Overview
The objective of this study is to evaluate the safety and effectiveness of the Solo+ Tympanostomy Tube Device (Solo+ TTD) for the placement of tympanostomy tubes in paediatric patients undergoing a tympanostomy procedure.
Description
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.
Eligibility
Inclusion Criteria:
- Patients aged ≥6 months to <13 years
- Planned tympanostomy tube insertion
- Patient is able to commit to the follow-up visits and assessments
Exclusion Criteria:
- 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