The production of hearing systems requires very high standards of quality at all levels. As an innovation and technology leader, Sonova strives to offer its customers the most technologically advanced products of unparalleled quality – not just with regard to their manufacture and safety, but also their user-friendliness and environmental footprint. To achieve these targets, Sonova has made a global commitment to uphold specific sustainability and quality principles.
The Sonova Group has a worldwide quality management system that concentrates on client focus, customer satisfaction, and also continuous improvement of products and processes. This is assured through certification in accordance with ISO 9001:2000 and 13485:2003. ISO 14001 certification is currently being prepared for the Sonova Group’s main site in Stäfa, Switzerland.
In financial year 2009/10, nine product lines were launched without any problems, all of which meet high international quality standards. All of Sonova’s products are subject to the safety guidelines set down in the European Medical Devices Directive (MDD). Sonova’s hearing systems are compliant with EU directive MDD 93/42/EEC and ISO standards 9001:2008 and 13485:2003. As a result, Sonova is not allowed to use any raw materials or substances in the production process that are classified as hazardous. This directive also places restrictions on the use of recycled or used components.
Supplementary technical certifications required by the EU Radio & Telecommunications Terminal Equipment Directive R&TTE 99/5/EU are applied – also to protect end customers – when using analogue or digital wireless technology. Sonova ensures biocompatibility in the use of the medical products it manufactures, in accordance with EN ISO 10993-1:2003. All products also have the relevant local homologation in each country where they are sold.
The product Lyric, by recently acquired InSound Medical, was cleared by the US Food and Drug Administration (FDA) in 2008 through the 510(k) process (K081136). As a medical device, Lyric is manufactured using processes and materials in compliance with the FDA Quality System Regulation 21 CFR § 820. InSound Medical has also been ISO 13485 certified since 2007 meaning it complies with international requirements for a medical device manufacturer as well.
The cochlear implant and its accessories, by recently acquired Advanced Bionics, are regulated medical devices which require approval in most global markets. In the United States, the HiRes 90K cochlear implant and its accessories were approved via a pre-market approval supplement which is filed with the FDA. Required approvals were also obtained from all other necessary markets. The HiRes 90K cochlear implant system also meets all other required performance standards.