The Food and Drug Administration moved on Tuesday to make hearing aids available over the counter and without a prescription to adults.
People with mild to moderate hearing loss will be able to buy hearing aids online and in retail stores without having to go to a doctor's office.
According to the F.D.A., 30 million Americans experience hearing loss, but only about 20% of them get help. The changes could upend the market, which is dominated by a relatively small number of manufacturers, and make it a broader field with less expensive and more innovative designs. Current costs for hearing aids, which tend to include visits with an audiologist, range from about $1,400 at Costco to about $4,700 at other places.
Nicholas Reed said that this could change technology. We don't know what these companies are going to do. We can see how hearing aids work.
The final rule of the F.D.A. will take effect within 60 days. Some device makers may need time to update packaging or comply with technical details in the rule, but they are mostly ready to launch new products, according to industry representatives.
The rule tackles a critical public health issue that affects millions.
People with mild to moderate hearing loss will be able to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.
Older adults with hearing loss are more likely to suffer from health problems. There are costs that are not covered by Medicare that make it hard to get hearing help. Stigma, such as appearing "old", can be used.
A recent survey found that people over the age of 50 were twice as likely to take their pet to the vet than to have their hearing checked.
The lead author of the study said it broke her heart. Ensuring that people understand that hearing is important is one of the biggest challenges as a profession and as a health care system. It needs their attention and action.
For a long time, the change has been percolating. There was a proposal for the F.D.A. to approve over-the-counter hearing aids for people with mild to moderate hearing loss. The agency was given the power to make the change that was signed into law by the senators.
Since then, the process to finalize regulations has moved slowly, with some conflict over details, like how the federal rule would interact with state laws on hearing aid returns or warrantee policies.
A call for the rule to promote the wide availability of low-cost hearing aids was included in an executive order by President Biden.
The rule was made public in the fall. The Hearing Industries Association warned the F.D.A. about hearing aids that were poor quality and dangerous after the initial law passed. The advice was given on how to avoid a scenario again.
Kate Carr, president of the trade group, applauds the action to increase access to care for persons who have difficulty and encourages them to seek a professional. The F.D.A. would be creating a safety issue if it allowed hearing aid makers to make devices that allow users to hear loud sounds.
The hearing aid makers were accused of engaging in an "astroturf lobbying" effort by flooding the F.D.A. with repetitive comments that would be "less effective, protecting manufacturers".
The report said that the less effective an O.T.C. hearing aid is, the more likely consumers will be forced to abandon these options and instead opt for more expensive, prescription devices.
The F.D.A. made a few changes to the final version of the rule after reviewing more than 1000 comments. The maximum sound output of the devices is being lowered. The rule requires that the hearing aids have simplified wording on their labels.
All Rights Reserved © 2024
