Abstract
ObjectiveTo determine the safety of Earigate™ as an ear wax softening product. Study DesignProspective, controlled animal study. MethodsBilateral 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. ResultsThe 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. ConclusionsThe administration of Earigate™ to the middle ear of chinchillas did not cause any ototoxicity as assessed by ABR.
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