Within two months, hearing aids for mild to moderate hearing problems will be available directly from stores without a prescription in the United States, the country’s health authorities announced Tuesday, August 16.
According to the authorities, this decision should encourage competition between manufacturers to stimulate innovation and bring down the price of these devices.
The (FDA) has concluded this new regulation creating a new category of products, which can be sold to people over 18 years without medical examination (hearing test) or adjustments with a hearing care professional. It will take effect in 60 days.
Hearing aids indeed cost an average of 5,000 USD per pair in the country, and above all, they are often not covered by health insurance.
President Biden estimates that this action will reduce the cost of a pair of hearing aids by about $2,800.
“Starting in mid-October, Americans will be able to buy more affordable hearing aids directly from pharmacies and stores across the country,” President Joe Biden said in a statement.
All of these self-service devices will have volume limits to prevent injury to the people using them. There is also a limit on the depth to which they can be inserted into the ear.
Devices designed for more severe hearing problems or for children will remain prescription-only.
According to the FDA, about 15 percent of U.S. adults, or more than 37 million people, report having hearing problems.
“Hearing loss has a profound impact on daily communication, social interaction, and the health and quality of life of millions of Americans,” FDA chief Robert Califf told a news conference, adding that his wife could be one of the first customers for this category of devices.
Hearing loss can be caused by various factors, such as aging, exposure to loud sounds or other medical reasons.
The FDA emphasized that these hearing aids should not be confused with assistive listening devices and that the difference between the two products should be specified. Listening amplifiers are intended for people without hearing problems, for example for activities such as hunting.
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