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....
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Discussion
Signed responses from readers of the wire.
No actionable change — this is a regulatory authorization for a pivotal trial; the BosSTENT device is investigational and not yet approved for clinical use.
If successful, this pivotal trial could establish the first dedicated device-based treatment pathway for cerebral venous sinus-related pulsatile tinnitus, a condition with very limited current options.
- 01FDA has authorized Sonorous Neurovascular to begin a pivotal trial of the BosSTENT device.
- 02The device targets pulsatile tinnitus caused by cerebral venous sinus stenosis (narrowing of brain drainage veins).
- 03Pulsatile tinnitus is a distinct subset of tinnitus driven by vascular, not auditory, pathology.
- 04BosSTENT remains investigational — no approval for routine clinical use has been granted.
- 05This represents a neurovascular/interventional approach to a condition traditionally managed conservatively.
Sonorous Neurovascular has received FDA authorization to begin a pivotal clinical trial of the BosSTENT device.
press releasesupportedThe BosSTENT is intended to treat pulsatile tinnitus associated with cerebral venous sinus conditions.
press releaseunclear