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ATTACHMENT 2y, and pediatrics.SULTS: The panel made a strong recommendation thatclinicians should treat cerumen impaction that causes symptomsressed by the patient or prevents clinical examination when

rranted. The panel made recommendations that 1) cliniciansuld diagnose cerumen impaction when an accumulation ofumen is associated with symptoms, or prevents needed assess-nt of the ear (the external auditory canal or tympanic mem-ne), or both; 2) clinicians should assess the patient with ceru-n impaction by history and/or physical examination for factorst modify management, such as one or more of the following:nintact tympanic membrane, ear canal stenosis, exostoses, dia-es mellitus, immunocompromised state, or anticoagulant ther-; 3) the clinician should examine patients with hearing aids for

DISCLAIMER: This clinical practice guideline is not intendedas a sole source of guidance in managing cerumen impaction.Rather, it is designed to assist clinicians by providing an evidence-based framework for decision-making strategies. It is not intendedto replace clinical judgment or establish a protocol for all individ-uals with this condition, and may not provide the only appropriateapproach to diagnosing and managing this problem. 2008 American Academy of OtolaryngologyHead and NeckSurgery Foundation. All rights reserved.

Cerumen, or earwax, is a naturally occurring sub-stance that cleans, protects, and lubricates the externalauditory canal. Cerumen forms when glandular secretionsfrom the outer one-third of the ear canal mix with exfoliated

Received June 17, 2008; accepted June 18, 2008.

4-5998/$34.00 2008 American Academy of OtolaryngologyHead and Neck Surgery Foundation. All rights reserved.linical practice guideline:

ter S. Roland, MD, Timothy L. Smiteth R. Schwartz, MD, MPH, Richardopanna Ballachanda, PhD, Jerry M.llen D. Harlor Jr, MD, Barry E. Hirschelene J. Krouse, PhD, Anthony Magavid R. Stutz, MD, and Stephen Wetd Eugene, OR; Seattle, WA; Brooklyn, Ns Angeles and San Diego, CA; Pittsburgh

hicago, IL; Ann Arbor, MI; and Morganto

JECTIVE: This guideline provides evidence-based recommen-ions on managing cerumen impaction, defined as an accumulationcerumen that causes symptoms, prevents assessment of the ear, orh. We recognize that the term impaction suggests that the earal is completely obstructed with cerumen and that our definition ofumen impaction does not require a complete obstruction. How-r, cerumen impaction is the preferred term since it is consistentlyd in clinical practice and in the published literature to describeptomatic cerumen or cerumen that prevents assessment of the ear.

is guideline is intended for all clinicians who are likely to diagnosemanage patients with cerumen impaction.RPOSE: The primary purpose of this guideline is to improvegnostic accuracy for cerumen impaction, promote appropriateervention in patients with cerumen impaction, highlight the need

evaluation and intervention in special populations, promoteropriate therapeutic options with outcomes assessment, and

prove counseling and education for prevention of cerumen im-tion. In creating this guideline the American Academy of Oto-

yngologyHead and Neck Surgery Foundation selected a panel:10.1016/j.otohns.2008.06.026rumen impaction

D, MPH,Rosenfeld, MD, MPH,l, MD, Jose Fayad, MD,D, Stacie S. Jones, MPH,D, Carrie Nelson, MD, MS,e, MD, MBA, Dallas, TX; Portlandlbuquerque, NM; Washington, DC;; Alexandria, VA; Detroit, MI;WVpresence of cerumen impaction during a healthcare encounter

amination more frequently than every three months, however,ot deemed necessary); 4) clinicians should treat the patient withumen impaction with an appropriate intervention, which maylude one or more of the following: cerumenolytic agents, irri-ion, or manual removal other than irrigation; and 5) cliniciansuld assess patients at the conclusion of in-office treatment ofumen impaction and document the resolution of impaction. Ifimpaction is not resolved, the clinician should prescribe addi-

nal treatment. If full or partial symptoms persist despite reso-ion of impaction, alternative diagnoses should be considered.e panel offered as an option that 1) clinicians may observeients with nonimpacted cerumen that is asymptomatic and doest prevent the clinician from adequately assessing the patienten an evaluation is needed; 2) clinicians may distinguish andmptly evaluate the need for intervention in the patient who may

t be able to express symptoms but presents with cerumen ob-ucting the ear canal; 3) the clinician may treat the patient withumen impaction with cerumenolytic agents, irrigation, or man-removal other than irrigation; and 4) clinicians may educate/nsel patients with cerumen impaction/excessive cerumen re-

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S2 OtolaryngologyHead and Neck Surgery, Vol 139, No 3S2, September 2008ATTACHMENT 2uamous epithelium.1 Normally, cerumen is eliminated orpelled by a self-cleaning mechanism, which causes it tograte out of the ear canal, assisted by jaw movement.2Accumulation of cerumen, caused by failure of the self-aning mechanism, is one of the most common reasonst patients seek medical care for ear-related problems.3,4cessive or impacted cerumen is present in one in 10ildren, one in 20 adults, and more than one-third of theriatric and developmentally delayed populations.5-7out 12 million people seek medical care annually forblematic cerumen in the United States, resulting in

arly eight million cerumen removal procedures.8,9 More-er, excessive or impacted cerumen in high-risk popula-ns such as the elderly and developmentally delayed isderdiagnosed and likely undertreated.6,10,11The target patient for this guideline is over six months of

e with a clinical diagnosis of cerumen impaction:

Cerumen is defined as a mixture of secretions (sebumtogether with secretions from modified apocrine sweatglands) and sloughed epithelial cells, and is a normalsubstance present in the external auditory canal. As ceru-men migrates laterally, it may mix with hair and otherparticulate matter.Cerumen impaction is defined as an accumulation ofcerumen that causes symptoms, prevents a needed assess-ment of the ear canal/tympanic membrane or audioves-tibular system, or both.Impaction vs obstruction: Although impaction usuallyimplies that cerumen is lodged, wedged, or firmly packedin the ear canal, our definition of cerumen impaction doesnot require a complete obstruction.

We have defined this term pragmatically to designaterumen that requires management either because it is as-ciated with symptoms or because it prevents a neededessment of the ear.1,4,7 Some patients will present withnimpacted cerumen that does not cause symptoms andes not prevent assessment of the ear and is asymptom-c. Asymptomatic cerumen often does not require activenagement. The guideline will discuss considerations rel-

ant to watchful waiting and surveillance.Symptoms associated with cerumen impaction in-de, but are not limited to: hearing loss, tinnitus, full-

ss, itching, otalgia, discharge, odor, or cough. Cerumenpaction can prevent diagnostic assessment by prevent-

complete examination of the external auditory canald/or tympanic membrane or by interfering with diag-stic assessment.The guideline does not apply to patients with cerumenpaction associated with the following conditions: derma-ogic diseases of the ear canal; recurrent otitis externa;ratosis obturans; prior radiation therapy affecting the ear;vious tympanoplasty/myringoplasty or canal wall down

stoidectomy.

paUIDELINE PURPOSE

e primary purpose of this guideline is to help cliniciansntify patients with cerumen impaction who may benefitm intervention, and to promote evidence-based manage-nt. Another purpose of the guideline is to highlight needs

d management options in special populations or in patientso have modifying factors. A guideline is necessary givenevidence of practice variation in medicine and the litera-

e. The secondary goal includes creating a guideline suitablederiving a performance measure on cerumen impaction.The guideline is intended for all clinicians who are likelydiagnose and manage patients with cerumen impactiond applies to any setting in which cerumen impactionuld be identified, monitored, or managed.The guideline does not apply to patients with cerumenpaction associated with the following conditions: derma-ogic diseases of the ear canal; recurrent otitis externa;ratosis obturans; prior radiation therapy affecting the ear;vious tympanoplasty/myringoplasty or canal wall downstoidectomy. However, the guideline will discuss the rele-

nce of these conditions in cerumen management. The fol-ing modifying factors are not the primary focus of the

ideline, but will be discussed relative to their impact onnagement: nonintact tympanic membrane (perforation orpanostomy tube); ear canal stenosis; exostoses; diabetes

llitus; immunocompromised state; or anticoagulant therapy.Existing guidelines12,13 concerning cerumen impactionmarily address scope of practice issues or diagnosis, withcross-specialty input. Moreover, there are no guidelinest contain explicit statements about management that areociated with evidence rankings. Our goal was to create altidisciplinary guideline with a limited set of focusedommendations based on a transparent and explicit pro-

ss that considers levels of evidence, harm-benefit balance,d expert consensus to fill evidence gaps. Moreover, theideline should have a well-defined focus based on aspectsmanagement offering the greatest opportunity for qualityprovement.

