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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

International Journal of Pediatric Otorhinolaryngology

|September 15, 2004

Summary

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.

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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.

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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.