Digital Healthcare Trends | Health IT Briefing

Published by

Tula® Tympanostomy System by Smith & Nephew

An in-office alternative to traditional tympanostomy using a revolutionary, local anesthesia system

The Tula System is a medical device that has been approved by the FDA for use in patients aged six months and older. It utilizes a technique called iontophoresis to apply a low-level electrical charge to the TYMBION™ ionic local anaesthetic, which accelerates the uptake of the drug into the tympanic membrane. This allows for a painless and minimally invasive procedure, with the child being able to play or watch videos during the treatment. The Tula Tube Delivery System also allows for a quick and efficient myringotomy and tube insertion in less than half a second, minimizing the amount of time the child needs to remain still. The system is supported by an educational and training program that has been designed with input from experts in paediatric psychology, medical stress, and pain management. In a clinical study, the Tula System had an in-office procedural success rate of 87%. Patients were treated in-office without the use of sedation, anxiolytics, or papoose boards. Additionally, at a three-week follow-up, the system had a 95% tube patency rate and 95% of parents reported being very satisfied with the procedure. The mean time from tube insertion to extrusion was 16.8 months. Overall, the Tula System offers an innovative and effective solution for the treatment of ear-related issues in children.