EN ISO 21388-2:2024

Acoustics - Hearing Aid Fitting Management - Part 2: Tele-services as part of hearing aid fitting management (tHAFM) (ISO 21388-2:2024)

This document is a supplement to ISO 21388 which applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP). It focusses on tele-services which can substitute, or complement services defined in ISO 21388, and it defines services which is provided in the facilities of the HAP.
Moreover, this document specifies important preconditions such as education, facilities and systems that are required to ensure proper tele-services. If not other stated all definitions and requirements of ISO 21388 also apply for this document without further notice. Furthermore, it is tried to keep the structure of ISO 21388 to make it easier to use both standards together. It is recognized that certain populations with hearing loss such as children, persons with other disabilities or persons with implantable devices can require services outside the scope of this document.
Assisted tele-services provided by non-hearing aid professionals, self-fitting, and other non-hearing care related services are also outside the scope of this document.

Akustik - Hörgeräteanpassungsmanagement - Teil 2: Teledienste als Teil des Hörgeräteanpassungsmanagements (tHAFM) (ISO 21388-2:2024)

Acoustique - Processus d'adaptation des aides auditives - Partie 2: Télé-services dans le cadre du processus d'adaptation des aides auditives (ISO 21388-2:2024)

Le présent document est un supplément à l’ISO 21388 qui s’applique aux services offerts par les audioprothésistes dans le cadre du processus d’adaptation des aides auditives. Il se focalise sur les télé-services qui peuvent remplacer ou compléter les services définis dans l’ISO 21388, et il définit les services qui sont fournis dans le cabinet de l’audioprothésiste.
Le présent document spécifie également les conditions préalables importantes telles que la formation, les installations et les systèmes qui sont exigés pour assurer des télé-services appropriés. Sauf indication contraire, toutes les définitions et exigences de l’ISO 21388 s’appliquent aussi au présent document sans autre préavis. En outre, la structure de l’ISO 21388 a été conservée dans la mesure du possible pour faciliter l’utilisation conjointe de ces deux normes. Il est reconnu que certaines populations de déficients auditifs, comme les enfants, les personnes souffrant d’autres handicaps ou les personnes porteuses d’implants, peuvent nécessiter d’autres services que ceux couverts par le domaine d’application du présent document.
Les télé-services assistés fournis par des personnes qui ne sont pas des audioprothésistes, l’auto-appareillage et d’autres services sans lien avec les soins auditifs sont également hors du domaine d’application du présent document.

Akustika - Vodenje ustreznosti slušnih pripomočkov - 2. del: Tele-storitve kot del vodenja ustreznosti slušnih pripomočkov (tHAFM) (ISO 21388-2:2024)

General Information

• Status: Published
• Publication Date: 21-May-2024
• ICS: 11.020.10 - Health care services in general
• ICS: 11.180.15 - Aids for deaf and hearing impaired people
• ICS: 17.140.01 - Acoustic measurements and noise abatement in general
• Technical Committee: CEN/TC 211 - Acuostics
• Drafting Committee: CEN/TC 211 - Acuostics
• Current Stage: 6060 - Definitive text made available (DAV) - Publishing
• Start Date: 22-May-2024
• Due Date: 17-May-2026
• Completion Date: 22-May-2024
• Ref Project: SIST EN ISO 21388-2:2024 - Acoustics - Hearing Aid Fitting Management - Part 2: Tele-services as part of hearing aid fitting management (tHAFM) (ISO 21388-2:2024)

Standards Content (Sample)

