Study of BosSTENT Device for Treating Pulse-Synchronous Tinnitus Caused by Venous Sinus Stenosis in Adults Aged 18 to 80

What this Trial Is About

Researchers are evaluating the safety and clinical performance of the BosSTENT, a new medical device designed specifically to treat pulse-synchronous tinnitus caused by venous sinus stenosis. The study aims to assess the long-term safety of the BosSTENT and its effect on reducing the severity of this type of tinnitus. This interventional trial is sponsored by Sonorous NV, Inc and targets adult participants aged 18 to 80 years with severe pulse-synchronous tinnitus that responds to jugular vein compression. Participants will undergo BosSTENT implantation in the transverse venous sinus. The study involves monitoring the incidence of major adverse events within three months after implantation and measuring improvement in tinnitus severity at 30 days using the Tinnitus Handicap Inventory THI. The trial does not include a comparator group or masking. The device is implanted to evaluate its therapeutic potential in this specific condition. During the study, participants must comply with all protocol requirements and attend clinical evaluations and follow-up visits. Researchers will track safety and tinnitus outcomes through clinical assessments and the THI questionnaire. The total study participation will extend at least three months after the procedure to monitor adverse events and treatment impact. Participants long-term health and tinnitus changes will be carefully observed under medical supervision throughout the trial period.

BosSTENT Implantation to Treat Pulse-Synchronous Tinnitus