OTC hearing aids: what to check before buying one

Search for hearing aids and you will be shown three categories of product with overlapping photographs and wildly different rules behind them. Telling them apart is most of the work, and it is easier than it looks once you know what separates them.

• Over-the-counter hearing aids. Medical devices, for adults 18 and over with perceived mild to moderate hearing loss. Bought in a shop or online with no exam, no prescription and no fitting. The user adjusts them through controls, an app or a built-in hearing check.
• Prescription hearing aids. The FDA defines these simply as any hearing aid that is not an OTC hearing aid. Available through a licensed hearing health care professional, who programs the device to the hearing loss that was actually measured, and appropriate at any age and any degree of loss.
• Personal sound amplification products. Not hearing aids. The FDA describes them as intended for people with normal hearing who want to amplify sound in particular situations, and gives birdwatching and hunting as the examples. They are regulated as consumer electronics rather than medical devices, and the FDA notes they vary more in quality as a result. The agency states directly that they are not alternatives to hearing aids.

This is why the two words on the package matter more than any specification in the listing. An amplifier can be sold with photographs of grey-haired couples at dinner and language about hearing conversation more clearly, and still not be a hearing aid, because what it is intended for is what determines how it is regulated.

For the wider question of which route suits your parent, and what to do before either, the hearing loss guide takes it in order. This page assumes you have decided to look at over-the-counter and want to buy carefully.

The most useful thing about this rule is the part nobody mentions: the FDA wrote the buyer checklist and made it a labelling requirement. The following has to appear on the outside package labelling, where you can read it before paying.

• The words “OTC” and “hearing aid” on the front panel, with the same prominence the rule requires for the product name.
• A warning against use by anyone under 18, alongside a plain-language description of the symptoms that suggest mild to moderate loss, and advice on when to see a professional instead.
• The “When to See a Doctor” warning listing the red-flag conditions, which are in the next section.
• The manufacturer return policy, stated accurately, or a statement that there is no return policy.
• Whether the device is used or rebuilt.
• Battery type and number, whether batteries are included, and whether a mobile phone or remote control is needed to operate the device at all.
• Contact details, and where the full labelling and user brochure can be read online, plus a way to request a paper copy.

Three things to do with that:

Read the packaging before you buy, including online. The FDA position is that if you cannot find the outside package labelling you should contact the seller or manufacturer. A listing that cannot produce it is telling you something.

Check whether a phone is required. It is on that list for a reason. Some devices cannot be set up or adjusted at all without a smartphone app, which is a different proposition for an eighty-year-old than for the adult child ordering it. If nobody nearby will own the phone side of it, that is a reason to choose differently rather than a detail to discover later.

Distrust the FDA badge. The FDA says this itself: claims like “FDA Registered” or “FDA Certified” on medical device packaging, and use of an FDA logo, may be misleading. Registration is not approval, and the agency does not licence its logo to sellers. On this product category, an FDA badge in a listing is closer to a warning sign than a reassurance.

This list is not editorial. It is the warning the FDA requires on the package, in plainer words. Any one of these is a reason to see a doctor, preferably an ear, nose and throat specialist, before buying anything.

• The ear has a birth defect or an unusual shape, or was injured or deformed in an accident.
• Blood, pus or fluid has come out of the ear in the past six months.
• The ear feels painful or uncomfortable.
• There is a lot of earwax, or you think something could be in the ear.
• There is real dizziness, or a feeling of spinning or swaying.
• Hearing changed suddenly in the past six months.
• Hearing gets worse, then gets better again.
• Hearing is worse in one ear than the other.
• There is ringing or buzzing in one ear only.

Two of those get waved away, and both are worth stopping for. The first is earwax. It is on the FDA list because impaction is common in older adults, genuinely reduces hearing, and is reversible in a single appointment. Buying a hearing aid to compensate for a blocked ear canal is an expensive way to not fix it.

The second is anything one-sided: worse hearing in one ear, or ringing in one ear only. Age-related hearing loss is usually symmetrical, so asymmetry is a question about why rather than a reason to amplify. The FDA has made that point plainly, noting that hearing loss can signal something easily treatable like built-up earwax or something more serious like a benign tumour on the hearing nerve.

An over-the-counter hearing aid is capped by the rule. Measured with the volume full on and a 90 dB input, it may not exceed 111 dB SPL at any frequency it is meant to operate on, or 117 dB SPL where input-controlled compression is activated.

That is the whole reason the category stops where it does. The FDA is direct about the consequence: OTC devices are limited in maximum output and may not provide adequate benefit for more severe hearing losses. Nothing about the shop, the price or the brand changes that ceiling.

Read practically, it means “these are not loud enough” is information rather than a fault. A device at its cap that still leaves your parent asking people to repeat themselves is evidence about the hearing loss, not about the purchase. The next step is a test, and the test is the part Medicare pays toward when a doctor orders it.

Before this rule, several states required a medical evaluation or the involvement of a licensed dispenser to buy a hearing aid. The rule preempts state and local requirements specifically related to hearing products that would restrict access to over-the-counter devices, and it names the kind it displaces: any requirement for the supervision, prescription, order, involvement or intervention of a licensed person for consumers to get OTC hearing aids.

