Advanced Bionics Recalls Cochlear Implants

Advanced Bionics Corporation, a wholly owned subsidiary of Boston Scientific Corporation , is conducting a voluntary recall of its un-implanted CLARION and HiResolution cochlear implants because some of the devices may malfunction due to moisture. The firm's recall includes notification to doctors and other healthcare professionals and patients.  Cochlear implants are intended to restore a level of auditory sensation to adults and children with severe-to-profound hearing loss via electrical stimulation of the auditory nerve.

Advanced Bionics  has determined that device failure may occur due to moisture inside the product.  Symptoms associated with device failure include, but are not limited to:

1) intermittent functioning;
2) sudden sensation of discomfort or pain;
3) sudden loud noise or popping sound;
4) complete loss of sound, and
5) unwillingness of a child to wear his or her external headpiece.

While Advanced Bionics is not recommending recall of implanted devices, anecdotal reports indicate that there have been incidents of developmental children who have sufferred hearing and developmental deficits due to unrecognized device failure over a prolonged time period.  If you have a child with an Advanced Bionics CLARION and HiResolution cochlear implant and suspect or have determined that the device is defective, contact Charlip Law Group, LC immediately.

Se habla español

Мы Говорим по Русски