Consumers with mild to moderate hearing loss will soon be able to purchase hearing aids over the counter without needing to consult an audiologist. The Food and Drug Administration released the final rules governing the design and sale of over-the-counter hearing aids on Tuesday, five years after the law legalizing such devices was passed.
“I have a big smile on my face,” said Frank Lin, PhD, director of the Johns Hopkins Cochlear Center for Hearing and Public Health, who testified before Congress in favor of the law back when it was being debated in 2017. “It’s a win-win all-around for consumers.”
About 15% of all American adults experience some level of hearing loss, according to the FDA, but currently only about one-fifth of people who could benefit from a hearing aid actually use one. Hearing aids can cost thousands of dollars and are not covered by Medicare. The Over-the-Counter Hearing Aid Act of 2017 aimed to address this problem by reducing cost and other access barriers to getting hearing aids.
“This rule is expected to help us achieve quality, affordable healthcare access for millions of Americans in need,” said Xavier Becerra, Secretary of the Department of Health and Human Services, in a news release. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
According to a statement from President Biden today, over-the-counter hearing aids could be available in stores as early as mid-October.
What the FDA Hearing Aid Rules Say
The rules released by the FDA define the category of over-the-counter hearing aids and make clear how they will be sold and regulated. This includes technical specifications manufacturers must meet in order to ensure that the over-the-counter hearing aids are safe, effective, and accessible to consumers with mild to moderate hearing loss.
The final rules maintain many of the features in the draft version, which was released in October 2021. They mandate an overall limit for how loud an over-the-counter hearing aid can be: 111 decibels in general and 117 decibels while certain sound-control features are activated. Those limits are just slightly lower than what the agency had initially proposed.
Other changes from the draft include a requirement that all over-the-counter hearing aids allow users to adjust the volume, and specifications to make the product labeling and instructions understandable for consumers. Barbara Kelley, executive director of the Hearing Loss Association of America (HLAA), said she was glad to see the FDA require that labeling make it clear whether a smartphone or other additional device is needed to use over-the-counter hearing aid, as is likely with some forthcoming products.
The final rules are very close to the draft, however. That’s despite intense opposition from the traditional hearing aid industry, which is dominated by five large companies, according to a June 2022 report compiled by Senators Elizabeth Warren (D-Massachusetts) and Chuck Grassley (R-Iowa). Grassley and Warren proposed the 2017 over-the-counter hearing aid law together. Opponents of the new rules argued that over-the-counter hearing aids should be more strictly limited in how loud their output could be and how much they could amplify incoming sound — the idea being that too much amplification could actually harm hearing.
But supporters of the rules have pointed out that such limitations would mean fewer consumers could benefit from the devices. Lin applauded the FDA for largely maintaining what the agency initially proposed, with only the minor change to the total output limit.
“It doesn’t cripple these devices unnecessarily from the get-go,” he said. “In short, the FDA got it right.”
Companies also will be motivated to design hearing aids that people actually want to use.
“It’s unlikely a company would add a ridiculous over-amplification of sound because the consumer probably wouldn’t like it,” said Nicholas Reed, AuD, an assistant professor of epidemiology and audiology with the Johns Hopkins Cochlear Center.
The final rules maintain a measure that ensures that the federal over-the-counter hearing aid rules will preempt (in other words, essentially nullify) any state-level rules that impose extra barriers to consumers seeking to buy hearing aids over the counter. Advocates, including experts from the President’s Council of Advisors on Science and Technology and the National Academies of Sciences, Engineering, and Medicine, have argued that the complex web of state laws restricting access to hearing aids isn’t good for consumers. The new rules make many of those laws moot. In a call with media this week, Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said that states will still be able to enforce consumer protections, such as requiring warranties or reasonable return policies for over-the-counter hearing aids.
The New Hearing Aid Marketplace
Over-the-counter hearing aids aren’t intended to be used by people under the age of 18. The FDA said kids and teens still need a hearing health professional’s guidance when getting them.
And not all hearing aids will be available over the counter under the new rules. Some hearing aids, particularly those for people with more severe hearing loss, will still be prescription devices. Consumers will need to consult an audiologist or other hearing care provider to get them.
The rules essentially create two categories, so all hearing aids will now be either prescription devices or over-the-counter devices. This should eliminate a de facto category of hearing aids that currently exists, often referred to as direct-to-consumer hearing aids, which have long been available without a doctor’s intervention when purchased online or via mail order.
Manufacturers could start selling over-the-counter hearing aids as soon as two months from now after the rules officially go into effect, assuming they have products ready that comply with the new regulations. Lin said he thinks some companies are ready to go and will be able to sell over-the-counter products this fall. Supporters of the new rules expect that consumers will soon have more affordable choices and also eventually more options and features to choose from.
Kelley of the Hearing Loss Association of America said that many consumers may not be certain whether an over-the-counter hearing aid is a good option for them, or whether they should see an audiologist or another healthcare provider for a hearing problem. The HLAA’s website offers tips on how to figure out if an over-the-counter might be a good choice for you. And Northwestern University’s Consumer Ear Disease Risk Assessment can help you figure out if you might be better off seeing a doctor for hearing help.