Over-The-Counter (OTC) Hearing Devices: What You Need to Know Today
March 14, 2023
What you need to know about over-the-counter hearing devices

For several years, modifications on how hearing devices are classified have been in the works. Keeping abreast of updates can be challenging since misinformation abounds on the topic. Below you will find background information as well as the most recent updates since the FDA guidelines were released in August 2022.


Two categories of hearing devices historically
Historically, two types of hearing devices were categorized—hearing aids and personal sound amplification products, or PSAPS.  


Hearing aids
For years,
programmable hearing aids have been classified by the U.S. Food and Drug Administration (FDA) as Class I or Class II medical devices. The difference between Class I and Class II hearing aids is that Class II hearing aids are those that integrate wireless technology, including ear-to-ear communication and Bluetooth. In order to be fit with one of these Class I or Class II hearing aids, a patient would see a licensed hearing care professional, namely an audiologist or a hearing aid dispenser. The hearing care professional conducts a diagnostic hearing test to determine the level of hearing loss, takes measurements and/or custom earmolds, and fits the person with hearing aids based on a thorough review of the person’s unique hearing loss, common listening environments, and other needs. During the fitting process, live measurements are made while the hearing aids are in the patient’s ear with the hearing care professional using the hearing manufacturer’s computer software to minimize feedback and adjust for optimal sound quality. Additionally, real-ear measurements are used to verify targets are met to insure the person is receiving proper amplification.


Personal Sound Amplification Products, or PSAPS
Available for many years and often confused with hearing aids are PSAPs, or personal sound amplification products, that are available in retail stores and through purchase online, by mail order or over the phone. PSAPs are not hearing aids. Instead, they amplify all sounds without discernment and, therefore, are not intended for those with hearing loss. Devices for those with hearing loss need to be tailored and programmed to an individual’s specific needs. Because of the low cost of PSAPs (anywhere from $10 to $500), many have sought to treat their hearing loss with these devices, however. Historically, the FDA has differentiated between hearing aids and PSAPs as a way of protecting consumers from the potential damage that PSAPs can do to a person’s hearing since the devices can be purchased without a prescription and without a hearing evaluation or ongoing care from a trained hearing care professional.


Changes in 2017 that initiated the redefinition of hearing devices
In 2017, two pieces of Congressional legislation were passed that significantly impact hearing devices—the FDA Reauthorization Act and the Over-the-Counter Hearing Aid Act


FDA Reauthorization Act of 2017
The FDA Reauthorization Act was signed into law in 2017. This sweeping act included revisions and extensions for things like user-fee programs for drugs, generic drugs, and other similar biological products. It also included revisions for medical devices, thus opening the door for a third category of hearing devices—an over-the-counter category.  The Act outlines that the new OTC class of hearing products are for people with “self-perceived mild-to-moderate hearing loss.” OTC devices will be available without a prescription or the involvement of a licensed professional for fitting and programming the hearing aids.


Over-the-Counter (OTC) Hearing Aid Act of 2017
The OTC Hearing Aid Act of 2017 was also signed into law in 2017 and is a rider on the FDA Reauthorization Act of 2017. It created a class of hearing aids regulated by the FDA that is available directly to consumers without involvement from a licensed professional like an audiologist or otolaryngologist.


FDA rules for this new class of hearing aid were expected to be released by the end of 2020, but a delay was announced noting the COVID-19 pandemic as the overarching factor for delay. However, further delay notices were forthcoming in March and April of 2021, pushing out the date when OTC regulations would be released by the FDA to the end of 2022. 


July 9, 2021 Executive Order
On July 9, 2021, President Joe Biden issued an executive order that included many health care related directives. The order included a directive to the Department of Health and Human Services, which oversees the FDA, to consider issuing the OTC hearing aid rules within 120 days of the order, or November 6, 2021.


