Acoustics - Hearing aid fitting management (HAFM) (ISO 21388:2020)

This document applies to hearing aid fitting management (HAFM) services offered by hearing aid professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate service in the interest of the client with hearing loss.
This document specifies general processes of HAFM from the client profile to the follow-up through administering, organising and controlling hearing aid fitting through all stages. It also specifies important preconditions such as education, facilities and systems that are required to ensure proper services.
The focus of this document is the services offered to the majority of adult clients with hearing impairment. 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. This document generally applies to air conduction hearing aids and for the most part also to bone conduction devices.
Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation without prior medical examination, hearing aid professionals are expected to be observant of symptoms of such conditions and refer to proper medical care.
Further to the main body of the document, which specifies the HAFM requirements and processes, several informative annexes are provided. Appropriate education of hearing aid professionals is vital for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other specialist examination and treatment. Annex E is a recommendation for important information to be exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list offering definitions of the most current terms related to HAFM.
It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.

Akustik - Hörsystemanpassungsmanagement (HAFM) (ISO 21388:2020)

Dieses Dokument ist anwendbar für Dienstleistungen des Hörsystemanpassungsmanagements (HAFM), die von Hörakustikern (HAP, en: hearing aid professionals) angeboten werden, wenn sie Leistungen für ihre Kunden erbringen. Die Versorgung mit Hörgeräten beruht auf den praktischen Erfahrungen des Hörakustikers, um eine angemessene Anpassung und einen adäquaten Service im Interesse des Kunden mit Hörverlust sicherzustellen.
Dieses Dokument legt allgemeine Prozesse des HAFM von der Erstellung des Kundenprofils bis hin zur Nachsorge durch die Administration, Organisation und Kontrolle der Hörsystemanpassung über alle Stufen fest. Es legt darüber hinaus wichtige Voraussetzungen, wie z. B. die zur vorschriftsmäßigen Bereitstellung der betreffenden Dienste erforderlichen Ausbildungen, Einrichtungen und Anlagen, fest.
Dieses Dokument konzentriert sich auf die für die Mehrheit an erwachsenen Kunden mit eingeschränktem Hörvermögen angebotenen Dienstleistungen. Es bleibt anzumerken, dass für bestimmte Gruppen von Menschen mit Hörverlust, wie z. B. Kinder, Personen mit anderen Behinderungen oder Personen mit implantierbaren Systemen, Dienste erforderlich sein können, die außerhalb des Anwendungsbereichs dieses Dokuments liegen. Dieses Dokument gilt im Allgemeinen für Luftleitungshörgeräte und größtenteils auch für Knochenleitungshörgeräte.
Ein Hörverlust kann die Folge ernstzunehmender Krankheiten sein. Hörakustiker sind nicht dafür zuständig, derartige Krankheiten zu diagnostizieren oder zu behandeln. Wenn Hörakustiker Kunden betreuen, die die Rehabilitation ihres Hörvermögens wünschen, ohne sich vorher medizinisch untersuchen zu lassen, müssen sie auf Symptome derartiger Krankheiten achten und auf angemessene ärztliche Betreuung verweisen.
In Ergänzung zum Hauptteil dieses Dokuments, der die Anforderungen an das HAFM und die HAFM-Prozesse festlegt, enthält es mehrere informative Anhänge. Um das HAFM ausführen zu können, ist eine entsprechende Ausbildung zum Hörakustiker unerlässlich. Anhang A legt die für die HAFM-Prozesse erforderlichen Kompetenzen fest. Anhang B enthält die für die Ausbildung von Hörakustikern empfohlenen Lehrinhalte. Anhang C enthält ein Beispiel für einen geeigneten Anpassungsraum. Anhang D enthält einen Leitfaden für den Verweis von Kunden an einen Arzt oder an sonstige Spezialisten zwecks entsprechender Untersuchung und Behandlung. Anhang E enthält Empfehlungen zu wichtigen, mit dem Kunden im Verlauf des HAFM auszutauschenden Informationen. Anhang F enthält eine umfassende Liste der maßgeblichen Terminologie mit Definitionen der meisten gegenwärtig im Zusammenhang mit HAFM verwendeten Begriffe.
Diese Anhänge sollen Personen dabei unterstützen, ein HAFM mit höchster Qualität zu etablieren.

