Figure 1
From: Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial
Timeline of different parameter settings for tinnitus treatment in the TENT-A2 study. (a) The Lenire bimodal neuromodulation device developed by Neuromod Devices is shown (CE-marked Class IIa; previously referred to as MBT in the study). Sound stimulation is delivered through wireless headphones and electrical stimulation is presented to the anterior-dorsal surface of the tongue via a 32-site electrode array. Both stimulation approaches are controlled using a battery-powered controller. Bimodal stimulation activates auditory and somatosensory pathways, as well as converging centers in auditory, limbic and attentional brain regions implicated in tinnitus. (b) Timeline of four treatment arms with different stimulation parameters over time (see Supplementary Table S1 for detailed description). Arm 1 and arm 2 are included for the primary endpoint analyses. Arm 3 and arm 4 are included for additional analyses. Evaluations of device safety and efficacy were conducted at interim and final visits with post-treatment follow-ups planned at weeks 18, 38 and 64 from enrollment.
