Hearing aids available in October without a prescription

August 16, 2022 – People with hearing loss will be able to buy hearing aids without a medical prescription as of mid-October.

The White House today announced that the FDA will move forward with plans to make hearing aids available over-the-counter at pharmacies, other retail outlets, and online.

This major step aims to make hearing aids easier to buy and more affordable, which could save families thousands of dollars.

An estimated 28.8 million American adults could benefit from using hearing aids, according to figures from the National Institute on Deafness and Other Communication Disorders. But only around 16% of people aged 20-69 who could benefit from hearing aids have ever used them.

The risk of 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’s final rule takes effect, Americans with mild to moderate hearing loss will be able to buy a hearing aid without a medical exam, prescription or fitting.

President Joe Biden announced in 2021 that he intended to allow over-the-counter sales of hearing aids to increase competition between 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 for minors or people with severe hearing loss will remain available by prescription only.

“This action delivers on my commitment to lowering costs for American families, saving American families nearly $3,000 for a pair of hearing aids and giving people more choices to improve their health and well-being. -be,” the president said in a statement announcing the news.

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, such as bird watching or hunting.


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