A guide to managing disorders of the ear pinna and canal.

This review will help you troubleshoot everything from infections and foreign bodies to trauma and neoplasm.

WITHDRAWN: Ear drops for the removal of ear wax.

BACKGROUND: Problems attributed to the accumulation of wax (cerumen) are among the most common reasons for people to present to their general practitioners with ear trouble. Treatment for this condition often involves use of a wax softening agent (cerumenolytic) to disperse the cerumen, reduce the need for, or facilitate syringing, but there is no consensus on the effectiveness of the variety of cerumenolytics in use. OBJECTIVES: To assess the effectiveness of ear drops (cerumenolytics) for the removal of symptomatic ear wax. SEARCH METHODS: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2008 issue 2); MEDLINE; EMBASE; CINAHL; ISI Proceedings; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials. The date of the most recent search was April 2008. SELECTION CRITERIA: We identified all randomised controlled trials in which a cerumenolytic was compared with no treatment, a placebo, or other cerumenolytics in participants with obstructing or impacted ear wax, and in which the proportion of participants with sufficient clearance of the external canal to make further mechanical clearance unnecessary (primary outcome measure) was stated or calculable. DATA COLLECTION AND ANALYSIS: The two authors reviewed all the retrieved trials and applied the inclusion criteria independently. MAIN RESULTS: Nine trials satisfied the inclusion criteria. In all, 679 participants received one of 11 different cerumenolytics. One trial compared active treatments with no treatment, three compared active treatments with water or a saline 'placebo', and all nine trials compared two or more active treatments. Eight trials included syringing as a secondary intervention.Overall, results were inconclusive. The majority of comparisons showed no difference between treatments.  Meta-analysis of two high quality trials produced a statistical difference in favour of triethanolamine polypeptide over saline in preventing the need for syringing, but no other significant differences between treatments.In three trials of high to moderate quality, no difference was found between the effectiveness of either sodium bicarbonate ear drops, chlorbutanol, triethanolamine polypeptide oleate condensate or docusate sodium liquid versus a sterile water or saline 'placebo'.One trial of moderate methodological quality found all three treatments - sodium bicarbonate ear drops, chlorbutanol and sterile water - to be significantly better than no treatment at preventing the need for syringing.None of the higher quality trials demonstrated superiority of one agent over another in direct comparisons. AUTHORS' CONCLUSIONS: Trials have been heterogeneous and generally of low or moderate quality, making it difficult to offer any definitive recommendations on the effectiveness of cerumenolytics for the removal of symptomatic ear wax. Using drops of any sort appears to be better than no treatment, but it is uncertain if one type of drop is any better than another. Future trials should be of high methodological quality, have large sample sizes, and compare both oil-based and water-based solvents with placebo, no treatment or both.

A new approach for cerumenolytic treatment in children: In vivo and in vitro study.

OBJECTIVES: To demonstrate the effects of various cerumenolytic solutions in vivo and in vitro and to measure the change in pain following treatment. METHODS: The study was done as a single-centre, prospective and double-blind study. Among 1243 paediatric patients with total or nearly total occlusive plug in 4 years period, those who accepted endoscopic ear examination and cleaning via aspiration after a follow-up period of at least 10 days following treatment were included in the study. Day of total TM visualisation was noted and removal co-efficient was calculated. The pre and post-treatment pain levels of the patients were assessed using analogue chromatic continuous scale (ACCS). In the in vitro part, cerumen samples collected at equal amounts from 20 patients were treated at 36-400°C in 6 different tubes with the same solutions and their dissolution degrees were assessed over a period of 5 days (Hour 6, Hour 12, Hour 48, Hour 72, Hour 92, Hour 120). Additionally, the degree of resolution in the tube treated with distilled water was considered to be the control reference. RESULTS: In the in vivo part of the study, total TM visualisation was observed in Group 1 at 50.2% (Day 3), in Group at 57.1%, in Group at 62.3%, in Group at 44.3% and in Group 5 at 73.5%. The group with the lowest removal co-efficient was Group 5 (removal co-efficient=1.623). In reference to the ACCS pain scores of the patients, the intra-group change pre-post treatment was found statistically significant for all groups (p=0.008; p=0.0222; p=0.005; p=0.026; p=0.018). After statistical analysis between the groups the difference between Group 5 and other groups was found statistically significant (p=0.002; p=0.026; p=0.044; p=0.034). In the in vitro part of the study, the best dissolution was observed in Group 2. CONCLUSIONS: In our study, the best cerumenolytic solutions were identified to be glycerine 10cc+3% hydrogen peroxide 10cc+10% sodium bicarbonate 10cc+distilled water 10cc. Especially the use of this mixture ease in terms of pain for the patient and in terms of time and comfort for the physician during the removal procedure.

