SIST EN 15927:2010
(Main)Services offered by hearing aid professionals
Services offered by hearing aid professionals
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 also 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 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 implantable devices may require services beyond what is covered in this European Standard.
Dienstleistungen in der Hörakustik
Diese Europäische Norm zielt darauf ab, dass die Dienstleistungen des Hörakustikers zum Nutzen der Kunden
sind.
Die Norm beschreibt den Ablauf der Hörsystemanpassung vom ersten Kundenkontakt bis zur Nachsorge.
Ebenfalls bestimmt diese Norm die Anforderungen an die Ausbildung, die Betriebsausstattung und die Verhaltensregeln.
Ein Qualitäts-Management-System, das die Zufriedenheit der Kunden umfassend absichert
und alle Elemente der Dienstleistung abdeckt, ist ein wesentlicher Teil der Anforderungen.
Im Mittelpunkt dieser Norm stehen die Dienstleistungen für die Mehrheit der Kunden mit einer Hörschädigung.
Andere Gruppen wie Kinder, Personen mit anderen Behinderungen oder Kunden mit Cochlear
Implants benötigen möglicherweise Dienstleistungen, die über die in dieser Norm beschriebenen Tätigkeiten
hinausgehen.
Services offerts par les audioprothésistes
La présente norme concerne les services offerts par les audioprothésistes pour améliorer les conditions de vie de leurs patients. La norme spécifie le processus de fourniture d’appareils de correction auditive, du premier contact patient au suivi à long terme. La norme définit également les exigences en termes d’éducation, d’installations,
d’équipement et de code de conduite. Un système de management de la qualité ayant pour objectif de satisfaire le patient et de couvrir les éléments du service est également un point essentiel des exigences. La norme concerne les services offerts à la majorité des patients souffrant de troubles de l’audition. Certains groupes de personnes malentendantes tels que les enfants, les personnes souffrant d’autres handicaps ou les personnes porteuses d’implants cochléaires, peuvent nécessiter d’autres services que ceux stipulés dans la présente norme.
Storitve ponudnikov slušnih pripomočkov
Ta evropski standard velja za storitve ponudnikov slušnih pripomočkov, in njihova prizadevanja zagotoviti korist svojim strankam. Ta evropski standard določa postopek zagotavljanja slušnih pripomočkov od prvega stika s stranko do dolgoročnega spremljanja. Ta evropski standard tudi opredeljuje zahteve za izobraževanje, objekte, opremo in kodeks ravnanja. Pomemben del zahtev je tudi sistem upravljanja kakovosti s splošnim ciljem stranki zagotoviti zadovoljstvo in pokrivanje sestavin storitve. Ta evropski standard se osredotoča na storitve, nudene večini strank s slušno okvaro. Določene skupine ljudi s slušno okvaro, kot so otroci, druge invalidne osebe ali osebe z vsadljivimi napravami lahko potrebujejo storitve, ki so izven področja, ki ga zajema ta evropski standard.
General Information
Relations
Standards Content (Sample)
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.Dienstleistungen in der HörakustikServices offerts par les audioprothésistesServices offered by hearing aid professionals11.180.15Aids for deaf and hearing impaired people03.080.01Storitve na splošnoServices in generalICS:Ta slovenski standard je istoveten z:EN 15927:2010SIST EN 15927:2010en01-oktober-2010SIST EN 15927:2010SLOVENSKI
STANDARD
SIST EN 15927:2010
EUROPEAN STANDARD NORME EUROPÉENNE EUROPÄISCHE NORM
EN 15927
August 2010 ICS 11.180.15 English Version
Services offered by hearing aid professionals
Services offerts par les audioprothésistes
Dienstleistungen in der Hörakustik This European Standard was approved 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 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 notified 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, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre:
Avenue Marnix 17,
B-1000 Brussels © 2010 CEN All rights of exploitation in any form and by any means reserved worldwide for CEN national Members. Ref. No. EN 15927:2010: ESIST EN 15927:2010
EN 15927:2010 (E) 2 Contents Page Foreword .3Introduction .41 Scope .52 Normative references .53 Terms and definitions .64 Service preconditions .75 Hearing aid provision 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 information on fitting process . 24Bibliography . 26 SIST EN 15927:2010
EN 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 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 document 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: Austria, 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. SIST EN 15927:2010
EN 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 elements 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 national 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 influenced 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 plays 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. SIST EN 15927:2010
EN 15927:2010 (E) 5 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 also 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 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 implantable devices may require services beyond what is covered in this European Standard. 2 Normative references The following referenced 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 systems 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 audiometers 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 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 389-2, 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 equivalent 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 audiometric 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) SIST EN 15927:2010
EN 15927:2010 (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 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 assesses 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 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 3.5 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 information or communication systems 3.7 hearing profile comprehensive account for a client's 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 aid using a prescriptive rule and relevant audiological data SIST EN 15927:2010
