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Charging accessories: Please note,
contraindications are not derived from the
charging accessories, but from the compatible
hearing aids.
Intended Patient Population
Hearing aid: This device is intended for
patients from 3 years of age who fulll the
clinical indication for this product. The tinnitus
soware feature is intended for patients from
18 years of age who full the clinical indication
for this feature.
Charging accessories: The intended population
is the user of the compatible hearing aids.
The primary criteria for the referral of a patient
for a medical or other specialist opinion and /
or treatment are as follows:
• Visible congenital or traumatic deformity
of the ear;
• History of active drainage from the ear in
the previous
90 days;
• History of sudden or rapidly progressive
hearing loss in one or both ears within
the previous 90 days;
• Acute or chronic dizziness;
• Audiometric air-bone gap equal to or
greater than 15 dB at 500 Hz, 1000 Hz
and 2000 Hz;
Visible evidence of signicant cerumen
accumulation or a foreign body in the ear
canal;
• Pain or discomfort in the ear;
• Abnormal appearance of the eardrum
and ear canal such as:
• Inflammation of the external auditory
canal
• Perforated eardrum
• Other abnormalities which the hearing
care professional believes are of medical
concern
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