FDA Expands Clearance of Preceptis Medical’s Hummingbird System

The FDA has expanded a 510(k) clearance of Preceptis Medical’s Hummingbird tympanostomy tube system for use in office-based pediatric ear tube procedures.

The ear tubes are small hollow cylinders inserted into the eardrum to enable drainage of the middle ear.

The system was previously only cleared for children six months to 24 months old. The expanded clearance now covers all children six months and older.

The Hummingbird system, which is designed to create an incision and place an ear tube in a single pass, has a 98 percent success rate when used in the office setting, the company said. The procedure does not require a general anesthetic.