The U.S. Food and Drug Administration recently announced the approval of a breakthrough in ear tube technology. The new system allows doctors to insert the tubes under local anesthesia in the office.
Forget about general anesthesia and a trip to the hospital’s OR. The Rubes Under Local Anesthesia, a.k.a. Tula system, may make this all-too-common procedure easier on everyone.
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Jeff Shuren, M.D., director of the FDA’s Center for Devices and Radiological Health said, in a press release, “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.”
Shuren continued, “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.”
The system, which is approved for children over the age of six months was tested on 222 pediatric patients. Researchers found the tubes have an 86 percent success rate in children under age five and an 89 percent success rate in the five to 12-year age group.