Preceptis Medical, a surgical technology company dedicated to providing less invasive options for pediatric patients, received U.S. FDA clearance for expanded indications for use for the Hummingbird Tympanostomy Tube System (TTS) for office-based pediatric ear tube procedures. Previously cleared in children 6-24 months, this new labeling allows in-office procedures in all children six months and older.
The Hummingbird Tympanostomy Tube System combines the separate tools and steps performed in standard ear tube procedures into one comprehensive device. With the Hummingbird, otolaryngologists or ear, nose, and throat specialists (ENTs) can now make an incision and deliver an ear tube using a single pass in the office environment. The device eliminates the need for fasting, general anesthesia, and an operating room—all with 98% success in the office setting. The procedure requires only a topical anesthetic, and parents can be present with their child to provide 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,” says Nathan Page, MD, pediatric otolaryngologist at Phoenix Children’s, one of the nation’s largest pediatric healthcare systems.
Approximately one million children undergo ear tube procedures annually in an operating room in the United States alone. In-office ear tube placement using the Hummingbird can save thousands of dollars per patient by shifting the procedure from the operating room to the office setting.
“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,” says Steve Anderson, CEO of Preceptis Medical.
Preceptis Medical has successfully completed its initial launch and plans to build on momentum and demand from parents and providers through a larger commercial launch to expand access to this option in the future.
“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,” added Greg Mielke, chief commercial officer for Preceptis. “We have also received strong support from the insurance community both locally and nationally, and this expanded label will increase patient access and improved health equity in our communities.”
1 FDA 510(k) files K200952 and K221254
2 IBM Marketscan Commercial Claims and Medicaid Database.