Dr. Brian Kaplan, cochlear implant surgeon and Senior Vice President of Clinical Strategy & Innovation at Cochlear, reviews the challenges clinicians have faced over the years to obtain consistent reliability data from manufacturers. As a result, this affected their ability to answer patients’ questions regarding implant safety and reliability.
The lack of a standard definition for an implant failure magnified the differences in manufacturers’ reporting methods and the need for consistency. Traumas, life stages and legacy products were also classified differently within these reliability reports.
As explained by Dr. Kaplan, a new AAMI standard calculates overall failure rates of the implant, regardless of the cause, and an assessment for external sound processors for the first time1. The report also covers the life cycle of the entire product portfolio and legacy products.
This AAMI standard can provide clinicians with the tools to confidently make decisions and to provide patients with an honest assessment of overall failure rates within the entire cochlear implant system through a standardized method for manufacturers to report reliability data1.
Watch now to learn more about reliability reporting and how the new standard can impact you.
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- AAMI:2017 CI86 Cochlear Implant Systems: Requirements for safety, functional verification, labeling and reliability reporting.