A Medical Device Daily
The FDA has reached a settlement with hearing device maker Advanced Bionics (Sylmar, California) and its president/CEO, Jeffrey Greiner, over alleged violations of federal law.
The alleged violations involved the failure to notify the FDA of a change of outside supplier or vendor, which may have exposed patients to unnecessary health risks, such as device failure and surgery, according to the agency.
Advanced Bionics will pay a civil money penalty of $1.1 million. Greiner will pay $75,000.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, an implant surgically placed under the skin behind the ear to treat profound hearing loss in some adults and children. The FDA regulates cochlear implants as Class III devices — the most stringent regulatory category for medical devices.
The FDA's complaint against Advanced Bionics, filed in November 2007 and amended July 7, alleges that Advanced Bionics shipped cochlear implants to customers in the U.S. without first filing appropriate supplemental information with the FDA, including notice of a change of a component supplier.
The failure to submit supplemental information prevented the FDA from being able to evaluate the potential impact of the changes on the safety and effectiveness of the device.
As a result, the FDA considered those devices — shipped to healthcare providers across the country after the company changed suppliers — to be adulterated, as they were no longer covered by the agency's original product approval, granted in 2003.
In March 2006, Advanced Bionics conducted a recall of the unimplanted devices containing components from the unapproved supplier, because of excessive moisture that could leak into the devices and cause device failure and possible surgery.
The FDA's complaint also stated that Advanced Bionics shipped two devices containing the component from the unapproved supplier after the March 2006 recall and subsequently implanted in patients.
Advanced Bionics and Greiner agreed to settle the complaint without admitting liability, and must remit payment to the U.S. Treasury within 10 days.