"Do-It-Yourself" Ear Canal Care.

There are a large variety of over-the-counter home remedies and devices for cerumen impaction available in the United States. It is a challenge for clinicians to maintain awareness of the safety and efficacy of these tools, as they are not considered "medical devices" and frequently have no requirement for demonstrating safety or efficacy. This article provides a broad overview of the products being advertised to patients and discusses considerations when recommending home cerumen maintenance.

Ear drops for the removal of ear wax.

BACKGROUND: Ear wax (cerumen) is a normal bodily secretion that can become a problem when it obstructs the ear canal. Symptoms attributed to wax (such as deafness and pain) are among the commonest reasons for patients to present to primary care with ear trouble.Wax is part of the ear's self-cleaning mechanism and is usually naturally expelled from the ear canal without causing problems. When this mechanism fails, wax is retained in the canal and may become impacted; interventions to encourage its removal may then be needed. Application of ear drops is one of these methods. Liquids used to remove and soften wax are of several kinds: oil-based compounds (e.g. olive or almond oil); water-based compounds (e.g. sodium bicarbonate or water itself); a combination of the above or non-water, non-oil-based solutions, such as carbamide peroxide (a hydrogen peroxide-urea compound) and glycerol. OBJECTIVES: To assess the effects of ear drops (or sprays) to remove or aid the removal of ear wax in adults and children. SEARCH METHODS: We searched the Cochrane ENT Trials Register; Cochrane Register of Studies; PubMed; Ovid Embase; CINAHL; Web of Science; ClinicalTrials.gov; ICTRP and additional sources for published and unpublished trials. The date of the most recent search was 23 March 2018. SELECTION CRITERIA: Randomised controlled trials (RCTs) in which a 'cerumenolytic' was compared with no treatment, water or saline, an alternative liquid treatment (oil or almond oil) or another 'cerumenolytic' in adults or children with obstructing or impacted ear wax. DATA COLLECTION AND ANALYSIS: We used the standard methodological procedures expected by Cochrane. The primary outcomes were 1) the proportion of patients (or ears) with complete clearance of ear wax and 2) adverse effects (discomfort, irritation or pain). Secondary outcomes were: extent of wax clearance; proportion of people (or ears) with relief of symptoms due to wax; proportion of people (or ears) requiring further intervention to remove wax; success of mechanical removal of residual wax following treatment; any other adverse effects recorded and cost. We used GRADE to assess the quality of the evidence for each outcome; this is indicated in italics. MAIN RESULTS: We included 10 studies, with 623 participants (900 ears). Interventions included: oil-based treatments (triethanolamine polypeptide, almond oil, benzocaine, chlorobutanol), water-based treatments (docusate sodium, carbamide peroxide, phenazone, choline salicylate, urea peroxide, potassium carbonate), other active comparators (e.g. saline or water alone) and no treatment. Nine of the studies were more than 15 years old.The overall risk of bias across the 10 included studies was low or unclear. PRIMARY OUTCOME: proportion of patients (or ears) with complete clearance of ear waxSix studies (360 participants; 491 ears) contributed quantitative data and were included in our meta-analyses.Active treatment versus no treatmentOnly one study addressed this comparison. The proportion of ears with complete clearance of ear wax was higher in the active treatment group (22%) compared with the no treatment group (5%) after five days of treatment (risk ratio (RR) 4.09, 95% confidence interval (CI) 1.00 to 16.80); one study; 117 ears; NNTB = 8) (low-quality evidence).Active treatment versus water or salineWe found no evidence of a difference in the proportion of patients (or ears) with complete clearance of ear wax when the active treatment group was compared to the water or saline group (RR 1.47, 95% CI 0.79 to 2.75; three studies; 213 participants; 257 ears) (low-quality evidence). Two studies applied drops for five days, but one study only applied the drops for 15 minutes. When we excluded this study in a sensitivity analysis it did not change the result.Water or saline versus no treatmentThis comparison was only addressed in the single study cited above (active versus no treatment) and there was no evidence of a difference in the proportion of ears with complete wax clearance when comparing water or saline with no treatment after five days of treatment (RR 4.00, 95% CI 0.91 to 17.62; one study; 76 ears) (low-quality evidence).Active treatment A versus active treatment BSeveral single studies evaluated 'head-to-head' comparisons between two active treatments. We found no evidence to show that one was superior to any other.Subgroup analysis of oil-based active treatments versus non-oil based active treatmentsWe found no evidence of a difference in this outcome when oil-based treatments were compared with non-oil-based active treatments. PRIMARY OUTCOME: adverse effects: discomfort, irritation or painOnly seven studies planned to measure and did report this outcome. Only two (141 participants;176 ears) provided useable data. There was no evidence of a significant difference in the number of adverse effects between the types of ear drops in these two studies. We summarised the remaining five studies narratively. All events were mild and reported in fewer than 30 participants across the seven studies (low-quality evidence).Secondary outcomesThree studies reported 'other' adverse effects (how many studies planned to report these is unclear). The available information was limited and included occasional reports of dizziness, unpleasant smell, tinnitus and hearing loss. No significant differences between groups were reported. There were no emergencies or serious adverse effects reported in any of the 10 studies.There was very limited or no information available on our remaining secondary outcomes. AUTHORS' CONCLUSIONS: Although a number of studies aimed to evaluate whether or not one type of cerumenolytic is more effective than another, there is no high-quality evidence to allow a firm conclusion to be drawn and the answer remains uncertain.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. However, we cannot conclude whether one type of active treatment is more effective than another and there was no evidence of a difference in efficacy between oil-based and water-based active treatments.There is no evidence to show that using saline or water alone is better or worse than commercially produced cerumenolytics. Equally, there is also no evidence to show that using saline or water alone is better than no treatment.

