WASHINGTON (Reuters) - The U.S. Food and Drug Administration said on Friday it wants to fine Advanced Bionics LLC, a maker of cochlear implant hearing aids, $2.2 million for alleged manufacturing violations that put patients at risk.
The FDA accused Advanced Bionics of failing to follow manufacturing standards to ensure the safety and quality of the hearing aids.
The company allegedly failed to sufficiently evaluate and select a new vendor to supply a critical component, and failed to properly test hearing aids containing the unapproved vendor’s component, the FDA said in a statement.
“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 FDA said in a statement.
The FDA said it filed a complaint against Advanced Bionics and its co-chief executive officer, Jeffrey Greiner, last November and amended it on March 17. The company is based in Sylmar, California.
A company spokesman was not immediately available for comment.
On July 7, 2003, Advanced Bionics received FDA approval to market the HiRes90k Implantable Cochlear Stimulator, a hearing aid 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 medical devices.
Reporting by Julie Vorman; Editing by Brian Moss
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