Evaluation of Outcomes Following In-office Tympanostomy Using the Tula® System: a Prospective, Multi-center Registry

Tolerability (physician reported)

Count (and percentage) of patients that tolerated the procedure acceptably as determined by physician's observation.

Time frame: Day of procedure (day 0)

Tolerability (parent reported) - anesthesia

Count (and percentage) of patients whose parents strongly agree or agree with the statement 'My child tolerated the anesthesia process well'

Time frame: Day of procedure (day 0)

Tolerability (parent reported) - procedure

Count (and percentage) of patients whose parents strongly agree or agree with the statement 'The tube placement portion of the procedure was tolerable for my child'.

Time frame: Day of procedure (day 0)

Recovery (physician reported)

Count (and percentage) of patients who recovered once back with parent, or prior to leaving the clinic, following procedure completion as determined by physician's observation.

Time frame: Day of procedure (day 0)

Recovery (parent reported)

Count (and percentage) of patients who returned to normal activities immediately following the procedure.

Time frame: Day of procedure (day 0)

Anesthesia effectiveness - patients

Count (and percentage) of patients who completed iontophoresis with adequate anesthesia for tube placement in all treated ears as determined by the physician's evaluation of tympanic membrane anesthesia

Time frame: Day of procedure (day 0)

Anesthesia effectiveness - ears

Count (and percentage) of ears that completed iontophoresis with adequate anesthesia for TT placement as determined by the physician's tympanic membrane anesthesia evaluation.

Time frame: Day of procedure (day 0)

Tula Tympanostomy Tube retention

Count (and percentage) of patients at the first post-operative visit in which a Tula Tympanostomy Tube was successfully placed, with presence of the Tula Tympanostomy Tube across the tympanic membrane

Time frame: 1 month post procedure

Parent satisfaction (informed)

Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'I felt well informed and prepared to help me/my child complete the procedure'

Time frame: 1 month post-procedure

Parent satisfaction (siblings)

Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'If my child had a sibling who needed ear tubes, I would choose this procedure in the office instead of going under general anesthesia in the operating room'

Time frame: 1 month post-procedure

Overall parent satisfaction

Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'Overall, I am very satisfied with the in-office ear tube procedure'

Time frame: 1 month post-procedure

Parent satisfaction (recommendation)

Count (and percentage) of patients whose parents strongly agree or agree with the survey question: 'I would recommend this procedure to family/friends who have children who need ear tubes'

Time frame: 1 month post-procedure