August 16, 2022 FDA Releases OTC Regulations
On August 16, the FDA released a 200+ page document outlining the regulations for entities bringing products in this new class of hearing aid to the market. It outlines requirements as to the way labeling and packaging on these devices are presented to the public. It makes recommendations that OTC devices are for those with self-perceived mild to moderate hearing loss rather than profound hearing loss. The final rule also includes specifications as to the performance and device design of OTC hearing aids.


Things to Consider With OTC Hearing Aids
Audiologist resoundingly resist  OTC hearing aids. Here's why.


Recognizable brands as well as obscure companies will jump in the market and then out again based solely on profit margin rather than customer satisfaction. Examples abound of the mercurial nature of companies that jump into (and often out of) the direct-to-consumer hearing aid realm, and the overarching reason tends to be lack of profit margin. One company that is well known for its home stereo systems and speakers jumped into the market with an OTC hearing aid stamped with their logo and then stepped out of the market just 10 months later, and this was before the FDA guidelines were even released. They then aligned themselves with a company that has had a direct-to-consumer hearing product that has been available for years, stamped it with the new label that the FDA classification now allows, and presents it to the public as if it is something brand new.


It remains to be seen what other devices will trickle into the OTC realm ultimately. No doubt, it will include a wide range of products that may be difficult for consumers to gauge the usefulness and safety of, despite the FDA's aim to monitor new devices. Using the term hearing aid to describe what will likely be distributed in the OTC market may be misleading, at best, and dangerous at worst, to the public welfare. How so?


Hearing loss is a health issue not a retail experience
Hearing loss and other disorders of the ear are health concerns, and should, thus, be diagnosed and treated by an audiologist, the university-trained health care provider with education, training and certification in conditions involving the ear and hearing. If a person has a heart condition, he seeks out a cardiologist. If a person has diabetes, she visits an endocrinologist. A person with hearing loss and other hearing disorders, like tinnitus and hyperacusis, should be treated by an audiologist or otolaryngologist, the health care providers most qualified to diagnose and treat hearing loss.


Self-fitting and self-programming a recipe for failure
OTC hearing aids are designed to be self-fitting and self-programming, and FDA regulations specify they are for those with perceived mild to moderate hearing loss. Predictions are that many companies will enter the market with devices where programming is based on an at-home hearing test or no hearing test at all. Questioning on these companies' website even asks potential customers to rate their own level of hearing loss. These scenarios can produce highly varied and potentially inaccurate hearing loss measures and, thus, can lead to ill-fit and ill-programmed hearing devices, which could translate into  low customer satisfaction and the danger of a person giving up on hearing aids completely because they feel like they "don't work."  This robs a person of the vast benefits they realize when they have hearing loss that is properly diagnosed and hearing aids that are properly fit and programmed. They also miss out on the ongoing support and care an audiologist provides.


Diagnoses of more serious health issues may be missed
Audiologists are often a patient’s first line of defense in detecting disease process, acoustic tumor, cerumen impaction, eardrum issues, balance disorders, etc. Hearing loss can result from a myriad of factors. Bypassing qualified hearing professionals for an OTC option may mean that a serious condition goes undetected and untreated.


Hearing loss on the rise worldwide
Hearing loss is on the rise worldwide, further punctuating the necessity for qualified professionals to treat this growing public health concern. Interestingly, political entities use the increase in hearing loss as an argument in favor of OTC hearing aids, reasoning that OTC will offer people greater accessibility to hearing devices. Again, an inaccurately fit and programmed hearing aid, however “accessible,” does not lead to better outcomes, but rather to frustration and attrition.


