Preceptis Device Cleared for Ear Tube Procedures

FDA has cleared a Preceptis Medical 510(k) for expanded indications for its Hummingbird Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children aged 6-24 months, the new labeling allows in-office procedures in all children six months and older. The company says about one million children undergo ear tube procedures annually in an operating room in the U.S.

The Hummingbird TTS combines the separate tools and steps performed in standard ear tube procedures into one consolidated device. “With the Hummingbird, otolaryngologists or ear, nose and throat specialists (ENTs) can now make an incision and deliver an ear tube using a single pass in the office environment,” the company says. “The device eliminates the need for fasting, general anesthesia, and an operating room – all with 98% success in the office setting.”