Sonorous wins FDA IDE for pulsatile tinnitus stent pivotal trial initiation

Sonorous’ FDA IDE approval follows its BosSTENT’s receipt of FDA breakthrough device designation in February 2026. Sonorous’ FDA IDE approval follows its BosSTENT’s receipt of FDA breakthrough device designation in February 2026. Venous sinus stenosis is increasingly recognised as the dominant cause of pulsatile tinnitus. Credit: New Africa/Shutterstock.com 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…

Source: Medical Device Network