Early Post‐Market Surveillance of Bimodal Neuromodulation for Tinnitus

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 MAUDE database has limitations, including underreporting and reporting bias. Nine unique reports related to the Lenire device were extracted from MAUDE. The most commonly reported events included tinnitus exacerbation (n = 6), no tinnitus improvement (n = 2), and fatigue (n = 1). There was a single death from suicide temporally associated with device use and preceded by episodic tinnitus worsening, then overall improvement, but causality could not be established. Five patients had sustained tinnitus exacerbation after device discontinuation and were reportedly unaware of the potential treatment-related adverse effect. The findings, although limited by reporting bias and lack of validation, have identified reports of users who may experience adverse effects, including tinnitus exacerbation that may continue even after device discontinuation.