An FDA approved device offers a new treatment for ringing in the ears : Shots

After using the Lenire device for an hour each day for 12 weeks, Victoria Banks says her tinnitus is “barely noticeable.”

David Petrelli/Victoria Banks


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David Petrelli/Victoria Banks


After using the Lenire device for an hour each day for 12 weeks, Victoria Banks says her tinnitus is “barely noticeable.”

David Petrelli/Victoria Banks

Imagine if every moment is filled with a high-pitched buzz or ring that you can’t turn off.

More than 25 million adults in the U.S., have a condition called tinnitus, according to the American Tinnitus Association. It can be stressful, even panic-inducing and difficult to manage. Dozens of factors can contribute to the onset of tinnitus, including hearing loss, exposure to loud noise or a viral illness.

There’s no cure, but there are a range of strategies to reduce the symptoms and make it less bothersome, including hearing aids, mindfulness therapy, and one newer option – a device approved by the FDA to treat tinnitus using electrical stimulation of the tongue.

The device has helped Victoria Banks, a singer and songwriter in Nashville, Tenn., who developed tinnitus about three years ago.

“The noise in my head felt like a bunch of cicadas,” Banks says. “It was terrifying.” The buzz made it difficult for her to sing and listen to music. “It can be absolutely debilitating,” she says.

Banks tried taking dietary supplements, but those didn’t help. She also stepped up exercise, but that didn’t bring relief either. Then she read about a device called Lenire, which was approved by the FDA in March 2023. It includes a plastic mouthpiece with stainless steel electrodes that electrically stimulate the tongue. It is the first device of its kind to be approved for tinnitus.

“This had worked for other people, and I thought I’m willing to try anything at this point,” Banks recalls.

She sought out audiologist Brian Fligor, who treats severe cases of tinnitus in the Boston area. Fligor was impressed by the results of a clinical trial that found 84% of participants who tried Lenire experienced a significant reduction in symptoms. He became one of the first providers in the U.S. to use the device with his patients. Fligor also served on an advisory panel assembled by the company who developed it.

“A good candidate for this device is somebody who’s had tinnitus for at least three months,” Fligor says, emphasizing that people should be evaluated first to make sure there’s not an underlying medical issue.

Tinnitus often accompanies hearing loss, but Victoria Banks’ hearing was fine and she had no other medical issue, so she was a good candidate.

Banks used the device for an hour each day for 12 weeks. During the hour-long sessions, the electrical stimulation “tickles” the tongue, she says. In addition, the device includes a set of headphones that play a series of tones and ocean-wave sounds.

The device works, in part, by shifting the brain’s attention away from the buzz. We’re wired to focus on important information coming into our brains, Fligor says. Think of it as a spotlight at a show pointed at the most important thing on the stage. “When you have tinnitus and you’re frustrated or angry or scared by it, that spotlight gets really strong and focused on the tinnitus,” Fligor says.

“It’s the combination of what you’re feeling through the nerves in your tongue and what you’re hearing through your ears happening in synchrony that causes the spotlight in your brain to not be so stuck on the tinnitus,” Fligor explains.

A clinical trial found 84% of people who used the device experienced a significant reduction in symptoms.

Brian Fligor


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Brian Fligor


A clinical trial found 84% of people who used the device experienced a significant reduction in symptoms.

Brian Fligor

“It unsticks your spotlight” and helps desensitize people to the perceived noise that their tinnitus creates, he says.

Banks says the ringing in her ears did not completely disappear, but now it’s barely noticeable on most days.

“It’s kind of like if I lived near a waterfall and the waterfall was constantly going,” she says. Over time, the waterfall sound fades out of consciousness.

“My brain is now focusing on other things,” and the buzz is no longer so distracting. She’s back to listening to music, writing music, and performing music.” I’m doing all of those things,” she says.

When the buzz comes back into focus, Banks says a refresher session with the device helps.

A clinical trial found that 84% of people who tried Lenire, saw significant improvements in their condition. To measure changes, the participants took a questionnaire that asked them to rate how much tinnitus was impacting their sleep, sense of control, feelings of well-being and quality of life. After 12 weeks of using the device, participants improved by an average of 14 points.

“Where this device fits into the big picture, is that it’s not a cure-all, but it’s quickly become my go-to,” for people who do not respond to other ways of managing tinnitus, Fligor says.

One down-side is the cost. Banks paid about $4,000 for the Lenire device, and insurance doesn’t cover it. She put the expense on her credit card and paid it off gradually.

Fligor hopes that as the evidence of its effectiveness accumulates, insurers will begin to cover it. Despite the cost, more than 80% of participants in the clinical trial said they would recommend the device to a friend with tinnitus.

But, it’s unclear how long the benefits last. Clinical trials have only evaluated Lenire over a 1-year period. “How durable are the effects? We don’t really know yet,” says audiologist Marc Fagelson, the scientific advisory committee chair of the American Tinnitus Association. He says research is promising but there’s still more to learn.

Fagelson says the first step he takes with his patients is an evaluation for hearing loss. Research shows that hearing aids can be an effective treatment for tinnitus among people who have both tinnitus and hearing loss, which is much more common among older adults. An estimated one-third of adults 65 years of age and older who have hearing loss, also have tinnitus.

“We do see a lot of patients, even with very mild loss, who benefit from hearing aids,” Fagelson says, but in his experience it’s about 50-50 in terms of improving tinnitus. Often, he says people with tinnitus need to explore options beyond hearing aids.

Bruce Freeman, a scientist at the University of Pittsburgh Medical Center, says he’s benefitted from both hearing aids and Lenire. He was fitted for the device in Ireland where it was developed, before it was available in the U.S.

Freeman agrees that the ringing never truly disappears, but the device has helped him manage the condition. He describes the sounds that play through the device headphones as very calming and “almost hypnotic” and combined with the tongue vibration, it’s helped desensitize him to the ring.

Freeman – who is a research scientist – says he’s impressed with the results of research, including a study published in Nature, Scientific Reports that points to significant improvements among clinical trial participants with tinnitus.

Freeman experienced a return of his symptoms when he stopped using the device. “Without it the tinnitus got worse,” he says. Then, when he resumed use, it improved.

Freeman believes his long-term exposure to noisy instruments in his research laboratory may have played a role in his condition, and also a neck injury from a bicycle accident that fractured his vertebra. “All of those things converged,” he says.

Freeman has developed several habits that help keep the high-pitched ring out of his consciousness and maintain good health. “One thing that does wonders is swimming,” he says, pointing to the swooshing sound of water in his ears. “That’s a form of mindfulness,” he explains.

When it comes to the ring of tinnitus, “it comes and goes,” Freeman says. For now, it has subsided into the background, he told me with a sense of relief. “The last two years have been great,” he says – a combination of the device, hearing aids and the mindfulness that comes from a swim.

This story was edited by Jane Greenhalgh

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