Earigate™ for softening ear wax: is it safe when the eardrum is perforated?

OBJECTIVE: To determine the safety of Earigate™ as an ear wax softening product. STUDY DESIGN: Prospective, controlled animal study. METHODS: Bilateral wide myringotomies were performed in eleven chinchillas. In each animal, Earigate™ was delivered to a randomly selected experimental ear canal as 2 puffs twice a day. Auditory brainstem response (ABR) was used to assess the hearing of the animals before, 3 days and 10 days following the local application of Earigate™. The ABR threshold shifts were compared for both experimental and control ears. RESULTS: The mean hearing threshold shifts in the experimental animals were comparable at all frequencies and at days 3 and 10. No statistically significant differences were observed in the mean threshold shifts for all of the frequencies evaluated, between the control and experimental ears. CONCLUSIONS: The administration of Earigate™ to the middle ear of chinchillas did not cause any ototoxicity as assessed by ABR.

Finding the most effective cerumenolytic.

AIM: To conduct an in-vitro study to determine the most effective topical cerumenolytic. METHOD: Cerumen was collected from patients who attended the ENT out-patient clinic. The collected cerumen was formed into a homogeneous ball. Discs of wax were punched out and weighed to create samples of uniform shape and size. Each cerumen sample was placed in a tube which contained one of six test solutions. The tubes were observed at specific time points. Digital photographs were taken to record the degree of cerumen disintegration. The cerumen discs were then removed from the solutions, dried and re-weighed. RESULTS: Distilled water caused the greatest reduction in the mass of the cerumen disc. Cerumen placed in distilled water and in sodium bicarbonate solution showed substantial disintegration at 12 hours. Cerumen placed in solutions containing oil-based agents showed no visible sign of disintegration and no reduction in dried weight. CONCLUSION: Distilled water resulted in the greatest degree of cerumenolysis. Oil-based cerumenolytics were ineffective.

A prospective study to evaluate the efficacy of isopropyl alcohol irrigations to prevent cerumen impaction.

We conducted a prospective crossover study to assess the safety and efficacy of 70% isopropyl alcohol delivered from a squeezable bottle with a specially designed tip as a weekly irrigant to reduce cerumen accumulation. Twenty patients were divided into 2 groups of 10 (20 ears in each group). The patients in group 1 instilled 70% isopropyl alcohol once a week for 2 months; this was followed by 2 months of no ear cleaning. The patients in group 2 performed the opposite routine. At each visit (0, 2, and 4 mo), cerumen accumulation was graded on a scale of 0 to 4, indicating 0, 25, 50, 75, and 100% occlusion, respectively. After the accumulation was graded, a cerumenectomy was performed. At the initial evaluation, the mean occlusion scores were 3.1 for group 1 and 3.3 for group 2-not a statistically significant difference. After the first 2 months of the study, there was a significant difference in occlusion scores between groups 1 and 2 (0.75 and 1.55, respectively; p < 0.0002). At 4 months, after the crossover, the occlusion scores were 1.15 and 0.95, respectively, not a significant difference (p = 0.38). At study's end, there were also significant differences within each group between occlusion scores obtained during the treatment and nontreatment periods (group 1: p < 0.02; group 2: p < 0.01). All patients tolerated the alcohol rinse well, and there were no cases of external otitis or other complications. We conclude that weekly irrigation with 70% isopropyl alcohol is safe and reduces the accumulation of cerumen in the external auditory canal. Routine use should decrease the number of office visits for cerumen removal and hearing aid cleaning.

Ototoxicity of baby oil in a chinchilla animal model.

OBJECTIVE: Baby oil is commonly used to soften ear wax in order to aid its removal. The aim of this study was to determine the potential ototoxicity of baby oil. METHOD: A prospective controlled animal study was conducted using ten chinchillas with normal hearing function. Each had bilateral myringotomies. One ear was randomly assigned to receive 1 ml of baby oil while the other ear received an equal volume of 0.45% NaCl. Distortion product otoacoustic emissions (DPOAEs) and Auditory Brainstem Response (ABR) measurements were recorded at baseline (post myringotomy and pre application of product) and on days 5 and 15 after application. Two months after application of baby oil, the cochleae were processed for light microscopy and qualitative comparisons were made between the cochleae of both control and experimental ears. RESULTS: There was no statistically significant difference in DPOAE between experimental and control ears at 5 and 15 days after treatment. ABR results did not reveal ototoxicity at days 5 and 15 post treatment. None of the animals developed facial paralysis or any signs of vestibular toxicity. There were no overt mucosal changes in the middle ear of the ears exposed to baby oil compared to the control ears. Light microscopy showed comparable features in the organ of Corti, stria vascularis, spiral ligament and the spiral ganglion cells of both groups of cochleae. CONCLUSION: Baby oil did not produce ototoxic effects when applied ototopically in chinchillas with non-intact tympanic membrane.

