LAKE FOREST, CALIFORNIA — Sonorous Neurovascular has received authorization from the U.S. Food and Drug Administration (FDA) to begin a pivotal clinical trial evaluating its investigational BosSTENT™ device for the treatment of pulsatile tinnitus associated with cerebral venous sinus stenosis.
The FDA approved the company’s Investigational Device Exemption (IDE) on October 2, 2026, allowing Sonorous to initiate B-SILENT 2, a U.S. clinical study designed to evaluate the safety and effectiveness of a stent developed specifically for the cerebral venous sinuses.
According to Sonorous, B-SILENT 2 represents the first FDA-authorized IDE pivotal trial of a venous sinus stent for the treatment of pulsatile tinnitus. The company expects to begin enrolling U.S. patients during the fourth quarter of 2026.
Evaluating a Vascular Treatment for Pulsatile Tinnitus
Pulsatile tinnitus is characterized by a rhythmic sound, frequently described as whooshing or pulsing, that synchronizes with a person’s heartbeat. Unlike many other forms of tinnitus, pulsatile tinnitus may have an identifiable vascular cause.
One potential cause is cerebral venous sinus stenosis, a narrowing of the large veins responsible for draining blood from the brain. In some patients, this narrowing can produce turbulent blood flow that is perceived as sound.
The BosSTENT is a braided, self-expanding stent engineered specifically for cerebral venous anatomy. It is designed to support the narrowed venous sinus and improve blood flow, potentially reducing or eliminating the vascular sound associated with the condition.
Although venous sinus stenting has been used in selected patients with pulsatile tinnitus, the new U.S. trial is intended to generate prospective clinical evidence for a device specifically developed for this application.
“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, MD, of Lahey Hospital & Medical Center, 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.”
B-SILENT 2 Expands Clinical Research Into the United States
The FDA authorization adds a U.S. pivotal study to Sonorous Neurovascular’s international clinical development program.
The company’s separate B-SILENT study, which expanded into Canada with its first patient enrollment in August 2026, is continuing across clinical sites in France and Canada. That international study is evaluating the safety and clinical performance of BosSTENT in patients with debilitating pulsatile tinnitus caused by symptomatic venous sinus stenosis.
The international B-SILENT study (NCT07070089) is intended to support a future CE Mark submission, while B-SILENT 2 will generate evidence for the U.S. regulatory pathway.
Joel M. Harris, chief executive officer of Sonorous Neurovascular, described the FDA authorization as an important step toward establishing a purpose-built treatment option for patients with debilitating pulsatile tinnitus.
“Together with our international B-SILENT program, B-SILENT 2 gives us a clear clinical pathway to generate the evidence needed to bring BosSTENT™ to patients in the United States and other major markets,” Harris said.
Building on Previous FDA Milestones
The IDE authorization follows two earlier regulatory developments for Sonorous Neurovascular in 2026.
In February, the FDA granted Breakthrough Device Designation to BosSTENT for the treatment of debilitating pulsatile tinnitus associated with symptomatic cerebral venous sinus stenosis. The designation is intended to facilitate the development and review of certain medical devices addressing serious conditions, but does not constitute marketing approval.
In April, Sonorous received FDA 510(k) clearance for its BosCATH™ support catheter, which is intended to facilitate the introduction of therapeutic devices into neurovascular and peripheral blood vessels.
The BosCATH clearance is separate from the regulatory status of BosSTENT, which remains investigational.
Omar A. Choudhri, MD, of University of Chicago Medicine AdventHealth, co-principal investigator of B-SILENT 2, said the new study also builds on the recently published ARISE II consensus concerning venous sinus stenting.
The ARISE II consensus, published in the American Journal of Neuroradiology, addresses clinical considerations surrounding venous sinus stenting, including patient selection and treatment of venous pulsatile tinnitus.
Next Steps for BosSTENT
With FDA IDE authorization secured, Sonorous Neurovascular plans to initiate U.S. enrollment in B-SILENT 2 during the fourth quarter of 2026, while continuing its international B-SILENT program.
The studies are intended to provide additional evidence concerning the safety and clinical effectiveness of a dedicated venous sinus stent in patients with pulsatile tinnitus associated with venous sinus stenosis.
BosSTENT remains an investigational device and is not approved for commercial sale in the United States. The FDA’s IDE authorization permits the clinical investigation to proceed; it does not establish that the treatment is safe or effective.
About Sonorous Neurovascular
Sonorous Neurovascular is a clinical-stage medical device company headquartered in Lake Forest, California, focused on developing technologies for cerebral venous diseases. Its product portfolio includes the investigational BosSTENT™, designed for cerebral venous sinus applications, and the FDA-cleared BosCATH™ support catheter.
The company is conducting clinical research in the United States, France, and Canada to evaluate the use of BosSTENT for pulsatile tinnitus associated with cerebral venous sinus stenosis. For more information, visit www.sonorousnv.com.
Source: Sonorous Neurovascular
