The Lenire system uses bimodal auditory and tongue stimulation to treat tinnitus. FDA-approved since 2023, the device has shown efficacy and safety in initial trials. Using the MAUDE database, we conducted preliminary post-market surveillance. This retrospective review analyzed reports of the Lenire device from 2023 to 2025. Event characteristics were examined for initial trends....
✦ The floor
Discussion
Signed responses from readers of the wire.
Clinicians fitting or referring patients for Lenire should review the emerging real-world adverse event and efficacy data from MAUDE to counsel patients accurately, though practice-changing conclusions require full review of the published findings.
Post-market surveillance of a novel FDA-approved tinnitus device provides early real-world safety signals that complement controlled trial data and can directly inform patient counselling.
- 01Post-market study of Lenire, the FDA-approved bimodal neuromodulation device for tinnitus, using MAUDE database reports.
- 02Evaluates real-world safety and efficacy signals outside of controlled trial conditions.
- 03MAUDE data captures adverse event and malfunction reports submitted to the FDA.
- 04First post-market surveillance analysis specifically targeting Lenire.
- 05Findings may help clinicians set realistic patient expectations for bimodal neuromodulation.
MAUDE database data can be used to evaluate real-world efficacy and safety of the Lenire bimodal neuromodulation system.
studypartially supportedLenire is an FDA-approved bimodal neuromodulation device for tinnitus.
guidelinesupported- PMID
- 42992588
- DOI
- 10.1002/ohn.70513.
- Journal
- Otolaryngology–Head and Neck Surgery
- Publication type
- research_article
- Evidence level
- 4
- Population
- Users of the Lenire FDA-approved tinnitus device reporting to the MAUDE adverse event database
- Intervention
- Lenire bimodal neuromodulation system (tongue + sound stimulation) for tinnitus
Primary outcomes
Real-world safety events (adverse events and malfunctions from MAUDE); Real-world efficacy signals post-FDA approval