RDEN OF CERUMEN IMPACTION

proximately 2% to 6% of the general population in theited Kingdom suffers from cerumen impaction at anyen time.7 Four percent of primary care patients will

nsult their clinician for cerumen impaction, and cerumenoval is the most common ear, nose, and throat procedure

rformed in the primary care setting in the United King-m.7 Applying these rates to the United States populationggests a prevalence of cerumen impaction of 12 millionividuals, ranging between six and 18 million. Further,

proximately eight million ear irrigations are performednually for this condition.8

Cerumen impaction is more common in the elderly and in

tients with cognitive impairment. Estimates suggest that

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S3Roland et al Clinical practice guideline: Cerumen impactionATTACHMENT 2m 19% to 65% of patients over 65 years old have cerumenpaction10,11 and that elderly patients in nursing homes areely at the upper end of this spectrum.5,14 In the develop-ntally delayed adult population, 28% to 36% have excessiveimpacted cerumen.5,6 Moreover, the presence of cerumenpaction has been associated with hearing loss15 and dimin-ed cognitive function11 in these populations.The prevalence of cerumen impaction varies enormously.a study of 1507 adults screened for hearing loss, 2.1% hadcluding cerumen.16 Another study found that almost 40% ofrsing home patients had cerumen impactions.17 Cerumenpaction is present in approximately 10% of children, 5% ofrmal healthy adults, up to 57% of older patients in nursingmes, and 36% of patients with mental retardation.5Patients seek treatment for cerumen impaction for a hostsymptoms. Pain, itching, sensation of fullness, tinnitus,or, drainage, cough, and dizziness have all been reported,d complete occlusion can result in significant hearings.7 Hearing loss can range from 5 to 40 dB depending ondegree of occlusion of the canal with cerumen.3,5 While

rumen impaction may be asymptomatic in some cases,nagement may be necessary for diagnostic purposes sot the ear canal and/or tympanic membrane can be visu-zed or diagnostic assessment can be performed.18Multiple treatment options exist for cerumen impaction,luding observation; cerumenolytic agents; irrigation; ornual removal other than irrigation.4,18 Combinations ofse treatment options also exist (eg, cerumenolytic fol-ed by irrigation; irrigation followed by manual removal).nual removal other than irrigation may be performed with a

rette, probe, hook, forceps, or suction under direct visualiza-n with headlight, otoscopy, or microscopy.1,7 The training,ll, and experience of the clinician play a significant role intreatment option selected.17 In addition, patient presenta-

n, preference, and urgency of the clinical situation influenceoice of treatment.Though generally safe, treatment of cerumen impaction

n result in significant complications. Complications suchtympanic membrane perforation, ear canal laceration,ection of the ear, or hearing loss occur at a rate of aboute in 1000 ear irrigations.3,19,20 Applying this rate to theproximate number of ear irrigations performed in theited States estimates that 8000 complications occur an-ally and likely require further medical services. Othermplications that have been reported include otitis externametimes secondary to external auditory canal trauma),

in, dizziness, and syncope.4,21The primary outcome considered in this guideline isolution or change in the signs and symptoms associatedth cerumen impaction. Secondary outcomes include com-cations or adverse events. Cost, adherence to therapy,ality of life, return to work or activity, return physicianits, and effect on comorbid conditions (eg, sensorineuralaring loss, conductive hearing loss) were also considered.e high incidence and prevalence of cerumen impaction

d the diversity of interventions available (Table 1) make lims an important condition for an up-to-date, evidence-sed practice guideline.

ETHODS

neral Methods and Literature Searche guideline was developed using an explicit and trans-rent a priori protocol for creating actionable statementssed on supporting evidence and the associated balance ofnefit and harm.22 The multidisciplinary guideline devel-ment panel was chosen to represent the fields of audiol-y, family medicine, geriatrics, internal medicine, nursing,laryngologyhead and neck surgery, and pediatrics. Sev-l group members had significant prior experience in

veloping clinical practice guidelines.Several literature searches were performed through Oc-er 16, 2007. The initial MEDLINE search using ceru-n or earwax or ear wax or ear secretions in anyld yielded 1219 potential articles:1) Clinical practice guidelines were identified by limit-the MEDLINE search using guideline as a publicatione or title word. Search of the National Guideline Clear-house (www.guideline.gov) identified three guidelines

th a topic of cerumen or earwax. After eliminating articlest did not have cerumen impaction as the primary focus,guidelines met quality criteria of being produced underauspices of a medical association or organization and

ving an explicit method for ranking evidence and linkingidence to recommendations.

able 1terventions considered in cerumen guidelineevelopment

iagnosisTargeted historyPhysical examinationOtoscopyBinocular microscopyAudiologic evaluation

reatmentWatchful waiting/observationEducation/informationCerumenolytic agentsEar canal irrigationManual removal other that irrigation (curette,

probe, forceps, suction, hook)Cotton-tip swabsEar candling

reventionCerumenolytic agentsHygieneEducationEnvironmental controls2) Systematic reviews (meta-analysis) were identified byiting the MEDLINE search to 10 articles using a validated

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S4 OtolaryngologyHead and Neck Surgery, Vol 139, No 3S2, September 2008ATTACHMENT 2er strategy for systematic reviews.23 Search of the Cochranerary identified one relevant title. After eliminating articlest did not have cerumen impaction as the primary focus, fivetematic reviews met quality criteria of having explicit cri-ia for conducting the literature search and selecting sourceicles for inclusion or exclusion.3) Randomized controlled trials were identified byrch of the Cochrane Controlled Trials Register, whichntified 33 trials with cerumen or earwax or earx in any field.4) Original research studies were identified by limitingMEDLINE search to articles on humans published in

glish since 1966. The resulting data set of 796 articleslded 177 randomized controlled trials, 78 reviews, 10

stematic reviews, three guidelines, and 538 other studies.e literature was further narrowed using the standard lit-ture review process including removal of: topics without

fficient evidence; nonoriginal research; letters; commen-ies; narrative reviews; nonclinical research; case reports;uncontrolled case series.22Results of all literature searches were distributed toideline panel members at the first meeting, includingctronic listings with abstracts (if available) of therches for randomized trials, systematic reviews, ander studies. This material was supplemented, as needed,

th targeted searches to address specific needs identified initing the guideline through December 14, 2007.In a series of conference calls, the working group definedscope and objectives of the proposed guideline. Duringnine months devoted to guideline development ending in

ne 2008, the group met twice, with interval electroniciew and feedback on each guideline draft to ensure

curacy of content and consistency with standardized cri-ia for reporting clinical practice guidelines.24An independent review group used the Guideline Imple-ntability Appraisal and Extractor (GEM-COGS)25 to ap-ise adherence of the draft guideline to methodologicndards, to improve clarity of recommendations, and todict potential obstacles to implementation. Guideline

nel members received summary appraisals in 2008 anddified an advanced draft of the guideline.The final draft practice guideline underwent extensive

ternal peer review. Comments were compiled and re-wed by the group chairpersons. The recommendations

ntained in the practice guideline are based on the bestailable published data through October 2007. Where data

lacking, a combination of clinical experience and expertnsensus was used. A scheduled review process will occurfive years from publication or sooner if new compellingidence warrants earlier consideration.

assification of Evidence-Based Statementsidelines are intended to reduce inappropriate variationsclinical care, to produce optimal health outcomes for

tients, and to minimize harm. The evidence-based ap-

ach to guideline development requires that the evidence

pporting a policy be identified, appraised, and summa-promeed and that an explicit link between evidence and state-nts be defined. Evidence-based statements reflect bothquality of evidence and the balance of benefit and harm

t is anticipated when the statement is followed. Thefinitions for evidence-based statements26 are listed inbles 2 and 3.Guidelines are never intended to supersede professionalgment; rather, they may be viewed as a relative constraintindividual clinician discretion in a particular clinical cir-

mstance. Less-frequent variation in practice is expected for arong recommendation than might be expected with a rec-mendation. Options offer the most opportunity for prac-

e variability.27 Clinicians should always act and decide in ay that they believe will best serve their patients interestsd needs, regardless of guideline recommendations. Guide-es represent the best judgment of a team of experiencednicians and methodologists addressing the scientific evi-nce for a particular topic.26Making recommendations about health practices in-lves value judgments on the desirability of various out-mes associated with management options. Values appliedthe guideline panel sought to minimize harm and dimin-unnecessary and inappropriate therapy. A major goal ofcommittee was to be transparent and explicit about how

lues were applied and to document the process.

nancial Disclosure and Conflicts of Intereste cost of developing this guideline, including travel ex-nses of all panel members, was covered in full by the

erican Academy of OtolaryngologyHead and Neckrgery Foundation (AAO-HNSF). Potential conflicts oferest for all panel members in the past five years werempiled and distributed before the first conference call.ter review and discussion of these disclosures,28 the panelncluded that individuals with potential conflicts could

ain on the panel if they: 1) reminded the panel oftential conflicts before any related discussion, 2) recusedmselves from a related discussion if asked by the panel,

d 3) agreed not to discuss any aspect of the guideline withustry before publication. Lastly, panelists were remindedt conflicts of interest extend beyond financial relation-

ips, and may include personal experiences, how a partic-nt earns a living, and the participants previously estab-

hed stake in an issue.29

RUMEN IMPACTION GUIDELINEIDENCE-BASED STATEMENTS

ch evidence-based statement is organized in a similarhion: evidence-based statement in boldface type, fol-ed by a statement on the strength of the recommenda-

n. Several paragraphs then discuss the evidence basepporting the statement, concluding with an evidence

file of aggregate evidence quality, benefit-harm assess-nt, and statement of costs. Lastly, there is an explicit

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S5Roland et al Clinical practice guideline: Cerumen impactionATTACHMENT 2tement of the value judgments, the role of patient pref-nces, and a repeat statement of the strength of the rec-mendation. An overview of evidence-based statements inguideline and their interrelationship is shown in Table 4.

