Preceptis Medical announced earlier this week that the FDA cleared expanded indications for its Hummingbird tympanostomy tube system (TTS).
New labeling for the Hummingbird system for office-based pediatric ear tube procedures allows for in-office procedures in all children six months and older.
Previous FDA clearance allowed for the use in children between six months old and 24 months old, Maple Grove, Minnesota-based Preceptis said in a news release. The FDA originally cleared the system in 2020.
The company designed the Hummingbird TTS to combine the separate tools and steps performed in standard ear tube procedures into one comprehensive device. It allows otolaryngologists, or ear, nose and throat specialists (ENTs) to make an incision and deliver an ear tube using a single pass in the office environment.
Preceptis said the device eliminates the need for fasting, general anesthesia, and an operating room and has demonstrated 98% success in the…