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This press release contains revisions posted April 8, 2008, to include additional information on the March 2006 recall.
The U.S. Food and Drug Administration (FDA) today announced it is seeking a $2.2 million penalty against a California hearing device manufacturer for violations of federal law, including manufacturing standards violations and the failure to notify the FDA of a change in an outside supplier or vendor, which may have exposed recipients of the devices to unnecessary health risks.
The cochlear implants pose a public health risk due to excessive moisture, exposing patients to the risk of device failure, possible surgery, and the potential for additional hearing loss.
The agency's complaint, originally filed this past November and amended on March 17, seeks penalties against California medical device manufacturer Advanced Bionics, LLC and its president and co-CEO, Jeffrey H. Greiner.
The complaint alleges that Advanced Bionics shipped cochlear implants to customers in the United States prior to filing appropriate supplemental information with the Agency, including a notice of changes made to the devices that affected their safety and effectiveness.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a cochlear implant surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The cochlear implant is considered a Class III device by the FDA—the most stringent regulatory category for devices.
The complaint alleges that the company failed to comply with the FDA's current Good Manufacturing Practice (GMP) requirements for devices. GMP requires that companies manufacturing medical devices for sale in the United States establish and follow quality systems procedures to assure the safety and quality of their products.
Advanced Bionic's alleged GMP violations include the failure to sufficiently evaluate and select a new vendor as the supplier of a critical device component and the failure to adequately validate the continued safety and effectiveness of the cochlear implant by testing lots under actual or simulated use when the unapproved vendor's component was used.
The complaint also states that Advanced Bionics shipped cochlear implants in violation of the law between January 2005 and July 2006. Two cochlear implants shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.
In addition to conducting a March 2006 recall of unimplanted devices containing the component from the unapproved vendor, Advanced Bionics also notified patients with such implants and instructed them to contact their health care providers if they suffered symptoms of device failure.
FDA's complaint states that the company's failure to file the required supplement occurred after a 2001 inspection. At that time, the company was cited for similar failures and made commitments to correct the problems.
Advanced Bionics, LLC, is located in Sylmar, Calif.
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