Evaluation of the safety and efficacy of a novel product for the removal of impacted human cerumen.

ABSTRACT:

Background

This open-label study evaluated the safety and efficacy of a novel product for the removal of impacted cerumen in adult patients.

Methods

This was a prospective, single-center, single-arm, self-controlled clinical trial conducted in a community general practice setting. The novel product contains glycolic acid in an otologically-acceptable buffer containing sodium bicarbonate and glycerin and other buffering agents. The product was instilled into the ear canal prior to irrigation with warm water. Severity of cerumen impaction was graded using a 5-point scale. Improvement in tympanic membrane visualization was assessed after instillation and irrigation.

Results

A majority (83%, 25/30) of ears showed improvement with one application: with 53% (16/30) totally

SUBMITTER: Fullington D 

PROVIDER: S-EPMC5455110 | biostudies-literature | 2017

REPOSITORIES: biostudies-literature