A new analysis of 97 patients found 84.1% experienced a clinically significant reduction in tinnitus symptoms with Lenire as measured by the Tinnitus Handicap Inventory.
A real-world analysis of 97 American patients treated with the Lenire bimodal neuromodulation device shows clinically significant improvement in tinnitus symptoms, according to a paper made available on the preprint server medRxiv. The study is notable for using two common clinical outcome measures, the Tinnitus Handicap Inventory (THI) and the Tinnitus Functional Index (TFI), to assess treatment impact.
The paper, authored by Brian Fligor, PhD, and Miles Sabine, AuD, of Tobias & Battite Hearing Wellness, reports that 84.1% of patients with bothersome tinnitus experienced a clinically significant reduction in symptoms as measured by the THI after 12 weeks of treatment. Using the TFI, 73.4% of patients reported significant relief.
Key Study Results
The analysis found that patients had a mean reduction of 28 points on the THI scale and 25.9 points on the TFI scale. According to the authors, this is nearly four times the clinically significant threshold. The data also showed improvement over time, with 80.3% of patients reporting a clinically meaningful reduction after six weeks of treatment with Lenire, increasing to 84.1% by the 12-week mark.
These findings are consistent with two previous real-world analyses of US patients treated with Lenire, as well as the TENT-A3 controlled clinical trial that supported the device’s FDA approval in 2023.
“This research underscores not just the proven effectiveness of Lenire, but also the important relationship between a hearing care professional and their patients,” says Brian Fligor, PhD, audiologist-in-chief and owner of Tobias & Battite Hearing Wellness.
Device and Treatment Protocol
Lenire is a tinnitus treatment device that uses bimodal neuromodulation, delivering audio tones through headphones combined with mild electrical stimulation to the tongue. Under the guidance of an audiologist, patients typically use the device at home for two 30-minute sessions daily for about 12 weeks.
“Across three papers, we are seeing consistent real-world outcomes that continue to demonstrate the replicability and scalability of Lenire as a treatment option for tinnitus patients, who are a growing and underserved patient population,” says Dr Ross O’Neill, founder and CEO of Neuromod Devices, in a release. “Analysis conducted by Tobias & Battite Hearing Wellness that publishes positive patient results using the TFI scale further demonstrates Lenire’s market-surpassing treatment effectiveness and positions Lenire as a leading standard of care for tinnitus patients.”