Acoustique - Processus d'adaptation des aides auditives (ISO 21388:2020)

Akustika - Vodenje ustreznosti slušnih pripomočkov (ISO 21388:2020)

General Information

Status
Published
Technical Committee
Drafting Committee
Current Stage
6060 - Definitive text made available (DAV) - Publishing
Due Date
21-Jul-2021
Completion Date
21-Jul-2021

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SLOVENSKI STANDARD
SIST EN ISO 21388:2021
01-september-2021
Nadomešča:
SIST EN 15927:2010
Akustika - Vodenje ustreznosti slušnih pripomočkov (ISO 21388:2020)
Acoustics - Hearing aid fitting management (HAFM) (ISO 21388:2020)
Akustik - Hörgeräteanpassungsmanagement (HAFM) (ISO 21388:2020)
Acoustique - Gestion des appareils de correction auditive (ISO 21388:2020)
Ta slovenski standard je istoveten z: EN ISO 21388:2021
ICS:
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 21388:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
SIST EN ISO 21388:2021
---------------------- Page: 2 ----------------------
SIST EN ISO 21388:2021
EN ISO 21388
EUROPEAN STANDARD
NORME EUROPÉENNE
July 2021
EUROPÄISCHE NORM
ICS 17.140.01; 11.180.15; 11.020.10 Supersedes EN 15927:2010
English Version
Acoustics - Hearing aid fitting management (HAFM) (ISO
21388:2020)

Acoustique - Gestion des appareils de correction Akustik - Hörgeräteanpassungsmanagement (HAFM)

auditive (ISO 21388:2020) (ISO 21388:2020)
This European Standard was approved by CEN on 11 July 2021.

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, Turkey 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

© 2021 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 21388:2021 E

worldwide for CEN national Members.
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SIST EN ISO 21388:2021
EN ISO 21388:2021 (E)
Contents Page

European foreword ....................................................................................................................................................... 3

---------------------- Page: 4 ----------------------
SIST EN ISO 21388:2021
EN ISO 21388:2021 (E)
European foreword

The text of ISO 21388:2020 has been prepared by Technical Committee ISO/TC 43 "Acoustics” of the

International Organization for Standardization (ISO) and has been taken over as EN ISO 21388:2021 by

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 January 2022, and conflicting national standards shall

be withdrawn at the latest by January 2022.

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.

This document supersedes EN 15927:2010.

Any feedback and questions on this document should be directed to the users’ national standards body.

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, Turkey and the

United Kingdom.
Endorsement notice

The text of ISO 21388:2020 has been approved by CEN as EN ISO 21388:2021 without any modification.

---------------------- Page: 5 ----------------------
SIST EN ISO 21388:2021
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SIST EN ISO 21388:2021
INTERNATIONAL ISO
STANDARD 21388
First edition
2020-03
Acoustics — Hearing aid fitting
management (HAFM)
Acoustique — Gestion des appareils de correction auditive
Reference number
ISO 21388:2020(E)
ISO 2020
---------------------- Page: 7 ----------------------
SIST EN ISO 21388:2021
ISO 21388:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 8 ----------------------
SIST EN ISO 21388:2021
ISO 21388:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3  Terms and definitions ..................................................................................................................................................................................... 2

4 Service preconditions...................................................................................................................................................................................... 4

4.1 General ........................................................................................................................................................................................................... 4

4.2 Educational requirements ............................................................................................................................................................. 4

4.2.1 General...................................................................................................................................................................................... 4

4.2.2 Requirements for hearing aid professionals ............................................................................................ 4

4.2.3 Maintenence of competencies and skills of hearing aid professionals ............................. 5

4.3 Facility requirements ........................................................................................................................................................................ 5

4.3.1 General...................................................................................................................................................................................... 5

4.3.2 Room requirements ...................................................................................................................................................... 5

4.4 Equipment requirements ............................................................................................................................................................... 5

4.4.1 General...................................................................................................................................................................................... 5

4.4.2 Audiometric equipment ........................................................................................................................................... .. 6

4.4.3 Equipment for otoscopy and earmould impressions ....................................................................... 6

4.4.4 Hearing aid programming equipment........................................................................................................... 6

4.4.5 Electroacoustic measurement equipment ................................................................................................. 6

4.4.6 Maintenance tools ........................................................................................................................................................... 6

4.4.7 Demonstration samples ............................................................................................................................................. 7

4.5 Ethical requirements ......................................................................................................................................................................... 7

