What Otolaryngologists Need to Know About Working with Patients as Over-the-Counter Hearing Aids Become Available

Over-the-counter (OTC) hearing aids will soon be available for purchase by consumers in the United States. People may be able to pick up a hearing aid somewhere between the milk and shampoo aisles at a big box store or order a hearing aid from the slick-looking website of a technology brand they’ve long trusted.

Although no one yet knows exactly when OTC hearing aids will be widely available, their appearance on the market is an inevitability. Their eventual existence also marks a huge shift in the provision of hearing care services; currently, most individuals can obtain a hearing aid only after undergoing a thorough physical and audiological assessment and receiving a prescription from a licensed physician, audiologist, or hearing aid dispenser. What will happen to hearing care when individuals can buy a hearing aid as easily as they can now buy reading glasses? 

That question—one that has lingered in the background for nearly a decade—is about to be answered in real time. 

A Massive Unmet Need 

Nearly 50 million Americans have some degree of hearing loss, according to the Hearing Loss Association of America. According to the Food and Drug Administration, however, only about one-fifth of individuals who could benefit from hearing treatment currently use a hearing aid or cochlear implant. That leaves approximately 40 million Americans with untreated hearing loss.

“Hearing loss is one of the most underrecognized and undertreated health conditions in the world,” said Jed Grisel, MD, an otolaryngologist with Texoma ENT and Allergy in Wichita Falls, Texas. “And in the last 10 years, we’ve learned that untreated hearing loss increases our risk for dementia, depression, and falls. So, as Americans live longer, it’s really important that we treat hearing loss, so people can continue to live high-quality lives.” 

The push for OTC hearing aids coincided with the emergence of research demonstrating a strong causal link between hearing loss and dementia. In 2015, the President’s Council of Advisors on Science and Technology delivered a report entitled Aging America & Hearing Loss: Imperative of Improved Hearing Technologies. The report implied that the cost of hearing aids was a prohibitive factor for many Americans, noting that “hearing aids have not experienced the dramatic reduction in price or increases in features and innovations as seen in other consumer electronics” and that six companies dominated the hearing aid market. Among the report’s recommendations to then-President Barack Obama: “The Food and Drug Administration (FDA) should create a new category for ‘basic’ hearing aids and associated hearing tests that are meant for sale over the counter.” 

In 2017, Congress directed the FDA to develop regulations for OTC hearing aids. Also in 2017, The Lancet published a report listing hearing loss as a modifiable risk factor for the development of dementia (Lancet. 2017;390:P2673-P2734). In a 2020 update, The Lancet listed hearing loss as one of 12 modifiable risk factors for developing dementia and noted that research has shown that hearing aid use can decrease the risk of dementia in individuals with hearing loss (Lancet. 2020;396:413-446). 

President Joseph Biden’s Executive Order on Promoting Competition in the American Economy, issued on July 9, 2021, directed the U.S. Secretary of Health to “promote the wide availability of low-cost hearing aids” and “publish for notice and comment a proposed rule on over-the-counter hearing-aids.” The FDA published their proposed OTC hearing aid rules on Oct. 20, 2021, noting that the intent of the rules is “to improve access to hearing aid technology for Americans.”

If used properly and with proper education, OTC hearing aids could be a boost to our practices.

—Jed Grisel, MD

The premise behind the push for OTC hearing aids “is that cost is a significant barrier for most people, and that is one of several reasons why hearing aid penetration for the subset of the general population that would benefit from hearing aids is so low,” said Elizabeth Toh, MD, an otolaryngologist with Beth Israel Lahey Health in Burlington, Mass. “The assumption is that cost is one of the primary barriers, and that if we bring down costs, we’ll be able to offer hearing rehabilitation for a wider swath of the hearing loss population.”

“Improving access to hearing devices is a good thing, but we should bear in mind that cost isn’t the most significant disincentive for hearing aid use,” added Stephanie Moody Antonio, MD, an otolaryngologist with Children’s Hospital of the King’s Daughters in Norfolk, Va. “The aesthetics and negative stigma of hearing loss and hearing aids are probably a more significant disincentive for hearing care. I’m hoping that the widespread advertisement of OTC devices that’s bound to occur with their introduction will improve the general awareness of the negative effects of hearing loss and acceptance of hearing aids so that more people will seek hearing care and hearing technology.”

Proposed Rules and Otolaryngologists’ Concerns

Under the FDA’s proposed rules, OTC hearing aids are “intended to address perceived mild to moderate hearing loss in people age 18 and older.” The proposed maximum acoustic output limit is 120 decibels (dB), with no proposed gain limit. 

The proposed rules have generated discussion and concern among otolaryngologists and audiologists. “Human beings are very poor judges of their own level of hearing loss,” Dr. Grisel said. “Thus, patients with severe or profound loss may initially seek treatment with an OTC aid.”

Additionally, an individual whose hearing falls within the normal range may perceive mild or moderate hearing loss, purchase and use an OTC hearing aid, and potentially damage their hearing, especially given the lack of a gain limit, Dr. Grisel said, noting that exposure to 120 dB of sound can cause noise-induced hearing loss in just 28 seconds. 

