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-

In The News

Health

Voting

In The News

March 22, 2023
by Tom Ramstack
Sens. Press Moderna Chief Exec on COVID Vaccine Price Hike

WASHINGTON — The chief executive of Moderna Inc. defended his plan to quadruple the price of the COVID-19 vaccine during... Read More

WASHINGTON — The chief executive of Moderna Inc. defended his plan to quadruple the price of the COVID-19 vaccine during a Senate hearing Wednesday by saying his company is preparing for a sharp decline in demand. With as much as a 90% drop in customers as... Read More

What Made Beethoven Sick? DNA From His Hair Offers Clues

NEW YORK (AP) — Nearly 200 years after Ludwig van Beethoven's death, researchers pulled DNA from strands of his hair,... Read More

NEW YORK (AP) — Nearly 200 years after Ludwig van Beethoven's death, researchers pulled DNA from strands of his hair, searching for clues about the health problems and hearing loss that plagued him. They weren't able to crack the case of the German composer's deafness or... Read More

Behind Massive Seaweed Belt Headed for Some Atlantic Beaches

WASHINGTON (AP) — A 5,000-mile seaweed belt lurking in the Atlantic Ocean is expected in the next few months to... Read More

WASHINGTON (AP) — A 5,000-mile seaweed belt lurking in the Atlantic Ocean is expected in the next few months to wash onto beaches in the Caribbean Sea, South Florida, and the Yucatán Peninsula in Mexico. The Great Atlantic Sargassum Belt — as the biomass stretching from... Read More

March 21, 2023
by Tom Ramstack
Reformers Seek to Block DC Law Allowing Noncitizen Voters

WASHINGTON — A group of Washington, D.C., voters is suing to overturn a new local law giving noncitizen residents a... Read More

WASHINGTON — A group of Washington, D.C., voters is suing to overturn a new local law giving noncitizen residents a right to vote. They say the law infringes on American citizens’ right to self-government and dilutes the value of their votes. “It follows from our national... Read More

Superbug Fungus Cases Rose Dramatically During Pandemic

NEW YORK (AP) — U.S. cases of a dangerous fungus tripled over just three years, and more than half of... Read More

NEW YORK (AP) — U.S. cases of a dangerous fungus tripled over just three years, and more than half of states have now reported it, according to a new study. The COVID-19 pandemic likely drove part of the increase, researchers at the Centers for Disease Control... Read More

March 21, 2023
by Dan McCue
Biden Designates Two National Monuments in Southwest

WASHINGTON — President Joe Biden on Tuesday will designate two new national monuments ahead of remarks at the White House... Read More

WASHINGTON — President Joe Biden on Tuesday will designate two new national monuments ahead of remarks at the White House Conservation in Action Summit being held at the headquarters of the U.S. Interior Department. In southern Nevada, Biden will bestow federal protection on about a half... Read More

News From The Well
scroll top