Clinical Study of Solo Tympanostomy Tube Device (TTD)

Post-Market Approval Study of the Solo Tympanostomy Tube Device

This is a multi-centre, single arm study to evaluate the placement of tympanostomy tubes with the AventaMed Solo Tympanostomy Tube Device (TTD)

Basic Inclusion Criteria:

• Listed for bilateral tympanostomy tube insertion only

Basic Exclusion Criteria:

• Anatomy that precludes sufficient visualisation of both the left and right eardrum with the Solo TTD in place.
• Anatomy that precludes safe access to both the left and right eardrum with the Solo TTD
• Patients in whom a reliable audiogram is not possible