Cochlear Implants
by Wade Colburn

Developing innovations with a proven track record of quality

September 27, 2019
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By Wade Colburn, Product Manager – Cochlear Implants

Cochlear is committed to the quality of our products and how these products advance hearing performance and quality of life for those affected by hearing loss. With a long-standing track record of reliable implants and durable sound processors2,we focus on delivering quality hearing solutions to meet patient needs.

Since 1982 when Rod Saunders became the first recipient of the Nucleus cochlear implant system3, Cochlear has concentrated on implant and sound processor innovations.  Here’s a glimpse of these innovations over time:

Implant Innovations:

Over the years, implants have improved in many ways, with notable innovations including:

  • Creation of a wide range of electrode variants for varying patient anatomy including the development of perimodiolar electrode arrays with proven performance benefits4,5,6
  • Development of thin and discreet implants reducing the need to drill and improving patient aesthetics
  • Design of an implant with a removable magnet with access to MRI for over 20 years*
  • Enhancement of the design elements and shape to reduce biofilm formation

However, while innovation has been a key focus area, the reliability of the implant over time remains one of the most important features of the Nucleus implant.  But this is nothing new for Cochlear – as those implanted in 1988 with our original implant technology are still able to benefit from our current sound processor offerings and innovations. Yet our commitment to quality means we will continue working to improve the lifespan of each implant generation . We have strived to improve the lifespan of each implant generation so that someone that was implanted in 1988 can still benefit from that original implant technology paired with today’s sound processors.

Processor Innovations:

Sound processor technology has also been transformed over time.  Key innovations of Cochlear sound processors include:

  • Automaticity enhanced sound processing, driving hearing improvement with scene classification and microphone directionality 7
  • Transitioning from body-worn sound processors to the smallest behind-the-ear and off-the-ear sound processors8
  • Chip technologies driving improvement in battery life9, targeted for all-day hearing in a connected world.
  • Direct connectivity of processor to iPhone® and Android™ phones10
  • Datalogs to drive evidence-based clinical decision making
  • Empowerment of patients to monitor and control their device between appointments with the Nucleus Smart App on their smartphone
  • Processors that are water resistant with adventure-proof accessories for hearing whether wet, dry or in between.±

Quite remarkably, Cochlear has designed solutions that make living with a cochlear implant easier, while still maintaining a durable, quality product.  The creation of smaller, smarter and more efficient sound processors has allowed Cochlear to push the cochlear implant industry into a new era. Cochlear promises high quality upgrades that impact performance and lifestyle through backwards compatibility availability.

As the most implanted cochlear implant system with over 395,000 registered systems worldwide2, Cochlear has driven the industry forward with innovations without sacrificing quality.

Historically in the cochlear implant industry, quality has primarily only been measured as implant reliability and all other assessments of quality have been subjective. Reliability reporting has historically been reported based on the European Consensus Statement, but not all manufacturers maintained compliance. 

Cochlear is now excited to also report in compliance with a new standard for the cochlear implant industry – ANSI/AAMI CI86: 2017 Cochlear implant systems: requirements for safety, functional verification, labeling and reliability reporting.  In accordance with this standard, quality of both implants and processors can be assessed. 

For implants, our new reporting measurement will be reported as the Cumulative Removal Percentage (CRP).  This new measurement will look at all implants that have been removed for any reason, including infection. The Profile series, with over 70,000 devices implanted, has a CRP of 1.21%, meaning that 98.79% of implants remain working within 5 years.

For the first time ever, processor reliability is being reported as Failed Component Return Rate (FCRR), which is a percentage calculated by comparing the number of faulty processors returned within a month compared to the cumulative sales of the sound processor over a period of up to 24 months. For Nucleus 7, the average FCRR is .2% over 16 months compared to Nucleus 6, with an average FCRR of .8% average over 24 months.

