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 may substitute,
or complement services defined in ISO 21388, and it defines services which shall be 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 standard without further notice. Furthermore, it is
tried to keep the structure if 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.
Other assisted tele-services provided by non-hearing aid professionals, self-fitting, and other nonhearing
care related will also be outside of the scope.

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
Public Enquiry End Date
14-Nov-2023
Publication Date
09-Jun-2024
Technical Committee
Current Stage
6060 - National Implementation/Publication (Adopted Project)
Start Date
29-May-2024
Due Date
03-Aug-2024
Completion Date
10-Jun-2024

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SLOVENSKI STANDARD
SIST EN ISO 21388-2:2024
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
SIST EN ISO 21388-2:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 21388-2:2024

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SIST EN ISO 21388-2:2024


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.

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SIST EN ISO 21388-2:2024
EN ISO 21388-2:2024 (E)
Contents Page
European foreword . 3

2

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SIST EN ISO 21388-2:2024
EN ISO 21388-2:2024 (E)
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, M
...

SLOVENSKI STANDARD
oSIST prEN ISO 21388-2:2023
01-november-2023
Akustika - Vodenje ustreznosti slušnih pripomočkov - 2. del: Tele-storitve kot del
vodenje ustreznosti slušnih pripomočkov (tHAFM) (ISO/DIS 21388-2:2023)
Acoustics - Hearing Aid Fitting Management - Part 2: Tele-services as part of hearing aid
fitting management (tHAFM) (ISO/DIS 21388-2:2023)
Akustik - Hörgeräteanpassungsmanagement - Teil 2: Teledienste als Teil des
Hörgeräteanpassungsmanagements (tHAFM) (ISO/DIS 21388-2:2023)
Acoustique - Gestion de l’appareillage auditif - Partie 2: Téléservices dans le cadre de la
gestion des ajustements auditifs (tHAFM) (ISO/DIS 21388-2:2023)
Ta slovenski standard je istoveten z: prEN ISO 21388-2
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
oSIST prEN ISO 21388-2:2023 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 21388-2:2023

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oSIST prEN ISO 21388-2:2023
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21388-2
ISO/TC 43 Secretariat: DIN
Voting begins on: Voting terminates on:
2023-08-07 2023-10-30
Acoustics — Hearing Aid Fitting Management —
Part 2:
Tele-services as part of hearing aid fitting management
(tHAFM)
ICS: 11.020.10; 17.140.01; 11.180.15
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
NOT BE REFERRED TO AS AN INTERNATIONAL
STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
Reference number
NATIONAL REGULATIONS.
ISO/DIS 21388-2:2023(E)
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. © ISO 2023

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oSIST prEN ISO 21388-2:2023
ISO/DIS 21388-2:2023(E)
DRAFT INTERNATIONAL STANDARD
ISO/DIS 21388-2
ISO/TC 43 Secretariat: DIN
Voting begins on: Voting terminates on:

Acoustics — Hearing Aid Fitting Management —
Part 2:
Tele-services as part of hearing aid fitting management
(tHAFM)
ICS: 11.020.10; 17.140.01; 11.180.15
COPYRIGHT PROTECTED DOCUMENT
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENT AND APPROVAL. IT IS
© ISO 2023
THEREFORE SUBJECT TO CHANGE AND MAY
This document is circulated as received from the committee secretariat.
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
NOT BE REFERRED TO AS AN INTERNATIONAL
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on STANDARD UNTIL PUBLISHED AS SUCH.
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
IN ADDITION TO THEIR EVALUATION AS
or ISO’s member body in the country of the requester. BEING ACCEPTABLE FOR INDUSTRIAL,
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NATIONAL REGULATIONS.
Website: www.iso.org ISO/DIS 21388-2:2023(E)
RECIPIENTS OF THIS DRAFT ARE INVITED
Published in Switzerland
TO SUBMIT, WITH THEIR COMMENTS,
NOTIFICATION OF ANY RELEVANT PATENT
RIGHTS OF WHICH THEY ARE AWARE AND TO
ii
  © ISO 2023 – All rights reserved
PROVIDE SUPPORTING DOCUMENTATION. © ISO 2023

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oSIST prEN ISO 21388-2:2023
ISO/DIS 21388-2:2023(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope .
...

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