As of 2021, about 28.8 million U.S. adults could benefit from hearing aids. Only about a third of them use hearing aids.  The number of hearing loss diagnoses rises yearly at increasingly younger ages. Studies show that untreated hearing loss heightens the risk of dementia, social isolation, tinnitus, memory impairment, anxiety, and mental exhaustion. Like never before, there is a need for increased treatment options to fit various clinical needs and lifestyles as more and more people are finding themselves needing hearing aids. 

Although hearing aids have been available for years, there have been some barriers to access, including cost and easy access to hearing clinics. Recently, the Food and Drug Administration (FDA) established a regulatory category for over-the-counter (OTC) hearing aids sold directly to consumers through retail stores.  What this means is that you will soon see hearing aids being sold on the shelves at your favorite retail locations as well as online at a less expensive price point than prescription hearing aids.  OTCs may be slightly more sophisticated than the personal hearing amplification devices previously available, and they are approved for consumers 18 years and older with mild to moderate hearing loss.  A hearing test is not required for purchase.

As with every technology, there will be better, probably more expensive OTC hearing aids, and cheaper, possibly less effective options.  It is also likely that many popular hearing aid manufacturers will start to offer over-the-counter versions of their own aids.  OTC hearing aids will be a self-fit technology model and will not require audiologists or physicians to prescribe or fit them. Many people with mild to moderate hearing loss will benefit from these devices, and this change will expand the number of people who can afford treatment for their hearing loss.  

We at Shohet Ear Associates support the use of technology that will expand access to hearing assistance to more people. Still, we feel there are some important medical and audiological considerations before buying technology of this type.  

First, there are a significant number of people that have “hearing loss” because they have occlusive wax or debris in their ears or other conditions that could be resolved by seeing a professional for an examination.  Second, some people will think they have mild to moderate hearing loss when, in actuality, their hearing loss is more severe.  These people will not benefit from the OTC hearing aids and require a more effective hearing solution.  Third, hearing loss can be a very complicated problem to treat, and, at times, using a hearing aid may not be enough.  Hearing exercises (auditory rehabilitation) may be required to obtain the greatest benefit.   Another important consideration is people with a medical condition that presents with hearing loss but may require medical attention.  If hearing loss is treated with an OTC without addressing the underlying condition, there may be a delay in treating a potentially harmful infection or tumor. 

From an audiologic perspective, there is a great deal of information a patient needs to learn to have a successful hearing aid experience.  This abundance of information is normally more than anyone can absorb in a single appointment. It often takes multiple visits for patients to feel comfortable with the physical fit of a new hearing aid and to acclimate to the new sound exposure they experience from daily life.  According to a study by Indiana University, published in the American Journal of Audiology, the number of follow-up visits is between two and three in the six months after an initial hearing aid fitting.  In addition, hearing aids should be properly programmed to optimize the benefit a patient will receive.  Fine-tuning hearing aids to maximize output and sound quality requires the services of an experienced hearing professional with sophisticated equipment, such as Real Ear measurements, available only in an advanced hearing clinic. (Humes, 2017)

For these reasons, we recommend that an audiogram and hearing exam be performed if you are considering an OTC hearing aid, to ensure that you have only mild to moderate hearing loss and that you don’t have a medical condition that requires treatment.  

Reasons to seek medical attention for your hearing loss include: fluid, pus, or blood coming out of your ear within the past 6 months;  pain or discomfort in your ear; a history of excessive ear wax or suspicion that something is in your canal;  episodes of vertigo or severe dizziness with hearing loss; sudden hearing loss or quickly worsening hearing loss; a hearing loss that has gotten more and then less severe within the last 6 months; and hearing loss or tinnitus (noise in the ear or head) in only one ear, or a noticeable difference in how well you can hear in each ear.

If you need hearing or ear care, don’t hesitate to reach out to us through the contact form on our website, or by calling any of our office locations. Our professionals are happy to help you navigate the wide array of hearing technologies available. For more information on the OTC hearing aid legislation, you can read the FDA’s announcement on the finalized rule.



Medical Devices; Ear, Nose, and Throat Devices; Establishing Over-the-Counter Hearing Aids. (2022, August 17). Federal Register.

Humes, L., Rogers, S., Quigley, T., Main, A., Kinney, D., & Herring, C. (2017). The Effects of Service-Delivery Model and Purchase Price on Hearing-Aid Outcomes in Older Adults: A Randomized Double-Blind Placebo-Controlled Clinical Trial. American Journal of Audiology, 26(1), 53-79.

Jorgensen L. E. (2016). Verification and validation of hearing aids: Opportunity not an obstacle. Journal of otology, 11(2), 57–62.