What the FDA’s over-the-counter rule allows
On October 17, 2022, a U.S. Food and Drug Administration rule took effect that created a new category of hearing aids sold over the counter. According to the FDA, OTC hearing aids are intended for adults 18 years of age and older with perceived mild to moderate hearing loss. You can buy them in a store or online, set them up yourself with the maker’s app or controls, and never see a hearing professional.
Everything else is a prescription hearing aid, fitted by a licensed professional who programs it to your hearing test. The National Institute on Deafness and Other Communication Disorders (NIDCD) puts it plainly: prescription hearing aids or other devices may be necessary for more significant or complicated hearing loss.
The word that matters in the FDA definition is “perceived.” OTC aids are for people who believe their loss is mild to moderate. Nothing in the rule checks whether that belief is right.
What OTC hearing aids do well
OTC aids have a real place, and it is worth being clear about it.
- Price. OTC aids cost a fraction of a clinic fitting. In HearingTracker’s 2025 survey of more than 1,100 hearing aid purchasers, the average price paid for an OTC pair was $502.
- Access. You can order a pair tonight. No appointment, no waiting.
- Mild loss. Someone who mainly struggles with soft speech and the TV, and hears fine one-on-one, often does well with a basic OTC aid.
- Tech-comfortable users. If you are happy pairing a device to your phone, running a hearing check in an app and adjusting settings yourself, the self-fitting models from makers such as Jabra Enhance, Sony, Lexie and Audien are built for exactly that.
Doing something about mild hearing loss early is better than waiting. If an OTC aid is what gets someone started, that is a good outcome.
Where OTC hearing aids fall short
The limits of OTC aids follow from how they are sold, not from poor quality.
- No hearing test, so you do not know your degree of loss. Most people underestimate their hearing loss, because it came on slowly. A loss that feels mild can test as moderate to severe at the high pitches where speech clarity lives. An OTC aid cannot help with loss beyond its range, and you have no way to know that without a test.
- One size, one fit. OTC aids ship with a few dome sizes and a generic shape. Fit affects comfort, feedback (whistling) and how much sound actually reaches your eardrum.
- No real-ear verification. Every ear canal is a different size and shape, and the same device delivers a different amount of sound in different ears. A prescription fitting measures what the aid is actually producing at your eardrum with a tiny probe microphone. OTC aids skip this step.
- Limited support. When something sounds wrong, you have a chat window or a phone line, not a person who can look in your ear and adjust the device while you listen.
- Not for greater loss. By the FDA’s own definition, OTC aids are not for severe hearing loss. People with greater loss who try them often conclude that hearing aids do not work, when it is the category that did not fit.
- Not for one-sided loss or sudden change. Loss in one ear, a sudden drop, pain, drainage, dizziness or ringing that started recently in one ear all need a doctor first, not a device. OTC aids are designed around loss in both ears.
How to tell if OTC is enough for you
This is a plain checklist, not a diagnosis. OTC may be a reasonable starting point if most of these are true:
- You are an adult, and the trouble came on gradually over years.
- Both ears seem about the same.
- You hear fine one-on-one in a quiet room, and struggle mainly with soft voices, the TV, or groups.
- You have never been told you have significant hearing loss.
- You are comfortable with a smartphone app and small devices.
- You can afford to find out it was not enough.
A prescription fitting is the better path if any of these are true:
- People have to speak up even in a quiet room, or you miss a lot on the phone.
- One ear is clearly worse than the other.
- Your hearing changed suddenly, or you have pain, drainage, dizziness or new ringing in one ear. See a doctor or ENT promptly first.
- You have tried OTC aids and they are too quiet, too loud, whistle, or sit uncomfortably.
- You want someone to adjust, clean, repair and re-check the aids over the years you will wear them.
- Your plan has a hearing aid benefit, since that benefit usually applies only to prescription aids.
The quickest way to settle it is a free hearing test. You leave with your results on paper and your actual degree of loss.
What a prescription fitting adds
A prescription fitting is not a more expensive version of the same thing. It is a different process, and each step does a job.
A hearing test first. Our licensed hearing instrument specialist tests each ear across the pitches of speech and checks your ear canals. The test is free and is not billed to any plan.
Programming to your audiogram. The aids are set to add the right amount of sound at each pitch for each ear, based on your test, rather than a generic curve. We fit and program most major brands, so the choice is about your hearing and your budget, not one maker’s lineup. Our Phonak and Oticon pages describe what we do with two of them.
Real-ear measurement. At the fitting we place a thin probe microphone in your ear canal beside the hearing aid and measure what it delivers at your eardrum, then adjust until it matches the target for your loss. This is the step that turns “programmed” into “verified.” Our fittings page walks through the visit.
A 45-day trial. You wear the aids through real life, at home, at work and in restaurants, and come back with notes. Ask us for the trial terms in writing.
Follow-up care. Adjustments, cleaning, dome and wax-guard changes, and re-checks are part of owning hearing aids from us. Hearing changes over time, and the aids are reprogrammed as it does.
Your OTC aids are not working. What we can do
A lot of people come to us after an OTC purchase that did not work out. Usually the device was asked to do more than it was built for. Here is what we do.
A free hearing test first. Before any talk of buying anything, we find out your degree of loss and check your ears for wax, which by itself can make any hearing aid sound muffled.
We tell you whether your loss is beyond the OTC range. If it is, that explains the result and you stop blaming yourself or the device. If it is not, we say that too. Sometimes the answer is a better fit or a different dome.
We can fit prescription aids from most major brands. If a prescription fitting is the right step, we check your insurance benefit before you buy, at no charge, and give you a written quote you can take home.
We cannot program most OTC devices. Most OTC aids are closed to clinic fitting software and are adjusted only through the maker’s app. We can look at the fit and clean them, but we cannot reprogram them to your test. Better to tell you that now than after you book a visit for it.
Insurance and OTC hearing aids
OTC hearing aids are generally not covered by plan hearing benefits. Those benefits are built around prescription aids fitted through the plan’s hearing network, with a licensed professional doing the test and the fitting.
Original Medicare (Parts A and B) does not cover hearing aids or exams for fitting them, according to Medicare.gov. Many Medicare Advantage plans include a hearing aid benefit, usually a yearly allowance or copay that resets each plan year on January 1, and that benefit applies to prescription aids through the plan’s network. It varies by plan. We work with plan hearing networks including UnitedHealthcare Hearing, TruHearing, Nations Hearing, Amplifon Hearing Health Care and Start Hearing, and we verify your benefit before any purchase. Our insurance page has the details.
If you have an HSA or FSA, both can generally be used for hearing aids, OTC or prescription. We also accept CareCredit.
What hearing aids cost
We do not publish our own hearing aid prices here, because the right answer depends on your hearing, your plan and the technology level you choose. Ask us for a written quote you can take home before you decide.
For a sense of the national picture: HearingTracker’s 2025 survey found the average price paid was $2,694 a pair across all channels, with OTC pairs averaging $502 and prescription pairs bought privately averaging $3,432. The same survey put the average at traditional clinics at $4,727 a pair without insurance and $2,567 with it. Those are typical national ranges from one published survey, not our prices. Our hearing aid cost guide goes deeper into what drives the number.
Both of our clinics, in Duluth and Houston, do the same free hearing test in English, Korean, Vietnamese and Chinese. Start there, and the OTC question usually answers itself.