As early as October, Americans will be able to buy hearing aids without an exam or a prescription for the first time. 

The Food and Drug Administration finalized a long-awaited new category of over-the-counter devices Tuesday. The hope is that new regulations will spur competition in the industry and make the devices more affordable. 

Matthew Pisani is hard of hearing, and got his first hearing aid when he was in the first grade. But after a few years, he grew out of the device. 

“So, like, it didn’t really fit any more. But the problem was insurance didn’t cover the cost of hearing devices, and they are, like, several thousand dollars,” he said.

So, for the next 15 years, he went without. 

This is a common choice. The FDA estimates some 30 million Americans could benefit from a hearing aid, but only about one-fifth actually use one, often because they learn how much it costs. 

“It’s like dropping a bomb on them,” said Nicholas Reed, an audiologist at Johns Hopkins University, who also said a device and fitting can come close to $5,000, which insurance won’t often cover. 

Some patients can’t afford that. Others wonder if it’s really worth it. 

“They sort of glaze over. They’re really walking out of there saying they can’t do this, they can’t justify this at this time,” he said.

Especially patients with mild or situational hearing loss. That’s the group over-the-counter devices have been approved for. 

Barbara Kelley with the Hearing Loss Association of America hopes the rule change will shake up what’s currently a highly concentrated market and drive down prices. 

“The marketplace is gonna bear out over the next couple years. What we hope to see is innovation,” she said, adding that people with severe hearing loss will still need to see an audiologist and get prescription devices. However, “if we can get hearing health more in the mainstream, where we see devices in our pharmacy, our big box stores,” then that could be a starting point for those who otherwise wouldn’t seek help at all — like Matthew Pisani, who in his 20s finally got a hearing aid through an audiologist. 

“It just gives you that peace of mind and confidence where you can go and do your job, you can interact with friends, you can go and talk with strangers,” he said.

He said a cheaper, over-the-counter option could have given him that confidence a long time ago.