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A new rule from the FDA slashed the prices for hearing aids, and now many are available in stores and online.

Over-the-counter hearing aids are available today. Here’s what to know

[Source Photo: Getty Images]

BY Sarah Lynch3 minute read

Hearing loss is the third most common chronic physical condition in the United States, affecting approximately 30 million people in the country. But starting today, hearing aids will be available for over-the-counter purchase.

Before, accessing hearing aids required a medical exam, prescription, and fitting, and traditional Medicare does not cover hearing aids. In its final rule, the Food and Drug Administration (FDA) acknowledged that hearing loss “can have a significant impact on communication, social participation, and overall health and quality of life.” This change seeks to address that disparity.  

The FDA announced the rule back in August, garnering praise from advocacy groups and President Biden, who said the rule will deliver “nearly $3,000 in savings to American families for a pair of hearing aids” and give people “more choices to improve their health and well-being.” 

For consumers looking to purchase a hearing aid over the counter, here are the most crucial details to know.  

Who can get an over-the-counter hearing aid?  

Starting today, adults 18 years and older with “perceived mild to moderate hearing loss” can now access over-the-counter hearing aids in stores and online, according to the FDA’s final rule. This excludes people with more severe hearing loss.  

The FDA declined to objectively define hearing impairment, leaving that delineation to the person seeking a hearing aid. It’s possible that someone with mild hearing loss, for instance, may find it difficult to understand some speech sounds, while someone with moderate hearing loss may struggle to do so even at normal speaking level in a quiet room.  

In another key distinction, people under the age of 18 cannot access over-the-counter hearing aids and must still receive a prescription. “The largest part of that is [children] really need and would benefit from a custom programmed instrument and ongoing care of an audiological professional,” says Dr. Sreek Cherukuri, a board-certified ear, nose, and throat surgeon in Chicago.  

Where can you get them? And how much do they cost?  

Over-the-counter hearing aids are now available in stores and online. Some retailers have already announced the available options, and others are rolling out this new option in the upcoming days. On the whole, the White House estimates that this ruling could cut the cost of a pair of hearing aids by $3,000. Indeed, before over-the-counter options, a pair of hearing aids could cost anywhere between $2,000 and $7,000, according to GoodRx Health.  

Now, at Walmart, for instance, people can purchase over-the-counter hearing aids for between $199 and $999 online or at over 1,000 Walmart stores and 474 Sam’s Club Hearing Aid Center locations. No hearing exam or audiological adjustment is required.  

“Offering easy access to OTC hearing aids––something that seems quite small––is a solution that can improve [our customers’] health outcomes and their ability to live better and healthier,” said Dr. John Wigneswaran, chief medical officer at Walmart, in a statement

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Starting today, Walgreens will sell hearing aids at their stores for $799 per pair. Hearing aids at CVS can be found online today and, in November, in select CVS pharmacy locations. Hearing aids from Hy-Vee will be available this week in 34 locations as well as online in models that range from $499.99 to $999.99. They plan to offer those products in 100 locations by the end of the year. The Lexie B2 hearing aids Powered by Bose cost $999 per pair, or $49 per month for 24 months.  

More developments are upcoming. Sony recently partnered with WS Audiology in Denmark with plans to produce products and services in the self-fitting hearing aid market, and companies are expected to showcase more devices at the Consumer Electronics Show in Las Vegas. 

What do consumers need to know?  

These over-the-counter hearing aids provide a wide array of options, from price point to functionalities; for instance, some require smartphone and Bluetooth technology. The FDA did not mandate “post-sale requirements” for manufacturers and sellers relating to return policies or trials.  

“It is very common for people to try two or three different types of hearing aids before they settle on the one they think is best,” Cherukuri says. Because of this, carefully reading return or trial period policies is crucial.  

“It’s kind of critically important that before you buy something, you understand what are the options if it doesn’t work for you.”

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