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

Introduction: Impacted cerumen is a widespread reason that patients visit 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 in vitro .  Methods: Samples of 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).  Results: Significantly greater disintegration of the cerumen was observed in the samples exposed to EOS-002 at every time point ( P < 0.0001). At 5 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.  Discussion: EOS-002 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 in vitro .