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Introduction: Chronic subjective tinnitus is highly debilitating and associated with psychological comorbidities and a significant burden on the healthcare system. Recent developments have led to the MDR (CE marking) and FDA de novo approval of bimodal neuromodulation, a non-invasive combination of acoustic and electrical tongue stimulation. Safety and efficacy have been demonstrated in several large-scale clinical trials, including TENT-A3, which led to the approval of Lenire in the USA [1], [2], [3]. Whether these results translate to real-world care in heterogeneous clinical practice remains unclear. This presentation presents the results of the pivotal TENT-A3 trial and, for the first time, multicenter real-world data on bimodal neuromodulation for tinnitus.

Methods: TENT-A3 was a prospective, single-arm, repeated-measures study investigating the additional effect of tongue stimulation compared to sound therapy alone on tinnitus reduction. A total of 112 participants were enrolled at three study centers: St. James Hospital (Ireland), BRAI3N Clinic (Belgium), and DHZ Hannover (Germany). The first six weeks consisted of acoustic stimulation alone, followed by six weeks of bimodal stimulation.

Since the completion of the TENT-A3 study, real-world data from Lenire treatment have been collected at several clinics in the EU and the USA. Patients with distressing tinnitus at the start of treatment (elevated THI score) were included. Follow-up examinations were generally conducted after 12–24 weeks; some clinics reported long-term data (>1 year). A reduction in the THI score by the MCID (>7 points) was defined as a responder.

Results: In the TENT-A3 study, participants with distressing tinnitus showed clinically superior efficacy of bimodal treatment compared to sound therapy alone (p = 0.022). No serious adverse events related to the treatment occurred; the majority of adverse events were mild (96.8%) and transient (98.4%).

Real-world data from EU and US centers showed a responder rate of over 80% after 12–24 weeks, with a mean THI improvement of more than three times the MCID (>21 points). Long-term data showed stable improvements for at least 12 months.

Conclusions: The care of tinnitus patients is often limited by short-term therapeutic effects, limited scalability, and resource-intensive interventions. This multicenter real-world analysis shows that bimodal neuromodulation is feasible in clinical practice, scalable, and associated with long-term effects. The results are consistent with previous observations.

References

[1] Boedts M, Buechner A, Khoo SG, Gjaltema W, Moreels F, Lesinski-Schiedat A, Becker P, MacMahon H, Vixseboxse L, Taghavi R, Lim HH, Lenarz T. Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial. Nat Commun. 2024 Aug 19;15(1):6806. DOI: 10.1038/s41467-024-50473-z
[2] Conlon B, Hamilton C, Meade E, Leong SL, O Connor C, Langguth B, Vanneste S, Hall DA, Hughes S, Lim HH. Different bimodal neuromodulation settings reduce tinnitus symptoms in a large randomized trial. Sci Rep. 2022 Jun 30;12(1):10845. DOI: 10.1038/s41598-022-13875-x
[3] Conlon B, Langguth B, Hamilton C, Hughes S, Meade E, Connor CO, Schecklmann M, Hall DA, Vanneste S, Leong SL, Subramaniam T, D'Arcy S, Lim HH. Bimodal neuromodulation combining sound and tongue stimulation reduces tinnitus symptoms in a large randomized clinical study. Sci Transl Med. 2020 Oct 7;12(564):eabb2830. DOI: 10.1126/scitranslmed.abb2830