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 3. FDA Newsroom
 4. Press Announcements
 5. FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids
    for Millions of Americans

 1. Press Announcements

FDA News Release


FDA FINALIZES HISTORIC RULE ENABLING ACCESS TO OVER-THE-COUNTER HEARING AIDS FOR
MILLIONS OF AMERICANS


MORE AFFORDABLE HEARING AIDS COULD BE IN STORES AS SOON AS MID-OCTOBER

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For Immediate Release: August 16, 2022



Español

Today, the U.S. Food and Drug Administration issued a final rule to improve
access to hearing aids which may in turn lower costs for millions of Americans.
This action establishes a new category of over-the-counter (OTC) hearing aids,
enabling consumers with perceived mild to moderate hearing impairment 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. 

The rule is expected to lower the cost of hearings aids, furthering the
Biden-Harris Administration’s goal of expanding access to high-quality health
care and lowering health care costs for the American public. It is designed to
assure the safety and effectiveness of OTC hearing aids, while fostering
innovation and competition in the hearing aid technology marketplace. 

Today’s action follows President Biden's Executive Order on Promoting
Competition in the American Economy, which called for the FDA to take steps to
allow hearing aids to be sold over the counter and set a swift 120-day deadline
for action, which the FDA met. In 2017, Congress passed bipartisan legislation
requiring the FDA to create a category of OTC hearing aids, but it was not fully
implemented until now. Consumers could see OTC hearing aids available in
traditional retail and drug stores as soon as mid-October when the rule takes
effect.

“Reducing health care costs in America has been a priority of mine since Day One
and this rule is expected to help us achieve quality, affordable health care
access for millions of Americans in need,” said Health and Human Services
Secretary Xavier Becerra. “Today’s action by the FDA represents a significant
milestone in making hearing aids more cost-effective and accessible.”

Close to 30 million adults in the U.S. could benefit from hearing aid use.
Individuals with permanent hearing impairment can use hearing aids to help make
speech and sounds louder, improving the ability to communicate effectively with
others. Many hearing aids can be expensive. The final rule aims to stimulate
competition and facilitate the sale of safe and effective OTC hearing aids in
traditional retail stores or online nationwide, providing consumers with
perceived mild to moderate hearing loss with improved access to devices that
meet their needs and are less expensive than current options. 

“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 OTC category established in this final rule applies to certain
air-conduction hearing aids intended for people 18 years of age and older who
have perceived mild to moderate hearing impairment. Hearing aids that do not
meet the requirements for the OTC category (for example, because they are
intended for severe hearing impairment or users younger than age 18) are
prescription devices. 

The FDA finalized the rule after receiving and reviewing more than 1,000 public
comments on the proposed rule issued on Oct. 20, 2021. Comments submitted by
consumers, professional associations, hearing aid manufacturers, public health
organizations and advocacy groups, members of Congress, state agencies, and
other stakeholders are summarized in the final rule, along with the FDA’s
respective responses. In response to public comments and to assure the safety
and effectiveness of OTC hearing aids, the final rule incorporates several
changes from the proposed rule, including lowering the maximum sound output to
reduce the risk to hearing from over-amplification of sound, revising the
insertion depth limit in the ear canal, requiring that all OTC hearing aids have
a user-adjustable volume control, and simplifying the phrasing throughout the
required device labeling to ensure it is easily understood. The final rule also
includes performance specifications and device design requirements specific to
OTC hearing aids.

Furthermore, today’s action correspondingly amends existing rules that apply to
prescription hearing aids for consistency with the new OTC category, it repeals
the conditions for sale for hearing aids, and it includes provisions that
address some of the effects of the FDA OTC hearing aid regulations on state
regulation of hearing aids.

Concurrently with issuing the final rule, the FDA also issued the final
guidance, 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 effective date for the final rule is 60 days following publication in the
Federal Register. Manufacturers of hearing aids sold prior to the effective date
of the final rule will have 240 days after its publication to comply with the
new or revised requirements. For hearing aids that have not been offered for
sale prior to the effective date, compliance with the new or revised
requirements must be achieved before marketing the device, including obtaining
510(k) clearance if applicable.


RELATED INFORMATION

Related Information
 * Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter
   Hearing Aids 
 * Regulatory Requirements for Hearing Aid Devices and Personal Sound
   Amplification Products
 * Hearing Aids and Personal Sound Amplification Products: What to Know

###

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protects the public health by assuring the safety, effectiveness, and security
of human and veterinary drugs, vaccines and other biological products for human
use, and medical devices. The agency also is responsible for the safety and
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that give off electronic radiation, and for regulating tobacco products.

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   08/16/2022


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