Over-the-Counter Hearing Aids - A New Avenue for Mild to Moderate Hearing Loss Treatment

by Lindsay Robinson, HIA Program Coordinator

August 17, 2022


On August 17, 2022, the final OTC rule issued by the FDA was published in the Federal Register. The final rule establishes a category for over-the-counter hearing aids and updates requirements for prescription hearing aids. The effective date of the final rule is October 17, 2022, 60 days after publication in the Federal Register.


OTC hearing aids are only intended for use by adults with mild to moderate hearing loss and will be available for purchase online, through the mail, or in a retail location without the intervention of a licensed hearing professional, which will reduce the overall cost of treatment. This new category is applauded by hearing industry and professional groups alike, as it will expand treatment options for many consumers who have yet to take the first step toward hearing health. Licensed hearing professionals agree that although this new avenue is widely supported, it is still important for all individuals with hearing loss to first consult with a licensed hearing professional to better understand their unique hearing loss. Hearing loss can occur because of aging, noise exposure, medical treatment, injury, genetics, and even excess earwax. Having a professional observe the inner ear and conduct a hearing test can help the individual eliminate other medical conditions and be advised on the treatment options that will work best for their specific type of hearing loss.


The FDA in the final OTC rule states the following: “Indeed, we recommend consulting licensed persons in several circumstances, including for the diagnosis of hearing impairment and in the fitting and continued use of OTC hearing aids when consumers choose to seek such services.”1

Here is what we know:

  • Healthy hearing results in positive health outcomes, increases social engagement, improves communications, and lowers the risk of depression and cognitive decline.2
  • If left untreated, hearing loss is associated with 46 percent higher total health care costs over a 10-year period.3
  • Those who reported moderate or worse untreated hearing loss were more likely to use mental health services for psychosocial disorders such as depression than their peers who wear hearing aids.4
  • Around 1 in 3 people between the ages of 65 and 74 have hearing loss and nearly half of those older than 75 have hearing difficulty.5
  • 8 in 10 who chose to treat their hearing loss report life-changing results and 91% of hearing aid owners say they are satisfied with their hearing professional.6


If you are interested in purchasing OTC hearing aids for treating your mild to moderate hearing loss, it's important to do your research and obtain a purchase receipt, understand the retailer’s return policy and the warranty on the device. Noise related hearing loss is on the rise so consumers should also be careful to choose a device and amplification level that will provide a benefit while doing no harm. If you have any questions about your hearing health or need advice about the various styles of hearing aids and treatment options, reach out to a licensed hearing professional. For more tips about how to choose a hearing device, visit our What to Consider When Looking for a Hearing Aid page.


1 Department of Health and Human Services – Food and Drug Administration, Docket No. FDA-2021-N-0555;
2 “The Hidden Risks of Hearing Loss.” Johns Hopkins Medicine. h?tps:// Accessed August 16, 2018.
3 Trends in Health Care Costs and Utilization Associated With Untreated Hearing Loss Over 10 Years.” Nicholas S. Reed, Aylin Altan, Jennifer A. Deal, Charlotte Yeh, Alexander D. Kravetz, Margaret Wallhagen, Frank R. Lin JAMA Otolaryngology Head Neck Surg. 2019 Jan; 145(1): 27–34. Published online 2018 Nov 8. doi: 10.1001/jamaoto.2018.2875, PMCID: PMC6439810.
4 Bigelow RT, Reed NS, Brewster KK, Huang A, Rebok G, Rutherford BR, Lin FR. Association of Hearing Loss With Psychological Distress and Utilization of Mental Health Services Among Adults in the United States. JAMA Netw Open. 2020 Jul 1;3(7):e2010986. doi: 10.1001/jamanetworkopen.2020.10986. PMID: 32687587; PMCID: PMC7372323.
5 U.S. Department of Health and Human Services. (n.d.). Hearing loss: A common problem for older adults. National Institute on Aging. Retrieved July 27, 2022, from
6 Powers TA, Carr K. MarkeTrak 2022: Naviga?ing the changing landscape of hearing healthcare. Hearing Review. 2022;29(5):12-17.

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