FDA Approves First System to Insert Ear Tubes Under Local Anesthesia; Success rates of 86 and 89 percent reported for children <5, 5 to 12 years, respectively.
TUESDAY, Nov. 26, 2019 (HealthDay News) -- The U.S. Food and Drug Administration has approved the first tympanostomy tube delivery system that can be performed under local anesthesia in a physician's office, the agency announced Monday.
The Tubes Under Local Anesthesia (Tula) System is indicated for inserting tympanostomy tubes for the treatment of otitis media in adults and children ages 6 months and older. The system includes the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and devices needed for delivery of the ear tubes and the anesthetic into the ear drum. The Tula System uses a small electrical current to deliver the local anesthetic into the ear drum before tube insertion.
Approval was based on data from 222 pediatric patients. Reported procedural success rates were 86 and 89 percent in children younger than 5 years and in children 5 to 12 years old, respectively. The most commonly reported adverse event was inadequate anesthesia during the procedure.
The Tula System is not indicated for patients younger than 6 months of age or patients with allergies to local anesthetics. Patients with preexisting issues with their eardrum, such as perforated eardrum, are also contraindicated for the Tula System.
Approval was granted to Tusker Medical.