We operate in a medical sector, where regulations vary from country to country. We constantly monitor the regulatory framework with the aim of reducing the impact of any unfavorable changes and maximizing the benefits of favorable ones.
Through the establishment of the Regulatory Affairs function, we have implemented a series of measures not only to monitor the regulatory framework in place and any potential change in all the countries in which we operate, but also to ensure a timely reaction to any potential changes in regulation, besides being able to engage in dialogue with institutions and actively take part in debates and conventions to make the voice of the sector heard.
three main regulatory areas
regulation on medical devices
regulation on hearing care professionals
Professionals qualified to select, fit and sell hearing solutions - whose required 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.
HEARING AIDS vs PSAPs
Hearing aids are medical devices subject to strict safety controls and are intended to improve hearing for individuals with hearing loss. In order to prevent potential hearing damage, hearing aids are customized according to individual needs and set up to ensure improvement in the perception of sounds within a safety threshold.
Personal sound amplification products (PSAPs) amplify sounds, but do not compensate hearing loss, are not medical devices and are not fitted by a hearing care professional. They may also breach the safety threshold of 120 dB in output and thus can be potentially harmful to hearing. For these very reasons, they cannot be sold to correct hearing loss. There are a variety of inner ear issues that only a hearing care professional or ENT can properly identify and address.