What is ANSI/AAMI CI86 and why is it important in the expansion and transparency of cochlear implant reliability reporting?

Question

What is ANSI/AAMI CI86 and why is it important in the expansion and transparency of cochlear implant reliability reporting?

Answer

Cochlear is expanding access to reliability information with the introduction of the ANSI/AAMI CI86 Standard, which externally reports on implant and sound processor reliability.¹ In accordance with this standard, quality of both implants and processors can be assessed for the first time.

Historically, quality has largely only been measured as implant reliability and through other subjective assessments. Reliability reporting had previously only been reported based on implant failures following the guidelines outlined by European Consensus Statement, but not all manufacturers maintained full compliance.

For implants, the new ANSI/AAMI CI86 Standard reporting measurement will be reported as the Cumulative Removal Percentage (CRP). This expanded reporting mechanism will look at all implants that have been removed for any reason, including infection. The Profile series, with over 90,000 devices implanted, has a CRP of 1.17%, meaning that 98.83% of implants remain functioning in place within 6 years of implantation.^2,3

For the first time, processor reliability is being reported as Failed Component Return Rate (FCRR), which is a percentage calculated by comparing the number of processors returned for repair within a calendar month compared to the cumulative sales of the sound processor over a period of up to 24 months. The Cochlear™ Nucleus^® 7 Sound Processor System accounted for 0.3% FCRR within 22 months.^2,3

Overall, this new reliability reporting standard allows for transparency and consistency to aid clinicians and their patients in the device decision-making process.

For more information about reliability reporting and the latest reliability report please visit Cochlear ProNews.

References:

ANSI/AAMI CI86. Cochlear implant systems: Requirements for safety, functional verification,. (2017). Arlington, VA: American National Standards Institute.
Cochlear Limited. D1712187 ISS1 MAR20. Cochlear™ Nucleus® Implant Reliability Report Volume 18, December 2019.
Cochlear Limited. D1712146. ISS1 MAR20. Cochlear™ Nucleus® Implant Reliability Report Volume 2, December 2019.

© Cochlear Limited 2020. 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.

This content is meant for professional use. 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. Views expressed are those of the individual. Consult your health professional to determine if you are a candidate for Cochlear technology.

What is ANSI/AAMI CI86 and why is it important in the expansion and transparency of cochlear implant reliability reporting?

Wade Colburn

May 20, 2020

Question