FDA on Tuesday issued a proposed rule to create a new category of over-the-counter hearing aids that would be available without an exam, prescription, or fitting—a move that, if approved, could lower costs and improve access to the devices for millions experiencing mild to moderate hearing impairments.

The agency is accepting comment on the proposed rule for 90 days. According to AP/PBS, officials with the agency declined to speculate as to when devices could hit the shelves, if the rule is finalized.

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'Barriers to access'

According to the National Institute on Deafness and Other Communication Disorders, more than 37 million adults in the United States suffer from a hearing impairment. However, very few people who could benefit from using hearing aids do so: According to Axios, only 30% of hearing-impaired individuals 70 and older, and 16% aged 20-69 years old, report ever using hearing aids.

While some individuals with hearing loss simply don't want to use the devices, many are inhibited by various barriers to access.

"We know that when people find out they have a hearing loss they take five to seven years before they do something about it," said Barbara Kelley, executive director of the Hearing Loss Association of America. "And there's a lot of reasons for that: One is cost, one is stigma, one is access to care."

Currently, according to the New York Times, regulations put in place more than 40 years ago permit only providers licensed by the states to prescribe and sell hearing aids. Moreover, health insurance typically doesn't cover the cost of hearing aids, which can cost nearly $5,000 per pair and require visits to an audiologist or technician for testing, fitting, and adjustments, the Times reports.

To address the situation, a scientific advisory committee to President Barack Obama in 2015 issued a report recommending FDA create a new category of basic, over-the-counter hearing aids with the goal of encouraging innovation and driving down costs. Then, in 2017, Congress passed the Over-the-Counter Hearing Aid Act as part of the FDA Reauthorization Act, which gave FDA until August 2020 to issue draft regulations for nonprescription hearing aids. The agency missed the deadline amid the pandemic, MedPage Today reports.

This prompted President Joe Biden in July to issue an executive order that required FDA to issue the proposed rule by early November.

Details of the proposed rule

Under FDA's proposed rule, traditional hearing aid manufacturers will be permitted to sell lower-cost, direct-to-consumer models—with the exception of devices intended for children and people with severe hearing loss, AP/PBS reports. According to FDA, these over-the-counter devices will be required to have volume limits and other safety measures to help prevent injuries.

In addition, under the rule, although companies manufacturing over-the-counter hearing aids generally will not be required to conduct studies on people, they will be required to submit applications to FDA to prove that they met the agency's standards for the devices.

Impact on affordability

The proposed rule "takes us another step closer to the goal of making hearing aids more accessible and affordable," according to HHS Secretary Xavier Becerra. "Today we open the door to an easier process and a more affordable process."

Separately, Vinay Rathi, an otolaryngologist at Massachusetts Eye and Ear, said, "This is going to be, I think, really transformative for a lot of people who are struggling to communicate but may not have the means or the ability to buy a prescription hearing aid or work with an audiologist."

According to Axios, many advocates predict the hearing aid market could one day mirror the eye care market, where consumers are able to choose between prescription bifocals and drugstore reading glasses depending on their budget and needs. (Frieden, MedPage Today, 10/19; Anthes, New York Times, 10/20; Fernandez, Axios, 10/19; Perrone, AP/PBS, 10/19)