Sonova’s devices are regulated by government agencies, healthcare authorities, and other regulatory bodies worldwide. These organizations verify that throughout the life cycle of our products we are fulfilling the requirements of applicable health and safety regulations. We are committed to maintaining transparent, constructive, and professional relationships with all applicable regulatory authorities on policy, product submissions, compliance, and product performance. Each national healthcare authority has specific requirements for products that are offered in its market which need to be respected. Find here the full text of the EU Declaration of Conformity.
Declaration of conformity