Prospective, multi-center, observational, real-world evidence data collection registry to confirm the continued clinical performance of the AERA® device in pediatric patients
Study Type
OBSERVATIONAL
Enrollment
300
Stanford University
Palo Alto, California, United States
RECRUITINGMichigan Pediatric ENT Associates
West Bloomfield, Michigan, United States
RECRUITINGChildren's Minnesota
Minneapolis, Minnesota, United States
Failure-free after ETBD with the AERA® device.
Failure is defined as revision ETD surgery (e.g. further ETBD, tympanostomy tube (TT) insertion, or adenoidectomy for ETD).
Time frame: 27 months
Tympanogram assessed by ear
Tympanogram
Time frame: 27 months
Pure tone audiometry (PTA) assessed by ear
Pure tone audiometry (PTA)
Time frame: 27 months
Valsalva maneuver assessed by ear
Valsalva maneuver
Time frame: 27 months
Inflammation score assessed by ear
Score 1-4. The higher the score, the worse the outcome.
Time frame: 27 months
Eustachian Tube Dysfunction Questionnaire (ETDQ-7) assessed by patient
Total score of 7-49. The higher the score, the worse the outcome.
Time frame: 27 months
Otitis Media- 6 Questionnaire (OM-6) assessed by patient
Total score 6-42. The higher the score, the worse the outcome.
Time frame: 27 months
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
RECRUITINGChildren's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
RECRUITINGEar and Sinus Institute
Fort Worth, Texas, United States
RECRUITING