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

Author

Listed:
  • Michael Boedts

    (BRAI3N Clinic
    Maria Middelares General Hospital)

  • Andreas Buechner

    (Hannover Medical School
    Hannover Medical School)

  • S. Guan Khoo

    (St. James’s Hospital
    St. Vincent’s Hospital)

  • Welmoed Gjaltema

    (Avania)

  • Frederique Moreels

    (BRAI3N Clinic)

  • Anke Lesinski-Schiedat

    (Hannover Medical School
    Hannover Medical School)

  • Philipp Becker

    (Hannover Medical School)

  • Helen MacMahon

    (Otologie Clinic)

  • Lieke Vixseboxse

    (Avania)

  • Razieh Taghavi

    (Avania)

  • Hubert H. Lim

    (Neuromod Devices Limited
    University of Minnesota, Minneapolis
    University of Minnesota, Minneapolis)

  • Thomas Lenarz

    (Hannover Medical School
    Hannover Medical School)

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.

Suggested Citation

  • 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 , 2024. "Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial," Nature Communications, Nature, vol. 15(1), pages 1-10, December.
    • Handle: RePEc:nat:natcom:v:15:y:2024:i:1:d:10.1038_s41467-024-50473-z
    DOI: 10.1038/s41467-024-50473-z
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    1. Navzer D. Engineer & Jonathan R. Riley & Jonathan D. Seale & Will A. Vrana & Jai A. Shetake & Sindhu P. Sudanagunta & Michael S. Borland & Michael P. Kilgard, 2011. "Reversing pathological neural activity using targeted plasticity," Nature, Nature, vol. 470(7332), pages 101-104, February.
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