oSIST prEN ISO 21388-1:2025
(Main)Acoustics - Hearing aid fitting management (HAFM) - Part 1: General process (ISO/DIS 21388-1:2025)
Acoustics - Hearing aid fitting management (HAFM) - Part 1: General process (ISO/DIS 21388-1:2025)
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.
Acoustique - Gestion des appareils d'aide auditive (HAFM) - Partie 1: Processus général (ISO/DIS 21388-1:2025)
Le présent document s’applique aux services offerts par les audioprothésistes lorsqu’ils prennent en charge leurs clients. La délivrance des aides auditives s’appuie sur les connaissances et les pratiques d’un audioprothésiste afin d’assurer une bonne adaptation prothétique et un service adéquat dans l’intérêt du déficient auditif.
Le présent document spécifie les processus généraux de l’adaptation des aides auditives, depuis le profil du client jusqu’au suivi, en passant par toutes les étapes d’administration, d’organisation et de contrôle de l’adaptation des aides auditives. Il présente également les conditions préalables importantes telles que la formation, les installations, les équipements et les systèmes qui sont exigés pour assurer des services appropriés.
Le présent document concerne les services offerts à la majorité des clients adultes souffrant de troubles de l’audition. 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. Le présent document s’applique généralement aux aides auditives en conduction aérienne et, pour la plupart, également aux aides auditives en conduction osseuse.
La déficience auditive peut être la conséquence de pathologies graves que les audioprothésistes ne sont pas en mesure de diagnostiquer ou de traiter. Lorsqu’ils aident des clients en quête d’une réhabilitation auditive sans examen médical préalable, les audioprothésistes sont censés identifier les symptômes de ces pathologies et orienter les malades vers les professionnels de santé appropriés.
Outre le corps principal du document, qui spécifie les exigences et processus d’adaptation des aides auditives, plusieurs annexes informatives sont fournies. Une formation appropriée des audioprothésistes est fondamentale pour assurer l’adaptation des aides auditives. L’Annexe A définit les compétences requises pour le processus d’adaptation des aides auditives. L’Annexe B propose un programme recommandé pour la formation des audioprothésistes. L’Annexe C montre un exemple de salle d’appareillage appropriée. L’Annexe D fournit des recommandations relatives à l’orientation des clients vers un autre spécialiste en vue d’un traitement et d’examens médicaux complémentaires. L’Annexe E présente les informations importantes qu’il est recommandé d’échanger avec le client pendant le processus d’adaptation des aides auditives. L’Annexe F est une liste terminologique complète offrant des définitions des termes les plus courants liés à l’adaptation des aides auditives.
L’objectif est que ces annexes soient utiles aux personnes désireuses d’assurer une gestion optimale du processus d’adaptation des aides auditives.
Akustika - Vodenje ustreznosti slušnih pripomočkov - 1. del: Splošni postopek (ISO/DIS 21388-1:2025)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-september-2025
Akustika - Vodenje ustreznosti slušnih pripomočkov - 1. del: Splošni postopek
(ISO/DIS 21388-1:2025)
Acoustics - Hearing aid fitting management (HAFM) - Part 1: General process (ISO/DIS
21388-1:2025)
Acoustique - Gestion des appareils d'aide auditive (HAFM) - Partie 1: Processus général
(ISO/DIS 21388-1:2025)
Ta slovenski standard je istoveten z: prEN ISO 21388-1
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
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 21388-1
ISO/TC 43
Acoustics — Hearing aid fitting
Secretariat: DIN
management (HAFM) —
Voting begins on:
Part 1: 2025-06-25
General process
Voting terminates on:
2025-09-17
ICS: 17.140.01; 11.020.10; 11.180.15
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Reference number
ISO/DIS 21388-1:2025(en)
DRAFT
ISO/DIS 21388-1:2025(en)
International
Standard
ISO/DIS 21388-1
ISO/TC 43
Acoustics — Hearing aid fitting
Secretariat: DIN
management (HAFM) —
Voting begins on:
Part 1:
General process
Voting terminates on:
ICS: 17.140.01; 11.020.10; 11.180.15
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2025
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
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Published in Switzerland Reference number
ISO/DIS 21388-1:2025(en)
ii
ISO/DIS 21388-1:2025(en)
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 .4
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 .5
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
6.5 Corrective actions . . 15
iii
ISO/DIS 21388-1:2025(en)
Annex A (informative) Minimum competencies of the hearing aid professional (HAP) .16
Annex B (informative) Recommendation for organisation of education and training for hea
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