Advanced Bionics, LLC, a maker of cochlear implant hearing aids, could face a stiff fine from the Food & Drug Administration (FDA) for manufacturing violations that may have resulted in dangerously defective hearing aids. The FDA has alleged that Advanced Bionics failed to follow manufacturing standards and wants to fine the California medical device manufacturer $2.2 million.
Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator in 2007. The cochlear implant hearing aid is surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children. The hearing aid is considered a Class III device by the FDA—the most stringent regulatory category for devices. The FDA says the hearing aids 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 Advanced Bionics and its president and co-CEO, Jeffrey H. Greiner. The complaint alleges that Advanced Bionics shipped hearing aids 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.
The agency says Advance Bionics 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 hearing aid by testing lots under actual or simulated use when the unapproved vendor’s component was used. The complaint also states that Advanced Bionics shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.
The complaint states that the company’s failure to file the required supplement occurred after a 2001 inspection. At that time, Advance Bionics was cited by the FDA for similar failures and made commitments to correct the problems.