The role of patient preference in making decisions de-ves further clarification. For some statements the evi-nce base demonstrates clear benefit, which would mini-ze the role of patient preference. If the evidence is weakbenefits are unclear, however, not all informed patientsght opt to follow the suggestion. In these cases, thectice of shared decision making, where the management

cision is made by a collaborative effort between thenician and the informed patient, becomes more useful.

able 2uideline definitions for evidence-based statements

Statement Definitio

trong recommendation A strong recommendation mthe recommended approaharms (or that the harmsbenefits, in the case of a srecommendation) and thasupporting evidence is exB)*. In some clearly identistrong recommendationson lesser evidence when his impossible to obtain anbenefits strongly outweigh

ecommendation A recommendation means tthe harms (or that the harbenefits, in the case of a nrecommendation), but theis not as strong (Grade Bclearly identified circumstrecommendations may belesser evidence when highimpossible to obtain andbenefits outweigh the har

ption An option means that eitherevidence that exists is susthat well-done studies (Grshow little clear advantaganother.

o recommendation No recommendation meansof pertinent evidence (Graunclear balance between

See Table 3 for definition of evidence grades.ctors related to patient preference include (but are notited to): absolute benefits (number needed to treat); ad-

clithirse effects (number needed to harm); cost of drugs orcedures; and frequency and duration of treatment. Co-rbidity can also impact patient preferences by severalchanisms, including the potential for drug-drug interac-ns when planning therapy.Statement 1a. DIAGNOSIS OF CERUMEN IMPAC-ON: Clinicians should diagnose cerumen impactionen an accumulation of cerumen 1) is associated with

mptoms, or 2) prevents needed assessment of the ear,3) both. Recommendation based on diagnostic studies

th minor limitations and a preponderance of benefit overrm.Although impaction implies 100% occlusion to many

Implication

the benefits ofarly exceed the

y exceed thenegative

quality of thet (Grade A orircumstances,e made baseduality evidenceanticipatedharms.

Clinicians should follow astrong recommendationunless a clear and compellingrationale for an alternativeapproach is present.

nefits exceedceed thevety of evidence. In some,e based onity evidence isticipated

Clinicians should also generallyfollow a recommendation,but should remain alert tonew information andsensitive to patientpreferences.

uality ofGrade D)* or, B, or C)*ne approach vs

Clinicians should be flexible intheir decision makingregarding appropriatepractice, although they mayset bounds on alternatives;patient preference shouldhave a substantial influencingrole.

is both a lack* and ants and harms.

Clinicians should feel littleconstraint in their decisionmaking and be alert to newpublished evidence thatclarifies the balance ofbenefit vs harm; patientpreference should have asubstantial influencing role.ve

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S6 OtolaryngologyHead and Neck Surgery, Vol 139, No 3S2, September 2008ATTACHMENT 2ered impacted. Clinicians should diagnose cerumen im-ction when an accumulation of cerumen causes symp-

s, prevents needed assessment of the ear, or both. It isphasized that total occlusion is not necessary in thisideline definition. It should be noted that when an unob-ucted ear canal or the view of the tympanic membrane ist essential to good care and is not associated with symp-

s, cerumen in the ear canal is not considered impactedthis definition, and thus may not require any interventioner than observation.Symptoms of cerumen impaction include: otalgia; tinni-; fullness in the ear; pain; cough; hearing loss; andrtigo.3,5,7 Presence of these symptoms should lead thenician to examine the ear canal and, if cerumen is en-untered, consider the diagnosis of impacted cerumen.

able 3vidence quality for grades of evidence

rade Evidence quality

A Well-designed randomized controlled trialsor diagnostic studies performed on apopulation similar to the guidelinestarget population

B Randomized controlled trials or diagnosticstudies with minor limitations;overwhelmingly consistent evidencefrom observational studies

C Observational studies (case-control andcohort design)

D Expert opinion, case reports, reasoningfrom first principles (bench research oranimal studies)

X Exceptional situations where validatingstudies cannot be performed and thereis a clear preponderance of benefit overharm

able 4utline of evidence-based statements

Cerumen Impaction (evidence-based statement num

Diagnosisa. Diagnosis (Statement #1a)b. Modifying factors (Statement #1b)

. Interventiona. Observation (Statement #2)b. Need for intervention (Statement #3a)c. Need for intervention in special populations (Statem

I. Hearing Aid Use (Statement #4). Treatment

a. Therapeutic interventions (Statement #5a)b. Cerumenolytic agents (Statement #5b)c. Irrigation (Statement #5c)d. Manual removal other than irrigation (Statement #

. Outcomes assessment (Statement #6)

I. Prevention (Statement #7)Physical examination of the external canal can be per-med using a handheld speculum, an otoscope, or a bin-ular microscope. Cerumen impaction may impair a clini-ns ability to visualize the tympanic membrane andess the status of the middle ear.30 In a study examining a

hort of children ranging in age from 2 to 60 months,rumen was removed in 89 of 279 children (29%) subse-ently diagnosed with acute otitis media. While the datalimited, they suggest that cerumen impaction can inhibit

prevent diagnosis of middle ear disease.Cerumen impaction is appropriately diagnosed if ceru-n in the ear canal prevents needed assessment even if the

nal is only partially occluded. For example, if cerumen inear canal prevents visualization of all or part of thepanic membrane in a patient suspected of having a

rforation, the cerumen should be removed. Note thaten visualization of ear canal anatomy or the tympanicmbrane is not essential to good care and is not associatedth symptoms, cerumen in the ear canal is not consideredpacted by this definition.

If cerumen in the ear canal would compromise auditoryvestibular testing, cerumen impaction is also diagnosed.veral audiologic tests cannot be performed accuratelycause of complete or partial impaction; these tests in-de: audiometry; immittance testing; electrocochleogra-y (ECochG); otoacoustic emissions (OAE); auditoryin stem responses (ABR); and real ear measurements

ring hearing aid fitting.

idence profile for 1a: Diagnosis of Cerumen Impaction.Aggregate evidence quality: Grade B, diagnostic studieswith minor limitations regarding impact of cerumen onhearing and visualizations and Grade C with respect tosigns and symptoms associated with cerumen impactionBenefit: Identify individuals with cerumen impaction whorequire intervention including those with otologic symp-

Statement strength

RecommendationRecommendation

OptionStrong recommendation

#3b) OptionRecommendation

RecommendationOptionOptionOptionRecommendationforoc

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S7Roland et al Clinical practice guideline: Cerumen impactionATTACHMENT 2toms and those who require diagnostic assessment (raiseawareness of the consequences of cerumen impactioneg, cerumen impaction prevents caloric stimulation dur-ing electronystagmography)Harm: Overdiagnosis of cerumen impaction based onsymptoms as a criterion resulting in failure to identifyanother cause of the symptomsCost: no additional costBenefits-harm assessment: preponderance of benefitsover harmValue judgments: emphasis on clinical symptoms andsigns for initial diagnosis; importance of avoiding unnec-essary diagnostic tests; consensus on using the termcerumen impaction to imply cerumen that requirestreatmentRole of patient preferences: not applicablePolicy level: Recommendation