EN 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 impaired person's 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 process 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. These 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 requirements 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 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 as 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 educational background. The overall responsibility of the service provision shall rest with a person having the educational background specified in 4.2.2. SIST EN 15927:2010
EN 15927:2010 (E) 8 In order to facilitate the acquisition of practical skills practice units may include trainees from educational 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 proficiencies 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 training 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 qualifications 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 2008/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 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 professional's working time shall be devoted to continuing education. 4.3 Facility requirements 4.3.1 General The service units where hearing aid professionals deliver their services may vary considerably with regard to size, placement and surroundings in accordance with national preferences and legislation. Regardless of such differences, the facilities of the practice unit shall meet standards that ensure proper performance of the services. In keeping with the service process descriptions in Clause 5 the following service areas shall be available: reception area; counselling area; audiometry area; fitting area; maintenance area. SIST EN 15927:2010
EN 15927:2010 (E) 9 The service provider shall ensure that the service is fully accessible to the clients, e.g.: it shall be easy to contact the service provider e.g. by telephone, SMS, telefax and/or email; the access to the practice unit shall be clearly signed; public information about contact and opening hours shall be given. The facilities should be adequately designed for persons with hearing disabilities. The design should also be adequate for persons with other disabilities, e.g. impaired vision and impaired mobility. It is recommended that the rooms should have low reverberation time, low ambient noise level and good lighting facilitating lip reading and sign language. 4.3.2 Reception When entering the practice unit a reception desk should be readily available. At the reception, clients can identify themselves to the personnel and be advised about the service options. Often the reception is naturally coinciding with the desk where sales of consumables and accessories take place. The desk should be equipped with an induction loop system connected to a microphone and other audio sources. A waiting area should be naturally connected with the reception area and separated from the other service areas. 4.3.3 Counselling area A secluded area for counselling of clients shall be available. It shall be separated from the reception/waiting area in such a way that waiting clients or other persons cannot overhear conversations between the hearing aid professional and the client. 4.3.4 Audiometry area Audiometric measurements can only reliably be performed in an area with the correct acoustic properties in terms of reverberation time and ambient noise level. Hearing threshold levels using earphones or bone vibrators shall be measurable down to 20 dB HL for air conduction (30 dB HL bone conduction), which means that maximum ambient sound levels shall fulfil the requirements in EN ISO 8253-1, EN ISO 8253-2, and EN ISO 8253-3. This requirement can be fulfilled by a sound insulating cabin for pure tone audiometric measurements. 4.3.5 Fitting area Hearing aid fitting also requires a controlled acoustic environment although the specifications are less demanding in terms of ambient noise. The fitting area should fulfil the following requirements: a minimum surface area of 10 m2 and a minimum volume of 25 m3; reverberation time should be less than 0,5 s at 500 Hz; an equivalent A-weighted ambient sound pressure level of less than 40 dB under operating conditions; no dominant pure-tone components in the background noise. The fitting area may also be used for pure-tone audiometry if the requirements on ambient noise levels are met. For sound field speech audiometry the ambient sound pressure levels in the test room shall not mask the speech signals. A quasi-free sound field as specified in EN ISO 8253-2 is recommended. SIST EN 15927:2010
EN 15927:2010 (E) 10 4.3.6 Maintenance area The maintenance area is intended for service activities on hearing aids and other devices. It should be separated from the other areas. It shall be ensured that activities in the maintenance area do not disturb (noise, fumes, etc.) the activities in the audiometry and fitting areas. 4.4 Equipment requirements 4.4.1 General In order to provide high quality services different types of equipment are needed for proper performance of the service processes and these are characterised in the subsequent subclauses. The equipment listed below shall be available as minimum requirement in order to provide the proper services. Means for documentation of measurement activity shall be available. Such means can be either paper based or computerized electronic records with print-out facilities. All equipment shall be CE marked. 4.4.2 Audiometric equipment For pure-tone audiometry an audiometer shall be used for testing of air-conduction as well as bone-conduction using masking when applicable. The audiometer should be capable of measuring with earphones as well as insert phones. The audiometer can be part of an integrated system with multiple functional modes. The audiometer shall be a pure-tone audiometer type 1 or type 2 fulfilling the requirements of EN 60645-1. The performance of this equipment shall be checked and calibrated according to EN ISO 8253-1 and the relevant parts of EN ISO 389. For speech audiometry, equipment fulfilling the requirements of EN 60645-2 shall be available. Power amplifier and loudspeaker shall be available if sound field speech audiometry is performed. The performance of this equipment shall be checked and calibrated according to EN ISO 8253-3. The maximum interval between objective periodical checks of the audiometric equipment shall not exceed 12 months. If national legislation calls for more frequent checks these shall be applied. 