The FDA has defended the 120 dB limit on the grounds that 28 seconds gives the user enough time to act before sustaining injury. The Hearing Industries Association (HIA) and American Academy of Otolaryngology–Head and Neck Surgery have both urged the FDA to limit output to 110 dB and gain to 25 dB, however. 

“The only thing standing between a patient and noise-induced hearing loss is their own perception that there’s a problem and the ability to take it out of their ears,” Dr. Grisel said. “This is problematic given that the hearing aid population tends to have higher levels of cognitive decline and dexterity problems. If these devices are intended for mild to moderate levels of hearing loss, why would you ever need more gain than 25 dB?” 

The otolaryngology community wants people to have easy access to hearing treatment, Dr. Grisel said. “But our concerns are, is this going to be done safely? Are patients with more severe hearing health problems going to miss out on medical treatment? Is the technology safe? Are these products going to achieve their intended goals?”

There is a risk that inappropriately used OTC hearing aids may lead some people to doubt the efficacy of hearing aids and other hearing devices. “If a patient uses an over-the-counter hearing device that doesn’t fit their hearing profile, it might actually make it more difficult for them to hear,” said Doug Backous, MD, a neurotologist with Puget Sound ENT Proliance Surgeons in Washington state. “You’re using a fixed solution for a dynamic problem, which may not help everyone.” 

People who have severe hearing loss and try an OTC device may be disappointed in their results, which, paradoxically, may drive them further from care. “There’s already a perception that hearing loss isn’t treatable, and failed attempts with an OTC hearing aid may discourage people from a professional audiological and otological evaluation and management,” Dr. Moody said. 

Improving access to hearing devices is a good thing, but we should bear in mind that cost isn’t the most significant disincentive for hearing aid use. 

—Stephanie Moody Antonio, MD 

There’s also concern that some people with medical conditions that require (or respond best to) medical or surgical treatment may miss out on appropriate treatment, as they may self-treat their hearing loss with an OTC hearing aid. People with hearing loss related to cholesteatoma, brain tumors, multiple sclerosis, osteosclerosis, acoustic neuroma, or infections may find their conditions worsening if they self-treat instead of seeking medical evaluation, for example. 

“When you do direct-to-consumer marketing without requiring any sort of medical clearance along the way, there’s going to be a subset of patients who don’t seek medical attention for something that’s potentially treatable or that needs intervention,” Dr. Toh said. 

“I recently operated on a 30-year-old woman with an acoustic neuroma who had a slight asymmetry in her hearing,” Dr. Backous said. “If she’d purchased a hearing device instead of seeking medical attention, the acoustic neuroma may have been missed.” 

Educating Patients and Community 

Because widespread availability of OTC hearing aids is an inevitability, otolaryngologists have a duty to educate their patients and community about hearing loss, treatment options, and the role of healthcare professionals. 

Dr. Backous said he typically sees 25 to 30 patients a day, almost all of them with some degree of hearing loss. “They don’t want to hear about hearing aids until I point them to the NIH website about dementia and hearing loss,” he said. “I tell them to call me back after they’ve looked at it if they’re interested in learning more. About 70% come back for a hearing aid evaluation.” 

There are several points you’ll want to convey to your patients and community: 

It’s best to seek a hearing evaluation and exam before buying a hearing aid. Although OTC hearing aids will be available to anyone age 18 and older with no physical exam or hearing evaluation required, it’s still a good idea for people to have their ears and hearing assessed by a professional. “People should get a full hearing evaluation and exam before putting any device in their ears,” Dr. Backous said. A thorough examination can reveal problems requiring treatment prior to placing a device, and chronic ear infections, acoustic neuroma, and multiple sclerosis can present with hearing loss as the only obvious symptom. 

Anxiety about cost may cause some people to resist a physical exam and audiological evaluation. Although coverage varies, it may be helpful to remind patients that hearing tests and otologic evaluations are typically covered by insurance. You can also point people to any low-cost options available in your community. 

Read the label. Make sure your patients understand that OTC hearing aids cannot (and are not intended to) treat all hearing loss. OTC hearing aids are expected to have clear labeling that outlines red flag warnings—symptoms or conditions that warrant a prompt call to a physician. People should carefully read the label of OTC hearing aids before purchasing them. Anyone who has unilateral hearing loss, pain, ear drainage, or vertigo should see a physician for proper evaluation and treatment. 

OTC hearing aids are one of many options. Many people don’t understand the spectrum of available hearing technology. Otolaryngologists should educate their patients about the different types of hearing aids and other available hearing treatments, including cochlear implants. 

“Patients need to know that an OTC hearing aid isn’t customizable to their hearing loss,” Dr. Grisel said. An OTC hearing aid can increase the volume of sounds for users but cannot amplify certain frequencies or tune out background noise, for instance. 

“Hearing aids need to be fit for the environment in which they function,” Dr. Backous added. A 75-year-old in poor physical health who spends most of his time at home has significantly different hearing needs than an active 75-year-old who serves on a board of directors and regularly engages in outdoor sports. 

