Cochlear Americas statement re: Advanced Bionics recall
Cochlear™ Nucleus® Reliability is Superior in Comparison to Competitive Devices
It is widely agreed that Cochlear employs rigorous Cumulative Survival Rate (CSR) reporting standards and shares the most transparent reliability data. Cochlear is the only implant manufacturer to openly report complete information on each implant we manufacture and the only company to report a full complement of reliability data every six months.
For details about Cochlear Nucleus reliability, you can read Reliability matters.
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 or call (888) INFO-FDA.
This problem pertains solely to the devices manufactured by Advanced Bionics and does not affect the Cochlear Nucleus® line of implants.
Cochlear is committed to the lifetime support of all of our recipients and we take our commitment very seriously. For the past 20 years, Cochlear proudly delivered the most reliable implant to the market. Today, Cochlear continues to bring the highest standard of implant reliability and safety to the cochlear implant community. We openly report all of our reliability data on a regular basis and routinely report to 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 at firstname.lastname@example.org or call us at (800) 458-4999(V), (800) 483-3123 (TTY).