4.4.3 Equipment for otoscopy and ear-mould impressions For examination of the ear-canal and tympanic membrane otoscopic equipment shall be available. Equipment for taking ear-mould impression shall also be available: otoscope with ear specula of different sizes; moulding syringes or moulding gun with suitable compounds for making ear-mould impressions; eardrum protectors; hygienic products for hands and equipment. 4.4.4 Hearing aid programming equipment A computer system with suitable hardware and software for hearing aid programming and storing of relevant client and fitting data shall be available. SIST EN 15927:2010
EN 15927:2010 (E) 11 4.4.5 Electro-acoustic measurement equipment Electro-acoustic equipment for measuring hearing aid characteristics on acoustic coupler or ear simulator (gain, output level, distortion, induction pick-up coil sensitivity, etc.) in accordance with EN 60118-7 shall be available. Furthermore, the following equipment should also be available: equipment for the measurement of real-ear acoustical characteristics of hearing aids fulfilling the requirements according to EN 61669; a class 1 or class 2 sound level meter according to EN 61672-1. The maximum interval between calibrations of such electro-acoustic equipment shall not exceed twelve months. 4.4.6 Maintenance tools Appropriate equipment for maintenance of hearing systems shall be available. Such equipment could comprise: rotary polisher for ear-mould adjustments; tool for drilling and trimming of tube ends; ultrasonic bath; set of screwdrivers and pliers; stethoscopic listening device; binocular magnifying glass or illuminated magnifying glass; vacuum pump, compressor or aerosol. 4.4.7 Demonstration tools For demonstration of products a selection of hearing aids and accessories shall be available. Other hearing assistive devices should also be available. An induction loop system with magnetic field in accordance with EN 60118-4 shall be available for demonstration of hearing aids with induction pick-up coil. 4.5 Ethical requirements and code of practice 4.5.1 General The services offered by hearing aid professionals are highly important to the clients receiving the services. It is therefore imperative that every activity is provided with the goal of achieving the best possible solution for the clients. Hearing aid professionals should exercise their profession for the purpose of seeking to assist their clients by offering the best solutions for the clients’ needs and preferences, e.g. communication. The services offered by hearing aid professionals involve relationships to other service providers and the proper relationship to these other stakeholders are also important for the total service provided to the hearing impaired clients. SIST EN 15927:2010
EN 15927:2010 (E) 12 4.5.2 Relationship with clients Hearing aid professionals should always bear in mind that their role is to use their knowledge and skills for the benefit of hearing impaired persons. In their relations with clients, the hearing aid professional should be discreet and tactful, and sensitive to client's psychological and psychosocial needs. The hearing aid professional should on all occasions be cautious, calm and understanding. Clients' confidence in their hearing aid professional is an essential requirement of the profession. In their relations with clients, the hearing aid professional should make sure that their comments have been well received and understood. The hearing aid professional should extend their service to the clients until best possible rehabilitation has been achieved. The hearing aid professional should provide all the information necessary for the correct use and maintenance of the hearing system and should give the client the instructions that are essential to ensure the continued efficacy of the system. The hearing aid professional should not attract or try to attract clients by means of gifts or other incentives unrelated to the service, either directly or indirectly through third parties. Where necessary and possible, the hearing aid professional should suggest that clients receive additional support that falls outside the scope of the services provided by hearing aid professionals to enable multi-disciplinary care in order to improve quality of life. Clients shall be able to freely choose any other health care professional as wished. Hearing aid professionals should provide contact details of relevant user organisations for hearing impaired. 4.5.3 Relationship with medical practitioners The hearing aid professional is aware that communication and hearing problems can be caused by medical conditions that require proper medical treatment. Such medical treatment falls outside the scope of the services offered by hearing aid professionals. The hearing aid professional should never attempt in any way to replace a medical service provider. Under circumstances where the client has not previously sought medical assessment of the hearing problem, the hearing aid professional should advise the hearing impaired person seeking his services to consult an appropriate medical practitioner. This can lead to situations where multiple service providers in concert are offering multi-disciplinary care. The hearing aid professional should undertake to make available to the physician and other involved service providers all necessary and relevant documentation with consent of client. The hearing aid professional should refrain from competition adverse arrangements that infringes the ethics of the profession. This includes collusion with medical practitioners or other third party health care professionals resulting in circumvention of normal competitive conditions.
