ISO/TC 43 N ISO/CD :2017 for comments

Transcription

1 ISO/TC 43 N 1327 ISO/TC 43 Acoustics of Secretary: hans-joachim.kornprobst@din.de Secretariat: DIN ISO/CD :2017 for comments Date of document Expected action Comment Due Date Background In May 2016, NWIP has been approved and allocated to the new working group ISO/TC 43/WG 10 Hearing aid fitting management (see doc. 43 N 1300). The present document constitutes the deliberations of WG 10 and is circulated as a Committee Draft for comments only by The comments will be discussed at the next meeting of WG 10 on /17 in Denmark.

2 ISO 2017 All rights reserved ISO/TC 43/SC N 1327 Date: ISO/CD :2017(E) ISO/TC 43/SC /WG10 Secretariat: DIN Acoustics Hearing aid fitting management Part 1: General framework Élément introductif Élément central Partie 1: Titre de la partie Warning This document is not an ISO International Standard. It is distributed for review and comment. It is subject to change without notice and may not be referred to as an International Standard. Recipients of this draft are invited to submit, with their comments, notification of any relevant patent rights of which they are aware and to provide supporting documentation. Document type: International Standard Document subtype: Document stage: (30) Committee Document language: E \\dbll9.orgdv.din.de\llprod_data\adlib\inputdocs\ _2.docx STD Version 2.8f

3 Copyright notice This ISO document is a working draft or committee draft and is copyright-protected by ISO. While the reproduction of working drafts or committee drafts in any form for use by participants in the ISO standards development process is permitted without prior permission from ISO, neither this document nor any extract from it may be reproduced, stored or transmitted in any form for any other purpose without prior written permission from ISO. Requests for permission to reproduce this document for the purpose of selling it should be addressed as shown below or to ISO's member body in the country of the requester: [Indicate the full address, telephone number, fax number, telex number, and electronic mail address, as appropriate, of the Copyright Manager of the ISO member body responsible for the secretariat of the TC or SC within the framework of which the working document has been prepared.] Reproduction for sales purposes may be subject to royalty payments or a licensing agreement. Violators may be prosecuted. ii ISO 2017 All rights reserved

4 Contents Page Foreword...iv Introduction...v 1 Scope Normative references Terms and definitions General framework Phases of general framework General Client profile Counselling Hearing aid fitting Verification and validation Auditory coaching Follow-up...7 Bibliography...8 ISO 2017 All rights reserved iii

5 Foreword ISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies). The work of preparing International Standards is normally carried out through ISO technical committees. Each member body interested in a subject for which a technical committee has been established has the right to be represented on that committee. International organizations, governmental and non-governmental, in liaison with ISO, also take part in the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of electrotechnical standardization. The procedures used to develop this document and those intended for its further maintenance are described in the ISO/IEC Directives, Part 1. In particular the different approval criteria needed for the different types of ISO documents should be noted. This document was drafted in accordance with the editorial rules of the ISO/IEC Directives, Part 2 (see Attention is drawn to the possibility that some of the elements of this document may be the subject of patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of any patent rights identified during the development of the document will be in the Introduction and/or on the ISO list of patent declarations received (see Any trade name used in this document is information given for the convenience of users and does not constitute an endorsement. For an explanation on the meaning of ISO specific terms and expressions related to conformity assessment, as well as information about ISO's adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: The committee responsible for this document is ISO/TC 43, Acoustics. iv ISO 2017 All rights reserved

