The FDA approved a new delivery system for tympanostomy tubes for the treatment of otitis media that does not require general anesthesia.
The Tubes Under Local Anesthesia (Tula) system is the first ear tube delivery system that can be used in the physician’s office in young children under local anesthesia, according to the FDA. It uses a small electric current to administer local anesthetic into the eardrum before tube insertion.
“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,” Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health, said in a news release. “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.”
Tula is comprised of Tusker Medical tympanostomy tubes, the anesthetic Tymbion and other equipment necessary for ear tube and anesthetic delivery to the eardrum. The FDA granted it Breakthrough Device status after Tula’s effectiveness was evaluated in 222 pediatric patients. Procedural success rates were 86% in children aged younger than 5 years and 89% in children aged 5 to 12 years, with the most common adverse event found to be inadequate anesthesia during the procedure.
The FDA warned that Tula is not suitable for use in patients aged younger than 6 months who have local anesthetic allergies or patients with pre-existing eardrum issues, such as a perforated eardrum.