HiRes 90K Cochlear Ear Implant Recalled By Advanced Bionics To Address Safety Concerns With FDA
Posted Nov 24 2010 10:51pm
The first time I heard of the implant was in the movie “Sicko” where the insurance company would only pay for one cochlear implant for a baby losing its hearing and a lot has happened since that time with many being able to hear again so the recall is for devices that have NOT been implanted yet, so patients who have them are fine. The company is working with the FDA to address 2 reported issues with pain and noise that was too loud with the device as well as shocking sensations so nobody is seriously hurt here. You can read below how the University of Washington has worked with this technology too.
OR IMMEDIATE RELEASE – Valencia, CA, November 23, 2010 – Advanced Bionics (AB), a global leader in developing advanced cochlear implant systems, 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 explanation. These recipients experienced severe pain, overly loud sounds and/or shocking sensations at 8-10 days after initial activation of their device. AB is continuing to evaluate the root cause(s) of the problem and is working closely with the FDA to address their questions and concerns, and institute changes to the product to ensure that the HiRes 90K has the highest quality for patients who use the device. This voluntary action is being taken to ensure continued patient safety and product quality. The risk of any significant adverse medical events appears to be remote at present.