6 Introduction The world report on disability in 2012 estimated there are 360 million people with hearing impairment representing, approximately 5,3 % of the world population [1]. Hearing aids (HAs) are one of the most widely-used treatment options for hearing impaired people [2,3,4]. For the proper use of HAs, hearing aid fitting management (HAFM) is a crucial issue for manufacturers, practitioners, service providers, and especially for HA users [2,5,6]. Individually optimized outcome of HA use is supported by comprehensive HA fitting protocols [5] and the impact of poor fit and comfort can lead to noncompliance and HA return [6]. Accordingly, the whole process of HA fitting should be optimized to achieve efficiency, transparency, user satisfaction, and cost effectiveness. Two observations are important to take into account when developing a HAFM standard. First, the term hearing aid fitting is widely used [7,8,9,10] among service providers and industry sectors. It has potentially conflicting interpretations, and there is a variety of guidelines for HA fitting [11-26]. It is likely that different understanding of fitting has led to non-uniform care, outcome variability, and in many cases dissatisfaction of the use of HAs. The main purpose of this standard is thus to provide general framework for HAFM including the preand post-fitting stages to make it more explicit and transparent so that its related tasks, including professional services, administration, and financial aspects can be systematized. The overall objective of the activities is that hearing aid fitting makes the minimum requirements to hearing rehabilitation. The general framework of HAFM in this standard is divided into six phases (client profile, counselling, hearing aid fitting, verification/validation, auditory coaching, and follow-up) based on the common practices of practitioners, and as recommended by various pre-existing guidelines. By phasing HAFM service providers can systematically identify and administer the service components needed for high service quality, user satisfaction, patient-centered services, patient self-efficacy, and compliance rates with HAs (e.g., consistently using HAs and attending follow-up appointments). The phases will focus on the components of the framework to achieve high rehabilitation outcomes such as speech intelligibility, perception of the acoustic environment, comfort for the HA users, and sound quality. In addition, this standard can be a basis to do a cost assessment for each phase or component, which may help improving public health funding systems. Another possible application is to develop professional training programs in HAFM. The standard makes general use of various existing guidelines such as: American Speech-Language Hearing Association [21], World Health Organization [25], International Society of Audiology [18], European Standard EN [10], Audiological Society of Australia [11], British Society of Audiology [13]. It also makes use of instructional material and research works, in particular: Moodie et al. [7], Kochkin et al. [5], Dillon [12], Schum & Weile [8], Stevens [9]. (to be added more at a later stage). ISO 2017 All rights reserved v

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8 COMMITTEE DRAFT ISO/CD :2017(E) Acoustics Hearing aid fitting management Part 1: General framework 1 Scope The ISO standard applies to Hearing Aid Fitting Management (HAFM) services offered by hearing care professionals in their efforts to provide benefit for their clients. The provision of hearing aids needs to involve the care of a hearing care professional, to ensure the correct fitting and adequate service in the interest of the hearing impaired client. The Part 1 of this ISO standard specifies general processes of HAFM from the client profile to the follow-up by administering, organizing, realizing, and controlling hearing aid fitting with all prior and subsequent stages. This ISO standard centers on the services offered to the majority of clients with hearing impairment. Certain groups of hearing impaired such as children, persons with other disabilities or persons with certain implantable devices may require services beyond what is covered in this ISO standard. 2 Normative references The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. ISO , Acoustics Audiometric test methods Part 1: Basic pure tone air and bone conduction threshold audiometry ISO , Acoustics Audiometric test methods Part 2: Sound field audiometry with pure-tone and narrow-band test signals ISO , Acoustics Audiometric test methods Part 3: Speech audiometry IEC 61669, Electroacoustics Equipment for the measurement of real-ear acoustical characteristics of hearing aids 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at ISO Online browsing platform: available at hearing manner in which a person detects, discriminates, identifies and cognitively processes sounds. ISO 2017 All rights reserved 1

9 3.2 hearing impaired person with hearing impairment having complete or partial impairment of hearing ability. 3.3 hearing care professional audiologically competent person who professionally assesses hearing, selects, fits and delivers hearing aid systems and rehabilitation services to persons with hearing impairment 3.4 hearing aid wearable electro-acoustic instrument intended to process sounds in order to compensate for hearing impairment. 3.5 hearing aid system customized system consisting of one or two hearing aids, ear-moulds and related components such as a remote control or interfaces to other information or communication systems 3.6 hearing aid fitting systematic procedure for individualizing and optimizing a hearing aid system to compensate for hearing impairment 3.7 hearing aid fitting management HAFM systematic process to administer, organize, realize and control hearing aid fitting including all prior and subsequent stages. 3.8 hearing rehabilitation systematic process for improving hearing abilities and communication skills through hearing aid fitting, counselling, education and training. 3.9 client profile comprehensive account for a client's auditory functionality, social situation, activity opportunities, needs and expectations as well as a client s audiological and medical history pre-setting of hearing aids adjustment of a hearing aid using a prescriptive rule and relevant audiological data 3.11 fine-tuning tuning of the hearing aid system to best match the needs and preferences of the hearing impaired 3.12 fitting system set of devices typically comprising a PC, fitting software and a programming interface used to adjust hearing aids 2 ISO 2017 All rights reserved

