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

AB, which develops cochlear implant systems, 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.

The voluntary action is being taken to ensure continued patient safety and product quality and the risk of any adverse medical events appears to be remote at present.