FDA approves Tula system for delivery of ear tubesFebruary 5, 2020
The US FDA has approved the Tubes Under Local Anaesthesia (Tula) System for the delivery of tympanostomy tubes that can be inserted into the eardrum to treat otitis media.
Tula is the first ear tube delivery system that can be performed in young children using local anaesthesia in a physician’s office setting.
The system consists of the anesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the ear tubes and the anesthetic into the eardrum.
“The approval offers patients an option for the treatment of recurrent ear infections that do not require general anaesthesia,” said Jeff Shuren, M D, director of the FDA’s Center for Devices and Radiological Health, in a statement.
It uses a small electrical current to deliver a local anaesthetic into the eardrum prior to tube insertion. It is approved for use in both adults and children as young as six months of age.
The FDA evaluated data provided by the sponsor from 222 paediatric patients to assess the effectiveness of the Tula System for the delivery of ear tubes. The procedural success rate was 86% and 89% in children younger than age 5 and between ages 5-12 years old, respectively. The most common adverse event observed was inadequate anaesthesia during the procedure.