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Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J. Eric Lupo MD, MS Allison Biever, AuD David C. Kelsall, MD CI2017 – San Francisco, CA - Jul 28 2017 Rocky Mountain Cochlear Implant Center Colorado Neurological Institute Englewood, Colorado, USA CNI Colorado Neurological Institute
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Page 1: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays:

Comparison of Performance Outcomes

J. Eric Lupo MD, MS Allison Biever, AuD David C. Kelsall, MD

CI2017 – San Francisco, CA - Jul 28 2017 Rocky Mountain Cochlear Implant Center

Colorado Neurological Institute Englewood, Colorado, USA

CNI Colorado Neurological Institute

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Presenter Disclosure Information

u  No relationships to disclose

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u  Round window insertion with a slim straight electrode may be less traumatic and more likely to preserve hearing

u  Perimodiolar (curved) electrode arrays tend to have lower neural response telemetry (NRT) thresholds, T and C levels and consume less power

u  Perimodiolar electrodes may provide improved hearing performance from a more focused, precise stimulation

u  Do the programming parameters and outcome data for subjects differ by type of CI electrode array?

Introduction

Page 4: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Methods

u  IRB-exempt, retrospective comparative study

u  Three groups of subjects u  Perimodiolar array (CI24RE or CI512) u  Thin straight array (CI422/522) u  Slim modiolar array(CI532)

u  Study period July 2012 to Jun 2017 of surgeries performed at a single CI center

u  FDA criteria met for implantation

u  Assessment u  Programming parameters - T and C Levels as well as NRT thresholds

u  AzBios sentences and CNC word performance at 3, 6, and 12 months post-activation

u  Hearing preservation

u  Statistical comparison by 1-way ANOVA

Page 5: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Demographics

Groups Subjects Age(years)Atsurgery

Perimodiolar(CI24RE/CI512)

N=64 Range:18-90yrsMean:62yrs

Thinstraight(CI422/CI522)

N=62

Range:20-91yrsMean:65yrs

Slimmodiolar(CI532)

N=35 Range:29-89yrsMean:61yrs

TOTAL N=160 Range:18-91yrsMean:63yrs

Page 6: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

T and C levels – Initial Activation

0

2

4

6

8

10

12

14

16

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

T Le

vel (

nC/p

h)

Electrode No.

Average T Levels by Implant Type

CI24Re (n=64) CI532 (n=34) CI422 (n=62)

0

2

4

6

8

10

12

14

16

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

C Le

vel (

nC/p

h)

Electrode No.

Average C Levels by Implant Type

Page 7: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

T and C levels - 6 months

0

2

4

6

8

10

12

14

16

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

T Le

vel (

nC/p

h)

Electrode No.

Average T Levels by Implant Type

CI24RE (n=64)

CI532 (n=25)

CI4222 (n=62)

0

2

4

6

8

10

12

14

16

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

C Le

vel (

nC/p

h)

Electrode No.

Average C Levels by Implant Type

Page 8: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

NRT thresholds by implant type N

RT T

hres

hold

(CL

Uni

ts)

Electrode No.

140 145 150 155 160 165 170 175 180 185 190

1 2 3 4 5 6 7 8 9 10 11 12 13 14 15 16 17 18 19 20 21 22

Average NRT Thresholds at 3 mo. by Implant Type

CI422 (n=57)

CI24RE/CI512 (n=57)

CI532 (n=28)

Page 9: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Outcome Data – Sentences in Quiet

SCO

RE

%

Pre 3m 6m 12m

% Co

rrec

t

No statistically significant performance difference seen at 3m, 6m, 12m

3m: F(2,152) = 2.691, p = 0.071 12m: F(2,82) = 0.669, p = 0.52 6m: F(2,112) = 2.89, p = 0.06

Pre 3m 6m 12m Pre 3m 6m 12m

Page 10: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Outcome Data – Words in Quiet

% Co

rrec

t

No statistically significant performance difference seen at 3m, 6m, 12m 3m: F(2,114) = 0.6142, p = 0.54 12m: F(2,76) = 0.6271, p = 0.52 6m: F(2,105) = 1.203, p = 0.3

