les symptmes les plus frquents, associs la BT comme l'cho, l'amplification des bruits ambiants et une sensation de bouchon dans l'oreille. La mise en place d'une charge dans la caisse du tympan a t ralise au moyen d'une substance non toxique, ressemblant de l'argile (Blu Tack).RSULTATS/CONCLUSION:Ce sont les basses frquences qui sont surtout transmises dans la BT, et il est possible d'attnuer les vibrations dans la caisse du tympan par la mise en place d'une charge. L'intervention a diminu sensiblement les principaux symptmes de la BT chez les sujets humains, bien que l'effet ft temporaire.

Keywordsautophony, mass loading, patulous eustachian tube, tympanic membrane.

The eustachian tube (ET) is a structure that connects the nasopharynx with the middle ear. One of the main functions of the ET is to allow ventilation and equalization of middle ear pressure. This seemingly simple function, in fact, requires an extremely complex interplay of anatomy and precisely sequenced contractions of a number of muscles to achieve. At rest, the tube is functionally collapsed to protect the middle ear from nasopharyngeal secretions and negative nasopharyngeal pressures, such as those generated during sniffing. This closed ET also attenuates sound transmission of a person's own voice to the middle ear (autophony). The ET typically opens when a subject yawns or swallows.13In patulous eustachian tube (PET), the ET is abnormally patent, even at rest, and, as a result, it can cause a variety of symptoms that are very frustrating for patients. PET is often defined by the presence of autophony, one of the most frustrating symptoms of an abnormally open ET. The annoyance of autophony can lead to major depression or even suicide.,4Other symptoms of PET include fluctuating aural fullness, audible breathing sounds, and a sensation of a plugged ear.,4It has been theorized that some patients with PET can develop habitual sniffing to try to force ET closure to damp these symptoms.,5The senior author (M.B.) of this study hypothesizes that this mechanism does not so much force closure of the ET as retract the tympanic membrane, and in doing so reduces tympanic membrane vibrations and response to the subject's own voice. In either case, sniffing can result in retraction-type middle ear disease owing to a retracted tympanic membrane from negative pressure in the middle ear.,5In most cases, the cause of PET is idiopathic.6A few predisposing factors include pregnancy, weight loss, stress, anxiety, fatigue, and temporomandibular joint syndrome.,79PET can also be caused by adhesions in the nasopharynx following surgery on the adenoids.,10Sometimes PET can be associated with medications such as diuretics and oral contraceptives. Neuromuscular disorders that cause atrophy, such as multiple sclerosis, stroke, and motoneuron disease, have also been postulated to cause PET.,1013Some patients can be treated with reassurance or treatment of the underlying factors. However, not all patients respond to these techniques. In patients who do not improve, few treatments are satisfactory. Many medical treatments, such as progesterone and iodine, have been tried but largely have not achieved widespread acceptance. Surgical therapies attempted in the past include injections of various substances into the ET opening, including paraffin, Teflon, fat, or Gelfoam.6,14Unfortunately, these methods are either temporary or can lead to serious complications, including cerebral thrombosis and death (owing to inadvertent injection into the carotid artery).,10Other treatments have focused on cauterizing the ET opening, but these have either been unsatisfactory or caused damage to the trigeminal nerve or stricture and stenosis.,10Myringotomy and insertion of a ventilation tube have helped some patients, but others have found that these increased the patient's discomfort.,1517More recently, some authors have started to operate directly on the ET. The abundance of treatment options bears out the reality that there are no simple, effective treatments for PET, although insertion of a ventilation tube is probably the simplest option.Enhancing the confusion, currently, there is no clinical tool for evaluating the subjective severity of symptoms in patients who suffer from PET. A clinical questionnaire would be useful to assist in monitoring the condition and deciding on treatment options and responses to treatment. In other studies, autophony alone has been used as an indicator for assessing the severity of the patulous condition and response to treatment.2We wanted to create a questionnaire to further define the symptoms of PET and then use it clinically to define the response to treatment. Nominally, for the purposes of easy reference, the tool is referred to as the BBK (after the initials of the primary authors) for this article and is shown infig1afig1b. We collated the most common symptoms that have been reported in the literature to create this questionnaire.,2,10,11

Figure 1BBK scale: the questionnaire used to measure the severity of subjective symptoms for patulous eustachian tube.

Figure 1Continued.

