On August 16, 2022, the Food and Drug Administration issued a final rule to create a new category of over-the-counter (OTC) hearing devices. Under this rule, OTC devices could be available on store shelves and online as soon as mid-October.
Here are some answers to some common questions about OTC hearing devices.
Do I need a prescription for OTC devices?
No, you can buy them without a prescription or a hearing exam.
Are OTC devices for everybody?
OTC devices are only for adults ages 18 and older with perceived mild to moderate hearing loss. If you have severe hearing loss or are under age 18, you will need prescription hearing devices.
Are OTC devices the same as prescription devices?
One significant difference is that OTC devices will be self-fitting, so you must adjust the device settings yourself.1 In contrast, prescription hearing devices are custom fit by a hearing professional to provide the right amplification levels for your individual hearing profile. Prescription hearing aids also allow for multiple custom settings. Your hearing professional can program these settings for specific environments such as family dinners or noisy car rides so that you can hear your best no matter where your day takes you.
According to the new FDA guidelines, OTC devices will also have a maximum sound output of 111 decibels and an insertion depth limit in the ear canal to minimize risk of harm. The devices must also meet performance specifications and design requirements.2
Like reading glasses, OTC devices may be appropriate for individuals with mild to moderate hearing loss who are not experiencing additional symptoms. Prescription hearing devices are recommended for individuals with moderate to severe hearing loss, or for individuals who experience additional complicating factors.
Is it okay to skip my hearing evaluation and buy OTC devices?
Hearing loss can change gradually over time, so getting a hearing evaluation before purchasing any hearing device is always a good idea, especially since OTC devices are only for certain types of hearing loss.
Hearing evaluations can help diagnose conductive hearing loss, or hearing loss caused by blockages in the outer ear. This type of loss may be reversible through medical or surgical intervention.
Skipping a hearing evaluation also means that your audiologist won’t get a chance to check for any serious underlying medical issues causing your hearing loss, which could have long-term consequences for your health. Sudden hearing loss, hearing loss or tinnitus in one ear only, pain or fullness in the ear, and dizziness are all signs that you should see a hearing professional for further evaluation.
The bottom line? With OTC hearing devices, you’re on your own to make them work for you; with prescription hearing devices, you get comprehensive medical care and fitting expertise to help you hear your best. Have questions? We’re here to help—set up an appointment with our team today by calling (703) 644-7800.
1 National Institute on Deafness and Other Communication Disorders. (2022). Over-the-Counter Hearing Aids. https://www.nidcd.nih.gov/health/over-counter-hearing-aids 2 Food and Drug Administration. (2022). FDA Finalizes Historic Rule Enabling Access to Over-the-Counter Hearing Aids for Millions of Americans. https://www.fda.gov/news-events/press-announcements/fda-finalizes-historic-rule-enabling-access-over-counter-hearing-aids-millions-americans