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 > or = 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, > or = 95% of the TM was visible in 24 ears, and > or = 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 >5 dB 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.