Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial

Michael Boedts, Andreas Buechner, S. Guan Khoo, Welmoed Gjaltema, Frederique Moreels, Anke Lesinski-Schiedat, Philipp Becker, Helen MacMahon, Lieke Vixseboxse, Razieh Taghavi, Hubert H. Lim () and Thomas Lenarz
Additional contact information
Michael Boedts: BRAI3N Clinic
Andreas Buechner: Hannover Medical School
S. Guan Khoo: St. James’s Hospital
Welmoed Gjaltema: Avania
Frederique Moreels: BRAI3N Clinic
Anke Lesinski-Schiedat: Hannover Medical School
Philipp Becker: Hannover Medical School
Helen MacMahon: Otologie Clinic
Lieke Vixseboxse: Avania
Razieh Taghavi: Avania
Hubert H. Lim: Neuromod Devices Limited
Thomas Lenarz: Hannover Medical School

Nature Communications, 2024, vol. 15, issue 1, 1-10

Abstract: Abstract Bimodal neuromodulation is emerging as a nonsurgical treatment for tinnitus. Bimodal treatment combining sound therapy with electrical tongue stimulation using the Lenire device is evaluated in a controlled pivotal trial (TENT-A3, NCT05227365) consisting of 6-weeks of sound-only stimulation (Stage 1) followed by 6-weeks of bimodal treatment (Stage 2) with 112 participants serving as their own control. The primary endpoint compares the responder rate observed in Stage 2 versus Stage 1, where a responder exceeds 7 points in the Tinnitus Handicap Inventory. In participants with moderate or more severe tinnitus, there is a clinically superior performance of bimodal treatment (58.6%; 95% CI: 43.5%, 73.6%; p = 0.022) compared to sound therapy alone (43.2%; 95% CI: 29.7%, 57.8%), which is not observed in the full cohort across all severity groups. Consistent results are observed for the secondary endpoint based on the Tinnitus Functional Index (bimodal treatment: 45.5%; 95% CI: 31.7%, 59.9%; sound-only stimulation: 29.6%; 95% CI: 18.2%, 44.2%; p = 0.010), where a responder exceeds 13 points. There are no device related serious adverse events. These positive outcomes led to FDA De Novo approval of the Lenire device for tinnitus treatment.

Date: 2024
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DOI: 10.1038/s41467-024-50473-z

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