Over-the-Counter Hearing Aids Could Be in Stores This Fall
The FDA today released its final rules for OTC devices after years of consumer anticipation
By Catherine Roberts
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 today released the final rules governing the design and sale of OTC hearing aids, five years after the law legalizing such devices was passed.
“I have a big smile on my face,” says 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 percent 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 health care access for millions of Americans in need,” said U.S. Department of Health and Human Services Secretary Xavier Becerra 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, OTC 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 the OTC hearing aids are safe, effective, and accessible to consumers with mild to moderate hearing loss.
The final rules maintain many of the features of the draft version, which was released in October 2021. They mandate an overall limit for how loud an OTC 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 OTC hearing aids allow users to adjust the volume and specifications for labeling of OTC hearing aids to make the product labeling and instructions understandable for laypeople.
The final rules are very close to the draft, however. That’s despite intense opposition from the existing traditional hearing aid industry, which is dominated by five large companies, according to a June 2022 report compiled by Senators Elizabeth Warren and Chuck Grassley. (Grassley and Warren together proposed the 2017 OTC hearing aid law.) Opponents of the new rules argued that OTC hearing aids should be more strictly limited in how loud their output could be and how much they could amplify an 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,” Lin says. “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,” says Nicholas Reed, Au.D., assistant professor of epidemiology and audiology with the Johns Hopkins Cochlear Center.
The final rules maintain a measure that ensures the federal OTC 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.
The New Hearing Aid Marketplace
OTC hearing aids aren’t intended to be used by people under the age of 18; the FDA says kids and teens still need a hearing health professional’s guidance when getting hearing aids.
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, for which consumers will need to consult an audiologist or other hearing care provider.
The rules essentially create two categories, so all hearing aids will now be either prescription devices or OTC 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 OTC 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 says he believes some companies out there are ready to go and will be able to sell OTC 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.
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