4.5.4 Relationship with colleagues A hearing aid professional should refrain from unjustifiable criticism of colleagues' judgement, training, knowledge or skills. A hearing aid professional should not knowingly ignore professional misconduct or incompetence. 4.5.5 Advertising A hearing aid professional who wishes to advertise his services should of course do so. It is important that points of service are easily found by those in need of the services. Such advertising shall be in compliance with the provisions of applicable EU directives and applicable national legislation. SIST EN 15927:2010
EN 15927:2010 (E) 13 5 Hearing aid provision process 5.1 General Hearing aid provision covers 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. 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 hearing aid provision process. The hearing aid professional should pay particular attention to clients with no previous experience in using hearing aids. 5.2 Client contact and registration When the client is met at the reception area it can either be by appointment or a spontaneous visit. If the client is scheduled for a hearing aid fitting the pertinent demographic data shall be recorded. The process flow of hearing aid provision shall be explained thoroughly to the client including the financial implications. Annex C gives a comprehensive account for the information that can be given to the client. The names and qualification of all the staff operating in the practice unit shall be readily identifiable, e.g. by a badge. 5.3 Hearing profile determination The hearing aid professional shall do a hearing profile determination that establishes an account for the client's auditory problems, social situation, activity limitations, needs and expectations. The assessment shall also include contributing factors such as visual impairments and fine motor skill impairments. The following conditions shall be considered for the hearing profile and properly documented: type, degree and history of the hearing impairment; communication and hearing disabilities, 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 impairments, visual impairments or other disabilities; tinnitus
...
SLOVENSKI STANDARD
oSIST prEN 15927:2009
01-junij-2009
6WRULWYHSRQXGQLNRYVOXãQLKSULSRPRþNRY
Services offered by hearing aid professionals
Services offerts par les audioprothésistes
Ta slovenski standard je istoveten z: prEN 15927
ICS:
11.180.15 3ULSRPRþNL]DJOXKHRVHEHLQ Aids for deaf and hearing
RVHEH]RNYDURVOXKD impaired people
oSIST prEN 15927:2009 en,fr
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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oSIST prEN 15927:2009
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oSIST prEN 15927:2009
EUROPEAN STANDARD
DRAFT
prEN 15927
NORME EUROPÉENNE
EUROPÄISCHE NORM
March 2009
ICS
English Version
Services offered by hearing aid professionals
Services offerts par les audioprothésistes
This draft European Standard is submitted to CEN members for enquiry. It has been drawn up by the Technical Committee CEN/TC 380.
If this draft becomes a European Standard, 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.
This draft European Standard was established by CEN 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 notified to the CEN Management Centre has the
same status as the official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, 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 United Kingdom.
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.
Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. prEN 15927:2009: E
worldwide for CEN national Members.