Natural products isolated from Tetragonula carbonaria cerumen modulate free radical-scavenging and 5-lipoxygenase activities in vitro.

BACKGROUND: Propolis and cerumen are plant-derived products found in honeybees and stingless bees, respectively. Although propolis is an ancient folk medicine, the bioactivities of cerumen obtained from Australian native stingless bees (Tetragonula carbonaria) have not been widely studied. Therefore, we investigated selected anti-oxidant and anti-inflammatory properties of T. carbonaria cerumen. METHODS: A methanolic extract was prepared from the combined cerumen of 40 T. carbonaria hives, and HPLC was used to screen for chemical constituents that scavenged 2,2-azobis(2-methylpropionamidine) dihydrochloride (AAPH). The ability of cerumen extracts to scavenge 1,1-diphenyl-2-picrylhydrazyl (DPPH) and to interfere with leukotriene B4 (LTB4) production in ionomycin-stimulated human neutrophils was also examined. RESULTS: The extract dose-dependently scavenged DPPH (EC50 = 27.0 ± 2.3 µg/mL); and inhibited the 5-lipoxygenase (5-LOX)-mediated oxidation of linoleic acid (IC50 = 67.1 ± 9.6 µg/mL). Pre-treatment of isolated human neutrophils with the methanolic cerumen extract additionally inhibited the ionomycin-stimulated production of LTB4 from these cells (IC50 = 13.3 ± 5.3 µg/mL). Following multi-solvent extraction, the free radical-scavenging and 5-LOX-inhibiting activities of the initial cerumen extract were retained in a polar, methanol-water extract, which contained gallic acid and a range of flavonone and phenolic natural products. CONCLUSIONS: The findings identify free radical scavenging activity, and interference by extracts of T. carbonaria cerumen in 5-LOX-LTB4 signaling. Further investigation is needed to determine whether the extracts will provide therapeutic benefits for medical conditions in which oxidative stress and inflammation are implicated, including cardiovascular disease and impaired wound healing.

Where there's smoke there's fire--ear candling in a 4-year-old girl.

It is estimated that one-third of the United States population subscribes to alternative medical therapies (Eisenberg et al, NEJM 1993;328:246-252). Ear candles are popular products promoted by alternative health practitioners, and sold by health shops and even over the Internet. They have been promoted for ear and sinus discomfort, rhinitis, sinusitis, glue ear, colds, flu, migraine, tinnitus, but particularly for removal of ear wax (cerumen). In this case report, a 4-year-old girl in New Zealand presents with otitis media and during the course of the ear examination white deposits were noticed on her eardrum; this was confirmed as being caused by ear candling.

Cerumen removal: comparison of cerumenolytic agents and effect on cognition among the elderly.