Statement 1b. MODIFYING FACTORS: Cliniciansould assess the patient with cerumen impaction bytory and/or physical examination for factors thatdify management such as one or more of the follow-: non-intact tympanic membrane, ear canal stenosis,

ostoses, diabetes mellitus, immunocompromised state,anticoagulant therapy. Recommendation based on ob-vational studies with a preponderance of benefit overrm.The management of cerumen can be influenced by hosttors or anatomic abnormalities of the ear canal or tym-

nic membrane. The initial approach to the patient withrumen impaction should include an assessment of thesetors by history, physical examination, or both. Failure tontify such factors may lead to suboptimal care, harm, orppropriate interventions.Anatomic factors, either congenital or acquired, candify the approach to treatment of cerumen impaction

sed on narrowing of the ear canal by either limitingualization or increasing the likelihood of trauma. A nar-

ear canal can make both irrigation and manual instru-ntation difficult to perform. Narrow canals can be foundsubjects with Down syndrome and other craniofacialorders, chronic external otitis, and post trauma (including

rgical).Stenosis may be congenital or acquired. Congenital ste-sis may involve both the lateral portion (cartilaginous)d the medial bony ear canal and can vary in severity fromld constriction of the external auditory canal (EAC) tomplete atresia.Diffuse exostoses and solitary osteomas of the external

ditory canal are acquired bony growths that may severelyit the size of the ear canal and may trap cerumen and

ratin debris in the bony canal and prevent adequate visu-zation of the tympanic membrane. Exostoses are broad-sed hyperostotic lesions that tend to be multiple andateral and are associated with a history of cold-waterimming.31 Osteomas are less common and are usuallylitary, unilateral, and pedunculated.32 cleSafe and effective irrigation is not always possible inse patients; specialized equipment and procedures mayrequired to safely remove cerumen in these patients

thout undue risk. The clinician can usually remove thepaction by combining the magnification from the binoc-r microscope with micro-instrumentation.A perforated tympanic membrane or patent tympanos-y tube limits the options available for cerumen removal.

e presence of a nonintact tympanic membrane may beessed by history and/or physical examination. Dependingthe irrigation solution used, infection, pain, or ototoxic

aring loss could result. In addition, use of irrigation in thesence of a perforated tympanic membrane could produce

loric effects resulting in vertigo. Mechanical removal ofrumen is the preferred technique when the ear drum is notact.Irrigation with tap water has been implicated as an etio-ic factor in several studies of malignant external oti-

.33-36 Given the reports of malignant otitis externa inmunocompromised AIDS patients, tap water ear irriga-n may pose risks for that group as well.37,38 Driscoll hasmonstrated that the pH of diabetic cerumen is signifi-ntly higher than that in persons without diabetes, whichy facilitate the growth of pathogens.39 Clinicians wholize irrigation in this patient population must be espe-lly careful to minimize trauma, consider using ear dropsacidify the ear canal post irrigation, and provide closelow-up.Patients who are on anticoagulant therapy are at higherk for cutaneous hemorrhage or subcutaneous hematomas.reful instrumentation is especially important if bleedingto be avoided or minimized.

idence profile for 1b: Modifying Factors.Aggregate evidence quality: Grade C and D, observa-tional studiesBenefit: Reduce complicationsHarm: No harmBenefits-harm assessment: preponderance of benefit overharmValue judgments: consensus that identifying modifyingfactors and modifying management will improve out-comes

Policy level: recommendation

Statement 2. OBSERVATION OF NONIMPACTEDRUMEN: Clinicians may observe patients with non-

pacted cerumen that is asymptomatic and does notevent the clinician from adequately assessing the pa-nt. Option based on randomized controlled trials withterogeneity in diagnostic criteria and illness severity, andelative balance of benefit and harm.Cerumen is a naturally occurring product of the ear

nal. The normal lateral migration of epithelium in theternal auditory canal is responsible for the ears self-

aning mechanism. Most cerumen is asymptomatic, and

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S8 OtolaryngologyHead and Neck Surgery, Vol 139, No 3S2, September 2008ATTACHMENT 2es not impair necessary physical examination.7 It is im-rtant that patients understand that cerumen does not al-ys need to be removed. Cerumen may have beneficialects; it serves as a self-cleaning agent with protective,ollient, and bacteriocidal properties.Epithelial cells move off the tympanic membrane andn travel down the ear canal toward the meatus of the

ternal canal. When Cerumen migrates toward the en-nce of the canal foreign bodies such as dirt, dust, ander small particles adhere to it and are extruded with the

rumen when it is cast off from the canal.5 This conveyorlt process has been shown to be an ongoing process inst individuals.2Since cerumen is naturally removed from the ear canalsmost people, observation over time can be offered assonable management. There have only been limited stud-investigating the outcome of observing cerumen in the

r canal. Keane performed a small randomized controlleddy of the use of solvents to disperse cerumen in thepacted ears of general practice patients in Dublin.40 Aftere days, 5% of patients in the control group demonstratedmplete cleaning of the ear and 26% demonstrated mod-te cleansing, when managed with observation alone.Moreover, residents at a privately owned intermediate

re facility for the mentally retarded, who had 50% to 80%their external canal occluded by cerumen but who did notve a related conductive hearing loss, had no interventiond were examined after a year.6 At the follow-up exam,% had no cerumen, 53% still had the same amount but nonductive hearing loss, and only 3% progressed to impac-n with associated hearing loss.

idence profile for 2: Observation of Nonimpactedrumen.

Aggregate evidence quality: Grade D, one observationalstudy, expert opinion, and first principlesBenefit: avoid unnecessary treatmentHarm: potential progression to impactionCost: noneBenefits-harm assessment: relative balance of harm vsbenefit for nonimpacted cerumenMedical reasons for exceptions to this statement include,but are not limited to, history of recurrent cerumen im-pactionValue judgments: minimize unnecessary treatment, in-crease recognition of the benefits of cerumenRole of patient preferences: substantial role for shareddecision makingPolicy level: option

Statement 3a. NEED FOR INTERVENTION: Clini-ns should treat cerumen impaction that causes symp-s expressed by the patient or prevents clinical exam-

tion when warranted. Strong recommendation basedrandomized controlled trials with heterogeneity with aeponderance of benefit over harm. chCerumen impaction has been reported to cause symp-s that include itching and pain in the ear, discharge fromear canal, ear fullness, cough, hearing loss, and tinnitus.

There are strong data that indicate removal of impactedrumen can improve hearing;3,11,15,41 however, there areited outcomes data that describe the benefit of cerumenoval as it relates to improvement or resolution of other

mptoms. If the patient has relevant symptoms (pain, tin-us, hearing loss, aural fullness, vertigo) and the ear ispacted with cerumen, cerumen impaction may be pre-med to be the etiology of the symptoms. Removal of thepaction is deemed efficacious if, after the Cerumen isoved, there is either improvement or complete resolu-

n of the presenting symptoms.While cerumen impaction may be a cause of reversible

aring loss, hearing acuity does not diminish until thess-sectional area of the ear canal is reduced by at least

%.42 Consequently, it is difficult to predict whether or notarticular patients cerumen impaction contributes to hisher hearing loss, and whether or not disimpaction will

rtially or completely correct the problem.Screening studies in a variety of settings have shown that

rumen impaction is a frequent reversible cause of hearings.6,43,44 A randomized community-based screening studyOman determined that 2.7% of the population had a

ilateral hearing impairment. Of those who were identifiedth a unilateral hearing loss, 54% were deemed to have aild impairment (hearing threshold 26 to 40 dB), and halfthat group had resolution of hearing loss after simplyaring the ear canal of cerumen at the time of screening.43another study, residents at a privately owned intermediatere facility for the mentally retarded were examined annu-y over a 12-year period.6 When examiners discoveredtients with a new conductive hearing loss (greater than 10air-bone gap at two or more frequencies) and a complete

near-complete ear canal occlusion by cerumen, the con-ctive hearing deficit resolved after the impactions were

oved. In an uncontrolled study of 125 consecutive pa-nts who had been referred by general practitioners to anr syringing clinic in Bristol, UK, those who presentedth difficulty hearing on the phone, ear pain, or blockedrs reported improvement or resolution of their symptoms% to 75% of the time after undergoing ear irrigation.41wever, only 40% to 50% of those who complained ofhing or dizziness reported improvement after ear lavage.Older patients are often unaware that they have a ceru-n impaction potentially impairing their hearing, or thatoval of the impaction may improve their hear-

.10,14,15,45 In a random sample of 226 patients over thee of 65 who were admitted to the nonintensive care unitsa hospital in the United States, 35% had cerumen impac-n that blocked visualization of the tympanic membrane ofher one or both ears. After lavage and otoscopic confir-tion of clearing, repeat hearing tests showed subjects hadproved hearing at several frequencies. There was no

ange in the control patients, who were not impacted.

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S9Roland et al Clinical practice guideline: Cerumen impactionATTACHMENT 2gardless of whether the subjects had cerumen impactionnot, the vast majority had been unaware of their hearingficits and had rated their hearing ability as either goodfair.15The presence of cerumen may also hinder or preventual assessment of the ear canal and tympanic membrane.is is especially important as it relates to children whosent with ear-related symptoms and in whom clinicians

ed to diagnose and treat acute otitis media and otitisdia with effusion.46 Unfortunately, most studies of inter-

ntions to remove cerumen impaction do not explicitlyscribe improved visualization of the tympanic membranean outcome, although ears may be described as com-tely cleared.9,40 One exception is a study of emergencym patients age 1 to 81 who presented with suspected earblems and in whom visualization of the tympanic mem-nes was partially or totally obscured by cerumen. Aftertillation of docusate sodium followed by irrigation ifcessary, there was full visualization 81% of the time.47

idence profile for 3a: Need for Intervention.Aggregate evidence quality: Grade B, randomized con-trolled trials with heterogeneityBenefit: improved hearing and symptom relief comparedwith no treatmentHarm: potential complications related to treatmentBenefits-harm assessment: preponderance of benefit overharmRole of patient preferences: some role for shared decisionmakingPolicy level: Strong recommendation

Statement 3b. NEED FOR INTERVENTION INECIAL POPULATIONS: Clinicians may distinguishd promptly evaluate the need for intervention in thetient who may not be able to express symptoms butesents with cerumen obstructing the ear canal. Optionsed on cohort and observational studies with a balance ofnefit and harm.Elderly patients, young children, and the cognitivelypaired are at high risk for cerumen impaction and may beaware of it or unable to express the symptoms associatedth cerumen impaction due to immaturity or cognitivepairment. The hearing loss associated with cerumen im-ction may further impair cognitive function.A higher incidence of cerumen impaction in these pop-tions is well documented.6,11,14,15,48-51 The specific rea-

ns are not clear, but it may be related to the size of theternal auditory canal in children and the cognitively im-ired, or may stem from changes in the skin of the externalditory canal in elderly patients. A study of 107 childrenth Down syndrome who were referred to otolaryngolo-ts showed that 39% had stenosis of the external auditory

nal frequently complicated by cerumen impaction.52 A

gitudinal study of 117 developmentally delayed adult tients followed over a 12-year period demonstrated a highidence of recurrent cerumen impactions in this popula-n.6 Data on recurrence rates are not available for childrenelderly patients. Some elderly and developmentally de-ed patients reside in nursing homes or institutions. Ceru-n impaction rates appear higher for institutionalized pa-nts.11,53 Patients in these settings may also suffer moreseline cognitive impairment than similar, ambulatorypulations.Impaired cognitive function in the elderly may preventm from recognizing hearing loss or other symptoms andy also impair their ability to bring symptoms to theention of caregivers. A study screening asymptomaticerly patients admitted to nursing homes11 and anothereening 755 asymptomatic developmentally delayed ath-es49 found relatively high levels of cerumen impactiond significant hearing loss in these populations. Smallildren may also lack the maturity to recognize hearings or to bring ear problems to the attention of their care-ers. A cross-sectional study of nearly 1000 South Indian

ildren in South Africa found that conductive hearing lossm cerumen impaction caused over 10% of children to failaring screening.54No randomized controlled trials compare hearing in pa-nts in these populations who have or have not beenaluated and treated for cerumen impaction. A case-con-l study of 226 hospitalized elderly patients with eachtient acting as his/her own control demonstrated an inci-nce of cerumen impaction of 35% and a statisticallynificant improvement in hearing in those patients whod an impaction removed.15 A survey study of over 14,000erly people in England found that 10% of people whotially failed a hearing screening passed after cerumenoval.55 A small cohort study by Moore et al of elderly

tients admitted to nursing homes found that 65% of pa-nts had cerumen impaction and removing the cerumenulted in a statistically significant improvement in hearingd cognitive function as demonstrated by a mini mentaltus exam.11 However, a strong conclusion cannot bede due to a small sample size (N 29). In addition, thereno data on the impact of cerumen-induced hearing losscognitive function in children.

idence profile for 3b: Need for Intervention in Specialpulations.

Aggregate evidence quality: Grade C, cohort and obser-vational studiesBenefit: improved hearing and functional health statusHarm: potential overtreatment of cerumen that is asymp-tomaticCost: evaluation and treatment costs; substantial admin-istrative burden in settings with a high prevalence ofcognitively impaired individuals, such as nursing homesand institutional facilities

Benefits-harm assessment: balance of benefit and harm

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S10 OtolaryngologyHead and Neck Surgery, Vol 139, No 3S2, September 2008ATTACHMENT 2Value judgments: importance of identifying and treatingcerumen impaction in special populationsRole of patient preferences: there is no role for patientpreferences when the patient is unable to express preferencesPolicy level: Option

Statement 4. HEARING AID USE: The clinicianould examine patients with hearing aids for the pres-ce of cerumen impaction during a healthcare encoun-. Recommendation based on cohort and observationaldies with a preponderance of benefit over harm.The normal self-cleaning process of cerumen can beturbed by the presence of objects such as hearing aids or

rplugs.5,56 Perry57 has suggested that the presence ofeign objects such as hearing aids and earplugs can causemulation of cerumen glands, leading to excessive ceru-n production, and he termed this process mechanicallking. Therefore, hearing aid users are at increased riskcerumen impaction.

The clinician should examine patients with hearing aidsimpacted cerumen during a healthcare encounter, but

s does not need to occur more frequently than every threenths. Examination is accomplished by removing the

aring aid and inspecting the ear canal with a handheldscope. If the patient has bilateral hearing aids, the second

r is examined after replacing the first hearing aid toilitate communication.Cerumen impaction may change hearing aid perfor-nce. Irrespective of the type of hearing aids being worn,

rumen impaction can reduce the intensity of sound reach-the tympanic membrane by as much as 10 to 15 dB inmid to high frequencies.56 In addition, even a partial

paction can change the resonance properties of the earnal, reducing mid and high frequency perception.58Current estimates from various hearing aid manufacturersicate that 60% to 70% of all hearing aids sent for repair are

maged as a result of contact with cerumen.59 If an in-the-earE) instrument is utilized, cerumen can enter the vent oreiver. The resulting added mass of cerumen on the receiverphragm causes low-output distortion and loss of high-fre-ency response. A more insidious process occurs as the acidicmpounds within the cerumen slowly deteriorate the dia-ragm suspension, resulting in receiver failure.Cerumen in the ear canal can cause the hearing aid to fitorly and not seal properly. If the hearing aid fits poorly,und produced by the aid passes around it and out of ther canal, where it is picked up by the microphone andmplified. A positive feedback loop is created and audi-, high-pitched feedback results. Cerumen removal elim-tes feedback when feedback is due to excess cerumen.

idence profile for 4: Hearing Aid Use.Aggregate evidence quality: Grade C, observational studiesBenefit: prevent hearing aid dysfunction and associatedrepair costs

Harm: overtreatment of asymptomatic cerumen priBenefits-harm assessment: preponderance of benefit overharmRole of patient preferences: some role for shared decisionmakingPolicy level: Recommendation

Statement 5a. THERAPEUTIC INTERVENTIONS:inicians should treat the patient with cerumen impac-n with an appropriate intervention, which may in-de one or more of the following: cerumenolytic

ents, irrigation, or manual removal other than irriga-n. Recommendation based on randomized controlled tri-and observational studies with a preponderance of ben-

t over harm.

propriate interventions for cerumen impaction. In themptomatic patient, the goal is to help alleviate or relieve

symptoms (pain, fullness, hearing loss, tinnitus, etc). Inasymptomatic patient with impacted cerumen, the goal

to allow visualization of the ear canal and the tympanicmbrane or perform audiometric or vestibular evaluations.veral methods for achieving these goals are widely used.wever, evidence in the literature that clearly identifies the

periority of one therapeutic option vs another is lacking.The treatment method(s) used should depend on: 1) the

ailable resources, 2) experience of the treating clinicianth the available options, and 3) the ease with which thenal can be cleared. Clinically accepted standards includer irrigation and manual disimpaction, although no com-rative randomized clinical trials addressing benefit orrm have been conducted.60Three effective therapeutic options are widely used: 1)

rumenolytic agents, 2) irrigation, and 3) manual removaler than irrigation. Combining one or more of these op-ns, on the same day, or at intervals, is routinely used ineryday practice.61 Irrigation or manual removal can beed alone or after softening the impacted cerumen. Noect comparison has been performed between same-dayoffice softening followed by irrigation or disimpaction vsme softening followed by irrigation and manual disim-ction. Until more placebo-controlled data are gener-d, recommendations must be based on the relativeety of the treatment strategies, on the small number ofect comparison trials within each strategy, and onpert opinion.60Irrigation or ear syringing involves flushing the wax outa jet of warm water. Cerumenolytics, or wax-softening

ents, are used to disperse the cerumen and reduce the needsyringing or for manual removal of the impaction. Ceru-nolytics can be used alone or in combination with irri-

tion or manual removal. Manual removal includes the useear curettes, probes, hooks, forceps, or microsuction.

ble 5 gives an overview of these methods.