Check out this example of how the FCRR is calculated (not real numbers):

To learn more about reliability reporting and download our latest reliability report in compliance with ANSI/AAMI CI86.  For more information on the difference between the European Consensus Report and ANSI/AAMI CI86, click here.

About the author: Wade is the Product Manager for Cochlear Implant product portfolio within Cochlear Americas.  Wade’s responsibilities include product positioning and messaging, life-cycle management, new product launches and surgical support and training. Wade has recently joined Cochlear, but comes from an engineering background with the medical device field, including previous otology experience. 

*Cochlear has had MRI access dating back to 1997.  With removal of the magnets, Freedom and Profile series implants are approved for 1.5T and 3.0T MRI’s. The latest implant generation, Profile Plus, allows for 1.5 T and 3.0 T without magnet removal or compression.

±The Nucleus 7 Sound Processor with Aqua+ is water resistant to level IP68 of the International Standard IEC60529. This water protection rating means that the sound processor with the Aqua+ can be continuously submerged under water to a depth of 3 m (9 ft and 9 in) for up to 2 hours. This water protection only applies when you use a Cochlear Standard Rechargeable Battery Module or Cochlear Compact Rechargeable Battery Module.

References:

  1. D1593476. Cochlear Nucleus Implant Reliability Report. Volume 17. December 2018.
  2. D1599672. Cochlear Nucleus Reliability Report (Reporting to ANSI/AAMI CI86 Standard). Volume 1. September 2019.
  3. https://www.cochlear.com/intl/about/company-information/history-of-innovation
  4. Hughes, ML, Abbas, PJ. Electrophysiological channel interaction, electrode pitch ranking, and behavioral threshold in straight versus perimodiolar cochlear implant electrode arrays. J Acoustic Soc Am. 2006; 119(3):1538-47.
  5. Cohen L., Richardson L., Saunders E., Cowan R. Spatial spread of neural excitation in cochlear implant recipients: comparison of improved ECAP method and psychophysical forward masking. Hearing Research. 2003; 179 (1-2):72-87.
  6. Holden LK, Finley CC, Firszt JB, Holden TA, Brenner C, Potts LG, et al. Factors affecting open-set word recognition in adults with cochlear implants. Ear Hear. 2013; 34(3):342-60
  7. Cochlear Limited. D1296247. CLTD 5620 Clinical Evaluation of Nucleus 7 Cochlear Implant System. 2017, Sept; Data on file
  8.  Cochlear Limited. D1190805. CP1000 Processor Size Comparison. 2019, Apr; Data on file
  9. Cochlear Limited. D1140877. Battery Life and Power Consumption Comparison between CP1000, CP900 Series and CP810 Sound Processors. 2017, Sept; Data on file.
  10. Compatibility can be found here: hhtp://www.cochlear.com/compatibility

The Cochlear Nucleus 7 Sound Processor is compatible with iPhone, iPad and iPod touch. Apple, the Apple logo, FaceTime, Made for iPad logo, Made for iPhone logo, Made for iPod logo, iPhone, iPad Pro, iPad Air, iPad mini, iPad and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.

App Store is a service mark of Apple Inc., registered in the U.S. and other countries.

Android and Google Play are registered trademarks of Google Inc. The Android robot is reproduced or modified from work created and shared by Google and used according to terms described in the Creative Commons 3.0 Attribution License.

The Cochlear Nucleus Smart App is available on App Store and Google Play. For complete smartphone compatibility information, please visit www.cochlear.com/compatibility.

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TECH Talk: Beyond One Ear – A Case Study with Dr. Shapiro

May 15, 2019

TECH Talks

In his latest TECH Talk, Bill Shapiro Au.D., Supervising Audiologist of the NYU Cochlear Implant Center, discusses the importance of thinking ‘Beyond One Ear’.

Dr. Shapiro explains that evolving candidacy criteria and technology development mean that professional understanding and patient counseling regarding either a bilateral or bimodal solution is critical to maximizing patient outcomes.

