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FDA clears the way for over-the-counter hearing aids

Hearing aid
Posted at 5:39 PM, Aug 17, 2022
and last updated 2022-08-17 19:39:13-04

DENVER — The U.S. Food and Drug Administration issued a final ruling this week to allow for a new category of over-the-counter hearing aids for consumers.

Consumers would not need a prescription, and the hearing aids would be available for those with mild to moderate hearing loss.

“It sets the skeleton of what we can expect with what over-the-counter hearing aids are going to be available to the public,” said Dr. Sandra Gabbard, president and CEO of the Marion Downs Center and the chair of the American Board of Audiology.

The ruling follows President Joe Biden’s executive order promoting more competition in the economy. It calls for the FDA to take steps on hearing aids and sets a 120-day deadline for action to be taken. There is now a 60-day comment period for the public to weigh in.

The hearing aids would not be available for kids under the age of 18, adults with severe or profound hearing loss or adults who are deaf.

Advocates are excited about the prospect the new FDA ruling will potentially mean for families.

“It has been a long time coming, and we're excited because it's giving people a way that they can start hearing better,” said Wynne Wayman, a hearing aid user and the volunteer chair for Let’s Loop Colorado.

Wayman says a large number of people who experience hearing loss choose not to get help due to the financial impact. She hopes this will result in a drop in hearing aid prices as competition enters the market.

“That's the hope and the promise that those ripples will affect the pricing, because you're getting a bigger quantity,” Wayman said. “I'm also hopeful that we're going to create, it's going to create some new innovation in the hearing aids.”

However, she believes the new rule will mean that business might need to change for audiologists.

FDA clears the way for over-the-counter hearing aids

For years, Kurt Sevits knew he needed hearing aids but was not able to afford them.

“I can't hear a lot of high-pitched noises. But I mean, the cost has always been a barrier. I've just never been able to afford them,” he said.

It wasn’t until his 30s that Sevits was able to save up enough money to buy hearing aids. Even with insurance, the hearing aids cost him $5,000 out of pocket.

“A lot of insurance plans don't cover them, especially for adults,” Sevits said.

He says if this option would have been available a few years ago, he would have likely tried an over-the-counter hearing aid while he saved up for the prescription ones.

“I would absolutely do that as a first step to kind of figure out is this something I want to do, you know, long-term and start saving money for,” Sevits said.

He’s hopeful that the new ruling will help drive competition to bring down the price of hearing aids. However, because he has profound hearing loss, Sevits knows this ruling doesn’t apply to him, and he hopes it won’t deter others from getting an exam from an audiologist.

Audiologists, however, are remaining more cautious in their optimism over the new ruling. Gabbard says one of the biggest challenges for consumers will be self-identifying the degree of their hearing loss.

“Mild hearing loss usually translates to, "I hear fine most of the time, but sometimes it seems like people are mumbling," as opposed to, "I don't hear people sometimes,"” Gabbard said.

Even after the new rule takes effect, Gabbard says it’s a good idea for people to see an audiologist to find out how bad their hearing actually is. She also believes there could be some potential downsides to these over-the-counter hearing aids.

“I think part of the harm might be from missing a medical condition. So, one of the harms is just assuming you have a straightforward hearing loss that needs no medical intervention or diagnosis, and you go ahead and treat it yourself,” Gabbard said.

She also worries that an over-the-counter device could cause more harm to a person’s hearing if they turn it up all the way.

Gabbard says she's waiting to see what changes manufacturers will make to amplification devices — which are already available over-the-counter — to follow FDA guidelines for the new category of hearing aids. However, she is hopeful that eventually, manufacturers might drop their prices and believes this is a good opportunity for people who have been putting off getting help.