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Thursday, September 1, 2022

FDA Final Rule Legalizes OTC Hearing Aids

​On August 16, 2022, the U.S. FDA issued a final rule establishing a new category of over-the-counter (OTC) hearing aids. Read the final rule here. Consumers with perceived mild-to-moderate hearing loss may purchase hearing aids from physical and online retailers without a medical exam, prescription, or audiologist fitting. The FDA says the goal of this final rule is to increase access to hearing aids by lowering the cost to obtain hearing aids.

“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, M.D. “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 new OTC hearing aid category only applies to certain air-conduction hearing aids for use by patients 18 years or older with mild-to-moderate hearing impairment. All other hearing aids that do not meet these criteria will still require prescriptions.

The impetus for the final rule came back in 2017 when Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids. The law was finally implemented last month. OTC hearing aids may become available in retail stores and pharmacies as early as mid-October, which is when the final rule takes effect.

After a proposed rule was issued on October 20, 2021, the FDA reviewed more than 1,000 public comments from a mix of consumers, professional associations, hearing aid manufacturers, public health organizations, advocacy groups, members of Congress, state agencies, and other stakeholders. The final rule includes several revisions from the original proposed rule to better ensure safety and effectiveness of OTC hearing aids, such as lowering the maximum sound output, revising the insertion depth limit in the ear canal, requiring user-adjustable volume control, and simplifying device labeling for ease of use. The new OTC category repeals the traditional conditions for hearing aid sale, such as the prescription requirement.

The FDA has also issued the Regulatory Requirements for Hearing Aid Devices and Personal Sound Amplification Products (PSAPs), to clarify the differences between hearing aids, which are medical devices, and PSAPs, consumer products that help people with normal hearing amplify sounds.  

The final rule goes into effect 60 days after publication in the Federal Register. Hearing aid manufactures who sold devices prior to the final rule's effective date must comply with the new regulations within 240 days after the final rule's publication. Manufacturers who have not yet sold devices must comply with the final rule before selling and marketing their new devices.