Yes, the FDA approved the Tula System in November 2019 for use in both adults and children as young as six months of age.
In announcing the approval, Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health, stated, “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. 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.”
More discussion on comfort level experienced by patients can be found here.
More information regarding the FDA’s approval can be found on the FDA website.