In vitro comparison of three earwax removal formulations for the disintegration of earwax

Abstract

Impacted cerumen is a widespread reason that patients visit Introduction: their health care providers. It effects approximately 2-6% of the general population and disproportionately impacts up to 65% of patients over 65. This study compared a new cerumen (earwax) removal product (Solution 1; EOS-002; a glycolic acid/bicarbonate formulation) versus two commercially available products (Solution 2 and Solution 3; both containing carbamide peroxide 6.5%) for their cerumenolytic activity . Samples of in vitro Methods: human cerumen were placed in 10 x 75 mm polypropylene test tubes. Approximately 1 mL of each test solution was added and incubated at room temperature for 30 minutes. The vials were shaken at the 15-and 30-minute time points to simulate rinsing in a clinical setting. Breakdown of the cerumen was graded at 5-, 10-, 15-, and 30-minute time points in a masked manner on a 5-point scale (Grade 0 = no change; Grade 4 = complete disintegration).Significantly greater disintegration of the cerumen was observed in Results: the samples exposed to EOS-002 at every time point ( < 0.0001). At 5 P minutes, disintegration was observed in 39 out of 43 samples exposed to EOS-002, 0 out of 24 samples exposed to Solution 2, and 1 out of 19 samples exposed to Solution 3. Mean disintegration scores at 5, 10, 15, and 30 minutes were 1.65, 2.38, 2.95, and 3.24 for EOS-002; 0, 0, 0, and 0.2 for Solution 2; and 0.05, 0.13, 0.16, and 0.21 for Solution 3, respectively.EOS-002 Discussion: exhibited a significantly greater ability to breakdown cerumen than the two other products. Disintegration of cerumen occurred with EOS-002 within 5 minutes in 91% (39/43) of the samples. Therefore, EOS-002 provides rapid disintegration of human cerumen . joe@eosera.comCompeting interests: JK, BH, and WD declare no conflict of interest. CA was a temporary employee of the sponsoring company (Eosera, Inc.) during the development of the product, was provided fair market compensation during his employment, and is an author on the pending patent application. JG is an employee and equity holder in Eosera, Inc., and is an author on the pending patent application.