FDA creates new category of OTC hearing aids, issues PSAP guidance

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via After pressure from the Biden Administration, the US Food and Drug Administration finalized a much-anticipated rule that allows certain air conduction hearing aids to be available over-the-counter (OTC) without the need for hearing exams or fittings. At the same time, the agency also published a final guidance on personal sound amplification products that clarifies how they are different from hearing aids.

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