A new retrospective real-world analysis of U.S. tinnitus patients treated with Lenire, an FDA-approved bimodal neuromodulation device, demonstrates effectiveness consistent with clinical trial results. The study offers hope for individuals suffering from tinnitus, a condition affecting millions.
The study, available on medRxiv, analyzed data from 220 patients with moderate or worse tinnitus who received treatment at the Alaska Hearing & Tinnitus Center (AHTC) between May 2023 and June 2024. Authored by Emily McMahan, AuD, of AHTC and Professor Hubert Lim, PhD, from the University of Minnesota, the analysis revealed that 91.5% of patients experienced a clinically meaningful reduction in tinnitus after 12 weeks of treatment with Lenire. Additionally, 78.0% reported similar benefits after just 6 weeks.
High Patient Satisfaction
The study also highlighted high patient satisfaction, with 89.2% of patients reporting they benefited from Lenire treatment. Impressively, 96.4% of patients completed the full 12-week treatment program.
"My tinnitus was getting worse and worse to the point it was affecting my sleep and causing me anxiety," said Mike McGaughey, a tinnitus patient at AHTC. "After 12 weeks of Lenire, I no longer feel tortured by my tinnitus. Lenire has given me a new lease on life."
TENT-A3 Clinical Trial Confirmation
Lenire's FDA approval was based on the success of the TENT-A3 clinical trial, whose results were published in Nature Communications. The trial included 112 participants, with 70.5% of those with moderate or worse tinnitus experiencing a clinically meaningful reduction after 6 weeks of Lenire use, when sound alone provided no significant benefit.
Over the entire TENT-A3 trial, 82.4% of participants were compliant with the bimodal treatment, and 88.6% indicated they would recommend Lenire as a tinnitus treatment.
Consistent Results
"Typically for medical interventions, results experienced by real-world patients are not as positive as clinical trial results due to the controlled nature of those trials," said Neuromod Chief Scientific Officer and University of Minnesota Professor Hubert Lim. "The real-world results from Dr McMahan’s practice are consistent with clinical trial data. They are a testament to her care for her patients and demonstrate that Lenire can be an effective treatment for tinnitus."
Lenire Training and Availability
Neuromod, the creator of Lenire, provides comprehensive training to partner clinics to ensure optimal patient care. Lenire is currently available in specialized tinnitus clinics across the United States and Europe and is also a treatment option for U.S. Veterans.
Tinnitus affects an estimated 25 million Americans and is the most prevalent service-connected disability compensated by the United States Veterans Administration (VA), with over 2.9 million veterans compensated in 2023.
