Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial
Summary
This controlled pivotal trial (TENT-A3) evaluated bimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire device in 112 participants. In participants with moderate or more severe tinnitus, bimodal treatment showed clinically superior performance (58.6% responder rate) compared to sound therapy alone (43.2%), leading to FDA De Novo approval of the Lenire device.
Why it matters
This pivotal trial provided the evidence base for FDA De Novo approval of the first bimodal neuromodulation device for tinnitus. The superior responder rates with bimodal versus sound-only treatment validate the principle that combined sensory stimulation can drive greater therapeutic plasticity in tinnitus-related neural circuits, offering a new non-surgical treatment option for millions of tinnitus sufferers.
Want the full NeurotechMag Pro intelligence database?
Access 800+ papers, trials, patents, funding rounds and news items — updated daily.
Start free trial