Post-Market Clinical Follow-Up Study of the Solo+ Tympanostomy Tube Device

The purpose of this project is to collect information from the doctor notes about the use of the device, to monitor the tubes after surgery, and collect information from patients and parents/guardians about their views on the procedure. Since the device became available in Europe, it is important to collect information from both patients planned for the procedure (prospective) and those who already underwent the procedure (retrospective) to have collect as much data as possible.

NCT Number	NCT07029997
Lead Sponsor	AventaMed DAC
Conditions	Otitis Media, Middle Ear Infections
Enrollment	160 participants
Start Date	2026-05-21
Primary Completion	2030-05 (estimated)
Study Completion	2030-05 (estimated)
Updated on ClinicalTrials.gov	2026-08-13