Young children with recurring ear infections may soon have a new surgical option following the FDA approval of a breakthrough ear tube system.
The Tubes Under Local Anesthesia (Tula) System, approved Monday, will be the first surgical ear tube option for young children that does not require general anesthesia.
Ear infections are extremely common. Five out of every six children will have one before their third birthday, according to the National Institute of Deafness and Other Communication Disorders.
A doctor may prescribe antibiotics for a middle ear infection, but many common ear infections get better without them, according to MedicineNet author David Perlstein, MD, MBA, FAAP. He said children with recurring infections may be referred to an ear, nose, and throat specialist (ENT), and some of these children would benefit from ear tube surgery.
Repeated ear infections can cause scarring that may lead to hearing problems, Dr. Perlstein said. Ear tubes may be recommended, which can remove scarring. The tubes puncture the eardrum to allow fluid to drain, reducing painful pressure and minimizing the risk of future infections by removing infected materials, Dr. Perlstein said.
The Tula system is approved for adults and children as young as six months old. It was given a “breakthrough device” designation to expedite the approval process.
The new system was tested on 222 children. On children 5-12, the procedure had a success rate of 89%. In children under 5, the success rate was 86%.
The standard ear tube operation requires an anesthesiologist, according to John P. Cunha, DO, FACOEP, of MedicineNet.
“In the operating room, the anesthesiologist will usually use a mixture of gas and an intravenous medication for sedation,” Dr. Cunha said. “During the procedure, which typically takes 10 to 15 minutes, your child will be continuously monitored including pulse oximeter (oxygen saturation of blood) and cardiac rhythm (EKG). The surgical team is prepared for any emergency.”
According to the FDA, the most common adverse event in trials for the Tula system was inadequate local anesthesia. The Tula system is not intended for patients with pre-existing ear drum issues such as perforated ear drums.