Hearing Industries Association Supports FDA Final Rule on the Sale of Prescribed and Over-The-Counter Hearing Aids

Annapolis, Maryland, UNITED STATES

Washington D.C., Aug. 16, 2022 (GLOBE NEWSWIRE) -- Today, the FDA released its final rule allowing adult consumers with perceived mild to moderate hearing loss to purchase certain hearing aids over-the-counter. The Hearing Industries Association (HIA), which represents hearing aid manufacturers, suppliers, distributors, and hearing health professionals, strongly supports broader access to safe and effective hearing aids, both OTC and prescription, for the estimated 38 million Americans with some degree of hearing loss for whom a hearing aid would help. [i]

“This is a significant step forward for the millions of Americans who suffer hearing loss yet are untreated,” said Kate Carr, President of HIA. “Hearing loss is unique to each person, and most do not know if their condition is mild, moderate, or greater, caused by another medical issue or something as simple as ear wax. HIA supports the final rule and recommends that the best treatment for hearing loss involves seeing a hearing professional.”  

The FDA in the final 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.” [ii]

  • Healthy hearing results in positive health outcomes, increases social engagement, improves communications, and lowers the risk of depression and cognitive decline. [iii]
  • If left untreated, hearing loss is associated with 46 percent higher total health care costs over a 10-year period.[iv]
  • 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.[v]
  • 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.[vi]
  • 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[vii]

Given the provisions of the new rule, which will go into effect in 60 days after publication in the Federal Register (scheduled for August 17, 2022), HIA suggests that consumers who purchase an OTC hearing aid obtain a purchase receipt, understand the retailer’s return policy and the warranty on the device. Noise related hearing loss is on the rise and consumers should be careful to choose a device and amplification level that will provide a benefit while doing no harm.

Earlier this summer, HIA, in partnership with multiple industry leaders, announced the Hear Well campaign, aiming to educate the public about the importance their hearing health and the value of seeing a hearing professional. The “Hear Well” campaign is educating audiences through an integrated, multi-platform approach using social media, traditional media, and paid advertisements.  

The campaign is sponsored by the Hearing Industries Association and its members. Other campaign partners joining the effort include Academy of Doctors of Audiology, Alexander Graham Bell Association for the Deaf and Hard of Hearing, American Academy of Audiology, American Academy of Otolaryngology-Head and Neck Surgery, American Cochlear Implant Alliance, American Speech-Language-Hearing Association, Coalition to End Social Isolation & Loneliness, the Ear Community, Healthy Hearing, Hearing Health Foundation, Hearing Loss Association of America, International Hearing Society, National Council on Aging, National Grange, and Retire Safe.

For more information about the Hear Well Campaign and the importance of visiting a hearing professional visit www.hearing.org. To learn more about HIA, please visit www.betterhearing.org.

About HIA

The Hearing Industries Association (HIA), a forum for hearing aid manufacturers, suppliers, and providers, strongly supports increased access to hearing health solutions and affordability of hearing aids. Through research, technological advancements, and a deep understanding of the importance of hearing health and the role of the hearing health professional, HIA members strive to provide the best hearing loss solutions to fit the unique hearing loss and lifestyle of each individual.

i Blackwell DL, Lucas JW, Clarke TC. Summary health statistics for U.S. adults: National Health Interview Survey, 2012 (PDF). National Center for Health Statistics. Vital Health Stat 10(260). 2014.

ii Department of Health and Human Services – Food and Drug Administration, Docket No. FDA-2021-N-0555; https://public-inspection.federalregister.gov/2022-17230.pdf

iii “The Hidden Risks of Hearing Loss.” Johns Hopkins Medicine. h‑tps://www.hopkinsmedicine.org/health/healthy_aging/healthy_body/the-hidden-risks-of-hearing-loss Accessed August 16, 2018.

iv 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.

v 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.

vi 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 https://www.nia.nih.gov/health/hearing-loss-common-problem-older-adults

vii 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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