The Food and Drug Administration (FDA) has approved the Tubes Under Local Anesthesia (Tula) System (Tusker Medical) for the treatment of recurrent otitis media in patients ≥6 months of age.
The Tula system is the first tympanostomy tube delivery system that can be performed in young children using local anesthesia in a physician’s office setting. The system uses a small electrical current to deliver the local anesthetic Tymbion into the eardrum prior to tube insertion.
The approval was based on data from 222 pediatric patients who received ear tubes through the Tula system. The procedural success rate was 86% in children under 5 years and 89% in those aged 5 to 12 years. The most common adverse reaction observed in the trial was inadequate anesthesia during the procedure. The procedure is not intended for patients who may have pre-existing eardrum issues (ie, perforated eardrum).
“Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anesthesia,” said Jeff Shuren, MD, director of the FDA’s Center for Devices and Radiological Health. “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.”
For more information visit tuskermed.com.