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Recommended Procedure 4

Determination of uncomfortable 5

loudness levels 6

Date: June 2019 7

Due for review: June 2024 8

Recommended Procedure Determination of uncomfortable loudness levels BSA 2018

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General foreword 9

This document presents Practice Guidance by the British Society of Audiology (BSA). This Practice 10

Guidance represents, to the best knowledge of the BSA, the evidence-base and consensus on good 11

practice, given the stated methodology and scope of the document and at the time of publication. 12

Although care has been taken in preparing this information, the BSA does not and cannot guarantee the 13

interpretation and application of it. The BSA cannot be held responsible for any errors or omissions, and 14

the BSA accepts no liability whatsoever for any loss or damage howsoever arising. This document 15

supersedes any previous Recommended Procedure by the BSA and stands until superseded or 16

withdrawn by the BSA. 17

Comments on this document are welcomed and should be sent to: 18

British Society of Audiology 19 Blackburn House, 20 Redhouse Road 21 Seafield, 22 Bathgate 23 EH47 7AQ 24 Tel: +44 (0)118 9660622 25

bsa@thebsa.org.uk 26 www.thebsa.org.uk 27 28 Published by the British Society of Audiology 29

© British Society of Audiology, 2018 30

All rights reserved. This document may be freely reproduced for educational and not-for-profit purposes. No other 31 reproduction is allowed without the written permission of the British Society of Audiology. 32

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Authors 33

Produced by: The BSA Tinnitus and Hyperacusis Special Interest Group and the BSA Professional Guidance Group 34 35 Key Authors: 36 Derek J Hoare 37 NIHR Nottingham Biomedical Research Centre, University of Nottingham 38 Declarations of interests: DJH is a researcher in tinnitus and hyperacusis at the NIHR Nottingham Biomedical 39 Research Centre, University of Nottingham. He has been chief investigator on tinnitus research funded by the 40 NIHR, the British Society of Audiology, the British Tinnitus Association, and Action on Hearing Loss. He is a past 41 Chair of the British Tinnitus Association’s Professional Advisor’s Committee. 42 43 Peter Byrom 44 Peter Byrom Audiology Ltd 45 Declaration of competing interests by the authors: Peter Byrom is a director of Peter Byrom Audiology Ltd and 46 holds shares in this company. However, none of the work discussed in this article was undertaken, influenced by 47 and / or financially supported by Peter Byrom Audiology Ltd. 48 49 Alice Shadis 50 Swansea University 51 Declaration of interests by the authors: None declared 52 53 Other contributors: Tony Kay, Barry Downes, Amanda Casey, Joanne Goss. 54

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Citation 56

Please cite this document in the following format: 57

BRITISH SOCIETY OF AUDIOLOGY, (2018), Recommended Procedure Determination of uncomfortable loudness 58 levels [Online]. Available from: insert web link. [Accessed date] 59

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Contents 69

General foreword ..................................................................................... 2 70

Author list…………………………………………………………………………………3 71

1. Introduction……………………………………………………………………………5 72

2. General considerations 73

2.1 Limitations of the test…………………………………………………………….....6 74

2.2. Cautions……………………………………………………………………………..6 75

3. Subject instructions…………………………………………………………………...8 76

4. Determining the ULL 77

4.1 Environment………………………………………………………………..………..9 78

4.1Stimulus………………………………………………………………………….…...9 79

4.2 Procedure…………………………………………………………………………...10 80

4.3 Recording………………………………………………………………………...…11 81

5. References………………………………………………………………… ………12 82

Appendix A. Acknowledgments .................................................. …… … .14 83

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1. Introduction 85

The purpose of this document is to describe the Recommended Procedure for determining an 86 uncomfortable loudness level (ULL). The objective of this test is to identify the minimum level of 87 sound that is judged to be uncomfortably loud by the subject. The terms loudness discomfort 88 level (LDL) and ULL are sometimes used synonymously; the preferred term is ULL. 89