The studies reported here stem from the central hypothesis described above, namely that the primary symptoms of PET arise from abnormal tympanic membrane vibrations owing to abnormal transmission of acoustic energy via the PET and that symptoms can be addressed at the level of the tympanic membrane by reducing its vibration responses to transmitted frequencies.Hence, studies reported here consist of two main parts. The first part identifies the frequencies in the transmitted own voice that contribute most to symptoms in patients with PET. To do this, we have used nasal audiometry. In this technique, we measure subjects' auditory thresholds to nasally presented sounds to determine which frequencies are preferentially conducted by the PET. In the second part, we describe methods developed to reduce the tympanic membrane vibrations to these frequencies in fresh cadaveric human models and live human subjects with PET.In particular, this article concentrates on the results of a new model to mitigate the symptoms of PET using tympanic membrane mass loading. We present the results of cadaveric studies that determine the change in frequency response with this mass loading and then clinical results as evaluated with our BBK questionnaire that specifically evaluates PET symptoms before and after mass loading of the tympanic membrane in a prospective cohort study. Other components of these studies will be published in more detail in companion articles.

Materials and MethodsDefining the PET PopulationThe PET was abstracted from the population of patients who were referred to the specialized ET Disorders Clinic at the Queen Elizabeth II Health Science Centre in Halifax, Nova Scotia (staffed by senior authors D.K. and M.B.), who were seen between January 2008 and March 2009.Patients were diagnosed with PET if they met accepted diagnostic criteria. Specifically, all patients had to exhibit clear autophony made better by lying down without any symptomatic evidence of superior canal dehiscence (which can cause similar symptoms). In addition, most had endoscopic evidence of an abnormally patent ET opening on fibre-optic examination of the ET valve region and/or movement of the tympanic membrane on forced respiration with one nostril occluded to increase the range of nasopharyngeal pressure changes. Patients were excluded from the study if they had previous surgical treatment for PET, including cauterization of the ET opening and injection of any substance such as Gelfoam or collagen analogues into the ET opening. They were also excluded if they did not have an intact tympanic membrane. All patients had medically refractory PET symptoms for 1 year or more. During the history, patients were screened for potentially reversible risk factors for PET.Nasal Audiometry StudyTo determine the range of frequencies that were most likely to be conducted to the ear via the PET, nasal audiometry was performed.4,18This technique measures the threshold for detection of a tone, analogous to an audiogram, when the tone is presented to the nasal orifice with the contralateral nares occluded. A 50% detection criterion is used. Those frequencies preferentially conducted via the PET should have lower thresholds for detection in PET subjects compared with non-PET subjects. It should be noted that those frequencies identified with the lowest thresholds overall are not necessarily those preferentially conducted up the ET because this reduced threshold could also result from resonances in the nasopharynx or nasal cavities. Hence, the differences between PET and non-PET subjects are the most important outcome measure.With nasal audiometry, we compared 10 subjects with symptomatic PET in at least one ear with 10 normal participants with normal hearing and no aural symptoms. The technique used was similar to that described by Kano and colleagues using insert phones in the nares and with a calibrated audiometer providing the sound source.4Cadaveric Fresh Temporal Bone StudyWe wanted to change the frequency response of the tympanic membrane and specifically to change the frequencies that were identified as being important in the nasal audiometry studies. To do this, we devised a fresh cadaveric temporal bone model. Fresh temporal bones harvested within 24 hours of death, although difficult to secure, provide vibration characteristics similar to the living human ear.19Vibration characteristics of the tympanic membrane in six human cadaver temporal bones were measured using a Scanning Laser Doppler Vibrometer (PSV400, Polytec, Tustin, CA). All temporal bones were prepared by performing a cortical mastoidectomy and posterior tympanotomy with removal of the facial nerve to get better exposure of the stapes. The external auditory canal was drilled away and a brass rod was glued with dental cement on top of the annulus to replace it. Calibrated ER-2 earphones and ER-7 microphones (Etymotic Research, Elk Grove Village, IL) were glued into the brass ring at 1 cm and 2 mm from the tympanic membrane, respectively. In addition, an ER-2 earphone was placed in the enlarged ET so that it could just be seen in the protympanum. During recordings, the sound pressure in the middle ear was measured with another ER-7 microphone. The sample was placed in a latex shell to prevent drying and was sealed with dental cement. Bones were kept well hydrated with saline throughout recordings.We attempted to investigate mass loading of the tympanic membrane as a possible measure to reduce eardrum vibrations. To do this with a substance that was nontoxic, we measured vibration characteristics before and after application of Blu Tack (Bostik Ltd., Stafford, UK), which is a complex mixture of hydrocarbons and a pliable, putty-like household adhesive. This clay-like substance is mildly adhesive and nontoxic and often used to hang paper posters. The Blu Tack was placed on the posterior quadrants of the tympanic membrane (fig2). The Scanning Laser Doppler Vibrometer was used to make noncontact vibration measurements of the stapes footplate. The vibration amplitude and frequency were extracted from the Doppler shift of the laser beam frequency owing to the motion of these objects elicited by a frequency sweep from 0.25 to 8 kHz at 90 dB SPL coming through the ER-2 earphones. Data were exported toMATLAB(Mathworks, Natick, MA) for further data analysis.

