21. Important safety information
Please read the relevant safety information and
limitations-of-use information on the following pages
before using your hearing aid.
Intended use
The hearing aid is intended to amplify and transmit sound
to the ear and thereby compensate for impaired hearing
Intended user
Intended for:
• People with hearing loss
• Caregivers of the person with hearing loss
• Hearing care professional responsible for adjusting the
hearing aid
Intended medical indication
Clinical indication for the use of hearing aids is:
Presence of hearing loss:
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• Unilateral or bilateral
• Conductive, sensorineural or mixed
• Mild to profound
Medical contraindications
Medical contraindications for the use of hearing aids are:
• Deformity of the ear (i.e. closed ear canal; absence of the
auricle)
• Neural hearing loss (i.e. retro-cochlear pathologies such
as absent/ non-viable auditory nerve)
Intended patient population
This device is intended for patients from 8 years of age who
ful l the clinical indication for this product.
Clinical bene t
Improvement in speech understanding.
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