Hearing aids are considered medical devices in all our markets and are subject to strict safety controls. They must comply with national and international regulations that establish product standards and packaging and labelling requirements. Moreover, to be able to sell a hearing aid on the EU market it is necessary that it bears the EC (European Community) marking, to confirm that the product meets the essential requirements of all the EU directives related to medical devices.

The use of hearing aid requires the support of a licensed professional to perform a thorough hearing assessment, as well as of the selection, personalization, application and sale of the device, whose qualifications vary from country to country. In the European Union, only professionals qualified under national law can select, adjust, sell and check the effectiveness of hearing solutions; the profession of hearing care professional is therefore regulated in most EU countries. In 2018 the Register of Hearing Care Technicians was established in Italy. In the US, hearing aids may be distributed only by authorized persons, while in Australia, hearing care professionals and audiometrists must be members of an accredited Australian professional association.

Reimbursement conditions also differ according to different national health systems. There are national health systems that offer hearing aids free of charge to everyone, like in the United Kingdom, and others, like in France and Italy, that partially or fully reimburse the cost of the hearing aid to people with a certain level of hearing impairment. Lastly, some healthcare systems do not offer any reimbursement, like in Spain and in the US.

In all countries, we promote efficient reimbursement systems and we participate in the debate with healthcare companies and regulators, to seek the right balance between free access to hearing care on the one hand, and on the other hand the maintenance of the economic sustainability of health systems.