ISO 21388:2020

Overview

ISO 21388:2020 - Acoustics - Hearing aid fitting management (HAFM) defines a systematic, client-centred framework for delivering hearing aid services. The standard covers the full HAFM process from initial client profile through counselling, fitting, verification and validation, post‑fitting counselling and follow‑up. It also specifies essential preconditions such as education, facility and equipment requirements, and ethical and quality-of-service elements to support effective hearing rehabilitation for most adult clients using air conduction (and largely bone conduction) devices.

Key topics and requirements

• Six-stage HAFM process: client profile, counselling, hearing aid fitting, verification & validation, post‑fitting counselling, follow‑up.
• Service preconditions: minimum competencies for hearing aid professionals (HAPs), facility and room requirements (e.g., fitting room), and necessary audiometric, otoscopy, programming and electroacoustic equipment.
• Education and training: Annex A lists minimum HAP competencies; Annex B recommends a curriculum for professional education (ISCED level 5).
• Clinical processes: guidance on audiological assessment, ear coupling and earmoulds, pre‑setting, fine‑tuning and verification of hearing aids.
• Safety and referrals: procedures for recognizing signs of medical conditions and referring clients for medical or specialist examination (Annex D).
• Client communication: recommended information exchange and counselling to support acceptance and compliance (Annex E).
• Quality management: documentation, client evaluation, complaint handling and corrective actions to ensure consistent service quality.
• Terminology and practical examples: comprehensive definitions (Annex F) and a fitting room example (Annex C).

Practical applications and users

Who uses ISO 21388:

• Hearing aid professionals (audiologists, hearing care practitioners) to structure clinical workflows and improve outcomes.
• Clinics and private practices to design compliant facilities, staff training and quality systems.
• Manufacturers and distributors to align product support, fitting tools and demonstration samples with professional practice.
• Educators and training programs for curriculum development and competency assessment.
• Regulators, payers and public health programs to set minimum service standards and cost‑assessment frameworks.

Practical benefits:

• Improves client satisfaction and hearing rehabilitation outcomes.
• Reduces variability in fitting practice and supports evidence‑based verification and validation.
• Facilitates consistent documentation, referrals and ethical practice.

Related standards and context

ISO 21388 was prepared by ISO/TC 43 (Acoustics) and aligns with ISO/IEC directives and international best practice. It is complementary to national clinical guidelines and can serve as a baseline for professional training, quality assurance and health‑system reimbursement models.