10 4 General framework The general framework of HAFM consists of six phases, as depicted in Figure 1: client profile, counselling, hearing aid fitting, verification/validation, auditory coaching, and follow-up. This general framework includes all the necessary components for a best practice of HAFM. Figure 1 General framework of HAFM The general framework of HAFM includes six phases. Client profile: assessment of the quantitative and qualitative functionality by interview and measurements; Counselling: selection, presentation, and common decision about the appropriate hearing aid system based on aligned with expectations and potentials; Hearing aid fitting: pre-setting and fine tuning; ISO 2017 All rights reserved 3

11 Verification/Validation: assessment of functionality, benefit and satisfaction based on objective and subjective measures; Auditory coaching: introduction of handling and support for acclimatization; Follow-up: periodic verification/validation of technical and auditory aspects and further support to optimize hearing aid system benefit. 5 Phases of general framework 5.1 General The phases of the general framework must be performed by a hearing care professional, to ensure the correct fitting and adequate service in the interest of the hearing impaired client. These phases cover assessment of the client's needs and degree of hearing loss followed by the selection and fitting of suitable hearing aids, rehabilitation and short and long term monitoring and support. Hearing aid fitting shall consist of both the delivery of the hearing instruments, the fitting process and the related care. The efficacy of the hearing system depends on the type of device chosen, its fitting, the counselling and the follow-up. Initially, the general process of HAFM shall be explained to the client including the financial aspects. During the entire fitting process, many decisions shall be taken in a close dialogue with the client. The availability of the proper facilities and equipment is important for a successful HAFM. The hearing care professional should pay particular attention to clients with no previous experience in using hearing aids. 5.2 Client profile The hearing care professional shall do a client profile assessment that establishes an account for the client's auditory functionality, social situation, activity limitations, needs and expectations. All test results of the client profile assessment shall be recorded in the client file General assessment The following conditions shall be considered for the client profile and properly documented: self-reported type, degree and history of the hearing impairment; communication and hearing challenges, social consequences; relevant living conditions, and the need for assistive listening devices, hearing expectations and individual hearing situations; relevant medical history including allergies and medication; fine motor skill, visual capabilities or other challenges; tinnitus, dizziness and hyperacusis; previous use of hearing aid and other assistive devices. The client profile should use the terminology of ICF (International Classification of Functioning, Disability and Health) to define the degree of hearing impairment. NOTE It is recommended to use validated questionnaires for the recording of these factors. 4 ISO 2017 All rights reserved

12 5.2.2 Audiological assessment Otoscopy Otoscopy shall be carried out with examination of the external ear canal, eardrum and also pinna and area behind the ear Pure-tone audiometry Pure-tone audiometry shall be carried out according to the test procedure described in ISO Hearing thresholds (with masking if necessary) shall be determined at least at the following frequencies: air conduction: 250 Hz, 500 Hz, Hz, Hz, Hz and Hz; bone conduction: 500 Hz, Hz, Hz and Hz. NOTE One should test semi-octave frequencies when there is an octave difference of more than 20 db Speech audiometry The client's ability to recognise speech is an important parameter for the audiological assessment and speech audiometry shall always be performed. Standardised recorded speech test material as specified in ISO should be used, if available. The speech signal may be presented monaurally through earphones or binaurally in a sound field. Speech presented in a background of competing noise should be used since it represents a more realistic situation than speech in quiet Other audiometric tests If deemed relevant other audiometric tests shall be carried out. Such measurements could be: subjective audiometric procedures like: uncomfortable loudness level (UCL) at relevant frequencies, most comfortable loudness (MCL), comfortable speech level (CSL), acceptable noise level (ANL), loudness scaling; objective audiometric procedures like tympanometry, ABR, OAE etc Medical referral If the results of the audiological assessment and the client profile indicate a disease or other cause of the hearing loss that could need medical or surgical treatment, the hearing care professional shall refer the client to a medical specialist. 5.3 Counselling At the end of the assessment of the client profile, the results shall be explained and discussed with the client, in particular it is important to manage expectations with regards to achievable functionality. A report of the assessment shall be made available to the client. ISO 2017 All rights reserved 5

