Evidence map›Paper›PMID 40295853›Full record

ArticleCommunications medicine2025

Retrospective chart review demonstrating effectiveness of bimodal neuromodulation for tinnitus treatment in a clinical setting.

Emily E McMahan, Hubert H Lim

Abstract read
In one paragraph

Article in Communications medicine, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 2 papers.

0numbers the graph read from it
0cells of the map it votes in
2citing papers in PubMed
–field-weighted citation impact
1 · What the graph read from it

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.

2 · The registry

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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

2 citing papers in PubMed.

  1. Efficacy of non-invasive neuromodulation for chronic tinnitus: a systematic review and meta-analysis of randomized controlled trials.European archives of oto-rhino-laryngology : official journal of the European Federation of Oto-Rhino-Laryngological Societies (EUFOS) : affiliated with the German Society for Oto-Rhino-Laryngology - Head and Neck Surgery · 2026
    Review
  2. Review
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

2 authors.

Emily E McMahanAlaska Hearing & Tinnitus Center, Anchorage, AK, USA.
Hubert H LimDepartment of Otolaryngology-Head & Neck Surgery, University of Minnesota, Minneapolis, MN, USA. hlim@umn.edu.ORCID http://orcid.org/0000-0001-5653-9679

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

backgroundBimodal neuromodulation combining sound therapy with electrical tongue stimulation using the Lenire® device is emerging as an effective treatment for tinnitus.

methodsA single-arm retrospective chart review of 220 patients with tinnitus from the Alaska Hearing & Tinnitus Center examines the real-world outcomes of the recently FDA-approved Lenire treatment. To the best of our knowledge, this is the first assessment of Lenire from a real-world clinic in the United States. The primary endpoint examines the responder rate and mean change in Tinnitus Handicap Inventory (THI) after ~12 weeks of treatment in eligible patients with moderate or worse tinnitus. A responder represents a THI improvement of greater than seven points (i.e., minimal clinically important difference, MCID).

resultsHere we show that, out of 212 patients with available data, there was a high responder rate of 91.5% (95% CI: 86.9%, 94.5%) with a mean improvement of 27.8 ± 1.3 (SEM) points, and no device-related serious adverse events. Furthermore, a THI MCID of seven points represents a consistent criterion for clinical benefit based on evidence from clinical practice settings.

conclusionsThese findings show that the Lenire device can be used to safely and effectively reduce tinnitus in a real-world clinical setting.

Identifiers

PMID40295853
PMCPMC12037789

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