NYU School of Medicine Evaluation of the Kanso Sound Processor: Clinical Trial Results

William Shapiro, AuD, CCC-A

Disclosures •  Audiology Advisory Board- Cochlear Corporation

•  IDE study sponsored by Cochlear Americas

1.  Able to describe Australian clinical study speech outcomes 2.  How does hearing performance with Kanso compare to that

with a BTE processor? 3.  Able to describe US and Australian qualitative outcomes with

regard retention, comfort and discretion

Goals for presentation

KANSO Overview

Dual microphones

KEY TECHNOLOGIES: •  Dual microphones •  SmartSound® iQ with

SCAN •  Wireless technology

capability •  Cable free, single unit with

one button

Disclaimer: The Nucleus Kanso Sound Processor is not approved for use in all countries. Please speak to your Cochlear representative for more information.

Mumbai

New Delhi

Kozhikode

Sydney

New York

Oklahoma

Denver

100 recipients across 8 sites involved in global clinical evaluations

Kanso clinical experience

1.  How does hearing performance with Kanso compare to that with a BTE processor?

2.  How satisfied are Kanso users with retention, comfort and discreetness?

Research questions

•  Upgrade study with take-home experience •  20 adult subjects

•  Objective: To evaluate acceptance of the Kanso processor by experienced users of a BTE processor

•  2 phases

•  Measures: –  Speech performance testing in quiet and noise

–  Subject questionnaire including comfort, retention, subjective performance and battery life ratings

Australian adult study

•  Upgrade study with take-home experience •  30 adult subjects

•  2 study visits •  3 centers

–  NYU Langone Medical Center

–  Rocky Mountain Ear Center

–  Hearts for Hearing

•  Objective: To evaluate acceptance of the Kanso processor by experienced users of a BTE processor

United States adult study

•  Average age at study enrollment: 57.1years (range 32-85 years)

•  Gender: 10 males, 10 females

Study demographics Australian study US study

•  Average age at study enrollment: 52.8 years (range 15-82 years)

•  Average age at implantation: 47.2 years (range 5-78 years)

•  Additional demographics: –  Average duration of device use: 5.7 years (3

months-15 years)

–  Gender: 17 males, 13 females

Microphone directionality with Kanso

Sounds from the front, overall sensitivity, and the standard frequency response of Kanso matches closely with a BTE (Nucleus 6)

•  For noisy conditions, zoom directionality is optimized for OTE placement

•  This produces variations in microphone sensitivity patterns between devices

Zoom directionality

Kanso performance is similar to Nucleus 6 in quiet and noise1

Kanso performance

CNC words | 50 dB SPL | N=20

Target Speech

4TB | 65 dB SPL | S0N0 | N=20

Target Speech & Noise

1. Mauger SJ, Jones M, Nel E, Del Dot J. Clinical outcomes with the Kanso off-the-ear cochlear implant sound processor. Int J Audiol. Published online 09 Jan 2017

Overall hearing performance

AUS study N=20 US study N=30

76%

Speech in noise

AUS study N=20 US study N=30

80%

Qualitative data-Subject hearing performance

Same or better rating than BTE processor

N=23 N=22

N=16 N=17

Qualitative data-Retention and discretion Same or better rating than BTE processor

Retention

AUS study N=20 US study N=30

62%

Discretion

AUS study N=20 US study N=30

86% N=27

N=16

N=20

N=11

rated the look and feel of Kanso to be the same or better than their BTE

rated comfort with Kanso the same or better than their BTE sound processor

88%

90%

Kanso user survey feedback

•  Speech outcomes are similar between Kanso and BTE processors in co-located noise

•  Qualitative data indicates the same or better rating for Kanso with regard to comfort, discretion, hearing performance and retention.

Summary

16

1.  Mauger SJ, Jones M, Nel E, Del Dot J. Clinical outcomes with the Kanso off-the-ear cochlear implant sound processor. International Journal of audiology.2017 Jan 9:1.

2.  Comfort and Listening Benefits of the Kanso Off-The-Ear Sound Processor in Children. Phillips B., Plasmans A., & Dhooge I. Cochlear White Paper 2016. D1110229 ISS1 NOV16.

References

Acknowledgements

I would like to thank the Rocky Mountain Ear Center and Hearts for Hearing

NYU School of Medicine 18

NYU Cochlear Implant Center • Co-Directors of the Cochlear Implant Center •  J. Thomas Roland Jr., M.D. •  Susan Waltzman, Ph.D.

• Surgeons •  J. Thomas Roland Jr., M.D. • Daniel Jethanamest, M.D. • David Friedmann, M.D. •  Sean McMenomey, M.D. • Baishakhi Choudhury, M.D. -Fellow

• Cochlear Implant Audiologists • William Shapiro, Au.D. –Supervisor • Betsy Bromberg, M.A. • Catherine Flynn, AuD •  Janet Green, Au.D. •  Laurel Mahoney, Au.D. • Alison Rigby, Au.D. • KaitlynTona, Au.D. •  Lavin Entwisle- audiology intern

• Educational Coordinator • Rose Drous, M.Ed., Cert AVT

• Speech Language Pathologist •  Sara Toline, M.A.

• Research • Mario Svirsky, Ph.D. •  Susan Waltzman, Ph.D. • Arlene Neuman, Ph.D. • David Landsberger, Ph.D. •  Elad Sagi, Ph.D. • Mahan Avadpour, Ph.D. • Monica Padilla-Velez, Ph.D. • Annette Zeman, Au.D. • Natalia Stupak, Au.D. • Ann Todd, PhD • Roozbeh Soleymani •  Jonathan Neukam

• Patients

MAXIMIZING PERFORMANCE IN COCHLEAR IMPLANT RECIPIENTS – PROGRAMMING CONCEPTS

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