Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AventaMed DAC
The study will be a multi-site, prospective, treatment-only study to gather safety and effectiveness data on the use of the Solo+ TTD in-office with topical anesthesia in children aged ≥6 months to \<13 years.
Age
0–13
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients aged ≥6 months to \<13 years
Planned tympanostomy tube insertion
Patient is able to commit to the follow-up visits and assessments
You may not be if
Anatomy that precludes sufficient visualization of the tympanic membrane
Anatomy that precludes safe access to the tympanic membrane and safe use of the Solo+ TTD
Narrow ear canals
Congenital or craniofacial abnormalities affecting the ear
No baseline audiometry or tympanometry
Familial history of insensitivity to anesthetic components
Patient unable to remain still or is unsuitable for protective stabilization to undergo an in-office procedure
Clareo Health | In-Office Clinical Study of the Solo+ TTD
