Important Safety Information - Phonak myPhonak 6 User Manual

Important safety information

Please read the relevant safety information on the following pages before using your app.
Intended use:
The app is standalone software for intended hearing
aid users to select, configure and save hearing aid
settings, within the limited range permitted by the
fitting software. The app also enables and empowers
intended hearing aid users to connect and communi-
cate with hearing care professionals for remote
hearing aid adjustments.
Intended patient population:
This device is intended for patients with unilateral and
bilateral, mild to profound hearing loss from 17 years
of age. The Tinnitus feature is intended for patients
with chronic tinnitus from 18 years of age.
Intended user:
Person with hearing loss using a compatible device.
Indications:
Please note, indications are not derived from the app,
but from the compatible hearing aids. General clinical
indications for the use of hearing aids and Tinnitus
feature are:
• Presence of a 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:
Please note, contraindications are not derived from the
app, but from the compatible hearing aids.
General clinical contraindications 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 auditory nerve)
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 significant cerumen accumula-
tion 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
The hearing care professional may decide that referral
is not appropriate or in the best interests of the patient
when the following applies:
• When there is sufficient evidence that the condition
has been fully investigated by a medical specialist
and any possible treatment has been provided;
• The condition has not worsened or changed signifi-
cantly since the previous investigation and / or
treatment
• If the patient has given their informed and compe-
tent decision not to accept advice to seek a medical
opinion, it is permissible to proceed to recommend
appropriate hearing aid systems subject to the
following considerations:
> The recommendation will not have any adverse
effects on the patients' health or general wellbe-
ing;
> The records confirm that all necessary considera-
tions about the patient´s best interests have been
made
If legally required, the patient has signed a disclaimer
to confirm that the referral advice has not been
accepted and that it is an informed decision.
22