Advanced Bionics Pays $1.1M To Settle With FDA

Law360, New York (July 17, 2008, 12:00 AM EDT) -- Medical device maker Advanced Bionics LLC has agreed to pay $1.1 million to settle a complaint by the U.S. Food and Drug Administration that the company violated federal guidelines in manufacturing cochlear implant hearing aids.

The settlement, reached on Monday, concerns Advanced Bionics’ HiRes90k Implantable Cochlear Stimulator, a type of hearing aid implanted in the skin behind the ear.

The company violated FDA guidelines by failing to properly notify the agency that it had switched to a new supplier for a part of the device, which...
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