The evidence grades (A-D, X) and evidence-based statements (Strong Recommendation, Recommendation, Option, and No Recommendation) are defined at the end of the "Major Recommendations" field.
Statement 1a. Diagnosis of Cerumen Impaction
Clinicians should diagnose cerumen impaction when an accumulation of cerumen 1) is associated with symptoms, or 2) prevents needed assessment of the ear, or 3) both.
Recommendation based on diagnostic studies with minor limitations and a preponderance of benefit over harm.
Evidence Profile:
- Aggregate evidence quality: Grade B, diagnostic studies with minor limitations regarding impact of cerumen on hearing and visualizations and Grade C with respect to signs and symptoms associated with cerumen impaction
- Benefit: Identify individuals with cerumen impaction who require intervention including those with otologic symptoms and those who require diagnostic assessment (raise awareness of the consequences of cerumen impaction—e.g., cerumen impaction prevents caloric stimulation during electronystagmography)
- Harm: Overdiagnosis of cerumen impaction based on symptoms as a criterion resulting in failure to identify another cause of the symptoms
- Cost: no additional cost
- Benefits-harm assessment: preponderance of benefits over harm
- Value judgments: emphasis on clinical symptoms and signs for initial diagnosis; importance of avoiding unnecessary diagnostic tests; consensus on using the term "cerumen impaction" to imply cerumen that requires treatment
- Role of patient preferences: not applicable
- Policy level: recommendation
Statement 1b. Modifying Factors
Clinicians should assess the patient with cerumen impaction by history and/or physical examination for factors that modify management such as one or more of the following: non-intact tympanic membrane, ear canal stenosis, exostoses, diabetes mellitus, immunocompromised state, or anticoagulant therapy.
Recommendation based on observational studies with a preponderance of benefit over harm.
Evidence Profile:
- Aggregate evidence quality: Grade C and D, observational studies
- Benefit: Reduce complications
- Harm: No harm
- Benefits-harm assessment: preponderance of benefit over harm
- Value judgments: consensus that identifying modifying factors and modifying management will improve outcomes
- Policy level: recommendation
Statement 2. Observation of Nonimpacted Cerumen
Clinicians may observe patients with non-impacted cerumen that is asymptomatic and does not prevent the clinician from adequately assessing the patient.
Option based on randomized controlled trials with heterogeneity in diagnostic criteria and illness severity, and a relative balance of benefit and harm.
Evidence Profile:
- Aggregate evidence quality: Grade D, one observational study, expert opinion, and first principles
- Benefit: avoid unnecessary treatment
- Harm: potential progression to impaction
- Cost: none
- Benefits-harm assessment: relative balance of harm vs benefit for nonimpacted cerumen
- Medical reasons for exceptions to this statement include, but are not limited to, history of recurrent cerumen impaction
- Value judgments: minimize unnecessary treatment, increase recognition of the benefits of cerumen
- Role of patient preferences: substantial role for shared decision making
- Policy level: option
Statement 3a. Need for Intervention
Clinicians should treat cerumen impaction that causes symptoms expressed by the patient or prevents clinical examination when warranted.
Strong recommendation based on randomized controlled trials with heterogeneity with a preponderance of benefit over harm.
Evidence Profile:
- Aggregate evidence quality: Grade B, randomized controlled trials with heterogeneity
- Benefit: improved hearing and symptom relief compared with no treatment
- Harm: potential complications related to treatment
- Benefits-harm assessment: preponderance of benefit over harm
- Role of patient preferences: some role for shared decision making
- Policy level: strong recommendation
Statement 3b. Need for Intervention in Special Populations
Clinicians may distinguish and promptly evaluate the need for intervention in the patient who may not be able to express symptoms but presents with cerumen obstructing the ear canal.
Option based on cohort and observational studies with a balance of benefit and harm.
