1 2 3 practice guidance - · pdf file1 2 3 4 practice guidance aural care (ear wax removal) 5...

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Practice Guidance 4

Aural Care (Ear Wax Removal) 5

Date: April 2017 6

Due for review: April 2021 7

Practice Guidance Aural Care (Ear Wax Removal) BSA 2017

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General foreword 8

This document presents Practice Guidance by the British Society of Audiology (BSA). This 9 Practice Guidance represents, to the best knowledge of the BSA, the evidence-base and 10 consensus on good practice, given the stated methodology and scope of the document and at 11 the time of publication. 12 13 Although care has been taken in preparing the information supplied by the BSA, the BSA does 14 not and cannot guarantee the interpretation and application of it. The BSA cannot be held 15 responsible for any errors or omissions, and the BSA accepts no liability whatsoever for any loss 16 or damage howsoever arising. This document is the first published BSA Practice Guidance 17 document on this procedure and stands until superseded or withdrawn by the BSA. 18 19 Comments on this document are welcomed and should be sent to: 20 21 British Society of Audiology 22 Blackburn House, 23 Redhouse Road 24 Seafield, 25 Bathgate 26 EH47 7AQ 27 Tel: +44 (0)118 9660622 28

[email protected] 29 www.thebsa.org 30 31 Published by the British Society of Audiology 32

© British Society of Audiology, 2017 33

All rights reserved. This document may be freely reproduced in its entirety for educational and not-for-34 profit purposes. No other reproduction is allowed without the written permission of the British Society of 35 Audiology. 36

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mailto:[email protected]

http://www.thebsa.org/

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Authors & Acknowledgments 41

42 Produced by: The Professional Guidance Group 43 44 Key Authors: 45

• Sarah Riches, Clinical Tutor and Senior Audiologist (Aston University) 46 • Martin Whitehouse, ENT Nurse Practitioner (Sandwell and West Birmingham Hospitals 47

NHS Trust) 48 49

With thanks to: Mr Arun Sinha, ENT Consultant (Sandwell and West Birmingham Hospitals NHS 50 Trust), and professional colleagues in the Pharmacy Department, Optometry Department, and 51 Engineering Department (Aston University). 52 53

Contents 54

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1. Introduction………………………………………………………………………………………………………… 5

2. Scope…………………………………………………………………………………………………………………… 5

2.1 Procedural Scope……………………………………………………………………………………… 5

2.2 Professional Scope…………………………………………………………………………………… 6

2.2.1 Registered professionals……………………………………………………………. 6

2.2.2 Other professionals…………………………………………………………………… 7

2.2.3 Supervision……………………………………………………………………………….. 7

2.3 Fitness to Practice considerations…………………………………………………………… 7

3. Training and competencies required …………………………………………………………………… 8

4. Equipment and working environment .………………………………………………………………… 9

4.1. Equipment………………………………………………………………………………………………… 8

4.1.1 Infection control related to equipment……………………………………… 9

4.1.2 Fitness for purpose……………………………………………………………………. 10

4.1.3 Safety and quality specifications and standards………………………… 10

4.1.4 Non-conformity and the use of off-label medical devices………….. 11

4.1.5 Equipment maintenance……………………………………………………………. 11

4.1.6 Risk assessments……………………………………………………………………….. 11

4.2 Environment…………………………………………………………………………………………… 12

5. Preparation for the procedure ……….…………………………………………………………………… 12

5.1 Patient preparation…………………………………………………………………………………… 12

5.1.1 Consent……………….…………………………………………………………………… 12

5.1.2 Softening of ear wax prior to the procedure……………………………. 12

6. Procedure time …………………………….……………………………………………………………………… 13

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6.1 Routine cases……………………………………………………………………………………………. 13

6.2 When a routine ear becomes non-routine……………………………………………….. 13

7. Contra-indications and special care considerations……………………………………………… 14

8. Risks associated with ear wax removal…………………………………………………………………. 14

8.1 Physical (direct) trauma…………………………………………………………………………… 14

8.2 Pressure trauma……………………………………………………………………………………… 14

8.3 Infection………………………………………………………………………………………………….. 14

8.4 Vertigo…………………………………………………………………………………………………….. 15

8.5 Noise exposure……………………………………………………………………………………….. 15

8.6 Risks arising from over-cleaning the ear canal …………………………………………. 16

9. Manual removal using simple extraction instruments…………………………………………. 16

9.1 Patient instruction…………………………………………………………………………………… 16

9.2 Method……………………..……………………………………………………………………………… 16

9.3 Variations in method………………………………………………………………………………. 17

9.4 Limitations of the procedure…………………………………………………………………… 17

9.5 Complications of the procedure……………………………………………………………… 17

10. Irrigation using irrigation machines…………………………………………………………………….. 18

10.1 Patient instruction……………….………………………………………………………………….. 18

10.2 Method……………………………………………………………………………………………………. 18

10.3 Variations in method………………………………………………………………………………… 18



11. Suction using microscopic examination or magnification through a head loupe 20

11.1 Patient instruction……………….………………………………………………………………….. 20

11.2 Method……………………………………………………………………………………………………. 20

11.3 Variations in method………………………………………………………………………………… 20



12. Advice and after-care………………………………………………………………………………………….. 22

12.1 Immediate aftercare………………………………………………………………………………… 22

12.2 Educating patients about ear wax management………………………………………. 22

13. References…………………………………………………………………………………………………………… 24

Appendices 25

A. Consent form for ear wax removal 26

B. Wax removal by manual instruments, suction or water irrigation - Contra-indications checklist to ensure ears are routine

