FDA Gives Millions of Americans Access to Over-the-Counter Hearing Aids

August 16, 2022 by Dan McCue
FDA Gives Millions of Americans Access to Over-the-Counter Hearing Aids
A hearing aid. (Photo by Mark Paton via UnSplash)

WASHINGTON — The Food and Drug Administration issued a final rule Tuesday morning that promises to provide millions of Americans with access to lower cost, over-the-counter hearing aids.

The action, which follows an executive order signed by President Joe Biden to promote competition in the U.S. economy, establishes a new category of over-the-counter hearing aids for those with perceived mild to moderate hearing impairments.

As a result of today’s action, consumers could see over-the-counter hearing aids available in traditional retail and drug stores as soon as mid-October when the rule takes effect.

What it all means is that consumers will soon be able 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.

According to administration officials, the new rule is expected to lower the cost of hearing aids generally, while still ensuring their safety and effectiveness.

At the same time, it will also foster innovation and competition in the hearing aid technology marketplace, they said.

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. 

“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,” he said

It is estimated that 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. 

But 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 Dr. Robert Califf. 

“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,” he said.

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) will continue to be available only by prescription.

Dan can be reached at [email protected] and at https://twitter.com/DanMcCue.

A+
a-
  • FDA
  • Health and Human Services
  • hearing
  • hearing aids
  • over-the-counter hearing aids.
  • In The News

    Health

    Voting

    In The News

    May 20, 2025
    by Dan McCue
    Johnson Pressing for Every Vote He Can Get for Trump’s ‘One, Big, Beautiful Bill’

    WASHINGTON — House Speaker Mike Johnson, R-La., flanked by staffers, was moving quickly across the first floor of the Capitol... Read More

    WASHINGTON — House Speaker Mike Johnson, R-La., flanked by staffers, was moving quickly across the first floor of the Capitol when he encountered a small clutch of reporters in a corridor lined with statuary. “Sorry,” he said as he looked up from his ever-present binder. “I... Read More

    May 20, 2025
    by Tom Ramstack
    Justice Dept. to Use False Claims Act Against Colleges Over DEI Programs

    WASHINGTON — The Justice Department plans to use an anti-fraud law to prosecute or sue university officials who continue to... Read More

    WASHINGTON — The Justice Department plans to use an anti-fraud law to prosecute or sue university officials who continue to promote diversity, equity and inclusion programs. The creation of the "Civil Rights Fraud Initiative" announced Monday is the latest government effort to remake universities that President... Read More

    After US Cuts Funding, WHO Chief Defends $2.1B Budget Request by Comparing It With Cost of War

    GENEVA (AP) — Stripped of U.S. funding, the World Health Organization chief on Monday appealed to member countries to support its “extremely... Read More

    GENEVA (AP) — Stripped of U.S. funding, the World Health Organization chief on Monday appealed to member countries to support its “extremely modest” request for a $2.1 billion annual budget by putting that sum into perspective next to outlays for ad campaigns for tobacco or the cost of... Read More

    These Surreal Trees Survived for Centuries. Scientists Worry for Their Future

    SOCOTRA, Yemen (AP) — On a windswept plateau high above the Arabian Sea, Sena Keybani cradles a sapling that barely... Read More

    SOCOTRA, Yemen (AP) — On a windswept plateau high above the Arabian Sea, Sena Keybani cradles a sapling that barely reaches her ankle. The young plant, protected by a makeshift fence of wood and wire, is a kind of dragon’s blood tree — a species found... Read More

    Trump Heading to Capitol Hill to Persuade Divided GOP to Unify Around His 'Big, Beautiful' Bill

    WASHINGTON (AP) — President Donald Trump is heading to Capitol Hill early Tuesday to seal the deal on his “big, beautiful bill,"... Read More

    WASHINGTON (AP) — President Donald Trump is heading to Capitol Hill early Tuesday to seal the deal on his “big, beautiful bill," using the power of political persuasion to unify divided House Republicans on the multitrillion-dollar package that is at risk of collapsing ahead of planned votes this week. Trump has implored... Read More

    May 19, 2025
    by Tom Ramstack
    FEMA Internal Documents Warn About Hurricane Unpreparedness

    WASHINGTON — Hurricane season starts in just over a week and internal documents of the Federal Emergency Management Agency acknowledge... Read More

    WASHINGTON — Hurricane season starts in just over a week and internal documents of the Federal Emergency Management Agency acknowledge the agency is not ready. Multiple news agencies quoted sometimes unnamed sources in recent days saying that Trump administration cutbacks in staffing and budget mean there... Read More

    News From The Well
    scroll top