March 3, 2017
Over-the-Counter Hearing AidsThe Path Forward
JAMA Intern Med. Published online March 3, 2017. doi:10.1001/jamainternmed.2017.0464
Untreated hearing loss is a major health problem in the United States, particularly for older Americans. Approximately 48 million Americans, including half of those in their 70s, have hearing loss in at least 1 ear.1The risk of hearing loss in older adults is about 10 to 20 times higher than the risk of heart disease and 100 times higher than the risk of cancer.2 Despite the large numbers with hearing loss, only a small share—roughly 14%, according to one analysis—actually use a hearing aid.3
Many factors are responsible for this large gap, including the lack of routine hearing screenings for older adults and social stigma that discourages people with hearing loss from seeking treatment. But the way that hearing aids are regulated and sold is also to blame for this disparity. Researchers, consumer advocates, and policymakers are demonstrating a growing interest in reforming the hearing aid market to increase access to these devices.
Both the President’s Council of Advisors on Science and Technology (PCAST)4 and the National Academies of Sciences, Engineering, and Medicine (NAS)2 recently released major reports on hearing loss, and the convergence in their recommendations could not have been clearer: certain types of hearing aids designed to address mild to moderate hearing loss in adults can be safely made available over the counter. Adopting the recommendations in these reports will substantially expand access to hearing technologies for the millions of Americans with hearing loss. In December 2016, the US Food and Drug Administration (FDA) took a promising step by announcing that it would no longer enforce a requirement that individuals obtain a medical evaluation or sign a waiver prior to purchasing hearing aids.5 The agency also announced a commitment to consider creating a category of over-the-counter hearing aids, including by proposing to modify regulations to expand access to innovative, lower-cost technologies./.../