Clinical Study of the Solo Tympanostomy Tube Device

Clinical Study of the Solo Tympanostomy Tube Device

The objective of this study is post-approval evaluation of the safety and performance of the Solo Tympanostomy Tube Device for the placement of tympanostomy tubes (grommets) in paediatric patients undergoing a tympanostomy procedure

The study will be a multi-site, prospective, treatment-only study of the Solo Tympanostomy Tube Device. Patients will already have a scheduled tympanostomy procedure.

Inclusion Criteria:

• Listed for bilateral tympanostomy tube insertion

Exclusion Criteria:

• Anatomy that precludes sufficient visualisation of both the left and right eardrum
• Narrow ear canals
• Anatomy that precludes safe access to both the left and right eardrum
• Membrane >25% sclerosis
• Congenital or craniofacial abnormalities
• No available baseline audiometry and tympanometry