4.5.1 General...................................................................................................................................................................................... 7

4.5.2 Professional competence .......................................................................................................................................... 7

4.5.3 Relationship with clients .......................................................................................................................................... 7

4.5.4 Conflict of interest .......................................................................................................................................................... 7

4.5.5 Relationship with medical and other health practitioners ......................................................... 7

4.5.6 Relationship with colleagues ................................................................................................................................ 8

4.5.7 Advertising ............................................................................................................................................................................ 8

5 General stages of HAFM ................................................................................................................................................................................. 8

5.1 General ........................................................................................................................................................................................................... 8

5.2 Client profile .............................................................................................................................................................................................. 9

5.2.1 General...................................................................................................................................................................................... 9

5.2.2 General assessment ....................................................................................................................................................... 9

5.2.3 Audiological assessment ........................................................................................................................................10

5.2.4 Medical referral ..............................................................................................................................................................11

5.3 Counselling ..............................................................................................................................................................................................11

5.3.1 General...................................................................................................................................................................................11

5.3.2 Selection of hearing aid system ........................................................................................................................11

5.4 Hearing aid fitting .............................................................................................................................................................................11

5.4.1 Ear coupling elements ........................................................................................................................................... ...11

5.4.2 Pre-setting of hearing aids ...................................................................................................................................12

5.4.3 Setting and fine-tuning of hearing aids .....................................................................................................12

5.5 Verification and validation .........................................................................................................................................................12

5.6 Post-fitting counselling .................................................................................................................................................................13

5.7 Follow-up ..................................................................................................................................................................................................13

6 Quality of service ...............................................................................................................................................................................................14

6.1 General ........................................................................................................................................................................................................14

6.2 Documentation ....................................................................................................................................................................................14

6.3 Client evaluation of services .....................................................................................................................................................15

6.4 Customer complaint handling ................................................................................................................................................15

© ISO 2020 – All rights reserved iii
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SIST EN ISO 21388:2021
ISO 21388:2020(E)

6.5 Corrective actions ..............................................................................................................................................................................15

Annex A (informative) Minimum competencies of the hearing aid professional (HAP) .............................16

Annex B (informative) Recommendation for organisation of education and training for

hearing aid professionals (ISCED level 5) ...............................................................................................................................19

Annex C (informative) Fitting room example ...........................................................................................................................................21

Annex D (informative) Recommendation on the referral of clients for medical

or other specialist examination and treatment ................................................................................................................23

Annex E (informative) Informational counselling to support hearing aid fitting management .........24

Annex F (informative) Terminology ...................................................................................................................................................................27

Bibliography .............................................................................................................................................................................................................................41

iv © ISO 2020 – All rights reserved
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SIST EN ISO 21388:2021
ISO 21388:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 43, Acoustics.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
© ISO 2020 – All rights reserved v
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SIST EN ISO 21388:2021
ISO 21388:2020(E)
Introduction

The World Health Organisation (WHO) estimates that there are 360 million people with hearing

[22]

impairment, approximately 5,3 % of the world population . Hearing aids (HAs) are one of the

[39][40]

most widely-used treatment options for people with a hearing loss . For the proper use of HAs,

hearing aid fitting management (HAFM) is a crucial issue for manufacturers, practitioners, hearing

[39][42][43]

aid professionals and especially for HA users . Individually optimized outcome of HA use is

[42]

supported by comprehensive HA fitting protocols and the impact of “poor fit and comfort” can lead

[43]

to non-compliance, HA return and additional hearing loss with over-amplification. Accordingly, the

whole process of HA fitting should be optimized to achieve functional benefits, user satisfaction and

cost-effectiveness.

Two observations are important to take into account when developing an HAFM standard. Firstly,

[16][44]–[46]

the term "hearing aid fitting" is widely used among service providers and industry sectors.

Secondly, it has potentially conflicting interpretations: while guidelines for HA fitting have been

[17][18][23]–[32][34]–[37][47][48]
written to tackle these issues by various national and professional bodies ,

many jurisdictions are still not covered worldwide and there is a need to promote a more common

understanding of the HA fitting process. It is likely that different understanding of fitting has led to

non-uniform care, outcome variability and, in many cases, dissatisfaction with the use of HAs.

