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Aural irrigation using the OtoClear Safe Irrigation System in children
Ellen M Mandel1, Joseph E Dohar, Margaretha L Casselbrant
1Department of Pediatric Otolaryngology, Children's Hospital of Pittsburgh, University of Pittsburgh School of Medicine, 3705 Fifth Ave., PA 15213, USA. mandele@pitt.edu
Insights
The OtoClear Safe Irrigation System effectively and safely removed earwax in children, proving well-tolerated and non-traumatic for cerumen removal. This method improved tympanic membrane visualization and hearing outcomes.
Area of Science:
- Otolaryngology
- Pediatric Audiology
Background:
- Cerumen impaction is common in children, potentially affecting hearing and ear health.
- Traditional methods for cerumen removal may carry risks of injury or discomfort.
Purpose of the Study:
- To assess the safety and efficacy of the OtoClear Safe Irrigation System for pediatric cerumen removal.
- To evaluate the impact of the system on external auditory canal visualization and hearing function.
Main Methods:
- Children aged 6 months to 17 years with significant cerumen obstruction were enrolled.
- The OtoClear system with warm water was used for irrigation, followed by otoscopy, tympanometry, and audiometry.
- Post-procedure assessments and 1-week follow-up for adverse events were conducted.
Main Results:
- The system successfully improved tympanic membrane visualization in most ears, with >80% visibility achieved in all.
- Audiometry showed resolution of conductive hearing loss in some cases, with a mean change in pure tone average of -2.9 dB.
- No tympanic membrane perforations or cases of otitis externa were reported.
Conclusions:
- The OtoClear Safe Irrigation System is a safe and effective tool for removing obstructive cerumen in children.
- The irrigation system was well-tolerated and provided a non-traumatic cerumen removal method.
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.
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