An FDA-approved device for treating tinnitus is showing strong results. The findings from a 12-month "real-world" study are published Monday in the journal Nature Communications Medicine.
Principal author, Emily McMahan, Au.D., says the treatment — a device called Lenire — works by essentially retraining the brain. The study finds 91.5% of patients experienced clinically meaningful reductions in tinnitus after 12 weeks of treatment using Lenire.
The National Institute on Deafness and Other Communication Disorders estimates 10% to 25% of adults experience some form of tinnitus — pronounced "tin-NITE-us" or "TIN-ne-tus" — a ringing, buzzing, or roaring sound in the ears that doesn't have an external source. In the U.S., that's more than 25 million people. For some, the condition is simply a nuisance. For others, it can be debilitating.
McMahan says the Lenire device works by combining sound therapy with stimulating a patient's tongue. It's called bimodal neuromodulation.
"We are helping the brain learn a new response or a new pathway," says McMahan. "The Lenire is using both the sound and the tongue stimulation to help the brain move away from that... it kind of gets stuck on the bothersome tinnitus, and helps the brain release that response."
For the treatment, a patient listens to headphones while multi-pattern pulses are delivered to the tongue by a "tonguetip" device the patient holds in their mouth.
Some tinnitus treatments involve using other sounds to try to mask the ringing noise. This treatment differs by adding a second stimulus that occupies the brain for a longer period of time. The dual stimulation weakens tinnitus pathways and helps the brain focus less on tinnitus sounds.
While the treatment doesn't eliminate or "cure" tinnitus, it makes the brain less sensitive to it.
Patients do two, 30-minute sessions per day for 12 weeks. The device can be used at home. It must be prescribed by a doctor and there are appointments at two, six, and 12 weeks. McMahan says some patients may need to continue a little bit longer, otherwise they move into what she refers to as "maintenance mode."
"Think of, like, our workout routine or food routine or a sleep routine. We maintain so many aspects of our life, and tinnitus just becomes part of that maintenance. Hopefully this patient — and about 91% of them have made it to this point — where if I asked if they had tinnitus, they would say yes, and they do, but they're no longer burdened by it. We want to keep their tinnitus where their brain knows that they have it and they can find it if they need to, but they're no longer just stuck with it bothering them all of the time. It's kind of in the background, and we want to maintain that."
McMahan is currently the only doctor in Cincinnati authorized to provide the treatment. She's a native of Hamilton, graduated from the University of Cincinnati, and has practices around the country.
The study published Monday followed patients for 12 months. McMahan says they hope to have two years worth of data soon.
"We haven't quite hit that time frame yet, but our 12-month, post-treatment data is showing that those patients are holding their positive results," she says.
The Lenire is currently classified by the FDA as a Class 2 medical device and isn't covered by health insurance. Treatment costs range from $4,000 to $5,000.
"The reason that finding this solution is so important is we've never had an FDA-approved device in the United States for tinnitus management," McMahan says, adding that people are sometimes so bothered by tinnitus that they're willing to try almost anything and can fall victim to online scam solutions. "It's been a really empowering shift in the last two years to finally have something that reliably is producing the results that we were told that it would produce with real patients."
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