The FDA issued a final rule (August, 2022), establishing over-the-counter hearing aids to improve access to safe, effective, and affordable hearing aids for millions of Americans. This action enables consumers 18 years of age and older to purchase hearing aids directly from stores or online retailers without the need for a medical exam, prescription, or a fitting adjustment by an audiologist.
Over-the-counter (OTC) hearing aids are a new category of hearing aids that consumers can buy directly, without visiting a hearing health professional. These devices are intended to help adults with perceived mild to moderate hearing loss. Like prescription hearing aids, OTC hearing aids make sounds louder so that some adults with difficulty hearing are better able to listen, communicate, and participate fully in daily activities. In addition, OTC hearing aids are regulated as medical devices by the U.S. Food and Drug Administration (FDA).
OTC hearing aids are an alternative to prescription hearing aids, which are currently only available from hearing health professionals, such as audiologists, otolaryngologists (ear, nose, and throat doctors), and hearing aid specialists. The hearing health professional fits you for the hearing aid, adjusts the device based on your hearing loss, and provides other services.
You can buy OTC hearing aids as soon as mid-October 2022 directly in stores and online, where prescription hearing aids are not available. You fit them yourself, and you may be able to control and adjust the devices in ways that users of prescription hearing aids cannot. Some OTC hearing aids might not look like prescription hearing aids at all.
OTC hearing aids are for adults with perceived mild to moderate hearing loss. They are not meant for children or for adults who have more severe hearing loss or significant difficulty hearing. If you have more severe hearing loss, OTC hearing aids might not be able to amplify sounds at high enough levels to help you.
The FDA has established regulations that manufacturers of OTC hearing aids need to follow. In general, these federal regulations:
- Ensure that the OTC devices are safe and effectivefor people with perceived mild to moderate hearing loss.
- Set standards for package labels to help buyers understand OTC hearing aids and who might benefit from them. The labels also include warnings and other information you should know before buying or when using the hearing aid, such as signs that indicate that you should see a doctor.
Who are OTC hearing aids for?
OTC hearing aids are for adults (18 and older) who believe they have mild to moderate hearing loss, even if they have not had a hearing exam. You might have mild to moderate hearing loss if, for example:
- Speech or other sounds seem muffled.
- You have trouble hearing when you’re in a group, in a noisy area, on the phone, or when you can’t see who is talking.
- You have to ask others to speak more slowly or clearly, to talk louder, or to repeat what they said.
- You turn up the volume higher than other people prefer when watching TV or listening to the radio or music.
If you have trouble hearing conversations in quiet settings—or have trouble hearing loud sounds, such as cars or trucks, noisy appliances, or loud music—consult a hearing health professional. These are signs that you might have more severe hearing loss and that OTC hearing aids won’t work well for you. A hearing health professional can help you determine if a prescription hearing aid or other device can help you hear better.
Some ear problems need medical treatment. If you have any of the following, please see a licensed physician promptly:
- Fluid, pus, or blood coming out of your ear within the previous 6 months.
- Pain or discomfort in your ear.
- A history of excessive ear wax or suspicion that something is in your ear canal.
- Episodes of vertigo (severe dizziness) with hearing loss.
- Sudden hearing loss or quickly worsening hearing loss.
- Hearing loss that has gotten more and then less severe within the last 6 months.
- Hearing loss or tinnitus (ringing) in only one ear, or a noticeable difference in how well you can hear in each ear.
Dr. Cindy Hogan, chair of the Division of Audiology and director of the Mayo Clinic Hearing Aid Program, says this move should help improve access.
“A lot of people live in rural areas or areas where they don’t have any specialists who might be specialized in ears or hearing. And this is going to bring them more access because we know that a lot of rural communities have drugstores or stores where these over-the-counter devices might be sold,” says Dr. Hogan.
She says it also will offer people options that are less expensive since there isn’t a lot of insurance coverage for hearing aids for adults.
Dr. Hogan continues, “However, I think there will be individuals who might have a problem that they cannot diagnose themselves. There are also some limitations people should be aware of. People are not always an accurate judge of their own hearing loss, which could mean that people purchasing over-the-counter devices could better manage their hearing loss another way.”
That’s why she recommends an audiologist evaluate those considering turning to an over-the-counter option to determine if they would be a good candidate.
Something else to consider is that hearing aids are not one-size-fits-all, and a hearing loss diagnosis is personalized.
“The needs of the individual really are taken into consideration when we recommend hearing aids. Because we do get a better picture of what are their communication needs and physical needs, as well as the hearing,” says Dr. Hogan.
Find more information about hearing loss and hearing aids
The National Institute on Deafness and Other Communication Disorders (NIDCD), https://www.nidcd.nih.govmaintains an online directory of organizations that provide information on the normal and disordered processes of hearing, balance, taste, smell, voice, speech, and language.
Sources: https://www.nidcd.nih.gov/health/over-counter-hearing-aids;
https://www.fda.gov/medical-devices/consumer-products/hearing-aids;
