There is good news for deaf Americans.
Hearing aids, which used to require a prescription and often had high costs and many complications, are now sold without a prescription from a professional.
Over-the-counter (OTC) hearing aids began to hit the market in October.
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Notably, the prices of these OTC devices can be thousands of dollars less than prescription hearing aids, the Associated Press reports.
According to the Food and Drug Administration (FDA), approximately 30 million people in the United States have hearing loss.
Earlier this year, the FDA issued a proposal to provide over-the-counter hearing aids. Today, nearly 30 million people in the United States suffer from hearing loss, and many are now buying over-the-counter devices to help.
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However, only 20% of those who can use a hearing aid seek help (for various reasons).
Here are more details.
Help for mild to moderate hearing loss
In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids — but it wasn’t fully implemented until August 2022, according to the FDA, which shares information on the topic on its website.
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On August 16, 2022, the FDA established 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 online retailers with a medical exam, prescription, or fit by an audiologist.” correction,” the FDA said.
This category includes people who have trouble hearing phone calls or turn up the TV volume to the point that others complain.
Adults who fall into this category are those who have trouble hearing phone calls or turn up the TV so loud that others complain, the AP noted.
This group also includes those who find it difficult to follow 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.
(REUTERS/Heinz-Peter Bade)
However, OTC hearing aids are not intended for people with more profound hearing loss.
This can include people who have trouble hearing louder sounds, such as power tools and cars, the AP said.
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According to Sterling Sheffield, an audiologist who teaches at the University of Florida, AP reports, these OTC hearing aids are not for people who have lost hearing suddenly or in just one ear.
Those people should consult a doctor.
Anyone can still see a professional for a hearing test, which is often covered by insurance; then people can buy their own hearing aids.
Previously, people with hearing loss had to have their hearing tested and then get hearing aids through a professional.
Now that’s no longer the case.
But it can be difficult for people to measure their own hearing, the AP noted.
Some over-the-counter vendors offer a hearing evaluation or online test for anyone who requests it.
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Anyone can still see a specialist for this test, which is often covered by insurance; then people can buy their own hearing aids.
People should check the specifics of their insurance coverage before making an appointment.
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Some over-the-counter vendors offer a hearing evaluation or online test, AP said.
Who sells what?
Several major retailers now sell OTC hearing aids both on store shelves and online.
All told, more than a dozen manufacturers now produce different models of OTC hearing aids.
For example, Walgreens drugstores nationwide sell Lexie Lumen hearing aids for $799.
The Walgreens website states that Lexie Lumen Bluetooth-enabled OTC hearing aids are “customizable” to an individual’s hearing profile.
Walmart offers OTC hearing aids that range from about $200 to $1,000 per pair (health centers will provide hearing tests), the same source noted.
The FDA noted that the new category of OTC hearing aids “applies to certain air conduction hearing aids intended for people 18 years of age and older with mild to moderate hearing loss.”
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In addition, consumer electronics chain Best Buy has OTC hearing aids available online and in nearly 300 stores.
The company also offers online hearing evaluations — and store employees are trained on the stages of hearing loss and how to fit devices.
And the prices?
All told, more than a dozen manufacturers now produce different models of OTC hearing aids.
According to the AP report, most OTC hearing aids will cost between $500 and $1,500 per pair.
The final version of the FDA rule came after a notice and comment period that drew more than 1,000 public comments.
Some can cost as much as $3,000, AP said.
Also, these costs are not one-time. They may need to be replaced every five years.
More information on developments
In July 2021, President Biden issued an Executive Order to Promote Competition in the American Economy, which required the Secretary of Health and Human Services (HHS) to publish a “proposed rule on over-the-counter hearing aids.”
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“This is the latest step in making our economy more competitive and less concentrated,” Biden said in a statement at the time.
According to the Associated Press, Walgreens pharmacies are selling over-the-counter Lexie Lumen hearing aids nationwide for $799.
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The final version of the FDA rule came after a notice and comment period that drew more than 1,000 public comments.
The FDA said these comments came from hearing aid manufacturers and consumers, as well as professional associations, lawmakers and government agencies.
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This resulted in changes to the proposed rule, such as lowering the maximum sound output for OTC hearing aids and requiring adjustable volume controls.
The FDA said the rule will go into effect in mid-October, and Americans will be able to find the hearing aids at drugstores and other retailers, including online.
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The FDA noted that the new category of OTC devices “applies to certain air conduction hearing aids intended for people 18 years of age and older with mild to moderate hearing loss.”
Anything else – whether it’s a different type of aid or for someone younger – still requires a prescription.
Fox News Digital’s Ronn Blitzer, as well as The Associated Press, contributed reporting to this article.