ISO 21388-2:2024

Overview

ISO 21388-2:2024 - "Acoustics - Hearing aid fitting management - Part 2: Tele‑services as part of hearing aid fitting management (tHAFM)" is a supplement to ISO 21388 that defines requirements and a practical framework for delivering tele-services within hearing aid fitting management. The standard clarifies which HAFM activities can be substituted or complemented by remote delivery, sets preconditions for safe and effective tele-audiology, and aligns structure with ISO 21388 to make combined use straightforward. It excludes assisted tele-services by non‑HAPs, self‑fitting, and certain populations (e.g., children, persons with implantable devices) that need services outside this document’s scope.

Key topics and technical requirements

• Service preconditions
  • Risk awareness (privacy, technical failure, depersonalization, inequitable access).
  • Compliance with local laws and clinical liability considerations.
• Privacy, security and ICT
  • Use of stable, reliable internet; encryption and two‑factor authentication; avoidance of unsecured public Wi‑Fi unless protected (e.g., VPN).
  • Secure storage/backups and understanding of platform security features.
• Educational requirements for HAPs
  • Training in tele-service terminology, ICT for tele-services, client candidacy assessment and onboarding, scripting/checklists, limitations/opportunities, and documentation practices.
• Facility and equipment requirements
  • Facilities designed for tele-services and conformity with ISO 13131 (telehealth quality planning).
  • Equipment guidance covering safety & quality, service delivery, infrastructure, deployment, operations, technical support and device management.
• Tele-service types and workflow integration
  • Definitions and use of synchronous tele-services and ecologic momentary tele-services.
  • Integration of tele-services into all HAFM stages: candidacy/profile, counselling, fitting, verification/validation, post‑fitting counselling and follow‑up.
• Ethical and quality-of-service requirements
  • Measures to ensure confidentiality, client privacy in remote environments, and consistent quality equivalent to face‑to‑face HAFM where appropriate.

Applications and who should use it

ISO 21388-2 is intended for:

• Hearing aid professionals (HAPs) implementing remote fittings and remote fine‑tuning.
• Audiology clinics and telehealth programs designing tele-audiology workflows and facility setups.
• Device manufacturers and vendors supporting remote configuration or remote-care platforms.
• Health IT and compliance teams creating secure tele-service deployments and documentation practices.
• Regulators and service quality managers assessing tele‑service safety, training and infrastructure.

Practical uses include establishing tele-audiology protocols, staff training curricula, IT/security checklists for remote sessions, and defining which fitting activities can be offered remotely while maintaining clinical quality.

Related standards

• ISO 21388 - Hearing aid fitting management (base standard)
• ISO 13131 - Health informatics - Telehealth services - Quality planning guidelines
• ISO 8253-2, IEC 60118-15, IEC 61669 (referenced for audiometric and electroacoustic methods)

Keywords: ISO 21388-2, tHAFM, tele-services, hearing aid fitting management, tele-audiology, hearing aid professionals, remote hearing care, privacy, security, telehealth.