Cerumen impaction may affect hearing and decrease hearing acuity, thus decreasing cognitive functions among the elderly. The objective of this study was to compare the safety and the efficacy of three cerumenolytic agents and to assess the effect of cerumen removal on cognition. Thirty eight elderly subjects (mean age: 78 years, total 76 ears) were treated with either Auro®, Cerumol® or the newer CleanEars®, and the change in the degree of ear canal occlusion was examined after a week. In addition, a change in cognition following cerumen removal was evaluated using Raven's standard progressive matrices (RSPM) test. There was no difference regarding the eventual degree of occlusion between the three treatment groups. Only in the CleanEars® group a complete resolution of obstruction in both ears was achieved. A statistically significant difference between the RSPM score before and after the removal of cerumen was found. Using CleanEars® is as effective and safe as other agents and may be advantageous due to its spray application. Removal of cerumen significantly improves the well-being of elderly patients.

The safety and effectiveness of different methods of earwax removal: a systematic review and economic evaluation.

BACKGROUND: Build-up of earwax is a common reason for attendance in primary care. Current practice for earwax removal generally involves the use of a softening agent, followed by irrigation of the ear if required. However, the safety and benefits of the different methods of removal are not known for certain. OBJECTIVES: To conduct evidence synthesis of the clinical effectiveness and cost-effectiveness of the interventions currently available for softening and/or removing earwax and any adverse events (AEs) associated with the interventions. DATA SOURCES: Eleven electronic resources were searched from inception to November 2008, including: The Cochrane Library; MEDLINE (OVID), PREMEDLINE In-Process & Other Non-Indexed Citations (OVID), EMBASE (OVID); and CINAHL. METHODS: Two reviewers screened titles and abstracts for eligibility. Inclusion criteria were applied to the full text or retrieved papers and data were extracted by two reviewers using data extraction forms developed a priori. Any differences were resolved by discussion or by a third reviewer. Study criteria included: interventions - all methods of earwax removal available and combinations of these methods; participants - adults/children presenting requiring earwax removal; outcomes - measures of hearing, adequacy of clearance of wax, quality of life, time to recurrence or further treatment, AEs and measures of cost-effectiveness; design - randomised controlled trials (RCTs) and controlled clinical trials (CCTs) for clinical effectiveness, cohort studies for AEs and cost-effectiveness, and costing studies for cost-effectiveness. For the economic evaluation, a deterministic decision tree model was developed to evaluate three options: (1) the use of softeners followed by irrigation in primary care; (2) softeners followed by self-irrigation; and (3) a 'no treatment' option. Outcomes were assessed in terms of benefits to patients and costs incurred, with costs presented by exploratory cost-utility analysis. RESULTS: Twenty-six clinical trials conducted in primary care (14 studies), secondary care (8 studies) or other care settings (4 studies), met the inclusion criteria for the review - 22 RCTs and 4 CCTs. The range of interventions included 16 different softeners, with or without irrigation, and in various different comparisons. Participants, outcomes, timing of intervention, follow-up and methodological quality varied between studies. On measures of wax clearance Cerumol, sodium bicarbonate, olive oil and water are all more effective than no treatment; triethanolamine polypeptide (TP) is better than olive oil; wet irrigation is better than dry irrigation; sodium bicarbonate drops followed by irrigation by nurse is more effective than sodium bicarbonate drops followed by self-irrigation; softening with TP and self-irrigation is more effective than self-irrigation only; and endoscopic de-waxing is better than microscopic de-waxing. AEs appeared to be minor and of limited extent. Resuts of the exploratory economic model found that softeners followed by self-irrigation were more likely to be cost-effective [24,433 pounds per quality-adjusted life-year (QALY)] than softeners followed by irrigation at primary care (32,130 pounds per QALY) when compared with no treatment. Comparison of the two active treatments showed that the additional gain associated with softeners followed by irrigation at primary care over softeners followed by self-irrigation was at a cost of 340,000 pounds per QALY. When compared over a lifetime horizon to the 'no treatment' option, the ICERs for softeners followed by self-irrigation and of softeners followed by irrigation at primary care were 24,450 pounds per QALY and 32,136 pounds per QALY, respectively. LIMITATIONS: The systematic review found limited good-quality evidence of the safety, benefits and costs of the different strategies, making it difficult to differentiate between the various methods for removing earwax and rendering the economic evaluation as speculative. CONCLUSIONS: Although softeners are effective, which specific softeners are most effective remains uncertain. Evidence on the effectiveness of methods of irrigation or mechanical removal was equivocal. Further research is required to improve the evidence base, such as a RCT incorporating an economic evaluation to assess the different ways of providing the service, the effectiveness of the different methods of removal and the acceptability of the different approaches to patients and practitioners.

Ear candling: a case report.

