Aural irrigation using the OtoClear^® Safe Irrigation System in children

Summary

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.

Introduction

Though some cerumen is necessary for the maintenance of normal physiologic homeostasis within the lateral auditory canal, excessive accumulation leads to a pathological condition known as cerumen impaction. Cerumen, or too much of it, is a problem in pediatrics for several reasons. Physicians must often remove cerumen in children’s ears to examine a febrile child or one complaining of ear pain or pulling at their ears. Lack of visibility of the tympanic membrane (TM) may prevent accurate diagnosis of middle-ear disease as well as problems of the external canal; cerumen accumulation has also been linked to chronic cough secondary to stimulation of Arnold’s nerve, a branch of the vagus nerve [1]. Decreased hearing, a common pediatric complaint, can be the result of mechanical blockage of the canal as well as middle-ear disease, and for some, removal of the obstructing wax plug may be curative. Watkins et al. [2] reported that among 2959 schoolchildren in Dallas, Texas who failed pure tone audiological screening, 137 (4.63%) failed because of cerumen in the canal. For audiologists, cerumen management becomes a very common problem, as use of hearing aids may obstruct the normal extrusion of cerumen from the external canal [3] in addition to preventing accurate audiological testing. Long-standing cerumen impaction may encourage proliferation of bacterial and fungal pathogens that, in turn, result in low-grade otitis externa. Certain populations are known to be particularly prone to cerumen impaction, such as children with Down syndrome [4], as well as others with mental retardation, and the geriatric population [5].

Several techniques have been used to remove cerumen from the external auditory canal. Cerumen can be removed mechanically under visualization by means of a curette or wire loop. Various substances have been used to try to soften the cerumen prior to removal. Oil-based organic solutions, such as olive oil, glycerin, and propylene glycol lubricate the plug and facilitate its mechanical removal. Aqueous solutions, such as water, 10% bicarbonate, 3% hydrogen peroxide, and 2% acetic acid, expand and loosen or dissolve the cerumen plugs [6]. Irrigation devices, such as an ear syringe, or Water Pik dental device [7] have also been widely used by practitioners. However, unlike devices which aim the stream of irrigation fluid at the TM, the OtoClear^® Safe Irrigation Tip (Bionix, Toledo, Ohio) directs the water stream to the canal wall. This non-comparative, descriptive study was designed to evaluate the safety and efficacy of the OtoClear^® Safe Irrigation System for removing cerumen from the external auditory canal in children.