https://www.npr.org/sections/health-shots/2024/04/15/1244501055/tinnitus-hearing-loss-ringing-ear-noise

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An FDA approved device offers a new treatment for ringing in the ears
: Shots - Health News More than 25 million adults in the U.S. have
tinnitus, a condition that causes ringing or buzzing in the ears. An
FDA approved device that stimulates the tongue, helped 84% of people
who tried it.
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How to Thrive as You Age

Got tinnitus? A device that tickles the tongue helps this musician
find relief

April 15, 20245:00 AM ET
Heard on Morning Edition
Allison Aubrey - 2015 square

Allison Aubrey

Got tinnitus? A device that tickles the tongue helps this musician
find relief

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[tinnitis-4]
Enlarge this image

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 hide caption

toggle caption
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.

Tinnitus Bothers Millions Of Americans. Here's How To Turn Down The
Noise

Shots - Health News

Tinnitus Bothers Millions Of Americans. Here's How To Turn Down The
Noise

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.

[leniredevi]
Enlarge this image

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

toggle caption
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

  * ringing in ears
  * hearing loss
  * Tinnitus

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