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Advanced Bionics recalls cochlear implant device

 
• By Joseph Harvey

Advanced Bionics (AB) is to recall all unimplanted units of its HiRes 90K cochlear implant. The move was prompted by two reports of malfunctioning devices causing severe pain to the patients. AB said that the implanted patients also experienced “overly loud sounds and/or shocking sensations" 8-10 days after initial activation of the device. The defective devices had to be explanted. However, AB said that the risk of the recalled product causing significant adverse medical events “appears to be remote at present”. The Valencia, California-based firm is continuing to evaluate the root cause of the malfunctions and will be working with the US FDA to solve the problems. The HiRes 90K implant is part of the company’s Harmony HiResolution bionic ear system, which it claims has five times more resolution than any other cochlear implant system.

Advanced Bionics (AB) is to recall all unimplanted units of its HiRes 90K cochlear implant. The move was prompted by two reports of malfunctioning devices causing severe pain to the patients. AB said that the implanted patients also experienced “overly loud sounds and/or shocking sensations" 8-10 days after initial activation of the device. The defective devices had to be explanted. However, AB said that the risk of the recalled product causing significant adverse medical events “appears to be remote at present”. The Valencia, California-based firm is continuing to evaluate the root cause of the malfunctions and will be working with the US FDA to solve the problems. The HiRes 90K implant is part of the company’s Harmony HiResolution bionic ear system, which it claims has five times more resolution than any other cochlear implant system.

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