What to know about over-the-counter hearing aids

September 1, 2022 Sanghmitra Arvindekar

In this article: 

  • The FDA has issued a new ruling on OTC hearing aids. A Swedish audiologist has advice to help you make the right choices. 
  • Research shows that people wait seven years on average to address hearing issues. 
  • A comprehensive evaluation by an audiologist can help if you think you may need hearing aids. 

In mid-August, the U.S. Food and Drug Administration (FDA) issued a final rule on over-the-counter (OTC) hearing aids, which will lower costs and improve access to the devices for millions of Americans. The FDA’s action establishes a new category of OTC hearing aids, enabling consumers with mild to moderate hearing impairment to purchase hearing aids directly from retailers without the need for a medical exam, prescription or fitting by an audiologist. The move is also expected to lower the cost of hearing aids and expand access to the devices for million of Americans.

There has been talk about OTC hearing aids for a while now. What exactly are OTC hearing aids and are they appropriate for you? Here are some things you will need to know when thinking about OTC hearing aids and hearing loss:

According to the data published by the National Institute on Deafness and Other Communication Disorders (NIDCD) 37.5 million Americans have some degree of hearing loss or perceived hearing difficulty. Approximately 28.8 million of those Americans would benefit with hearing aids.

Research from the Hearing Loss Association of America (HLAA) has indicated that on average people wait seven years to address their hearing issues. This can further lead to social isolation, depression, anxiety, increased falls, and increased risk of dementia. Research further indicates that 8% of the possibly modifiable dementia cases have untreated hearing loss as one of the causes.

Many insurance plans provide little to no coverage for hearing aids leaving many Americans without help and at risk for multiple ailments. The currently available hearing aids are categorized as a medical device by the FDA which require a licensed professional to fit them appropriately. To address this issue and make hearing aids more accessible, the FDA is working on creating a new category for OTC Hearing Aids under the FDA Reauthorization Act of 2017.

This side-by-side comparison of the devices from the American Speech-Language-Hearing Association is a helpful quick reference for understating the differences between prescription and overt-the-counter hearing aids.  

Prescription hearing aids 

OTC hearing aids

Fit by licensed professionals (audiologists and hearing aid dispensers).

Fit by self

Average Cost: $2000 to $7000 per pair

Average Cost: $1000 per pair

For all ages

For those 18 years of age and older

Hearing Loss: Diagnosed and confirmed through comprehensive audiologic evaluation

Hearing Loss: Perceived and estimated by online tests and other self-used tools (mild to moderate loss only)

Design: customized to fit different styles

Design: one size

Return policy/ Trial period: Mandated by most states

Return policy/ Trial period: No proposed requirement by the FDA

Verification of Fit: obtained by Real Ear Measurements

Verification of fit: None

Severity of Hearing Loss: All

Severity of Hearing loss: Perceived mild to moderate

Selection Process: Communications and assessment with the licensed professional

Selection Process: Self selection

It is still important to receive a comprehensive hearing evaluation by an audiologist if you plan to pursue OTC devices.  This exam will rule out medical problems that may need treatment, including ear wax build-up, possible ear infections, middle ear conditions, and in some cases tumor(s) on the hearing nerve. Self-fit devices may provide a competitive price point, but do not provide the services included when being fit by a licensed professional. The cost of prescription hearing aids is higher as it includes necessary follow up care to ensure proper physical fit, prescription volume for the loss, care and maintenance to ensure that the device will function for multiple years.

If you are considering OTC devices for yourself or a loved one, it’s important to know when they are and are not appropriate. Be sure to consult your healthcare provider if any of the following occurs:

  1. Drainage of any kind from one or both ears.
  2. Experience dizziness or imbalance.  
  3. Pain or debilitating discomfort in one or both ears.
  4. Ringing/tinnitus in one or both ears.
  5. Any sudden changes in hearing in one or both ears.
  6. Perceive difficulty understanding conversation with the OTC devices,

If you opt for the OTC devices, a comprehensive audiologic evaluation by an audiology professional at Swedish is strongly recommended.


Sanghmitra Arvindekar is clinical audiologist at Swedish Medical Center.   


Learn more and find a provider 

Think you may be experiencing some hearing loss? See a Swedish audiologist for an evaluation if your hearing has changed. If you are exposed to loud noise regularly, get an annual hearing checkup. Learn about hearing services at Swedish or call 1-800-793-3474 for an appointment.

Swedish Virtual Care connects you face-to-face with a nurse practitioner who can review your symptoms, provide instructions and follow up as needed. If you need to find a doctor, you can use our provider directory.

Join our Patient and Family Advisory Council.

This information is not intended as a substitute for professional medical care. Always follow your health care professional's instructions.

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