The main purpose of this document is thus to provide a general framework for HAFM including the

pre- and post-fitting stages to make it more explicit and transparent so that all related tasks, including

professional services, administration and financial aspects can be systematized. The overall objective

is to achieve the best possible hearing rehabilitation, which can only be accomplished through adequate

knowledge, training and skills of the professional and a systematic approach to HA fitting in close

collaboration with the client. The general framework of HAFM in this document is divided into six

stages (client profile, counselling, hearing aid fitting, verification and validation, post-fitting counseling,

and follow-up) based on the common practices of hearing aid professionals, and as recommended by

various pre-existing guidelines.

By dividing the hearing aid fitting process into stages, HAFM service providers can systematically

identify and administer the service components needed for high service quality, user satisfaction,

client-centered services, client self-efficacy and compliance rates with HAs (e.g. consistently using

HAs and attending follow-up appointments). The stages focus on the components of the framework to

achieve high rehabilitation outcomes such as communication skills, speech intelligibility, perception of

the acoustic environment, comfort for the HA users and sound quality. In addition, this document can

be a basis for making cost assessments for each stage or component, which can help improve public

health funding systems. Another possible application is to use this document as a minimum basis for

the development of professional training programs in HAFM.
vi © ISO 2020 – All rights reserved
---------------------- Page: 12 ----------------------
SIST EN ISO 21388:2021
INTERNATIONAL STANDARD ISO 21388:2020(E)
Acoustics — Hearing aid fitting management (HAFM)
1 Scope

This document applies to hearing aid fitting management (HAFM) services offered by hearing aid

professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on

the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate

service in the interest of the client with hearing loss.

This document specifies general processes of HAFM from the client profile to the follow-up through

administering, organising and controlling hearing aid fitting through all stages. It also specifies

important preconditions such as education, facilities and systems that are required to ensure proper

services.

The focus of this document is the services offered to the majority of adult clients with hearing

impairment. 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. This document generally applies to air conduction hearing aids and for the most part also to

bone conduction devices.

Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in

a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation

without prior medical examination, hearing aid professionals are expected to be observant of symptoms

of such conditions and refer to proper medical care.

Further to the main body of the document, which specifies the HAFM requirements and processes,

several informative annexes are provided. Appropriate education of hearing aid professionals is vital

for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B

offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example

of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other

specialist examination and treatment. Annex E is a recommendation for important information to be

exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list

offering definitions of the most current terms related to HAFM.

It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 8253-1, Acoustics — Audiometric test methods — Part 1: Pure-tone air and bone conduction audiometry

ISO 8253-2, Acoustics — Audiometric test methods — Part 2: Sound field audiometry with pure-tone and

narrow-band test signals
ISO 8253-3, Acoustics — Audiometric test methods — Part 3: Speech audiometry

IEC 60118-7, Electroacoustics — Hearing aids — Part 7: Measurement of the performance characteristics

of hearing aids for production, supply and delivery quality assurance purposes

IEC 60645-1:2017, Electroacoustics — Audiometric equipment — Part 1: Equipment for pure-tone and

speech audiometry
© ISO 2020 – All rights reserved 1
---------------------- Page: 13 ----------------------
SIST EN ISO 21388:2021
ISO 21388:2020(E)

IEC 60645-5, Electroacoustics — Audiometric equipment — Part 5: Instruments for the measurement of

aural acoustic impedance/admittance

IEC 61669, Electroacoustics — Measurement of real-ear acoustic performance characteristics of hearing aids

International Standard Classification of Education, ISCED. United Nations Educational, Scientific

and Cutural Oganization, 2011, ISBN 978-92-9189-123-8, http:// uis .unesco .org/ sites/ default/ files/

documents/ international -standard -classification -of -education -isced -2011 -en .pdf

3  Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
auditory dynamic range

difference between the hearing (3.7) threshold and the uncomfortable loudness level (UCL)

3.2
client
person with hearing loss (3.8) being serviced by a HAP (3.13)
3.3
client profile

comprehensive record of a client's (3.2) auditory functionality, social situation, activity opportunities,

needs and expectations as well as a client’s audiological and medical history
3.4
ear impression

representation of the three-dimensional geometry of the relevant part of the concha and ear canal

3.5
fine-tuning

adjustment of the hearing aid system (3.10) to best match the needs and preferences of the client (3.2)

3.6
fitting system

set of devices typically comprising a computer, fitting software and a programming interface used to

adjust hearing aids (3.9)
3.7
hearing

manner in which a person detects, discriminates, identifies and cognitively processes sounds

3.8
hearing loss
reduction of the hearing (3.7) ability
3.9
hearing aid

wearable electroacoustic instrument intended to process sounds in order to compensate for hearing

loss (3.8)

Note 1 to entry: Hearing aids are medical devices and comply with the requirements of IEC 60601-2-66.

