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Millions Of Americans Can Soon Benefit From Over-The-Counter Hearing Aids

The new FDA rules will also reduce the cost of hearing aids "by hundreds or even thousands of dollars".


Tom Hale


Tom Hale

Senior Journalist

Tom is a writer in London with a Master's degree in Journalism whose editorial work covers anything from health and the environment to technology and archaeology.

Senior Journalist

A doctor inserts a hearing aid onto the ear of a young woman who stares boldly into an uncertain future.
The FDA estimates almost 30 million adults in the US could benefit from hearing aid use. Image credit: Monkey Business Images/

People in the US will soon be able to get their hands on over-the-counter hearing aids without a prescription or a medical exam thanks to a "historic" new ruling by the US Food and Drug Administration (FDA). The move hopes to make it easier and cheaper for Americans to treat hearing impairment following a goal set by the Biden-Harris Administration to ease healthcare costs.

Under the new FDA rules, people 18 years of age and older with mild to moderate hearing loss should be able to buy hearing aids online and in retail stores by mid-October.


“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,” Xavier Becerra, US secretary of health and human services, said in a statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

The ruling specifically applies to air-conduction hearing aids, which sit on the outside of the ear and amplify sound down the ear canal. 

The FDA estimates almost 30 million adults in the US could benefit from hearing aid use. However, it’s estimated that just 14 percent of people with hearing difficulties actually use hearing aids. One of the big hurdles to access is money. Hearing aids and exams are not covered by Medicare and they’re often not covered by medical insurance. 

Now, a costly medical exam is not necessary and the move is set to drop the price of hearing aids. US Vice President Kamala Harris has boasted that the new FDA rules will effectively reduce the cost of hearing aids "by hundreds or even thousands of dollars."

This price drop is predicted to occur because the removal of red tape will make the market more innovative and competitive, in theory. Currently, the “Big Five” hearing aid manufacturers control more than 90 percent of the highly-concentrated market and have attempted to undermine efforts to make over-the-country hearing aids available. 

With the new FDA ruling, that monopoly is set to end. 

“This action makes good on my commitment to lower costs for American families, delivering nearly $3,000 in savings to American families for a pair of hearing aids and giving people more choices to improve their health and wellbeing,“ President Joe Biden added.

“And, it’s the latest action we are taking to make our economy more competitive and less concentrated. When too few companies dominate, American consumers pay higher costs.”


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