Figure 2Clinical photograph of a right eardrum with Blu Tack on the posterior third of the eardrum.

Clinical Mass Loading of Tympanic Membrane StudyPatients diagnosed with PET were asked to complete a pretreatment questionnaire using the BBK scale to determine the severity of their symptoms of PET. Once complete, the patients' affected ear or ears were treated. Treatment consisted of placing a small piece of Blu Tack similar tofig2(which is from a live patient) on the posterior quarter to posterior half of the eardrum. The placement of Blu Tack was performed under a microscope looking through a speculum while the patient was in a supine position. No anesthetic was used for the procedure as it was generally well tolerated. A small piece of Blu Tack was moulded to shape and placed carefully on the tympanic membrane using a blunt microspatula. If the patient had two affected sides, then the procedure was repeated on the opposite ear.Fourteen patients underwent this procedure. Patients were asked to go home and fill out a second BBK questionnaire within a day or two of having the Blu Tack placed. They were given a copy of their premass loading BBK questionnaire for comparison. The results were compared. Statistical analysis of the data was performed usingSAS/STATsoftware (SAS Institute, Cary, NC) for medical statistics. Pairedt-tests were used for data analysis for pre- and posttreatment measures. Apvalue < .05 was considered to indicate statistical significance, with Bonferroni correction as needed for multiple comparisons.

ResultsDemographicsFourteen patients with PET were studied, nine females (64.3%) and five males (35.7%). The mean age was 43.57 years. Five patients had bilateral involvement and nine patients had unilateral involvement. Eleven BBK questionnaires had all sections completed, and some subjects missed some of the questions, so there are not 19 data points (19 ears) for each outcome measure. Not all patients underwent all tests.Nasal AudiometryThe results of nasal audiometry showed that in comparing 10 normal ears with 10 PET ears, there was preferential conduction of the lower frequencies up the ET in PET, as evidenced by the reduced thresholds at these frequencies (fig3), with little difference above 2 kHz between the two groups.

Figure 3Results of nasal audiometry in 10 ears with patulous eustachian tube (PET) compared with 10 normal ears. The upper line represents the average pure-tone normal audiometric thresholds of the groups. The normal subjects' results are shown with standard deviation. The PET patients showed a lower threshold (ie, increased conduction of sound) than normal subjects at the lower frequencies.

Cadaveric Eardrum Studiesfig4shows the results of vibration measurements from the stapes footplate in six fresh temporal bones. It can be seen that mass loading primarily affects the vibration responses in the low frequencies, those that have been identified from nasal audiometry as being preferentially conducted in PET

Figure 4Normalized stapes footplate vibration amplitudes before and after application of mass loading to the tympanic membrane. EAC=external auditory canal.

Clinical Eardrum Mass Loading StudiesTable 1shows the raw results of the subsections of the questionnaire before and after the eardrum mass loading, with a representing the average score prior to mass loading and b representing the average score after mass loading. Standard deviation, standard error, and 95% confidence intervals are reported as well.Table 2focuses on the differences before and after mass loading of the eardrum in the six major symptoms, echoing of own voice in the ear (echo), hearing own breathing in the ear (breathing), plugged feeling in the ear (plugged sensation), hearing environmental sounds too loudly (environmental sounds), symptoms improving when lying down (lying down), sniffing making symptoms better (sniffing), and pressure in the ear (applying pressure), as well as global percentage improvement subjectively estimated by patients (overall), from the BBK questionnaire infig1afig1b. Negative values represent improvements in scores. Clearly, there are large improvements in the scores in echo, breathing, plugged sensation, and enviromental sounds.