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oSIST prEN 15927:2009
prEN 15927:2009 (E)
Contents Page
Foreword .3
Introduction .4
1 Scope .5
2 Normative references .5
3 Terms and definitions .6
4 Service preconditions .7
5 Hearing aid provision process . 12
6 Quality management system . 17
Annex A (informative) Minimum competencies and training requirements of the hearing aid
professional . 19
Annex B (informative) Recommendation for client information on fitting process . 27
Bibliography . 29
2
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oSIST prEN 15927:2009
prEN 15927:2009 (E)
Foreword
This document (prEN 15927:2009) has been prepared by Technical Committee CEN/TC 380 “Project
Committee - Hearing aid specialist services”, the secretariat of which is held by AFNOR.
This document is currently submitted to the CEN Enquiry.
3
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oSIST prEN 15927:2009
prEN 15927:2009 (E)
Introduction
The 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 elements 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 EU standards in their national 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 influenced by how the service delivery
is managed in terms of staff behaviour and motivation, design and layout of facilities, choice of suppliers and
products. Such management and availability play an important role, but falls outside the scope of this
standard.
4
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oSIST prEN 15927:2009
prEN 15927:2009 (E)
1 Scope
This standard applies to the services offered by hearing aid professionals in their efforts to provide benefit for
their clients.
The standard specifies the process of hearing aid provision from the first client contact to the long term follow-
up. The standard also defines requirements for education, facilities, equipment and code of conduct. A quality
management system with the over-all objective of securing client satisfaction and covering the elements of the
service is also an essential part of the requirements.
The standard centres on the services offered to the majority of clients with hearing impairment. Certain groups
of hearing impaired such as children, persons with other handicaps or persons with cochlear implants may
require services beyond what is covered in this standard.
2 Normative references
The following referenced 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 systems for hearing aid purposes -
Magnetic field strength.
EN 60118-7, Electroacoustics – Hearing aids – Part 7 : Measurement of performance characteristics of
hearing aids for production, supply and delivery quality assurance purposes.
EN 60645-1, Electroacoustics – Audiometric equipment – Part 1 : Pure-tone audiometers.
EN 60645-2, Audiometers – Part 2 : Equipment for speech audiometry.
EN 61669, Electroacoustics – Equipment for the measurement of real-ear acoustical characteristics 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.
EN ISO 389-2, Acoustics – Reference zero for the calibration of audiometric equipment – Part 2 : Reference
equivalent threshold sound pressure levels for pure-tones and insert earphones.
EN ISO 389-3, Acoustics – Reference zero for the calibration of audiometric equipment – Part 3 : Reference
equivalent threshold force levels for pure-tones and bone vibrators.
EN ISO 8253-1, Acoustics – Audiometric test methods – Part 1 : Basic pure-tone air and bone conduction
threshold audiometry.
EN ISO 8253-2, Acoustics – Audiometric test methods – Part 2 : Sound field audiometry with pure-tone and
narrow-band test signals.
EN ISO 8253-3, Acoustics – Audiometric test methods – Part 3 : Speech audiometry.
EN ISO 9000. Quality management systems – Fundamentals and vocabulary.
EN ISO 9001, Quality management systems – Requirements.
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EN ISO 13485, Medical devices – Quality management systems – Requirements for regulatory purposes.
ISO 12124, Acoustics – Procedures for the measurement of 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
an audiologically competent person who professionally assesses hearing, selects, fits and delivers hearing
systems and rehabilitation services to persons with hearing loss
3.2
hearing impaired
a person with hearing loss in one or both ears
3.3
client
a person with a hearing impairment being serviced by a hearing aid professional
3.4
hearing aid
a device designed to amplify and process sounds in order to compensate for a hearing loss based on electro-
acoustic or electro-magnetic systems, placed outside or inside the ear
3.5
ear-mould
an individually customised or selected mechanical-acoustical coupling between a hearing aid and the ear
canal
3.6
hearing system
an integral and customised device consisting of a hearing aid, ear-mould and related components such as a
remote control or interfaces to other information or communication systems
3.7
hearing profile
a comprehensive account for a hearing impaired client's auditory problems, social situation, activity limitations,
needs and expectations
3.8
fitting
a systematic procedure for adapting a hearing system to compensate for hearing loss
3.9
pre-setting
the adjustment of a hearing aid using a prescriptive rule and relevant audiological data
3.10
fine-tuning
the adjustment of the hearing system to best match the needs and preferences of the hearing impaired
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3.11
auditory training
a set of procedures, exercises and tests used to improve a hearing impaired person's auditory performance
3.12
fitting system
a set of devices typically comprising a PC, fitting software and a programming interface used to adjust
hearing aids
3.13
practice unit
a physical location where services are delivered by a hearing aid professional
3.14
rehabilitation
a systematic process for improving hearing abilities through education, training and instruction after hearing
system fitting
4 Service preconditions
In order to provide a high quality service, certain preconditions and applicable national laws and regulations
shall be fulfilled. These essential preconditions fall in four categories :
1) educational requirements specifying the competencies that shall be required to perform the services ;
2) facility requirements specifying how the appropriate environment shall be for the proper delivery of
the services ;
3) equipment requirements specifying what the necessary equipment for performing the services shall
be ;
4) ethical recommendations specifying what the ethical framework and code of conduct should be.
