In 2017, Congress directed the FDA to develop regulations for OTC hearing aids. Also in 2017, The Lancet published a report listing hearing loss as a modifiable risk factor for the development of dementia (Lancet. 2017;390:P2673-P2734). In a 2020 update, The Lancet listed hearing loss as one of 12 modifiable risk factors for developing dementia and noted that research has shown that hearing aid use can decrease the risk of dementia in individuals with hearing loss (Lancet. 2020;396:413-446).
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April 2022President Joseph Biden’s Executive Order on Promoting Competition in the American Economy, issued on July 9, 2021, directed the U.S. Secretary of Health to “promote the wide availability of low-cost hearing aids” and “publish for notice and comment a proposed rule on over-the-counter hearing-aids.” The FDA published their proposed OTC hearing aid rules on Oct. 20, 2021, noting that the intent of the rules is “to improve access to hearing aid technology for Americans.”
If used properly and with proper education, OTC hearing aids could be a boost to our practices.
—Jed Grisel, MD
The premise behind the push for OTC hearing aids “is that cost is a significant barrier for most people, and that is one of several reasons why hearing aid penetration for the subset of the general population that would benefit from hearing aids is so low,” said Elizabeth Toh, MD, an otolaryngologist with Beth Israel Lahey Health in Burlington, Mass. “The assumption is that cost is one of the primary barriers, and that if we bring down costs, we’ll be able to offer hearing rehabilitation for a wider swath of the hearing loss population.”
“Improving access to hearing devices is a good thing, but we should bear in mind that cost isn’t the most significant disincentive for hearing aid use,” added Stephanie Moody Antonio, MD, an otolaryngologist with Children’s Hospital of the King’s Daughters in Norfolk, Va. “The aesthetics and negative stigma of hearing loss and hearing aids are probably a more significant disincentive for hearing care. I’m hoping that the widespread advertisement of OTC devices that’s bound to occur with their introduction will improve the general awareness of the negative effects of hearing loss and acceptance of hearing aids so that more people will seek hearing care and hearing technology.”
Proposed Rules and Otolaryngologists’ Concerns
Under the FDA’s proposed rules, OTC hearing aids are “intended to address perceived mild to moderate hearing loss in people age 18 and older.” The proposed maximum acoustic output limit is 120 decibels (dB), with no proposed gain limit.