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Any serious incident that has occurred in relation
to the hearing aid, should be reported to the
manufacturer representative and the competent
authority of the state of residence. The serious
incident is described as any incident that directly or
indirectly led, might have led or might lead to any of
the following:
•
the death of a patient, user or other person
•
the temporary or permanent serious
deterioration of a patient’s, user’s or other
person’s state of health
•
a serious public health threat
To report an unexpected operation or event, please
contact the manufacturer or a representative.
Intended use:
The hearing aid is intended to amplify and transmit
sound to the ear and thereby compensate for
impaired hearing.
The Tinnitus feature is intended for use by people
with tinnitus who also desire amplification. It
provides supplementary noise stimulation which
can help defocus the user`s attention from their
tinnitus.
Intended patient population:
This device is intended for patients with unilateral
and bilateral, mild to profound hearing loss from
18 years of age. The Tinnitus feature is intended for
patients with chronic tinnitus from 18 years of age.
Intended user:
Intended for people with hearing loss using a
hearing aid and their caregivers. A hearing care
professional is responsible for adjusting the hearing
aid.