4.1 Educational requirements
This section specifies the competencies required for performing the hearing aid provision processes that are
described in chapter 6 of the service specifications.
The competencies of the persons delivering the service are very important for the quality of the service and
must be rooted in proper education from recognized educational institutions as well as 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 educational background. The overall responsibility of the service provision must rest with a
person having the educational background specified in the following section 4.1.1.
In order to facilitate the acquisition of practical skills practice units may include trainees from educational
programs in their staff. Services performed by trainees shall take place under the close supervision of the
hearing aid professional that remains responsible for the activities.
4.1.1 Requirements for Hearing Aid Professionals
A robust foundation of knowledge and proficiencies 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.
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The hearing aid professionals should actively seek information and training for state-of-the-art hearing and
communication systems and their proper application.
In order to be in compliance with this standard the hearing aid professional shall hold qualifications recognized
by applicable national laws and regulations concerning hearing aid services. The qualifications 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 EQF-level-5 (EU 2008/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 for a sufficient education are outlined in Annex A.
4.1.2 Continued education
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 professional’s working time shall be devoted to continuing
education.
4.2 Facility Requirements
The service units where hearing aid professionals deliver their services may vary considerably with regard to
size, placement and surroundings in accordance with national preferences and legislation. Regardless of
such differences the facilities of the practice unit shall meet standards that ensure proper performance of the
services. In keeping with the service process descriptions in chapter 6 the following service areas shall be
available :
reception area ;
counselling area ;
audiometry area ;
fitting area ;
maintenance area.
The service provider shall ensure that the service is fully accessible to the clients, eg :
it shall be easy to contact the service provider by telephone, telefax and/ or e-mail ;
the access to the practice unit shall be clearly signed ;
public information about contact and opening hours shall be given.
The facilities should be adequately designed for persons with hearing disabilities. This entails that the rooms
should have low reverberation time and good lighting facilitating lip reading.
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4.2.1 Reception
When entering the practice unit a reception desk should be readily available. At the reception clients can
identify themselves to the personnel and be advised about the service options. Often the reception is naturally
coinciding with the desk where sales of consumables and accessories take place. The desk should be
equipped with an induction loop system. A waiting area should be naturally connected with the reception area
and separated from the other service areas.
4.2.2 Counselling Area
A secluded area for counselling of clients shall be available. It shall be separated from the reception/waiting
area in such a way that waiting clients cannot overhear conversations between the hearing professional and
the client.
4.2.3 Audiometry and Fitting areas
Audiometric measurements can only reliably be performed in an area with the correct acoustic properties in
terms of reverberation time and ambient noise level. Hearing threshold levels using headphones shall be
measurable down to 20 dB HL which means that maximum ambient sound levels shall fulfil the requirements
in EN ISO 8253-1. This requirement can be fulfilled by a sound insulating cabin for pure tone audiometric
measurements.
Hearing aid fitting also requires a controlled acoustic environment although the specifications are less
demanding in terms of ambient noise. The fitting area should fulfil the following requirements :
2 3
a minimum surface area of 7 m and a minimum volume of 15 m ;
reverberation time should be less than 0.5 s at 500 Hz ;
an equivalent A-weighted ambient sound pressure level of less than 35 dB ;
no dominant pure-tone components in the background noise.
The fitting area may also be used for pure-tone audiometry if the requirements on ambient noise levels are
met.
For sound field speech audiometry the ambient sound pressure levels in the test room shall not mask the
speech signals. A quasi-free sound field as specified in EN ISO 8253-2 is recommended.
A practice unit can have more than one audiometry and fitting areas.
