FDA on Tuesday finalized a rule making hearing aids available over-the-counter (OTC) for individuals with mild-to-moderate hearing loss, widely expanding the availability of the devices and potentially reducing their cost by thousands of dollars.

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Details on the final rule

In 2017, Congress passed the Over-the-Counter Hearing Aid Act as part of the FDA Reauthorization Act, which gave FDA until August 2020 to issue draft regulations for nonprescription hearing aids. However, FDA missed the initial deadline due to the pandemic, and a proposed rule was not issued until October 2021 following an executive order by President Joe Biden.

FDA on Tuesday finalized its rule on OTC hearing aids after considering nearly 1,100 comments from stakeholders. According to FDA, several parts of its initial proposal were changed in response to public comments, including how the rule will impact state regulations.

Under the final rule, air-conduction hearing aids, which are worn behind or inside the ear, can be sold OTC to adults ages 18 and older with mild-to-moderate hearing loss.

According to the New York Times, people with this type of hearing loss may struggle to hear conversations on the phone or in crowded places, and consistently turn up the volume on computers or televisions. They may also have a hard time distinguishing between voices when multiple people speak at once, feel like they miss words in a conversation, and frequently ask people to repeat themselves.

To ensure the safety of these devices, FDA has set specific volume limits, as well as certain performance and design requirements.

In a press release, FDA said the new rule will allow adults with mild-to-moderate hearing loss "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."

"The rule is designed to provide a reasonable assurance of safety and effectiveness of OTC hearing aids, while fostering innovation and competition in the hearing aid technology marketplace," the agency wrote.

How the new rule will affect the accessibility and cost of hearing aids

According to NIH, around 28.8 million Americans could potentially benefit from hearing aids, but only 16% of people ages 20 to 69 and 30% of people ages 70 and older currently use them.

For many people, the steep price of hearing aids, which can cost between $1,000 and $4,000 per ear, can be a deterrent. Hearing aids are also not typically covered by private insurance or Medicare.

Under the new rule, the prices of hearing aids are expected to fall significantly, making them more affordable for many people. "The FDA estimates this rule will save consumers on the order of about $1,400 per individual hearing aid or over $2,800 per pair," said Brian Deese, director of the National Economic Council.

However, some experts noted that consumers will likely have to go through a trial-and-error process to find the right OTC hearing aid for them. This is because many cases of hearing loss are highly individualized and can be associated with specific environments or frequencies.

"Hearing loss is unique to each person, and most do not know if their condition is mild, moderate, or greater, caused by another medical issue or something as simple as ear wax," said Kate Carr, president of the Hearing Industries Association.

Although many people may benefit from OTC hearing devices, some may still need to visit a physician and an audiologist for more in-depth guidance and care, Carr and other experts said.

Retailers are already preparing for new OTC hearing aids

FDA's final rule is expected to go into effect in 60 days, and OTC hearing aids could be available as soon as mid-October. Currently, FDA Commissioner Robert Califf said the agency is working with manufacturers to ensure that the OTC devices are of "good quality" and meet performance criteria.

"This will create new avenues for individuals to obtain more affordable hearing aids and will hopefully create opportunities to introduce innovative technology to the market," said Meaghan Reed, director of audiology at Massachusetts Eye and Ear, a hospital in Boston.

Already, several retailers, including CVS Health and Walgreens, have said they will sell OTC hearing aids online and in their physical stores when they become available. "This is an important step toward increasing accessibility and affordability of hearing aids for Americans who need them," CVS said.

In addition, Best Buy, which recently began its own expansion into health care, on Wednesday announced that it will expand its collection of hearing devices in the fall. The company also plans to offer an online tool to help consumers determine their level of hearing loss and which specific products could benefit them.

"Our expansion of the hearing collection and new store experience will let customers easily find a hearing loss solution from brands they trust," said Frank Bedo, Best Buy's category officer. "Our customers come to us for quality tech products and expertise, and this fall we'll be able to better help them find the right solutions specific to their needs." (Reed, Axios, 8/17; AP/STAT, 8/16; Frieden, MedPage Today, 8/16; Clason, Roll Call, 8/16; Chappell, NPR, 8/17; Blum, New York Times, 8/16; Sullivan, The Hill, 8/16; Sellers, Washington Post, 8/17; Mosbergen/Jargon, Wall Street Journal, 8/16; Scott/Shepherd, Washington Post, 8/16; Treisman, NPR, 8/16; Japsen, Forbes, 8/17; Barnes, "Changing America," The Hill, 8/17)