PSAP Standard Review

Legislation recently passed in the U.S. House of Representatives1 and expected to be passed soon in the U.S. Senate2, requires the FDA to establish an OTC (over-the-counter) hearing aid category for adults with perceived mild-to-moderate hearing impairment, within three years. This category is estimated to overlap the hearing levels of approximately 60-80% of all hearing aids…

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OTC Hearing Aid Standard

Both PCAST1 (President’s Council of Advisors on Science and Technology) and NAS2 (National Academies of Sciences) have recommended that OTC (over-the-counter) hearing aid sales be permitted for mild-to-moderate hearing losses. Additionally, the SB 9 Over-the-Counter Hearing Aid Act of 2016 introduced by Senators Warren and Grassley calls for the same.  These recommendations resulted from the…

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