Cochlear™ Nucleus® Reliability

Cochlear Nucleus Implants: Reliability Matters

For many years an annual Cochlear™ Nucleus® Implant Reliability Report has been produced in accordance with the reporting methodology recommended by ISO 5841-21, the recommended reporting principles in the European Consensus Statement on Cochlear Implant Failures and Explantations2, and the International Classification of Reliability for Implanted Cochlear Implant Receiver Stimulators3.

In the United States a new cochlear implant industry standard (CI86)4 has now been published by the Association for the Advancement of Medical Instrumentation (AAMI) in conjunction with the Food and Drug Administration (FDA). As a result, Cochlear has produced two reliability reports to ensure we provide both the public and the regulators with fully compliant data.

We will refer to these two reports as the European Consensus Statement Reliability Report and the ANSI/AAMI CI86 Reliability Report.


Cochlear Nucleus reliability reports

ANSI/AAMI CI86 Reliability Report June 2019

Cochlear Nucleus Implant Reliability Report
December 2018

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Past Reliability Reports

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 – second edition 2000, third edition 2014.
  2. European Consensus Statement on Cochlear Implant Failures and Explantations. Otol Neurotol. 2005 Nov;26(6):1097-9. 
  3. 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. 
  4. ANSI/AAMI CI86:2017 Cochlear implant systems: Requirements for safety, functional verification, labeling and reliability reporting.