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Intended patient population
Hearing aids: This device is intended
for patients with unilateral and bilateral,
mild to profound hearing loss from 8
years of age.
The tinnitus masker soware feature is
intended for patients with chronic tinni-
tus from 18 years of age.
Charger: The intended patient popula-
tion is the user of the compatible hearing
aids.
Intended users:
Hearing aids: Intended for people with
hearing loss using a hearing aid and
their caregivers. A hearing care profes-
sional is responsible for adjusting the
hearing aid.
Charger: Intended for people with hear-
ing loss using the compatible recharge-
able hearing aid and their caregivers,
hearing care professional.
Indications
General clinical indications for the use of
hearing aids and tinnitus feature are:
• Presence of hearing loss
• Uni- or bilateral hearing loss
• Conductive, sensorineural or mixed
hearing loss
• Mild to profound hearing loss
• Presence of a chronic tinnitus (only
applicable for devices which pro-
vide the tinnitus feature).
Contraindications
General clinical contraindications for the
use of hearing aids and tinnitus soware
are:
• Hearing loss is not in the tting
range of the hearing aid (i.e. gain,
frequency response)
• Acute tinnitus
• Deformity of the ear (i.e. closed ear
canal; absence of the auricle)