The short version
- The FDA has given Sonorous Neurovascular permission to run a pivotal US trial of a stent built to treat pulsatile tinnitus caused by a narrowed vein in the head.
- Pulsatile tinnitus is a whooshing in time with the heartbeat, and a July consensus paper calls a narrowed venous sinus its most common cause.
- The permission is to test the device and not to sell it, and the company has not published the trial’s size, comparison group or endpoints.
Most tinnitus is a steady ring or hiss. Pulsatile tinnitus is a whoosh that keeps time with the heartbeat, and it can have a plumbing cause: a narrowing in one of the large veins that drain blood from the brain, where turbulent flow becomes audible. This month the FDA gave Sonorous Neurovascular, of Lake Forest, California, an investigational device exemption to run B-SILENT 2, a pivotal US trial of its BosStent, a braided, self-expanding stent designed for those veins. The company calls it the first FDA-authorized pivotal trial of a venous sinus stent for the condition and expects to enroll US patients in the fourth quarter of 2026.
Doctors already place stents in these veins. A consensus statement published in July in the American Journal of Neuroradiology called venous sinus stenosis the most common cause of pulsatile tinnitus and backed stenting for carefully selected patients. That statement is expert opinion from a roundtable that included industry, and one of the new trial’s two lead investigators is among its authors. The other, Emanuele Orru of Lahey Hospital & Medical Center, said patients “deserve treatment decisions based on rigorous evidence rather than extrapolation from devices and indications developed for other conditions.” Endovascular Today, citing the consensus paper, reports that 46% of people with pulsatile tinnitus describe significant depression and 37% disabling anxiety.
The news comes from a company release. It gives no sample size, comparison group or endpoints. A sister study, B-SILENT, is enrolling in France and Canada. This is a different condition from the steady tinnitus in the UConn blood-marker studies and the French sound-generator trial.
An exemption is permission to test a device, and no results exist yet.
