The Food and Drug Administration announced Tuesday it will allow the sale of over-the-counter hearing aids without a medical examination or a doctor's referral.
Officials hope the new rule will improve the accessibility and affordability of aids for Americans suffering from hearing loss.
Congress passed the Over-the-Counter Hearing Aid Act, directing the FDA to authorize the sale of over-the-counter hearing aids five years ago, and Biden added pressure with an executive order in 2021.
What does the final rule include? Who is eligible and how much will it cost? Your questions answered.
The FDA's new rule in greater context: FDA allows over-the-counter sales of hearing aids without doctor exam or referral
When will OTC hearing aids be available for purchase?
Where will OTC hearing aids be for sale?
Hearing aids will be available for purchase at pharmacies across the country, as well as some retail stores.
Best Buy announced on Wednesday it plans to participate in the program and make hearing aids available to customers.
In an email, Walgreens confirmed to USA TODAY it plans to participate as well, and "will offer over-the-counter hearing aids later this year nationwide, both in-store and online."
CVS also plans to offer the aids at its pharmacies and online " in the near future," the company said in an email.
More on hearing aids: An alternative to traditional hearing aids
How much will they cost?
It's not yet known how much the over-the-counter devices will cost. Price likely will vary.
Biden estimated consumers could save nearly $3,000 for a pair of hearing aids, which can currently cost up to $5,000.
Do you need health insurance for over-the-counter hearing aids?
No. Over-the-counter medical products don't require a prescription or medical examination and are available to all through retail purchase.
"Despite the high prevalence and public health impact of hearing loss, only about one-fifth of people who could benefit from a hearing aid seek intervention," according to the FDA. The agency adopted the new rule in part because the fitting and purchase of hearing aids is not always covered by insurance, making the cost a burden for many individuals.
What kinds of hearing aids are available?
The rule applies to air-conduction hearing aids, worn behind or inside the ear.
The devices also must have user-adjusted volume controls and a lower maximum sound output. The new rule also has limits on how deep the device can be placed in the ear canal.
Another advancement in accessibility: Why captions are suddenly everywhere and how they got there
How do I know if I need a hearing aid?
The hearing aids available for over-the-counter sale are meant to address mild to moderate hearing loss in people aged 18 or older, the FDA rule specifies.
The CDC defines mild hearing loss as the inability to hear some soft speech sounds and moderate hearing loss as not being able to hear most all speech spoken at a normal level.
If your hearing loss is more severe than this, over-the-counter devices might not be the right choice. For those with severe hearing loss more advanced hearing aids are available with a doctor's recommendation.
This article originally appeared on USA TODAY: OTC hearing aids: What to know about when (and where) you can get them