Stäfa, Switzerland — On November 23rd, 2010, the Sonova Group. parent company of Advanced Bionics (AB), developer of cochlear implant systems, announced it had notified the US Food & Drug Administration (FDA) that AB is voluntarily recalling its HiRes 90K cochlear implant device worldwide.
The device will be removed from the market as a precaution while the company works with the US Food & Drug Administration to address the issue, said the company.
In the Sonova press statement, AB said that the action is being taken in response to two known instances where the product experienced a rare malfunction requiring explanation.
According to AB, the two HiRes 90K cochlear recipients experienced severe pain, overly loud sounds, and/or shocking sensations, at 8-10 days after initial activation of their device.
AB said that it was working closely with the FDA to identify the problem and institute any needed changes to the product. The company further emphasized that the recall was a voluntary action and that it is a precaution, and that the risk of adverse medical events is presently remote.
A notification letter is being sent to HiRes 90K cochlear implant professionals and recipients.
SOURCE: Sonova Group