13 Based on the client profile the hearing care professional shall inform the client what types of hearing aid systems would be suitable. The various options in terms of models, styles, features including connectivity opportunities, control possibilities, accessories and prices shall be presented to the client and their respective advantages and limitations described. If no contra-indications are present, bilateral fitting shall be recommended. The selection of hearing aid system to be fitted as well as other assistive listening devices shall be based on informed consent by the client with all relevant information including the financial aspects. Product and cost documentation on the proposed solution shall be given to the client. 5.4 Hearing aid fitting Ear coupling elements If a custom mould/shell is needed for the hearing system chosen, an ear impression or scanning shall be made and the proper acoustic properties of the customised part determined. This impression/scan is to be used for the production of the custom mould/shell Pre-setting of hearing aids Depending on the type of hearing system chosen certain preparations may be needed before the actual fitting can be carried out. The hearing care professional shall enter the following data in the fitting system from the manufacturer: data from the client profile; properties of acoustic coupling (e.g. ear-mould). Based on this data, a pre-setting shall be programmed into the hearing aid to be the starting point for the fine-tuning of the fitting. In case the hearing system includes a storage for client specific data, data logging or data transmission system for use data, consent from the client has to be obtained before these systems are enabled Fine-tuning of hearing aids The hearing system is physically placed on the client who can then verify the proper physical fit of the hearing aids and the coupling elements and these shall be modified until proper fit is achieved. The hearing aid is fine-tuned in close interaction with the client until a setting, accepted by the client, has been reached. In cases where an acceptable fitting is not obtained, additional assessments shall be carried out to identify the ways to improve the fitting. All method of the section on verification can be used to support fine-tuning, e.g. real-ear measurements. 5.5 Verification and validation To verify that a proper fitting has been achieved, steps shall be taken to evaluate the signal processing characteristics. For instance by means of real-ear measurements that shall be performed in accordance with IEC or by means of functional gain evaluation. It shall be assured that no discomfort is created in particularly loud situations. The client shall be exposed to situations that likely will be part of the client's everyday life in accordance with the hearing profile. This can be accomplished by using recordings of typical real-life situations (soundscapes). 6 ISO 2017 All rights reserved

14 If the hearing system includes several user programs and additional devices, it shall be assured that each user program is properly adjusted and that additional devices are connected and functioning, e.g. telecoil, remote microphones etc. Validation of improvement in hearing ability shall be performed. At least one of the following shall be used and the results reviewed with the client: speech audiometry in sound field with and without noise, aided compared to unaided; standardised recorded speech test material as specified in ISO should be used, if available; questionnaire concerning the perceived benefit of the hearing system. The questions may refer to before and after fitting or focus directly on perceived benefit. A scientifically validated questionnaire should be used, and the client should have at least several weeks of everyday experience with the hearing system. Other validation methods that can also be applied are: measurement of aided hearing threshold levels in sound field according to ISO ; localisation performance using loudspeaker arrays; presentation of relevant soundscapes. 5.6 Auditory coaching Before the hearing aid fitting phase can be considered completed the client shall be given a comprehensive introduction to the hearing systems fitted and available assistive listening devices, in particular clients who have no experience of using a hearing aid. This shall at least include: product-specific instructions and demonstrations; instructions and demonstrations on how to place and operate the hearing aids; instructions and demonstrations on how to replace batteries; hearing tactics: teaching and training of individual behavioural patterns to cope with difficult acoustic environments; advise on the use of the hearing aid with induction loops or other hearing enhancement systems within buildings; instructions on how to clean and maintain hearing aids and ear-moulds; support for acclimatization including auditory training if needed. 5.7 Follow-up The purpose of the follow-up services is for periodic verification/validation of technical and auditory aspects and further support to optimize hearing aid system benefit. Follow-up visits shall also be scheduled when clients experience situations where the hearing system is not performing as expected. ISO 2017 All rights reserved 7

