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 office setting. The procedure only requires a topical anesthetic, with parents allowed to be present with their child to provide any further comfort.
“This device has been a gamechanger for patients and families. Having their child’s ear tubes placed in a quick office visit is comforting to parents, and they have been happy with the results. We look forward to offering 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 that approximately 1 million children undergo ear tube procedures annually in U.S. operating rooms, meaning in-office placement using the Hummingbird system could save thousands of dollars per patient by shifting the location of the prcocedure.
The company has completed the initial launch of the Hummingbird TTS system and said it plans to “build on strong momentum and demand” through a larger commercial launch with eyes on further expanding access to its system down the line.
“Our goal when we started Preceptis was to provide a safe, simple, and less expensive ear tube procedure option to all families,” Preceptis CEO Steve Anderson said. “This final label expansion represents the work of many ENTs, clinical study coordinators, and team members, and I appreciate the trust parents put into Preceptis and our ENTs while participating in the study.”