A Complete Guide to Over-the-Counter Hearing Aids

While some hearing devices have long been sold online or by mail order without a prescription, they were loosely regulated, so there were few guardrails in place to ensure that they worked. But thanks to a 2017 law designed to make hearing aids more accessible and affordable, there is now a clear set of rules for OTC aids. These rules, which went into effect in the fall of 2022, require that hearing aids sold without a prescription meet specific standards for safety and effectiveness. And they can’t be sold to children.

OTC aids must also comply with certain technical requirements, including restrictions on how much they can amplify sound, which is intended to protect users from hearing damage. These restrictions, however, also make OTC aids unsuitable for people with severe hearing loss. (Signs include being unable to hear spoken words even in a quiet room or trouble hearing loud music or power tools.) That’s why OTC aids are specifically intended for people with self-perceived mild-to-moderate hearing loss. (Signs include trouble hearing speech in noisy places, in groups, and during phone calls.)

Prescription hearing aids and OTC devices function in essentially the same way. Both pick up sounds with tiny microphones, amplify them, and transmit them to your ear via a speaker. And they use similar technology to do this.

Perhaps the most significant difference between OTC and traditional aids isn’t the technology they use but how you go about obtaining them—and in some cases, setting them up.

With prescription hearing aids, you go to a healthcare provider such as an audiologist, an otolaryngologist, or a licensed hearing aid specialist. These providers test your hearing and evaluate your needs, and help you decide on the hearing aid that might be best for you. They also program the device you select so that it’s set up for your specific hearing profile—i.e., a "fitting"—and provide follow-up adjustments as needed.

With OTC hearing aids, there’s no requirement to go to a provider or even have a hearing test before settling on a device. And any setup and adjustments may be largely up to you.

Given the differences noted above, if you’re thinking about buying hearing aids, you’ll want to carefully consider whether a prescription or OTC version is best. These steps can help.

Rule out other problems. Hearing loss can sometimes be caused by issues such as infections, earwax buildup, or certain injuries. Hearing aids won’t fix these problems, but other treatments may help. So it’s important to have a doctor check your ears if you notice any of the following: blood, pus, or fluid coming out of your ears; ear pain or discomfort; feelings of dizziness or vertigo; or sudden changes in your hearing. You can also use an online tool called the Consumer Ear Disease Risk Assessment to help you determine whether such issues are at fault.

Get your hearing tested. The gold standard for assessing hearing is a test with a hearing care provider such as an audiologist, according to experts we spoke with. This can give you a precise measure of your hearing loss, says Jasleen Singh, PhD, a postdoctoral scholar at Northwestern University’s Auditory Research Lab. And that’s key in helping you determine whether your hearing loss is too severe for OTC aids.

Even with milder hearing loss, you may want professional help if you have complex hearing needs—say, you work in a classroom full of kids with sounds all around, says Sumit Dhar, PhD, a professor in the department of communication sciences and disorders at Northwestern University.

Private medical insurance usually covers in-person hearing tests, and Medicare will pay for general hearing evaluations without a doctor’s referral.

There are also plenty of ways to assess your hearing at home using your computer or smartphone. These include tone-based testing apps, where audio tones are played in decreasing volumes, and digits-in-noise or speech-in-noise tests, where you try to identify spoken numbers or words while background noise plays.

Apple’s Hearing Test—which you can take if you have a newer iPhone or iPad running up-to-date software and a pair of AirPods Pro 2 with the latest firmware—uses tone-based testing. The World Health Organization’s hearing test app, hearWHO, uses the digits-in-noise method, as does online screening offered by Best Buy.

Or try a self-evaluation of your auditory wellness, which can help you figure out whether an OTC might be a good option for you.

Consider your DIY comfort level. Vinaya Manchaiah at the University of Colorado Hospital recommends thinking through whether you’re in a position to manage the selection and setup of OTC aids on your own. While some companies offer high levels of phone-based or online support (see below), you still have to pick a device, figure out its settings, and in some cases, program it. You’ll also need to learn how to put it on correctly, clean it, and troubleshoot problems. When you buy prescription hearing aids, an audiologist, a doctor, or a licensed hearing aid dispenser helps you with all of those tasks.

