Millions of Americans will have access to this fall to less expensive hearing aids sold over the counter without a required doctor exam and prescription.
A Food and Drug Administration rules unveiled Tuesday allows retail sales of hearing aids by mid-October for people with mild to moderate hearing loss. Regulators said the new rule should give millions of consumers less expensive options and broaden access for those who can’t afford hearing aids, some of which cost several thousand dollars.
“Today the FDA opens the door to quality, affordable hearing aids to consumers over the counter,’ said Department of Health and Human Services Secretary Xavier Becerra. “For many Americans who suffer from hearing loss, safe and effective and high quality hearing aid have been unaffordable.”
Nearly 30 million million adults have trouble hearing, but only about 1 in 5 people with hearing loss use a hearing aid. Aging, exposure to loud noises, medical conditions and other factors contribute to hearing loss. Hearing aids can help make speech and sounds louder and allow people to better communicate.
The agency estimates the new rule would save consumers about $1,400 for a single hearing aid or $2,800 for a pair, officials said.
The rule does not extend to children or adults with more severe types of hearing loss. People should seek medical care if they have more complex conditions, such as ear deformities or symptoms such as discomfort or bleeding, officials said.
The agency made changes from a proposed rule last October based on public comments from consumers and hearing experts. The final rule requires retail hearing aids to lower maximum sound and to include a user-adjustable volume control. The final rule also limits how deep the devices can be placed in the ear canal. Manufacturers must meet performance and device design requirements in order to sell the devices directly to consumers.
The rule comes five years after Congress passed the Over-the-Counter Hearing Aid Act, directing the FDA to authorize the sale of over-the-counter hearing aids. In July 2021, President Joe Biden’s executive order called for the FDA to issue a proposed rule within 120 days to allow over-the-counter sales of the product.
“Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions,” said FDA Commissioner Robert M. Califf. “Establishing this new regulatory category will allow people with perceived mild to moderate hearing loss to have convenient access to an array of safe, effective and affordable hearing aids from their neighborhood store or online.”
While the new rule could provide affordable options for millions of people with hearing loss, some urged consumers to be careful.
The Hearing Industries Association, which represents hearing aid manufacturers, suppliers and hearing health professionals, said hearing loss is “unique to each person, and most do not know if their condition is mild, moderate, or greater, caused by another medical issue or something as simple as ear wax.”
“A hearing professional will perform a hearing exam, determine the cause and severity of the hearing loss, and advise the individual on the options available and the cost,” the association said in a statement.
Ken Alltucker is on Twitter as @kalltucker or can be emailed at [email protected].
George is Digismak’s reported cum editor with 13 years of experience in Journalism