Ototoxicity of intratympanic docusate sodium and mineral oil in the guinea pig.

OBJECTIVES: (1) To evaluate the ototoxic potential of docusate sodium and mineral oil and (2) to compare the cerumenolytic properties of these agents to water and a commercially available product. STUDY DESIGN: Prospective animal study. SETTING: Docusate sodium and mineral oil are being used to dissolve cerumen plugs. Their ototoxicity has never been assessed. METHODS: Nineteen guinea pigs represented 38 ears, which formed 4 groups. Each group was injected with an intratympanic solution once a week for 4 weeks. Group 1 was injected with a negative control solution of saline, group 2 with docusate sodium, group 3 with a positive control solution of gentamicin, and group 4 with mineral oil. Auditory brainstem responses (ABRs) were recorded before any procedure and 1 week after the final injections. Cochleas were analyzed under scanning electron microscopy. The cerumenolytic properties of water, docusate sodium, mineral oil, and cerumol were evaluated. RESULTS: There was no significant ABR threshold increase for saline or mineral oil. Gentamicin and docusate sodium caused a significant threshold increase that averaged 51.9 dB and 44.9 dB over all the frequencies (P < .001). Electron microscopy could not be performed on the cochleas treated by docusate sodium because of very severe osteitis. All of the agents tested seemed to be effective cerumenolytics compared with no treatment, but water was significantly more effective compared with any of the other tested products (P < .001). CONCLUSION: Docusate sodium was severely ototoxic, and its use should be discouraged. Mineral oil was not ototoxic. Water seemed to be the most effective cerumenolytic agent.

Ear drops for the removal of ear wax.

BACKGROUND: Problems attributed to the accumulation of wax (cerumen) are among the most common reasons for people to present to their general practitioners with ear trouble. Treatment for this condition often involves use of a wax softening agent (cerumenolytic) to disperse the cerumen, reduce the need for, or facilitate syringing, but there is no consensus on the effectiveness of the variety of cerumenolytics in use. OBJECTIVES: To assess the effectiveness of ear drops (cerumenolytics) for the removal of symptomatic ear wax. SEARCH STRATEGY: We searched the Cochrane Ear, Nose and Throat Disorders Group Trials Register; the Cochrane Central Register of Controlled Trials (CENTRAL) (The Cochrane Library, 2008 issue 2); MEDLINE; EMBASE; CINAHL; ISI Proceedings; Cambridge Scientific Abstracts; mRCT and additional sources for published and unpublished trials. The date of the most recent search was April 2008. SELECTION CRITERIA: We identified all randomised controlled trials in which a cerumenolytic was compared with no treatment, a placebo, or other cerumenolytics in participants with obstructing or impacted ear wax, and in which the proportion of participants with sufficient clearance of the external canal to make further mechanical clearance unnecessary (primary outcome measure) was stated or calculable. DATA COLLECTION AND ANALYSIS: The two authors reviewed all the retrieved trials and applied the inclusion criteria independently. MAIN RESULTS: Nine trials satisfied the inclusion criteria. In all, 679 participants received one of 11 different cerumenolytics. One trial compared active treatments with no treatment, three compared active treatments with water or a saline 'placebo', and all nine trials compared two or more active treatments. Eight trials included syringing as a secondary intervention.Overall, results were inconclusive. The majority of comparisons showed no difference between treatments. Meta-analysis of two high quality trials produced a statistical difference in favour of triethanolamine polypeptide over saline in preventing the need for syringing, but no other significant differences between treatments.In three trials of high to moderate quality, no difference was found between the effectiveness of either sodium bicarbonate ear drops, chlorbutanol, triethanolamine polypeptide oleate condensate or docusate sodium liquid versus a sterile water or saline 'placebo'.One trial of moderate methodological quality found all three treatments - sodium bicarbonate ear drops, chlorbutanol and sterile water - to be significantly better than no treatment at preventing the need for syringing.None of the higher quality trials demonstrated superiority of one agent over another in direct comparisons. AUTHORS' CONCLUSIONS: Trials have been heterogeneous and generally of low or moderate quality, making it difficult to offer any definitive recommendations on the effectiveness of cerumenolytics for the removal of symptomatic ear wax. Using drops of any sort appears to be better than no treatment, but it is uncertain if one type of drop is any better than another. Future trials should be of high methodological quality, have large sample sizes, and compare both oil-based and water-based solvents with placebo, no treatment or both.

Ear wax.

