The FDA has approved a new system that will make it easier for physicians to treat recurring, childhood ear infections during a visit to the doctor’s office by placing tubes in the eardrum using only a local anesthetic.
Developed by Tusker Medical, the system includes the company’s tympanostomy tubes, its painkiller Tymbion and separate devices used in the delivery of the treatment. The FDA described it as the first designed for young children in this care setting.
“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,” said the FDA’s device center director, Jeff Shuren, in an agency statement. “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.”
Also known as otitis media, inflammatory ear infections are common in children, with the NIH’s National Institute of Deafness and Other Communication Disorders estimating that five in every six children will have at least one ear infection before their third birthday.
If antibiotics fail in the face of repeated infections, small tubes can be used to drain and help prevent fluid and pressure from building up behind the eardrum. In young children, these tubes are typically placed at a hospital or surgery center under general anesthesia.
By comparison, Tusker Medical’s system uses a small electric current to deliver a local numbing agent directly into the eardrum, needle-free, just before a tube is inserted. The FDA approved the procedure for adults and children as young as six months old.
A clinical study of 222 pediatric patients showed the device was 86% successful in children under age five and demonstrated a rate of 89% between ages five and 12.
It is not intended for people with preexisting eardrum issues, such as a perforation. Dubbed the Tula System, for tubes under local anesthesia, the product previously received a breakthrough device designation from the FDA.