Cochlear™ Nucleus® Reliability

Cochlear™ Nucleus® Reliability Reporting:

Human needs have always been our inspiration. We start with people in mind and the understanding that reliability is incredibly important in helping recipients experience a life full of hearing.

Cochlear has now provided more than 410,000 cochlear implants to people of all ages across more than 180 countries. When someone chooses Cochlear, they are choosing a quality partner who will support their hearing experience over the long term. We are the leader in implant reliability for both adults and children, and no other cochlear implant manufacturer can demonstrate the same reliability track record.


ABOUT OUR REPORTING

Cochlear reliability reporting provides reliability data for the internal (cochlear implant) and external (sound processor) components of our Nucleus Implant Systems.

IMPLANT RELIABILITY DATA

The implant data in the annual reliability report is based on the reporting methodology recommended by International Standard ISO 5841-2 1,2, the reporting principles outlined in the European Consensus Statement on Cochlear Implant Failures and Explantations 3 and expert recommendations from the International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators 4. This annual reliability report meets the standards for cochlear implant reliability reporting outlined in these standards.

For implant reliability data based on the reporting standards and methodology recommended by ANSI/AAMI CI86 – Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting 5, the Cochlear Nucleus ANSI/AAMI Standard report will continue to be available on an annual basis.

SOUND PROCESSOR RELIABILITY DATA

The sound processor data in our annual reliability report meets the reporting standards and methodology recommended by ANSI/AAMI CI86 – Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting 5.

Cochlear Nucleus reliability reports

Cochlear Nucleus Implant Reliability Report
December 2019

Understand our Reliability Reporting

ANSI/AAMI CI86 Reliability Report June 2019

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Past Reliability Reports

Cochlear™ Nucleus® Reliability Report - Volume 17, Dec 2018

Cochlear™ Nucleus® Reliability Report - Volume 16, Dec 2017

Cochlear™ Nucleus® Reliability Report - Volume 15, Jan 2017

Cochlear™ Nucleus® Reliability Report - Volume 14, Feb 2016

Cochlear™ Nucleus® Reliability Report - Volume 13, Feb 2015

Cochlear™ Nucleus® Reliability Report - Volume 12, Feb 2014 

Cochlear™ Nucleus® Reliability Report - Volume 11, Feb 2013 

Cochlear™ Nucleus® Reliability Report - Volume 10, Feb 2012

Cochlear™ Nucleus® Reliability Report - Volume 9, Aug 2011

Cochlear™ Nucleus® Reliability Report - Volume 8, Jun 2011

Cochlear™ Nucleus® Reliability Report - Volume 7, Dec 2010

Cochlear™ Nucleus® Reliability Report - Volume 6, Jun 2010 

Cochlear™ Nucleus® Reliability Report - Volume 6, Jun 2009

Cochlear™ Nucleus® Reliability Report - Volume 5, Jun 2008

Cochlear™ Nucleus® Reliability Report - Volume 3, Jun 2007

 

References

  1. International Standard ISO 5841-2. Implants for Surgery — Cardiac Pacemakers — Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads. Geneva (Switzerland): International Organization for Standardization. 2000.
  2. International Standard ISO 5841-2. Implants for Surgery — Cardiac Pacemakers — Part 2: Reporting of Clinical Performance of Populations of Pulse Generators or Leads. Geneva (Switzerland): International Organization for Standardization. 2014.
  3. European Consensus Statement on Cochlear Implant Failures and Explantations. Otol Neurotol. 2005 Nov;26(6):1097-9.
  4. Battmer RD, Backous DD, Balkany TJ, Briggs RJ, Gantz BJ, van Hasselt A, et al. International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators. Otol Neurotol. 2010 Oct;31(8):1190-3.
  5. ANSI/AAMI CI86. Cochlear implant systems: Requirements for safety, functional verification,. (2017). Arlington, VA: American National Standards Institute.
  6. Cochlear Limited, 454378. Comparison of reliability of cochlear implants commercially available (as at 25 February 2020). Data on file.
  7. Hearing Implant Reliability Reporting | MED-EL [Internet]. Medel.com. 2020 [cited 25 February 2020]. Available from: http://www.medel.com/hearing-solutions/cochlear-implants/reliability
  8. 2019 Global Implant Reliability Report. 027-N025-02 RevC. Advanced Bionics AG and affiliates.; 2019.