New tinnitus treatment receives FDA approval (2024)

FAQs

New tinnitus treatment receives FDA approval? ›

The non-invasive device, called Lenire, is now available in the U.S. The device, manufactured by Neuromod Devices, is the first-of-its-kind device granted approval by the U.S. Food and Drug Administration (FDA) to treat tinnitus in the U.S. market. The device has been available since 2019 in Europe.

Lenire is first and only dual mode technology for the treatment of tinnitus granted US FDA approval. Large scale clinical trial results show the device to be a safe and effective tinnitus treatment. What is Lenire?

A new treatment approach for tinnitus is called bimodal neuromodulation, which targets the brain by stimulating two sensory systems. In a device called Lenire, patients wear headphones and a mouth device every day for an hour for at least six weeks.

It could be tinnitus, a condition experienced by anywhere from 4% to 37% of people around the world. There's no cure yet, but tinnitus can be successfully managed, and some cases clear up on their own.

How Much Does Lenire Cost? Actual prices vary by location, but based on information from multiple clinics offering Lenire, the typical cost of the device ranges between $3,500 to $4,000.

Currently, there is no known cure for tinnitus. However, experts suggest trying one of the following to find relief: Hearing aids. These may benefit some people with tinnitus who have hearing loss.

Ginkgo biloba

Ginkgo is also the most studied dietary supplement in tinnitus treatment. It is believed to improve tinnitus by increasing inner ear and cerebral blood circulation and by protecting against free radicals.

Medications: Medications cannot cure tinnitus, but medications such as tricyclic antidepressants and alprazolam may help reduce the severity of symptoms or complications. Nutritional supplements: These containing ginkgo Bilbao, zinc, and vitamin B may help reduce tinnitus.

Additionally, study participants with vitamin B12 deficiency and tinnitus reported a reduction in tinnitus symptom severity following therapy with vitamin B12 injections. However, study participants without vitamin B12 deficiency reported hardly any reduction in tinnitus symptom severity with the same therapy.

University of Minnesota Professor Hubert Lim is part of an international team that has developed a new device that could help millions of people worldwide with tinnitus. The non-invasive device, called Lenire, is now available in the United States.

Is tinnitus a precursor to dementia? ›

While researchers are still trying to fully understand the relationship between tinnitus and dementia, some studies have suggested that people with severe tinnitus may have a higher risk of developing early-stage dementia.

Research has shown that magnesium supplements can help improve ear function. They may also reduce the symptoms of tinnitus. Current knowledge on tinnitus remains limited, and health experts do not have a firm understanding of what causes of this condition.

One down-side is the cost. Banks paid about $4,000 for the Lenire device, and insurance doesn't cover it.

Will it be possible to purchase a Lenire system over the counter? No. The Lenire device is tailored specifically for each patient based on their hearing profile.

Lenire is intended for use in adults over 18 years of age, who have experienced chronic subjective tinnitus for three months or longer.

Medicare will not cover the cost of treating either hearing loss or tinnitus. However, Medicare will reimburse patients around $38 per year for a hearing exam. And while Medicare doesn't provide coverage for tinnitus, it's still important to address it, especially if it lasts longer than two weeks.

Yes. Lenire is FDA Approved and is available at specialized clinics across the United States of America. You can find a clinic near you using Lenire's Find a Clinic Map. You can also fill out the Assessment Waitlist Form if there are no specialized Lenire Providers near your location.

Out of 191 subjects, 95 percent reported improvement in symptom severity. Furthermore, 91 percent of participants in this latest study reported sustained benefit at 12 months post-treatment.