ArticleNature communications2024
Combining sound with tongue stimulation for the treatment of tinnitus: a multi-site single-arm controlled pivotal trial.
Article in Nature communications, 2024. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT05227365 (Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3), which is not on this map. Cited by 11 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Treatment Evaluation of Neuromodulation for Tinnitus - Stage A3 (TENT-A3)
Who cites it
11 citing papers in PubMed.
- Auditory Network Discoherence in Chronic Tinnitus.medRxiv : the preprint server for health sciences · 2026Article
- Tinnitus.Nature reviews. Disease primers · 2026Review
- A Review of Vagus Nerve Stimulation for Disease: Comprehensive Theory and Evidence for Mechanisms of Action.Comprehensive physiology · 2026Review
- Repurposing Renin-Angiotensin System Drugs for the Treatment of Audiovestibular Disorders.Journal of clinical medicine · 2026Review
- [Tinnitus-current developments : Overview and summary of current state of knowledge in 2024].HNO · 2025Review
- Inhibition of Cortical Evoked Responses to Sound Pulses by Preceding Silent Gaps.Journal of the Association for Research in Otolaryngology : JARO · 2025Article
- Tinnitus risk factors and its evolution over time.Nature communications · 2025Article
- Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting.Communications medicine · 2025Article
- An innovative predictive model for assessing tinnitus sound therapy outcomes: integrating audiological and psychometric variables.Frontiers in neurology · 2025Article
- Comparison of augmented reality glasses for the assistive communication support of hearing loss.Frontiers in neurology · 2025Article
- Pathophysiological Insights and Multimodal Interventions in Chronic Tinnitus, Anxiety, and Sleep Disorders.Nature and science of sleep · 2025Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
12 authors.
Funding
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.