SLOVENSKI STANDARD
01-julij-2024
Akustika - Vodenje ustreznosti slušnih pripomočkov - 2. del: Tele-storitve kot del
vodenja ustreznosti slušnih pripomočkov (tHAFM) (ISO 21388-2:2024)
Acoustics - Hearing Aid Fitting Management - Part 2: Tele-services as part of hearing aid
fitting management (tHAFM) (ISO 21388-2:2024)
Akustik - Hörgeräteanpassungsmanagement - Teil 2: Teledienste als Teil des
Hörgeräteanpassungsmanagements (tHAFM) (ISO 21388-2:2024)
Acoustique - Processus d'adaptation des aides auditives - Partie 2: Télé-services dans le
cadre du processus d'adaptation des aides auditives (ISO 21388-2:2024)
Ta slovenski standard je istoveten z: EN ISO 21388-2:2024
ICS:
11.020.10 Zdravstvene storitve na Health care services in
splošno general
11.180.15 Pripomočki za gluhe osebe in Aids for deaf and hearing
osebe z okvaro sluha impaired people
17.140.01 Akustična merjenja in Acoustic measurements and
blaženje hrupa na splošno noise abatement in general
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 21388-2
EUROPEAN STANDARD
NORME EUROPÉENNE
May 2024
EUROPÄISCHE NORM
ICS 17.140.01; 11.180.15; 11.020.10
English Version
Acoustics - Hearing Aid Fitting Management - Part 2: Tele-
services as part of hearing aid fitting management
(tHAFM) (ISO 21388-2:2024)
Acoustique - Processus d'adaptation des aides Akustik - Hörgeräteanpassungsmanagement - Teil 2:
auditives - Partie 2: Télé-services dans le cadre du Teledienste als Teil des
processus d'adaptation des aides auditives (ISO 21388- Hörgeräteanpassungsmanagements (tHAFM) (ISO
2:2024) 21388-2:2024)
This European Standard was approved by CEN on 12 May 2024.

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-CENELEC 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-CENELEC 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, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2024 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21388-2:2024 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 21388-2:2024) has been prepared by Technical Committee ISO/TC 43
"Acoustics" in collaboration with Technical Committee CEN/TC 211 “Acoustics” the secretariat of which
is held by DIN.
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 November 2024, and conflicting national standards
shall be withdrawn at the latest by November 2024.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national standards
body/national committee. A complete listing of these bodies can be found on the CEN website.
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, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Türkiye and the
United Kingdom.
Endorsement notice
The text of ISO 21388-2:2024 has been approved by CEN as EN ISO 21388-2:2024 without any
modification.
International
Standard
ISO 21388-2
First edition
Acoustics — Hearing aid fitting
2024-05
management —
Part 2:
Tele-services as part of hearing aid
fitting management (tHAFM)
Acoustique — Processus d'adaptation des aides auditives —
Partie 2: Télé-services dans le cadre du processus d'adaptation
des aides auditives
Reference number
ISO 21388-2:2024(en) © ISO 2024

ISO 21388-2:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: [phone]
Email: [e-mail]
Website: www.iso.org
Published in Switzerland
ii
ISO 21388-2:2024(en)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2  Normative references . 1
3  Terms and definitions . 1
4 Service preconditions . 2
4.1 General .2
4.2 Educational requirements for HAPs providing tele-services as part of hearing aid
fitting management (HAFM)) .3
4.3 Facility requirements (for tele-services) .4
4.3.1 General .4
4.3.2 Guidelines for client facilities .4
4.4 Equipment requirements .4
4.4.1 General .4
4.4.2 Guidelines for safety and quality .5
4.4.3 Guidelines for service support .5
4.4.4 Guidelines for service delivery .6
4.4.5 Guidelines for infrastructure management .6
4.4.6 Guidelines for deployment management .6
4.4.7 Guidelines for operations management .7
4.4.8 Guidelines for technical support .7
4.4.9 Guidelines for device management .7
4.5 Ethical requirements .8
5  Tele-services as part of the general stages of HAFM . 8
5.1 General .8
5.2 Client candidacy and profile .9
5.3 Counselling.10
5.4 Hearing aid fitting .10
5.5 Verification and validation .10
5.6 Post-fitting counselling .10
5.7 Follow-up .11
6 Quality of service .11
Bibliography .12

iii
ISO 21388-2:2024(en)
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 document should be noted. This document was drafted in accordance with the editorial rules of the
ISO/IEC Directives, Part 2 (see www.iso.org/directives).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the lat
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