Tinnitus Treatment Device Granted FDA De Novo Approval

The Food and Drug Administration (FDA) has granted De Novo approval to a bimodal (sound and tongue) neuromodulation device (Lenire; Neuromod, Dublin, Ireland) that improved patients’ tinnitus symptoms more than sound therapy alone. The approval is based on the TENT-A3 trial (NCT05227365), a controlled clinical study that compared 6 weeks of bimodal neuromodulation with 6 weeks of sound therapy alone in 112 patients and was supported by confirmatory real-world evidence from 204 patients, according to a press release issued by Neuromod. The primary endpoint analysis of TENT-A3 showed that patients who are at least moderately impacted by tinnitus achieved a clinically meaningful improvement after the bimodal phase of the trial. This was consistent with real-world evidence submitted to the FDA.

During the course of the trial, 79.4% of patients experienced a clinically significant improvement in their symptoms according to self-reported scores on the Tinnitus Handicap Inventory; 82.4% were compliant to bimodal treatment; and 88.6% responded that they would recommend the device as a treatment for tinnitus. According to details provided on clinicaltrials.gov, “The sound stimulus is comprised of sequences of tones and is spectrally modified according to the participant's hearing thresholds so that different components of the sound stimulus can be sufficiently heard by the participant irrespective of their hearing characteristics (audiological profile). The tongue stimulus is delivered by an array of electrical signals via 32 transmucosal electrodes contacting the anterodorsal surface of the tongue.” (https://clinicaltrials.gov/ct2/show/NCT05227365?term=TENT-A3&draw=2&rank=1)

“Many tinnitus patients are not availing of currently available options, such as hearing aids and counseling, and success with these options is varied,” said Jason Leyendecker, AuD, of The Tinnitus and Hyperacusis Clinic of Minnesota. “What is especially encouraging about this new bimodal treatment is that it can deliver clinical benefits in a 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.”