Over-the-Counter Hearing Aids: Who They Help and When to See a Professional
Who the FDA's over-the-counter hearing aid category is meant for, the warning signs that call for a doctor first, and how to shop for OTC aids carefully.
What changed in 2022
The U.S. Food and Drug Administration created a new category of over-the-counter (OTC) hearing aids, which went into effect on October 17, 2022. Since then, adults can buy hearing aids in stores and online without a hearing exam, a prescription or a fitting appointment with a licensed professional. Hearing aids sold this way must be labeled as OTC hearing aids. Prescription hearing aids, fitted by a licensed professional, remain available alongside them.
Who OTC hearing aids are for
According to the FDA, OTC hearing aids are intended for adults 18 and older with perceived mild to moderate hearing loss. "Perceived" matters: the rule assumes you are judging your own hearing, without a test. Signs that a person may be in the mild-to-moderate range include:
- Speech sounds muffled, or you hear people talking but miss some words
- You struggle to follow conversation in groups or noisy places
- You turn up the TV or radio louder than others prefer
- You often ask people to repeat themselves or to speak more slowly
- You find phone calls harder to follow than in-person conversation
OTC hearing aids are not intended for severe or profound hearing loss. The FDA notes that if you cannot hear speech even in a quiet room, or you do not hear loud sounds well, OTC devices may not be enough, and you should see a hearing health professional. One reason is an output ceiling: the FDA rule at 21 CFR 800.30 caps an OTC hearing aid's maximum output at 111 dB SPL, or 117 dB SPL when input-controlled compression is switched on. Anyone under 18 needs a prescription hearing aid.
Warning signs that call for a doctor first
The FDA requires OTC hearing aid labeling to tell buyers to see a doctor, preferably an ear, nose and throat (ENT) specialist, before using the device if they have any of the following:
- An ear that was deformed at birth or has an unusual shape
- An ear injured or deformed by an accident
- Blood, pus or fluid coming out of the ear within the past six months
- Ear pain or discomfort
- A history of excessive earwax, or suspicion that something is in the ear canal
- Severe dizziness or vertigo
- A sudden change in hearing within the past six months
- Hearing that has gotten worse and then better again (fluctuating hearing)
- Hearing loss that is worse in one ear than the other
- Ringing or buzzing (tinnitus) in only one ear
These symptoms can point to conditions that need medical treatment, some of them time-sensitive. Sudden hearing loss in particular is one the NIDCD describes as a medical emergency. A hearing aid would only mask the problem.
When a professional fitting makes more sense
Even without warning signs, some people are better served by prescription hearing aids fitted by an audiologist or licensed hearing instrument specialist. Consider a professional route if:
- You have tried OTC hearing aids and still struggle to understand speech
- You are not sure how much hearing loss you have and want a real test
- You have difficulty with small controls, smartphone apps or setting up devices yourself
- You want in-person help with adjustments, cleaning and repairs over time
- You want the fit checked in your own ear with real-ear measurement
- You are considering options beyond hearing aids, such as cochlear implants
A middle path is also common: get a professional hearing evaluation first, then decide. Knowing your audiogram can tell you whether your loss falls in the range OTC devices are designed for. Some clinics also offer help setting up or adjusting OTC devices for a fee, so it is worth asking.
What the box must tell you
FDA rules require the outside package of an OTC hearing aid to show, before you pay:
- A warning against use under age 18, and the signs of mild to moderate loss it is meant for, such as finding that listening makes you tired
- When to see a hearing professional, and the "red flag" conditions listed above
- Where to find the full instructions online, and how to request a paper copy
- The manufacturer's return policy, or a statement that there is none
- Whether the device is used or rebuilt
- Battery type and number, whether batteries are included, and whether a phone or remote is needed to operate it
If it is missing, the FDA suggests asking the seller or manufacturer. It also warns that "FDA Registered" or "FDA Certified" claims, or an FDA logo on the box, may be misleading.
Shopping for OTC hearing aids carefully
If you decide to try OTC hearing aids, a few habits help:
- Check the label. Look for the words "OTC hearing aid." Products marketed as personal sound amplification products (PSAPs) are not hearing aids and are not meant to treat hearing loss.
- Read the return policy before buying. It must appear on the box, but the FDA points out that its OTC rules do not require a warranty, so return windows and restocking fees depend on the seller and manufacturer.
- Understand how it is adjusted. Some models are set up through a smartphone app with a self-test; others have a few preset programs. Choose one you are comfortable operating.
- Give it time. The FDA notes that getting used to hearing aids usually takes a while, and that many sounds, including your own voice, may seem too loud at first.
- Keep realistic expectations. No hearing aid restores normal hearing. If you are not benefiting after a fair trial, see a professional rather than giving up.
Who sells them, and your test records
The FDA rule also bars states from requiring a licensed professional's involvement in an adult's OTC purchase, or a special license to sell OTC hearing aids, so pharmacies and websites can sell them. Audiologists and hearing aid dispensers can sell them too. If you have had a hearing test, the FDA notes that you can request your evaluation records and buy your hearing aid elsewhere.
If something goes wrong
Report injuries or malfunctions to the FDA through its MedWatch program or by calling 1-800-FDA-1088. The FDA's examples include skin irritation in the ear, burns from an overheated battery, pieces of the device lodged in the ear canal, and hearing that suddenly gets worse with use. The OTC rule leaves your rights under state warranty and consumer protection law in place, so a refund dispute can go to your state attorney general's consumer office.
The bottom line
OTC hearing aids have made it easier for many adults with milder hearing loss to take a first step. They are not the right answer for everyone. If any of the FDA's warning signs apply, if your hearing loss seems more than moderate, or if a self-fitted device is not helping, a licensed audiologist or hearing instrument specialist near you can test your hearing and explain your options. For a broader overview of how hearing aids work and the styles available, see the NIDCD's hearing aids page.
General information only, current as of the date above. The information on Hearing Clinic Finder is not medical advice and does not replace a doctor, nurse, discharge planner or other qualified professional. Do not use it to make decisions about diagnosis or treatment. If you have a medical emergency, call 911. Rules and programs change; check the official sources linked in this guide.