Sonorous Neurovascular Receives FDA Breakthrough Device Designation for BosSTENT™, First Braided Self-Expanding Cerebral Venous Stent, to Treat Debilitating Pulsatile Tinnitus

LAKE FOREST, Calif., Feb. 5, 2026 /PRNewswire/ -- Sonorous Neurovascular, a pioneering medical device company dedicated to advancing neurovascular therapies, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Device Designation to the BosSTENT™ device.  

The FDA's Breakthrough Devices Program aims to provide patients and healthcare providers with more timely access to innovative medical devices that have the potential to provide more effective treatment or diagnosis of life-threatening or irreversibly debilitating diseases or conditions.

Symptomatic venous sinus stenosis is a primary contributor to debilitating pulsatile (pulse-synchronous) tinnitus. Current treatment options remain limited for many patients. The BosSTENT™, a purpose-built braided, self-expanding stent, delivers an optimized solution through its proprietary design —featuring optimal radiopacity, enhanced visibility, resheathability for precise deployment, and excellent conformability in complex anatomy.

"This FDA Breakthrough Device Designation is a major milestone for Sonorous Neurovascular and, most importantly, for the patients suffering from debilitating pulsatile tinnitus," said Joel Harris, President, Sonorous Neurovascular. "The BosSTENT™ represents years of focused innovation to deliver an on-label, minimally invasive solution that normalizes venous hemodynamics and has the potential to dramatically improve quality of life for individuals with pulsatile tinnitus. We are grateful for the FDA's recognition and look forward to collaborating closely under this program to accelerate access to treating patients."

The designation follows promising early clinical experience, including first-in-human uses and ongoing studies evaluating the safety and performance of the BosSTENT™ in treating pulse-synchronous tinnitus and other symptoms of venous sinus stenosis.

Sonorous Neurovascular is advancing clinical trials and regulatory pathways to bring the BosSTENT™ to patients in the United States and beyond.

About Pulsatile (pulse-synchronous) Tinnitus

Pulsatile (pulse-synchronous) tinnitus is a form of tinnitus characterized by a rhythmic whooshing, thumping, or pulsing sound in one or both ears that synchronizes with the individual's heartbeat. The condition often stems from identifiable vascular or circulatory issues, such as turbulent blood flow near the ear caused by cerebral venous sinus abnormalities.

About Sonorous Neurovascular

Sonorous Neurovascular is a clinical-stage medical device company focused on developing transformative solutions for cerebral venous diseases. The company's flagship BosSTENT™ is designed to address symptomatic cerebral venous sinus stenosis, offering hope to patients with debilitating pulsatile tinnitus. Headquartered in Lake Forest, California, USA, Sonorous Neurovascular is committed to innovation that improves patient outcomes through minimally invasive technologies and diagnostics to enhance patient care.

Contact Information:
James D. Nonato
Sonorous Neurovascular
Email: [email protected]
Phone: +1 (949) 810 0055
https://www.sonorousnv.com/ 

SOURCE Sonorous Neurovascular