For the first time ever, hearing aids may now be purchased over-the-counter at retailers nationwide.
It's due to a new FDA rule that went into effect on Monday, allowing adults with perceived mild to moderate hearing impairment to buy hearing aids directly from stores or online retailers without a prescription, medical exam or a fitting adjustment by an audiologist.
The change is also expected to dramatically reduce the cost of hearing aids, by as much as $3,000 per pair.
Some of the retailers now offering OTC hearing aids include Walgreens, Walmart, and Best Buy, with CVS set to join the list next month.
In 2017, Congress passed bipartisan legislation requiring the FDA to create a category of OTC hearing aids, but it was not fully implemented until now.
"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," Health and Human Services Secretary Xavier Becerra said in a statement. "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 on Deafness and Other Communication Disorders. Individuals with permanent hearing impairment can use hearing aids to help make speech and sounds louder, improving the ability to communicate effectively with others.
Experts are calling it a "game changer" in health care, per CNN.
"Hearing loss is a critical public health issue that affects the ability of millions of Americans to effectively communicate in their daily social interactions," FDA Commissioner Robert Califf said in a statement. "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."
The OTC category applies to certain air-conduction hearing aids intended for people 18 years of age and older who have perceived mild to moderate hearing impairment. Hearing aids intended for severe hearing impairment or users younger than age 18 are still considered prescription devices and do not meet the requirements for the OTC category.
The average cost of one hearing aid is approximately $2,000, Dave Fabry, chief innovation officer at hearing aid manufacturer Starkey, told Forbes. Because most people need one for each ear, and depending on the technology used in the hearing aids, a pair could cost between $4,000 to $6,000 out of pocket.
Under the new rule, individuals can now get hearing aids for as low as $200 a pair. The FDA says the move provides significant breathing room for the nearly 30 million Americans with hearing loss, including nearly 10 million adults under age 60.
Related
Related
