March 28, 2008 the FDA announced that it will be seeking a $2.2 million dollar penalty against Advanced Bionics for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor. The hearing aid is said to pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss. The hearing aid, known as the HiRes90k Implantable Cochlear Stimulator, is considered a Class III device by the FDA—the most stringent regulatory category for devices.

The HiRes90k Recall

Advanced Bionics, a subsidiary of Boston Scientific Corporation, is the only company in the U.S. that develops cochlear implant technology. The HiRes90k was released in 2003 for implantation in both adults and children. The recall of all implanted devices began in September 2004. Users are warned to take heed of symptoms such as a sudden sensation of discomfort or pain, a sudden loud noise or popping sound, an intermittent functioning, a complete loss of sound, and in a child, unwillingness to wear the external headpiece.

FDA Press Release March 28, 2008 - FDA Seeks Civil Penalties from Calif. Device Maker

Advanced Bionics Recall Press Release September 24, 2004 - Boston Scientific Announces Recall of Advanced Bionics Cochlear Auditory Implants Worldwide

First Cochlear Implant

Check out the First Cochlear Implant Approved by the FDA on the ATWiki.