FDA clears ear tube device for all children aged 6 months or older
Click Here to Manage Email Alerts
The FDA recently cleared the use of Preceptis Medical’s Hummingbird Tympanostomy Tube System, a device for in-office ear tube procedures, for children aged 6 months and older.
Previously cleared for use only in children aged 6 to 24 months, the device is marketed as eliminating any need for intense surgical intervention during ear tube procedures, with the ability to allow an otolaryngologist to perform procedures in the office.
Steve Anderson, CEO of Preceptis Medical, told Healio the idea for the device came from an exchange with a neighbor while Anderson’s two children — both of whom had received ear tubes at a young age — played nearby.
“We were both kind of focused on the potential for doing something new in the ear, nose and throat [ENT] space with ear tubes,” Anderson said.
“We had both seen the opportunity,” Anderson continued, “because there are 1 million children a year in the United States alone who get ear tubes, and these are all done in the operating room under general anesthetic with the requisite costs. Both my kids had gone through tubes and multiple sets of tubes: my daughter had tubes; my son had four sets of tubes. Our thought was that we could come up with a technology that would significantly reduce the trauma for the child and make it so that they could enable your true procedure in the office for the child.”
The device, Anderson explained, replaces the instruments and surgical passes into the ear required by surgical tube procedures, “which cause pain and trauma for the child and make it very hard for them to sit still and withstand the procedure.” The Hummingbird was built to deliver a single incision in the eardrum and deliver the tube “in one pass,” he said.
“You've got a reduction in cost for the parents because you're not in the expensive operating room, you have an increase in convenience, and you have a reduction in risk because you're not having to deal with anything associated with an operating room or the child being under general anesthetic,” Anderson said.
Shelagh A. Cofer, MD, is division chair of pediatric otolaryngology at the Mayo Clinic in Rochester, Minnesota, and was among the first to test the device in its early stages of development.
“Most ENT clinics don't offer sedation. They're not set up to administer nitrous oxide or to give sedating drugs,” Cofer told Healio. “That's not really a part of the ENT clinic workflow. But we decided that maybe [we] are different. Our device is so slick and could allow us to insert tube so quickly that you could just do it on young children in the office with just using topical anesthesia.”
Cofer said the device enables her to perform procedures “usually in under 3 minutes.” She estimates that she has used the device in 100 procedures since the initial FDA clearance.
Parents are also enthused by the results of the device, Cofer said, which allows them to sit by their child’s side in the physician’s office instead of sending them into an operating room.
“The parents are really happy that [their child avoids] general anesthesia, that their child didn't have to fast, that it was convenient for them, and that they did not have to schedule a date in the future to come back [for a follow-up],” Cofer said.
Cofer added that although not every patient is eligible for the procedure, the clearance is a massive step forward for those who are.
“My philosophy has always been, let's get the right patients and the right procedure in the right setting,” Cofer said. “So, it's not a fail if you have to take somebody to [the operating room] to put your tubes in, but if you can accomplish it in clinics, for the vast majority of young children who need and will only need one set of ear tubes, this is an awesome option.”
Collapse
Read more about
Click Here to Manage Email Alerts