Congress expects the new regulations to increase competition and innovation in the hearing industry and among hearing professionals while ensuring the safety and effectiveness of both prescription and over-the-counter hearing aids. Manufacturers have until mid-April 2023 to comply with the rules.
The resulting rule creates two groups for air-conduction hearing aids:
- Over the counter hearing aids.
- Traditional prescriptive hearing aids – like we have today.
So, what does this really mean for consumers? How will things change? Will OTC hearing aids lead to low-cost innovations that will solve all your hearing problems, or will they turn out to be cheap, low-quality devices that cause more harm than good?
In this post, we will dig deeper into the FDA’s rules and many questions about OTC hearing aids. If you have any questions even after reading this article, please click here to submit your thoughts, questions, or concerns. We will update this post regularly as the specifics regarding product quality, price, and availability have yet to be seen.
What are OTC Hearing Aids?
Over-the-counter (OTC) hearing aids are a new category of hearing aids that you can now buy without visiting an audiologist or a hearing specialist. These over-the-counter hearing devices are intended to help adults with perceived mild-to-moderate hearing loss. OTC hearing aids are regulated as medical devices by the U.S. Food and Drug Administration (FDA). OTC hearing aids primarily function as a one size fits all alternative to prescription hearing aids, which are currently only available from hearing health professionals.
How Do OTC Hearing Aids Work?
With traditional hearing aids, a patient is required to visit a hearing health professional. However, with OTC hearing aids, the patient must rely on unreliable results from an online assessment. The audiology community strongly discourages potential users from going this route. Before doing anything, people should visit an audiologist first.
Why are hearing aids available without a prescription?
Hearing loss significantly affects the quality of life for millions of individuals in the US. As a result, this common health problem contributes to higher healthcare costs for many Americans. But regardless of cost, your hearing health is important. Untreated hearing loss can lead to many serious health issues. These include depression, anxiety, low self-esteem, less independence and mobility, and dangerous falls. Despite this, only one in four adults who could benefit from hearing aids has ever even used them. Ensuring that hearing health care is more accessible and affordable is now a major public health priority. This is especially as the number of older adults in the U.S. continues to grow each year.
Many experts in hearing healthcare have worked with researchers, audiologists, and even consumers to find safe ways to improve access to hearing health care medical devices. They suggested changing some regulations that some suggested were barriers to adults getting the hearing help they desperately needed. This then led to the discussion that the FDA should create guidelines and quality standards for OTC hearing aids.
As part of this process, the FDA formally proposed a rule to establish the new category of OTC hearing aids. This ruling now allows certain hearing aids to be sold directly to consumers in stores (or even online) without a medical exam or a professional fitting by an audiologist. However, it’s important to note that hearing aids for more severe hearing loss or for patients under 18 remain should continue to use prescription devices.
What exactly has changed with the FDA rules?
Quite a bit. Basically, there are two major changes, and both have to do with how the FDA views the role of the audiologist in dispensing hearing aids:
- You can now buy a device that belongs to this new class of OTC self-fitting hearing aids without going through a licensed audiologist. Self-treatment may be appropriate for minor issues, but OTC could cause someone to miss out on proper ear and hearing treatment.
- The FDA removed all hearing aids from its list of restricted devices, a list reserved for products that can only be sold through state-licensed practitioners or under certain conditions of sale. However, state laws will continue to restrict the sale of prescriptive hearing aids to licensed professionals. The removal of hearing aids from the restricted list also changes the governing of warranties and hearing aid returns. This is very important to consumers and is addressed later in this article.
What are the benefits of OTC Hearing Aids?
The FDA’s intent is that adults (age 18+) with perceived mild-to-moderate hearing loss will see greatly expanded treatment options to correct their hearing loss. However, without a thorough hearing exam performed by an audiologist, a potential consumer will not know the extent of their hearing loss.
The new OTC hearing aid regulations ignore the most urgent hearing healthcare needs in the United States:
- People with moderately-severe to severe hearing loss who are most in need of prescriptive hearing aids and must pay large out-of-pocket costs for them.
- Sufferers of tinnitus and/or decreased sound tolerance who are most effectively treated by an experienced audiologist.
- Children with hearing loss.
OTC hearing aids are not a good option for the following types of patients:
- That hear better in one ear than the other
- Whose hearing has suddenly changed
- With a history of taking medication that causes hearing loss or tinnitus
- With a history of chemotherapy and/or radiation to the head or neck
- With a history of drainage from one or both ears
- With ear pain or discomfort
- With dizziness
- With a history of ear or head trauma
What will the new FDA OTC hearing aids look and sound like?
Most OTC hearing aids will resemble current hearing aids or earbuds. The first two FDA-cleared “self-fit hearing aids” – the Bose SoundControl – now the Lexie B1 – and the Jabra Enhance Plus – look like receiver-in-canal (RIC) hearing aids and earbuds.
One important difference is that the tip of the receiver of an OTC hearing aid – the part that generates the sound like a stereo receiver – cannot come closer than one centimeter from the eardrum. How will the FDA police this with such a wide range of ear canal lengths in both men and women? This safety concern will have a big impact on performance and comfort for the consumer.
