After a period of two months, Americans will be able to purchase hearing devices that treat mild to moderate hearing problems directly from stores without requiring a prescription, the US health authorities announced Tuesday.
This step is supposed to enhance competition among manufacturers of these devices with the aim of stimulating innovation and lowering prices, according to the authorities.
During its work on this new decision, the Food and Drug Administration (FDA) created a new class of products that people over the age of 18 can purchase without the obligation to undergo a medical examination (hearing test) or modifications to the devices from a hearing orthopedic therapist.
The decision will enter into force within sixty days.
The average price of a pair of hearing aids in the United States is $5,000, and insurance providers usually don’t cover the costs.
The White House believed that this measure would lead to a decrease in the prices of the devices by about 2,800 dollars per device.
“As of mid-October, Americans will be able to purchase affordable hearing devices directly from pharmacies or stores across the country,” President Joe Biden said in a statement.
It is assumed that these devices respect the standard of size, as their size should not exceed a certain size in order to avoid any injury to their users during their placement, and the standard of depth that the devices need to be installed inside the patient’s ears will also be taken into consideration.
As for devices designed to treat major hearing problems and those intended for children, the purchaser will still be required to possess a prescription.
The FDA notes that about 15% of American adults, or more than 37 million people, have hearing problems.
“Hearing problems dramatically affect millions of Americans’ daily communication, social interactions, health and lives,” FDA President Robert Califf told a news conference, adding that his wife could be one of the first customers to buy this class of devices.
Hearing problems are recorded in people as a result of several factors, including aging, loud noises, or other medical reasons.
The FDA stressed that these headphones should not be confused with hearing aids, and that the difference will be clearly defined between the two products. Hearing aids are used by people without hearing problems, for example for activities such as hunting.
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