What Physicians Need to Know About Over-the-Counter Hearing Aids

Brian K. Unwin, MD, FAAFP, AGSF, CMD,
Carilion Clinic Center for Healthy Aging, Roanoke, Virginia
Julia M. D'Amora, DO,
Virginia Tech Carilion School of Medicine, Roanoke, Virginia
Corinne O'Shaughnessy, Au.D.,
Carilion Clinic Audiology, Roanoke, Virginia

American Family Physician. 2024;109(3):279-283A.

Author disclosure: No relevant financial relationships.

Case Scenario

My 74-year-old patient, V.P., who has a history of osteoarthritis and hypertension, reports hearing loss during a wellness visit. V.P. works in customer service taking telephone calls but is becoming fatigued trying to hear customers on the phone and is concerned that hearing loss may be affecting their ability to remember details at work. On further questioning, V.P. reports slowly progressive, bilateral hearing loss without ear pain, drainage, tinnitus, or vertigo. Examination shows normal-appearing external ears without injury or deformity, clear canals bilaterally, and normal-appearing tympanic membranes.

V.P. also states that family members have been complaining about the excessive volume of the television at home. V.P. has taken a home hearing test, which shows evidence of bilateral hearing loss. My patient is concerned about the cost of prescription hearing aids and asks whether less expensive, over-the-counter (OTC) hearing aids could help or whether it would be better to see a specialist. Is my patient a suitable candidate for OTC hearing aids? What can I offer my patient to help them make the best choice?

Commentary

Helen Keller famously stated that deafness separates us from people. Reports of perceived hearing loss should be taken seriously and explored with patients. Of American adults 75 years or older, 50% have perceived disabling hearing loss; fewer than one-third of patients 70 years and older who could benefit from hearing aids have ever used them.1 Hearing loss is invisible, often unacknowledged or denied, and is a potentially modifiable risk factor for dementia.2,3 Hearing loss is strongly tied to social determinants of health and is associated with geriatric frailty, depression, disability, social isolation, unmet medical needs, and increased health care costs. In primary care, patients are not routinely screened for hearing loss, and the issue is not often addressed.4–6 The average age at which people first use hearing aids is 80 years, with approximately 10 years lapsing between identified hearing loss and use of amplification.7 Traditional Medicare Part B does not cover hearing examinations or hearing aids but does pay for hearing tests related to treating conditions other than hearing loss (e.g., memory loss). Some state Medicaid programs and more than 90% of Medicare Advantage programs pay for hearing assessments and amplification, but regulations and coverage vary among programs.8,9

With the U.S. Food and Drug Administration (FDA) approval of OTC hearing aids in August 2022, physicians will likely have a larger role in guiding patients interested in acquiring hearing aids.10 OTC hearing aids received approval after determination that safety and effectiveness were well established and that the benefits of a regulated market for hearing aids outweighed any theoretical risks. This position is supported by the Hearing Loss Association of America as an initiative to destigmatize hearing loss and support affordable hearing care services and technology innovation for the more than 48 million Americans who experience hearing loss.11

HEARING ASSESSMENT

OTC hearing aids are appropriate for adults 18 years and older who have self-perceived, mild to moderate hearing loss and who have no concerning conditions that require a formal hearing evaluation. Symptoms warranting medical evaluation, including warning symptoms as defined by the FDA (e.g., sudden-onset hearing loss, pain, vertigo, unilateral hearing loss), should be assessed by a primary care physician. Table 1 details signs and symptoms of hearing loss, including additional indications for medical assessment.10 An article containing a detailed differential diagnosis and information on the assessment of hearing loss is available in American Family Physician.12

Address correspondence to Brian K. Unwin, MD, FAAFP, AGSF, CMD, at bkunwin@carilionclinic.org. Reprints are not available from the authors.

Author disclosure: No relevant financial relationships.

