US regulators lay out plan for over-the-counter hearing aids
3 years, 5 months ago

US regulators lay out plan for over-the-counter hearing aids

Associated Press  

WASHINGTON — Health regulators on Tuesday unveiled their proposal to allow Americans to buy hearing aids without a prescription, a long-awaited move intended to make the devices more accessible to millions of people with hearing problems. Consumer electronic companies for years have produced lower-cost “personal sound amplification” devices, but U.S. regulations bar them from being marketed as hearing aids and they do not undergo FDA review. Regulators said Tuesday that the new rules will make explicit that those devices are not alternatives to FDA-vetted hearing aids. Companies making over-the-counter hearing aids generally wouldn’t be required to conduct studies in people. Tuesday’s announcement follows prodding from medical committees and Congress, which in 2017 instructed the agency to lay out a plan for over-the-counter hearing devices by August 2020.

Hearing Devices Fda Aids  hearing  rules  regulators  agency  prescription  devices  medical  required  plan  overthecounter  aids  fda  lay

History of this topic

Apple’s new AirPods are also hearing aids. Can they really save you thousands of dollars?
6 months, 3 weeks ago

Apple’s new AirPods are also hearing aids. Can they really save you thousands of dollars?

CNN  

CNN — During its glossy product announcement event on Tuesday, Apple unveiled a new role for its latest AirPods Pro model: medical device. “We’re adding this groundbreaking capability to help more than 1 billion people living with mild to moderate hearing loss,” said Sumbul Ahmad Desai, Apple’s vice president of health. Over-the-counter hearing aids, such as Apple’s offering, also are …

The Best Over-the-Counter Hearing Aids
9 months ago

The Best Over-the-Counter Hearing Aids

Wired  

In 2022, the US Food and Drug Administration approved the sale of over-the-counter hearing aids to supplement traditional prescription options, increasing accessibility and affordability for millions of Americans affected by untreated hearing loss. I wore each of them personally for an extended period to gauge sound quality, ease of use, and overall comfort, putting over 20 OTC hearing aids to …

FDA change ushers in cheaper, easier-to-get hearing aids
2 years, 3 months ago

FDA change ushers in cheaper, easier-to-get hearing aids

Associated Press  

It’s now a lot easier — and cheaper — for many hard-of-hearing Americans to get help. Here’s a closer look: WHO MIGHT BE HELPED The FDA approved OTC hearing aids for adults with mild-to-moderate hearing loss. OTC hearing aids aren’t intended for people with deeper hearing loss, which may include those who have trouble hearing louder noises, like power tools …

Over-The-Counter Hearing Aids: Disability Experts Weigh Benefits And Concerns
2 years, 5 months ago

Over-The-Counter Hearing Aids: Disability Experts Weigh Benefits And Concerns

Huff Post  

LOADING ERROR LOADING The U.S. Food and Drug Administration finalized a ruling Monday that will make hearing aids available over the counter without a prescription or an appointment. “People that want to enhance their hearing, or get back to a level of hearing that they had, if they have mild or moderate hearing loss, that couldn’t afford it in the …

What to know now that hearing aids are available over the counter
2 years, 5 months ago

What to know now that hearing aids are available over the counter

NPR  

What to know now that hearing aids are available over the counter Enlarge this image toggle caption Rick Bowmer/AP Rick Bowmer/AP Starting Monday, hearing aids will be available to buy over the counter across the U.S. People can still get hearing aids by seeing a doctor first, and experts say there are advantages to this option, such as being professionally …

Over-the-counter hearing aids expected this fall in US
2 years, 7 months ago

Over-the-counter hearing aids expected this fall in US

Associated Press  

WASHINGTON — Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday. The regulation creates a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations, the Food and Drug Administration said. “Today’s action by the FDA represents a significant milestone …

The Unintended Consequences of OTC Hearing Aids
2 years, 7 months ago

The Unintended Consequences of OTC Hearing Aids

Wired  

I have nearly 98 percent hearing loss in both ears. In 2017, Congress passed the FDA Reauthorization Act to create a category of OTC hearing aids for adults with perceived mild or moderate hearing loss. Once OTC hearing aids hit the market, they will offer consumers cheaper, accessible, and technologically sophisticated options for improving hearing. But despite these improvements, the …

Is It Time For Hearing Aids To Be Sold Over The Counter?
7 years, 11 months ago

Is It Time For Hearing Aids To Be Sold Over The Counter?

NPR  

Is It Time For Hearing Aids To Be Sold Over The Counter? "It's pretty much a hearing aid," says Liu, except the company isn't allowed to call it that. Sponsor Message The Hearing Loss Association of America, a consumer group, wants Congress to create a new category of aids for people with mild to moderate hearing loss by passing the …

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