Study Status: RECRUITING
Recruit Status: RECRUITING
Study Type: OBSERVATIONAL
Official Title: Evaluation of Clinical and Health Economic Outcomes Following In-office Tympanostomy Using the Tula� System: a Prospective, Multi-center Registry
Brief Summary:
This prospective, single-arm, multicenter registry is being conducted to collect real world post-market data from patients aged from 6 months to 17 years of age who are undergoing an in-office ear tube placement procedure (tympanostomy) using the Tula� System.
The Registry will include up to 20 centers in the US and up to 200 patients for the initial evaluation.
The FDA-approved Tula System includes the Tula Iontophoresis System (IPS) with TYMBION� otic anesthetic for local anesthesia of the ear drum and the Tula Tube Delivery System (TDS) for ear tube placement.
Clinical research established the safety, efficacy and tolerability of this system for in-office procedures in the pediatric population.
Patients will be treated and evaluated according to standard medical care.
Outcome data is collected up to 6 months following extrusion or removal of their tube(s).