NORTH TEXAS (CBSDFW.COM) – Some parents will no longer have to take their child to the hospital to have tubes put in their ears.
The U.S. Food and Drug Administration has approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that are inserted into the eardrum to treat recurrent ear infections.
“Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anesthesia. As millions of children suffer from ear infections every year, it is important to have safe and effective treatments available to this susceptible patient population,” said Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health.
The Tubes Under Local Anesthesia (Tula) System is the first ear tube delivery system that can be performed in young children using local anesthesia in a physician’s office setting. It uses a small electrical current to deliver a local anesthetic into the ear drum prior to tube insertion. It is approved for use in both adults and children as young as six months of age.
The Tula System consists of the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the ear tubes and the anesthetic into the ear drum.
“This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anesthesia and minimal discomfort,” said Dr. Shuren.
Ear infections are common in children, with the National Institute of Deafness and other Communication Disorders (NIDCD) estimating that 5 of 6 children will have at least one ear infection before their third birthday. While health care professionals frequently prescribe antibiotics as a treatment, if antibiotics fail to treat an ear infection, or if infections continue to occur, a doctor may recommend a surgical procedure to place a small tube in the eardrum. In young children, the delivery of an ear tube has traditionally been performed in a hospital setting or surgery center and required the patient to receive general anesthesia.
The FDA evaluated data provided by the sponsor from 222 pediatric patients to assess the effectiveness of the Tula System for the delivery of ear tubes. The procedural success rate was 86% and 89% in children younger than age 5 and between ages 5-12 years old, respectively.