Tag: hearing aid fitting

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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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Preparing for OTC Hearing Aids

Unless you’ve been locked in your soundbooth for the past three years, you’re probably well aware that a new class of over-the-counter (OTC) hearing aids will get the green light from the US Food and Drug Administration (FDA) sometime around August 2020, with the notice of proposed rulemaking (NPRM) slated for this November.

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Preparing for OTC Hearing Aids

Unless you’ve been locked in your soundbooth for the past three years, you’re probably well aware that a new class of over-the-counter (OTC) hearing aids will get the green light from the US Food and Drug Administration (FDA) sometime around August 2020, with the notice of proposed rulemaking (NPRM) slated for this November.

Read More
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