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Hearing aids can give hearing impaired people a better quality of life. For people who have mild to moderate hearing loss, the devices can enhance people’s communication by making speech and the sounds around them louder.
Now, a new proposal could make hearing aids over-the-counter and readily available to those people who need them, according to a news release from the US Food and Drug Administration (FDA).
“The new regulatory category will provide the public with greater control over their hearing aid purchasing decisions at stores nationwide or online without the need for a professional hearing exam, fitting adjustment or a prescription,” acting FDA Commissioner Janet Woodcock, M.D. said in the news release.
Seniors will benefit from the new hearing aid proposal
While most people view loss of hearing as part of the aging process, it doesn’t have to incapacitate people. Hearing loss has actually been linked to cognitive decline and other issues in seniors like insecurity and isolation according to National Public Radio (NPR).
“The greater the hearing loss, the greater the risk of loss of thinking and memory abilities over time,” Dr. Frank Lin, a researcher at the Johns Hopkins University School of Medicine, told NPR.
But seniors are just one part of the approximately 15 percent of Americans over the age of 18 who have experienced difficulty hearing, according to the FDA. But only one-fifth of the people who could benefit from this hearing technology receive it,
This is largely due to financial concerns – currently hearing aids cost more than $5,000 – or lack of access to audiologists, reported The Washington Post. The cost of hearing aids is usually not covered by Medicare or other insurers. This directly impacts seniors living on fixed incomes.
How the new regulations will encourage hearing aid innovation
For years, the FDA regulated hearing aids as prescription medical devices, something that added to the cost. A change in regulations could lead to more competition and therefore more innovative designs along with lower prices, allowing more people to purchase these life-changing devices. It will also help regulate unlicensed companies that bypass the FDA by selling personal amplification products.
The proposed changes were five years in the making. In fact, in 2015, the President’s Council of Advisors on Science and Technology recommended that the FDA recognize a new category of basic hearing aids that could be purchased without a prescription.
The Over-the-Counter Hearing Aid Act of 2017 was signed into law two years later and gave the FDA three years to implement it. Although the original deadline was missed, an executive order was signed in July 2021 that spurred the FDA to act.
Reducing health care costs for everyone in America is a top priority,” said Health and Human Services Secretary Xavier Becerra in a statement. “Today’s move by [the]FDA takes us one step closer to the goal of making hearing aids more accessible and affordable for the tens of millions of people who experience mild to moderate hearing loss.” This is very welcome news!
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