FDA Issues Proposed Rule For OTC Hearing Aids

A white person's hand holding a hearing aid.


Key Takeaways

  • Hearing aids are only available by prescription but a proposed rule from the Food and Drug Administration (FDA) is expected to make the devices available over-the-counter (OTC) for people with mild to moderate hearing loss.
  • The hearing aids could be available in retail stores and online for hundreds—instead of thousands —of dollars as soon as 2022.
  • The FDA said that OTC hearing aids are not intended for children under the age of 18 or adults with severe hearing loss. 

The Food and Drug Administration (FDA) has recently proposed a rule to create a new hearing aid category: over-the-counter (OTC) devices. 

The new rule is expected to be made final after the period of public comment, which could be as soon as early 2022. The rule would officially permit the purchase of hearing aids in retail stores and online without a prescription.

Why Make Hearing Aids OTC?

According to the National Institute of Deafness and Communications Disorders, about 28.8 million adults in the United States could benefit from using hearing aids, but fewer than 1 in 3 (or 30%) have ever used them.

Even fewer adults between the ages of 20 to 69 who could benefit from wearing hearing aids have ever used them (approximately 16%).

In most states, people who want hearing aids must have a hearing test and be fitted for the devices by a hearing specialist. These steps add to the cost and can be difficult for people who do not have access to hearing specialists where they live.

Hearing aids can cost anywhere between $4,000 to $5,000 per pair. Currently, the devices are not covered by basic Medicare plans. When insurance does cover the devices, it usually only covers part of the cost.

In October, U.S. Department of Health and Human Services (HHS) Secretary Xavier Becerra said in a statement that the FDA's move "takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss."

An executive order released by President Biden in July said OTC hearing aids were one example of how "a lack of competition in healthcare increases prices and reduces access to quality care."

The White House fact sheet also said that "hearing aids are so expensive that only 14% of the approximately 48 million Americans with hearing loss use them."

Janet Woodcock, MD, the FDA’s acting commissioner, said in a statement the proposed rule "represents a significant step toward helping ensure that adults with mild to moderate hearing loss have improved access to more affordable and innovative product options."

Who Could Get OTC Hearing Aids?

Once the rule is final, the OTC category for hearing aids will be intended for adults age 18 and older who have mild to moderate hearing loss. Hearing aids for severe hearing loss and for users younger than age 18 will still require an evaluation and prescription. 

Types of Hearing Loss

The FDA defines types of hearing loss as: 

  • Mild. A person with mild hearing loss may hear some speech sounds but soft sounds are hard to hear.
  • Moderate. A person with moderate hearing loss may hear almost no speech when another person is talking at a normal level.
  • Severe. A person with severe hearing loss will hear no speech when a person is talking at a normal level and only some loud sounds.
  • Profound. A person with a profound hearing loss will not hear any speech and only very loud sounds.

Will OTC Hearing Aids Be Safe?

To ensure patient safety, the FDA's proposed rule also places a maximum volume limit for OTC hearing aids to prevent injuries from the overamplification of sound.

The rule also includes certain device performance and design requirements, including those that apply to how quickly an OTC hearing aid can process, amplify, and relay sound. It would also limit how deeply in the ear the hearing aid can fit to help avoid ear injury.

William Shapiro, AUD, an audiologist at NYU Langone Medical Center in New York City, told Verywell that he thinks OTC hearing aids “are a great idea if implemented appropriately and thoughtfully.”

William Shapiro, AUD

Stigma and cosmetic concerns are also reasons people don’t use hearing aids, not just cost.

— William Shapiro, AUD

While Shapiro said that OTC devices will allow many patients to access the devices, “stigma and cosmetic concerns are also reasons people don’t use hearing aids, not just cost."

To that end, Shapiro recommends that patients remain open to the idea of improving their hearing—rather than try to get by asking people to repeat what they’ve said, or turning up the volume on the TV.

“What may happen is that if a patient wears an OTC device and finds some benefit, they may see it as a starter hearing aid and then move to a more sophisticated one, if needed," said Shapiro.

Concerns About OTC Hearing Aids

One concern that hearing experts have is that people who purchase OTC hearing aids may have hearing loss for a reason that needs to be evaluated by a specialist.

Eric Mann, MD, PhD, the chief medical officer in the FDA office responsible for hearing aids, said in the agency's statement that it's important that people know that "hearing loss could be a sign of an easily treatable problem like built-up earwax or a more serious problem like a benign tumor on the hearing nerve."

Therefore, Mann advised that people "see a doctor when things don’t feel right, when your hearing loss is progressing, or if you are having associated symptoms like dizziness, ear pain, or drainage from the ear canal."

The FDA's proposed rule was released in late October. The agency will be accepting comments from the public, as is required by law, through early 2022. After the comment period closes, it will have two months to issue final rules.

It will take some time for the first OTC devices to appear on the market, but according to Barbara Kelley, executive director of the Hearing Loss Association of America, "the good news is that you will soon have more options" for hearing aids if you have mild to moderate hearing loss.

That said, Kelley said that people should not "wait for OTC devices to come to market" to address any problems with their hearing. "If you think you have a hearing loss, get tested now.” 

In a statement that was released with the Hearing Loss Association, Kate Carr, president of the Hearing Industries Association, said that "good hearing increases social engagement, improves communication, lowers the risk of isolation and depression, and is part of healthy aging."

Other OTC Hearing Devices

There are some products on the market that seem like OTC hearing aids but are not. One category is Personal Sound Amplification Products (PSAPs.) These devices are intended to amplify sound during noisy situations, such as hunting, for people with normal hearing.

In the FDA's statement, Mann said that because "PSAPs are regulated as consumer electronics and not medical devices, they may be more variable in terms of product quality compared to hearing aids" and added that "the FDA does not regulate such PSAPs for safety and effectiveness" as they do for hearing aids.

Several companies, such as Bose (which makes headphones) currently sell what they call direct-to-consumer hearing aids for mild to moderate hearing loss. Some people may want to try these options and see if they are helpful.

Selena Briggs, MD, vice-chair of the department of otolaryngology at Medstar Health Washington Hospital Center in Washington DC, told Verywell that one advantage to OTC hearings aids is that because they are less expensive and will be more widely available, people with hearing difficulty might be more willing to try them.

“Right now, people are far more likely to get their vision corrected with glasses than to improve their hearing with hearing aids,” Briggs said. “I’d like to see no concern to wear either.” 

What This Means For You

The FDA has proposed a new rule that could allow people with mild-to-moderate hearing loss to get hearing aids over-the-counter (OTC) at pharmacies and retail stores as soon as 2022.

However, if you are having trouble hearing, it's still important to talk to your doctor. Some causes of hearing loss are easily treatable, while others might need more treatment than OTC hearing aids.

November 16, 2021: A previous version of this article misspelled the name of William Shapiro, AUD, an audiologist at NYU Langone Medical Center in New York City.

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2 Sources
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  1. National Insitute of Deafness and Other Communication Disorders. Quick Statistics About Hearing.

  2. John Hopkins Bloomberg School of Public Health. The Hearing Aid Revolution: Cheaper and Easier to Get.