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October 21, 2021

FDA Moves to Allow Over-the-Counter Hearing Aids

On October 19, FDA announced a proposed new rule published on October 20 to establish a new category of over-the-counter hearing aids. If finalized, this rule would allow those with mild to moderate hearing loss to purchase hearing aids at brick and mortar retail stores or online without the need for a medical exam or fitting by an audiologist. The new rule would lower the barrier to entry for new hearing aid manufacturers and likely make hearing aids much less expensive. Among other actions, the new rule would "repeal the conditions for sale for hearing aids and address state regulation of hearing aids."  Because the proposed rule would only allow for the sale of  certain "air-conduction hearing aids" for use in adult patients, hearing aids for severe hearing loss or for use in those younger than 18 would still be prescription devices.