Evidence Profile:
- Aggregate evidence quality: Grade C, cohort and observational studies
- Benefit: improved hearing and functional health status
- Harm: potential overtreatment of cerumen that is asymptomatic
- Cost: evaluation and treatment costs; substantial administrative burden in settings with a high prevalence of cognitively impaired individuals, such as nursing homes and institutional facilities
- Benefits-harm assessment: balance of benefit and harm
- Value judgments: importance of identifying and treating cerumen impaction in special populations
- Role of patient preferences: there is no role for patient preferences when the patient is unable to express preferences
- Policy level: option
Statement 4. Hearing Aid Use
The clinician should examine patients with hearing aids for the presence of cerumen impaction during a healthcare encounter.
Recommendation based on cohort and observational studies with a preponderance of benefit over harm.
Evidence Profile:
- Aggregate evidence quality: Grade C, observational studies
- Benefit: prevent hearing aid dysfunction and associated repair costs
- Harm: overtreatment of asymptomatic cerumen
- Benefits-harm assessment: preponderance of benefit over harm
- Role of patient preferences: some role for shared decision making
- Policy level: recommendation
Statement 5a. Therapeutic Interventions
Clinicians should treat the patient with cerumen impaction with an appropriate intervention, which may include one or more of the following: cerumenolytic agents, irrigation, or manual removal other than irrigation.
Recommendation based on randomized controlled trials and observational studies with a preponderance of benefit over harm.
- Aggregate evidence quality: Grade B and C, randomized controlled trials with limitations and cohort studies
- Benefit: improved cerumen removal by using effective therapies and to avoid harm from ineffective or untested therapies
- Harm: specific adverse effects related to treatments used
- Cost: no cost associated with the decision to use appropriate therapy
- Benefits-harm assessment: preponderance of benefit over harm
- Value judgments: Therapy should be effective and minimize harm
- Role of patient preferences: Selection of office vs appropriate home treatment
- Policy level: recommendation
Statement 5b. Cerumenolytic Agents
Clinicians may use cerumenolytic agents (including water or saline solution) in the management of cerumen impaction.
Option based on limited randomized trials with a balance of benefit and harm.
Evidence Profile:
- Aggregate evidence quality: Grade C, individual treatment arms of randomized trials showing beneficial outcomes, one randomized controlled trial suggesting better outcomes over no treatment
- Benefit: safe and effective removal of impacted cerumen
- Harm: potential external otitis, allergic reactions, and otalgia
- Cost: cost of cerumenolytic agents other than water or saline solution, cost of procedure if performed in an office setting
- Benefits-harm assessment: balance of benefit and harm
- Medical reasons for exceptions to this statement include, but are not limited to, persons with a history of allergic reactions to any component, persons with infection of the ear canal or active dermatitis, and persons with a nonintact tympanic membrane
- Value judgments: the panel values cost control and safety in view of limited data on absolute and comparative efficacy
- Role of patient preferences: substantial role for shared decision making
- Policy level: option
Statement 5c. Irrigation
Clinicians may use irrigation in the management of cerumen impaction.
Option based on randomized controlled trials with heterogeneity and with a balance of benefit and harm.
Evidence Profile:
- Aggregate evidence quality: Grade B, one randomized controlled trial verifying absolute efficacy but multiple treatment arms of comparative studies verifying benefit over cerumenolytic alone
- Benefit: improved outcome of irrigation vs cerumenolytic alone
- Harm: external otitis, vertigo, tympanic membrane perforation, otalgia, temporal bone osteomyelitis
- Cost: cost of supplies and procedure
- Benefits-harm assessment: balance of benefit and harm
- Value judgments: panel enthusiasm was tempered by the lack of appropriate head-to-head trials comparing irrigation to manual removal or cerumenolytics
- Medical reasons for exceptions to this statement include, but are not limited to, persons with open tympanic membrane, active dermatitis or infection, or anatomic abnormalities of the ear canal
- Role of patient preferences: role for shared decision making
- Policy level: option
Statement 5d. Manual Removal
Clinicians may use manual removal other than irrigation in the management of cerumen impaction.
Option based on case series and expert opinion with a balance of benefit and harm.
