FDA seeks $2.2M from hearing aid maker

Washington -- The U.S. Food and Drug Administration said it is seeking a $2.2 million penalty against a California hearing aid manufacturer for violations of federal law.

The agency is seeking penalties against Advanced Bionics LLC of Sylmar, Calif., and its president Jeffrey Greiner.

The FDA said hearing aids produced by the company 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 agency also accuses the company of shipping hearing aids to U.S. customers before notifying the FDA of changes to the devices that affected their safety and effectiveness.

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