Measuring the cost of OTC hearing devices
Political entities site cost as an overarching factor for the need for OTC hearing aids; yet, closer examination reveals that price gouging on hearing aids has much more to do with the hodgepodge of legal dispensing entities that have been allowed by the government to enter the hearing aid arena. At Johnson Audiology, we implore people to educate themselves on which entities that can dispense hearing aids, albeit legally, are the actual culprits in price gouging. Audiologists earn a doctoral degree from an accredited university, they devote years to their education while in school and beyond, and are bound by strict ethics in the way they treat patients and dispense hearing aids. Other types of dispensing entities, however, like big box store hearing aid counters and franchise hearing aid dispensers do not necessarily operate under that same ethical code. One could argue that OTC, a retail-based dispensing entity, will likely fall into the same category—more interested in selling hearing devices than helping people be successful on a lifelong journey to healthier hearing. And while the cost may appear cheaper up front for OTC hearing aids, spending less money on a hearing device that provides limited benefit is actually less cost effective in the long run. Reputable audiologists, on the other hand, are committed to offering information and access to a wide range of support options for patients who cannot afford hearing aids. Many audiology practices commit time and human resources in working with patients’ insurance companies and third-party hearing aid plans, despite low reimbursement rates for many services. They work with Veterans by way of the VA, which offers hearing aid benefits, and they help individuals with special needs acquire hearing devices by way of state Vocational Rehabilitation programs. They put patients in touch with non-profit groups, like Easter Seals’ and Lions Club International’s hearing programs, that provide help for hearing health care, all in an effort to get people hearing again. In 2019, Johnson Audiology launched its own non-profit organization to help those in need get hearing aids, the Johnson Audiology Hearing Foundation. Learn more at
www.johnsonaudiology.com/foundation.


As additional information continues to be available about OTC hearing devices, Johnson Audiology will provide further updates.