2 © ISO 2020 – All rights reserved
---------------------- Page: 14 ----------------------
SIST EN ISO 21388:2021
ISO 21388:2020(E)
3.10
hearing aid system

customized structure consisting of one or two hearing aids (3.9), earmoulds and related components

such as a remote control or interfaces to other information or communication systems

3.11
hearing aid fitting

systematic procedure for individualizing and optimizing a hearing aid system (3.10) to compensate for

hearing loss (3.8)
3.12
hearing aid fitting management
HAFM

systematic process to administer, organise and control hearing aid fitting (3.11) through all stages

3.13
hearing aid professional
HAP

person who is appropriately trained and has proven competency in professionally assessing hearing,

selecting, fitting and delivering hearing aid systems (3.10) and rehabilitation services to persons with

hearing loss (3.8)
3.14
hearing rehabilitation

systematic process for improving functional hearing abilities and communication skills through hearing

aid fitting (3.11), counselling, instruction, education, training and developing listening

...

SLOVENSKI STANDARD
oSIST prEN ISO 21388:2021
01-julij-2021
Akustika - Vodenje ustreznosti slušnih pripomočkov(ISO 21388:2020)
Acoustics - Hearing aid fitting management (HAFM) (ISO 21388:2020)
Acoustique - Gestion des appareils de correction auditive (ISO 21388:2020)
Ta slovenski standard je istoveten z: prEN ISO 21388
ICS:
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 21388:2021 en,fr,de

2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

---------------------- Page: 1 ----------------------
oSIST prEN ISO 21388:2021
---------------------- Page: 2 ----------------------
oSIST prEN ISO 21388:2021
INTERNATIONAL ISO
STANDARD 21388
First edition
2020-03
Acoustics — Hearing aid fitting
management (HAFM)
Acoustique — Gestion des appareils de correction auditive
Reference number
ISO 21388:2020(E)
ISO 2020
---------------------- Page: 3 ----------------------
oSIST prEN ISO 21388:2021
ISO 21388:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020

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: +41 22 749 01 11
Fax: +41 22 749 09 47
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
ii © ISO 2020 – All rights reserved
---------------------- Page: 4 ----------------------
oSIST prEN ISO 21388:2021
ISO 21388:2020(E)
Contents Page

Foreword ..........................................................................................................................................................................................................................................v

Introduction ................................................................................................................................................................................................................................vi

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ...................................................................................................................................................................................... 1

3  Terms and definitions ..................................................................................................................................................................................... 2

4 Service preconditions...................................................................................................................................................................................... 4

4.1 General ........................................................................................................................................................................................................... 4

4.2 Educational requirements ............................................................................................................................................................. 4

4.2.1 General...................................................................................................................................................................................... 4

4.2.2 Requirements for hearing aid professionals ............................................................................................ 4

4.2.3 Maintenence of competencies and skills of hearing aid professionals ............................. 5

4.3 Facility requirements ........................................................................................................................................................................ 5

4.3.1 General...................................................................................................................................................................................... 5

4.3.2 Room requirements ...................................................................................................................................................... 5

4.4 Equipment requirements ............................................................................................................................................................... 5

4.4.1 General...................................................................................................................................................................................... 5

4.4.2 Audiometric equipment ........................................................................................................................................... .. 6

4.4.3 Equipment for otoscopy and earmould impressions ....................................................................... 6

4.4.4 Hearing aid programming equipment........................................................................................................... 6

4.4.5 Electroacoustic measurement equipment ................................................................................................. 6

4.4.6 Maintenance tools ........................................................................................................................................................... 6

4.4.7 Demonstration samples ............................................................................................................................................. 7

4.5 Ethical requirements ......................................................................................................................................................................... 7

4.5.1 General...................................................................................................................................................................................... 7

4.5.2 Professional competence .......................................................................................................................................... 7

4.5.3 Relationship with clients .......................................................................................................................................... 7

4.5.4 Conflict of interest .......................................................................................................................................................... 7

4.5.5 Relationship with medical and other health practitioners ......................................................... 7

4.5.6 Relationship with colleagues ................................................................................................................................ 8

