Purpose Real-world evidence (RWE) is of practical significance as it enables the evaluation of whether findings observed in rigorously controlled clinical trial settings are generalizable to routine clinical practice. While Lenire, a bimodal neuromodulation tinnitus treatment device, has demonstrated efficacy and safety within controlled trials, further RWE from clinics is needed to reinforce these results. This is the first real-world study to assess the therapeutic effects of Lenire on tinnitus using the Tinnitus Functional Index (TFI), a multidimensional instrument designed to capture tinnitus severity and treatment responsiveness. The study correlates findings with the Tinnitus Handicap Inventory (THI), a well-established tool that assesses the perceived functional, emotional, and catastrophic impact of tinnitus that was used in previous clinical trials and real-world studies. The use of an alternative validated outcome measure in a real-world study may add more feasible, relevant and patient-centered research findings to the body of evidence for Lenire, while maintaining scientific credibility.

Methods A single-site, single-arm retrospective study examining patients fitted with the Lenire device was conducted. Ninety-seven patients with moderate or greater tinnitus severity used the Lenire device for 12 weeks, for up to 60 minutes a day. The primary outcome was change in tinnitus severity, assessed using the TFI at 6-week (FU1) and 12-week (FU2) follow-ups. The THI was included as a secondary outcome measure. Responder rates and mean score changes between initial assessment and FU1 and FU2 were compared using Z-tests for proportions and t-tests, respectively. Pearson’s correlations were used to examine the relationship between the TFI and THI change scores.

Results After just 12 weeks of treatment, 73.4% [95% CI: 62.6%, 84.3%] of patients achieved a clinically significant improvement, defined as a reduction of at least 13 points on the TFI. This improvement was strongly supported by results from the THI, where 84.1% [95% CI: 75.1%, 93.2%] of patients met the minimum clinically important difference of 7 points. Mean score reductions were-25.9 (2.4, SEM) for the TFI and - 28.0 (2.4, SEM) for the THI. Change scores from initial assessment to FU2 on the TFI and THI were highly correlated (r = 0.74, p < 0.001), indicating strong agreement between the two measures in capturing treatment related improvements. All eight TFI subdomains showed reductions ranging from 18.5 to 31.4 points at FU2.

Conclusions This retrospective study demonstrates that 12 weeks of treatment with the Lenire device resulted in clinically meaningful improvements in tinnitus severity on the TFI which was strongly supported by the THI. The high correlation between TFI and THI change scores indicates strong correlation between the two questionnaires in capturing treatment effects. Furthermore, all eight TFI subdomains showed notable reductions, underscoring the multidimensional impact of the treatment. These findings support the clinical utility of both the TFI and THI as complementary tools for evaluating treatment outcomes and guiding tinnitus management in routine practice.

The authors have declared no competing interest.

The data was collected during the daily operations at Tobias & Battite Hearing Wellness, with funds for ethics fees being provided by Neuromod Devices.

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

Advarra Institutional Review Board (IRB number: 00000971) waived ethical approval for this work.

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