So if a seller tells you that your state needs a professional involved before your parent can buy an over-the-counter device, that is not what the federal rule says.

The one condition of sale the rule does impose is age. Selling an OTC hearing aid to or for anyone under 18 is prohibited outright, and under-18s need a prescription device and a doctor, because the causes and consequences of hearing loss at that age are different.

An over-the-counter purchase has no fitting appointment and no scheduled follow-up. Everything that a professional would normally catch in the weeks afterwards, you are catching yourself. That makes the return period the only real protection on the purchase, and the FDA requires it to be stated on the box precisely because it does not require it to exist.

There is no warranty requirement either. The FDA advice is to understand the terms of any return or warranty period so that there is enough time to test the device in different environments and to adjust to hearing sounds that have been missing.

What that looks like in practice:

• Get the return window in writing before paying, and write the end date on a calendar rather than trusting anyone to remember it.
• Start on the day they arrive. Adjusting takes weeks of regular wear, and a device that sits in a drawer for three of them has used up the window without producing any information.
• Try them where your parent actually struggles. A restaurant, a family gathering, the telephone. A quiet living room is the one environment that tells you nothing.
• If the benefit is not there by the end of the window, treat that as a reason to get the hearing measured rather than a reason to try a different brand. The FDA suggests the same: if you are not getting benefit from OTC hearing aids, consider a consultation with a hearing health care professional.

What is the difference between an OTC hearing aid and a sound amplifier?

An OTC hearing aid is a medical device intended to compensate for hearing loss, and it has to meet the FDA requirements in the over-the-counter rule. A personal sound amplification product, or PSAP, is a consumer electronic intended for people with normal hearing who want to amplify sound in a particular situation, the FDA gives birdwatching and hunting as the examples. The FDA states plainly that PSAPs are not alternatives to hearing aids, and that because they are regulated as consumer electronics rather than medical devices they vary more in quality. The fastest way to tell them apart is the front of the package: an OTC hearing aid has to carry the words "OTC" and "hearing aid" with the same prominence the rule requires for the product name.

Does my parent need a hearing test before buying over-the-counter?

Not legally. Removing that requirement is what the rule did: since 17 October 2022 an adult who believes they have mild to moderate hearing loss can buy one in a shop or online with no medical exam, no prescription and no fitting appointment. The word carrying the rule is "perceived", though. Nobody has measured the loss, so the buyer is judging their own, and someone whose hearing has faded over a decade is the least well-placed person to judge it. A test tells you whether the loss is in the range this category is built for, and it also rules out the causes a hearing aid does not fix.

Can a shop tell me my state requires an exam first?

The federal rule says otherwise. It preempts state and local requirements specifically related to hearing products that would restrict access to OTC hearing aids, and it names requirements for the supervision, prescription, order, involvement or intervention of a licensed person as the kind it displaces. The one condition of sale the rule does impose is age: selling an OTC hearing aid to or for anyone under 18 is prohibited. If a seller tells you that a professional has to be involved before you can buy an over-the-counter device, that is not what the rule requires.

What if the hearing aids are not loud enough?

That may not be a faulty unit. An OTC hearing aid is capped: it cannot exceed 111 dB SPL at any frequency it operates on, or 117 dB SPL where input-controlled compression is switched on. The ceiling is why the category stops at moderate loss. The FDA says directly that OTC devices are limited in maximum output and may not provide adequate benefit for more severe losses. So "it is not loud enough" is worth reading as information rather than as a defect, and the next step is a test rather than a louder purchase.

Does Medicare pay for over-the-counter hearing aids?

No. Original Medicare pays nothing toward hearing aids, over-the-counter or prescription, and it does not cover the exams used to fit them. It does cover diagnostic hearing and balance exams when a doctor orders them to work out whether you need medical treatment. Some Medicare Advantage plans add a hearing benefit, and what it covers varies by plan and by state, so check the plan rather than assuming.

Is there a trial period?

Only if the seller offers one, and the rule makes them tell you either way. The outside packaging has to carry a statement of the manufacturer return policy, or a statement that there is not one. The FDA does not require a warranty at all. On an over-the-counter purchase there is no fitting appointment and no professional follow-up built in, so the return window is the whole of your protection: get it in writing before paying, note the date it ends, and use the time to try the device in the places your parent actually struggles rather than only at home.

Everything on this page is a requirement of the federal rule or a statement by the agency that wrote it. Where the rule gives two figures, we have kept both.

• 21 CFR 800.30, Over-the-counter hearing aid controls. The definition, the labelling requirements, the 111 and 117 dB SPL output limits, the age condition of sale, and the preemption of state requirements.
• FDA, OTC Hearing Aids: What You Should Know. The outside-package labelling in plain language, the red-flag warning, the position on “FDA Registered” claims, and the advice on return and warranty terms.
• FDA, Hearing Aids and Personal Sound Amplification Products: What to Know. The comparison of the three product categories, and the statement that PSAPs are not alternatives to hearing aids.
• NIDCD, Hearing Aids. Background on device types, and the difference between over-the-counter and prescription devices.
• Medicare.gov, Hearing aid coverage. What Original Medicare excludes.