LAKE FOREST, Calif., Oct. 7, 2026 /PRNewswire/ -- Sonorous Neurovascular, a clinical-stage medical device company developing purpose-built therapies for cerebral venous disease, today announced that the U.S. Food and Drug Administration (FDA) approved its Investigational Device Exemption (IDE) on October 2, 2026, authorizing the company to begin B-SILENT 2, a U.S. pivotal trial of the BosSTENT™. The BosSTENT™ is a braided, self-expanding stent engineered specifically for the cerebral venous sinuses to treat pulsatile tinnitus caused by venous sinus stenosis. B-SILENT 2 is the first FDA-approved IDE trial of a venous sinus stent for the treatment of pulsatile tinnitus.
Venous sinus stenosis is the most common cause of pulsatile tinnitus, which can be severely disabling. As reported in the ARISE II consensus on venous sinus stenting (American Journal of Neuroradiology, 2026), 46% of patients with pulsatile tinnitus report significant depression, 37% report disabling anxiety, and 15% report suicidal ideation.
The IDE approval is Sonorous' third FDA milestone in eight months, following Breakthrough Device Designation for the BosSTENT™ in February 2026 and 510(k) clearance of the BosCATH™ Support Catheter in April 2026. Sonorous now has parallel pivotal programs in the United States and internationally alongside an FDA-cleared product. The company expects to begin U.S. enrollment in the fourth quarter of 2026.