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advanced bionics recalls cochlear implants Advanced Bionics Recalls Cochlear Implants
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24 September 2004, 4:51pm ET

WASHINGTON (AP) -- CLARION and HiResolution cochlear implants can malfunction if moisture reaches the circuitry, the manufacturer said Friday, advising consumers to contact their doctor if they suspect a problem.

Advanced Bionics issued a worldwide recall of the devices that have not yet been implanted. The recall was triggered by a company review of complaints and analyses of returned devices.

No patient injuries have been reported. The recall does not extend to the 2,500 devices that already have been implanted in patients' ears.

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Cochlear implants, which employ digital pulses that the brain interprets as sound, are used by the profoundly deaf. Faulty devices can produce a loud noise or pop, cause sudden pain, lose function intermittently or stop producing sound entirely. Malfunctioning devices may require replacement.

Recalled are roughly 440 devices made by Advanced Bionics, a Sylmar, Calif., company that was acquired by Boston Scientific Corp. in June. The recalled devices can stop working if moisture reaches internal circuitry.

Implant recipients who suspect a faulty cochlear implant should use the back-up cable, external headpiece, then the sound processor. Remove the external headpiece and contact a doctor if problems with the device persist.

People with questions may call Advanced Bionics at 1-877-454-5038 on weekdays, from 8 a.m. to 8 p.m. EDT.