If you decide that an OTC hearing aid may work for you, check out our evaluation of eight models. Also, considering the following questions can help you narrow down your choices.

How customizable is it? OTC hearing aids come in two types: self-fitting and preset.

With a self-fitting hearing aid, you’ll typically use a smartphone app during the initial setup to help you adjust the device to suit your specific hearing issues. In addition to determining the level of amplification needed, these apps can zero in on such factors as which frequencies of sound you have the most trouble hearing. Often, this means that self-fitting aids are far more customizable than many preset models.

Self-fitting hearing aids have another key advantage over presets, which is that the Food and Drug Administration requires manufacturers to submit performance data showing the hearing aids are both safe and effective. OTC aids that don’t claim to be self-fitting don’t need to be cleared for safety and efficacy by the FDA. The Hearing Aid feature available for Apple’s AirPods Pro 2 received FDA clearance as self-fitting. Still, some users may find the self-fitting process difficult.

Preset OTC aids generally come with a number of set programs, each one for different levels of hearing loss in the mild-to-moderate range, and these programs may be good enough for many users. A study published in the American Journal of Audiology in 2021 found that devices with presets fit the hearing needs of 68 percent of older adults with mild-to-moderate hearing loss. Some models may be even simpler, offering not much more than volume control.

Somewhat confusingly, some preset hearing aids may also offer customization of the different programs, similar to what you might find on a self-fitting aid. Still, keep in mind that preset hearing aids don’t need to be cleared by the FDA before being sold, so you have less certainty that they’re proven to work and are safe.

What shape works best for you? Like prescription hearing aids, OTC devices come in two basic shapes: in the ear or behind the ear. In-the-ear aids tend to be smaller, sometimes small enough to fit completely inside the ear canal. Behind-the-ear aids consist of connected pieces: a case that contains the device’s hardware and sits behind the ear, and a receiver that sits in the canal or an earbud.

Does one shape work better than the other? "I actually tend to think whatever hearing aid you want to wear and you will wear more and you like wearing, you should pick that one," says Laura Coco, AuD, PhD, an assistant professor in the School of Speech, Language, and Hearing Sciences at San Diego State University. Still, she says that behind-the-ear styles tend to be slightly better at filtering out background noise.

Smaller devices also tend to be a bit more difficult to manipulate and clean, and may have less capacity for features like wireless audio streaming, says Anna Jilla, AuD, PhD, an assistant professor of audiology at Lamar University in Beaumont, Texas.

How good is the customer support? One of the advantages of buying hearing aids through an audiologist or other hearing professional is that you have an expert helping you figure out how to customize, use, and troubleshoot your hearing aid. That support may make a difference. In one study, people who got hearing aids either through an audiologist or OTC reaped similar benefits—but those who saw an audiologist expressed more satisfaction with their hearing aids.

It would be unfortunate if people who could benefit from an OTC hearing aid ended up not using them because of insufficient assistance, says Larry Humes, PhD, an author of that study and a distinguished professor emeritus of speech, language, and hearing sciences at Indiana University. "Not because the device isn’t good—it meets FDA guidelines, it’s a good quality device," he says. "But all the extra support somebody needs in adjusting to hearing aids that normally could be provided through an audiologist isn’t available."

That’s why it’s critical to find out exactly what support you’ll have access to with the hearing aid you’re buying, including what days and hours the support is available, for how long after your purchase, and what sorts of experts will be providing it. For example, while most companies have phone-based customer support, in some cases the people you reach when you call may not have any special expertise with hearing aids. Other companies will connect you to licensed hearing care professionals via phone or even at walk-in stores in your area.

At some companies, you can pay for extra support. For example, Jabra offers preset hearing aids as a baseline. But you can buy a package that includes custom programming of your hearing aids and three years of follow-up care with hearing specialists who can adjust your hearing aids remotely. (Buying the hearing aids with extra support will run you between $1,195 and $1,995, depending on the hearing aid model you select.)

What’s the return policy? It takes time to get used to hearing aids and to figure out whether they’re really working for you or not. A return policy of at least a month should give you the opportunity to thoroughly try out your OTC hearing aid but send it back if it’s simply not helping you sufficiently. As you shop, compare different products’ warranty periods, too.