4.5.7 Advertising ............................................................................................................................................................................ 8

5 General stages of HAFM ................................................................................................................................................................................. 8

5.1 General ........................................................................................................................................................................................................... 8

5.2 Client profile .............................................................................................................................................................................................. 9

5.2.1 General...................................................................................................................................................................................... 9

5.2.2 General assessment ....................................................................................................................................................... 9

5.2.3 Audiological assessment ........................................................................................................................................10

5.2.4 Medical referral ..............................................................................................................................................................11

5.3 Counselling ..............................................................................................................................................................................................11

5.3.1 General...................................................................................................................................................................................11

5.3.2 Selection of hearing aid system ........................................................................................................................11

5.4 Hearing aid fitting .............................................................................................................................................................................11

5.4.1 Ear coupling elements ........................................................................................................................................... ...11

5.4.2 Pre-setting of hearing aids ...................................................................................................................................12

5.4.3 Setting and fine-tuning of hearing aids .....................................................................................................12

5.5 Verification and validation .........................................................................................................................................................12

5.6 Post-fitting counselling .................................................................................................................................................................13

5.7 Follow-up ..................................................................................................................................................................................................13

6 Quality of service ...............................................................................................................................................................................................14

6.1 General ........................................................................................................................................................................................................14

6.2 Documentation ....................................................................................................................................................................................14

6.3 Client evaluation of services .....................................................................................................................................................15

6.4 Customer complaint handling ................................................................................................................................................15

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6.5 Corrective actions ..............................................................................................................................................................................15

Annex A (informative) Minimum competencies of the hearing aid professional (HAP) .............................16

Annex B (informative) Recommendation for organisation of education and training for

hearing aid professionals (ISCED level 5) ...............................................................................................................................19

Annex C (informative) Fitting room example ...........................................................................................................................................21

Annex D (informative) Recommendation on the referral of clients for medical

or other specialist examination and treatment ................................................................................................................23

Annex E (informative) Informational counselling to support hearing aid fitting management .........24

Annex F (informative) Terminology ...................................................................................................................................................................27

Bibliography .............................................................................................................................................................................................................................41

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oSIST prEN ISO 21388:2021
ISO 21388:2020(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www .iso .org/ directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www .iso .org/ patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to the

World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see www .iso .org/

iso/ foreword .html.
This document was prepared by Technical Committee ISO/TC 43, Acoustics.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
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Introduction

The World Health Organisation (WHO) estimates that there are 360 million people with hearing

[22]

impairment, approximately 5,3 % of the world population . Hearing aids (HAs) are one of the

[39][40]

most widely-used treatment options for people with a hearing loss . For the proper use of HAs,

hearing aid fitting management (HAFM) is a crucial issue for manufacturers, practitioners, hearing

[39][42][43]

aid professionals and especially for HA users . Individually optimized outcome of HA use is

[42]

supported by comprehensive HA fitting protocols and the impact of “poor fit and comfort” can lead

[43]

to non-compliance, HA return and additional hearing loss with over-amplification. Accordingly, the

whole process of HA fitting should be optimized to achieve functional benefits, user satisfaction and

cost-effectiveness.

Two observations are important to take into account when developing an HAFM standard. Firstly,

[16][44]–[46]

the term "hearing aid fitting" is widely used among service providers and industry sectors.

Secondly, it has potentially conflicting interpretations: while guidelines for HA fitting have been

[17][18][23]–[32][34]–[37][47][48]
written to tackle these issues by various national and professional bodies ,

many jurisdictions are still not covered worldwide and there is a need to promote a more common

understanding of the HA fitting process. It is likely that different understanding of fitting has led to

non-uniform care, outcome variability and, in many cases, dissatisfaction with the use of HAs.

The main purpose of this document is thus to provide a general framework for HAFM including the

pre- and post-fitting stages to make it more explicit and transparent so that all related tasks, including

professional services, administration and financial aspects can be systematized. The overall objective

is to achieve the best possible hearing rehabilitation, which can only be accomplished through adequate

knowledge, training and skills of the professional and a systematic approach to HA fitting in close

collaboration with the client. The general framework of HAFM in this document is divided into six

stages (client profile, counselling, hearing aid fitting, verification and validation, post-fitting counseling,

and follow-up) based on the common practices of hearing aid professionals, and as recommended by

various pre-existing guidelines.

