In-Office Clinical Study of the Solo+ TTD

Pivotal In-Office Clinical Study of the Solo+ Tympanostomy Tube Device

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.

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.

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