This document supersedes the recommended procedure British Society of Audiology (BSA) 90 Determination of uncomfortable loudness levels (2011). Revisions include a more detailed 91 description of steps in the procedure, use of alternative stimuli, ULLs in tinnitus and hyperacusis, 92 and a description of self-report questionnaire measures of loudness tolerance or sensitivity. The 93 ULL procedure once again appears in its own document, primarily to enable more efficient 94 review of this procedure independently to that for pure-tone audiometry. The reader is referred 95 to the Recommended Procedure for pure-tone audiometry (BSA, 2018) for general 96 recommendations regarding calibration, equipment, test environment and subject preparation. 97

It is not the purpose of this document to provide specific guidance on when ULLs should be 98 determined or how they should be interpreted. It is essential that the competent person 99 carrying out the test (i.e. the ‘tester’), or responsible for it, uses their professional judgement 100 when deciding on when and how extensively to determine the ULLs of the person being tested 101 (‘subject’) given the specific circumstances and the recommendations here. Further, this 102 Recommended Procedure may require modification and even greater care when testing special 103 populations, such as children and subjects with tinnitus or hyperacusis; the tester will also 104 require greater competency. Any modification shall be recorded with the results. 105

The term ‘shall’ is used in this document to refer to essential practice, and ‘should’ is used to 106 refer to desirable practice. 107

Unless stated otherwise, the procedure described here represents the status of the current 108 evidence base, taking into account other factors that influence desirable procedure, as 109 interpreted by the Professional Guidance Group of the BSA in consultation with its stakeholders 110 (see Appendix A). The document was developed in accordance with BSA (2003). 111

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Shared Decision-making 113

It is implied throughout this document that the subject should be involved in shared decision-114 making when undertaking audiological intervention, receiving subsequent information and 115 understanding how it will impact on the personalisation of care. Individual preferences should 116 be taken into account and the role of the clinician is to enable a person to make a meaningful 117 and informed choice. Audiological interventions bring a variety of information for both the 118

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clinician and the subject that can be used for counselling and decision-making regarding 119 technology and anticipated outcomes. 120

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2. General considerations 122

2.1 Limitations of the test 123

It is important to recognise that the pure-tone stimuli typically used in ULL testing may not 124 reflect the stimuli from which the subject may experience discomfort. There is also debate in the 125 literature regarding the value of ULL testing in hearing aid fitting and the assessment of tinnitus 126 and hyperacusis, including concerns regarding its test-retest reliability (see Formby et al., 2017; 127 Fackrell and Hoare, 2018). 128

ULLs are affected by various factors including the choice of stimulus, the instruction given to the 129 patient, and the psychophysical method used. For example, Anari and colleagues (1999) found 130 that ULLs using pure tones varied between patients from extreme hypersensitivity (ULLs 131 between 35 and 45 dB HL) to apparently normal ULLs sometimes exceeding 110 dB HL at all 132 frequencies. ULLs for everyday sounds were generally lower and not directly relatable to the 133 ULLs for pure tones. 134 135 Bornstein and Musiek (1993) reported how a simple difference in instruction can affect results. 136 Subjects were asked to identify a loudness level at which they would choose ‘not to listen for 137 any period of time’, or a loudness level that they ‘would choose not to listen for 15 minutes or 138 longer’. ULLs generated using the ‘not to listen for any period of time’ were 9 dB higher than 139 those using the ‘not to listen for 15 minutes or longer’ instruction. 140 141 ULLs can be very reproducible but it is important to know the impact of instruction on the 142 estimate. A consistent test procedure is required for comparable estimates over time or 143 between subjects. 144 145

2.2 Cautions 146

Due to the risks involved in exposing patients to high levels of sound it is recommended that this 147 test is not routinely performed in clinical situations; it is understood that this assessment may be 148 used in research and it is primarily for this group that this recommendation is prepared. 149 Particular care shall be taken with a subject reporting tinnitus, unusual distress from loud 150 sounds or exhibiting symptoms of hyperacusis (decreased tolerance or increased sensitivity to 151 everyday sounds) or related conditions. These subjects need to be identified through interview 152 and use of multi-item questionnaire measures. ULLs are not for general use and should not be 153 used in certain populations such as those with cognitive impairment or learning disabilities. 154

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Where decreased tolerance or increased sensitivity to sound is a suspected problem, multi-item 155 questionnaires such as the Hyperacusis Questionnaire, Multiple-Activity Scale for Hyperacusis, 156 or the German Questionnaire on Hypersensitivity to Sound, can be used to measure the impact 157 it has on a subject. 158

Hyperacusis Questionnaire (HQ) 159 The Hyperacusis Questionnaire (HQ) was developed to quantify and characterise hypersensitivity 160 to sound, but it also used as an outcome measure for changes in sound tolerance (Khalfa et al., 161 2002). Part 1 of the questionnaire consists of binary questions to collect general information on 162 noise exposure history and auditory disorders. The second part of the HQ consists of 14 negatively 163 worded questions scored as either: “no” (0 points), “yes, a little” (1 point), “yes, quite a lot” (2 164 points), or “yes, a lot” (3 points). The mean global score reflects the sum of all responses with a 165 maximum score of 42, with higher scores reflecting greater sensitivity to sound. A score of 28 or 166 more is generally taken to indicate the presence of significant hyperacusis. Some studies have 167 compared ULLs to scores on the HQ. For example, Wallén and colleagues (2012) found that HQ 168 scores and ULLs negatively correlated in those with intermediate and high levels of emotional 169 exhaustion, but there was no correlation in those with low emotional exhaustion. HQ score have 170 also been reported as influenced by sex and age. 171

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The Multiple-Activity Scale for Hyperacusis (MASH) 173 The Multiple-Activity Scale for Hyperacusis (MASH) is a clinician-led questionnaire describing 15 174 activities for which subjects provide a score out of 10 to indicate their level of annoyance 175 relative to that activity (Dauman and Bouscau-Faure, 2005). The questionnaire allows irrelevant 176 questions to be deleted. A mean MASH score is calculated by summing all scored questions and 177 dividing the total by the number of activities giving a possible range of 0–10. 178

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German Questionnaire on Hypersensitivity to Sound 180

(Geräuschüberempfindlichkeit; GÜF) 181

The German Questionnaire on Hypersensitivity to Sound (GÜF) is a questionnaire developed by 182 Nelting and colleagues (2002). It is a brief tool (15 questions) to inform treatment needs 183 (identify urgency) and treatment planning. The possible responses to each question are ‘not 184 true’, ‘sometimes true’, ‘often’ or ‘always true’, scored 0-3 respectively to give a total score 185 between 0 and 45, with greater total scores indicate a bigger problem. The GÜF has been 186 translated into Spanish (test hypersensitivity to sound; THS) and English (Noise Avoidance 187 Questionnaire; Bläsing and Kroener-Herwig, 2012), however the English version has not been 188 subject to validation studies and has not yet been used in the clinics or research. 189

190 3. Subject instructions 191

Prior to testing, the tester shall explain the procedure to, and obtain informed verbal consent 192 from, the subject or person responsible for the subject. The tester shall inform the subject that 193

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they can stop the test at any point (e.g. if (s)he finds the stimuli uncomfortably loud), and 194 explain how to signal to the tester if they want to stop. 195

The exact instructions given have a considerable effect on the outcome of the test. It is also 196 important that clear and accurate instructions are given, taking into account possible 197 communication difficulties (e.g. hearing impairment and language capability). Instructions 198 should be given verbally. Written instructions can also be provided and should be used where 199 there is doubt that the subject has understood the verbal instructions. The following instructions 200 or equivalent should be used: 201

“I now want to measure the level at which sounds become so loud that they are uncomfortable 202 for you, so I am going to slowly and steadily increase the level of sounds that I present to you. 203 Please raise your hand as soon as the sound reaches a level of loudness that you feel is so loud 204 that it has become uncomfortable. This is not an endurance test; please don’t wait until you 205 can’t cope with the test any further before raising your hand. You should raise your hand only 206 when the sound becomes so loud it is uncomfortable; but make sure you do raise it as soon as 207 the sound reaches that level. If at any stage you are unhappy to continue please also raise your 208 hand.” 209

The test shall not proceed if there is doubt that the subject understands the instructions. This 210 can be checked by asking the subject to repeat their interpretation of the instructions given. 211 When there is any doubt, the tester should check thoroughly with the subject and, if necessary, 212 carefully repeat the instructions. If necessary, the subject should be encouraged to stay at ease 213 during the test. Unlike pure-tone audiometry, the subject can be told which ear is to be tested 214 before starting. 215

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4. Determining the ULL 217

4.1 Environment 218

The ULL test is usually performed in a sound-proofed room. 219

4.2 Stimulus 220

The usual stimulus is a pure tone. While tones may not be the most relevant stimulus, as noted 221 in Section 2.1, the use of alternative stimuli is not recommended at this time given the absence 222 of reference levels for calibration or clinical indication (see Ricketts, Bentler, and Mueller, 2017). 223

The tester, or person responsible for the test, shall consider for each subject her/his potential 224 risk from sound exposure and balance this against the potential clinical benefits obtained from 225 ULL testing. It is recommended that assessment of potential risk be based on assumptions of (1) 226

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a safe maximum exposure equivalent to 76 dB(A) continuously for 8 hours per ear per 24 hours, 227 (2) that dB HL is approximately equivalent to dB(A), and (3) that maximum sound dose increases 228 by 3 dB with a halving of exposure time, although the latter assumption should be regarded with 229 caution above 100 dB HL. This allows for testing up to 110 dB HL four times per ear per 24 hours 230 given reasonable allowances for variation in stimulus duration. The 76 dB(A) is more cautious 231 than 80 dB(A) used in The Control of Noise at Work Regulations (Health & Safety Executive, 232 2005). This includes considering sound exposure from other audiometric testing (e.g. masking in 233 pure-tone audiometry, real-ear measures, acoustic reflex testing). For pure tones and 234 frequency-modulated tones, presentation levels above 110 dB HL shall not be used and levels 235 above 100 dB HL should be used with caution. An exception is where there is clear evidence of a 236 sufficient physical conductive hearing loss (e.g. arising from middle ear pathology; not ‘cochlear 237 conductive’). 238

The test should be conducted on one ear at a time. Testing at two frequencies may be sufficient 239 for most subjects, such as a low and high frequency (e.g. 500 and 2000/4000 Hz). 240

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4.3 Procedure 242

The tester shall: 243

1. Monitor the subject’s face throughout the test and monitor the subject for the signal to 244 stop testing. It does not matter if the subject can see what the tester is doing; this may 245 actually be helpful. Cease testing immediately if the subject shows any sign of distress or 246 flinching; then ask if the sound was uncomfortable. Ask the subject if they want to 247 continue and if appropriate, reinstruct and retest as below. Testing shall also be ceased 248 if it becomes clear to the tester that the subject does not understand the test 249 procedure. 250

2. Start testing at 60 dB HL or at the subject’s hearing threshold level for that ear at that 251 frequency, whichever is highest, unless otherwise indicated (e.g. see Section 2.2). Start 252 with the better/non pathology ear, if known. 253

3. Present a 1-second-long tone, followed by at least a 1-second quiet period. Increase the 254 stimulus by 5 dB and present the stimulus in the same manner. Repeat this process. 255 Cease testing immediately if the subject responds, if the subject shows any sign of 256 distress or flinching or if an appropriate maximum level has been reached (see Section 257 4.1). The tester should affirm that the patient found that stimulus level to be 258 uncomfortably loud and would not like it to be raised any higher in intensity. 259

4. It does not matter if the presentation of the tones is rhythmical; this may actually be 260 helpful. Sufficient time (2-5 seconds), using sensitive professional judgement, shall be 261

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provided between presentations for the subject to respond, which may be greater for 262 some subjects than others. 263

5. The level of the tone at which the subject responds is the ULL. If the test is terminated 264 because the subject flinches before making a formal response, that level can also be 265 taken as the ULL if the subject confirms that the last tone, but not the previous tone, 266 was uncomfortable. 267

A retest at one or more frequencies may be conducted if there is reason to doubt the reliability 268 of the ULLs obtained or if enhanced precision is required. 269

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4.4 Recording 271

See Figure 1 for the symbols used for recording ULLs. When the maximum recommended level, 272 or the maximum output of the audiometer, is reached without the subject responding, the ULL 273 is recorded as “greater than” this value. Any modifications to the procedure, use of alternative 274 stimuli, or the change of behaviour taken to indicate the ULL should be documented with the 275 audiogram. 276

