Overview
EN ISO 21388-2:2024 is a European and International standard developed by CEN and ISO, addressing the integration of tele-services in hearing aid fitting management. As a supplement to ISO 21388, it sets out requirements and guidance for hearing aid professionals (HAPs) offering remote services (tele-services) as part of hearing aid fitting management (tHAFM). This standard supports hearing care practices in adapting to advancements in telecommunication technologies, ensuring quality, privacy, and professional standards are maintained in remote hearing health services. The standard emphasizes that tele-services can either substitute or complement traditional face-to-face services, covering essential preconditions in education, infrastructure, security, and client management.
Key Topics
- Tele-services in Hearing Aid Fitting Management: Guidance on the use of telecommunication technologies to remotely deliver critical stages of hearing aid fitting, including assessment, counseling, fitting, and follow-up.
- Professional Qualification and Education: Hearing aid professionals must be appropriately trained in providing remote services, understanding telehealth technologies and maintaining high-quality care.
- Infrastructure and Facility Requirements: Requirements for suitable physical and digital environments for tele-service delivery, including privacy, stable high-speed internet connections, and secure workspaces.
- Security and Privacy: Emphasis on safeguarding client health information during all tele-service interactions through encryption, secure storage, and proper consent procedures.
- Client Eligibility and Support: Assessment of client suitability for tele-services, taking into account their digital literacy, access to necessary devices, and support needs.
- Service Quality and Continuity: Service level agreements (SLAs) and quality management processes to ensure reliable, safe, and effective tele-services are provided consistently.
Applications
EN ISO 21388-2:2024 is applicable for hearing aid professionals, clinics, and service providers who wish to implement or improve tele-services in their hearing aid fitting workflows. Key applications include:
- Remote Client Assessments: Initial client evaluations and candidacy assessments performed securely over telecommunication platforms.
- Tele-counseling and Education: Providing counseling sessions and training for clients and their families via video or audio calls.
- Remote Hearing Aid Adjustment: Fine-tuning of hearing aids using specialized apps and software platforms while the client remains at home or another location.
- Verification, Validation, and Follow-up: Ongoing support, troubleshooting, and adjustments performed remotely, ensuring continued hearing aid effectiveness and client satisfaction.
- Documentation and Compliance: Maintaining digital records aligned with privacy regulations and professional standards for telehealth services.
These applications significantly expand access to hearing care, especially for individuals in remote or underserved areas and those who may face barriers to in-person visits.
Related Standards
EN ISO 21388-2:2024 is closely related to a range of international and European standards that define quality, safety, and procedures in hearing care and telehealth. Key related standards include:
- ISO 21388: Acoustics – Hearing aid fitting management – general requirements.
- ISO 13131: Health informatics – Telehealth services – Quality planning guidelines.
- ISO 8253-2: Acoustics – Audiometric test methods – Sound field audiometry.
- IEC 60118-15: Electroacoustics – Hearing aids – Methods for characterising signal processing in hearing aids.
- IEC 61669: Measurement of real-ear acoustic performance characteristics of hearing aids.
By aligning with these standards, organizations can ensure that their tele-services for hearing aid fitting are reliable, safe, and effective, supporting better hearing health outcomes and facilitating compliance with both national and international regulatory frameworks.
Keywords: EN ISO 21388-2:2024, tele-services, hearing aid fitting management, hearing aid professional, hearing care, telehealth, remote hearing aid fitting, hearing health standards, tele-audiology, privacy and security in telehealth, CEN standards.