Health regulators, drug regulators, and the Food and Economic Safety Authority warned today that the diagnosis of hearing loss and the placement of devices must be carried out by health professionals and accredited entities.
In a joint press statement, the National Medicines Authority (Infarmed), the Health Regulatory Authority (ERS), and ASAE say that it is common to see the sale of hearing aids and hearing amplifiers, “advertised, however, the information given is ambiguous and can put those in need at risk.”
In this sense, they warn that the diagnosis of hearing loss and the rehabilitation of people with hearing problems are health care and, as such, have to be provided by qualified and accredited health professionals for this purpose.
The authorities explain the differences between hearing aids and hearing amplifiers, stressing that they are different products with different purposes regulated by dissimilar legal diplomas. Hearing aids are medical devices that process and amplify sound to compensate for hearing impairment, while amplifiers are electrical and electronic equipment that only amplify ambient sound for people without hearing impairment and are not medical devices.
In this sense, the safety and performance requirements that must be met by the respective manufacturers in order to make them available on the market are also different, including the type of conformity assessment procedure to which they are subject and the information that accompanies them, namely labelling, instructions for use, and promotional material.
The authorities explain that, as hearing aids are designed and manufactured for the medical purpose of partially restoring hearing function in patients with hearing impairment, they fall under the definition of a medical device. Thus, only hearing aids that comply with the European Union harmonisation legislation applicable to the medical device sector can be placed and made available on the market.
Hearing amplifiers, on the other hand, are not registered as medical devices. They are intended to be used for short periods with the sole purpose of amplifying sound. These, however, can be marketed provided they have the CE mark of approval.
Moreover, the regulators and the ASAE want to make the population aware that the diagnosis of hearing loss and the subsequent rehabilitation of people presuppose the provision of specific services (screenings, diagnostic tests, consultations) that can only be performed by otorhinolaryngologists and audiologists.
Samantha Gannon
info at madeira-weekly.com