NOTE Documents with detailed advice on calibration of sound field systems in a fitting area are available from the
HIMSA website, www.himsa.com.
4.2.4 Maintenance area
The maintenance area is intended for service activities on hearing aids and other devices. It should be
separated from the other areas. It should be ensured that activities in the maintenance area do not disturb
(noise, fumes etc) the activities in the audiometry and fitting areas.
4.3 Equipment Requirements
In order to provide high quality services different types of equipment are needed for proper performance of the
service processes and these are characterised in the subsequent sections.
The equipment listed below shall be available as minimum requirement in order to provide the proper services.
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Means for documentation of measurement activity shall be available. Such means can be either paper based
or computerized electronic records with print-out facilities.
4.3.1 Audiometric Equipment
For pure-tone audiometry an audiometer shall be used for testing for of air-conduction as well as bone-
conduction using masking when applicable. The audiometer should be capable of measuring with
headphones as well as insert phones. The audiometer can be part of an integrated system with multiple
functional modes.
The audiometer shall be a pure-tone audiometer type 1 or 2 fulfilling the requirements of EN 60645-1. The
performance of this equipment shall be checked and calibrated according to EN ISO 8253-1 and relevant
parts of EN ISO 389.
For speech audiometry equipment fulfilling the requirements of EN 60645-2 shall be available including power
amplifier and loudspeaker. The performance of this equipment shall be checked and calibrated according to
EN ISO 8253-3.
The maximum interval between objective periodical checks of the audiometric equipment shall not exceed
12 months. If national legislation calls for more frequent, safety related checks these shall be applied.
4.3.2 Equipment for Otoscopy and ear-mould impressions
For examination of the ear-canal and tympanic membrane otoscopic equipment shall be available. Equipment
for taking ear-mould impression shall also be available :
otoscope with ear specula of different sizes ;
moulding syringes or moulding gun with suitable compounds for making ear-mould impressions ;
eardrum protectors ;
hygiene products for hands and equipment.
4.3.3 Hearing Aid programming equipment
A computer system with suitable hardware and software for hearing aid programming and storing of relevant
client and fitting data shall be available.
4.3.4 Electro-acoustic measurement equipment
The following equipment should be available :
equipment for the measurement of real-ear acoustical characteristics of hearing aids fulfilling the
requirements according to EN 61669 ;
electro-acoustic equipment for measuring hearing aid characteristics on acoustic coupler or ear simulator
(gain, output level, distortion, induction pick-up coil sensitivity etc.) in accordance EN 60118-7 ;
the maximum interval between calibrations of such electro-acoustic equipment should not exceed 12
months ;
a class 1 or 2 sound level meter according to EN 61672-1 should also be available.
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4.3.5 Maintenance tools
For maintenance of hearing aids the following equipment should be available :
rotary polisher for ear-mould adjustments ;
tool for drilling and trimming of tube ends ;
ultrasonic bath ;
set of screwdrivers and pliers ;
stethoscopic listening device ;
binocular magnifying glass or illuminated magnifying glass ;
vacuum pump; Compressor or aerosol.
4.3.6 Demonstration tools
For demonstration of products a selection of hearing aids and accessories shall be available. Other
rehabilitation devices should also be available.
An induction loop system with magnetic field in accordance EN 60118-7:2006 shall be available for
demonstration of hearing aids with induction pick-up coil.
4.4 Ethical Requirements and Code of Practice
The services offered by hearing aid professionals are highly important to the clients receiving the services. It is
therefore imperative that every activity is provided with the goal of achieving the best possible solution for the
client. Hearing aid professionals should exercise their profession for the purpose of seeking to assist hearing
impaired persons providing solutions which best provides which best provide for the subject’s needs and
preferences, eg, communication.
The services offered by hearing aid professionals involve relationships to other service providers and the
proper relationship to these other stakeholders are also important for the total service provided to the hearing
impaired clients.
4.4.1 Relationship with Clients
Hearing aid professionals should always bear in mind that their role is to use their knowledge and skills for the
benefit of hearing impaired persons.
In their relations with clients, the hearing aid professional should be discreet and tactful, and sensitive to
clients’ psychological needs. The hearing aid professional should on all occasions be cautious, calm and
understanding. Clients’ confidence in their hearing aid professional is an essential requirement of the
profession. In their relations with clients, the hearing aid professional should make sure that their comments
have been well received and understood.