Evidence Profile:
- Aggregate evidence quality: Grade C and D, observational case series and expert opinion
- Benefit: removal of cerumen impaction under direct visualization
- Harm: bleeding, laceration, tympanic membrane perforation, otalgia
- Cost: procedural cost; equipment cost
- Benefits-harm assessment: balance of benefit and harm
- Value judgments: Recommendation acknowledges widespread practice of manual removal but this is tempered by the relative absence of evidence
- Role of patient preferences: role for shared decision making
- Policy level: option
Statement 6. Outcomes Assessment
Clinicians should assess patients at the conclusion of in-office treatment of cerumen impaction and document the resolution of impaction. If the impaction is not resolved, the clinician should use additional treatment. If full or partial symptoms persist despite resolution of impaction, alternative diagnoses should be considered.
Recommendation based on randomized controlled trials with limitations supporting a failure of clearance of cerumen in some cases and randomized controlled trials with limitations and a preponderance of benefit over harm.
Evidence Profile:
- Aggregate evidence quality: Grade C; observation in treatment arms of several randomized trials shows that retreatment is sometimes necessary and can be effective; first principles support evaluation for efficacy after treatment
- Benefit: detect complications, detect misdiagnosis, institute effective therapy
- Harm: see sections on individual treatments
- Cost: cost of additional treatment or evaluation
- Benefits-harm assessment: preponderance of benefit over harm
- Value judgments: importance of clinician assessment after treatment; avoid misdiagnosis
- Role of patient preferences: limited
- Policy level: recommendation
Statement 7. Prevention
Clinicians may educate/counsel patients with cerumen impaction/excessive cerumen regarding control measures.
Option based on survey and comparative studies with unclear balance of benefit vs harm.
Evidence Profile:
- Aggregate evidence quality: Grade C; observational studies and expert opinion
- Benefit: prevent development of cerumen impaction
- Harm: side effects of preventive measures
- Cost: cost of control measures, minimal
- Benefits-harm assessment: balance benefit over harm
- Value judgments: importance of prevention in managing patients with cerumen impaction
- Role of patient preferences: substantial opportunities for shared decision making
- Policy level: option
Definitions:
Guideline Definitions for Evidence-Based Statements
Strong Recommendation: A strong recommendation means the benefits of the recommended approach clearly exceed the harms (or that the harms clearly exceed the benefits, in the case of a strong negative recommendation) and that the quality of the supporting evidence is excellent (Grade A or B). In some clearly identified circumstances, strong recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits strongly outweigh the harms. Implication: Clinicians should follow a strong recommendation unless a clear and compelling rationale for an alternative approach is present.
Recommendation: A recommendation means the benefits exceed the harms (or that the harms exceed the benefits, in the case of a negative recommendation), but the quality of evidence is not as strong (Grade B or C). In some clearly identified circumstances, recommendations may be made based on lesser evidence when high-quality evidence is impossible to obtain and the anticipated benefits outweigh the harms. Implication: Clinicians should also generally follow a recommendation, but should remain alert to new information and sensitive to patient preferences.
Option: An option means that either the quality of evidence that exists is suspect (Grade D) or that well-done studies (Grade A, B, or C) show little clear advantage to one approach versus another. Implication: Clinicians should be flexible in their decision making regarding appropriate practice, although they may set bounds on alternatives; patient preference should have a substantial influencing role.
No Recommendation: No recommendation means there is both a lack of pertinent evidence (Grade D) and an unclear balance between benefits and harms.
Implication: Clinicians should feel little constraint in their decision making and be alert to new published evidence that clarifies the balance of benefit versus harm; patient preference should have a substantial influencing role.
Evidence Quality for Grades of Evidence
Grade A: Well-designed randomized controlled trials or diagnostic studies performed on a population similar to the guideline's target population
Grade B: Randomized controlled trials or diagnostic studies with minor limitations; overwhelmingly consistent evidence from observational studies
Grade C: Observational studies (case-control and cohort design)
Grade D: Expert opinion, case reports, reasoning from first principles (bench research or animal studies)
Grade X: Exceptional situations where validating studies cannot be performed and there is a clear preponderance of benefit over harm
