Efficacy of Over-the-Counter Cerumen Removal Devices: A Randomized Trial

Area of Science:

• Otolaryngology
• Consumer Health Products

Background:

• Consumer interest in ear hygiene has fueled a $2 billion market for earwax removal tools.
• The efficacy of self-operated over-the-counter (OTC) cerumen removal devices remains largely unproven.

Purpose of the Study:

• To compare the efficacy of self-operated OTC cerumen removal devices against a cotton swab control.
• To evaluate cerumen burden reduction and complication rates associated with OTC cerumen removal devices.

Main Methods:

• A community-based, prospective randomized trial involving 149 adult participants with moderate to excessive cerumen.
• Randomization to four groups: cotton swab control, irrigator, powered spiral tool, and non-powered spiral tool.
• Video-otoscopy by otolaryngologists assessed cerumen burden and complications before and after device use.

Main Results:

• 88% of participants showed no improvement or worsening of cerumen burden after using OTC devices.
• No significant difference in efficacy was found among the four OTC cerumen removal device groups.
• Complications included cerumen displacement (17%), pain (5%), and canal trauma (1%).

Conclusions:

• Commonly used OTC cerumen removal devices are not effective for reducing earwax burden in the general public.
• These devices did not demonstrate superiority over cotton swabs.
• Current evidence does not support the routine use of OTC cerumen removal devices for excess earwax removal.