Hearing aids are becoming cheaper, more accessible, and more technologically sophisticated. But with many new options on the market, the process of choosing a pair has also become more complicated.
In the past, consumers usually bought hearing aids from an audiologist or other medical professional, and they cost an average of $2,363 per ear. Then, four years ago, Congress passed a landmark law allowing hearing aids to be sold over-the-counter (OTC) to adults with mild to moderate hearing loss.
The law was intended to make the devices more affordable and easier to buy. But the Food and Drug Administration (FDA) only just released its first draft of the rules about OTC devices in October 2021. The final rules won’t be implemented until at least 2022.That means OTC hearing aids aren’t technically available today.
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The market for easy-to-buy hearing-improvement products has exploded anyway, resulting in a confusing array of options sold with claims that they can boost your hearing without the need to see a doctor or audiologist. These devices are often cheaper—some far cheaper—than conventional hearing aids. But without federal standards or professional guidance, it can be difficult to know which products will really help.
Broadly speaking, these devices break down into three categories. Personal sound amplification products (PSAPs), which you might see on store shelves, provide simple amplification. But the FDA forbids them from being marketed as hearing aids or as a treatment for hearing loss. Legally speaking, they’re not medical devices at all. (Apple AirPods Pro and Max, for example, can be configured to function similarly to PSAPs.)
There’s also a single device made by Bose that’s in a separate FDA-cleared category for self-fitting hearing aids. (More on that in “Guide to Hearing Helpers.”)
A third type of product is one many experts refer to as direct-to-consumer (DTC) hearing aids. Sold by upstart companies like Eargo, Lexie, and Lively as well as older ones like Lloyd, DTC devices don’t require a visit to an audiologist or hearing aid dispenser, and consumers can get them online or by mail order.
“The issue right now, from a consumer point of view, is that it’s so confusing,” says Frank Lin, MD, PhD, director of the Cochlear Center for Hearing and Public Health at the Johns Hopkins Bloomberg School of Public Health. “You don’t know which ones are good. You don’t know which ones are bad.”
Conflicting Regulations
The legal reasons why hearing aids can be sold online or by mail without the involvement of a licensed hearing aid dispenser are complicated. At the federal level, it helps that the FDA has long allowed adults to waive a medical evaluation before buying a hearing aid. And federal laws don’t prohibit the online or mail-order sale of hearing aids. But that doesn’t mean there are no rules.
Hearing aids are classified as medical devices. And the FDA does require that all hearing aids, wherever they are sold, comply with certain labeling requirements. Customers must also, on request, be able to look over an informational brochure about any hearing aid before buying it.
“The current regulations for hearing aids do allow for direct-to-consumer marketing of hearing aids,” an FDA spokesperson told CR, “so long as they comply with these device-specific restrictions and other applicable requirements.” Representatives from Eargo, Lively, and Lexie all told CR that they make their brochures available online, for example, in order to comply with this aspect of the FDA’s requirements.
There are also state-level regulations governing hearing aids that sometimes add to the federal rules. The laws vary from state to state, but generally speaking, they require people who sell hearing aids, such as hearing aid specialists or audiologists, to be licensed by the state. These regulations don’t generally apply to hearing aids sold online, but a few states have gone further and enacted laws that prohibit online sales of hearing aids.
There are a few problems with those laws, however, which may help explain why you can purchase direct-to-consumer hearing aids all over the country. First, enforcing those state laws is challenging, given that mail isn’t inspected for the presence of illicitly sold hearing aids, says Thomas Powers, PhD, a consultant to the hearing aid industry.
The second problem is the legal principle of federal preemption, which means that if state law conflicts with or goes above and beyond federal law, the higher-level law—federal law—usually prevails. In one case, a court determined that Missouri’s law prohibiting the online or mail-order sales of hearing aids was preempted by federal law and therefore unenforceable. And similar laws in other states may also be subject to federal preemption, the Academy of Doctors of Audiology—which commissioned a legal review of the matter—told CR.
Such legal disputes about state hearing aid restrictions have left the validity and enforceability of those restrictions in question.
