First Bimodal Neuromodulation Device for Tinnitus Gets FDA Nod

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Ringing ears may get relief with sound and tongue stimulation.

The FDA granted de novo approval to Neuromod Devices’ Lenire, a bimodal neuromodulation device that is the first of its kind to be approved to treat tinnitus, the company announcedopens in a new tab or window.

The device provides non-invasive sound and tongue electrical stimulation to alleviate symptoms of chronic, subjective tinnitus.

The FDA decision was based on findings from the pivotal TENT-A3 trialopens in a new tab or window, a single-arm prospective study of 112 people with chronic, subjective tinnitus, which aimed to determine whether tongue stimulation provided additional benefits over sound-only treatment.

Compared with sound therapy alone, participants who were at least moderately affected by tinnitus — measured by Tinnitus Handicap Inventory scores, which assess how severely tinnitus impacts a patient’s life — were more likely to achieve a clinically meaningful improvement using bimodal stimulation, Neuromod reported. TENT-A3 showed no serious adverse events.

The findings were consistent with real-world evidence from 204 patients, the company said.

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