LAKE FOREST, CALIFORNIA — Sonorous Neurovascular has enrolled the first Canadian patient in its international B-SILENT clinical study evaluating the investigational BosSTENT™ for the treatment of debilitating pulsatile tinnitus associated with symptomatic cerebral venous sinus stenosis.
The enrollment took place at The Ottawa Hospital under principal investigator Dr. Robert Fahed and marks the study’s expansion into Canada. The B-SILENT study (NCT07070089) is also actively enrolling patients at four sites in France.
Dr. Robert Fahed, Principal Investigator for the B-SILENT study at The Ottawa Hospital
Pulsatile tinnitus is characterized by a rhythmic sound, often described as a whooshing sensation, that synchronizes with a person’s heartbeat. Unlike more common forms of subjective tinnitus, pulsatile tinnitus can sometimes be linked to an identifiable vascular cause.
In some patients, narrowing of the large veins that drain blood from the brain — known as cerebral venous sinus stenosis — can create turbulent blood flow that is perceived as sound.
B-SILENT Study Evaluates BosSTENT for Venous Pulsatile Tinnitus
The B-SILENT clinical trial is evaluating the investigational use of BosSTENT™, a braided, self-expanding cerebral venous stent developed by Sonorous Neurovascular. The device is intended to restore blood flow through areas of venous narrowing and reduce or relieve pulsatile tinnitus associated with symptomatic cerebral venous sinus stenosis.
The study is designed to generate safety and performance data in support of a future CE Mark submission.
“Achieving our first enrollment in Ottawa is an important milestone for Sonorous Neurovascular and, most importantly, for patients living with debilitating pulsatile tinnitus,” said Joel Harris, CEO of Sonorous Neurovascular.
“With four sites already actively enrolling in France and now our first Canadian enrollment complete, B-SILENT is advancing exactly as planned. We are grateful to Dr. Fahed and the team at The Ottawa Hospital for their partnership, and to our study teams across France and Canada for the continued momentum. This is an exciting step forward for the program and for the patients we aim to serve.”
“As Principal Investigator for the B-SILENT study at The Ottawa Hospital, I’m encouraged by the successful enrollment of our first patient. Pulsatile tinnitus can be a debilitating and often under-recognized condition, and studies like B-SILENT are important steps toward giving physicians new tools to help patients who have limited options today. I look forward to our site’s continued contribution to this study,” said Dr. Robert Fahed, The Ottawa Hospital.
International Clinical Development Continues
The Canadian enrollment follows continued recruitment in France as Sonorous advances the B-SILENT program across multiple international sites.
Dr. Robert Fahed (center) with members of the clinical care team at The Ottawa Hospital following the study’s first patient enrollment. Source: Sonorous Neurovascular
The company has also reached several regulatory milestones in the United States. In February 2026, the BosSTENT received FDA Breakthrough Device Designation for the treatment of debilitating pulsatile tinnitus associated with symptomatic cerebral venous sinus stenosis. Sonorous subsequently received FDA 510(k) clearance for its BosCATH™ neurovascular catheter in April 2026.
According to Sonorous, the company is continuing to pursue both U.S. and international regulatory pathways for its neurovascular technologies while advancing clinical research focused on pulsatile tinnitus and other cerebral venous disorders.
About Sonorous Neurovascular
Sonorous Neurovascular is a clinical-stage medical device company headquartered in Lake Forest, California, dedicated to developing transformative technologies for the treatment of cerebral venous diseases. The company’s innovative portfolio, including the BosSTENT™ (recently granted FDA Breakthrough Device Designation) and BosCATH™, aims to provide safe, effective, and purpose-built solutions that improve patient outcomes.
Sonorous is actively advancing international clinical research, including the B-SILENT study (NCT07070089) evaluating the investigational use of BosSTENT™ for debilitating pulsatile tinnitus at sites in France and Canada to support CE Mark submission. For more information, visit www.sonorousnv.com.
Source: Sonorous Neurovascular
