A final rule issued by the U.S. Food and Drug Administration on Tuesday will allow adults with perceived mild to moderate hearing impairment to purchase hearing aids directly from stores, pharmacies and online retailers.
As soon as mid-Octobers, adults with perceived mild to moderate hearing impairment will be able to buy hearing aids without prescriptions from doctors or without seeing an audiologist, as per NPR.
The new ruling is set to effect in two months. This comes after years of campaigning by lawmakers and advocates.
New Ruling Creates Over-the-Counter Hearing Aids Category
With the new ruling, a new category of over-the-counter hearing aids will be created. According to the Biden administration, this will make the devices more accessible and affordable for millions of Americans.
According to White House National Economic Council director Brian Deese, it is estimated that about $2,800 per pair of hearing aids could be saved by the consumers, as per Reuters.
The Congress passed a legislation in 2017 asking the FDA to make a category of over-the-counter hearing aids. However, the ruling was not fully implemented.
President Joe Biden signed a broad competition executive order in June 2021, which requested the Health and Human Services Department to "promote the wide availability of low-cost hearing aids."
According to Hearing Industries Association, the one representing hearing aid manufacturers, suppliers, distributors and hearing health professionals, new rule will be beneficial to millions of Americans
The new rule of FDA will "expand access to hearing aids among the estimated 38 million Americans who have perceived mild to moderate hearing loss," said the Hearing Industries Association.
Meanwhile, the final rule was "good news for consumers" according to Republican Senator Chuck Grassley. He said that the measure would "lower prices" and result in "more competition."
Read Also: Why are Bluetooth Hearing Aids Getting More Popular Today?
FDA Works With Manufacturers to Ensure Devices are of Good Quality
According to NPR, the new rule of FDA covers only particular air-conduction hearing aids for those who are ages 18 and older who have mild to moderate hearing impairment.
This only means that hearing aids intended for pediatric use or severe hearing impairment will still require prescription from doctors.
The rule also does not apply to "personal sound amplification products," or "consumer products that help people with normal hearing amplify sounds."
Hearing loss has been a causing a struggle for those who are experiencing it. Aside from complicating communication, it can contribute to social isolation.
There are also studies that links it to walking problems, falls, dementia and depression.
According to the FDA, around 30 million U.S. adults could potentially benefit from hearing aid use. However, data said that only about 14% of Americans with hearing loss actually use hearing aids.
The high cost of hearing aids and exams has been affecting many people. The price of the devices usually ranges from $1,000 to $6,000 per ear. In addition, and consumers need to spend additional money getting examined by a specialist.
With the new rule, the Biden administration estimates that the cost of hearing aids would be lowered by hundreds or even thousands of dollars.
On a press call, FDA Commissioner Robert Califf told reporters that the agency is working with manufacturers to make sure that the over-the-counter devices are of "good quality" and "meet the agency's performance criteria."
Related Article: Apple Creates Special Hearing Aids For iPhone And iPad
