Sonite R | 77
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 a patient’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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