In Historic Ruling, FDA Allows Sale of Over-the-Counter Hearing Aids

The FDA finalized a historic ruling, creating a new category of hearing aids that can be sold over the counter (OTC) to patients with mild to moderate hearing impairment. 

Under this new rule, patients will no longer need to undergo medical examinations or see a doctor for a prescription and device fitting before they can buy a hearing aid. 

Of note, this new device category only applies to patients over 18 years old with mild or moderate hearing problems. Devices meant for severe impairments, for example, or for younger users, will still need a physician’s prescription. 

The rule, which the Agency called “historic,” is expected to foster innovation and competition among manufacturers, which would lower the prices of hearing aids without compromising their quality. The rule is set to take effect 60 days after the notice was published in the Federal Register. OTC hearing aids will likely become available in retail and drug stores by mid-October. 

“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” Xavier Becerra, secretary of Health and Human Services, said in a statement. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”

The FDA’s ruling is also in line with the Biden-Harris Administration’s aim to lower healthcare costs for Americans while bringing high-quality services to more people. 

The bid to make hearing aids more accessible started in 2017, when Congress passed legislation calling the FDA to make an OTC category for these devices. Action on the bill stalled until July 2021, when President Biden signed an executive order that he said would reinvigorate competition in the country’s economy. 

Hearing aids were explicitly a part of this EO, which called the HHS secretary to “not later than 120 days after the date of this order, publish for notice and comment a proposed rule on over-the-counter hearing aids.”

The FDA met the President’s deadline and published its proposal in October last year. Since then, more than 1,000 public comments—from consumers, professional organizations, advocacy groups, industry representatives and other stakeholders—have been lodged.

Taking all of these into consideration, the Agency finalized yesterday’s rule to include a lower maximum sound output to prevent OTC hearing aids from being too loud and a fixed limit to how deep the hearing aid can go into the ear. The rule also requires that users be able to control the volume on their hearing aids and that wording on labels and inserts be simple enough to be easily understood.

Hearing problems are extremely common in the U.S. Nearly 40 million adults aged 18 years or older experience some difficulty hearing, and almost 30 million would benefit from hearing aids. Meanwhile, among older adults aged 70 and above who should be using hearing aids, less than 30% do. Figures are even worse for younger people, who only around 16% use hearing aids even if they already need to.

Such a low level of device uptake is due to many factors, including the high upfront costs of hearing aids and the additional expenses from needing a prescription and a medical exam. Now, the number of users may increase, as many of these barriers will be lessened or removed.