regulatory framework

Constant monitoring

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

Hearing aids – unlike personal sound amplification products – 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.

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.

reimbursement conditions

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. 

HEARING AIDS vs PSAPs

Hearing aids

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.

PSAPS

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.

want to know more about regulations? read the report

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