Intended Patient Population; Contraindications - Unitron Inseramd B1-312 Guide D'utilisation

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.

Intended patient population:

This device is intended for patients with
unilateral and bilateral, mild to profound
hearing loss from 18 years of age. The Tinnitus
feature is intended for patients with chronic
tinnitus from 18 years of age.
Intended user:
Intended for people with hearing loss using a
hearing aid and their caregivers. A hearing care
professional is responsible for adjusting the
hearing aid.
54
Indications:
General clinical indications for the use of
hearing aids and Tinnitus feature are:
Presence of hearing loss
•
Uni- or bilateral
•
Conductive, sensorineural or mixed
•
Mild to profound
•
Presence of a chronic tinnitus (only
•
applicable for devices which provide the
Tinnitus feature)

Contraindications:

General clinical contra-indications for the use of
hearing aids and Tinnitus feature are:
Hearing loss is not in the fitting range of the
•
hearing aid (i.e. gain, frequency response)
Acute tinnitus
•
Deformity of the ear (i.e. closed ear canal;
•
absence of the auricle)
Neural hearing loss (retro-cochlear
•
pathologies such as absent/non-viable
55