Cochlear implants used to provide a sense of sound to people who are profoundly deaf or hard of hearing are being recalled by the manufacturer because the devices may malfunction and cause recipients to experience severe pain, overly loud sounds, and/or shocking sensations 8-10 days after the device was activated.

The recall involves HiRes 90K Cochlear Implant devices made by Advanced Bionics that have not yet been implanted. At least two confirmed reports of product malfunction have been reported. The manufacturer is working closely with the Food and Drug Administration (FDA) to evaluate the root causes of the problem and institute changes to the product. The risk of any significant adverse medical events associated with the device malfunction appears to be remote at this time, though health care professionals and patients are advised to report any side effects with to the FDA MedWatch Adverse Event Reporting Program at www.FDA.gov/MedWatch.

Cochlear implants are surgically implanted electronic devices that can be seen directly behind the ear. During implantation, surgeons make a small incision in the skin just behind the ear and drill into the mastoid bone and the inner ear, where the electrode array is inserted into the cochlea. After 1-4 weeks of healing, the device is “activated.” Results often take time for the brain to adapt to hearing new sounds. While it will not cure deafness or hearing impairment, the devices can be highly effective by helping recipients hear and understand sounds in their environment.

Approximately 200,000 people worldwide have received cochlear implants, including about 30,000 adults and more than 30,000 children in the United States alone.