Sonorous gains FDA IDE for pulsatile tinnitus stent trial

Sonorous has received FDA investigational device exemption approval to begin a pivotal trial of its BosSTENT device for pulsatile tinnitus, according to Medical Device Network.

The FDA IDE approval is the latest regulatory milestone reported for the company’s pulsatile tinnitus stent program. Medical Device Network said the authorization supports initiation of the pivotal trial.

Regulatory milestone for BosSTENT

The IDE approval follows BosSTENT’s FDA breakthrough device designation in February 2026, Medical Device Network reported. The sequence places the device’s breakthrough designation ahead of the newly reported trial authorization.

For medical-device sales professionals, the update is a focused example of how regulatory designations and IDE decisions can shape the development path of a specialized device program. The reported event concerns the authorization to initiate a pivotal clinical trial rather than a commercial clearance or approval.

Why the update matters

Pulsatile tinnitus is the clinical area named in the report, and BosSTENT is the device at the center of the FDA action. The reported IDE gives Sonorous the ability to move its pivotal trial forward.

Medical Device Network identified the prior breakthrough device designation as an important part of the program’s regulatory history. Together, the milestones provide a concise update for professionals tracking FDA activity, clinical-trial progression, and emerging technologies in medical devices.

Key reported details

• Sonorous received FDA IDE approval, according to Medical Device Network.
• The approval supports initiation of a pivotal trial for BosSTENT.
• The device is associated with pulsatile tinnitus.
• BosSTENT received FDA breakthrough device designation in February 2026.