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
Understand our Reliability Reporting
Past Reliability Reports