Real-World Study Reports 91% of Tinnitus Patients Improved With Neuromod's FDA-Approved Device

A real-world study published in Nature Communications Medicine has reported that 91.5 percent of tinnitus patients experienced a clinically meaningful reduction in symptoms after 12 weeks of treatment using Lenire, a non-invasive, FDA-approved neuromodulation device. The study analyzed 220 patients treated at the Alaska Hearing and Tinnitus Center and represents one of the largest real-world assessments of tinnitus therapy published to date.

Lenire delivers bimodal stimulation (pairing sound through headphones with mild electrical pulses to the tongue) and is prescribed for at-home use under audiologist supervision. Interim results showed 78 percent of patients had symptom relief by six weeks, with further improvement by the 12-week mark. The outcomes mirror results from Neuromod Devices’ TENT-A3 trial, which supported the device’s FDA De Novo authorization in 2023.

The study adds to a growing base of real-world evidence compiled by Neuromod across thousands of patients, and is expected to be followed by additional publications. Lenire is currently available in the US, Europe, and through the Department of Veterans Affairs.