Focusing on the experience of his patient, Dr. Shapiro describes the case of a unilateral Nucleus™ implant recipient who was fitted with a ReSound hearing aid on the contralateral side (known as a Cochlear™ Smart Bimodal solution) Over the course of the first year, the patient continued to experience improved outcomes, including a ‘bimodal bump’ from the hearing aid. Recently she started to have reduced performance on the non-implanted side, so Dr. Shapiro will soon see her for a sequential evaluation and expects she will likely move to a bilateral implant.  He feels this is a reasonable progression and that professionals and patients should always consider how to maximize the performance of both ears.

Dr. Shapiro continues on to suggest that audiologists should refer anyone that may be a candidate to a cochlear implant center, stressing that even patients with one better ear may benefit from a cochlear implant. “You cannot over-refer,” says Dr. Shapiro, reinforcing that with expanding criteria and developing technology, cochlear implantation should be considered as a treatment pathway.

For more TECH Talk videos from industry experts, including additional ‘Beyond One Ear’ content from Dr. Shapiro, please stay up-to-date with the Cochlear ProNews blog and visit our TECH Talks page.

© Cochlear Limited 2019. All rights reserved. Hear now. And always and other trademarks and registered trademarks are the property of Cochlear Limited or Cochlear Bone Anchored Solutions AB. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.
Please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information. Views expressed are those of the individual. Consult your health professional to determine if you are a candidate for Cochlear technology.
woman with bimodal solution using phone

Introducing the Nucleus® 7 Bimodal Solution

October 5, 2017

Two global leaders in the hearing loss industry, Cochlear and ReSound, are now partners!

Give your patients the opportunity for a richer and more natural hearing experience with the new Nucleus 7 Smart bimodal hearing solution1, the world’s first and only bimodal solution that is Made for iPhone.2 Your patients with a Cochlear Nucleus® 7 Sound Processor and a compatible ReSound LiNX3D™ hearing aid* can now stream sound simultaneously to both ears from a compatible Apple® device.± With a smart bimodal hearing solution they can use their iPhone® to:Nucleus 7 sound processor compatibility

  • Connect with others on the phone with confidence and improved understanding3
  • Rediscover the joy of music, movies and entertainment
  • Easily control their device settings through the Nucleus® Smart App directly on their iPhone®
  • Locate the sound processor with Find my Sound Processor functionality

Compared to using two hearing aids, a bimodal hearing solution is proven to help people understand speech and improve the clarity of words in various listening environments, including noisy listening situations.4, 5, 6 The benefits of bimodal hearing also include the following:

  • Improved hearing in quiet and noise
  • Better sound quality and music appreciation7
  • Prevention of auditory deprivation8
  • Improved ease of listening9, 10
  • Superior sound localization11Nucleus 7 Bimodal Solution

Cochlear promises to provide your patients with the best possible hearing solution, plus reliability that lasts a lifetime. With more than 30 years of quality and innovation, we have helped over 450,000 people who have chosen Cochlear solutions. You can feel confident that Cochlear is also here to support you, as you support your patients.

Visit our Bimodal Solution webpage today to learn more!

