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

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:

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

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