Hearing aids to be available without prescription after FDA rule The U.S. Food and Drug Administration issued a rule Tuesday to allow certain types of hearing aids to be made available over the counter without the need for a prescription or medical examination. The FDA said the rule, which will create a new regulatory category for over-the-counter hearing aids, applies to those “with perceived mild to moderate hearing impairment. “ “In creating a regulatory category for OTC hearing aids and amending existing rules, we intend to provide reasonable assurance of safety and effectiveness for these devices as well as foster access to, and innovation in, hearing aid technology, thereby protecting and promoting the public health,” the rule says. The FDA claims that the rule will lower the costs of hearing aids as well. It follows President Biden’s July 2021 Executive Order on Promoting Competition in the American Economy, which specifically said that the Secretary ...
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