By Jan Hollingsworth July 22, 2025
Wondering about that ringing in your ears? Join us for a free community event where our audiologists will discuss tinnitus—what causes it, how it can affect you, and real solutions. Whether you are new to it or have lived with it for years, come learn and ask questions in a relaxed setting. Space is limited! Reserve your spot today! Date: Friday, August 16, 2025 Time: 10 am to 11 am Location: Johnson Audiology's Chattanooga office location at 6830 Lee Highway RSVP to 423-710-1432 or submit the form below.
By Jan Hollingsworth June 4, 2025
Like anything new in life, adjusting to hearing aids can take time and perseverance to achieve the best results. Yet many people are too quick to give up, not allowing the brain the chance to relearn how to hear or not giving themselves the opportunity to become accustomed to the use and maintenance of their devices. “We meet so many people who wait—who convince themselves their hearing is not ‘bad enough’ or that they can just get by. But untreated hearing loss quietly steals moments, connection, and joy. At Johnson Audiology, we understand the fear, the frustration, and the doubt. That is why we offer more than hearing aids—we offer compassion, answers, and a partner you can trust. You don’t have to do this alone. Let us help you hear your life again,” says Dr. Megan Johnson, audiologist and owner of Johnson Audiology. “Hearing aids should never be an experience where a person is fit with devices and then they never see their hearing care provider again. To ensure patient success, Johnson Audiology seeks to be a lifelong partner on a person’s journey to healthy hearing, someone who is there at every turn,” says Dr. Megan Johnson, audiologist and owner of Johnson Audiology. What are the most common reasons why people give up on hearing aids and why is it important to stick with it? Reasons why people might give up on hearing aids An adjustment period It is your brain that hears, not your ears. The ears transmit sound to the brain where it is interpreted. Dr. Johnson explains, “When a person’s brain has not been stimulated by sound because of hearing loss and then sound is restored with hearing aids, it can take some getting used to. For some people, it takes more than one appointment to get them up to full sound prescription, stair stepping up gradually to let the brain adjust. The brain’s capacity to do this is called neural plasticity .” Research by the University of Colorado Boulder’s Hearing Epidemiology and Research Diagnostic Laboratory has revealed that what the brain can experience impacts within weeks rather than years when hearing loss reaches a certain level. Dr. Johnson says, “The brain’s temporal lobe is where much of hearing and sound interpretation happens. Electroencephalogram (EEG), which is a medical test that measures the electrical activity of the brain, shows that in the presence of hearing loss, the brain will recruit areas assigned to other tasks—like vision—to compensate. The trouble is that this extra cognitive load can tax those areas. However, after treatment with hearing aids, brain recruitment is shown to reverse, partially or fully.” The adjustment period for hearing aids tends to be more seamless for those who have not been without sound for years and years. Dr. Johnson says, “I always encourage people to get their hearing checked when they first notice they are struggling. Sooner is always better.” An investment in quality of life People often make an investment in their health and well-being—for example, purchasing glasses, getting a knee replacement, straightening their teeth—and yet many relegate hearing to the backburner because of cost. Dr. Johnson says, “I’ve seen many patients struggle with hearing aids after buying inferior products in an attempt to save money. Without the guidance of a hearing care provider, even the best device can quickly become ineffective and frustrating.” Dr. Johnson encourages making hearing a priority and budgeting for your hearing health. Perceived benefits and ease of use Getting in the routine of putting hearing aids in each day and being diligent about regular cleaning and maintenance might be a challenge that some face and which deters them from being successful with their aids. “At Johnson Audiology, we offer a plan for regular in-office cleaning and maintenance, easing the task of upkeep for patients. Plus, our offices have dedicated walk-in hours that do not require an appointment. We are here to answer questions, make hearing aid adjustments, and much more as we seek to help people safeguard their investment in hearing technology and make the process easy and convenient.” Family attitudes and support When it comes to hearing aids, having a support system can be crucial to success. “In my 20 years as an audiologist, I have seen the immense benefits when a person’s family members show patience and support during the adjustment period with new hearing aids,” said Dr. Johnson. What about patients who do not have that familial encouragement? Dr. Johnson says, “We are your support system. That’s where our caring and professional audiologists, audiology assistants, and patient care coordinators can lend a helping hand. Success with hearing aids is our goal for every patient, so we promise to be there every step of the way.” Why is healthy hearing so important Hearing loss is a family affair The positive impact of treating hearing loss is often manifested most significantly through improved relationships with family and friends. Hearing loss leads to miscommunication. It can also cause mounting frustration as family members must constantly repeat every sentence. Dr. Johnson comments, “Living with the TV blaring can put a strain on others living in the same household. Untreated hearing loss can quietly tear at the fabric of your relationships. When words go unheard and conversations fade, love and connection start to suffer, and that pain is felt by all involved.” Healthy hearing can help the brain stay sharp and pliable For many years, researchers at Johns Hopkins University have been studying the relationship between hearing loss and dementia. While there is still much left to discover, increasingly scientists recognize healthy hearing as a key factor in maintaining a healthy brain and potentially decelerating the risk of dementia, like Alzheimer’s disease. Dr. Johnson says, “It seems logical that when certain areas of the brain are not stimulated by sound, they atrophy. In fact, research suggests an actual reduction in the physical size of the brain, especially in areas where sound processing and memory take place.” She goes on to say that “while there are many risk factors that individuals cannot control about the effects of aging on the brain, hearing is definitely one that can and should be addressed.” Healthy hearing keeps a person engaged in life Humans are social beings. Since hearing loss can impair effective communication, it is not difficult to understand how it also could lead to social isolation, which can cause increased anxiety and depression. “Conversely, addressing hearing loss can keep a person engaged in life and connected to family and friends,” Dr. Johnson says. Falls and other health risks The ears have two main functions. Hearing is one that most of us learn as youngsters, but the ears also play a major role in helping a person maintain their balance and knowing where their body is in space. “The fluid, or endolymph, in the ear’s semicircular canals is what helps a person do things like stand up from a seated position without falling, walk a straight line, and not run into a door frame when turning a corner into a room,” says Dr. Johnson. In the presence of hearing loss, the reduction in acoustic signals impairs a person’s ability to process spatial information and can mean a higher risk for falling. In turn, falling can lead to broken bones and other injuries and a cascading effect of hospital stays and loss of independence. If you have been unsuccessful with hearing aids in the past, call Johnson Audiology, a hearing health clinic comprised of caring and professional staff. The team can bring a range of options to the table to help people hear better, including hearing aids from all six of the major manufacturers, custom fit products, cochlear implants, and Lyric, the world’s only extended wear hearing aid. Call your office of choice today or schedule online.