FDA Reaches Settlement with California Hearing Device Maker Advanced Bionics
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Below is the press release issued by the FDA regarding its Settlement Agreement with Advanced Bionics, LLC, which also manufactures Clarion cochlear implants. (You may also view the release regarding the settlement on the FDA's website.)
July 17, 2008--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, amended in March 2008 and then again on 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.
For more information:
View the Settlement Agreement, the Amended FDA Complaint and the Certificate of Service.
see also:
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