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The hearing aid is suitable for the home
healthcare environment and due to their
portability it may happen that it is used in
professional healthcare facility environment
like physician offices, dental offices etc.
A hearing aid will not restore normal hearing
and will not prevent or improve a hearing
impairment resulting from organic conditions.
Infrequent use of a hearing aid does not permit
a user to attain full benefit from it. The use of a
hearing aid is only part of hearing habilitation
and may need to be supplemented by
auditory training and instruction in lipreading.
Feedback, poor sound quality, too loud or too
soft sounds, inadequate fitting or problems
when chewing or swallowing, can be resolved
or improved during the fine-tuning process
at the fitting procedure by a hearing care
professional.
Any serious incident that has occurred in
relation to the device 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.
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