Additionally, without proper guidance from an audiologist, many will struggle with properly inserting their devices or knowing if they have a good physical fit. A poor-fitting hearing instrument can lead to feedback, poor sound quality, pain and discomfort, and an increased likelihood of losing devices.
Another safety concern about OTC hearing aids is the potential of irreversible hearing damage by over-amplifying loud noises for extended periods of time – roughly 12-16 hours per day. Loudness limits were the most hotly debated topic in the FDA ruling because they determine how many people can safely use these devices. Unfortunately, the FDA’s solution requires all OTC hearing aids have a volume control so the user can manually turn down loud sounds. The problem is people cannot manually adjust a device fast enough when a sudden loud sound occurs. So the potential for damaging a person’s hearing with OTC hearing aids seems to be high.
- Are There Any Potential Problems with OTC Hearing Aids?
Lots of people are excited about what OTC hearing aids offer without realizing the additional side effects that come along with this new legislation. Here are just a few reasons to be concerned with OTC hearing aids:
- OTC Hearing Aids Might Not Fit Properly.
Buying an over-the-counter (OTC) hearing aid seems like a great idea at first, but unless you get fitted by a hearing specialist, there’s no guarantee the hearing aid will fit properly. And if it doesn’t fit well, it may be uncomfortable and won’t be as effective.
- OTC Hearing Aids Might Not Be Suitable for Your Hearing Loss.
OTC hearing aids aren’t suitable for all levels of hearing loss. If you have mild hearing loss, an OTC hearing aid might be fine. But if you have moderate or severe hearing loss, you’ll need a more powerful device
custom-fit to your ear. You cannot effectively diagnose hearing loss with online methods. Accurately diagnosing your hearing loss is only possible with a training hearing health professional in a soundproof booth.
| Degree of hearing loss | Hearing loss range (dB HL) |
| Normal | –10 to 15 |
| Slight | 16 to 25 |
| Mild | 26 to 40 |
| Moderate | 41 to 55 |
| Moderately severe | 56 to 70 |
| Severe | 71 to 90 |
| Profound | 91+ |
- Less Quality Control Can Lead to Sub-Par Medical Devices. As many of the leading companies rush to ensure that their OTC hearing aids out there for the public, this will most likely lead to a lack of quality control. Poor construction and development using cheap materials could end up resulting in hearing aids that don’t work well. These cheaper hearing aids might even cause more damage to your hearing health.
- Spending More Money in the Long Run. FDA OTC hearing aids might seem like a good deal at first, but you could ending up spending more in the big picture, especially if you have to keep buying new devices because they break easily or don’t work well. You can avoid a lot of frustration by working with an audiologist from the very beginning.
- Lack of Access for Professional Support. If you have any problems with your OTC hearing aid or hearing care, you won’t have anyone to turn to for help. But you might be on your own trying to figure out how to make OTC hearing devices work for you.
Will the new FDA rules ensure high-quality products?
While these devices must meet some basic electroacoustic standards – i.e., distortion and self-generated noise controls, frequency response, latency, etc., this does not necessarily ensure high quality or effectiveness.
Personal sound amplification products (PSAPs), some with a rechargeable battery, have been available for years, and the current online amplification marketplace is loaded with outdated and poor sound quality devices. The FDA will regulate all hearing aids as Class I and Class II devices using new baseline standards and good manufacturing practices (GMPs) which will hopefully provide at least some quality assurances. However, Buyer Beware!! Even with these standards and regulations, you can count on a lot of corner-cutting and substandard OTC hearing aids found online and on the shelf.
Are OTC Hearing Aids Programmable?
Currently, OTC hearing aids are not programmable. This is just one more reason why we recommend that patients receive a hearing aid from a medically-trained audiologist. We can ensure that your hearing aid is both comfortable and effective for your hearing health.
Will the price of prescription devices decrease due to competition from OTC Hearing Aids?
Most likely not. Audiology is similar to optometry and dentistry in that the products sold are secondary to professional services. Fitting and customizing devices for tinnitus or hearing loss is essential to ensure a positive outcome. Top-tier audiologists use specialized, expensive equipment for extensive testing, comfortable fitting, and precise programming of hearing devices. Also, in order to keep hearing instruments working optimally, patients with mild to serious hearing loss generally require several office visits each year. With tinnitus or decreased sound tolerance patients, the audiologist’s role is even more important.
Staffing an office with audiologists, purchasing the required equipment, and even paying rent require substantial investments and fixed costs. On average, about 1/2 to 2/3 of the cost of hearing aids is attributable to audiology services and related overhead that are usually “bundled” into the price of the devices. These costs will not change with OTCs so prescription hearing devices may increase in price as a result of fewer audiology practices remaining in business combined with an aging population in need of professional services.
What happens with hearing aid returns and warranties and the FDA taking them off its list of restricted devices?
