American Academy of Otolaryngology–Head and Neck Surgery’s foundation now lists bimodal neuromodulation as a treatment option in its tinnitus guideline, giving eligible adults another choice despite mixed trial results.
The update, published Oct. 12, covers adults whose tinnitus has lasted at least six months and disrupts daily life. The bimodal recommendation applies to patients with moderate-to-severe symptoms under the criteria used in U.S. approval trials. It identifies a treatment method, not a specific device.
Lenire pairs sound with electrical stimulation of the tongue. Its manufacturer, Neuromod Devices Limited, said the guidance covers its product. The U.S. Food and Drug Administration granted Lenire’s De Novo request on March 6, 2023.
In the TENT-A3 trial, 44 participants still had a Tinnitus Handicap Inventory (THI) score of at least 38 after six weeks of sound-only treatment. Their estimated response rate was 58.6% during the following six weeks of combined treatment, compared with 43.2% during the sound-only phase. A response required a THI score drop of at least seven points within a phase.
Across all 112 participants, the estimated response rate was 43.3% with combined treatment and 63.3% with sound alone. The trial’s planned test did not establish that combined treatment worked better for the full group. TENT-A3 used a single group without randomization or masking; participants received sound alone before combined treatment.
The guideline panel assigned medium confidence to the evidence, pointing to company-sponsored studies and uncertainty about how long any improvements last. It also noted treatment time and cost, limited access to centers, and the possibility that symptoms might not improve or could worsen.
Ten members of the guideline update group favored adding the option, seven considered it premature and two abstained. Group chair Meredith E. Adams did not join the discussion or vote because of a disclosed potential professional conflict tied to her Lenire research.
The update replaces the foundation’s 2014 tinnitus guideline. The panel called for independent studies to assess whether benefits persist and appear in routine care.