Hearing needs change throughout life. The general population needs to understand that just as a person’s vision changes throughout life, so does human hearing. The first pair of glasses a person buys is almost never their last; as time goes on, they require stronger glasses and may need to switch to multifocal lenses. An OTC hearing aid may work well for a few years, but people should expect that they will likely need to upgrade their hearing technology every few years. 

“For the vast majority of people, their hearing journey will be an appropriately programmed hearing aid for five to seven years and then a technology update. But some individuals will experience a decline in speech discrimination in one or both ears and no longer perceive hearing benefit with conventional hearing aid technology,” Dr. Toh said. “We can help those people with other advanced hearing technologies or surgical solutions.” 

The cost of OTC hearing aids doesn’t include fitting, programming, or support. Many people don’t realize that the current cost of hearing aids often includes expert fitting, programming, and follow-up appointments, typically over several years. Finding a properly fitting OTC hearing aid that adequately improves hearing may be even more difficult than buying a pair of great-fitting jeans off the rack. 

“I have patients now who come in with hearing aids they bought elsewhere who tell me they can’t wear their hearing aids because they hurt,” Dr. Backous said. “I’ll look at the molds, give them to the audiologist to grind down, and guess what? The hearing aids are suddenly comfortable, the patient can hear, and they do great.” 

Some patients will find great satisfaction with the first OTC hearing aid they try. Many will not. Help patients understand the value of professional fitting and programming and the benefits and limitations of over-the-counter technology. People who understand the value of expert evaluation and individually tailored hearing solutions may be more inclined to seek professional assistance for hearing loss, even if they choose to purchase an OTC device. 

Incorporating OTC Hearing Aids into Your Practice 

Although most otolaryngologists agree that physicians and audiologists should continue to play an important role in the treatment of hearing loss, they also agree that the best path forward is to integrate OTC hearing aids into the hearing care continuum. 

“As otolaryngologists, we don’t want to present to our patients that we’re against over-the-counter hearing aids,” Dr. Grisel said. “We want to do the right thing for our patients, and if we can get them in a safe pair of hearing technology that’s cheaper and works for them, we should be for that. If used properly and with proper education, OTC hearing aids could be a boost to our practices.” 

If we do this properly, the overall savings for our country and healthcare system are going to be enormous. 

—Doug Backous, MD 

Dr. Backous also believes that integrating OTC aids into existing practices can be a “margin-positive experience,” he said. “There’s no question that hearing aid sales are currently a significant part of most private practices. But I personally believe that by embracing over-the-counter technologies and getting involved in fitting them properly, we can actually deliver a higher level of care to patients. I’d rather have us fit them with a device we’ve vetted, where we know the company, its service agreement, and reliability, than have them go out and buy one elsewhere, try it and say, ‘Well, these don’t work,’ and walk away from hearing care.” 

Consider these points if you’re thinking about incorporating OTC hearing aids into your practice: 

Offer a range of options. Many people are unaware of the wide range of available hearing technology, and few know that an OTC hearing aid may be similar in price to an entry-level programmable hearing aid. Have a wide range of options available, at varying price points, and be prepared to explain capabilities of each in easy-to-understand language. 

“Because most people have heard how expensive hearing aids are, they often assume they’re going to have to spend a couple of thousand dollars for a hearing aid,” said Dr. Moody. “I sometimes tell patients it’s like buying a car, with a wide range of options and prices. A less expensive Toyota Corolla may meet your needs, or you may opt for the upgraded technology you can get in a Mercedes.” 

Charge separately for professional services. Many otolaryngology services have already moved toward unbundled hearing aid services—charging separately for the device, fitting and programming, and follow-up visits. You may want to use that approach with OTC hearing aids, whether the devices are purchased from your practice or elsewhere; however, be aware that this approach may dissuade some patients from seeking professional care. “Asking the patient to pay out-of-pocket for audiologic services may discourage the patient from returning for fine tuning of programming, which could potentially reduce their benefit and the patient’s satisfaction with the device,” Dr. Moody said. “It also potentially disincentivizes the patient from returning when they notice a change in their hearing.” 

Offer a rebate that can be rolled into the purchase of another device. One obvious risk inherent to the availability of OTC hearing aids is that some people will purchase an OTC device, believing it to be the most cost-effective means of managing their hearing loss, only to discover that the device doesn’t help them at all. With hundreds of dollars already spent, they may be reluctant to seek additional care or treatment. 

One way to draw patients to your practice and increase the likelihood that they’ll end up with an appropriately fit, well-functioning device is to sell OTC hearing aids and then offer patients a rebate or credit they can roll into the purchase of a programmable hearing aid if the OTC device doesn’t meet their needs. “That links patients to your practice,” Dr. Grisel said. 

Team up with colleagues. Otolaryngologists should also educate their primary care colleagues about the eventual availability of OTC hearing aids. If you choose to sell OTC hearing aids in your office, let your primary care colleagues know they can send interested patients your way. 

Talk with the audiologists in your area as well, and brainstorm how you can best educate and serve your local community. “It takes a village to take care of people,” Dr. Backous said. “If we do this properly, the overall savings for our country and healthcare system are going to be enormous.” 

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Jennifer Fink is a freelance medical writer based in Wisconsin.