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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
66
The Solo+ TTD is intended to deliver a tympanostomy tube through the tympanic membrane of a patient.
Southern Head & Neck Surgery
Alexander City, Alabama, United States
North Alabama ENT
Huntsville, Alabama, United States
East Alabama ENT
Opelika, Alabama, United States
Sacramento ENT
Sacramento, California, United States
Procedure Success
Percentage of subjects in which the Solo+ TTD tympanostomy tube is inserted in all indicated ears
Time frame: Intra-operative
Rate of Adverse Events
Incidence and nature of device- or procedure-related adverse events
Time frame: 24 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Advanced ENT & Allergy
Louisville, Kentucky, United States
Specialty Physician Associates
Bethlehem, Pennsylvania, United States
South Carolina ENT
Columbia, South Carolina, United States