EN 15927-2010 en Services offered by hearing aid professionals《助听器专业人员提供的服务》.pdf

1、raising standards worldwideNO COPYING WITHOUT BSI PERMISSION EXCEPT AS PERMITTED BY COPYRIGHT LAWBSI Standards PublicationBS EN 15927:2010Services offered by hearing aidprofessionalsBS EN 15927:2010 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of EN 15927:2010.The

2、UK participation in its preparation was entrusted to TechnicalCommittee EH/1/1, Hearing.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible for i

3、ts correctapplication. BSI 2010ISBN 978 0 580 66697 1ICS 11.180.15; 17.140.50Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy and Strategy Committee on 31 October 2010.Amendments issued sinc

4、e publicationDate Text affectedBS EN 15927:2010EUROPEAN STANDARD NORME EUROPENNE EUROPISCHE NORM EN 15927 August 2010 ICS 11.180.15 English Version Services offered by hearing aid professionals Services offerts par les audioprothsistes Dienstleistungen in der Hrakustik This European Standard was app

5、roved by CEN on 12 June 2010. CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references concerning such national

6、standards may be obtained on application to the CEN Management Centre or to any CEN member. This European Standard exists in three official versions (English, French, German). A version in any other language made by translation under the responsibility of a CEN member into its own language and notif

7、ied to the CEN Management Centre has the same status as the official versions. CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxemb

8、ourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom. EUROPEAN COMMITTEE FOR STANDARDIZATION COMIT EUROPEN DE NORMALISATION EUROPISCHES KOMITEE FR NORMUNG Management Centre: Avenue Marnix 17, B-1000 Brussels 2010 CEN All right

9、s of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15927:2010: EBS EN 15927:2010EN 15927:2010 (E) 2 Contents Page Foreword 3Introduction .41 Scope 52 Normative references 53 Terms and definitions .64 Service preconditions .75 Hearing aid provision

10、 process 136 Quality management system . 17Annex A (normative) Minimum competencies of the hearing aid professional 19Annex B (informative) Recommendation for an appropriate organization of education and training for hearing aid professionals 22Annex C (informative) Recommendation for client informa

11、tion on fitting process 24Bibliography . 26BS EN 15927:2010EN 15927:2010 (E) 3 Foreword This document (EN 15927:2010) has been prepared by Technical Committee CEN/TC 380 “Project Committee - Hearing aid specialist services”, the secretariat of which is held by AFNOR. This European Standard shall be

12、given the status of a national standard, either by publication of an identical text or by endorsement, at the latest by February 2011, and conflicting national standards shall be withdrawn at the latest by February 2011. Attention is drawn to the possibility that some of the elements of this documen

13、t may be the subject of patent rights. CEN and/or CENELEC shall not be held responsible for identifying any or all such patent rights. According to the CEN/CENELEC Internal Regulations, the national standards organizations of the following countries are bound to implement this European Standard: Aus

14、tria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.

15、 BS EN 15927:2010EN 15927:2010 (E) 4 Introduction This European Standard provides a set of minimum requirements for the essential elements of the service provision. Furthermore, recommendations for other aspects of good practice are provided. Emphasis is placed on defining requirements for the eleme

16、nts of the service provision where the quality of the service offered is not readily assessed by the average client. Certain aspects of the service delivery by hearing aid professionals are likely to be covered by other already existing standards. These may be other European Standards in their natio

17、nal implementation or local standards that implement certain national requirements. Examples of such aspects are Business certificates, occupational safety and hygiene requirements, confidentiality and data protection. The quality of the service delivered by hearing aid professionals is also influen

18、ced by how the service delivery is managed in terms of staff behaviour and motivation, design and layout of facilities, choice of suppliers and products. The quality of the service delivered by hearing aid professionals relies on the personnel, their competencies and their motivation. Management pla

