Authorities warn that hearing aids can only be prescribed by accredited professionals

Authorities underline that the diagnosis of hearing loss and the recommendation for the use of devices must be performed by health professionals and accredited entities.

In a joint statement, Infarmed, the Health Regulatory Entity (ERS) and ASAE warn that it is common to sell and promote hearing aids and hearing amplifiers, “with advertising and unaffected information about the characteristics and purpose of each, which induces error and can endanger their users”.

The authorities highlight, in the statement, the differences between hearing aids and hearing amplifiers, noting that these are « distinct products for different purposes regulated by spreading legal diplomas. »

« Hearing aids are medical devices that process and amplify sound to compensate for hearing impairment, » they clarify. Amplifiers “are electrical and electronic equipment that only amplify ambient sound for people without hearing impairment and are not medical devices,” they add.

In this sense, they also explain those authorities, safety and performance requirements to be met are also different.

Hearing aids designed and manufactured for medical purpose to partially restore hearing function in hearing impairment are covered by the definition of medical device, while hearing amplifiers are not qualified as a medical device, but can only be placed and made available on the market if they have CE marking.