Study of In-Office Ear Tube Placement Using the Tula4 System in Children Ages 6 Months to 17 Years

What this Trial Is About

Researchers are collecting real-world data on children aged 6 months to 17 years undergoing an in-office ear tube placement procedure called tympanostomy using the Tula4 System. This prospective, single-arm, multicenter registry aims to evaluate the outcomes and experiences associated with this FDA-approved system, which has been previously studied for safety and tolerability in pediatric patients. The study is sponsored by Smith & Nephew, Inc. and involves up to 20 centers across the US. The Tula System includes two main components the Tula Iontophoresis System, which delivers the TYMBION12 otic anesthetic to numb the ear drum, and the Tula Tube Delivery System, which is used to place the ear tubes. Patients will receive their treatment during a single in-office visit, and no comparison groups are included since this is an observational registry. The procedure is performed following the System Instructions For Use, and patients are treated as part of standard medical care. Participants will be monitored with outcome data collected up to six months following the extrusion or removal of their tubes. Assessments include procedure success, tolerability and recovery reported by physicians and parents on the day of the procedure, anesthesia effectiveness, tube retention after one month, and various measures of parent satisfaction. This follow-up helps researchers understand the real-world performance and patient experience with the Tula System over time.

Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry