Cochlear Ltd. statement re: Advanced Bionics recall
On September 24, 2004 - Advanced Bionics Corporation announced a product recall of its Clarion® and 90K HiResolution® cochlear implants due to potential device malfunction. To learn more about this recall, visit the FDA website at www.fda.gov.
This problem pertains solely to the devices manufactured by Advanced Bionics and does not affect the Cochlear Nucleus® line of implants.
Advanced Bionic devices are available in many countries, they are not available in Australia.
Cochlear is committed to the lifetime support of all of our recipients and we take our commitment very seriously.
Cochlear openly reports all of our reliability data on a regular basis and routinely test all our products against the International Organization for Standardization (ISO) criterion that governs most medical devices.
We value the relationship we share with our recipients and the professionals who support them.
If you have additional questions about this information and would like to speak to someone directly, please do not hesitate to e-mail us or call your nearest Cochlear office.