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First received: June 13, 2023

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

Study Status: Completed

Recruit Status: RECRUITING

Condition: Otitis Media With Effusion

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…

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