19、ys an essential role. Quality requires the initial and continuing training of all the personnel, and an ongoing exchange of multidisciplinary expertise. Such management and availability play an important role, but falls outside the scope of this European Standard. BS EN 15927:2010EN 15927:2010 (E) 5

20、 1 Scope This European Standard applies to the services offered by hearing aid professionals in their efforts to provide benefit for their clients. This European Standard specifies the process of hearing aid provision from the first client contact to the long term follow-up. This European Standard a

21、lso defines requirements for education, facilities, equipment and code of conduct. A quality management system with the overall objective of securing client satisfaction and covering the elements of the service is also an essential part of the requirements. This European Standard centres on the serv

22、ices offered to the majority of clients with hearing impairment. Certain groups of hearing impaired such as children, persons with other disabilities or persons with implantable devices may require services beyond what is covered in this European Standard. 2 Normative references The following refere

23、nced documents are indispensable for the application 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. EN 60118-4, Electroacoustics Hearing aids Part 4: Induction loop syst

24、ems for hearing aid purposes Magnetic field strength EN 60118-7, Electroacoustics Hearing aids Part 7: Measurement of the performance characteristics of hearing aids for production, supply and delivery quality assurance purposes EN 60645-1, Electroacoustics Audiological equipment Part 1: Pure-tone a

25、udiometers EN 60645-2, Audiometers Part 2: Equipment for speech audiometry EN 60645-5, Electroacoustics Audiometric equipment Part 5: Instruments for the measurement of aural acoustic impedance/admittance EN 61669, Electroacoustics Equipment for the measurement of real-ear acoustical characteristics

26、 of hearing aids EN 61672-1, Electroacoustics Sound level meters Part 1: Specifications EN ISO 389-1, Acoustics Reference zero for the calibration of audiometric equipment Part 1: Reference equivalent threshold sound pressure levels for pure tones and supra-aural earphones (ISO 389-1:1998) EN ISO 38

27、9-2, Acoustics Reference zero for the calibration of audiometric equipment Part 2: Reference equivalent threshold sound pressure levels for pure tones and insert earphones (ISO 389-2:1994) EN ISO 389-3, Acoustics Reference zero for the calibration of audiometric equipment Part 3: Reference equivalen

28、t threshold force levels for pure tones and bone vibrators (ISO 389-3:1994) EN ISO 389-4, Acoustics Reference zero for the calibration of audiometric equipment Part 4: Reference levels for narrow-band masking noise (ISO 389-4:1994) EN ISO 389-8, Acoustics Reference zero for the calibration of audiom

29、etric equipment Part 8: Reference equivalent threshold sound pressure levels for pure tones and circumaural earphones (ISO 389-8:2004) EN ISO 8253-1, Acoustics Audiometric test methods Part 1: Basic pure tone air and bone conduction threshold audiometry (ISO 8253-1:1989) BS EN 15927:2010EN 15927:201

30、0 (E) 6 EN ISO 8253-2, Acoustics Audiometric test methods Part 2: Sound field audiometry with pure-tone and narrow-band test signals (ISO 8253-2:2009) EN ISO 8253-3, Acoustics Audiometric test methods Part 3: Speech audiometry (ISO 8253-3:1996) ISO 12124, Acoustics Procedures for the measurement of

31、real-ear acoustical characteristics of hearing aids ISO 16832, Acoustics Loudness scaling by means of categories 3 Terms and definitions For the purposes of this document, the following terms and definitions apply. 3.1 hearing aid professional audiologically competent person who professionally asses

32、ses hearing, selects, fits and delivers hearing systems and rehabilitation services to persons with hearing loss 3.2 hearing impaired person with hearing impairment having complete or partial loss of the ability to hear from one or both ears NOTE The level of impairment can be mild, moderate, severe

33、 or profound. 3.3 client person with a hearing impairment being serviced by a hearing aid professional 3.4 hearing aid device based on electro-acoustic or electro-magnetic systems, placed outside or inside the ear and designed to amplify and process sounds in order to compensate for a hearing loss 3

