Earigate™ for softening ear wax: is it safe when the eardrum is perforated?

Abstract

OBJECTIVE: To determine the safety of Earigate™ as an ear wax softening product. STUDY DESIGN: Prospective, controlled animal study. METHODS: Bilateral wide myringotomies were performed in eleven chinchillas. In each animal, Earigate™ was delivered to a randomly selected experimental ear canal as 2 puffs twice a day. Auditory brainstem response (ABR) was used to assess the hearing of the animals before, 3 days and 10 days following the local application of Earigate™. The ABR threshold shifts were compared for both experimental and control ears. RESULTS: The mean hearing threshold shifts in the experimental animals were comparable at all frequencies and at days 3 and 10. No statistically significant differences were observed in the mean threshold shifts for all of the frequencies evaluated, between the control and experimental ears. CONCLUSIONS: The administration of Earigate™ to the middle ear of chinchillas did not cause any ototoxicity as assessed by ABR.