Tympanostomy tube insertion medical kit Tula®

An in-office alternative to traditional tympanostomy using a revolutionary, local anesthesia system and an automated, 1-click tube delivery device. Procedure overview The Tula System is FDA-approved for patients 6-months of age and older. The Tula Iontophoresis System applies a low-level electrical charge to the TYMBION™ ionic local anaesthetic, accelerating drug uptake into the tympanic membrane. The child may play quietly, watch videos or snack during the process. The Tula Tube Delivery System allows a physician to create a myringotomy and insert a 1.14 mm inner diameter grommet in less than half a second, minimising the amount of time the child needs to remain still. The Tula System is supported by an educational and training program designed with input from experts in paediatric psychology, medical stress and pain management. Product Features 87% in-office procedural success rate In the Tula pivotal study, success was defined as tubes placed successfully in both ears for a bilateral case. Tula procedural success was 86% for ages less than 5 years and 89% for ages 5-12 years. Patients were treated in-office without use of sedation, anxiolytics or papoose boards. 95% Tube patency at 3-week follow up Functional patency rates for office-placed Tula tubes are similar to rates reported in the literature for traditional tubes placed in the operating room. 95% of parents were very satisfied with the Tula procedure