The U.S. Food and Drug Administration (FDA) has reached a settlement with California hearing device manufacturer Advanced Bionics LLC and its president and 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.
Under the terms of the settlement, agreed to on July 14, 2008, 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 November 2007 and amended July 7, 2008, alleges that Advanced Bionics shipped cochlear implants to customers in the United States 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 health care 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 two devices containing the component from the unapproved supplier were shipped by Advanced Bionics 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 of settlement.
Advanced Bionics LLC, is based in Sylmar, Calif.