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Efficacy of Over-the-Counter Cerumen Removal Devices: A Randomized Trial
William E Kamm1, McKenzie M Tolan2, Catherine L Kennedy2
1School of Medicine University of Minnesota Minneapolis Minnesota USA.
Objective:
Consumer interest in ear hygiene has created an industry worth $2 billion, offering tools claiming to assist in cerumen removal. In this study, we aimed to compare the efficacy of self-operated over-the-counter (OTC) cerumen removal devices.
Methods:
A community-based, prospective randomized trial was conducted at the Driven to Discover Research Facility at the Minnesota State Fair. A total of 529 adults aged ≥ 18 years were prospectively recruited; 149 met inclusion criteria for randomization to one of four OTC cerumen removal devices (cotton swab control, irrigator, powered and non-powered spiral tools). Cerumen burden and complications were evaluated via video-otoscopy by otolaryngologists before and after self-use of the assigned device using an objective grading system. Surveys on cerumen removal practices and consumer attitudes were completed. Group sociodemographic, survey, and cerumen burden data were compared between groups.
Results:
Of 147 randomized trial participants with moderate to excessive cerumen in at least one ear (mean age 49 years, 48% female), 130 (88%) showed no improvement or worsening of cerumen burden grade following device use. There was no significant difference in the efficacy of the four OTC cerumen removal device groups. Observed complications included medial displacement of cerumen (17%), pain or discomfort (n = 7, 5%) and canal trauma (1%). While some participants would consider purchasing (29%) or recommending the device they used to others (27%), their preferred price point ($10-$20) was lower than the market price for all devices except cotton swabs.
Conclusion:
Commonly used OTC cerumen removal devices did not result in a meaningful reduction of cerumen burden when used by the public and did not show superiority to cotton swabs. While it is unknown if device efficacy would improve with repeated use and familiarization, these findings do not currently support routine use of OTC cerumen removal devices for removal of excess cerumen.
Level Of Evidence:
Level II, randomized controlled trial.
