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 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 , 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.
The study compared the effects of 6 weeks of bimodal neuromodulation versus 6 weeks of sound therapy alone from March to October 2022. Of the participants, 82.4% were compliant to bimodal treatment and 79.4% experienced a clinically significant improvement over the entire trial.
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.
"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, in the Neuromod press release.
"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 added.
The earlier and studies supported the safety and efficacy of combined sound and tongue stimulation therapy.
The bimodal treatment is currently available in Europe and will be available in the U.S. this year, Neuromod said. The company will begin training audiologists and ENT surgeons specializing in tinnitus as early as April.