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Cochlear Implants
Weitz & Luxenberg Informs the Public of Defective Advanced Bionic Cochlear Implants
April 19th, 2008
The Food and Drug Administration announced that it is seeking a $2.2 million penalty against California-based cochlear implant manufacturer Advanced Bionics, LLC, for manufacturing violations that may have exposed recipients of its cochlear implants to unnecessary health risks. According to the FDA, the Advanced Bionics Implantable Cochlear Stimulators pose a danger due to excessive moisture, thus exposing patients to the risk of device failure, including possible explant surgery and additional hearing loss. Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator in 2003. This surgical implant includes an electrode array which, when...
Source: Law & Health Weekly (2008-04-19)
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