ppropriate interventions for cerumen impaction. Ac-rding to expert opinion, interventions that are not appro-

ate for cerumen removal include home use of oral jet

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S11Roland et al Clinical practice guideline: Cerumen impactionATTACHMENT 2igators and cotton-tip swabs.62 Removing cerumen withoral jet irrigator has been described by Larsen.63 Flaredand OtoClear Tip are promoted as safer tips to eliminate

erinsertion and direct the water away from the tympanicmbrane, theoretically avoiding the risk of injury by re-cing the build-up of pressure causing damage or pain.search demonstrating the effectiveness of these homerapeutic options is lacking. Expert opinion favors theee clinician-administered methods discussed above as thest safe and effective options.Expert opinion recommends against the use of cotton-tipabs to remove cerumen from the ear canal, although theidence against it is sparse. The product label of one of theding manufactures of cotton-tip swabs specifically notest the product should not be placed into the ear canal. The

tton buds at the end of cotton-tip applicators may sepa-e, requiring removal as a foreign body.62 Although onlyase report, fatal otogenic meningitis and brain abscess

e to retained cotton tips has been reported.64In a prospective study, Lee et al showed that complica-ns do arise from self-cleaning of the external auditorynal.65 Thirty-six percent of the patients cleaned their earsintroducing a foreign object into the ear. The majority ofpatients in that study were not willing to change their

bits for a safer method of cleaning.A nonrandomized comparison of earwax removal with a

o-it-yourself ear vacuum kit vs the conventional manualthod of removal with a Jobson-Horne probe concludedt the probe is significantly more effective than an ear

cuum for the removal of earwax.66Complementary medicine is becoming more popular inUnited States and use of alternative therapies has in-

ased from 33% to 42%.67 Otolaryngologists will there-e encounter patients who have tried one type or anotheralternative practices. The most popular alternative prac-e for cerumen removal is ear candling, also known as earning or thermo-auricular therapy. Ear candles are hol-

tubes of fabric soaked with warm beeswax and subse-

able 5herapeutic options: advantages, disadvantages

Option Irrigation

dvantages Effective

omplications/disadvantages TM perforationPain, vertigoEAC traumaOtitis externaFailure of wax removalSevere audio-vestibular lo

TM, tympanic membrane; EAC, external auditory canal.ently hardened through cooling. The procedure of can-ng involves sticking such a candle into the ear, lighting coother end, and letting it burn for 15 minutes. Once thendle is extinguished, the near end is inspected. The patienttold that the waxy material at the end of the cone isrumen from the ear, and has been drawn out through ahimney effect or capillary forces produced by the burn-

candle.68In addition to cerumen removal, ear candling is some-es recommended for common conditions such as head-

hes, rhinosinusitis, colds, and tinnitus.69 No reliable prev-nce data is available on candling, but data fromolesale distributors, thousands of Internet references to

r candling, and a survey of 122 US otolaryngologistsowing that they were aware of ear candle use in at leaste of their patients support the assumption that the prev-nce of ear candle use is high.70Adequate research on the effect of ear candling is lim-d. However, a series of experiments have concluded thatndling does not eliminate wax from the ear, but rather theterial deposited at the end of the cone is from the candle

elf, and not wax from the external auditory canal.70-72ditionally, Seely et al concluded that the burning of the

ndle does not produce negative pressure.70 Comparison ofotographs from each subjects ear canals taken before ander the ear candling procedure revealed that no cerumens removed from these ears. These investigators also sur-yed a small sample of otolaryngologists regarding the used safety of ear candles in their patient population. Four-n out of 122 otolaryngologists who responded to the

rvey had treated 21 patients for complications from earndles, which included: 13 burns of the auricle; 7 ear canalclusions; and 1 tympanic membrane perforation. Externaltis and temporary hearing loss were secondary complica-ns in three and six patients, respectively.In summary, these studies have shown that although ear

ndling is heavily promoted, the mechanism of action isplausible. Furthermore, it has no observable positive ef-ts and ear candling use may be associated with consid-ble risks. The Food and Drug Administration (FDA)

Cerumenolytics Manual removal

sy applicationfectiveness not superior tosaline or water

Effective

titis externallergic reactionsin or vertigo if TM is notintactansient hearing loss

Special skills requiredSkin laceration, painCooperation

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S12 OtolaryngologyHead and Neck Surgery, Vol 139, No 3S2, September 2008ATTACHMENT 2pport the efficacy of the ear candles and warns againstir use.73

idence profile for 5a: Therapeutic Options.Aggregate evidence quality: Grade B and C, randomizedcontrolled trials with limitations and cohort studiesBenefit: improved cerumen removal by using effectivetherapies and to avoid harm from ineffective or untestedtherapiesHarm: specific adverse effects related to treatments usedCost: no cost associated with the decision to use appro-priate therapyBenefits-harm assessment: preponderance of benefit overharmValue judgments: Therapy should be effective and min-imize harmRole of patient preferences: Selection of office vs appro-priate home treatmentPolicy level: Recommendation

Statement 5b. CERUMENOLYTIC AGENTS: Clini-ns may use cerumenolytic agents (including water or

line solution) in the management of cerumen impac-n. Option based on limited randomized trials with alance of benefit and harm.Clinicians may use cerumenolytic agents or instruct pa-nts in home use. Cerumenolytic agents include water.pical therapy is regularly used to manage cerumen im-ctions either as a single therapeutic intervention or inmbination with other techniques, including irrigation of

ear canal and manual removal of cerumen. Topicalparations exist in three forms: water-based; oil-based;

d nonwater-, nonoil-based (Table 6). Water-basedents have a cerumenolytic effect by inducing hydrationd subsequent fragmentation of corneocytes.Oil-based preparations are not true cerumenolytics.ey lubricate and soften cerumen without disintegratingrumen.74 The mechanism by which nonoil-, nonwater-

able 6opical preparations (Hand 2004)75

Preparation

ater-based Acetic acidCerumenexColaceHydrogen peroxideSodium bicarbonateSterile saline solution

il-based Almond oilArachis oilEarexOlive oilMineral oil/liquid petrola

onwater-, nonoil-based Audax

Debroxsed ear drops manage cerumen has not been defined by inro studies.75

rumenolytic agents without irrigation. Cerumenolyticents as a single intervention have been evaluated throughdies comparing active agents to: 1) another active agent,plain water, 3) saline, and 4) no intervention. The studiese various endpoints, including the need for subsequentigation and the ability to examine the tympanic mem-ne. The studies are heterogeneous with a diversity ofatment protocols and outcomes. One systematic reviewd meta-analysis evaluated 15 preparations, including sa-e and plain water, and concluded that without syringing,re was weak evidence that both water-based and oil-

sed ear drops were more effective than no treatment.nwater-, nonoil-based preparations were more effec-e than oil-based preparations. Pooled data from this re-w suggest that longer treatment results in greater successclearing of cerumen.75A single study illustrates a comparison between controlcerumenolytic), water, sodium bicarbonate, and an oil-

sed cerumenolytic.40 Subjects were treated for five daysor to reassessment. There was no statistical difference inrs requiring irrigation to achieve complete clearance of

ear canal between the three cerumenolytic groups. Priorsyringing of the ear canal, moderate or complete clear-ce of the ear canal was achieved in 32% of the controlup, 50% of the water group, 46% of the sodium bicar-

nate group, and 60% of the oil-based group. The authorsncluded that using any cerumenolytic is better than usingcerumenolytic.The conclusion of a Cochrane review of water-based and-based preparations concluded that no specific agent wasperior to another and none were superior to either salinewater.1 One study of children compared a single 15-

nute installation of: Cerumenex (10 percent triethanol-ine polypeptide oleate condensate); Colace (docusate so-m), and saline drops.76 There was no difference in the

Active constituents

Aqueous acetic acidTriethanolamine polypeptide oleate condensateDocusate sodiumHydrogen peroxide solutionSodium bicarbonateWaterAlmond oilArachis oilArachis oil, almond oil, rectified camphor oilOlive oilLiquid petrolatumCholine salicylate, glycerinebavit

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linthebaCarbamide peroxide (ureahydrogen peroxide)

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S13Roland et al Clinical practice guideline: Cerumen impactionATTACHMENT 2arance of cerumen with this protocol that included irri-tion if the ears were not completely clear after the 15-nute period.Children age 6 months to 5 years were treated withcusate, triethanolamine polypeptide, or saline with notistical difference between groups after instillation ofps and following one or two attempts of irrigation.77 Theee treatment groups were similar with regard to age, sex,e, type of wax, and number of tympanic membranes

rtially or completely obstructed.An in vitro study of multiple aqueous solutions andanic solvents demonstrated that a 10% solution of so-m bicarbonate was the most effective preparation forintegration of a wax plug.78In summary, the evidence indicates that any type of

rumenolytic agent tends to be superior to no treatment butks evidence that any particular agent is superior to anyer. In vitro studies support using a true cerumenolyticher than an oil-based lubricant for disintegration of ceru-n, with a longer period of treatment tending to be morecacious.

