Preceptis Medical announced earlier this week that the FDA has cleared expanded indications for its Hummingbird Tympanostomy Tube System (TTS).
New labeling for the Hummingbird system for in-office pediatric ear tube procedures allows for in-office procedures in all children six months and older.
Previous FDA clearance permitted use in children ages six months to 24 months, Maple Grove, Minn.-based Preceptis said in a press release. The FDA initially 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 (ENT) specialists to make an incision and place an ear tube in a single pass in the office environment.
Preceptis said the device eliminates the need for fasting, general anesthesia and the operating room and has demonstrated 98% success in an office setting. The procedure only requires topical anesthesia, with parents allowed to be present with their child for additional comfort.
“This device has been a game-changer for patients and families. Having their child’s ear tubes placed during a quick visit to the office is comforting to parents, and they are pleased with the results. We look forward to bringing this procedure to even more eligible patients,” said Dr. Nathan Page, pediatric otolaryngologist at Phoenix Children’s, one of the nation’s largest pediatric health care systems.
Preceptis said approximately 1 million children undergo ear tube procedures each year in US operating rooms, meaning office placement using the Hummingbird system could save thousands of dollars per patient. by moving the location of the procedure.
The company has completed the initial launch of the Hummingbird TTS system and said it plans to “build on strong momentum and strong demand” with a broader commercial launch to further broaden access to its system down the line.
“When we launched Preceptis, our goal was to provide a safe, simple and less expensive ear tube procedure option for all families,” said Preceptis CEO Steve Anderson. “This final label extension represents the work of many ENTs, clinical study coordinators and team members, and I appreciate the trust parents place in Preceptis and our ENTs while participating in the study. .”