41
40
11.2 Contraindications
Hearing aids should not be used under the following
circumstances:
•
Hearing loss due to mainly neural deficits
•
Insufficient size/shape of the ear canal or malformations at
the ear that do not allow for easy insertion and retrieval of
the respective device.
•
Adverse medical conditions of the outer ear and the ear
canal e.g., chronic inflammations, chronic skin irritations,
cholesteatoma
•
Known allergies to any materials that have skin contact
Patients who are unable to operate the devices independently
require competent assistance. The use of hearing aids for
mentally impaired persons and for children should only be
done on the recommendation of a doctor. A comprehensive
risk assessment should be performed for the specific individual
case. Close supervision by a caregiver is recommended to ensure
proper use of the hearing instruments and to avoid accidental
swallowing of hearing instruments or parts thereof..
12 OPERATING CONDITIONS
•
Relative humidity between 10% and 90%
•
Operating temperature between 0 °C and 40 °C
•
Air pressure between 500 and 1060 hPa