Analysis of FDA Proposed Rule to Establish Over the Counter Hearing Aids

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Download the Statement from ADA on the FDA Hearing Aid Proposed Rule Provisions for Maximum Sound Output and Gain, or read ADA's public submission on Regulations.org Re: Docket No. 2021-N-0555, U.S. Food and Drug Administration (FDA) Proposed Rule, Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids.