Informed Consent for Microsuction: What Clinicians Must Cover

Key Takeaways:

• The Montgomery ruling (2015) requires clinicians to disclose all material risks that a reasonable patient would consider significant — not just those the clinician deems important
• Key risks to disclose for microsuction include pain, bleeding, tinnitus, temporary or permanent hearing change, tympanic membrane perforation, dizziness, and procedural noise
• Consent can be verbal or written, but must be documented in the clinical record with sufficient detail to demonstrate an informed discussion took place
• Capacity must be assessed on a decision-specific basis under the Mental Capacity Act 2005, with additional considerations for children under the Gillick competence framework

The Legal Basis for Informed Consent

The Montgomery Ruling

The landmark Montgomery v Lanarkshire Health Board Supreme Court decision (2015) fundamentally changed consent law in the UK. It established that clinicians must disclose any material risk — defined as a risk that a reasonable person in the patient’s position would attach significance to, or that the clinician is or should be aware that the individual patient would attach significance to.

This replaced the previous Bolam standard, which allowed clinicians to withhold risk information if a responsible body of medical opinion supported that approach. Under Montgomery, the test is patient-centred: what would this patient want to know?

For microsuction, this means clinicians must proactively discuss risks rather than waiting for patients to ask.

Risks to Disclose

The following risks should be discussed as part of the consent process for microsuction ear wax removal:

Common Risks

• Discomfort or pain — A pulling, tickling, or mildly painful sensation during suction, particularly if the wax is firmly adherent to the canal wall
• Noise — Traditional devices generate significant noise levels (up to 140 dB); patients should be informed of the noise they will experience and the equipment being used
• Dizziness — Transient vertigo can occur due to caloric stimulation or negative pressure effects on the tympanic membrane

Uncommon but Material Risks

• Bleeding — Minor canal wall abrasion causing bleeding (approximately 0.5% of procedures)
• Tinnitus — New onset or worsening of tinnitus, which may be temporary or, rarely, persistent
• Temporary hearing change — Sounds may seem louder or different immediately after wax removal

Rare but Serious Risks

• Tympanic membrane perforation — Exceedingly rare with appropriate technique, but a recognised complication
• Permanent hearing change — Very rare, but should be mentioned
• Ear canal laceration — Deep trauma requiring further management

Procedure-Specific Information

Patients should also be informed about:

• The type of equipment being used (including noise characteristics)
• The possibility that wax may not be fully removed in a single appointment
• The need for pre-treatment softening and what this involves
• Alternative methods of wax removal (irrigation, manual removal) and why microsuction is recommended in their case

Verbal vs Written Consent

There is no legal requirement for written consent for microsuction in most settings. However, the choice between verbal and written consent should be guided by clinical governance and the practice’s risk management framework.

Verbal Consent

• Appropriate for routine, low-risk procedures
• Must be documented in the clinical record
• Record the date, time, risks discussed, questions asked, and that the patient agreed to proceed
• Suitable for most straightforward microsuction appointments

Written Consent

• Provides a signed record of the consent discussion
• Recommended by many professional indemnity insurers
• Particularly advisable for higher-risk patients (e.g., those with previous complications, only hearing ear, pre-existing tinnitus)
• Should include the specific risks discussed, not just a generic signature

Regardless of format, the quality of the consent discussion matters more than whether a form was signed. A signed form without a meaningful conversation does not constitute valid consent.

Documenting Consent

Good documentation should include:

• Date and time of the consent discussion
• Risks discussed — listed specifically, not just “risks and benefits explained”
• Patient’s questions and the clinician’s responses
• Relevant patient factors — e.g., only hearing ear, pre-existing tinnitus, anticoagulant use
• Patient’s decision — that they agreed to proceed after discussion
• Capacity confirmation — that the patient had capacity to consent (or, if not, the basis on which treatment proceeded)

Capacity Assessment

Adults — Mental Capacity Act 2005

Under the Mental Capacity Act 2005, capacity is presumed unless there is reason to doubt it. A person lacks capacity if they cannot:

1. Understand the relevant information
2. Retain it long enough to make the decision
3. Weigh the information to reach a decision
4. Communicate their decision (by any means)

Capacity is assessed for each specific decision at the specific time it needs to be made. A patient with dementia may retain capacity for a straightforward consent decision even if they lack capacity for more complex decisions.

If a patient lacks capacity, treatment may proceed in their best interests, with appropriate consultation with carers or family. The assessment and best interests decision must be documented. For detailed guidance on treating elderly patients with cognitive impairment, see our article on microsuction for elderly patients.

Children — Gillick Competence

For patients under 16, consent follows the Gillick competence framework:

• A child who demonstrates sufficient understanding and intelligence to fully comprehend the proposed treatment can consent independently
• For younger children or those who do not meet the Gillick threshold, parental consent is required
• Both the child’s views and the parent’s consent should be documented
• If there is disagreement between parent and child, seek senior clinical advice

For patients aged 16–17, consent is governed by the same principles as adults under the Mental Capacity Act.

Consent Checklist for Clinicians

The following template can guide the consent discussion:

• Explain what microsuction involves and why it is recommended
• Discuss the noise the patient will experience and the equipment being used
• Disclose risks: discomfort, dizziness, bleeding, tinnitus, perforation, hearing change
• Explain that wax may not be fully removed in one visit
• Discuss alternatives (irrigation, manual removal, no treatment)
• Ask about relevant history: previous complications, tinnitus, only hearing ear, anticoagulants
• Confirm the patient understands and agrees to proceed
• Assess and document capacity (if any concern)
• Record the discussion in the clinical notes

The Role of Patient Information Leaflets

Providing a written patient information leaflet before the appointment allows patients time to read and consider the information. This supports — but does not replace — the face-to-face consent discussion. Leaflets should cover the procedure, expected sensations, risks, aftercare, and how to raise concerns. Information on what to expect is covered in detail in our guide to microsuction side effects.

Informed consent is not a form to be signed — it is a process of communication that respects the patient’s right to make decisions about their own care. Clinicians who invest time in a thorough consent discussion not only meet their legal obligations but build trust and improve the patient experience.