The United States will allow the free sale of hearing aids without a prescription and without the need for expensive medical consultations, as announced on Tuesday by the regulator, the Food and Drug Administration (FDA).
It is a measure that has been demanded for a long time by associations of people with hearing problems and that will improve access to these devices.
The new regulation, which takes effect in two months, is expected to make hearing aids cheaper in two ways.
On the one hand, saving those affected by moderate or slight deafness the costly medical consultations now required.
On the other hand, promoting competition and innovation among manufacturers, who will be able to sell through any channel, including the Internet, and not depend only on winning the favor of the ENT doctor to prescribe their products.
The president of the United States, Joe Biden, who promoted the measure, has celebrated the decision: “For millions of Americans, hearing aids and the visit to the doctor to have them prescribed are too expensive.
In the executive order I issued last year to increase competition in key industries and reduce costs, I asked the FDA to finally make hearing aids available over the counter," he said in a statement.
The FDA estimates that about 30 million Americans can benefit from hearing aids, but many of them don't because of the cost, both of the device itself and of the medical exam, prescription and fitting by an ENT doctor, services not normally covered by health insurance.
Among adults age 70 and older with hearing loss who could benefit from hearing aids, fewer than one in three (30%) have ever used them, according to studies referred to by the FDA.
Even fewer adults aged 20 to 69 (approximately 16%) who would need them have come to use them.
Hearing loss among the elderly can lead to cognitive decline, depression, isolation, and other problems.
more competition
“Americans,” says Biden, “will be able to buy more affordable hearing aids without a prescription at pharmacies and stores across the country.
This action delivers on my commitment to lower costs for American families by providing nearly $3,000 in savings to American families on a pair of hearing aids and giving people more choices to improve their health and well-being."
According to the FDA, the rule is designed to ensure the safety and effectiveness of over-the-counter hearing aids, while also seeking to stimulate competition and innovation by providing consumers with mild-to-moderate hearing loss "better access to hearing aids." that meet their needs and are less expensive than current options,” says the regulator.
”When very few companies dominate, American consumers pay higher costs.
We are finally building an economy that works for working families,” says the president.
The category established in the standard applies to certain hearing aids intended for use by persons 18 years of age or older who have mild to moderate hearing loss.
Hearing aids that do not qualify for that category (for example, because they are intended for severe hearing impairment or users under the age of 18) will still require a prescription.
The FDA also regulates in detail the requirements that hearing aids must meet and to which manufacturers will have to adapt.
This will make it possible to clarify the differences between medical devices and other consumer products that function as sound amplifiers.
