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Civil Penalties Sought Against Maker of Hearing Aid

The Food and Drug Administration (FDA) is seeking a $2.2 million penalty against a hearing aid manufacturer for violations of federal law. The violations may have exposed recipients of the devices to unnecessary health risks.

The manufacturer, Advanced Bionics LLC, of Sylmar, Calif., makes a hearing aid called the HiRes90k Implantable Cochlear Stimulator, which is surgically implanted under the skin behind the ear to treat profound hearing loss in adults and children.

The hearing aids pose a health risk due to excessive moisture, exposing people who received the devices to the risk of

• device failure
• possible need for surgery
• potential for additional hearing loss

FDA's complaint, originally filed in November 2007 and amended on March 17, 2008, seeks penalties against Advanced Bionics and its president and co-CEO, Jeffrey H. Greiner.

FDA's complaint alleges that Advanced Bionics

• shipped hearing aids to customers in the United States prior to filing appropriate supplemental information with FDA, including a notice of changes made to the devices that affected their safety and effectiveness.
• failed to comply with FDA's current Good Manufacturing Practice (GMP) requirements for devices. The alleged GMP violations include the failure to sufficiently evaluate and select a new vendor to supply a critical device component, and the failure to adequately test the continued safety and effectiveness of the hearing aid when the unapproved vendor's component was used.
• shipped hearing aids in violation of the law between January 2005 and July 2006. Two hearing aids shipped and implanted after a March 2006 recall contained the component from the unapproved vendor.

For More Information

Press Release
http://www.fda.gov/bbs/topics/NEWS/2008/NEW01813.html

Date Posted: April 4, 2008

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