Preceptis Medical today announced its Hummingbird tympanostomy tube system (TTS) has received FDA 510(k) clearance for use in children six months and older.
The Hummingbird TTS is used in office-based pediatric ear tube procedures. The Maple Grove, Minnesota-based company designed the system to allow ENTs to make an incision and deliver, position and place an ear tube using a single device in a single pass. Hummingbird TTS was previously cleared in children six to 24 months old.
“This device has been a game changer 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,” Dr. Nathan Page, pediatric otolaryngologist at Phoenix Children’s, said in a news release.
Ear tubes are designed to drain fluid from the Eustachian tube in the ear. They also allow air to get into the middle ear, according to Children’s Minnesota. The procedures are typically performed in the operating room under general anesthesia.
“Our goal when we started Preceptis was to provide a safe, simple, and less expensive ear tube procedure option to all families. 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,” CEO Steve Anderson said.
Preceptis Medical launched Hummingbird TTS for in-office pediatric ear tube procedures in June last year.
“Parent and ENT feedback has been extremely positive, and we have seen ever-increasing demand for the in-office ear tube procedure option as more parents, pediatricians, and ENTs become aware of the product,” said Chief Commercial Officer Greg Mielke.