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1. Introduction 57

This document provides best practice guidelines for safe removal of ear wax (aural care) by 58

professionals trained to complete this activity. Its purpose is to describe recommendations for safe 59

aural care using manual instruments, water irrigation and suction under magnification. 60

61

BSA acknowledges that ear wax can also be removed under an endoscopic view using suction 62

devices or manual instruments such as Jobson Horne probes. This newer method of wax removal 63

currently has a limited evidence base. Unless the professional is already experienced in endoscopic 64

techniques and uses them regularly BSA would advise caution in the adoption of this technique until 65

a firmer base of evidence can be developed. Furthermore, if a professional chooses to adopt this 66

method, as for the other wax removal techniques, they must develop skills via training which meets 67

the criteria described in BSA (2013) Minimum Training Guidelines in Aural Care Delivered By 68

Hearing Care Professionals. 69

70

The term ‘must’ is used in this document to refer to essential practice, and ‘should’ is used to refer 71

to desirable practice. 72

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The document was developed in accordance with the current National Institute for Health and Care 74

Excellence (NICE) Clinical Knowledge Summaries (last updated in July 2016) and based on clinical 75

evidence reviewed in BMJ Clinical Evidence Systematic Review (2015). In addition, in January 76

2017 a comprehensive Clinical Practice Guideline document was updated and published by The 77

American Academy of Otolaryngology (Head and Neck Surgery) which the authors recommend as 78

further useful reading on this subject. 79

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Unless stated otherwise, this document represents the consensus of expert opinion and evidence as 81

interpreted by the Professional Guidance Group of the British Society of Audiology (BSA) in 82

consultation with its stakeholders. 83

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2. Scope 85

2.1 Procedural scope 86

This document intends to describe aural care only in regards to necessary ear wax removal in routine 87

ears. 88

Necessary ear wax removal refers to the removal of ear wax which is: 89

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• occluding the view of the tympanic membrane and external auditory meatus thus preventing 90

their effective examination 91

• causing the patient to report a blocked/occluded sensation 92

• reducing the hearing beyond the usual baseline ability of the patient 93

• preventing a required procedure or activity from safely or effectively taking place which may 94

include a hearing test, tympanometry, impression-taking, or fitting of a hearing aid including real 95

ear measures 96

• interfering with the performance of a hearing aid when in situ 97

98

Routine refers to ears which have none of the referable conditions described in the checklist in 99

Appendix B and which, to the best of the professional’s knowledge through otoscopy and through 100

history-taking and previous case notes (especially if unable to fully observe the tympanic membrane), 101

contain a tympanic membrane which is intact and healthy. 102

Therefore these practice guidelines do not extend to cover non-routine cases such as: 103

• perforated ears 104

• post-surgery ears including provision of post-surgery care/treatment 105

• the removal of foreign objects 106

• the treatment of medical conditions 107

• removal of discharge or debris caused by acute or chronic ear infections, or which arise from 108

skin conditions such as eczema or psoriasis 109

110

See Appendix B for the complete checklist of contra-indications and special care conditions. 111

Please note that children under the age of 16 years are also beyond the scope of this document. 112

113

2.2 Professional scope 114

2.2.1 Registered professionals 115

The audiology, nursing or medical professional usually undertaking this procedure will be registered with 116

HCPC or RCCP. 117

It is acknowledged that some individuals under specific circumstances may be able to remove ear wax 118

from non-routine cases or from the ears of patients under the age of 16 years. This must depend on 119

extended additional training, a suitable working environment and equipment, and availability of support 120

from nursing or medical staff should complications arise. 121

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2.2.2 Other professionals 123

If professionals of a non-registerable status such as assistant audiologists, hearing care assistants (HCA) 124

or healthcare assistants (HCA) are trained in the removal of ear wax their employers must ensure that 125

the procedural and professional scope is made clear. 126

As for any other procedure the assistant/HCA will not be responsible for the full pathway of care in 127

relation to this activity and must have access to direct supervision from their registered professional. 128

The assistant/HCA must not be in a situation where they are lone-working, particularly in a domiciliary 129

capacity. 130

Both the assistant/HCA and their supervising professional must complete the same level of training in 131

aural care as any other aural care professional, via training which meets the current BSA Minimum 132

Training Guidelines in Aural Care, which means that they must demonstrate theoretical and practical 133

competency as detailed in section 3.4. 134

For assistants/HCA’s procedural scope must not be extended to include non-routine cases, or patients 135

under the age of 16. 136

2.2.3 Supervision 137

138

Further to the points made in section 2.2.2, registered professionals who are supervising wax removal 139

activities for unregistered professionals (or supervising registered staff who are training in this activity) 140

must ensure that they are available for direct supervision. The supervisor must have undertaken wax 141

removal training which meets the current BSA Minimum Training Guidelines for Aural Care and must 142

have been practising this procedure for a minimum of 12 months. 143

The supervisee must not attempt to undertake aural care activities without the direct supervision of 144

their supervisor, and must not act beyond their current professional scope of practice. 145

2.2.4 Fitness to Practice considerations 146

As well as being appropriately trained, the professional undertaking the procedure must ensure that 147

they have sufficient visual ability and manual dexterity to undertake the procedure safely. 148

This extends to ensuring that the equipment they use (see section 4.1) meets the correct quality and 149

safety specifications to allow them to examine the ear confidently, and that it is set up correctly for their 150

own vision. Magnification equipment such as the microscope, head loupe or endoscope should have 151

clean lenses and a good light source and should be set up prior to the appointment to meet the 152

professional’s own visual requirements. This is especially important for shared equipment. 153

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Professionals must be aware that proceeding without being able to clearly see what they are doing, or 154

proceeding without the required manual strength or dexterity to manipulate the equipment is a Fitness 155

to Practice issue which could affect their registration 156

Fitness to Practice for this procedure also includes: 157

a) adherence to infection prevention and control policies and procedures 158

b) adherence to referral guidelines reflecting recognition of scope of practice 159

160

3. Training and competencies required 161

The professional undertaking the procedure will have completed training with an accredited provider via 162

a course which meets the current BSA Minimum Training Guidelines for Aural Care, see details below: 163

Using this route, the following knowledge, skills and understanding will be developed: 164

a) Communication with patients, carers or significant others 165

b) Infection control and health and safety 166

c) Aural anatomy and physiology 167

d) Medico-legal issues 168

e) Competent use of associated equipment and procedure 169

Assessment will be completed through observation, and oral, practical and written examination. On 170

successful completion of the training full theoretical and practical competence in the following learning 171

outcomes must have been achieved: 172

a) Communication with patients, parents or significant others (including those with hearing loss) 173

174

• Issuing clear and appropriate instructions and information 175

• Obtaining informed consent 176

177 b) Correct management of infection control and other health and safety issues 178

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• Correct procedures for personal hygiene and disinfection 180

• Equipment cleaning and maintenance 181

• Correct handling and disposal of waste and instruments 182

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c) Understanding of relevant anatomy and physiology 186

• Knowledge of the anatomy and physiology of the outer and middle ear 187

• Identification of the structures of the outer ear 188

• Examination of the ear with and without magnification 189

• Ability to recognise abnormal conditions and refer accordingly 190

191 d) Understanding of medico legal issues 192

193

• Knowledge of current issues 194

• Contraindications and special care considerations for aural care 195

• Obtaining appropriate consent for the procedure to be performed 196

• Referral criteria and process 197

• Public liability and professional indemnity insurance 198

• Maintain accurate records of tasks undertaken 199

200 e) Correct use of equipment 201

• Perform thorough and safe otoscopy 202

• Use safe technique for aural examination using magnification equipment. 203

• Perform effective and safe aural care using the most appropriate method(s) and 204

equipment available to clear the ear canal of ear wax 205

• Identify any underlying pathology and decide whether the ear has been satisfactorily 206

cleared, and whether further treatment or referral is needed 207

• Knowledge of techniques and range of equipment available for aural care procedures 208

209

4. Equipment and working environment 210

4.1 Equipment 211

4.1.1 Infection control related to equipment 212

Equipment must be kept clean in adherence to local infection control policies and according to any 213

manufacturers’ recommendations. 214

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If equipment requires disinfection (such as the irrigation system) this must be carried out carefully 215

according to the manufacturer’s recommendations. Care should be taken to ensure that if using chlorine 216

cleaning tablets for irrigation tanks that the hands are washed thoroughly afterwards, that fumes are 217

not inhaled and that contact with the eyes is avoided. During the soaking period the irrigation system 218

must be left in a safe place to avoid spills. Following the recommended soak time the system must be 219

thoroughly flushed with clean water and dried. 220

Single use consumables must not be disinfected or sterilised, and must be disposed of according to local 221

infection control and disposal policies. Single use items must stay in their protective packaging until the 222

point of use. 223

4.1.2 Fitness for purpose 224

When purchasing equipment procurers must be advised that equipment must be fit for purpose, and 225

recognised as appropriate for use with the ear, nose or throat, i.e. it should be an ENT grade 226

otorhinolaryngology medical product. 227

This therefore indicates that the equipment is appropriate for use in soft tissue orifices encountered in 228

ENT such as those lined with skin or mucous membrane. 229

4.1.3 Safety and quality specifications and standards 230

For otorhinolaryngology and endoscopic medical products such as suction units, warm water rinsing 231

devices and nasopharyngoscopes the equipment must meet the following necessary minimum safety 232

and quality standard specifications according to the International Organisation for Standardisation (ISO) 233

and the Conformité Européene CE (translation = European Conformity): 234

1. The class II medical equipment must possess a CE certificate from an official certification body 235

which confirms that it “meets the requirements of Annex II, excluding section 4 of the directive 236

93/42/EEC. The manufacturer of the equipment must be able to prove that they have a quality 237

assurance system which is subject to periodic surveillance, defined by Annex II, section 5 of the 238

aforementioned directive. For placing on the market of class III devices covered by the 239

certificate a CE design-examination certificate according to Annex II, section 4 is required.” 240

(Standard CE Certificate wording). 241

2. The equipment must also possess a certificate from an official certification body that it meets 242 the requirements specified in EN ISO 9001:2008, and also EN ISO 13485:2012 and EN ISO 243 13485:2012/AC:2012 244

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4.1.4 Non conformity and the use of off-label medical equipment 249

Professionals must think carefully before proceeding with aural care using off-label equipment (i.e. 250

equipment which does not have a CE mark). If it is not possible to source a CE marked device consult the 251

UK Government Medicines and Healthcare products Regulatory Agency (MHRA) guidelines. 252

The key point is that the professional must firstly ensure that there is truly no other option than to use 253

an off label device. If so, the patient must be made aware of the non-conformity of the equipment and 254

must give their informed consent to the professional that they are willing to allow the use of the off-255

label device in their treatment. 256

The following advice is taken directly from the current UK Government MHRA guidance on this area: 257

“You must balance the risks and benefits to the patient taking into account recommendations which 258 include: 259

• carrying out a risk assessment and documenting it 260

• considering the ethical and legal implications 261

• implementing suitable precautions to minimise the risk 262

• reviewing the risk assessment at suitable periods 263

• getting approval from MHRA for exceptional use of non-complying devices (if necessary) 264

You must inform the patient during the consent procedure and make a note on their records that you 265 will be using a medical device off-label.” 266

4.1.5 Equipment maintenance 267

A planned preventative maintenance (PMM) schedule must be in place to ensure that equipment is in 268

good working order and checked and replaced regularly. 269

The procedure must be abandoned immediately if it is suspected or identified that a machine has 270

developed a fault whilst in the process of undertaking the aural care procedure. 271

4.1.6 Risk assessments 272

Procedural risk assessments for wax removal must include appropriate use of equipment and should 273

also acknowledge as a risk the possibility of inappropriate use of the equipment. 274

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4.2 Environment 277

Aural care must only be performed where room lighting levels allow safe illumination of the equipment 278

and of the patient/ears. This must be further supported by additional light sources e.g. head loupes, 279

otoscopes etc. 280

For irrigation, the room must have a sink with hot and cold water and facilities for waste disposal. It may 281

be helpful if this includes a sluice if working in a medical environment. 282

The environment must be conducive to infection control. 283

These factors will be more difficult to control in a domiciliary environment therefore extra care must be 284

taken. 285

286

5. Preparation for the procedure 287

5.1 Patient preparation 288

5.1.1 Consent 289

Patients must give informed consent for this procedure. This may be verbal or written consent according 290

to local policy. 291

The risks of the procedure must be clearly explained to the patient. See section 8 for details of risks. 292

Patients must be advised to report back to the professional immediately if discomfort, pain, swelling, 293

discharge or odour, or disruption to the hearing is experienced following any procedure so that 294

inspection and referral can take place. See section 12 regarding advice and aftercare. 295

See Appendix A for an example of a consent sign off form. 296 297

5.1.2 Softening of ear wax prior to the procedure 298

Prior to ear wax removal by any method patients must be advised to use an ear wax softener. This is 299

usually in the form of olive oil spray or drops, unless the patient or professional is aware of any known 300

previous reactions to this preparation. This must be used for a minimum of 3-5 days following the 301

manufacturers’ guidelines on use which usually involves application between 2 – 4 times daily. If the ear 302

wax remains very firm the olive oil may be applied for a further 3-5 days up to a max of 10 days. Expert 303

opinion varies on the appropriateness of using olive oil in non-routine ears. 304

The patient must be advised that their ear may feel more occluded following application of an ear wax 305

softener due to the expansion of the ear wax. For some it may also induce fluctuations in their hearing 306

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and mild discomfort or irritation. In addition, for patients who wear hearing aids, particularly those with 307

receiver in the ear/canal (RITE/RIC) and in the ear/canal (ITE/ITC/ICC) models, olive oil may adversely 308

affect the function of the hearing aid if it enters the hearing aid, therefore it may be advisable to avoid 309

wearing the hearing aid when olive oil has recently been administered. 310

If the ear wax is very hard and has been present for a long time sodium bicarbonate drops may be of 311

benefit. This preparation should be obtained following consultation with their pharmacist and should 312

generally only be applied to ears which are considered to be routine. 313

314

6. Procedure time 315

6.1 Routine cases 316

Adequate time should be allocated to allow the safe removal of the ear wax using whichever method is 317

deemed most suitable by the professional. Sometimes a combination of methods may be required in 318

order to remove the ear wax and time should be sufficient to allow for a switch in method if required. 319

Providing that the ear wax has been softened sufficiently it should not take longer than half an hour on 320

average to clear both ears. 321

It can sometimes be the case that the softener has not completely penetrated a long or very hard plug 322

of ear wax and it may have only softened the outer layers. This means that it is not always possible to 323

remove all it. In this case it is important to be able to recognise when to cease the procedure and advise 324

further application of the softener so that the remaining ear wax can be removed on a future 325

appointment. 326

327

6.2 When a routine ear becomes non-routine 328

During ear wax removal it can sometimes be the case that an ear considered to be routine is revealed as 329

non-routine as the ear wax comes away. For example a foreign object may be uncovered, or an infection 330

or trauma or other referable abnormality may become visible. If this occurs the procedure should be 331

stopped and the patient must be informed. They should be referred for a medical opinion and for 332

continued treatment according to the condition revealed and the professional referral guidelines. 333

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7. Contra-indications and special care considerations 337

See Appendix B for a checklist to help identify if an ear is to be considered as routine. Ear wax removal 338

should not be attempted if the ear is identified prior to the procedure as non-routine, unless the 339

professional has been trained to work with non-routine ears and is working in an environment with 340

appropriate medical support available. See section 2 for more details on scope. 341

8. Risks and complications associated with ear wax removal 342

8.1 Physical (direct) trauma 343

During any ear wax removal method there is the risk of physical trauma to the skin of the ear canal 344

walls. Manual instruments such as loops, curettes, forceps and black needles carry the greatest risk of 345

abrasion to the skin, but suction tube appendages, Tumarkins and Rosen speculae, and endoscopes can 346

also cause injury. 347

To minimise this risk it is important that the patient position is as stable as possible, either lying on a 348

raised couch or sat in an upright position in a chair ideally with a head rest. No instrument should be 349

introduced into the ear beyond the line of sight of the professional performing the procedure. 350

Furthermore it is not recommended that instruments are used in the inner third of the ear canal or near 351

the tympanic membrane unless the individual performing the procedure is medically trained and/or 352

experienced, and has appropriate risk mitigation measures in place for the enhanced risk, for example 353

quick access to medical help should it be required. 354

8.2 Pressure trauma 355

Risk of damage to the tympanic membrane due to pressure from an irrigation or suction device is 356

possible. These are minimised by restricting the depth of insertion of the suction tube and assistive 357

Tumarkins or Rosen speculae. 358

Risks from water pressure are minimised by ensuring that the irrigator pressure is kept low. Higher 359

pressures from the irrigator are not necessary to remove ear wax from an ear which has been prepared 360

well with softeners. In addition, the water jet from the irrigator should be directed at the ear canal wall 361

or wax and not the tympanic membrane itself. 362

8.3 Infection 363

During any ear wax removal method there is the risk of infection developing after the procedure. 364

Risks can be minimised by ensuring adherence to infection control policies and any manufacturer’s 365

guidelines regarding equipment disinfection, and by ensuring that single use items are kept packaged 366

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until the point of use and not re-used. (See section 4.1). Effective audit should also be used to ensure 367

that consumable stock is rotated and items are not used if out of date. 368

Infection from Pseudomonas or other microbial agents may occur following these procedures. Following 369

water irrigation the ear should be dry-mopped using a curette wrapped in cotton wool to minimise the 370

risk of a Pseudomonas bacterial infection forming as a result of water remaining trapped in the ear. It is 371

not necessary to use sterilised water for this procedure as water introduced into the ear possesses the 372

same risk of carrying infectious agents as water from a domestic tap. 373

8.4 Vertigo 374

Some patients may experience dizziness as a result of wax removal. This can arise from the physical 375

sensations created by the movement of the instruments in the ear canal, or may be induced by the 376

movement of the wax plug itself. It is thought that this may also be due to the mild compression (or 377

release of compression) of underlying facial nerves during the process. 378

Dizziness (caloric reactions) can also arise from temperature changes occurring in the external auditory 379

meatus and particularly at the tympanic membrane. Temperature variations can occur in the water used 380

to irrigate the ear, or may arise from changes in temperature created by the suction device. 381

Occasionally dizziness may be a result of poor breathing (either holding the breath or hyperventilation) 382

due to anxiety if the patient has had negative experiences of the wax removal process in the past. 383

In rare cases, fainting may also occur. 384

If the patient is lying down or in a seated position during the procedure this makes these occurrences 385

easier to manage. 386

8.5 Noise exposure 387

Sound pressure levels created in the ear during irrigation but more particularly during suction have the 388 potential to reach levels of greater than 85 dB in some cases (Snelling et al. 2009). 389 Noise levels from this procedure therefore have the potential to exacerbate or trigger existing tinnitus 390

and in rare cases trigger newly presenting tinnitus. These levels also have the potential to cause a 391

temporary hearing threshold shift. 392

Efforts should be made to minimise the time taken to complete the procedure so as to reduce the 393

length of exposure to noise generated by the equipment and procedure and therefore reduce the risk or 394

tinnitus and temporary threshold shift. 395

396

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8.6 Risks arising from over-cleaning the ear canal 398

Removal of essential moisture can encourage dryness and irritation of the ear canal skin. 399

Skin layers may be physically disrupted resulting in the natural microbial flora of the skin surface 400

entering the inner epidermal layers, and therefore possibly leading to the development of otitis externa. 401

As detailed in section 2.1, only necessary ear wax removal should be performed. 402

403

9. Manual removal using simple extraction instruments 404

Please note these are practice guidelines, not step-by-step recommended 405

procedures. 406

9.1 Patient instruction 407

The patient must be instructed to remain as still as possible and to keep the professional informed of 408

changes in comfort. The professional must also regularly visually and verbally monitor the patient’s 409

comfort. The professional must be seated during the procedure. 410

9.2 Method 411

Safe use of instruments such as loops, curettes and forceps must be demonstrated. When holding the 412

instrument bracing a finger on the patient’s cheek is recommended to steady the hand where it is 413

physically possible to do so, according to the professional’s hand and finger span and where safety will 414

be improved by doing so. 415

The pinna should be pulled backwards and upwards to open and straighten the ear canal and improve 416

the line of sight. 417

The working end of the instrument must be directly applied to the wax itself. Contact of the working end 418

of the instrument with the skin must be avoided. 419

The ear canal should be viewed via a binocular head loupe with its own light source, or through a 420

binocular microscope either with its own light source or with an additional directional external light 421

source. These binocular systems allow a 3 dimensional (3D) view which enables good depth perception – 422

important to assist in the avoidance of contact with the ear drum. 423

If these are unavailable otoscopy must be used regularly throughout the procedure and vision should 424

also be supported by an additional light source to illuminate the ear canal. This may include a simple 425

head torch or head mirror and lamp. 426

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9.3 Variations in method 427

Use of ear speculae, usually Tumarkins or Rosen speculae, may assist the process by keeping the ear-428

canal open and the skin protected. 429

An endoscope may also be used to view the ear during the procedure if the ear canal is wide enough to 430

allow the safe insertion of both the endoscope and the ear wax removal instrument, and providing that 431

the endoscope does not impede the required movement of the instrument. Professionals should be 432

aware that the 2 dimensional (2D) view achieved by the endoscopic system may not be as effective as a 433

binocular view at enabling good depth perception in a small space such as the ear canal. See advice in 434

section 1 regarding endoscopic methods. 435

9.4 Limitations of the procedure 436

This method must only be used to remove ear wax which is within easy reach in the outer regions of the 437

ear canal, within a clear line of sight and of a consistency which is soft enough to extract without causing 438

disruption to the ear structures or discomfort to the patient. 439

Patient tolerance – the patient may start to become uncomfortable if the procedure continues for too 440

long. 441

9.5 Complications of the procedure 442

Professionals must not perform this procedure on ears which are not routine unless it is within their 443

current scope of practice. See section 2.1 and 2.2 for details. 444

Infection is possible even when ears are routine due to the risk of abrasion by the wax removal 445

instruments. Where the skin of the ear is already traumatised due to existing abrasions, cuts, bruising, 446

inflammation, infection, or skin conditions such as otitis externa, eczema and psoriasis, the risk may be 447

increased. 448

Patients who take anticoagulant medicines may be at more risk of abrasion, bruising and bleeding with 449

this method if the wax removal instruments come into contact with the skin. 450

If a patient has a dry, irritable or tickly cough this method may trigger or exacerbate it due to stimulation 451

of the cough reflex. 452

Patients must be advised to report back to the professional as soon as possible if discomfort, pain, 453

swelling, discharge or odours occur, or if any disruption to hearing is experienced in the hours or days 454

following this procedure. This will ensure that ear examination and referral can take place. See section 455

12 for more details on advice and aftercare. 456

457

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10. Irrigation using irrigation machines 458


procedures. 460




comfort. 464

Patients must be sat upright in a stable position on a stable chair which has a head support/rest and no 465

wheels. The professional must also be seated during the procedure. 466

The patient’s shoulder and clothes should be protected from water spillage using absorbent paper on 467

the neck and shoulder, or a cape. The patient will be asked to hold the water-collecting receptacle 468

securely under their ear during the procedure. A colleague or relative may need to hold this if the 469

patient lacks the dexterity or strength to do this. 470

10.2 Method 471

A water irrigator is used to gently circulate water in the ear canal. 472


the line of sight 474

The jet tip must rest gently in the inter-tragal notch while the water jet is directed at the ear canal walls 475

or wax, and not the tympanic membrane. 476

The water jet must enter the ear under low pressure according to the pressure gauge on the equipment. 477

Following water irrigation the ear should be dry-mopped using a curette wrapped in cotton wool to 478

minimise the risk of a Pseudomonas bacterial infection forming as a result of water remaining trapped in 479

the ear. See section 8.3. 480


For ear wax which proves difficult to remove sodium bicarbonate powder may be added to the irrigation 482

water to assist in the reduction of ear wax adherence to the ear canal walls. 483

484

485

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Ear wax may remain adhered to the ear canal walls if the softening preparation has only penetrated the 487

outermost layers of the ear wax obstruction. 488

The procedure must be abandoned if the ear wax remains too solid to move, or if the usual procedure 489

time has been significantly prolonged. 490


long. 492


Irrigation is not suitable for ears which are not routine. 494

In particular, harm could occur if water is introduced into an ear where the ear drum is known (or is 495

suspected) to be not intact, e.g. where the ear currently has (or has had) perforations, surgery, where 496

grommets remain in situ, or where cleft palates are present (even if repaired) as water may enter areas 497

which would not normally admit water and may create a risk of infection. 498

Infection from Pseudomonas or other microbial agents is possible even when ears are routine and the 499

skin presents originally as intact. Where the skin of the ear is already traumatised due to existing 500

abrasions, cuts, bruising, inflammation, infection, or skin conditions such as otitis externa, eczema and 501

psoriasis, the risk may be increased. See section 8.3. 502

Careful monitoring of the water temperature should be maintained to reduce the risk of dizziness, even 503

in patients who do not have existing or known vertigo. The water temperature should be at body 504

temperature 37° or within a variation tolerance of ideally less than 1 degree Celsius above or below 505

body temperature. 506

If a patient has a dry, irritable or tickly cough care must be taken as this method may trigger or 507

exacerbate it due to stimulation of the cough reflex. 508

Efforts must be made to minimise the time taken to complete the procedure so as to reduce the length 509

of exposure to noise generated by the equipment, and to reduce the risk of triggering new tinnitus or 510

affecting existing tinnitus, or creating a temporary hearing threshold shift. 511

Care must be taken to keep the water pressure low to prevent discomfort or pressure trauma. 512





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11. Suction using microscopic vision or via magnification through a head 517

loupe 518


procedures. 520




comfort. 524

Patients may be lying down on a raised couch or may be sat upright in a stable position on a stable chair 525

which has a head support and no wheels. The professional must also be seated during the procedure. 526

11.2 Method 527

A suction device should be used to extract the ear wax from the ear canal. 528


the line of sight. The ear canal may also be held open by the insertion of a Tumarkin or Rosen speculum 530

which will also serve to protect the skin of the ear canal. 531

The working end of the suction instrument must be directly applied to the ear wax itself. Contact with 532

the skin must be avoided. 533

The ear canal should be viewed via a binocular head loupe with its own light source, or through a 534

binocular microscope either with its own light source or with an additional directional external light 535

source. These binocular systems allow a 3 dimensional (3D) view which enables good depth perception – 536

important to assist in the avoidance of contact with the ear drum. 537


The patient must be able to keep the head still, or be assisted to do so, for the procedure to be 539

undertaken safely. A chair head rest or pillow behind the head can therefore be of help. 540

An endoscope may also be used to view the ear if the ear canal is wide enough to allow the safe 541

insertion of the endoscope and the suction tube, and providing the endoscope will not impede the 542

required movement of the suction tube. Professionals should be aware that the 2 dimensional (2D) view 543

achieved by the endoscopic system may not be as effective as a binocular view at enabling good depth 544

perception in a small space such as the ear canal. See advice in section 1 regarding endoscopic methods. 545

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This method should only be used to remove ear wax which is within easy reach in the outer regions of 547

the ear canal, within a clear line of sight and of a consistency which is soft enough to extract without 548

causing disruption to the ear structures or discomfort to the patient. 549


long. 551


An ear care professional must not perform this procedure on ears which are not routine unless it is 553

within their current scope of practice. See sections 2.1 and 2.2 for details. 554

Infection is possible even when ears are routine due to the risk of abrasion by the wax removal 555

instruments. Where the skin of the ear is already traumatised due to existing abrasions, cuts, bruising, 556

inflammation, infection, or skin conditions such as otitis externa, eczema and psoriasis, the risk may be 557

increased. 558

If the patient has troublesome vertigo this may be triggered or exacerbated by this procedure due to 559

possible caloric effects caused by changing temperatures in the ear canal by the suction device, or by 560

stimulation of local nerves. 561

Patients who take anticoagulant medicines may be at more risk of abrasion, bruising and bleeding with 562

this method if the wax removal instruments come into contact with the skin. 563

If a patient has a dry, irritable or tickly cough this method may trigger or exacerbate it due to stimulation 564

of the cough reflex. 565

Efforts must be made to minimise the time taken to complete the procedure so as to reduce the length 566

of exposure to noise generated by the equipment, and to reduce the risk of triggering new tinnitus, 567

affecting existing tinnitus, or creating a temporary hearing threshold shift. 568





573

574

575

576

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12. Advice and aftercare 577

12.1. Immediate aftercare 578

Patients must be advised to report back as soon as possible to the professional if discomfort, pain, 579


following any ear wax removal procedure. This will ensure that inspection and referral can take place. 581

Patients should be given written details of possible complications to take away and given clear advice 582

about how to contact the department or seek medical advice if complications arise. 583

12.2. Educating patients about ear wax management 584

There is limited advice and evidence available regarding how often ear wax should be removed and also 585

whether regular removal actually encourages the production and accumulation of ear wax, therefore 586

expert opinion varies on these matters. 587

Patients should be advised following an ear wax removal episode that a build-up of ear wax may recur in 588

the future and require further management. 589

Education regarding the prevention and reduction of ear wax levels should be encouraged. This may 590

include advising regular use of softening preparations and regular check-ups. Patients with non-routine 591

ears should discuss with their pharmacist or GP regarding the use of over the counter devices or 592

treatments. 593

To reduce opportunities for patients to harm themselves, patients should be advised against the use of 594

cotton buds or any other devices to manually remove the wax themselves. The use of Hopi candles 595

should also be discouraged due to the lack of evidence that this is a safe or effective wax removal 596

method. 597

NICE guidance on these areas: 598

• Advise people against inserting anything in the ear. Cotton buds, matchsticks, and hair pins can: 599

o Damage the wall of the canal and increase the likelihood of otitis externa. 600

o Cause the wax to become impacted by pushing it further into the canal. 601

o Perforate the tympanic membrane. 602

• Advise that the use of ear candles has no benefit in the management of earwax removal and 603

may result in serious injury. 604

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o Ear candling should never be used: a hollow candle is burned with one end in the ear 605

canal. The intention is to create a negative pressure which draws the earwax out of the 606

ear canal. 607

608

609

610

611

612

613

614

615

616

617

618

619

620

621

622

623

624

625

626

627

628

629

630

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631

13. References 632

Beatrice F, Bucolo S, Cavallo R. Earwax, clinical practice ACTA Otorhinolaryngologica Italica.2009;29 (Suppl 1):1–20 633 634 British Society of Audiology (2003) Procedure for Processing Documents. Reading: British Society of Audiology. 635 636 British Society of Audiology (2010) Recommended Procedure. Ear Examination. Reading: British Society of 637 Audiology. 638 639 British Society of Audiology (2013) Minimum Training Guidelines for Aural Care. Reading: British Society of 640 Audiology. 641

Clegg A.J. et.al (2010) The safety and effectiveness of earwax removal: a systematic review and economic 642 evaluation. Health Technology Assessment (14) 28 643

Guest. J.et al (2004) Impacted wax: composition, production, epidemiology and management QJM. 97:477-488 644

Department of Health (2007) Transforming Adult Hearing Services for Patients with Hearing Difficulties – A good 645 practice guide http;//www.thebsa.org.uk/index.php?option=comconten&view=article&id=100&Itemid=7 646

L. A. Fox (2015) Successful Removal and Complication rates for the Instrumented Wax Removal in the Audiology 647 Clinic. BAA Magazine Summer 2015. 26-27 648

MRHA (2008) Medicine and Medical Devices Regulation – what you need to know 649 http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf (last viewed 650 07.04.17) 651

NICE Clinical Knowledge Summaries https://cks.nice.org.uk/earwax (last viewed 07.04.17) 652

Schwartz SR, Mait AE, Rosenfield RM, et.al. (2017) Clinical practice guideline (update): Earwax (cerumen 653 impaction). Otolaryngol Head Neck Surg. 2017;156 (1):S1-S29 654 655 Snelling JD, Smithard A, Waddell A. (2009) Noise levels generated within the external auditory canal during 656 microsuction aural toilet and the effect on hearing: a prospective controlled series. Clinical Otolaryngology 2009; 657 34:21-5 658 659 Wright T (2015) Ear wax. Systematic review 504.BMJ Clinical Evidence 660 http://clinicalevidence.bmj.com/x/systematic-review/0504/overview.html. (last viewed 07.04.17) 661

662 663

664

665

http://www.mhra.gov.uk/home/groups/comms-ic/documents/websiteresources/con2031677.pdf

https://cks.nice.org.uk/earwax

http://clinicalevidence.bmj.com/x/systematic-review/0504/overview.html

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Appendices 666

667

668

669

670

671

672

673

674

675

676

677

678

679

680

681

682

683

684

685

686

687

688

689

690

691

692

693

694

695

696

697

http://www.actaitalica.it/issues/2009/Argomenti/supplementi.pdfAppendices

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Appendix A 698

699

Consent form for Ear Wax Removal 700

Your Ear Care Professional has discussed with you the need to remove wax from your ear canal/s. In 701 order to do this it is necessary to carry out otoscopy or microscopy (a visual inspection of the ear 702 structures). Wax will be removed from your ear using the safest and most appropriate method for the 703 wax discovered. 704 705

Three methods of wax removal may be used, and these are sometimes used in combination: 706

Removal of wax deposits using manual instruments 707

Fine instruments are inserted carefully into your ear and used to gently extract the wax from the ear 708

canal 709

710

Wax removal using suction 711

A fine suction tube is carefully inserted into the ear canal while being viewed closely through a 712

microscope or under magnification from a head loupe. Wax is removed by suction from the tube. This 713

procedure can be noisy. 714

715

Wax removal using irrigation 716

A fine jet of water is gently circulated around the ear canal to loosen and remove the wax deposit. This 717

procedure can also be noisy. 718

719 Your Ear Care Professional has undertaken training in wax removal and will use best-practice 720 procedures to minimise any risk of harm. However, even when performed with the utmost care, there 721 are risks involved in wax removal. These risks include: 722 723

• damage to skin of the ear canal or the ear-drum during the procedure 724

• infection of the ear canal or other ear structures following the procedure 725

• temporary reduction in hearing 726

• temporary dizziness and (rarely) possible sickness or fainting 727

• triggering of new tinnitus 728

• temporary aggravation of existing tinnitus 729

• temporary irritation to the throat, especially if already dry, tickly or sensitive Page 1/2 730

731

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If the wax cannot be removed 732

Sometimes, depending on the amount and consistency of the wax and your own comfort, it may not be 733

possible to remove all of the wax in one attempt. If this situation occurs the Ear Care Professional will 734

stop the procedure and you will be advised to continue to use a wax softener for a specified number of 735

days and return to have the remainder removed. 736

737

Please tick the box to confirm: 738

I have read the information above and understand there are risks involved. I give my 739

consent to allow the Ear Care Professional to remove wax from my ear using the most 740

appropriate method for the amount and consistency of wax discovered. 741

I understand that the removal may take more than one attempt/visit. 742

743

Signed:…………………………………………………………………………… 744

745

Date signed:……………………………………………………………………… 746

747

748

749

750

751

752

753

754

755

756

Page 2/2 757

758

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Appendix B 759

760

Ear wax removal by manual instruments, suction or water irrigation 761

Contra-indications checklist to ensure ears are routine 762

Contra-indication No Yes

Recent or current pain

Foreign object

Middle ear infection (within last 6 weeks)

Acute otitis externa (outer ear infection)/itchy or irritated ears/eczema/psoriasis

Abrasions or inflammation of the ear-canal

Perforations or recently healed perforations

Ear surgery (of any type, particularly if recent)

Troublesome vertigo

Cleft palate (even if repaired)

Grommet in situ

History of any previous complications from wax removal procedures (e.g. vertigo, pain, tinnitus or other)

Anticoagulant or blood thinning medication e.g. Warfarin*

Troublesome tinnitus*

Dry, tickly or irritable throat* 763

* Extra care will be required. For tinnitus and throat issues the ear wax removal procedure may 764

aggravate these symptoms temporarily. Discuss risk with patient/client as it may be possible to proceed 765

with additional patient informed consent based on the ear care professional’s clinical judgement. 766

767