ISO 21388-2020 PDF

Full title and description

St ISO 21388:2020 — Acoustics — Hearing aid fitting management (HAFM). This International Standard specifies the processes, preconditions and organisational requirements for providing hearing‑aid fitting services by hearing aid professionals, covering client profiling, fitting, verification, counselling and follow‑up for the majority of adult clients with hearing impairment.

Abstract

The standard defines general HAFM processes from initial client profile through follow‑up, and sets out required preconditions such as education, facilities, equipment and systems to ensure appropriate service delivery. It focuses on services for most adult clients and notes that some groups (children, people with additional disabilities, implantable device users) may need services outside this document’s scope. Informative annexes cover competencies, recommended curricula, fitting‑room examples, referral guidance, client information and terminology.

General information

• Status: Published.
• Publication date: March 2020 (ISO publication 2020‑03).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.020.10; 11.180.15; 17.140.01 (health services, aids for deaf and hearing impaired, acoustic measurements).
• Edition / version: Edition 1 (ISO 21388:2020).
• Number of pages: 43 pages (main ISO edition).

Scope

ISO 21388:2020 applies to hearing aid fitting management (HAFM) services delivered by hearing aid professionals and addresses the administration, organisation and control of fitting processes across all stages (client profiling, candidacy assessment, device selection, fitting and verification, counselling and follow‑up). The document generally applies to air‑conduction hearing aids and, for the most part, to bone‑conduction devices; it also emphasises that HAPs should identify and refer clients with potential medical conditions for appropriate care.

Key topics and requirements

• Definition of HAFM process steps: client profile, assessment, device selection, fitting, verification, validation and follow‑up.
• Preconditions and organisational requirements: education and competency of hearing aid professionals, facility and equipment needs, record keeping and quality control.
• Competency framework and recommended curriculum for HAP education (informative annexes provide detailed guidance).
• Guidance on fitting-room setup, referral pathways for medical or specialist care, and recommended client information exchange.
• Applicability to typical adult populations with note of exclusions/limitations for children, people with additional disabilities and implantable device users.
• Baseline requirements that support integration with tele‑services addressed by the later Part 2 (tHAFM).

Typical use and users

Primary users are hearing aid professionals, audiology clinics and hospital audiology services. Secondary users include hearing‑care educators and training bodies, device manufacturers (to align service workflows with product capabilities), telehealth/teleaudiology platform developers, healthcare administrators and regulators developing hearing‑care service frameworks. The standard is used to define and audit clinical service processes, staff competencies and facility requirements.

Related standards

Key related documents include the tele‑services supplement ISO 21388‑2 (Part 2: tele‑services as part of HAFM, 2024), audiometric and electroacoustic method standards (for example ISO 8253 series, IEC 60118‑15, IEC 61669), telehealth quality guidance such as ISO 13131, and other audiology/medical device standards (e.g., ISO 7029, relevant parts of the IEC/ISO 60601 family). These references support verification, measurement, telehealth integration and safety aspects of hearing‑aid fitting and remote care.

Keywords

Hearing aid fitting management; HAFM; hearing aid professional; HAP; fitting process; verification; tele‑audiology; competencies; audiology services; client profiling; follow‑up.

FAQ

Q: What is this standard?

A: ISO 21388:2020 is an international standard that specifies the management and process requirements for hearing‑aid fitting services provided by hearing aid professionals (HAFM).

Q: What does it cover?

A: It covers the end‑to‑end process for hearing aid fitting management — client profiling, assessment, device selection, fitting, verification, counselling and follow‑up — and sets out required preconditions such as education, facilities and systems; several informative annexes give competency, curriculum and practical guidance.

Q: Who typically uses it?

A: Hearing aid professionals, audiology clinics and hospitals, educators and training organisations, device manufacturers, telehealth platform developers, and healthcare administrators or regulators involved in hearing‑care service design and quality assurance.

Q: Is it current or superseded?

A: ISO 21388:2020 is the published (first) edition from March 2020. The topic is under active development (a tele‑services Part 2 was published in 2024); ISO standards are normally reviewed every five years, so users should check for amendments or newer parts when implementing long‑term programmes.

Q: Is it part of a series?

A: Yes — ISO 21388 has been extended by a Part 2 (ISO 21388‑2:2024) addressing tele‑services as an element of hearing‑aid fitting management; the standard also cross‑references related audiometric, electroacoustic and telehealth standards.

Q: What are the key keywords?

A: HAFM, hearing aid fitting management, hearing aid professional, fitting verification, counselling, competencies, tele‑services, audiology services.