FDA finalized historic rule enabling access to Over-the-Counter hearing aids for millions of Americans

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On Oct. 19, 2022, the U.S. Food and Drug Administration final rule establishing Over-the-Counter Hearing Aids to improve access to safe, effective, and affordable hearing aids for millions of Americans went into effect.

This action established a new category of over-the-counter (OTC) hearing aids, enabling consumers 18 years of age and older with perceived mild to moderate hearing loss to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.

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