Tag: NASEM Committee on Evaluating Hearing Loss for Individuals with Cochlear Implants

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FDA Proposed Rules for OTC Hearing Aids Extend Beyond OTC

The 114-page rules document published today in the Federal Register covers most aspects related to OTC hearing aid manufacturing, electroacoustic requirements, packaging and labeling, returns, and conditions for sale. In an effort to promote more consistency in the regulations and enforcement of hearing aid manufacturing and distribution, the FDA is also proposing several important changes that could affect the industry and state-wide hearing aid dispensing.

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