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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.
