Over-the-Counter Hearing Aids – Where Do They Fit?

Authors:
Lucas A. Berenbrok, PharmD, MS, BCACP
Elaine Mormer, PhD, CCC-A

Reviewers:
Kathryn (Katie) Kiser, PharmD, BCACP
Tyan Thomas, PharmD, MS MEd, BCPS

Citation:
De Sousa KC, Manchaiah V, Moore DR, Graham MA, Swanepoel DW. 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.

The Problem

Approximately 1 in 6 adults in the United States report some trouble with their hearing. You or a family member may be among the nearly 29 million adults living in the U.S. who could benefit from using a hearing aid. Untreated hearing loss has been linked to increased risks of dementia, depression, and social isolation. Despite the prevalence and implications of hearing loss, hearing aid use is strikingly low and has plateaued in recent decades even with steady improvement in device appearance and technology. Two of the primary reasons people with hearing loss choose not to use hearing aids include accessibility and cost. There are fewer than 14,000 audiologists nationwide and the average cost of a pair of hearing aids is $5,000. To address these barriers, the FDA finalized regulations for over-the-counter hearing aids, to be sold without medical evaluation and without the services of a hearing professional in October 2022. But will self-fitting OTC hearing aids be as effective as audiologist-fitted prescription hearing aids?