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Figure 1 283

Illustration of the symbols used to record ULLs on the audiogram. ULL is at 90 and 284

85 dB HL at 500 Hz on the right and left, respectively, and greater than 110 dB HL 285

at 2000 Hz on both sides. 286

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5. References 287

Anari, M., Axelsson, A., Eliasson, A., & Magnusson, L. (1999). Hypersensitivity to sound: questionnaire 288 data, audiometry and classification. Scandinavian Audiology, 28, 219-230. 289

Bläsing, L., & Kroener-Herwig, B. (2012). Self-reported and behavioral sound avoidance in tinnitus and 290 hyperacusis subjects, and association with anxiety ratings. International Journal of Audiology, 51, 611-291 617. 292

Bornstein, S. P., & Musick, F. E. (1993). Loudness discomfort level and reliability as a function of 293 instructional set. Scandinavian Audiology, 22, 125-131. 294

British Society of Audiology (2003) Procedure for Processing Documents. Reading: British Society of 295 Audiology. 296

British Society of Audiology (2011a) Determination of uncomfortable loudness levels. Reading: British 297 Society of Audiology. 298

British Society of Audiology (2018) Pure tone air and bone conduction threshold audiometry with and 299 without masking and determination of uncomfortable loudness levels. Reading: British Society of 300 Audiology. 301

Dauman, R., & Bouscau-Faure, F. (2005). Assessment and amelioration of hyperacusis in tinnitus 302 patients. Acta Oto-laryngologica, 125, 503-509. 303

Fackrell, K. & Hoare, D., J. (2018) Scales and Questionnaires for Decreased Sound Tolerance. In (Eds.) 304 Fagelson, M. & Baguley, D. M. Hyperacusis and Disorders of Sound Intolerance: Clinical and Research 305 Perspectives. Pleural Publishing Inc. San Diego, CA. 306

Formby, C., Payne, J., Yang, X., Wu, D., & Parton, J. M. (2017). Consideration of Methodology and 307 Measures of Loudness for Prescriptive Hearing Aid Fitting and Auditory Dynamic Range Expansion: 308 Repeated Measurement of Absolute and Relative Judgments of Loudness: Clinical Relevance for 309 Prescriptive Fitting of Aided Target Gains for soft, Comfortable, and Loud, But Ok Sound Levels. Seminars 310 in Hearing, 38, 26-52. 311

The Health & Safety Executive (2005) Controlling Noise at Work. The Control of Noise at Work 312 Regulations 2005. Guidance on Regulations. Crown. 313

Jastreboff PJ, Hazell JWP (2004) Tinnitus retraining therapy. Implementing the neurophysiological 314 model. Cambrdge: Cambridge University Press. 315

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Khalfa, S., Dubal, S., Veuillet, E., Perez-Diaz, F., Jouvent, R., & Collet, L. (2002). Psychometric 316 normalization of a hyperacusis questionnaire. ORL, 64, 436-442. 317

Nelting, M., Rienhoff, N. K., Hesse, G., & Lamparter, U. (2002). Die Erfassung des subjektiven Leidens 318 unter Hyperakusis mit einem Selbstbeurteilungsbogen zur Geräuschüberempfindlichkeit (GÜF). Laryngo-319 Rhino-Otologie, 81, 327-334. 320

Ricketts, T. A., Bentler, R., & Mueller, H. G. (2017). Essentials of Modern Hearing Aids: Selection, Fitting, 321 and Verification. Plural Publishing. 322

Wallén, M. B., Hasson, D., Theorell, T., & Canlon, B. (2012). The correlation between the hyperacusis 323 questionnaire and uncomfortable loudness levels is dependent on emotional exhaustion. International 324 journal of audiology, 51(10), 722-729. 325

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Appendix A. Authors and acknowledgments 342

This revision was conducted by the BSA Tinnitus and Hyperacusis Special Interest Group and 343 Professional Guidance Group in 2018 in accordance with BSA (2003). The authors thank all involved with 344 previous versions of this document and all who contributed to this revision. An electronic copy of the 345 anonymised comments (from NN individuals) received during consultation, and the responses to these 346 by the authors, is available on request from the BSA. 347