15 Bibliography [1] WHO global estimates on prevalence of hearing impairment. Geneva: World Health Organization Available from: URL: [2] Hougaard S, Ruf S. EuroTrak I: A consumer survey about hearing aids in Germany, France and the UK. Hear Rev 2011; 18(2): [3] Storm KE. Hearing aid sales increase by 4,8 % in 2014; RICs continue market domination. Hear Rev 2015; 22(3): 6 [4] Hear well in noisy world. Consumer Reports 2009(July); Available from: URL: [5] Kochkin S, Beck D L, Christensen L A, Compton-Conley C, Fligor BJ, Kricos PB, et al. MarkeTrak VIII: The Impact of the Hearing Healthcare Professional on Hearing Aid User Success. Hear Rev 2010; 17(4): [6] Kochkin S. MarkeTrak VII: Obstacles to adult non-user adoption of hearing aids. Hear J 2007; 60(4):24 50 [7] Moodie S, Scollie S, Seewald R, Bagatto M, Beaulac S. The DSL Method for Pediatric and Adult Hearing Instrument Fitting; Version 5. Phonak Focus 2007; 1-22 [8] Schum DJ, Weile JN. Creating More Personalized Hearing Aid Fittings. Oticon white paper 2013;1-22 [9] Stevens K. A hearing aid fitting protocol; Take the time, do it right Innovations. Starkey Audiology Series 2014; 4(3): [10] EN 15927, Services offered by hearing aid professionals. Belgium: European Standard; 2010 [11] Audiology Australia professional practice standards-part B clinical standards. Audiological Society of Australia Available from: URL: [12] Dillon H. Hearing aids, 2nd edition, Australia; Thieme; p [13] Scope of practice document. British Academy of Audiology Available from: URL: [14] Feirn R, Wood S, Sutton G, Booth R, Meredith R, Brennan S, et al. Guidelines for fitting hearing aids to young infants. Modernising Children s Hearing Aid Services Available from: URL: lines.pdf [15] Preferred practice guideline for the prescription of hearing aids for children. College of audiologist and speech-language pathologist of Ontario Available from: URL: s.pdf 8 ISO 2017 All rights reserved

16 [16] Resolutions and recommendations adopted in the general assembly. Association European hearing aid professionals Available from: URL: resolutions/item/158-resolutions-andrecommendations-adopted-in-thegeneral-assembly/158-resolutions-and-recommendationsadopted-in-the-general-assembly?start=5 [17] 10 step catalogue on the quality of hearing aid fitting. European Union of Hearing Aid Acousticians Available from URL: [18] Good Practice Working Group of the International Collegium of Rehabilitative Audiology. Good practice guidance for adult hearing aid fittings and services-background to the Document and Consultation. The International Society of Audiology Available from URL: [19] Hearing aid selection, fitting and follow-up. New Zealand Audiological Society Inc. Available from URL: [20] Lee JH, Lee KW. Hearing aid evaluation. Korea: Hakjisa; p [21] American Speech-Language Hearing Association. Guidelines for hearing aid fitting for adults. Am J Audiol 1998; 7: 5-13 [22] Audiologic management of adult hearing impairment. Audiology today 2006; 18(5): [23] American Academy of Audiology Clinical Practice Guidelines. Pediatric amplification. American Academy of Audiology Available from URL: [24] Adult patients with severe to profound unilateral sensorineural hearing impairment. American Academy of Audiology Available from URL: [25] Guidelines for hearing aids and services for developing countries. Geneva: World Health Organization; p.1-38 [26] National competency standards. Human resources development service of Korea 2013 ISO 2017 All rights reserved 9