Pre 3m 6m 12m Pre 3m 6m 12m Pre 3m 6m 12m

Page 11: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

0

10

20

30

40

50

60

56 46 50

% Co

rrec

t

Perimodiolar Thin Straight Slim modiolar

No statistically significant performance difference seen F(2,66) = 1.995, p = 0.14

Outcome Data – Sentences in Noise

Page 12: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Hearing Preservation - Perimodiolar LFPTA(dBHL)

Pre-op(%)

IniGal–2wk(%)

Latest–11m(%)

<25 0 0 0

26-40 1 0 0

41-55 4 3 0

56-70 22 3 6

71-85 22 16 8

>85 51 78 86

TotalN 64 37 51

LF PTA - Low Frequency Pure Tone Average (250 and 500 Hz) Initial Activation at 2 weeks Latest follow up – average 0.9y range 0.5-3.5y

LF PTA <85 dB: 31/64 pt - 49% LF Hearing Preservation: 7/31 pt - 22%

Page 13: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Hearing Preservation -Thin straight

LFPTA(dBHL)

Pre-op(%)

IniGal–2wk(%)

Latest–12m(%)

<25 5 3 3

26-40 10 2 2

41-55 21 3 2

56-70 29 8 6

71-85 22 21 13

>85 13 63 74

TotalN 62 59 62

LF PTA - Low Frequency Pure Tone Average (250 and 500 Hz) Initial Activation at 2 weeks Latest follow up – average 1.0y range 0.5-3.3y

LF PTA <85 dB: 54/62 pt - 87% LF Hearing Preservation: 16/54 pt - 30%

Page 14: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Hearing Preservation - Slim modiolar LFPTA(dBHL)

Pre-op(%)

IniGal-2wk(%)

Latest-4m(%)

<25 0 0 0

26-40 0 0 0

41-55 22 7 4

56-70 16 11 19

71-85 31 22 7

>85 31 59 70

TotalN 35 27 27

LF PTA - Low Frequency Pure Tone Average (250 and 500 Hz) Initial Activation at 2 weeks Latest follow up – average 0.3y range 0.5-1y

LF PTA <85 dB: 24/35 pt - 69% LF Hearing Preservation: 8/24 pt - 33%

Page 15: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Slim Modiolar Audiological Experience

u  With the slim modiolar array, impedances are more uniform, and tend to be low. Unusual to have electrodes out of voltage compliance.

u  Because electrodes are in voltage compliance, and T-levels are relatively uniform, faster programming time noted. Fewer T-levels need to be measured and interpolation is more accurate.

u  Battery power consumption appears lower, leading to longer battery life, which is extremely important for Kanso recipients.

u  Despite hearing preservation with the thin straight and slim modiolar, patients are preferring to utilze the Kanso processor and forgo an acoustic component.

Page 16: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Conclusions u  T and C values similar between perimodiolar and slim modiolar

electrode

u  No statistically significant difference in sentence and word performance amongst electrodes

u  To date with early data, LFHP possible with slim modiolar at rate similar to thin straight

u  Early Audiological experience

Study Limitations u  Limitations inherent in retrospective review

u  Continual accrual of data for the slim modiolar array

u  Confounders not controlled for ie. Surgical approach

Page 17: Perimodiolar, Slim Straight and Slim Modiolar Cochlear ... · Perimodiolar, Slim Straight and Slim Modiolar Cochlear Implant Electrode Arrays: Comparison of Performance Outcomes J.

Acknowledgements

u  Judith Stuckey MS – CNI

u  Rocky Mountain Ear Center Audiologists

u  Megan Read AuD

u  Rebecca Kyllonen AuD

u  Shawna Steib AuD

u  Kevin Peterson – 4th year RMEC/Cochlear Corp AuD extern

u  Kimberly Nix – Cochlear Corp – T/C, NRT data collection

u  Allysa Biever – Data collection

CNI Colorado Neurological Institute


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