Ellen M. Mandel*, Joseph E. Dohar, Margaretha L. Casselbrant. International Journal of Pediatric Otorhinolaryngology (2004) 68, 1295—1299.
Objective: To evaluate the safety and efficacy of the OtoClear® Safe Irrigation System for removing cerumen from the external auditory canal in children.
Methods: Eligible subjects were 6 months—17 years of age with cerumen obstructing 50% of the tympanic membrane (TM) from view (by otoscopy). Pneumatic otoscopy, tympanometry, and audiometry were performed followed by cleansing of the affected ear canal(s) with the OtoClear® Safe Irrigation System and warm tap water. Otoscopy was performed after each wash of the canal. A curette or small alligator forceps was used to remove remaining cerumen if necessary. Tympanometry and audiometry were repeated after all procedures were completed. Telephone contact was made 1 week later regarding symptoms of acute otitis externa or any other problems.
Results: Eighteen children (28 ears) ages 1 – 10/12 to 11 – 2/12 years were entered. Four had previously had tympanostomy tubes. At entry, there was no visible TM in 19 ears, 5 – 10% visible TM in 5 ears, 20% in 1 ear, and 30 – 40% of the TM in 3 ears. The number of washes needed per ear was: 1 wash – 16 ears, 2 washes – 8 ears, 3 washes – 1 ear, 4 washes – 2 ears; washing was stopped in 1 ear because of pain. After irrigation, a curette or forceps was used in 6 ears. Following the procedures, 95% of the TM was visible in 24 ears, and 80% was visible in all ears. Six ears (4 children) with flat tympanograms at entry became normal after irrigation. On audiometry, a conductive loss in 2 ears at entry resolved after irrigation. The mean change in pure tone average (PTA) was 2.9 dB. Three subjects were noted to have hearing losses >5dB at some frequencies which on review by audiologists were deemed non-significant. No perforations of the TM occurred. There were no reports of otitis externa or any other adverse events occurring after leaving the clinic.
Conclusion: We found the OtoClear® Safe Irrigation System to be safe and effective in our small sample of children. It was well tolerated in most and provided a non-traumatic method for the removal of obstructing cerumen.