FDA Issues Final Rule for Over-the-Counter Hearing Aids

The Food and Drug Administration (FDA) has issued a final rule establishing a new category of over-the-counter (OTC) hearing aids, allowing individuals 18 years of age and older with mild to moderate hearing impairment to purchase hearing aids without a prescription.

The final rule is expected to lower the cost of hearing aids while ensuring their safety and efficacy. It comes after President Biden’s Executive Order on Promoting Competition in the American Economy, which called for the Secretary of Health and Human Services to “promote the wide availability of low-cost hearing aids.” In 2017, Congress passed legislation requiring the FDA to create a category for OTC hearing aids, but it was not fully implemented until now.

“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf, MD. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”

The final rule takes effect in 60 days and consumers will be able to purchase hearing aids directly from stores or online retailers as soon as mid-October without the need for a medical exam, prescription or a fitting adjustment by an audiologist. Manufacturers of hearing aids sold prior to the effective date of the final rule will have 240 days after its publication to comply.

The new OTC category applies to certain air-conduction hearing aids intended for individuals 18 years of age and older who have perceived mild to moderate hearing impairment. Moreover, the final rule lowers the maximum sound output to reduce the risk to hearing from over-amplification of sound, revises the insertion depth limit in the ear canal, requires that all OTC hearing aids have a user-adjustable volume control, and includes performance specifications and device design requirements specific to OTC hearing aids.

Reference

FDA finalizes historic rule enabling access to over-the-counter hearing aids for millions of Americans. News release. US Food and Drug Administration (FDA). Accessed August 16, 2022. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-american