Table 1Average Scores and Descriptive Statistics for the BBK Scale Before and After Mass Loading of the Eardrum with Blu Tack

Table 2Mean Difference between Eardrum Pre and PostMass Loading Scores and Minimum and Maximum Differences Encountered

Table 3andfig5show the results of pairedt-tests on these variables before and after mass loading. The results for echo, breathing, plugged sensation, enviromental sounds, and overall are clearly highly statistically significant at the .001 level, even with Bonferroni correction. The variable total, the sum of these four variables, is also very significantly different. However, there is no significant change in lying down, sniffing, or applying pressure.

Figure 5Results of the BBK questionnaire before and after mass loading the tympanic membrane with Blu Tack. There are significant reductions in symptoms of voice echoing, hearing breathing in the ear, plugged feeling, and sensitivity to environmental sounds after mass loading.

Table 3Results of Paired t-Tests for Significant Differences between the Pre and PostMass Loaded Results

DiscussionMost PET studies involve treatments targeted at the ET orifice. These various treatments have generally tried to cause inflammation of the ET orifice. Unfortunately, these results are typically transient.20Our studies have flowed systematically from our hypothesis that PET symptoms can be treated at the level of the eardrum, which is much more accessible than the ET. We have measured the transmitted frequencies, devised an intervention in the temporal bone laboratory that targets these frequencies, and then applied this treatment to patients with successful results.Our results using nasal audiometry showed that the auditory thresholds were typically elevated in the low-frequency region in PET subjects. Our results confirmed that these previous studies showing that sound patency in patents with PET tend to be more pronounced at low frequencies.4,17It is relatively easy to understand why the symptoms echo and breathing get better with mass loading. Echo is a response of the tympanic membrane to low-frequency vibrations and is damped by the mass loading. Similarly, breathing is a very low-frequency stimulus, and the mass limits excursion of the eardrum to static pressure changes. It is less clear why plugged sensation and sensitivity to enviromental sounds improve. The senior author's (M.B.) hypothesis (based on observation over some years) is that many of these patients develop thin atrophic ballooning segments of the eardrum that may respond abnormally to external sounds as well as the patient's own sounds transmitted via the PET. This may lead to a plugged feeling and a sensation that loud environmental sounds do not sound crisp and are muffled. In fact, just focusing a small piece of the Blu Tack directly on the atrophic segment of the eardrum alone often dramatically reduced these symptoms of plugged feeling and sensitivity to enviromental sounds.The duration of the efficacy of mass loading was highly variable. Two patients had results lasting over 4 months, but the majority of patients had results lasting only 2 to 4 weeks. In patients whose eardrums were highly mobile with respiration, the Blu Tack was easily dislodged and sometimes lasted only days. Patients were usually immediately aware of when it came off the eardrum. Nevertheless, this change in symptoms represented an important confirmation of the diagnosis, with immediate relief in true PET patients. Given that this can be a subtle diagnosis sometimes, with nonspecific symptoms in early cases, an improvement in symptoms after application of Blu Tack is a useful diagnostic tool. The intervention itself is easy and nonharmful, and we have encountered no adverse effects in 2 years of use of this technique. One or two patients seemed to experience residual relief of symptoms even when the mass loading came off the eardrum, with marked reduction in symptoms even without reloading. We are currently experimenting with changing the frequency response of the eardrum with a KTP laser and have successfully treated three subjects long term for PET with this, subjects who were initially identified by their responses to mass loading. In this way, mass loading may function to screen patients for other, potentially longer-lasting treatments.To our knowledge, there is no standard questionnaire for PET to help guide treatment and symptom severity. Studies in the past have used improvement in autophony symptoms as their main outcome measure.2We developed the BBK scale as a first step in this process. Clearly, this is a tool that needs further work to refine and validate. However, it proved quite capable of capturing changes in severity scores with mass loading of the eardrum. It is important to note that not all patients had complete resolution of symptoms with application of Blu Tack. There was a range of responses that varied from minimal response to complete resolution.We are not advocating the use of Blu Tack in particular-any safe, nontoxic mass that will adhere to the tympanic membrane will function, and we have also used other materials (not reported here) in our learning curve over the last few years. In our study, no patients had adverse reactions to the Blu Tack. The main reason for choosing this material is that it is nontoxic and a common, pliable, putty-like material that could be easily moulded to shape and placed on the eardrum. To our knowledge, this has not been previously done. Blu Tack has been used safely in the past as an earplug.21Currently, it is too early to advocate for this treatment until further research is performed, particularly to determine the long-term effects of mass loading as a treatment for PET. Randomized controlled trials are ideally needed before widespread adaptation of this technique.

