A Novel Device for the Evacuation of Cerumen.

Objectives: The aim of this study was to assess a new device designed to safely remove cerumen from the external auditory canal in an office setting with minimal training.

Methods: The research was conducted in the Department of Otolaryngology at Kaplan Medical Center in Israel. Patients with cerumen were treated with the device. Efficacy, safety, and pain were evaluated using scales developed for this experiment. The cerumen obstruction scale (0-5) was assessed before and after the procedure. Improvement by 2 or more grades was considered to indicate at successful procedure.

Results: Fifty-nine ears in 46 patients were treated. Seventeen patients (37%) had recurrent cerumen impaction, and 14 (30.4%) used cotton swabs frequently. Fifty-two ears (88%) had hard cerumen. The procedure was successful in 51 ears (86.4%). In 48 ears (81%) there was no pain or mild pain, and in 11 ears (19%), the patient reported the procedure to be uncomfortable. Seven patients (15.2%) asked to abort the procedure because of discomfort or pain. In 39 ears (66%), the cerumen was evacuated easily. Inspection after the procedure revealed no injury in 56 ears (95%). Three ears (5%) had mild irritation of the ear canal, and none had injury to the tympanic membrane. Median length of the procedure was 30 ± 42.1 seconds (range, 2-240 seconds). The median number of insertions of the device in 1 procedure was 2 (range 1-7; SD, 1.3).

Conclusions: The tested device is an effective and safe device for the evacuation of cerumen. It can be used by general practitioners, pediatricians, and audiologists.