Home ›› 19 Oct 2021 ›› World Biz
US health authorities on Tuesday proposed creating a new category of non-prescription hearing aids for people with mild to moderate hearing loss.
The proposal aims to make "hearing aids more accessible and affordable for ... tens of millions of people," Health and Human Services Secretary Xavier Becerra said in a statement.
The proposed reform will allow for hearing aids to be sold directly to consumers in stores or online without a medical exam or a fitting by an audiologist, said the Food and Drug Administration.
"The proposed rule is designed to help increase competition in the market while also ensuring the safety and effectiveness of OTC (over-the-counter) and prescription hearing aids," according to the FDA.
About 15 per cent of American adults, or more than 37 million people, report having hearing problems, according to the agency, but only about one-fifth of Americans who could benefit from a hearing aid use one.
Hearing aids cost an average of $5,000 a pair in the US, the White House said in July, and they are often not covered by health insurance. Four groups control 84 per cent of the market.
Hearing loss can be caused by different factors, such as aging, exposure to loud sounds, or other medical reasons.
Hearing aids intended for minors or people with severe hearing loss will still need to be prescribed.
The regulations will be finalized after a period of public debate.