ConclusionsMass loading the eardrum with Blu Tack decreased the overall symptoms of PET. This seems to function by lowering the low-frequency responses to sound. This was initially shown in the temporal bone laboratory in fresh human bones by mass loading the tympanic membrane and measuring the change in vibrational characteristics of the tympanic membrane and stapes. Subsequently, the treatment was applied clinically. This was shown using a novel symptom reporting scale (the BBK). Specifically, patients found that there was an improvement in autophony, hearing breathing sounds, aural fullness, and increased environmental sounds. These results were short term, and future research is needed to provide a longer-term solution, but they do represent a novel treatment option and a change in paradigm from limiting air flow up the ET, which has been commonly focused on.

AcknowledgementsFinancial disclosure of authors and reviewers: None reported.

References

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Figure 1.BBK scale: the questionnaire used to measure the severity of subjective symptoms for patulous eustachian tube.

Figure 1.Continued.

Figure 1.BBK scale: the questionnaire used to measure the severity of subjective symptoms for patulous eustachian tube.

Figure 2.Clinical photograph of a right eardrum with Blu Tack on the posterior third of the eardrum.

Figure 3.Results of nasal audiometry in 10 ears with patulous eustachian tube (PET) compared with 10 normal ears. The upper line represents the average pure-tone normal audiometric thresholds of the groups. The normal subjects' results are shown with standard deviation. The PET patients showed a lower threshold (ie, increased conduction of sound) than normal subjects at the lower frequencies.

Figure 4.Normalized stapes footplate vibration amplitudes before and after application of mass loading to the tympanic membrane. EAC=external auditory canal.

Figure 5.Results of the BBK questionnaire before and after mass loading the tympanic membrane with Blu Tack. There are significant reductions in symptoms of voice echoing, hearing breathing in the ear, plugged feeling, and sensitivity to environmental sounds after mass loading.

VariablenMeanSDSELower 95% CL for MeanUpper 95% CL for Mean

Echo a177.742.390.586.518.96

Echo b173.262.440.592.014.52

Breathing a177.682.110.516.598.76

Breathing b173.592.260.552.534.75

Plugged sensation a177.122.910.715.628.61

Plugged sensation b173.292.140.522.194.40

Enviromental sounds a156.872.690.695.388.36

Enviromental sounds b153.972.550.662.555.38

Lying down a144.863.941.052.587.13

Lying down b144.543.921.052.276.80

Sniffing a166.133.550.864.287.97

Sniffing b165.783.620.903.357.71

Applying pressure a164.383.500.882.516.24

Applying pressure b164.943.860.962.886.99

CL = confidence limit.This table includes only those ears that have a premeasurement (variable a) and a postmeasurement (variable b).

Table 1.Average Scores and Descriptive Statistics for the BBK Scale Before and After Mass Loading of the Eardrum with Blu Tack

VariableMeanSDMinimumMaximum

Echo4.472.71100

Breathing4.092.628.50

Plugged sensation3.822.680

Enviromental sounds2.93.0172

Lying down0.322.0762

Sniffing0.342.8484

Applying pressure0.561.7924

Overall73.0928.5912.5100

Table 2.Mean Difference between Eardrum Pre and PostMass Loading Scores and Minimum and Maximum Differences Encountered

VariablenMeanSEp > |t|*ImprovementsLower 95% CL for MeanUpper 95% CL for Mean

Echo174.470.66< .0001Yes5.873.08

Breathing174.090.63< .0001Yes5.432.74

Plugged sensation173.820.63< .0001Yes5.162.49

Enviromental sounds152.90.78.0023Yes4.571.23

Lying down140.320.55.5715No1.520.87

Sniffing160.340.71.6358No1.861.17

Applying pressure160.560.45.2274No0.391.52

Total1515.872.57< .0001Yes21.3910.35

Overall1173.098.62< .0001Yes53.8892.3

CL = confidence limit.*p values based on paired t-test.Significant improvements were observed for echo, breathing, plugged sensation, and enviromental sounds. No improvements were noted in lying down, sniffing, or applying pressure.The measure total was calculated by summing the improvements for echo, breathing, plugged sensation, and enviromental sounds but not lying down, sniffing, or applying pressure.The overall measure represents estimated percent improvement.Both the combined measure (total) and the overall percent measure of improvement showed improvement with the application of Blu Tack (p < .0001).

Table 3.Results of Paired t-Tests for Significant Differences between the Pre and PostMass Loaded Results