 
* With compatible ReSound hearing aids. A list of compatible hearing aids is available online at: www.cochlear.com/nucleus/compatibility
± A list of compatible Apple devices can be found at the bottom of this document.
References:
  1. Sammeth CA, Bundy MBM, D. A. (2011) Bimodal Hearing or Bilateral Cochlear Implants: A Review of the Research Literature. Semin Hear 32:3-31.
  2. Apple support. 2017 [cited 24 February 2017]. Available from: https://support. apple.com/en-au/HT201466#compatible.
  3. Cochlear Limited, D1182081. CLTD 5620 Clinical Evaluation of Nucleus 7 Cochlear Implant System. 2017, Mar; Data on file.
  4. Gottermeier L, De Filippo C, Clark C. Trials of a Contralateral Hearing Aid After Long-Term Unilateral Cochlear Implant Use in Early-Onset Deafness. American journal of audiology. 2016 Jun 1;25(2):85-99.
  5. Dorman MF, Gifford RH, Spahr AJ, McKarns SA. The benefits of combining acoustic and electric stimulation for the recognition of speech, voice and melodies. Audiology and Neurotology. 2008;13(2):105-12.
  6. Gifford RH, Dorman MF, McKarns SA, Spahr AJ. Combined electric and contralateral acoustic hearing: Word and sentence recognition with bimodal hearing. Journal of Speech, Language, and Hearing Research. 2007 Aug 1;50(4):835-43.
  7. Sucher CM, McDermott HJ. Bimodal stimulation: benefits for music perception and sound quality. Cochlear Implants International. 2009 Jan 1;10(S1):96-9.
  8. Ching TY, Van Wanrooy E, Dillon H. Binaural-bimodal fitting or bilateral implantation for managing severe to profound deafness: a review. Trends in amplification. 2007 Sep 1;11(3):161-92.
  9. Hamzavi J, Marcel Pok S, Gstoettner W, Baumgartner WD. Speech perception with a cochlear implant used in conjunction with a hearing aid in the opposite ear. International journal of audiology. 2004 Jan 1;43(2):61-5.
  10. Ching TY, Incerti P, Hill M. Binaural benefits for adults who use hearing aids and cochlear implants in opposite ears. Ear and hearing. 2004 Feb 1;25(1):9-21.
  11. Potts LG, Skinner MW, Litovsky RA, Strube MJ, Kuk F. Recognition and localization of speech by adult cochlear implant recipients wearing a digital hearing aid in the nonimplanted ear (bimodal hearing). Journal of the American Academy of Audiology. 2009 Jun 1;20(6):353-73.
© Cochlear Limited 2017. All rights reserved. Hear Now And Always and other trademarks and registered trademarks are the property of Cochlear Limited.
The Nucleus 7 Sound Processor is compatible with iPhone 7 Plus, iPhone 7, iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone SE, iPhone 5s, iPhone 5c, iPhone 5, iPad Pro (12.9-inch), iPad Pro (9.7-inch), iPad Air 2, iPad Air, iPad mini 4, iPad mini 3, iPad mini 2, iPad mini, iPad (4th generation), iPod touch (6th generation) and iPod touch (5th generation) using iOS 10.0 or later. Apple, the Apple logo, Made for iPad logo, Made for iPhone logo, Made for iPod logo, iPhone, iPad Pro, iPad Air, iPad mini, iPad and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a service mark of Apple Inc., registered in the U.S. and other countries. Information accurate as of June 2017
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©Cochlear Limited 2024. All rights reserved. ACE, Advance Off-Stylet, AOS, Ardium, AutoNRT, Autosensitivity, Baha, Baha SoftWear, BCDrive, Beam, Bring Back the Beat, Button, Carina, Cochlear, 科利耳, コクレア, 코클리어, Cochlear SoftWear, Contour, コントゥア, Contour Advance, Custom Sound, DermaLock, Freedom, Hear now. And always, Hugfit, Human Design, Hybrid, Invisible Hearing, Kanso, LowPro, MET, MP3000, myCochlear, mySmartSound, NRT, Nucleus, Osia, Outcome Focused Fitting, Off-Stylet, Piezo Power, Profile, Slimline, SmartSound, Softip, SoundArc, True Wireless, the elliptical logo, Vistafix, Whisper, WindShield and Xidium are either trademarks or registered trademarks of the Cochlear group of companies. The names of actual companies and products mentioned herein may be the trademarks of their respective owners.

 

This material is intended for health professionals. If you are a consumer, please seek advice from your health professional about treatments for hearing loss. Outcomes may vary, and your health professional will advise you about the factors which could affect your outcome. Always read the instructions for use. Not all products are available in all countries. Please contact your local Cochlear representative for product information.

 

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