The system enables delivery of ear tube to patients under local anaesthesia in a physician’s office setting, therefore avoiding administration of general anaesthesia
The US Food and Drug Administration recently approved a new system for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections (i.e., otitis media). The Tubes Under Local Anesthesia (Tula) System is the first ear tube delivery system that can be performed in young children using local anaesthesia in a physician’s office setting. The Tula System consists of the anaesthetic Tymbion, Tusker Medical tympanostomy tubes, and several devices needed for the delivery of the ear tubes and the anaesthetic into the ear drum.
“Today’s approval offers patients an option for the treatment of recurrent ear infections that does not require general anaesthesia. 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,” said Jeff Shuren, Director, FDA’s Center for Devices and Radiological Health. “This approval has the potential to expand patient access to a treatment that can be administered in a physician’s office with local anaesthesia and minimal discomfort.”
The Tula System enables the delivery of an ear tube to patients under local anaesthesia in a physician’s office setting, therefore avoiding the administration of general anaesthesia. The Tula System uses a small electrical current to deliver a local anaesthetic into the ear drum 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 per cent and 89 per cent in children younger than age five and between ages 5-12 years old, respectively. The most common adverse event observed was inadequate anaesthesia during the procedure. The Tula System should not be used in patients younger than six months of age or patients who have allergies to some local anaesthetics. This product is not intended for patients who may have pre-existing issues with their eardrum, such as a perforated eardrum.
The Tula System was granted Breakthrough Device designation, meaning the FDA provided intensive interaction and guidance to the company on efficient device development to expedite evidence generation and the agency’s review of the product. To qualify for such designation, a device must be intended to treat or diagnose a life-threatening or irreversibly debilitating disease or condition and meet one of the following criteria: the device must represent a breakthrough technology; there must be no approved or cleared alternatives; the device must offer significant advantages over existing approved or cleared alternatives; or the availability of the device is in the best interest of patients.
The FDA granted approval of the Tula System to Tusker Medical.