In a joint advisory note, Portugal’s national medicines authority (Infarmed), the Health Regulation Authority (ERS), and ASAE highlight the prevalent issue of hearing aids and amplifiers being sold with misleading information regarding their features and purpose, potentially endangering users.
The advisory stresses that the diagnosis and rehabilitation of hearing loss are health care services that must be provided by properly qualified and licensed healthcare professionals.
The authorities elaborate on the distinctions between hearing aids and hearing amplifiers, noting that “they are distinct products with different purposes, governed by different legal regulations.”
“Hearing aids are medical devices designed to process and amplify sound to compensate for hearing loss,” whereas amplifiers “are electronic devices that simply amplify ambient sound for individuals without hearing impairment and are not classified as medical devices,” they clarify.
Accordingly, the safety and performance standards that manufacturers must meet to market these devices differ, encompassing the type of compliance assessment procedures they undergo and the accompanying information, including labeling, usage instructions, and promotional materials.
Authorities explain that hearing aids, being designed and manufactured for the medical purpose of partially restoring hearing function in individuals with hearing loss, fall under the definition of a medical device.
“Therefore, only hearing aids that comply with the applicable European Union harmonization legislation in the medical devices sector can be placed on the market,” they emphasize.
Conversely, hearing amplifiers are not deemed medical devices, as they are intended for “short-term use solely to amplify sound,” but they can only be marketed if they have CE marking.
The regulators and ASAE urge the public to understand that diagnosing hearing loss and subsequent rehabilitation require specific services (screenings, diagnostic exams, consultations) that can only be conducted by otolaryngologists and audiologists.
