For the media

Hearing aids are now available over the counter

By The Health News Team | November 2, 2022
Man holding a hearing aid

Hearing aids can now be purchased over the counter (OTC) in the U.S. for the first time, thanks to a new ruling announced last month by the Food and Drug Administration (FDA). The historic ruling is expected to lower the cost of hearing aids and expand access for millions of adults across the country.

Hearing loss is the third most prevalent chronic health condition facing older adults. The FDA estimates that 15% of American adults report some trouble hearing. However, only one-fifth of people who could benefit from a hearing aid use one.

Drs. Christine Jardel and Kristy Baldwin, clinical audiologists with Sharp Rees-Stealy Medical Group, are hopeful the change will encourage more people to address their hearing loss but urge consumers to weigh the benefits and drawbacks of OTC options. Before shopping, here’s what you need to know.

OTC hearing aids are for mild to moderate hearing loss
OTC hearing aids are a new category of hearing aid assistance that allow consumers to purchase directly without having to visit a health care professional. OTC hearing aids are designed for adults 18 and older who have perceived mild to moderate hearing loss. For those with more severe hearing loss and people under the age of 18, prescription hearing aids are still the only option.

“Over-the-counter devices have limitations and may be inappropriate or inadequate to address issues including severe hearing loss, particular problems with speech discrimination or challenging hearing loss configurations, to name a few,” Dr. Jardel says.

OTC hearing aids pros and cons
Close to 30 million adults in the U.S. could benefit from hearing aid use. In older adults, untreated hearing loss has been linked to isolation, depression, falling risk and dementia.

A primary advantage of OTC hearing aids is that they reduce barriers around access. This new class of hearing aid is expected to increase competition among manufacturers and lower costs.

But Dr. Baldwin says that like any medical device, OTC hearing aids should be purchased with caution. “While over-the-counter hearing aids are more readily available than prescription devices, they’re not the best choice for everyone,” she says.

Compared to prescription hearing aids, OTC options are limited in the level of personalized care provided. What’s more, they can’t treat all levels of hearing loss or hearing-related medical conditions.

“With custom hearing aids, measurements are made to ensure the different pitches of speech sounds are getting to the ear drum to meet a target prescription based on the individuals' unique hearing loss,” Dr. Jardel says. “Even with this, the audiologist may have to make adjustments to help troubleshoot issues or provide further counseling.”

Consider seeing an audiologist first
Both Drs. Jardel and Baldwin recommend getting a hearing test if you suspect you may be experiencing hearing loss. If you skip this step, there are issues that can be missed, Dr. Jardel says.

“It could be something simple like a plug of ear wax that can be easily fixed, or it can be a symptom of a more significant medical problem,” Dr. Jardel says. “A hearing evaluation also gives us valuable insight to counsel the patient on realistic expectations with amplification — whether that’s with a custom-programmed hearing aid or a device purchased directly from a retailer.”

The lower prices and easier buying process offered by OTC hearing aid manufacturers is a big step forward in allowing more people in the U.S. the opportunity to get the help they need. But before heading straight to a website or drugstore to purchase, it’s best to educate yourself, talk with your doctor and make an informed decision about what option is best to address your hearing needs.

Learn more about audiology and hearing services at Sharp Rees-Stealy; get the latest health and wellness news, trends and patient stories from Sharp Health News.


Dr. Kristy Baldwin


Dr. Kristy Baldwin is a clinical audiologist with Sharp Rees-Stealy Medical Centers.


Dr. Christine Jardel


Dr. Christine Jardel is a clinical audiologist with Sharp Rees-Stealy Medical Group.

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