The hearing aid professional should extend their service to the clients until optimal rehabilitation has been
achieved. The hearing aid professional should provide all the information necessary for the correct use and
maintenance of the hearing aid and should give the client the instructions that are essential to ensure the
continued efficacy of the device.
The hearing aid professional should not attract or try to attract clients by means of gifts or other incentives
unrelated to the service, either directly or indirectly through third parties.
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Where necessary and possible, the hearing aid professional should suggest that clients receive additional
support that falls outside the scope of the services provided by hearing aid professionals to enable multi-
disciplinary care. The client should be able to freely choose any other service professional as wished.
Hearing aid professionals should provide contact details for relevant client organisations for hearing impaired.
4.4.2 Relationship with Physicians
The hearing aid professional is aware that communication and hearing problems can be caused by medical
conditions that require proper medical treatment. Such medical treatment falls outside the scope of the
services offered by hearing aid professionals.
The hearing aid professional should never attempt in any way to replace a medical service provider. Under
circumstances where the client has not previously sought medical assessment of the hearing problem, the
hearing aid professional should advise the hearing impaired person seeking his services to consult a
physician. This can lead to situations where multiple service providers in concert are offering multi-disciplinary
care. The hearing aid professional should undertake to make available to the physician and other involved
service providers all necessary and relevant documentation with the consent of client.
The hearing aid professional should refrain from any action that infringes the ethics of the profession. This
includes collusion with physicians or other third party health care professionals resulting in unfair trading.
4.4.3 Relationship with Colleagues
A hearing aid professional should refrain from unjustifiable criticism of colleague’s judgement, training,
knowledge or skills. A hearing aid professional should not knowingly ignore professional misconduct or
incompetence.
4.4.4 Advertising
A hearing aid professional who wishes to advertise his services should of course do so. It is important that
points of service are easily found by those in need of the services.
Such advertising shall be in compliance with the provisions of EU directive (reference to be added) and
applicable national legislation.
5 Hearing aid provision process
Hearing aid provision covers assessment of the client 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 aids depends on the type of device chosen, its fitting, the counseling
and the follow-up.
During the entire fitting process many decisions must be taken in a close dialogue with the client. The
availability of the proper facilities and equipment is important for a successful hearing aid provision process.
The hearing aid professional should pay particular attention to clients with no previous experience in using
hearing aids.
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5.1 Client contact and registration
When the client is met at the reception area it can either be by appointment or a spontaneous visit. If the
client is scheduled for a hearing aid fitting the pertinent demographic data shall be recorded.
The process flow of hearing aid provision shall be explained thoroughly to the client including the financial
implications. Annex B gives a comprehensive account for the information that can be given to the client.
The names and qualification of all the staff operating in practice unit shall be readily identifiable, e.g. by a
badge.
5.2 Hearing Profile determination
The hearing aid professional shall do a hearing profile determination that establishes an account for the
client's auditory problems, social situation, activity limitations, needs and expectations. The assessment shall
also include contributing factors such as visual acuity and dexterity. The following conditions shall be
considered for the hearing profile and properly documented :
type, degree and history of the hearing impairment ;
communication and hearing disabilities, social consequences ;
relevant living conditions, hearing expectations and individual hearing situations ;
relevant medical history including allergies and medication ;
motor skill impairments ;
tinnitus, dizziness and hyperacusis ;
previous hearing aid use.
The hearing profile should use the terminology of ICF to define the degree of hearing impairment.
NOTE It is recommended to use validated questionnaires for the recording of these factors.
5.3 Audiological Assessment
An audiological assessment shall be made as an essential basis for the selection of suitable hearing aids for
the individual client. All test results of the audiological assessment shall be recorded in the client file. The
sections below specify the elements of the audiological assessment.
5.3.1 Otoscopy
Otoscopy shall be carried out with examination of the external ear canal, eardrum and also pinna and area
behind the ear.
5.3.2 Pure-tone Audiometry
Pure-tone audiometry shall be carried out according to the procedure described in EN ISO 8253-1.
Hearing thresholds (with masking if necessary) shall be determined at least at the following frequencies :
air conduction : 500, 1000, 2000, 3000, 4000, 6000 an
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