By dividing the hearing aid fitting process into stages, HAFM service providers can systematically

identify and administer the service components needed for high service quality, user satisfaction,

client-centered services, client self-efficacy and compliance rates with HAs (e.g. consistently using

HAs and attending follow-up appointments). The stages focus on the components of the framework to

achieve high rehabilitation outcomes such as communication skills, speech intelligibility, perception of

the acoustic environment, comfort for the HA users and sound quality. In addition, this document can

be a basis for making cost assessments for each stage or component, which can help improve public

health funding systems. Another possible application is to use this document as a minimum basis for

the development of professional training programs in HAFM.
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INTERNATIONAL STANDARD ISO 21388:2020(E)
Acoustics — Hearing aid fitting management (HAFM)
1 Scope

This document applies to hearing aid fitting management (HAFM) services offered by hearing aid

professionals (HAP) when providing benefit for their clients. The provision of hearing aids relies on

the knowledge and practices of a hearing aid professional, to ensure the proper fitting and adequate

service in the interest of the client with hearing loss.

This document specifies general processes of HAFM from the client profile to the follow-up through

administering, organising and controlling hearing aid fitting through all stages. It also specifies

important preconditions such as education, facilities and systems that are required to ensure proper

services.

The focus of this document is the services offered to the majority of adult clients with hearing

impairment. 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. This document generally applies to air conduction hearing aids and for the most part also to

bone conduction devices.

Hearing loss can be a consequence of serious medical conditions. Hearing aid professionals are not in

a position to diagnose or treat such conditions. When assisting clients seeking hearing rehabilitation

without prior medical examination, hearing aid professionals are expected to be observant of symptoms

of such conditions and refer to proper medical care.

Further to the main body of the document, which specifies the HAFM requirements and processes,

several informative annexes are provided. Appropriate education of hearing aid professionals is vital

for exercising HAFM. Annex A defines the competencies required for the HAFM processes. Annex B

offers a recommended curriculum for the education of hearing aid professionals. Annex C is an example

of an appropriate fitting room. Annex D gives guidance on the referral of clients for medical or other

specialist examination and treatment. Annex E is a recommendation for important information to be

exchanged with the client during the process of HAFM. Annex F is a comprehensive terminology list

offering definitions of the most current terms related to HAFM.

It is the intention that these annexes be helpful to those who wish to deliver HAFM of the highest quality.

2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 8253-1, Acoustics — Audiometric test methods — Part 1: Pure-tone air and bone conduction audiometry

ISO 8253-2, Acoustics — Audiometric test methods — Part 2: Sound field audiometry with pure-tone and

narrow-band test signals
ISO 8253-3, Acoustics — Audiometric test methods — Part 3: Speech audiometry

IEC 60118-7, Electroacoustics — Hearing aids — Part 7: Measurement of the performance characteristics

of hearing aids for production, supply and delivery quality assurance purposes

IEC 60645-1:2017, Electroacoustics — Audiometric equipment — Part 1: Equipment for pure-tone and

speech audiometry
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IEC 60645-5, Electroacoustics — Audiometric equipment — Part 5: Instruments for the measurement of

aural acoustic impedance/admittance

IEC 61669, Electroacoustics — Measurement of real-ear acoustic performance characteristics of hearing aids

International Standard Classification of Education, ISCED. United Nations Educational, Scientific

and Cutural Oganization, 2011, ISBN 978-92-9189-123-8, http:// uis .unesco .org/ sites/ default/ files/

documents/ international -standard -classification -of -education -isced -2011 -en .pdf

3  Terms and definitions
For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

— ISO Online browsing platform: available at https:// www .iso .org/ obp
— IEC Electropedia: available at http:// www .electropedia .org/
3.1
auditory dynamic range

difference between the hearing (3.7) threshold and the uncomfortable loudness level (UCL)

3.2
client
person with hearing loss (3.8) being serviced by a HAP (3.13)
3.3
client profile

comprehensive record of a client's (3.2) auditory functionality, social situation, activity opportunities,

needs and expectations as well as a client’s audiological and medical history
3.4
ear impression

representation of the three-dimensional geometry of the relevant part of the concha and ear canal

3.5
fine-tuning

adjustment of the hearing aid system (3.10) to best match the needs and preferences of the client (3.2)

3.6
fitting system

set of devices typically comprising a computer, fitting software and a programming interface used to

adjust hearing aids (3.9)
3.7
hearing

manner in which a person detects, discriminates, identifies and cognitively processes sounds

3.8
hearing loss
reduction of the hearing (3.7) ability
3.9
hearing aid

wearable electroacoustic instrument intended to process sounds in order to compensate for hearing

loss (3.8)

Note 1 to entry: Hearing aids are medical devices and comply with the requirements of IEC 60601-2-66.