By taking hearing aids off the FDA’s list of restricted devices, some aspects of consumer protection – specifically return for credit and warranties – will now largely flow through individual state laws and the professional licensure requirements in those states. The smart consumer should look carefully at the OTC hearing aid warranty and return provisions which are often stated in the “fine print.”
Will OTC devices help with tinnitus?
No, OTC hearing aids will most likely not help patients with tinnitus. At Sound Relief, we are able to help over 90% of our patients find significant relief for their tinnitus. One of the reasons for this success is the number of patients we help to help them manage that ringing in their ears. Every year we see thousands of patients at varying stages of treatment. An audiologist without our level of expertise using traditional hearing devices has a 50/50 chance of success. With OTC hearing aids, we anticipate help rates for tinnitus below 25%. OTC hearing devices may help some with tinnitus, but not most.
Can Children Use OTC Hearing Aids?
OTC hearing aids are not meant for children. Additionally, they are not intended for adults who have more severe hearing loss or significant difficulty hearing. If you have more severe hearing loss, OTC hearing aids will not be able to help you.
Warranties and return provisions are extremely important.
Hearing instruments are tiny electronic devices used for up to 16 hours per day and are constantly exposed to rain, wind, sweat, dust, heat/cold, etc. Not an ideal environment for any electronics and the need for repair and adjustments will be a major issue. The pharmacist at Walgreens or the cashier at Best Buy will likely not have the time, training, or patience to troubleshoot a malfunctioning OTC device. So how will the consumer resolve their problem? Call Bose and talk to customer service? Watch a YouTube video ten times to learn how to remove wax from the receiver? Send it back to the manufacturer and be without amplification for a few weeks?
None of these are ideal outcomes, and many fear these reliability problems will erode consumer satisfaction with OTC hearing aids provided by the Food and Drug Administration (FDA). The Hearing Loss Association of America (HLAA) encourages consumers to scrutinize return policy details before purchasing. If you’re having major problems with the hearing aid and are not getting the help you need, please file a complaint with the FDA or call 1-800-FDA-1088.
Will OTC Hearing Aids drive new innovations and greater competition among hearing aid manufacturers?
The competition will certainly intensify among over-the-counter hearing aid manufacturers, but not all the current prescriptive hearing aid manufacturers will participate in OTC – most notably Oticon.
We believe there will be accelerated innovations in the new OTC devices, apps, and speech-in-noise and self-fitting solutions, but that innovation has been progressing rapidly in prescriptive hearing aids as well. Once again, the cost of devices is not the main issue. Nobody questions the cost of an implanted piece of a hip or knee replacement. Why? Because everyone understands that the orthopedic surgeon’s skills are most important to ensure the best outcome for the patient. Similarly, the cost of hearing aids is such a small part of the overall package, there is little manufacturers can do to mitigate the pressure on price.
The idea that only companies outside the hearing industry can transform hearing aid technology is ludicrous, and the evidence does not support this idea. Many major, well-respected brands and start-ups – from Panasonic, Bose, J&J (Songbird), and Doppler, have entered the US hearing aid market and failed.
That does not mean Google, Apple, or Elon Musk will not come up with something amazing and significantly accelerate innovation. However, creating and improving a tiny hearing aid with great sound quality, comfort, battery life, speech-in-noise capabilities, rechargeability, and Bluetooth capability – is a lot harder than people think.
Is Congress Passing The Buck on Hearing Health?
Sound Relief and the audiology community continue to work for better insurance coverage for audiology services and hearing devices. Better coverage will have a much greater impact than this shortsighted, half-measure OTC legislation. Still, to this day, Medicare does not allow direct access to audiologists with a referral from a Primary Care Physician.
Even with that, Medicare only pays $34 for a hearing test but nothing for hearing aids, hyperacusis, or tinnitus treatment. Before commercial health insurance offers better hearing health-related benefits, Medicare must change. Please consider submitting a form letter to your representatives in Congress in support of H.R. 1587/S.1731 – Medicare Audiologist Access & Services Act. Click here to show your support.
A new era of hearing healthcare?
OTC hearing aids aim to provide more affordable and convenient options for adults (age 18+) with mild to moderate hearing loss. That sounds great – pun intended – but they could be opening Pandora’s Box. These new rules open hearing aid sales to online and retail stores and provide very basic safety and quality standards. Consumers will need to be cautious when reviewing warranties, return policies, and amplification settings.
Regardless of which direction you choose to pursue, please, please, please, go see an audiologist if you suspect that you have hearing loss or ringing in the ears. The smartest move is to have a comprehensive evaluation by a licensed audiologist before you purchase anything. That way, you are best informed of your true needs.
At Sound Relief Tinnitus & Hearing Center, we provide hope and help to those living with tinnitus and other hearing health issues. Our patients are at the center of everything we do, and we strive to guide them to overcome their challenges by delivering innovative and compassionate healthcare.
Dr. Julie Prutsman, owner of this family-owned practice, has expanded to 9 locations across Colorado and Arizona. In 2012, she founded Sound Relief in her hometown of Highlands Ranch, Colorado and continues to foster their mission through mentorship of the brightest minds in the field of Audiology.