In recent years, with fully sanctioned OTC hearing aids on the horizon, the number of DTC aids on the market has ballooned. The FDA considers most hearing aids to be low-risk devices, so it doesn’t require companies to demonstrate that they’re safe and effective before selling them.
DTC and traditional hearing aids are often essentially the same, sometimes even produced by the same manufacturer. The main difference is in how you buy them. While buying in person allows providers to spot-test products and offer some quality control, they may carry only a limited selection of brands and models. Many consumers are understandably tempted to try the DTC route instead because those aids often cost less and are easier to get.
Because the FDA rules on OTC hearing aids won’t be finalized still for some time, you may wonder whether a DTC hearing aid is worth trying now. Experts we asked had a range of opinions. What’s clear is that it’s better to get hearing help sooner rather than later.
“The risks of nontreatment are greater than the risk of less-than-perfect treatment,” says Kim Cavitt, AuD, a hearing healthcare consultant. Untreated hearing loss is linked to an increased risk of depression, isolation, and even dementia.
In the past decade, experts have come to realize that requiring people to see a doctor or an audiologist may provide some quality control but also adds cost and complication, and limits consumers’ options. Those obstacles—along with the persistent stigma of wearing hearing aids—may explain why so many people who need the devices don’t get them. Cavitt’s advice is that while there are no guarantees about DTC hearing aids, any hearing help is better than none at all.
Some experts told us that they advise consumers to stick with purchasing hearing aids through a licensed provider, at least until FDA-approved OTC aids are available. The Federal Trade Commission also advises consumers to avoid DTC hearing aids, because people might not get the professional guidance that could help steer them to the right aid for their particular needs. It’s likely that the final FDA rules for OTC devices won’t be released until sometime in 2022, and then there will be an additional lag while manufacturers make sure their products are in compliance.
With all that in mind, if you do opt to go the DTC route, here are tips to help you weigh your many options.
Get your hearing tested. Several of the experts we spoke with recommend getting a hearing test before embarking on a search for DTC hearing aids. Start with your primary care doctor, because some insurance plans, including Medicare, will cover a test only if you have a referral.
Some DTC companies let you upload an audiogram from an audiologist, or they offer remote hearing assessments that can help you determine whether their product might work for you. Without a hearing test, many people underestimate the amount of hearing loss they have, says hearing aid industry consultant Powers. “You may not get something that’s appropriate for you if you don’t know exactly what you need,” he says.
Still, having to get a hearing test can be a significant barrier for some, says Carrie Nieman, MD, an assistant professor in the department of otolaryngology, head and neck surgery at the Johns Hopkins University School of Medicine. If you don’t have ear pain or other concerns and the trouble you’re having with hearing is relatively mild, she says that getting a test may not be an absolute necessity.
You may also want to be checked for possible medical problems. The FDA requires hearing aids to be sold with a notice to consumers that a medical evaluation is advisable to rule out reversible or medically serious causes of hearing loss. (The agency requires such an evaluation for people younger than 18, though adults can waive it.)
If you’re not sure whether you should seek a doctor’s help, consider starting with the free online Consumer Ear Disease Risk Assessment, developed by Northwestern University. It’s still in the testing phase but may help flag ear problems that require a doctor’s visit.
Check out the return policy before buying. Make sure you can return whatever you buy. Several companies offer a full refund for 30 or 60 days after you receive the hearing aids, and some, such as MDHearingAid and Lexie, recommend you try them out for a minimum of 21 days. That’s because it can take some time to adjust to a new pair. Whatever company you choose, make sure you’ll be able to try the hearing aids for at least a few weeks.
Don’t be fooled by "FDA registered." The terms “FDA registered” and “FDA cleared” don’t mean much. Companies sometimes use tricky language to imply that their devices have been carefully reviewed in some way by the agency, when that’s generally not the case.
Consider customer service. You may prefer to buy from a company that offers more support, such as consultations with an audiologist over the phone or online. Eargo and Lively, for example, offer consults with licensed hearing professionals who can also make remote adjustments to your hearing aids. But keep in mind that the more services a company offers, the more expensive the product may be. This is a reason the cost of traditional hearing aids is high; the evaluation, customization, and service are a significant part of the price.
