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.
“FDA IDE approval represents a major milestone for Sonorous and for our mission to establish a purpose-built treatment for patients suffering from debilitating pulsatile tinnitus caused by venous sinus stenosis,” said Joel M. Harris, Chief Executive Officer of Sonorous Neurovascular. “Together with our international B-SILENT program, B-SILENT 2 gives us a clear clinical pathway to generate the evidence needed to bring BosSTENT™ to patients in the United States and other major markets. BosSTENT™ was designed specifically for cerebral venous anatomy, and this milestone further advances our strategy of building a comprehensive platform for cerebral venous disease.”
“Pulsatile tinnitus can be profoundly disabling, and our patients deserve treatment decisions based on rigorous evidence rather than extrapolation from devices and indications developed for other conditions,” said Emanuele Orru, MD, of Lahey Hospital & Medical Center, Co-Principal Investigator of B-SILENT 2. “This study is an important opportunity to evaluate a device designed specifically for the venous sinus and to establish a more rigorous framework for patient selection and treatment of venous pulsatile tinnitus.”
“This is an important milestone in the journey to have purpose-built devices for debilitating pulsatile tinnitus. It also builds on the ARISE II consensus that we recently published, to recognize venous sinus stenting as a first line solution for debilitating venous pulsatile tinnitus,” said Omar A. Choudhri, MD, of University of Chicago Medicine AdventHealth, Co-Principal Investigator for B-SILENT 2.
Outside the United States, the B-SILENT study (NCT07070089) is actively enrolling over six sites in France and Canada to support CE Mark certification of the BosSTENT™.
CAUTION: The BosSTENT™ is an investigational device. Limited by United States law to investigational use. It is not available for sale in the United States.
About Pulsatile Tinnitus
Understanding Sonorous Neurovascular and Its Role in Pulsatile Tinnitus Treatment
Pulsatile tinnitus is a rhythmic whooshing or pulsing sound synchronized with the heartbeat. Unlike most tinnitus, it often has an identifiable vascular cause, most commonly a narrowed transverse or sigmoid venous sinus, and for many patients it is persistent and disabling.