Why we think the FDA sued Advanced Bionics
Jan 30th, 2009 | By Ed Wallis | Category: Cochlear ImplantI’ve been asked by several persons, “Why did the Food and Drug Administration sue Advanced Bionics?” The answer, as concise is possible, is as follows.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Implant. Worth noting, a cochlear implant is classified as a Class III medical device by the [...]