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Regulatory Briefs: Draft Guidances On Hearing Aids, Syphilis Tests; Upcoming Panel Meetings

FDA issues draft guidance clarifying the difference between hearing aid devices and personal sound amplification products. Agency also issues draft guidance on the use of tests to screen human cells and tissues for syphilis. Boston Sci gets a new panel date for Watchman. More regulatory news.

FDA issued a draft guidance Nov. 7 on regulatory requirements for hearing aid devices and personal sound amplification products. It clarifies the difference between hearing aids and personal sound amplification products (PSAPs) and the regulatory controls that apply to each. FDA regulates hearing aids, which are defined as wearable sound-amplifying devices that are intended to compensate for impaired hearing, whereas, PSAPs are for people with normal hearing who need to amplify sounds in certain situations. PSAPs are not regulated as devices and there are no requirements for registration and listing of such products with FDA. In conjunction, FDA issued a consumer update

Nov. 6 notifying the public of this guidance and the clarified definitions.

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