(Washington) US health officials said on Tuesday they wanted to allow the purchase of hearing aids directly in stores or online, without a doctor’s prescription, for people with mild to moderate hearing loss.
The American Medicines Agency (FDA) has published new regulations to create this new category of products, which can be sold without a medical examination (hearing test) or adjustments with a hearing care professional. After a period of mandatory public debate, the regulations will be finalized.
More accessible, less expensive
The goal is to “make hearing aids more accessible, more affordable, for tens of millions of people,” said US Minister of Health Xavier Becerra at a press conference.
About 15% of American adults, or more than 37 million people, report having hearing problems, according to the FDA.
These over-the-counter devices must respect volume limits to prevent people using them from injuring themselves. There is also a limit on the depth at which they can be inserted.
Hearing aids intended for minors or people with severe hearing loss will always have to be prescribed.
The FDA hopes that this measure will encourage innovation and competition between manufacturers, through easier access to this market, with a view to lowering prices.
Hearing aids cost an average of $ 5,000 (C $ 6,178) a pair in the United States, the White House noted in July, and are often not reimbursed by health insurance. Four groups control 84% of the market.
Hearing loss can be caused by different factors, such as aging, exposure to loud sounds, or other medical reasons.
“It can have significant consequences for communication with others, personal relationships, job performance or emotional health,” said Acting FDA Chief Janet Woodcock.
The agency stressed that these hearing aids should not be confused with listening amplifiers and that the difference would be well specified between the two products.
“Personal sound amplifiers are aimed at people with normal hearing, amplifying sounds in certain environments, for hunting or for other hobbies, such as bird watching,” said Jeff Shuren of the FDA.