Pay close attention to the features. Rechargeable batteries rather than tiny, hard-to-handle replacement batteries can be a plus for many people. Another helpful feature is a telecoil or T-coil, which allows you to use your hearing aids to tap directly into assistive listening systems at large events, places of worship, theaters, and elsewhere. And Bluetooth can be useful for people who are regular smartphone users. It can allow you to use your hearing aid to talk on the phone or stream music, Nieman says.
Enlist a friend. Janice Moten of Baltimore served as a hearing care peer mentor for Baltimore HEARS, a study on community-delivered hearing care for older adults conducted by Johns Hopkins. She suggests asking a friend or loved one to help you learn how to use whatever device you select, someone who could help to go over the instructions for the device and also be there to troubleshoot. That’s just one of the functions she served for others in the study, and she says it can be very helpful to have someone looking at a device with you and helping you figure things out.
Keep looking. If you buy a DTC hearing aid and it doesn’t work for you, don’t give up, urges Barbara Kelley, executive director of the Hearing Loss Association of America. “It might just not be a good device,” she says. Return it and try again—or consider consulting an audiologist. There’s almost surely something out there that can help.
What About PSAPs?
Research suggests that at least some PSAPs operate very similarly to hearing aids, and can be helpful to some people with mild to moderate hearing loss. Anne Madison, 70, had waited several years after being told she had hearing loss before trying out a PSAP as part of Baltimore HEARS, the Johns Hopkins study. The study trained older adult peer mentors to help their neighbors procure and use a few types of PSAPs that were vetted by the research team. The device helped her feel more comfortable distinguishing road noise while driving, and has other benefits too.
“It’s wonderful for talking with grandchildren,” Madison says. “Those little, tiny voices just seem to go right past you, and this has been a big help with that.”
PSAPs, however, are largely unregulated. Without expert advice on which PSAPs work well, it’s hard for consumers on their own to know which products will really be effective and which won’t. Consumer Reports conducted a limited test of four PSAPs in 2017 and found that two models running around $350 per pair could be useful for some people with mild hearing loss, but that two cheaper models—each below $50—weren’t of any real use.
It’s likely that just as with DTC hearing aids, some makers of PSAPs will seek approval for their products as OTC hearing aids once the FDA finalizes the rules, says Kelley.
And in a separate piece of draft guidance also issued last month, the FDA clarified that even PSAPs that don’t explicitly claim to address hearing loss could be considered hearing aids. Those devices could be subject to the new OTC hearing aid rules, if their marketing implies that they could be useful for the same types of situations in which you might need a hearing aid, that they might be a less expensive alternative to a hearing aid, or if they are tailored to a person’s hearing loss similarly to a hearing aid.
What’s Next for OTC Hearing Aids
The draft rules the FDA recently released on OTC hearing aids may help clear up some of the confusion with regard to how hearing aids are classified. “If this action is finalized, all non-OTC hearing aids will be prescription devices,” the rule reads. OTC hearing aids will need to meet the detailed technical standards the FDA lays out in the proposed rule, such as the maximum volume of a hearing aid’s output and requirements about sound quality. Two DTC hearing aid companies, Lexie and Eargo, told CR that they’re planning to ensure their hearing aids comply with the new rules so that they can be classified as OTC.
Still, OTC hearing aids won’t be available until after the rule is finalized sometime next year, and the current draft could still change once FDA takes public comments into account. Until then, consumers who need hearing help now are left to navigate a confusing marketplace.
Editor’s Note: A version of this article also appeared in the December 2021 issue of Consumer Reports magazine. It has been corrected to clarify that the Bose SoundControl hearing aid is FDA-cleared.
Catherine Roberts
Catherine Roberts is a health and science journalist at Consumer Reports. She has been at CR since 2016, covering infectious diseases, bugs and bug sprays, consumer medical devices like hearing aids and blood pressure monitors, health privacy, and more. As a civilian, her passions include bike rides, horror films and fiction, and research rabbit holes. Follow her on Twitter @catharob.
