People dealing with hearing loss will be able to buy hearing aids without a doctor’s prescription as soon as mid-October.
An estimated 28.8 million U.S. adults could benefit from using hearing aids, according to numbers from the National Institute on Deafness and Other Communication Disorders. But only about 16% of people ages 20 to 69 years who could be helped by hearing aids have ever used them.
The White House announced that the FDA will move forward with plans to make hearing aids available over the counter in pharmacies, other retail locations, and online. This major milestone aims to make hearing aids easier to buy and more affordable, potentially saving families thousands of dollars.
The risk for hearing loss increases with age. Among Americans ages 70 and older, only 30% who could hear better with these devices have ever used them, the institute reports.
Once the FDA final rule takes effect, Americans with mild to moderate hearing loss will be able to buy a hearing aid without a doctor’s exam, prescription, or fitting adjustment.
President Joe Biden announced in 2021 that he intended to allow hearing aids to be sold over the counter without a prescription to increase competition among manufacturers. Congress also passed bipartisan legislation in 2017 requiring the FDA to create a new category for hearing aids sold directly to consumers. Some devices intended for minors or people with severe hearing loss will remain available only with a prescription.
“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,” the president said in a statement announcing the news.
The new over-the-counter hearing aids will be considered medical devices.
To avoid confusion, the FDA explains the differences between hearing aids and personal sound amplification products (PSAPs). For example, PSAPs are considered electronic devices designed for people with normal hearing to use in certain situations, like birdwatching or hunting.
Parvathy Sukumaran 
