Preceptis Medical today announced FDA clearance that allows placement of its Hummingbird tympanostomy tube system in an ENT surgeon’s office.
Officials at Maple Grove, Minn.–based Preceptis say the Hummingbird system significantly reduces trauma and procedure time for ear tube placement in young children. Kids receiving the ear tubes don’t need general anesthesia, and they don’t need to be in an operating room.
“Our office clinical study in over 200 children 6- to 24-months-old showed a 99% success rate in the office and a total procedure time of 5 minutes. This clearance will allow parents an option to have their child’s ear tubes placed without the need for general anesthesia or an operating room, while significantly reducing their costs,” Preceptis Medical CEO Steve Anderson said in a LinkedIn post.
Anderson in a company news release described the 510(k) clearance as an important milestone.
Dr. Shelagh Cofer, an otolaryngologist at Mayo Clinic and principal investigator for the Hummingbird, thinks the system represents a major advancement. “The benefits of the option of office ear tubes are huge in terms of convenience for patients and caregivers, reduction of risk and exposure to general anesthetic, and potential cost savings as well.”
Preceptis Medical plans a pilot commercial launch in select markets in the second half of 2020.