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Intended medical indication
General clinical indication for the use of hearing aids is:
Presence of hearing loss:
• Unilateral or bilateral
• Hearing loss type: conductive, sensorineural or mixed
• Grades of hearing loss:
• Mild
• Moderate
• Moderately Severe
• Severe
General clinical indication for the use of Tinnitus Balance
software feature is presence of chronic tinnitus (>3 months,
after occurrence) in addition to the presence of hearing loss.
Medical contraindications
Medical contraindications for the use of hearing aids are:
• Deformity of the ear (i.e. closed ear canal; absence of the
auricle)
• Neural hearing loss (i.e. retro-cochlear pathologies such
as absent/ non-viable auditory nerve)
• Evidence of active or chronic middle or outer ear
pathology, chronic drainage or discharge, evidence of
chronic inammation
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 hearing aid is intended to amplify and transmit sound
to the ear and thereby compensate for impaired hearing.
The Tinnitus Balance software is intended for use by people
with tinnitus who also desire amplication. It provides
supplementary noise stimulation which can help defocus
the user`s attention from their tinnitus.
Intended user
Intended for:
• People with hearing loss
• Caregivers of the person with hearing loss
• Hearing care professional responsible for adjusting the
hearing aid
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