WASHINGTON — Millions of Americans will be able to buy hearing aids without a prescription later this fall, under a long-awaited rule finalized Tuesday.
The Food and Drug Administration said the new regulation cuts red tape by creating a new class of hearing aids that don’t require a medical exam, a prescription and other specialty evaluations. Instead the devices will be sold online or over-the-counter at pharmacies and other retail stores.
The devices are intended for adults with mild to moderate hearing problems. The FDA estimates that nearly 30 million adults could potentially benefit from hearing aid use, but only about one-fifth of people with hearing problems use the devices currently. The FDA first proposed the rule last October. The new rule will take effect in mid-October.
Massachusetts Sen. Elizabeth Warren teamed up with Iowa Republican Sen. Chuck Grassley to pass the bipartisan “Over-the-Counter Hearing Aid Act” in 2017, which got the FDA process started.
“A HISTORIC day for Americans,” Warren posted to Facebook. “It took years of hard work, but I’m glad that millions of Americans-many of whom aren’t using hearing aids because they are too expensive-will soon be able to buy safe and affordable hearing aids over the counter.”
Biden administration officials highlighted the potential cost savings.
“Today’s action by the FDA represents a significant milestone in making hearing aids more cost-effective and accessible,” Health and Human Services Secretary Xavier Becerra, said in a statement.
The move follows years of pressure from medical experts and consumer advocates to make the devices cheaper and easier to get.
Cost is a big obstacle now. Between the device itself and fitting services, Americans can pay more than $5,000 to get a hearing aid. Insurance coverage is very limited, and Medicare doesn’t pay for hearing aids, only diagnostic tests.
The new over-the-counter status won’t apply to devices for more severe hearing loss, which will remain prescription only.
Consumer electronic companies for years have produced lower-cost “personal sound amplification” devices, but U.S. regulations bar them from being marketed as hearing aids and they do not undergo FDA review. The new rule makes explicit that those devices are not alternatives to FDA-vetted hearing aids. Companies that market them inappropriately could face penalties, such as fines or product seizures.
The FDA said it changed several parts of its initial proposal in response to public comments, including clarifying how the federal rule will impact state regulations on hearing aids.
Once the federal rule takes effect, traditional manufacturers are expected to begin selling cheaper, direct-to-consumer models.
Eventually, advocates predict the hearing aid market will resemble eye care, where consumers can choose between drugstore reading glasses or prescription bifocals.
Tuesday’s announcement follows prodding from medical committees and Congress, which in 2017 instructed the agency to lay out a plan for over-the-counter hearing devices.
Dustin Feldman of Chelsea told WBZ-TV he uses an audiogram due to bilateral profound hearing loss. The 32-year-old is a pro at lip reading.
“Without my hearing aids I don’t hear too much. I can’t hear high pitches, bells whistles, alarms, a baby crying. Most female high pitched voices,” Feldman said.
Feldman has worn hearing aids since he was five years old. His latest pair came with a $6,000 price tag.
“That’s why this moment, today, this news, is so big for so many people,” Feldman said.
Dr. Meaghan Reed of Mass Eye and Ear said the move announced Tuesday is critical.
“Making things just more readily available can help reduce the stigma of hearing health care,” Reed said.
And for people like Feldman, that is something to celebrate.
“People will buy those hearing aids with pride and excitement. Not ‘I have to buy that, or I’ve got to buy that.’ No. ‘I get to buy that! I get to do these things!'” Feldman said.
The over the counter devices are intended for adults 18 and older with mild to moderate hearing issues. Patients and providers agree this is an exciting and important first step.
“There’s a lot of noise in this industry right now. Pun intended. It’s for the better,” Feldman said.