Advanced Bionics Recalls Cochlear Implant Devices

Advanced Bionics is voluntarily recalling its HiRes 90K cochlear implant device due to instances of product malfunction, the Valencia-based company announced. The company has informed the U.S. Food and Drug Administration of the action and is retrieving all the un-implanted electronic hearing devices in distribution. The recall occurs after two confirmed instances in which the product malfunctioned during explantation, causing severe pain, overly loud sounds and shocking sensations at eight to 10 days after initial activation of the devices. The company said it is continuing to evaluate the root cause, or causes, of the problem, and it is working closely with the federal agency to address questions and concerns and to institute changes to the product. Jessica Vernabe