The US Food and Drug Administration (FDA) has approved a new system for placement of tympanostomy tubes in children with otitis media that does not require general anesthesia. The Tubes Under Local Anesthesia (Tula, Tusker Medical) system is the first tympanostomy tube delivery system that can be performed in young children under local anesthesia in a physician's office. The system uses a small electrical current to deliver a local anesthetic into the ear drum prior to tube insertion. It is approved for use in adults and children as young as 6 months of age. In young children, the tympanostomy tube placement has traditionally been performed in a hospital setting or surgery center under 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. 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," Jeff Shuren, MD, director of the FDA's Center for Devices and Radiological Health, said in a statement. The FDA granted Breakthrough Device designation to the Tula system for outpatient tympanostomy tube placement. In a study involving 222 pediatric patients, the procedural success rate was 86% in children younger than age 5 and 89% in children ages 5 to 12 years. The most common adverse event observed was inadequate anesthesia during the procedure. The Tula system is not for use in children younger than 6 months of age or patients with allergies to some local anesthetics. It is also not intended for use in patients who may have preexisting issues with their eardrum, such as a perforated eardrum. Source
