inVENT-In-Office Study

A Clinical Study Of The Acclarent Tympanostomy Tube (Tula™) Delivery System In-Office

The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TTDS) for the placement of tympanostomy tubes (TT) under local anesthesia in an office/clinic setting.

Inclusion Criteria:

• Scheduled to undergo tympanostomy tube insertion
• At least 6 months old
• Behavioral capacity and cooperative temperament to undergo an awake procedure (based on physician judgement)

Exclusion Criteria:

• History of sensitivity or reaction to anesthesia chosen for the procedure
• Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
• Otitis externa
• Anatomy that precludes sufficient visualization of and access to the tympanic membrane
• Anatomy that necessitates tympanostomy tube placement in the posterior half of the tympanic membrane