34、.5 ear-mould individually customised or selected mechanical-acoustical coupling between a hearing aid and the ear canal 3.6 hearing system integral and customised system consisting of one or two hearing aids, ear-moulds and related components such as a remote control or interfaces to other informati

35、on or communication systems 3.7 hearing profile comprehensive account for a clients auditory problems, social situation, activity limitations, needs and expectations 3.8 fitting systematic procedure for adapting a hearing system to compensate for hearing loss 3.9 pre-setting adjustment of a hearing

36、aid using a prescriptive rule and relevant audiological data BS EN 15927:2010EN 15927:2010 (E) 7 3.10 fine-tuning adjustment of the hearing system to best match the needs and preferences of the hearing impaired 3.11 auditory training set of procedures, exercises and tests used to improve a hearing i

37、mpaired persons auditory performance 3.12 fitting system set of devices typically comprising a PC, fitting software and a programming interface used to adjust hearing aids 3.13 practice unit physical location where services are delivered by a hearing aid professional 3.14 rehabilitation systematic p

38、rocess for improving hearing abilities and communication skills through education, training and instruction after hearing system fitting 4 Service preconditions 4.1 General In order to provide a quality service, certain preconditions and applicable national laws and regulations shall be fulfilled. T

39、hese essential preconditions fall in four categories: a) educational requirements specifying the competencies that shall be required to perform the services; b) facility requirements specifying how the appropriate environment shall be for the proper delivery of the services; c) equipment requirement

40、s specifying what the necessary equipment for performing the services shall be; d) ethical recommendations specifying what the ethical framework and code of conduct should be. 4.2 Educational requirements 4.2.1 General This subclause specifies the competencies required for performing the hearing aid

41、 provision processes that are described in Clause 5 of the service specifications. The competencies of the persons delivering the service are very important for the quality of the service and shall be rooted in proper initial and continued education from recognized educational institutions as well a

42、s relevant practical skills obtained in a structured process. In general, delegation of tasks to staff without the required education shall not be allowed. Some national regulations may allow for more than one type of staff to be allowed to perform certain tasks in accordance with their specific edu

43、cational background. The overall responsibility of the service provision shall rest with a person having the educational background specified in 4.2.2. BS EN 15927:2010EN 15927:2010 (E) 8 In order to facilitate the acquisition of practical skills practice units may include trainees from educational

44、programs in their staff. Services performed by trainees shall take place under the supervision of the hearing aid professional that shall be present at the premises and who remains responsible for the activities. 4.2.2 Requirements for hearing aid professionals A robust foundation of knowledge and p

45、roficiencies in audiology and acoustics is a vital necessity for providing hearing and communication rehabilitation which meets the clients needs and expectations and the current standards of technological and medical progress. The hearing aid professionals shall actively seek information and traini

46、ng for state-of-the-art hearing and communication systems and their proper application. In order to be in compliance with this European Standard the hearing aid professional shall hold qualifications recognised by applicable national laws and regulations concerning hearing aid services. The qualific

47、ations should correspond to point (d) of article 11 in Directive 2005/36/EC. However, as a minimum the qualifications shall correspond to a degree of Article 11 point (c) of this directive. If no national regulations exist a degree equivalent to European Qualification Framework (EQF) level-5 (EU 200

48、8/C111/01) should be required. If national regulations are changed to require an EQF-level-5 education, the requirement shall be valid only from date of publication. The skills and competencies to be acquired from a sufficient education are outlined in Annex A. 4.2.3 Continued education requirements

49、 for hearing aid professionals In order to continuously ensure high quality service provision the hearing aid professional shall keep current with the developments in the field of audiology, hearing aid technology, methods and procedures as well as related products. Such additional education can be achieved in several ways such as short courses, workshops, training seminars and conferences. A minimum of 20 hours per year of a hearing aid professionals working time shall be devoted to continu