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Medical Devices / Regulatory Affairs

FDA Will Not Enforce Certain Requirements for Hearing Aid Sales

Jan. 3, 2017
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The FDA will not enforce existing medical evaluation or recordkeeping requirements for the sale of air-conduction hearing aids to people 18 and older, in an effort to improve accessibility of the devices.

Under guidance that is effective immediately, the FDA will not enforce regulations requiring all prospective hearing aid users to be evaluated by a licensed physician no more than six months before receiving the device. It also will not enforce regulations requiring dispensers to retain copies of medical evaluations.

The FDA said that according to recent reports, the medical evaluation requirement provides little patient benefit and can present an unnecessary barrier to access.

The guidance applies to Class I air-conduction and Class II wireless air conduction hearing aids. It does not apply to Class II bone-conduction hearing aids. — Jeff Kinney

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