Litigation

Advanced Bionics Announces Voluntary Recall of the HiRes 90K Cochlear Implant

By Mark Zamora

Advanced Bionics has announced today that it has notified the US Food & Drug Administration (FDA) that it will voluntarily recall its HiRes 90K cochlear implant device and is retrieving all unimplanted devices in distribution. 

This action is being taken in response to two confirmed instances where the product experienced a malfunction requiring explantation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device.

A cochlear implant (CI) is a surgically implanted electronic device that provides a sense of sound to a person who is profoundly hard of hearing.

As of April 2009, approximately 188,000 people worldwide had received cochlear implants; in the United States, about 30,000 adults and over 30,000 children are recipients. The vast majority are in developed countries due to the high cost of the device, surgery and post-implantation therapy. (Source is Wiki)

Full post as published by Trial Lawyer Resource Center on November 27, 2010 (boomark / email).