Sonorous Neurovascular has announced that the US Food and Drug Administration (FDA) approved its investigational device exemption (IDE) earlier this month, authorising the company to begin B-SILENT 2—a US pivotal trial of the BosSTENT device.
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 described by Sonorous as the first US FDA-approved IDE trial of a venous sinus stent for the treatment of pulsatile tinnitus.
“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 (Lahey Hospital & Medical Center, Burlington, USA), 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 recognise venous sinus stenting as a first-line solution for debilitating venous pulsatile tinnitus,” added B-SILENT 2 co-principal investigator Omar Choudhri (University of Chicago Medicine AdventHealth, Chicago, USA).
This IDE approval is Sonorous’s third US 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 programmes in the USA and internationally alongside a US FDA-cleared product. The company expects to begin US enrolment in the fourth quarter of 2026.
Additionally, outside the USA, the B-SILENT study is actively enrolling across six sites in France and Canada to support CE-mark certification of the BosSTENT.
“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,” commented Joel Harris, chief executive officer (CEO) of Sonorous. “Together with our international B-SILENT programme, B-SILENT 2 gives us a clear clinical pathway to generate the evidence needed to bring BosSTENT to patients in the USA 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.”
