60
61
24.
Important safety information
Please read the relevant safety information and
limitations-of-use information on the following
pages before using your hearing aid.
Intended use
The intended use of hearing aids is to amplify
and transmit sound to the ears and hereby
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.
The chargers are intended to charge the battery
of the rechargeable hearing aid.
Intended patient population:
Hearing aids: This device is intended for patients
with unilateral and bilateral, mild to severe
hearing loss from 8 years of age. The tinnitus
software feature is intended for patients with
chronic tinnitus from 18 years of age.
Charger: The intended patient population is the
user of the compatible hearing aids.
Intended user:
Hearing aids: Intended for people with hearing
loss using a hearing aid and their caregivers.
A hearing care professional is responsible for
adjusting the hearing aid.
Charger: Intended for people with hearing loss
using the compatible rechargeable hearing aid
and their caregivers, or hearing care professional.
Indications:
General clinical indications for the use of
hearing aids and tinnitus feature are:
•
Presence of hearing loss
•
Uni- or bilateral hearing loss
•
Conductive, sensorineural or mixed hearing
loss
•
Mild to profound hearing loss
•
Presence of a chronic tinnitus (only applicable
for devices which provide the Tinnitus feature)