What is a ceruminolytic (cerumen-removing) agent?

From the Guidelines

Cerumenolytic agents, such as water or saline solution, may be used in the management of cerumen impaction, as they have a balance of benefit and harm, according to the clinical practice guideline update by the American Academy of Otolaryngology-Head and Neck Surgery 1.

Key Points to Consider

• The use of cerumenolytic agents is based on limited randomized trials, but they can be an effective option for managing cerumen impaction 1.
• Common over-the-counter cerumenolytic agents include hydrogen peroxide solutions (3%), carbamide peroxide (6.5%), mineral oil, baby oil, glycerin, and commercial products like Debrox or Murine Ear Wax Removal.
• These agents work by either breaking down the wax through oxidation (peroxide-based products), moisturizing and softening the wax (oils), or changing its surface tension (glycerin).
• For use, typically 5-10 drops are placed in the affected ear with the head tilted, remaining in position for 5-10 minutes to allow the solution to work.
• This process can be repeated twice daily for 3-5 days if needed, and gentle irrigation with warm water using a bulb syringe may help flush out the loosened wax after treatment.

Important Considerations

• Cerumenolytic agents should not be used if there is ear pain, discharge, known eardrum perforation, or recent ear surgery.
• If symptoms persist after treatment or if there is difficulty hearing, pain, or dizziness, professional medical evaluation is recommended.
• Clinicians should treat, or refer to a clinician who can treat, the patient with cerumen impaction with an appropriate intervention, which may include ≥1 of the following: cerumenolytic agents, irrigation, or manual removal requiring instrumentation, as recommended by the clinical practice guideline update 1.

From the FDA Drug Label

Uses For occasional use as an aid to soften, loosen, and remove excessive earwax. The sodium bicarbonate (OTIC) can be used as a cerumenulytic agent to soften, loosen, and remove excessive earwax, as stated in its drug label 2.

From the Research

Cerumenolytic Agents

• Cerumenolytic agents are used to remove or aid in the removal of ear wax in adults and children 3, 4, 5, 6, 7
• The effectiveness of these agents can be measured by the proportion of patients with complete clearance of ear wax, adverse effects, and other secondary outcomes 3

Types of Cerumenolytic Agents

• Oil-based treatments (e.g. olive oil, almond oil) 3, 4
• Water-based treatments (e.g. sodium bicarbonate, carbamide peroxide) 3, 4, 5, 6, 7
• Non-water, non-oil-based solutions (e.g. urea-hydrogen peroxide complex) 3, 4
• Combination of the above or other active comparators 3

Efficacy of Cerumenolytic Agents

• A single study suggests that applying ear drops for five days may result in a greater likelihood of complete wax clearance than no treatment at all 3
• There is no evidence to show that one type of active treatment is more effective than another 3, 5
• Sodium bicarbonate and paradichlorobenzene were associated with significantly greater proportions of patients with wax clearance following syringing compared to normal saline 6
• Urea/hydrogen peroxide/glycerol was observed with significant cerumenolytic activity without the need for further interventions such as syringing/aspiration/suction 6

Adverse Effects

• Adverse effects such as discomfort, irritation, or pain were reported in some studies, but there was no evidence of a significant difference in the number of adverse effects between the types of ear drops 3
• All events were mild and reported in fewer than 30 participants across the seven studies 3