inVENT-visIOn Study

Not Applicable

Completed

Interventions: Device: Tympanostomy tube placement (Acclarent iontophoresis device)

Brief Summary: The objective of the study is to evaluate the safety and efficacy of the Acclarent Tympanostomy Tube Delivery System (TDS) for the placement of Tympanostomy Tube TT(s) under local anesthesia delivered by iontophoresis in an office/clinic setting.

Recruitment & Eligibility

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)
No history of sensitivity or reaction to anesthesia chosen for the procedure

Exclusion Criteria

Pregnant or lactating females
Significantly atrophic, bimeric, or completely atelectatic tympanic membrane
Otitis externa
Lacerations or abrasions to the external auditory canal or damaged or denuded skin in the auditory canal
Cerumen impaction resulting in a significant amount of cleaning required to visualize the tympanic membrane
Electrically sensitive subjects and subjects with electrically sensitive support systems (pacemakers, defibrillators, etc.)
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

Arm && Interventions

Group	Intervention	Description
Tympanostomy Tube Placement	Tympanostomy tube placement (Acclarent iontophoresis device)	-

Primary Outcome Measures

Name	Time	Method
Number of Subjects With Procedural, Serious and Device-related Adverse Events.	Procedure through 2 weeks post-procedure	Adverse events which are procedural, serious, and device-related.
Device Success	Day 0 (day of procedure)	Device Success is defined as the successful delivery of the tympanostomy tube (TT) across the tympanic membrane (TM) using the Tube Delivery System(TDS). Device Success will be evaluated on a per device basis.

Secondary Outcome Measures

Name	Time	Method
Procedure Success	Day 0 (day of procedure)	Procedure Success is defined as the successful placement of any tympanostomy tube in all enrolled ears in a given subject. Procedure Success is determined on a per subject basis.
Procedure Tolerability	Day 0 (day of procedure)	Procedure Tolerability is defined as the proportion of subjects reporting the procedure as tolerable, where tolerable is defined as a score of 0 through 3, using the Wong-Baker FACES pain scale.The Wong-Baker FACES pain scoring system is a scale of 0 to 5, where 0 means 'no hurt', 1 = 'hurts a little bit', 2 = 'hurts little more', 3 = 'hurts even more', 4 = 'hurts whole lot' and 5 = 'hurts worst'. Procedure Tolerability will be determined on a per patient basis, with the patient's score being the average of the scores for the left and right ear if both ears are successfully treated with the Tube Delivery System.
Tube Retention	2 weeks post-procedure	Tube retention is the presence of a tympanostomy tube placed successfully by the Tula TDS device across the tympanic membrane at the two-week follow-up visit.