There is good news for hearing-impaired Americans.
Hearing aids – once requiring a prescription and often accompanied by a high price and many complications – are now sold without a prescription from a specialist.
Over-the-counter (OTC) hearing aids began hitting the market in October.
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Notably, prices for these over-the-counter devices can be thousands of dollars lower than prescription hearing aids, the Associated Press reported.
Some 30 million people in the United States have hearing loss, according to the Food and Drug Administration (FDA).
Earlier this year, the FDA released a proposal to provide over-the-counter hearing aids. Today, some 30 million people in the United States have hearing loss – and many are now buying over-the-counter devices to help them.
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Even so, only about 20% of those who could use a hearing aid seek help (for a variety of reasons).
Here are more details.
Help for mild to moderate hearing loss
Congress passed bipartisan legislation in 2017 requiring the FDA to create a category of over-the-counter hearing aids — but it wasn’t fully implemented until August 2022, according to the FDA, which shares information on this. topic on its website.
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On August 16, 2022, the FDA created a new category of over-the-counter (OTC) hearing aids – “allowing consumers with mild to moderate hearing loss to purchase hearing aids directly from stores or retailers in online without the need for a medical exam, prescription, or adjustment by an audiologist,” the FDA noted.
This category includes people who have trouble hearing phone calls or turn up the volume on the TV loud enough to make others complain.
The adults included in this category are people who have trouble hearing phone calls or turn up the volume on the TV loud enough to cause others to complain, the AP noted.
This group also included those who have difficulty following group conversations in noisy places.
An employee of GN, the world’s fourth largest hearing aid manufacturer, demonstrates the use of ReSound LiNX in Vienna in November 2013.
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However, OTC hearing aids are not intended for people with more profound hearing loss.
That can include people who have trouble hearing louder noises, like power tools and cars, the AP said.
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These over-the-counter hearing aids are also not for people who have lost their hearing suddenly or in one ear, according to Sterling Sheffield, an audiologist who teaches at the University of Florida, as reported by the AP. .
These people should see a doctor.
Anyone can always choose to see a specialist for a hearing test, which is often covered by insurance; then people can buy hearing aids themselves.
Previously, people with hearing problems had to have their hearing tested and then purchase hearing aids through a specialist.
It is not the case anymore.
But it can be difficult for people to assess their own hearing, the AP noted.
Some over-the-counter vendors offer a hearing assessment or test online to anyone who wants one.
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Anyone can always choose to see a specialist for this test, which insurance often covers; then people can buy hearing aids themselves.
People should check their insurance cover details before making an appointment.
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Some over-the-counter vendors provide a hearing assessment or test online, the AP said.
Who sells what?
Several major retailers now sell OTC hearing aids both on store shelves and online.
In total, more than a dozen manufacturers now manufacture different models of OTC hearing aids.
Walgreens pharmacies, for example, sell Lexie Lumen hearing aids nationwide for $799, according to the AP.
The Walgreens website reports that Lexie Lumen Bluetooth-enabled OTC hearing aids “can be personalized” to an individual’s hearing profile.
Walmart offers over-the-counter hearing aids ranging from around $200 to $1,000 a pair (its health centers will provide hearing tests), the same source also noted.
The FDA clarified that the new category of OTC hearing aids “applies to certain air conduction hearing aids intended for individuals 18 years of age and older who have mild to moderate perceived hearing impairment.”
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Additionally, consumer electronics chain Best Buy has OTC hearing aids available online and in nearly 300 stores.
The company also offers an online hearing assessment – and store employees are trained in the stages of hearing loss and how to fit the devices.
What about prices?
In total, more than a dozen manufacturers now manufacture different models of OTC hearing aids.
Most over-the-counter hearing aids will cost between $500 and $1,500 for a pair, according to AP reports.
The FDA’s final version of the rule came after a notice-and-comment period that elicited more than 1,000 public comments.
Some can cost up to $3,000, the AP said.
Moreover, these expenses are not one-time. They may need to be replaced every five years or so.
More information on the developments
In July 2021, President Biden issued an Executive Order on Promoting Competition in the U.S. Economy, which specifically stated that the Secretary of Health and Human Services (HHS) should issue “a proposed rule on aids over-the-counter hearing aids.
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Biden said in a statement at the time, “This is the latest step we are taking to make our economy more competitive and less concentrated.”
Walgreens pharmacies sell over-the-counter Lexie Lumen hearing aids nationwide for $799, according to The Associated Press.
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The FDA’s final version of the rule came after a notice-and-comment period that elicited more than 1,000 public comments.
These comments came from hearing aid manufacturers and consumers, as well as professional associations, legislators and state agencies, the FDA said.
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This resulted in changes to the proposed rule, such as reducing the maximum sound output for over-the-counter hearing aids and requiring an adjustable volume control.
The FDA said the rule would go into effect in mid-October and Americans could find over-the-counter hearing aids at pharmacies and other retail stores, including online.
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The FDA clarified that the new category of OTC devices “applies to certain air conduction hearing aids intended for persons 18 years of age and older who have mild to moderate perceived hearing impairment.”
Anything else – whether a different type of aid or aid for a younger person – would still require a prescription.
Fox News Digital’s Ronn Blitzer and The Associated Press contributed to this article.
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