54
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:
a) the death of a patient, user or other person
b) the temporary or permanent serious deterioration of
apatient’s, user’s or other person’s state of health
c) a serious public health threat
To report an unexpected operation or event, please contact
the manufacturer or a representative.
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