IDE Approved for Sonorous Neurovascular’s B-SILENT 2 Pivotal Trial for BosStent to Treat Pulsatile Tinnitus

October 9, 2026—Sonorous Neurovascular announced that the FDA approved an investigational device exemption (IDE) authorizing the company to begin B-SILENT 2, the United States pivotal trial of the BosStent. The company expects to begin United States enrollment in the fourth quarter of 2026.

According to the company, the BosStent is a braided, self-expanding stent designed for the cerebral venous sinuses to treat pulsatile tinnitus caused by venous sinus stenosis.

Sonorous noted that the recent ARISE II consensus on venous sinus stenting reported that 46% of patients with pulsatile tinnitus report significant depression, 37% report disabling anxiety, and 15% report suicidal ideation. ARISE II was published Matthew R. Amans, MD, et al online in the American Journal of Neuroradiology.

The IDE approval is the company’s third FDA milestone in 2026 after receiving Breakthrough Device designation for the BosStent in February 2026 and 510(k) clearance of the BosCath support catheter in April 2026.

The company further stated that outside the United States, the B-SILENT study is actively enrolling more than six sites in France and Canada to support CE Mark certification of the BosStent, noted the company. In August and September 2026, the company announced commencement of enrollment at Canadian sites in B-SILENT.

Emanuele Orru, MD, and Omar A. Choudhri, MD, are Coprincipal Investigators of B-SILENT 2. Dr. Orru is from Lahey Hospital & Medical Center in Burlington, Massachusetts. Dr. Choudhri is from University of Chicago Medicine AdventHealth in Chicago, Illinois.

“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,” commented Dr. Orru in the Sonorous press release. “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.”

Dr. Choudhri added, “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.”