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Hearing aids to reach millions with FDA over-the-counter approval

Finally finalized on Tuesday, the FDA’s rules for the sales of hearing aid without prescriptions in the US entail some wins for the hearing aid lobby that wanted stricter product requirements.

Photo: Jens Dresling

Nearly 30 million US adults impacted by hearing loss will now have easier access to hearing aids under a final rule from the FDA allowing them to be purchased over the counter.

The action, which finalizes an October 2021 draft rule, would establish a separate medical device category for certain air-conduction hearing aids used among people 18 years old and older with mild to moderate hearing issues. The new rule stems from President Joe Biden‘s sweeping mandate to crack down on monopolistic practices in agriculture, technology, pharmaceuticals, and other industries. Biden’s order instructed the FDA to take actions within 120 days that would allow hearing aids to be sold over the counter.

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