  1. 1.National Institute on Deafness and Other Communication Disorders. Quick statistics about hearing. Updated March 25, 2021. Accessed August 6, 2023. https://www.nidcd.nih.gov/health/statistics/quick-statistics-hearing
  2. 2.Reed M, Freedman M, Mark Fraser AE, et al. Enhancing clinical visibility of hearing loss in cognitive decline. J Alzheimers Dis. 2022;86(1):413-424.
  3. 3.Cantuaria ML, Pedersen ER, Waldorff FB, et al. Hearing loss, hearing aid use, and risk of dementia in older adults. JAMA Otolaryngol Head Neck Surg. 2024;150(2):157-164.
  4. 4.Mahmoudi E, Zazove P, Pleasant T, et al. Hearing loss and healthcare access among adults. Semin Hear. 2021;42(1):47-58.
  5. 5.Genther DJ, Betz J, Pratt S, et al.; Health, Aging and Body Composition Study. Association between hearing impairment and risk of hospitalization in older adults. J Am Geriatr Soc. 2015;63(6):1146-1152.
  6. 6.Zazove P, Plegue MA, Mulhem E, et al. The association of hearing loss with hospitalization. J Am Board Fam Med. 2023;36(3):439-448.
  7. 7.Simpson AN, Matthews LJ, Cassarly C, et al. Time from hearing aid candidacy to hearing aid adoption: a longitudinal cohort study. Ear Hear. 2019;40(3):468-476.
  8. 8.Gangopadhyaya A, Shartzer A, Garrett B, et al. Are vision and hearing benefits needed in Medicare? November 1, 2021. Accessed August 6, 2023. https://www.rwjf.org/en/insights/our-research/2021/11/are-vision-and-hearing-benefits-needed-in-medicare.html
  9. 9.Freed M, Damico A, Neuman T. Medicare Advantage 2022 spotlight: first look. November 2, 2021. Accessed February 2, 2024. https://www.kff.org/medicare/issue-brief/medicare-advantage-2022-spotlight-first-look/
  10. 10.Federal Register. Medical devices; ear, nose, and throat devices; establishing over-the-counter hearing aids. A rule by the Food and Drug Administration on 08/17/2022. Accessed August 6, 2023. https://www.federalregister.gov/documents/2022/08/17/2022-17230/medical-devices-ear-nose-and-throat-devices-establishing-over-the-counter-hearing-aids#print
  11. 11.Hearing Loss Association of America. Position paper: over-the-counter hearing aids. Accessed August 6, 2023. as://www.hearingloss.org/wp-content/uploads/PositionPaper_OTC_Hearing_Aids.pdf?pdf=PositionOTC
  12. 12.Michels TC, Duffy MT, Rogers DJ. Hearing loss in adults: differential diagnosis and treatment. Am Fam Physician. 2019;100(2):98-108.
  13. 13.Mosley CL, Langley LM, Davis A, et al. Reliability of the home hearing test: implications for public health. J Am Acad Audiol. 2019;30(3):208-216.
  14. 14.Mayo Clinic. Hearing aids: how to choose the right one. September 20, 2022. Accessed August 6, 2023. https://www.mayoclinic.org/diseases-conditions/hearing-loss/in-depth/hearing-aids/art-20044116
  15. 15.National Institute on Deafness and Other Communication Disorders. Hearing aids. Updated October 11, 2022. Accessed August 6, 2023. https://www.nidcd.nih.gov/health/hearing-aids
  16. 16.Cleveland Clinic. Types of hearing aids. (September 2022). Accessed August 6, 2023. https://my.clevelandclinic.org/health/articles/5122-hearing-aid-styles
  17. 17.Roberts C. A complete guide to over-the-counter hearing aids. April 20, 2023. Updated November 7, 2023. Accessed February 1, 2024. https://www.consumerreports.org/health/hearing-aids/complete-guide-to-over-the-counter-hearing-aids-a3898239010
  18. 18.Everett C (Ingrao B, Cameron K, eds). 10 best hearing aides of February 2024: expert reviewed. February 1, 2024. Accessed February 2, 2024. https://www.ncoa.org/adviser/hearing-aids/best-hearing-aids/
  19. 19.Johns Hopkins Medicine. How do hearing aids work? Accessed August 6, 2023. https://www.hopkinsmedicine.org/health/conditions-and-diseases/hearing-loss/how-do-hearing-aids-work
  20. 20.Boys Town Hearing and Balance Center. Hearing aids automatically adjust for different noise levels. Accessed August 6, 2023. https://www.boystownhospital.org/knowledge-center/hearing-aids-automatic-settings
  21. 21.Oregon Health and Science University. Benefits of hearing aids. Accessed August 6, 2023. https://www.ohsu.edu/ent/benefits-hearing-aids
  22. 22.American Tinnitus Association. Hearing aids/masking devices. Accessed August 6, 2023. https://www.ata.org/about-tinnitus/therapy-and-treatment-options/hearing-aids-masking-devices
  23. 23.De Sousa KC, Manchaiah V, Moore DR, et al. Effectiveness of an over-the-counter self-fitting hearing aid compared with an audiologist-fitted hearing aid: a randomized clinical trial. JAMA Otolaryngol Head Neck Surg. 2023;149(6):522-530.
  24. 24.Urbanski D, Hernandez H, Oleson J, et al. Toward a new evidence-based fitting paradigm for over-the-counter hearing aids. Am J Audiol. 2021;30(1):43-66.
  25. 25.U.S. Food and Drug Administration. OTC hearing aids: what you should know. Accessed Februar y 2, 2024. https://www.fda.gov/medical-devices/hearing-aids/otc-hearing-aids-what-you-should-know
  26. 26.Virginia Department for the Deaf and Hard of Hearing. Technology Assistance Program (TAP). Accessed August 6, 2023. https://www.vddhh.virginia.gov/equipment.htm
  27. 27.U.S. Food and Drug Administration. Other hearing devices and products: personal sound amplification products. Accessed August 26, 2023. https://www.fda.gov/medical-devices/hearing-aids/other-hearing-devices-and-products#5

Case scenarios are written to express typical situations that family physicians may encounter; authors remain anonymous. Send scenarios to afpjournal@aafp.org. Materials are edited to retain confidentiality.

This series is coordinated by Caroline Wellbery, MD, associate deputy editor.

A collection of Curbside Consultation published in AFP is available at https://www.aafp.org/afp/curbside.

Copyright © 2026 by the American Academy of Family Physicians.

This content is owned by the AAFP. A person viewing it online may make one printout of the material and may use that printout only for his or her personal, non-commercial reference. This material may not otherwise be downloaded, copied, printed, stored, transmitted or reproduced in any medium, whether now known or later invented, except as authorized in writing by the AAFP. See permissions for copyright questions and/or permission requests.