Advanced Bionic Could be Fined for Defective Cochlear Implants
March 31st, 2008 joshua
The Food and Drug Administration (FDA) is pursuing a $2.2 million penalty against a California cochlear implant hearing aid maker because its device poses a public health risk.
The FDA says Advanced Bionics LLC violated federal law as its manufacturing standards don’t meet the federal standard, and the company failed to notify the FDA when it changed a supplier of component parts.
The hearing aids manufactured by the company pose a risk due to excessive moisture, which exposes patients to the risk of device failure, possible surgery and the potential for additional hearing loss.
The FDA says Advanced Bionics shipped hearing aids to customers in the U.S. prior to filing appropriate supplemental information with the regulatory agency, including a notice of changes made to the devices that affected their safety and effectiveness, an FDA release states.
Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator to treat profound hearing loss in adults and children. The device is classified Class III, meaning it must pass the most stringent regulations to be approved by the FDA.
The FDA says Advanced Bionics failed to comply with the FDA’s current Good Manufacturing Practice requirements for devices. The complaint alleges the company failed to sufficiently evaluate and select a new vendore 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 part was used.
The FDA’s first complaint against Advanced Bionics occurred in 2001, when the company said it would correct the issues found during a federal inspection.
