Summary:
A retrospective real-world analysis of U.S. tinnitus patients treated with Lenire, an FDA-approved neuromodulation device, shows effectiveness consistent with clinical trial results, providing hope for tinnitus sufferers.
Key Takeaways:
- 91.5% of patients experienced a meaningful reduction in tinnitus after 12 weeks of treatment with Lenire.
- The study’s real-world results align closely with those from controlled clinical trials.
- Lenire is now a treatment option for U.S. Veterans and is available in specialized clinics in the U.S. and Europe.
The first retrospective real-world analysis study of U.S. tinnitus patients treated with Lenire, the FDA-Approved bimodal neuromodulation tinnitus treatment device, has been made available on medRxiv, the online pre-print server for health sciences.
Further Reading: Case Study: Using Lenire on Patient With Acoustic Neuroma
The results in the clinical trial paper, “Effectiveness of bimodal neuromodulation for tinnitus treatment in a real-world clinical setting in United States: A retrospective chart review,” found Lenire’s real-world effectiveness to be consistent with clinical trial results. This study has been reviewed by an Institutional Review Board (IRB).
The paper is available at: https://doi.org/10.1101/2024.08.22.24312175
Tinnitus, which is commonly known as “ringing in the ears,” is a complex neurological condition that causes a perception of sound when there is no external source. It is estimated that at least 25 million Americans are currently living with tinnitus3. Tinnitus is also the most prevalent service-connected disability compensated for by The United States Veterans Administration (VA), with more than 2.9 million veterans compensated in 20234.
Further Reading: Lenire Tinnitus Device Now a Treatment Option for US Veterans
Real-World Study Details
The paper, authored by Emily McMahan, AuD, of the Alaska Hearing & Tinnitus Center (AHTC) and Professor Hubert Lim, PhD, from the University of Minnesota, analyzed the results of 220 patients with moderate or worse tinnitus who treated their tinnitus at AHTC with Lenire between May 2023 and June 2024.
The analysis of 220 individuals is one of the largest ever conducted of real-world patients following their treatment for tinnitus with a medical device. The retrospective analysis of real-world patients revealed that 91.5% of patients experienced clinically meaningful reduction in tinnitus after 12 weeks of treatment with Lenire. 78.0% experienced clinically meaningful reduction in tinnitus after 6 weeks of treatment with Lenire1,5,6.
89.2% of patients in the real-world study said they benefited from treatment with Lenire1, where 96.4% of patients completed 12 weeks of treatment with Lenire1.
“My tinnitus was getting worse and worse to the point it was affecting my sleep and causing me anxiety.” says Mike McGaughey, 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.”
These positive results and high level of patient satisfaction in the real-world patient environment are consistent with clinical trial results and could give new hope to the chronically underserved tinnitus patient population.
“A combination of AHTC’s expertise, and collaboration with Lenire creator, Neuromod, has helped us achieve clinical outcomes that have exceeded our expectations and, in many instances, the results of the device’s clinical trials,” says Dr McMahan. “Lenire is a powerful tool, and the results outlined in this paper highlight how effective it can be with the right support and guidance.”
TENT-A3 Clinical Trial
Lenire is the first and only tinnitus treatment device of its kind approved by the US FDA following the success of the device’s controlled clinical trial, TENT-A3, according to the company. TENT-A3’s results were recently published in Nature Communications.2
TENT-A3 included 112 clinical trial participants. 70.5% of those with moderate or worse tinnitus had a clinically meaningful reduction in tinnitus after 6 weeks of using Lenire when sound alone had no clinically meaningful benefit2,5,6.
Over the entire TENT-A3 clinical trial, 82.4% were compliant to bimodal treatment, and 88.6% responded that they would recommend Lenire as a tinnitus treatment2.
“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,” says 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 Plan
According to the company, Lenire’s real-world success is a combination of scientifically proven technology and the expertise of a robust network of leading tinnitus experts. Neuromod, creators of Lenire, train and qualify partner clinics in person and supplement this education with the Lenire Academy learning platform and ongoing clinical affairs support to ensure positive patient outcomes.
“Neuromod operates a practice-enablement program with rigorous partner selection criteria, which ensures the highest level of tinnitus patient care in the real world,” says Neuromod USA CEO and Neuromod Devices President of Global Commercial Operations, Eric Timm. “This approach, combined with the expertise of our network of leading tinnitus care professionals, embodied by Dr McMahan, has ensured our real-world results closely resemble our clinical trial data.”
Lenire is available in specialized tinnitus clinics in the United States and Europe. Lenire is also a treatment option through Veterans Affairs.
Featured image: Patient using Neuromod’s Lenire bimodal neuromodulation tinnitus treatment device. Photo: Neuromod
