HiRes 90K Cochlear Implant Device: Recall - Malfunction
MedSun: Newsletter #55, December 2010

FDA MedWatch Safety Alert

Advanced Bionics (AB) announced that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.

Additional Information:

FDA MedWatch Safety Alert. HiRes 90K Cochlear Implant Device: Recall – Malfunction. November 27, 2010.
http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm235009.htm


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