Apr 21, 2024 19:00:00

Lenire, an FDA-approved device that electrically stimulates the tongue to reduce tinnitus

Tinnitus, such as a 'ringing' sound, is said to be caused by diseases such as sudden hearing loss and otitis media, as well as noise, stress, and lack of sleep. According to a survey by

the American Tinnitus Association , more than 25 million adults suffer from tinnitus, which can cause significant stress and panic. A device called ' Lenire ', approved by the US Food and Drug Administration (FDA) in March 2023, is expected to distract people from tinnitus by electrically stimulating the tongue.

FDA Grants Lenire® Tinnitus Treatment Device De Novo Approval
https://www.lenire.com/lenire-granted-fda-approval/

An FDA approved device offers a new treatment for ringing in the ears : Shots - Health News : NPR
https://www.npr.org/sections/health-shots/2024/04/15/1244501055/tinnitus-hearing-loss-ringing-ear-noise

Lenire, developed by Neuromod Devices Ltd., is a device that uses a plastic mouthpiece with stainless steel electrodes to deliver electrical stimulation to the tongue while the user hears the sound of waves or tones through the attached headphones. Using this device, it is said that it is possible to shift the brain's attention away from tinnitus, and in a survey so far, 84% of subjects who tried Lenire

reported that their symptoms were 'significantly reduced.'

Based on the results of this experiment, the FDA approved Lenire as a treatment device for tinnitus in March 2023 (PDF file) . Until now, there has been no treatment for tinnitus, and wearing hearing aids and mindfulness therapy have been used, but Lenire is the first FDA-approved device to reduce the symptoms of tinnitus.

In fact, Victoria Banks, a singer-songwriter living in Tennessee, has been suffering from severe tinnitus since around 2021. 'It was like a chorus of cicadas was spreading through my head, making it difficult to sing or listen to music,' Banks said. Banks tried taking nutritional supplements that supposedly suppress tinnitus and increasing her exercise, but none of them helped improve her tinnitus.

But after discovering Lenire, Banks was able to dramatically improve his tinnitus by using it for an hour every day. 'My tinnitus hasn't gone away completely, but now it's barely noticeable,' Banks said.

Audiologist Brian Frigger said, 'We are designed to focus on important information coming from the brain, and Lenire's electrical stimulation of the tongue helps to shift the brain's attention away from tinnitus. Also, what you feel through the nerves in your tongue and the sound coming from the headphones will direct the spotlight in your brain away from tinnitus. ' Banks also said, 'The sensation of wearing Lenire is like living near a waterfall and hearing the sound of the waterfall all the time. It's bothersome at first, but over time the sound of the waterfall fades from your consciousness.'

On the other hand, Lenire has several problems, one of which is its cost. Lenire, which costs about $4,000 (about 610,000 yen) per unit, is not covered by insurance.

It's also unclear how long Lenire's therapeutic effects will last. Clinical trials have shown that it can be effective for a year, but it's unclear whether it will continue to be effective beyond that. Bruce Freeman, a tinnitus sufferer at the University of Pittsburgh Medical Center, said, 'When I stopped taking Lenire, my tinnitus symptoms returned.'

Still, Freeman is impressed with the research showing Lenire's effectiveness as a treatment, and says the improvement in his own tinnitus has 'put an end to all my worries.'

Continued

FDA-approved electronic tinnitus treatment device 'Lenire' peer-reviewed paper published - GIGAZINE