FDA wants to make (some) hearing aids available without a prescription

FDA posted a Tuesday proposed rule to create a new class of over-the-counter hearing aids that would be available without a test, prescription or fitting – a move that, if approved, could reduce costs and improve access to devices for millions of people with disabilities mild to moderate hearing aids.

The agency accepts comments on the proposed rule for 90 days. According to PA/ PBS, agency officials declined to speculate on when the devices might hit shelves, if the rule is finalized.

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“Access barriers”

According to National Institute on Deafness and Other Communication Disorders, more than 37 million adults in the United States have hearing loss. However, very few people who could benefit from using hearing aids do so: according to Axes, only 30% of people with hearing loss aged 70 and over and 16% aged 20 to 69 say they have ever used hearing aids.

While some people with hearing loss simply do not want to use the devices, many are inhibited by various barriers to access.

“We know that when people find out they have hearing loss, it takes them five to seven years to do something,” said Barbara Kelley, executive director of Hearing Loss Association of America. “And there are a lot of reasons for this: one is the cost, the other is the stigma, the other is access to care.”

Currently, according to the New York Times, regulations put in place over 40 years ago only allow state-approved suppliers to prescribe and sell hearing aids. Additionally, health insurance typically does not cover the cost of hearing aids, which can cost close to $ 5,000 per pair and require visits to an audiologist or technician for testing, fitting, and adjustments. Times reports.

To remedy the situation, a scientific advisory committee of President Barack Obama published a report in 2015 recommending that the FDA create a new category of basic over-the-counter hearing aids in an effort to encourage innovation and reduce the costs. Then, in 2017, Congress passed the Over-the-Counter Hearing Aid Act as part of the FDA Reauthorization Act, which gave the FDA until August 2020 to publish proposed regulations on hearing aids for sale. free. The agency missed the deadline amid the pandemic, MedPage today reports.

This prompted President Joe Biden in July to issue an executive order requiring the FDA to publish the proposed rule in early November.

Details of the proposed rule

Under the rule proposed by the FDA, manufacturers of traditional hearing devices will be allowed to sell models cheaply and directly to consumers, with the exception of devices intended for children and people with severe hearing loss. , PA/ PBS Reports. According to the FDA, these over-the-counter devices will need to have volume limits and other safety measures to help prevent injury.

Additionally, under the rule, although companies making over-the-counter hearing aids are generally not required to conduct studies in people, they will have to submit applications to the FDA to prove that they meet standards for the agency for the devices.

Affordability impact

The proposed rule “brings us one step closer to the goal of making hearing aids more accessible and affordable”, according to HHS Secretary Xavier Becerra. “Today we are opening the door to an easier and more affordable process.”

In addition, Vinay Rathi, otolaryngologist at Massachusetts Eye and Ear, said: “This is going to be, I think, really transformative for a lot of people who have difficulty communicating but who may not have the means or the ability to purchase or work with a prescription hearing aid. an audiologist. “

According to Axes, Many advocates predict that the hearing aid market may one day mirror the eye care market, where consumers can choose between prescription bifocals and drugstore reading glasses depending on their budget and needs. (Frieden, MedPage today, 19/10; Anthes, New York Times, 10/20; Fernandez, Axes, 19/10; Perrone, PA/ PBS, 10/19)

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