BS EN IEC 60118-4:2015+A1:2018

# BS EN IEC 60118-4:2015+A1:2018 - Hearing Aids Performance Measurement Standard## OverviewBS EN IEC 60118-4:2015+A1:2018 is the definitive standard for measuring and testing the performance of hearing aids. This British Standard, which is identical to the international IEC 60118-4 standard, provides detailed technical specifications and test methods to ensure hearing aids meet strict quality and compliance requirements.## Key Benefits- Ensures consistent performance and quality for hearing aids- Enables reliable testing and measurement of critical hearing aid parameters- Supports regulatory compliance for hearing aid manufacturers- Promotes best practices in hearing aid design and production## Technical Specifications### Acoustic Measurements- Sound pressure level (SPL) at the eardrum- Frequency response- Total harmonic distortion- Equivalent input noise- Induction coil sensitivity- Battery current consumption### Electrical Measurements- Input-output characteristics- Gain control range- Maximum output sound pressure level- Equivalent input noise voltage### Environmental Testing- Temperature and humidity testing- Mechanical shock and vibration testing- Electromagnetic compatibility (EMC) testing## Compliance and RegulationsBS EN IEC 60118-4:2015+A1:2018 is a harmonized standard that supports the essential requirements of the EU Medical Devices Regulation (MDR) 2017/745. Hearing aid manufacturers can use this standard to demonstrate compliance and CE mark their products for the European market.The standard is also widely recognized and referenced in national regulations and guidelines for hearing aids in countries around the world, making it a global benchmark for hearing aid performance.## Who Uses This Standard?This British Standard is primarily used by:- Hearing aid manufacturers- Hearing aid testing laboratories- Regulatory bodies and market surveillance authorities- Healthcare professionals involved in hearing aid fitting and evaluationBy adhering to the specifications in BS EN IEC 60118-4:2015+A1:2018, hearing aid manufacturers can ensure their products meet the highest standards of quality, safety, and performance, ultimately benefiting end-users and supporting better hearing health outcomes.