WEITZ & LUXENBERG
PATIENT NEWS
Patients injured by certain hearing devices manufactured by Advanced Bionics may be eligible for compensation

News: Free legal consultation for an Advanced Bionics hearing device injury.

July 6, 2009 — Weitz & Luxenberg P.C. is accepting cases from clients injured by certain defective hearing devices: models of the HiRes90k cochlear implant or the earlier Clarion II device, both manufactured by Advanced Bionics.

A cochlear implant is a small, complex electronic device containing electrodes that is positioned in the inner ear to activate auditory nerve fibers, allowing for transmission of sound signals to the brain.

The FDA regulates cochlear implants as Class III devices—the most stringent regulatory category for medical devices.

In 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator to treat hearing loss in adults and children. However, Advanced Bionics soon began shipping the HiRes90k devices to health care providers without informing the FDA about a change in their component supplier.

The failure to submit supplemental information prevented the FDA from properly evaluating the safety and effectiveness of the new device. As a result, the FDA fined the company $2.2 million, but could not prevent potential injuries arising from the unapproved devices already on the market.

If you or your child has an Advanced Bionics HiRes90k device that was implanted prior to March 2006 (or the earlier Clarion II device), please complete the form below. A representative from our firm will contact you as soon as possible.