Corporate Social Responsibility at Sonova
Sonova is committed to performance in compliance with applicable health and safety regulations throughout the product lifecycle. We believe that excellent health and safety performance supports our competitive industry position and provides value for our customers, employees, and all other stakeholders.
Regulatory and standards
Our processes for identifying potential hazards related to our products, and estimating, evaluating, controlling, and monitoring these risks, are governed by the EN ISO 14971:2012 standard, which specifies the application of risk management to medical devices. All of our hearing instruments comply with the European Medical Device Directive MDD 93/42/EEC and the international standard EN 60601-1:2006/A1:2013 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance). Cochlear implants must comply with the requirements of regional or country-specific directives, laws, and standards for active implantable medical devices. All of our operation centers and major group companies are certified according to the EN ISO 13485:2012/AC2012 standard, which specifies the requirements for quality management systems in the design and manufacture of medical devices.
Supplementary technical certifications required by the EU’s Radio and Telecommunications Terminal Equipment Directive R&TTE 1999/5/EU ensure that the wireless technology we use meets defined safety and performance requirements.
Each national health care authority has specific requirements for products that are offered in its market. In the US, hearing instruments are regulated by the United States Food and Drug Administration (FDA) Quality Systems Regulations 21 § CFR 820. Hearing instruments are classified as class I medical devices that can be launched without premarket approval (PMA), under an exemption in accordance with the 510(k) approval process. Wireless hearing aids are class II, exempted both from PMA and 510(k) requirements.
Cochlear implants and their respective accessories from Advanced Bionics are classified as active implantable medical devices (Class III-AIMD), which are regulated by the EU Active Implantable Medical Devices Directive AIMDD 90/ 385 /EEC and must generally undergo a formal PMA process wherever they are launched.
The majority of products from Sonova group companies are covered by these regulations, standards, and medical classes. All of these products are continuously assessed for health and safety improvements, using such tools as our complaint handling system and process, post-market surveillance, vigilance reporting, reliability trending, and post-launch engineering.
Sonova provides a broad range of professional training and courses that address the various specializations in the hearing care industry. We also organize conferences, e-learning seminars, road shows, face-to-face in-clinic training, and scientific marketing material to help transfer our knowledge and train hearing care specialists.
Product service and labelling
The majority of products from Sonova’s brands are subject to information requirements listed under harmonized standards for medical devices developed by recognized European Standards Organizations, US FDA standard 21 CFR 801.420, and various national requirements, such as instructions for use.