The US Food and Drug Administration (FDA) has approved Sonorous Neurovascular’s investigational device exemption (IDE) application for its venous sinus stent, making it the first company to receive a green light from the agency to evaluate a purpose-built stent for the treatment of pulsatile tinnitus in a pivotal trial.
The California-based company’s BosSTENT, a self-expanding stent designed for the cerebral venous sinuses to treat pulsatile tinnitus caused by venous sinus stenosis, will be evaluated in the B-SILENT 2 trial, with enrolment expected to begin in Q4 2026.
Venous sinus stenosis, which causes blood vessels on the surface of the brain that drain deoxygenated blood and cerebrospinal fluid (CSF) back toward the heart to narrow, is increasingly recognised as the dominant cause of pulsatile tinnitus. While Neuromod Devices’ Lenire is approved in the US for tinnitus, the pulsatile form remains an unaddressed area. There are no devices authorised by the FDA specifically to treat pulsatile tinnitus.