Sonorous Neurovascular BosSTENT for Pulsatile Tinnitus Receives FDA Breakthrough Device Designation

February 6, 2026—Sonorous Neurovascular announced that the FDA has granted Breakthrough Device designation for its BosSTENT, a braided, self-expanding cerebral venous stent for treating pulsatile tinnitus (PT).

According to the company, BosSTENT is purpose-built for the cerebral venous system and incorporates a proprietary braided design intended to provide radiopacity and enhanced visibility, resheathability for precise deployment, and conformability in complex anatomy. The device is designed to address symptomatic cerebral venous sinus stenosis, a primary contributor to debilitating PT.

Joel Harris, President of Sonorous Neurovascular, commented in the press release, “This FDA Breakthrough Device designation is a major milestone for Sonorous Neurovascular and, most importantly, for the patients suffering from debilitating PT. 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 PT.”

As noted in the press release, the designation follows early clinical experience with BosSTENT, including first-in-human uses and ongoing studies evaluating safety and performance in treating PT and other symptoms of venous sinus stenosis.

Sonorous added in the release that it is advancing clinical trials and regulatory pathways to bring BosSTENT to patients in the United States and beyond.