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3.10
hearing aid system

customized structure consisting of one or two hearing aids (3.9), earmoulds and related components

such as a remote control or interfaces to other information or communication systems

3.11
hearing aid fitting

systematic procedure for individualizing and optimizing a hearing aid system (3.10) to compensate for

hearing loss (3.8)
3.12
hearing aid fitting management
HAFM

systematic process to administer, organise and control hearing aid fitting (3.11) through all stages

3.13
hearing aid professional
HAP

person who is appropriately trained and has proven competency in professionally assessing hearing,

selecting, fitting and delivering hearing aid systems (3.10) and rehabilitation services to persons with

hearing loss (3.8)
3.14
hearing rehabilitation

systematic process for improving functional hearing abilities and communication skills through hearing

aid fitting (3.11), counselling, instruction, education, training and developing listening skills

Note 1 to entry: The term “habilitation” includes all rehabilitation processes with additional interventions to

develop listening, speech and language skills for prelingually deafened individuals such as children which are

outside the scope of this document.
3.15
maximum output

maximum sound pressure level at the output of a hearing aid (3.9) as adjusted by the HAP (3.13)

3.16
pre-setting of hearing aids

configuration and adjustment of a hearing aid (3.9) using a prescriptive rule and relevant audiological data

3.17
verification
provision of objective evidence that a given item fulfils specified requirements

Note 1 to entry: In the field of hearing aid fitting (3.11), the verification usually means evaluating physical,

electroacoustic and psycho-acoustic aspects of a hearing aid fitting by presenting signals to hearing aids (3.9) in a

hearing aid test box or a real-ear or by using functional gain measurement in accordance with ISO 8253-2.

[SOURCE: ISO/IEC Guide 99:2007, 2.44, modified - Examples removed, original Notes to entry replaced

with Note 1 to entry.]
3.18
validation

verification (3.17), where the specified requirements are adequate for an intended use

Note 1 to entry: In the field of hearing aid fitting (3.11), the verification usually means a comprehensive evaluation

of the user benefits of a hearing aid fitting using methods which include speech audiometry and subjective

response questionnaires.

[SOURCE: ISO/IEC Guide 99:2007, 2.45, modified - Example removed, Note 1 to entry added.]

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4 Service preconditions
4.1 General
For quality service provision, the following preconditions shall be fulfilled:
— educational requirements;
— facility requirements;
— equipment requirements;
— ethical requirements.
Further preconditions are given by local applicable laws and regulations.
4.2 Educational requirements
4.2.1 General

The competencies of persons delivering the service are essential to the quality of service and should be

rooted in appropriate education from recognized educational institutions and organisations as well as

relevant practical skills obtained in a structured process. Ongoing education is required as it is vital to

maintaining the competencies, skill levels and knowledge needed for best practice.

In general, delegation of tasks to staff without the required education should not be permitted. More than

one type of staff can perform certain tasks in accordance with their specific educational background

following national or regional regulations. The overall responsibility of the service provision shall rest

with a HAP with the education specified in 4.2.2.

In order to facilitate the acquisition of practical skills, practices may include trainees from educational

programs in their staff. Services performed by trainees shall take place under the supervision of

a qualified HAP who shall be present at the facilities and who remains responsible for all activities

carried out by the trainee.
4.2.2 Requirements for hearing aid professionals

A minimum education level 5 according to the International Standard Classification of Education,

ISCED, or equivalent is required in order to perform all stages of hearing aid fitting management. A

level 6 education is recommended.

It is recommended that the educational program includes the following academic topics: basic

mathematics and science including acoustics, anatomy and physiology, psychology and linguistics,

audiology, hearing aid technology, hearing rehabilitation processes, hearing aid fitting.

The following practical skills should be obtained through training: client interaction, audiometric

measurements, earmould management, hearing aid programming, fitting verification and validation,

hearing aid modification and repair.

Suggestions for minimum competencies of the HAP and a suitable education program are given in

Annexes A and B, respectively.
Any HAP shall have proven minimal competencies through t
...

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