Regulatory review of over-the-counter hearing aids completed, and with changes. Is this the endgame?



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The long drawn-out process of regulating over-the-counter hearing aid sales in the USA may now be closer to completion following a key review of the FDA's proposed guidance.

It was 2017 when Congress passed a law requiring the US Food and Drug Administration to regulate for retail sales of hearing devices for people with mild- to moderate-hearing loss. But the audiology market and profession has watched its coffee go cold and slimy while the process lumbered through a pandemic and periods of apparent administrative paralysis, the last signs of life coming in October 2021 when the FDA published its proposal and called for comments by January 18, 2022.

It has taken until July for the next movement from those charged with making OTC happen, the submission on this July 8 of the FDA's guidance to the Office of Information and Regulatory Affairs (OIRA).

Political pressure and possible acceleration

Although the OIRA has up to 90 days to review regulations, it took the body under one month to deliver a verdict. The relative haste is being linked to big noise in recent months from the quarter of the original bill's backers, including from a letter earlier this year to the FDA from Senators Elizabeth Warren and Chuck Grassley accusing dominant manufacturers of hearing aids of running “astroturf campaigns", in other words creating the false impression of grass roots objections to OTC sales. The accusation was substantiated on a claimed analysis that allegedly revealed 40% of the comments received by the agency on the issue were form letters.

Changes, but what changes?

While the OIRA has now found the FDA document meets the principles set out in an executive order on regulatory planning, changes have been made to the proposal. No details have been released on these changes, nor any indication of their dimensions and impact on shaping the OTC panorama.

Source: MedTech Dive