FDA Grants De Novo Approval to Non-Invasive Tinnitus Treatment Device


The product, called Lenire, uses bimodal stimulation and will be available in April 2023

Over 25 million Americans suffer from live with tinnitus, a ringing, humming, buzzing, or clicking that an individual hears in 1 or both ears. Tinnitus is often caused by ear injury, continuous exposure to extremely loud noises, or natural age-related hearing loss. But relief may be coming soon: after a highly successful trial run, Irish firm Neuromod Devices announced on March 7 that their product Lenirehas been granted De Novo approval from the FDA.1

"Lenire's approval not only means that millions of Americans living with tinnitus can get the treatment they need, but further validates over a decade of research and development that resulted in a safe solution that provides relief for tinnitus patients,” said Neuromod CEO Ross O’Neil in the release.1

“The FDA's De Novo approval is based on the success of Lenire's third large-scale clinical trial…over the entire trial, 79.4% of the patients experienced a clinically significant improvement…and 88.6% responded that they would recommend Lenire as a tinnitus treatment,” Neuromod said in a news release.

Patients who were at least moderately bothered by Tinnitus “were more likely to achieve a clinically meaningful improvement using Lenire's bimodal sound and tongue stimulation than sound therapy alone,” the release continued.

There were no meaningful adverse health effects observed during the trial. Americans will be able to use Lenire starting in April 2023, when it will become widely available. Currently, tinnitus treatment is extremely limited; a product like Lenire will provide much-needed relief for millions of people who deal with the condition.

De Novo approval was based on the results of TENT-A3 (NCT05227365), a single-arm, repeated measures, prospective investigation, conducted at 3 independent sites from March to October 2022. A total of 112 participants were enrolled; researchers sought to compare the effects of 6 weeks bimodal neuromodulation with 6 weeks sound therapy alone.

One of the demographics most prone to tinnitus are veterans, with 2.7 million former military members living with the condition. Though tinnitus treatment cost is not exorbitant on the individual level—it costs the health care system approximately $660 per patient—these costs add up due to the prevalence of tinnitus. “It is estimated that the [Department of Veterans Affairs] paid out more than $4.9 billion through its Veterans Compensation benefits program for tinnitus alone in 2022,” the release noted.

Jason Leyendecker AuD, owner of Audiology Concepts LLC and The Tinnitus Clinic of Minnesota, is encouraged by Lenire and the efficiency with which it helps individuals with tinnitus. “What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in as short as 6 weeks of treatment, which can greatly improve our capacity issues since more patients can be helped in a shorter period of time,” he said.


1. FDA grants Lenire tinnitus treatment device De Novo approval. News Release. Neuromod Devices Ltd. March 7, 2023. Accessed March 8, 2023. https://www.prnewswire.com/news-releases/fda-grants-lenire-tinnitus-treatment-device-de-novo-approval-301764416.html

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