We describe a case of ear candling presenting as hearing loss, and review the literature. Ear candling is considered as an alternate medical therapy for dewaxing the ears, discomfort in ears and sinuses, rhinitis, sinusitis, glue ear, colds, flu, migraines, poor or "muffled" hearing, high stress, and ringing in the ear. There is no evidence of its effectiveness, and it can actually cause damage to the ears.

Safe and effective ear irrigation.

This article outlines the key skills required to undertake safe and effective ear irrigation in the management of ear wax, a common problem experienced by patients in primary care. Nurses require training and practice to ensure competence and the provision of high quality patient care.

Back to basics: finding an optimal cerumenolytic (earwax solvent).

An in vitro study was conducted to assess the effectiveness of the commonly used aqueous and organic cerumenolytic (earwax solvent). Three agents were included in the study: olive oil, sodium bicarbonate and urea-hydrogen peroxide complex 5% in glycerol. Distilled water was used as a control. The disintegration of preformed wax plug was noted at specific intervals. The test tube containing distilled water as a control was found to be most effective and fastest in completely disintegrating the wax. This was closely followed by sodium bicarbonate. In contrast, the organic products, namely urea-hydrogen peroxide complex 5% in glycerol showed very little cerumenolytic effect. Olive oil, the most commonly used solution, was ineffective in disintegrating the wax plug even after 24 hours. The study shows aqueous cerumenolytics are more effective than organic agents.

Cerumen impaction.

Cerumen is a naturally occurring, normally extruded product of the external auditory canal. It is usually asymptomatic, but when it becomes impacted it can cause complications such as hearing loss, pain, or dizziness. It also can interfere with examination of the tympanic membrane. Depending on available equipment, physician skill, and patient circumstances, treatment options for cerumen impaction include watchful waiting, manual removal, the use of ceruminolytic agents, and irrigation with or without ceruminolytic pretreatment. The overall quality of the evidence on treatment is limited. Referral to an otolaryngologist for further evaluation is indicated if treatment with a ceruminolytic agent followed by irrigation is ineffective, if manual removal is not possible, if the patient develops severe pain or has vertigo during irrigation, or if hearing loss is still present after cerumen has been removed. The use of cotton swabs and ear candles should be avoided.

A strong association between human earwax-type and apocrine colostrum secretion from the mammary gland.

Here we provided the first genetic evidence for an association between the degree of apocrine colostrum secretion and human earwax type. Genotyping at the earwax-type locus, rs17822931 within the ABCC11 gene, revealed that 155 of 225 Japanese women were dry-type and 70 wet-type. Frequency of women without colostrum among dry-type women was significantly higher than that among wet-type women (P<0.0002), and the measurable colostrum volume in dry-type women was significantly smaller than in wet-type women (P=0.0341).

Role of impacted cerumen in hearing loss.

We performed a study to determine if cerumen in the ear canal causes significant hearing loss and to ascertain if there is any correlation between the amount of cerumen and the degree of hearing loss. Our study was conducted on 109 ears in 80 patients. The results indicated that impacted cerumen does cause a significant degree of conductive hearing loss. We found no significant correlation between the length of the cerumen plug and the severity of hearing loss. Nor did we find any significant correlation between the presence of impacted cerumen and variables such as age, sex, ethnicity, or affected side.

Prevention of cerumen impaction by treatment of ear canal skin. A pilot randomized controlled study.

OBJECTIVES: To evaluate the effect of topical skin treatment of the ear canal in the prevention of impacted earwax. DESIGN: The study was prospective, randomized and controlled. SETTING: Secondary ORL care and Institute for the Mentally Retarded. PARTICIPANTS: Thirty-nine consecutive patients aged 1-74 years. Selection criteria were impacted earwax more than once a year and impacted earwax completely obstructing the lumen of the ear canal at the time of inclusion. Patients were randomized to active therapy or no intervention. The active therapy was Ceridal lipolotion instilled in the ear canal with a syringe once a week for 12 months. In the control group, earwax was removed without other intervention. The lipolotion was administered by the participants themselves with exception of the mentally retarded who were treated by nurses. Follow-up visits were at 3 and 12 months. MAIN OUTCOME: The main outcome was recurrence of impacted earwax with complete obstruction of the ear canal. There was significantly lower recurrence rate of impacted earwax in the treated compared with the control group (23%versus 61%, P < 0.05). CONCLUSIONS: This study suggests that prophylactic treatment of the ear canal with a topical emollient may prevent formation of impacted earwax.