rumenolytic agents with irrigation. Variables evaluatedth regard to cerumenolytics and irrigation include choiceear drop and method of administration. Instilling water15 minutes prior to irrigation compared to immediate

ringing reduced the number of syringing attempts in ady of 26 adult subjects.79 A comparison of 15 minutes ofter instilled in the ear to three days of using an oil-basedduct resulted in a non-statistical difference in the numberirrigation attempts to clear cerumen.9 Ease of irrigations one outcome for a study comparing Cerumol (turpen-e oil 10%, chlorbutol 5%, paradichlorobenzene 2%, ara-is oil 57.3%) with Otocerol (arachis oil, almond oil,tified camphor oil), with no difference found betweenups.80A comparison of the prescription ear drop Cerumenex% triethanolamine polypeptide oleate condensate), Mu-e ear drops (6.5% carbamide peroxide), and a placebonsisting of BSS Sterile Irrigating Solution showed notistical difference in clearance of cerumen.81 This studyowed up to two 15-minute applications of the dropslowed by water irrigation. Cerumenex and Murine areed only in combination with irrigation because leaving ther drops in the ear canal for more than 30 minutes isntraindicated.The systematic review by Hand concluded that there was

uivalent success with irrigation after the instillation of-based and water-based preparations; dwell time of ther drop was not a factor in determining success.75 Instillingter prior to irrigation tended to be more successful thanmediate irrigation.Use of a cerumenolytic improves success of irrigation,t no cerumenolytic has been shown to be superior toother in this respect. Instilling a preparation immediately

or to irrigation has not been shown to be superior orerior to using cerumenolytics for several days beforeigation.

difying factors. Factors to consider in evaluating cerum-olytics for managing cerumen are patient age, type ofrumen, and temperature of the cerumenolytic. One studychildren between ages 6 months and 5 years comparingcusate, triethanolamine polypeptide, and saline showed and toward a higher success rate for soft wax (68%) than

mixed wax (50%) or hard wax (43%).77 Two studiesggest topical therapy is more effective in children than inults.47,82Study protocols and medication instructions variably rec-mend warming the cerumenolytic in the palm of the handor to instillation but do not provide data demonstratingtter efficacy at higher temperatures. A laboratory studyorted hydrogen peroxide was more successful dissolving

rumen if warmed to 37C.78

ecautions. Instilling cerumenolytic agents can result incomfort, transient hearing loss, dizziness, and skin irri-ion. Studies evaluating cerumenolytics exclude patientsth otitis externa; therefore, cerumenolytics should beoided in patients with active infections of the ear canal.any commercially available cerumenolytics contain pos-le irritants. Subjects may have epidermal sensitivity toanic oils present in agents (ie, almond oil). Such agents

ould be applied for limited periods of time. For example,rumenex (10% triethanolamine polypeptide oleate) has aorted incidence of allergic dermatitis of 1%.

sks and harms. The risk of a local skin reaction in re-onse to a cerumenolytic appears to be lowest with non-anic solutions like saline.

idence profile for 5b: Cerumenolytic Agents.Aggregate evidence quality: Grade C, individual treat-ment arms of randomized trials showing beneficial out-comes, one randomized controlled trial suggesting betteroutcomes over no treatmentBenefit: safe and effective removal of impacted cerumenHarm: potential external otitis, allergic reactions, andotalgiaCost: cost of cerumenolytic agents other than water orsaline solution, cost of procedure if performed in an officesettingBenefits-harm assessment: balance of benefit and harmMedical reasons for exceptions to this statement include,but are not limited to, persons with a history of allergicreactions to any component, persons with infection of theear canal or active dermatitis, and persons with a nonin-tact tympanic membraneValue judgments: the panel values cost control and safetyin view of limited data on absolute and comparative

efficacy

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S14 OtolaryngologyHead and Neck Surgery, Vol 139, No 3S2, September 2008ATTACHMENT 2Role of patient preferences: substantial role for shareddecision makingPolicy level: Option

Statement 5c. IRRIGATION: Clinicians may use ir-ation in the management of cerumen impaction. Op-n based on randomized controlled trials with heteroge-ity and with a balance of benefit and harm.Aural irrigation is a widely practiced form of cerumenoval and can be performed with a syringe or electronic

igator. While there are no randomized controlled clinicalals of aural irrigation vs no treatment, there is a consensust aural irrigation is effective in removing cerumen. Man-

l irrigation, performed by using a large syringe typicallyde out of metal or plastic, is the most commonly em-yed method in general practice. Evidence has suggestedt only a minority of general practitioners (19%) per-med the procedure themselves. Most often, physicianslegated the task to practice nurses, some of whom re-ived no instructions.3Sorenson has assessed the pressure developed duringtine ear syringing and found it safe for normal ears. Butdid note that it may present a risk of perforation when thepanic membrane is atrophic.84

A standard oral dental jet irrigator, with or without aecially modified tip, is commonly used. Electronic irriga-s specially designed for aural irrigation are also available.ese irrigators claim to have controlled pressures andecially modified tips which make them safer than standardl jet irrigators, but comparative trials are not available to

rify this assertion. A study by Dinsdale et al suggests thatndard oral jet irrigators are safe if used at low pressuretings and if the jet of water is directed at the canal walld not longitudinally down the canal toward the tympanicmbrane.85 The OtoClear safe irrigation system was foundbe safe and effective in a small sample of children.83There are no randomized controlled clinical trials com-

ring ear syringing to controls. However, clinical trialsmparing earwax softeners to controls prior to syringingicate that softeners enhance the efficacy of irrigations inoving earwax.18

A systemic review of the available evidence suggestst pretreatment with an otic drop improves the efficacy of

ral irrigation, regardless of solution type. Therefore, sa-e and tap water may be as good as specially formulatedducts.1,18In an unblinded study of 39 ears, Pavlidis et al found that

nsiderably less water was required to completely removeerumen impaction if water had been instilled 15 minutesor to syringing (87 mL vs 35 mL; P 0.043).79Meehan76 and Singer47 both compared the relative effi-

cy of liquid docusate sodium to triethanolamine with orthout irrigation. In both studies, irrigation was performedcause the otic drop alone did not remove the cerumen.ither study found a statistically significant difference

tween the two pretreatment agents. neIn one study, Roland et al compared pretreatment withher 10% solution of triethanolamine polypeptide oleatendensate or 6.5% carbamide peroxide or balanced saltlution prior to aural irrigation using an oral jet irrigator.81the end of treatment there was no statistical significance;

wever, 29.2% of subjects treated with triethanolaminelypeptide, 15.4% of subjects treated with carbamide per-ide, and 41.7% of subjects treated with balanced saltlution experienced a resolution of occlusion.A systematic review suggests that there are no significantferences between oil-based and water-based preparationsfacilitating cerumen removal when administered prior to

ral irrigation.75 Pretreatment may be effective; however,idence to this effect is limited. Data analysis suggests nonificant difference between pretreatment followed by sy-ging within 15 to 30 minutes vs regular application ofumenolytics for several days prior to syringing. Althoughreview included 18 randomized controlled clinical trials,

ly four were assessed as being of high quality. Fifteenferent preparations were included across 18 clinical trials.

aring outcomes. In uncontrolled studies following auraligation of 28 ears with varying levels of occlusion, Man-l demonstrated, on average, that less than 5 dB improve-nt in hearing at all frequencies could be expected.83her research also suggests an average 5-dB increase inaring after aural irrigation.3 In contrast, a randomized,gle-blind, controlled trial found an average of 10 dBprovement in 34% of ears that had cerumen removed byral irrigation vs only 1.6% of control ears.41 Furthermore,aring improvements up to 36 dB were observed.

rms. The main complications reported after aural irriga-n are pain, injury to the skin of the ear canal withmorrhage, and acute otitis externa. Commonly reportednificant complications are perforation (0.2% in Pavlidisies) and vertigo (0.2% in Pavlidis series).79Complications were experienced by 38% of 274 practi-ners who performed aural irrigation for cerumen re-val.3 Most complications either were relatively minor orponded promptly to initial management by the treatingctitioner. Adverse events reported include pain, tinnitus,

rtigo, otitis media, otitis externa, and perforation. Sharp etestimated that only 1 in 1000 episodes of aural irrigationulted in a complication significantly severe to require

ecialist referral.3 Similarly, Bird asserts that major com-cations occur in 1 in 1000 ears syringed.20 Roland et alorted a total of six adverse events in 74 patients who had

rumen removed with cerumenolytics followed by auraligation.81 All were minor (3 puritis, 1 dermatitis, 1 ver-o, 1 discomfort) and resolved spontaneously.Tympanic membrane perforation with serious injury tomiddle and inner ear is rare but has been reported on a

mber of occasions.3,19,85,86 Bapat et al19 have reportedcture of the stapedial footplate with subsequent profound

urosensory hearing loss following aural irrigation using

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S15Roland et al Clinical practice guideline: Cerumen impactionATTACHMENT 2ear syringe, and Dinsdale et al85 have reported a similarmplication resulting in profound deafness following thee of an oral jet irrigator.

