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# FDA Grants De Novo Device for Tinnitus
- URL: https://www.fdaweb.com/fda-grants-de-novo-device-for-tinnitus/
- Published: 2023-03-07T12:00:00.000Z
- Updated: 2026-09-14T18:18:18.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5153923

FDA has granted Neuromod Devices a *de novo* request to market Lenire, the first bimodal neuromodulation device for treating tinnitus. The device comprises a controller, a tongue stimulator, and Bluetooth headphones. The handheld controller controls the timing, intensity and synchronization of the sound and tongue stimuli, according to the company. The Tonguetip is designed to sit in the closed mouth, and it delivers mild energy pulses to the tip of the tongue. And the Bluetooth headphones deliver customized paired sound stimuli to the auditory nerve, the company says.

Neuromod says Lenire has now been shown to be more effective than sound therapy, which is one of the current standards of care. In granting the de novo request, FDA relied on data from theTENT-A3 clinical trial and supporting real-world evidence from 204 patients. “Over the entire trial, 79.4% of the patients experienced a clinically significant improvement, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment,” it says.