What are over-the-counter (OTC) hearing aids?
In 2017 the Over-the-Counter Hearing Aid Act was signed into law, directing the FDA to establish regulations that would 1) provide reasonable assurances of safety and efficacy, 2) establish output limits and labeling requirements, and 3) describe requirements for the sale of hearing aids in person, by mail, or online without a prescription. This took years longer than expected. In 2021, Senators Warren and Grassley publicly called out the FDA for the delay, and in July 2021 President Biden issued an executive order pushing for OTC hearing aids to move forward. The FDA finally published its final rule in August 2022, which took effect on October 17, 2022, officially establishing the OTC hearing aid category for adults with self-reported mild to moderate hearing loss.
Since then, the OTC market has grown well beyond the early entrants. Bose was one of the first companies to offer a self-fitting device under the earlier de novo pathway, but it exited the hearing aid hardware business in 2022 and now licenses its self-fitting technology to Lexie Hearing’s OTC devices instead. Jabra also entered the OTC space early on but discontinued its self-fitting product in 2024, shifting to a remote-programming model instead. Today, there are many more OTC brands on the market — including Lexie, Sony, Eargo, HP, and others — all legally selling OTC hearing aids online and in stores nationwide. The federal rule also preempts state and local laws that would restrict OTC sales, so there’s no longer a patchwork of states where these devices are or aren’t available.
Many people wait 7 to 10 years before they seek help with amplification, and this law was designed to give people better access to amplification at a lower cost as a first step. These hearing aids are self-fit, using an app or in-device controls to adjust settings based on user feedback. Again, these aids are not for severe to profound hearing loss, nor for anyone under the age of 18. The challenge is, and will continue to be, that hearing loss is usually so gradual that individuals have a difficult time knowing when they should seek help. OTC hearing aids might be a great first step in getting people the help they need. When the degree of hearing loss becomes moderate to severe, though, an audiologist should be involved in the hearing aid fitting process.
Who can benefit from over the counter hearing aids?
Anyone over the age of 18 could benefit from OTC hearing aids. It is critical to note OTC will never be appropriate for children. An Audiologist will still be required to best fit kids due to the medical nature, community, state and federal support and being part of the medical team needed to best care for those under 18. Children must have a medical clearance for hearing aids provided by a physician, and in most cases should be an ENT. OTC hearing aids are for those experiencing mild hearing loss and possibly some moderate types. When the professional is taken out of the process then simple to complicated medical issues are often missed. These include asymmetrical hearing loss, when one ear is better than the other, as a specialist in the auditory system we need to know and understand why. We see many hunters and military service members who have hearing loss worse in the left ear and we almost always know it is because they are a right handed shooter. But there are times the in-between ear difference can be due to a tumor on the auditory nerve in very rare cases. Hearing loss can come from something as common as ear wax! Not all medical professionals know as much about ear wax as an audiologist! We are the most knowledgeable about the types of wax and when it needs to be removed. There can be middle ear issues that need medical attention. OTC is supposed to refer to a specialist if there is a difference between the ears, but we have already seen this does not always happen. Bone conduction testing is never done with OTC, nor looking in the canal. But one can always have their hearing exam done and still purchase OTC. Moisture and earwax are the most common problems with any electronic that goes in the ears. Oro Valley Audiology has a Redux system that can vacuum out AirPods, to OTC, prescriptive and custom hearing aids. We can keep them running and the charge is $35.
Over the Counter Hearing Aids: Not for Severe Hearing Loss
Over-the-counter hearing aids are specifically designed for mild to moderate hearing losses. Those individuals who suffer moderately severe to profound hearing loss should not be obtaining hearing aids directly through the Internet. Oro Valley audiology incorporates best practices and excellent medical care by exploring medication usage, health issues such as diabetes and dementia, and verifies the hearing aid function with real air measurements, none of which you can get through an online company.
Over the Counter Hearing Aids Regulations
The FDA has finalized regulations for over-the-counter hearing aids. The rule was published on August 17, 2022, and took effect on October 17, 2022, establishing a new OTC category for adults 18 and older with perceived mild to moderate hearing loss. As part of the process, the FDA opened the proposed rule to public comment, receiving more than 1,000 responses before finalizing it. The final rule addressed the concerns we and others in the field had about volume: it lowered the maximum sound output allowed for OTC devices to help minimize the risk of noise-induced hearing loss for people using them without professional supervision. Devices intended for more severe hearing loss, or for anyone under 18, still require a prescription and remain classified as prescription medical devices.
Over the Counter Hearing Aids and PSAPs
We do get asked the difference between OTC, over-the-counter hearing aids and PSAPs, which stands for personal sound amplification. The main difference is PSAPs have not been cleared by the FDA To be called a hearing aid. They are purely amplifiers of sound, where as OTCs will take more of a prescription and use algorithms to amplify where the hearing loss is most prominent. Both of which if misused could cause a noise-induced hearing loss if not monitored.
Why are OTC hearing aids becoming available now?
OTC hearing aids trace back to 2017, when the Over-the-Counter Hearing Aid Act was signed into law, directing the FDA to establish rules for this category. The FDA took years longer than expected to finalize those rules, which led to some companies releasing early OTC-style devices even before formal regulations existed. Once the FDA’s final rule took effect in October 2022, it opened the door for a much wider range of manufacturers to legally sell OTC hearing aids, both online and in stores. What started with just a couple of early entrants has grown into a full category with many more direct-to-consumer options now available to adults with mild to moderate hearing loss.
Over the Counter Hearing Aids: From an Audiologist’s POV
Working in audiology for 30 years I have seen extraordinary technological changes surrounding hearing aids. We work in audiology because we want to help every person if they have a damaged auditory system, and hearing aids are a small part of this. The frustration of a long-standing audiologist in the industry I have seen too much emphasis on the widget. If every single audiologist knew what’s best for the patient, their lifestyle, and verified with real ear we would be in a much better position at this time. There are many audiologists that are nervous about OTC hearing aids coming into the market. But there is a marked difference in counseling for tinnitus, auditory processing, and balance disorders from a live person and somebody on the other side of a chatbox or telephone. The longer a person waits to seek help for their hearing loss the more difficult the fitting will be. If OTC hearing aids gets people to seek help faster than I would call this a win for audiology.
Over the Counter Hearing Aids Pros and Cons
As an audiologist I know there is so much more to explore and diagnose beyond a simple audiogram, unfortunately many professionals do not go beyond this basic test. If more audiologists did a functional hearing assessment, speech and noise testing and processing disorder tests they would have a much broader picture to better serve their patients. All of this is our philosophy at Oro Valley audiology. I am concerned that those with a more significant hearing loss or parents with children with hearing loss may purchase direct to consumer or OTC hearing aids through the Internet never seeing an audiologist, therefore medical diagnoses will be missed. Many audiologists have stories of how the referral changed a patient’s life and saved their life. Earwax removal is easy for us and sometimes a hearing aid is not needed after This procedure. But there have been times we’ve referred and tumors have been found and unfortunately I do not feel these things will be caught with OTC amplification.