INTRODUCTION: Ear wax only becomes a problem if it causes a hearing impairment or other ear-related symptoms. Ear wax is more likely to accumulate and cause a hearing impairment when normal extrusion is prevented--for example, by the use of hearing aids, or by the use of cotton buds to clean the ears. Ear wax can visually obscure the ear drum, and may need to be removed for diagnostic purposes. METHODS AND OUTCOMES: We conducted a systematic review and aimed to answer the following clinical question: What are the effects of methods to remove ear wax? We searched: Medline, Embase, The Cochrane Library and other important databases up to June 2007 (Clinical Evidence reviews are updated periodically, please check our website for the most up-to-date version of this review). We included harms alerts from relevant organisations such as the US Food and Drug Administration (FDA) and the UK Medicines and Healthcare products Regulatory Agency (MHRA). RESULTS: We found nine systematic reviews, RCTs, or observational studies that met our inclusion criteria. We performed a GRADE evaluation of the quality of evidence for interventions. CONCLUSIONS: In this systematic review we present information relating to the effectiveness and safety of the following interventions: ear syringing, manual removal (other than ear syringing), and wax softeners (alone or prior to syringing).

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.

Topical pimecrolimus 1% for the treatment of pruritic external auditory canals.

OBJECTIVES/HYPOTHESIS: To understand the role and efficacy of topical pimecrolimus in the treatment of refractory pruritus of the external auditory canals (EACs). STUDY DESIGN: Retrospective chart review. METHODS: Thirty-six patients with pruritic EACs who had failed conventional therapy with topical and systemic medications were treated with topical pimecrolimus 1% for a period of 3 months. Baseline and follow-up evaluation of the degree of pruritus among other variables was performed. A control group of 19 patients was instructed on aural toilet alone and was not treated with topical pimecrolimus 1%. RESULTS: Of the 36 patients who were treated with topical pimecrolimus for their pruritic EACs, 34 patients had resolution of their symptoms. There was evidence of return of cerumen production in 86% of patients. In the control group, 16% of patients had improvement of their symptoms with aural toilet. This difference was statistically significant (chi, P < .0001). CONCLUSIONS: Topical pimecrolimus appears to be more efficacious than aural toilet in the treatment of pruritic ears for chronic use without side effects.

Safety and efficacy of Sofenz ceruminolytic solution.

We conducted an open-label study of 109 untreated patients who had excessive or impacted cerumen. Our goal was to evaluate the safety and efficacy of Sofenz Cerumenolytic Solution, a methyltrypsin-containing earwax removal solution. Each patient's external auditory canal was filled with Sofenz for 15 minutes. The primary measure of efficacy--visibility of the tympanic membrane--was assessed after the solution had been drained from the canal and again after the canal had been irrigated with lukewarm water. If the tympanic membrane was not completely visible following either application, the procedure was repeated. A safety examination was conducted 1 to 3 days after treatment. Secondary outcomes measures included relief of otologic symptoms (e.g., hearing loss, tinnitus, etc.) and patients'overall satisfaction with treatment. Immediately after treatment, we found that the external auditory canal was completely visible in 81 patients (74.3%) after 1 application of Sofenz and subsequent irrigation, and in 98 patients (89.9%) after 2 applications of each. At the safety follow-up visit, we determined that the number of otologic symptoms had declined by 93.2%. A self-reported assessment completed by each patient following the procedure revealed a high degree of satisfaction with treatment. A total of 58 adverse events were reported, but only 16 were directly related to treatment, and all were transient and either mild or moderate. We conclude that 1 or 2 applications of Sofenz followed by irrigation with lukewarm water is a safe, well-tolerated, and effective treatment for excessive or impacted cerumen in the external auditory canal.

In vitro investigation of ceruminolytic activity of various otic cleansers for veterinary use.

Knowledge of the ceruminolytic activity of commercially available ear cleansing products assists the practitioner to choose the best available product for specific clinical situations. The aim of this study was to quantify and compare the ceruminolytic activity of commercially available canine ear cleansers. For this purpose, the ceruminolytic activity of 13 ear cleansers was evaluated using a standardized synthetic cerumen (SSC) that mimics the composition and texture of canine cerumen. The test products were incubated with mild agitation for 20 min with 500 mg of SSC previously compacted at the bottom of a test tube. Ceruminolytic activity was then assessed by quantifying the SSC removed by decantation. This procedure was repeated five consecutive times on each tube simulating repeated applications in the canine ear canal. Good repeatability among replicates was found in this assay, allowing direct comparisons between products. The final percentage of SSC elimination ranged from none (similar to water), between 8 and 39% for three products and up to 90% for one product (P<0.001). It is concluded that, in the experimental conditions used in this study, only 1/13 products had significant ceruminolytic activity.