The U.S. Food and Drug Administration has ruled that adults with mild-to-moderate hearing loss can now buy hearing aids over the counter, without needing to get a prescription, medical exam or audiologist fitting.
The hearing aids will also cost thousands of dollars less, according to the White House, with the savings estimated to be $1,400 per individual hearing aid, or over $2,800 per pair.
The Ruling Has Been In The Works For A While
This ruling was finalized back in August as part of President Biden’s 2021 Executive Order on Promoting Competition in the American Economy, as well as ensuring the safety and effectiveness of OTC hearing aids. Biden gave the FDA a 120-day deadline for action.
Previously, Congress had passed legislation on over-the-counter hearing aids in 2017, but it was not fully implemented until the FDA ruling.
“Reducing health care costs in America has been a priority of mine since Day One and this rule is expected to help us achieve quality, affordable health care access for millions of Americans in need,” said Health and Human Services Secretary Xavier Becerra at at the time of ruling. “Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible.”
Close to 30 million adults in the U.S. could benefit from hearing aid use, according to the National Institute of Deafness and Other Communication Disorders, which notes that approximately 15% of American adults (37.5 million) aged 18 and over report some trouble hearing.
The devices are worn inside the ear or on the ear, with an inside-the-ear component that amplifies sound into the ear canal. These devices have sound limits in order to prevent further hearing loss, as reported by ABC News.
“The new over-the-counter category applies to certain air conduction hearing aids, intended for adults aged 18 and older who have perceived mild-to-moderate hearing loss,” Dr. Jeffrey Shuren, director of the FDA's Center for Devices and Radiological Health, said at the August briefing. “Hearing aids for severe hearing loss or for users younger than age 18 will be prescription devices, to assure patient safety as well as effectiveness.”
Walgreens, Best Buy Plan To Carry Over-The-Counter Hearing Aids
People who have been waiting for the rule will not have to look far for the device, as many major retail chains already have plans to stock the devices.
As of this month, Walgreens (WBA) is selling hearing aids in stores and online for $799 a pair, while CVS (CVSGF) has begun selling them online at different price points, and Best Buy (BBY) plans to offer nearly 20 hearing devices online and at nearly 300 stores by the end of the October for as low as $200, as noted by The Hill.
Walmart (WMT) and Sam’s Club also plan to offer many locations for between $199 and $999 per pair.
“A person's 'whole health' is a combination of many factors, including hearing, that influence physical and mental well-being,” Walmart's chief medical officer, Dr. John Wigneswaran, said in a statement. “Offering easy access to OTC hearing aids — something that seems quite small — is a solution that can improve our customer’s health outcomes and their ability to live better and healthier.”