Matthew Perrone | Associated Press
On Tuesday, health regulators unveiled their proposal to allow Americans to buy hearing aids without a prescription. This is a long-awaited step to make devices more accessible to millions of people with hearing problems.
The FDA said the proposed rule would reduce the red tape that currently requires hearing and prescription testing for people with mild to moderate hearing loss. According to the plan, the devices could be ordered online or purchased without a prescription from pharmacies and other retail stores.
The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and more affordable.
According to the FDA, more than 37 million Americans, or 15% of the adult population, have hearing problems, but only about one-fifth of people who may benefit from a hearing aid use hearing aids.
Cost is a big hurdle. In addition to the device itself and fitting services, Americans can pay over $ 5,000 for a hearing aid. Coverage is very limited and Medicare does not pay for hearing aids, it only pays for diagnostic tests.
US officials said on Tuesday that the FDA change, when completed, should stimulate competition and lower prices.
“Today we are opening the door to an easier and more accessible process,” Secretary of Health and Human Services Xavier Becerra told reporters.
The agency will consider public comments on its proposal within 90 days before finalizing the new rules. FDA officials have not speculated on when the new devices will actually hit store shelves.
Consumer electronics companies have made low-cost “personal amplification” devices for years, but US law prohibits them from being sold as hearing aids, and they do not pass FDA approval. On Tuesday, regulators said the new regulation will clearly state that these devices are not an alternative to FDA-tested hearing aids. Companies that sell them inappropriately can face federal sanctions such as fines or product confiscations.
For their part, hearing aid manufacturers have long argued that it takes professional experience to properly select a device and adjust its settings to function properly.
As soon as FDA regulations go into effect, traditional manufacturers are expected to start selling cheaper models to direct consumers. Over time, proponents predict that the hearing aid market will resemble ophthalmology, where consumers will be able to choose between reading glasses at the pharmacy or prescription bifocals.
The softer rules will not apply to devices for people with severe hearing loss or for children. In addition, the agency said over-the-counter devices would require volume restrictions and other measures to prevent injury.
Companies that make over-the-counter hearing aids are generally not required to conduct human studies. Instead, they will file applications with the FDA showing that they meet its device standards.
Tuesday’s announcement follows recommendations from medical committees and Congress, which in 2017 instructed the agency to develop a plan to launch over-the-counter hearing aids by August 2020. The agency missed this deadline, in part due to the workload associated with COVID-19. pandemic. In addition, an executive order from President Joe Biden earlier this year mandated the agency to take action no later than mid-November.
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