difying factors. Ear syringing should not be performed inividuals who have had ear surgery or who have a non-act tympanic membrane. An intact tympanic membraney be more vulnerable to perforation if a portion of thepanic membrane is atrophic. Consequently, it is gener-

y agreed that ears with a history of ear surgery should notsubject to aural irrigation. Since the eardrum is fre-

ently not visualized due to cerumen impaction, cliniciansmetimes must rely on history to establish that the eardrumintact. If a small portion of the drum is visible and isbile with pneumatic otoscopy, it is unlikely to be perfo-ed. Similarly, if tympanometry can be performed and a

volume verified, tympanic membrane perforation isprobable.A higher incidence of malignant otitis externa is foundong patients with diabetes following aural irrigation withwater, which may suggest that aural irrigation may have

used the disease in some number of these individuals.34,36nsequently, aural irrigation, especially with water, shouldperformed with caution in patients with diabetes. If

tients with diabetes have cerumen removal by aural irri-tion, they should be instructed to report the developmentotorrhea and/or otalgia promptly. Consideration shouldgiven to reacidifying the ear canal since the slightly

idic pH of the normal external auditory canal may be anificant factor in producing resistance to external otitisd/or malignant otitis externa.39 Alternatively, consider-on could be given to an irrigation solution other thanter: hydrogen peroxide and solutions containing 50%ite vinegar are reasonable alternatives. These consider-ons are based on expert opinion and made with a view toventing the serious harm that can arise from temporal

ne osteomyelitis (malignant otitis externa, necrotizingternal otitis). Solutions containing alcohol should proba-

be avoided unless one can be certain that the tympanicmbrane is intact. Alcohol in the middle ear space is both

inful and potentially ototoxic.Aural irrigation should be avoided in individuals with

atomic abnormalities of the canal (congenital malforma-ns, osteomas, exostosis, scar tissue, etc) that might trapter in the external auditory canal after irrigation.

idence profile for 5c: Irrigation.Aggregate evidence quality: Grade B, one randomizedcontrolled trial verifying absolute efficacy but multipletreatment arms of comparative studies verifying benefitover cerumenolytic aloneBenefit: improved outcome of irrigation vs cerumenolyticaloneHarm: external otitis, vertigo, tympanic membrane per-

foration, otalgia, temporal bone osteomyelitisCost: cost of supplies and procedure nyBenefits-harm assessment: balance of benefit and harmValue judgments: panel enthusiasm was tempered by thelack of appropriate head-to-head trials comparing irriga-tion to manual removal or cerumenolyticsMedical reasons for exceptions to this statement include,but are not limited to, persons with open tympanic mem-brane, active dermatitis or infection, or anatomic abnor-malities of the ear canalRole of patient preferences: role for shared decision mak-ingPolicy level: Option

Statement 5d. MANUAL REMOVAL: Cliniciansy use manual removal other than irrigation in thenagement of cerumen impaction. Option based on

se series and expert opinion with a balance of benefit andrm.Advantages of manual removal are that it is oftenicker, allows direct visualization of the external auditorynal, and does not expose the ear to moisture. Manual

oval requires adequate illumination, visualization, andtrumentation. Examination of the ear throughout the pro-

ss can determine when removal of the cerumen impactioncomplete.87A handheld speculum or otoscope, headlamp, or theocular microscope are all appropriate instruments forualization. The binocular microscope offers the advan-e of stereoscopic magnification.4 Instruments used foroval include a metal and plastic loop or spoon, alligator

ceps, curette, right-angled hook, a straight applicatorth applied wisps of cotton wool, angulated suction tipsrench size 3,5,7), and a Jobson-Horne probe.66 Wax thatof a softer consistency can sometimes be wiped outth cotton wool applied to an applicator or aspiratedth the use of a suction tip attached to a negative-ssure pump.Manual removal of cerumen is often considered in pa-nts with abnormal otologic findings or systemic illnesst may compromise immunity. Patients with perforationthe tympanic membrane are at risk for developing sup-rative otitis media should irrigation or cerumenolyticents enter the middle ear. The tympanic membrane mayo be attenuated in patients who have had previous earrgery, making them at greater risk of creating a pressure-uced perforation from irrigation.Adequate training, experience, and the appropriate

uipment will minimize the risk of adverse events andximize the likelihood of successful cerumen removal.

rms. Trauma to the external auditory canal, includingin and/or bleeding, perforation of the tympanic mem-ne, and, rarely, infection, has been reported. Suctioningear canal can produce noises that are quite loud and may

rtle the patient. Suctioning may create a cooling effectd elicit a caloric response from the inner ear, causing

stagmus and vertigo.

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S16 OtolaryngologyHead and Neck Surgery, Vol 139, No 3S2, September 2008ATTACHMENT 2difying factors. Attempted manipulation of cerumen in aall external auditory meatus or canal stenosis may im-de successful elimination of the cerumen impaction andy make it worse by pushing the cerumen further downcanal. The presence of exostoses in the ear canal may

pair direct visualization and additional care is necessaryavoid contact with these bony lesions due to the sensi-ity of the skin of the medial bony canal.

idence profile for 5d: Manual Removal.Aggregate evidence quality: Grade C and D, observa-tional case series and expert opinionBenefit: removal of cerumen impaction under direct vi-sualizationHarm: bleeding, laceration, tympanic membrane perfora-tion, otalgiaCost: procedural cost; equipment costBenefits-harm assessment: balance of benefit and harmValue judgments: Recommendation acknowledges wide-spread practice of manual removal but this is tempered bythe relative absence of evidenceRole of patient preferences: role for shared decision mak-ingPolicy level: Option

Statement 6. OUTCOMES ASSESSMENT: Clini-ns should assess patients at the conclusion of in-officeatment of cerumen impaction and document the res-tion of impaction. If the impaction is not resolved, the

nician should use additional treatment. If full or par-l symptoms persist despite resolution of impaction,ernative diagnoses should be considered. Recommen-tion based on randomized controlled trials with limita-ns supporting a failure of clearance of cerumen in someses and randomized controlled trials with limitations andreponderance of benefit over harm.The symptoms of cerumen impaction include hearings, tinnitus, fullness, itching, otalgia, and occasionallyugh. These symptoms overlap with those for many othernditions. Moreover, trials indicate that in-office treatmentcerumen impaction is variably effective.75 In order toertain whether symptoms were in fact due to cerumen,

e must evaluate the patient once the impaction has beenolved. Outcome assessment requires 1) examination ofear and 2) patient assessment for symptom resolution.

th of these steps require collection and interpretation ofnical data and, depending on state laws governing scopepractice, the post-treatment evaluation may be performeda physician, audiologist, advance practice nurse, physi-n assistant, or registered nurse. The laws governing scopepractice for medical assistants vary by state and thereforeould be referenced before delegating the post-treatmentessment to a medical assistant.88In addition, post-treatment evaluation for complicationsthe removal procedure is important for patient safety and

dicolegal purposes.89 While the techniques for cerumen suoval are generally safe, these procedures have beenociated with otitis externa, pain, dizziness, syncope, tin-us, and tympanic membrane perforation.3 For these rea-ns, the results of both the post-treatment otoscopic exam-tion and symptom assessment should be documented inmedical record.

The impaction is resolved when 1) the clinician canamine the ear or perform the appropriate testing without

interference of cerumen and 2) associated symptomsve resolved. If this first condition is met but symptomsrsist, the clinician should consider alternative diagnoses.pending on the nature of the patients symptoms, theseght include: sensorineural hearing loss; otosclerosis; oti-media; medication side effects; head and neck tumors;poromandibular joint syndrome; upper respiratory infec-

ns; eustachian tube dysfunction; or disorders of the skinthe canal.If either of the above conditions is not met, suggesting

rsistent impaction, additional treatment should be pre-ibed (see the guideline section on Therapeutic Options).

idence profile for 6: Outcomes Assessment.Aggregate evidence quality: Grade C; observation intreatment arms of several randomized trials shows thatretreatment is sometimes necessary and can be effective;first principles support evaluation for efficacy after treat-mentBenefit: detect complications, detect misdiagnosis, insti-tute effective therapyHarm: see sections on individual treatmentsCost: cost of additional treatment or evaluationBenefits-harm assessment: preponderance of benefit overharmValue judgments: importance of clinician assessment af-ter treatment; avoid misdiagnosisRole of patient preferences: limitedPolicy level: Recommendation

Statement 7. PREVENTION: Clinicians may edu-te/counsel patients with cerumen impaction/excessiverumen regarding control measures. Option based onrvey and comparative studies with unclear balance ofnefit vs harm.Although empirical evidence supporting measures tovent cerumen impaction is limited, practitioners have the

portunity to counsel patients on the risks and potentialnefits of specific control measures. Measures that may beneficial in reducing cerumen impaction include 1) instill-

prophylactic topical preparations, 2) irrigating the earnal, or 3) routine cleaning of the ear canal by a clinician.oices regarding topical preparations and devices for irri-ting the ear should be discussed with the patient, allowing

substantial patient preference and cost factors in deter-ning treatment options.Patients should be counseled not to insert foreign objects,ch as cotton-tip swabs or bobb