oticon Opn miniRITE Manuale utente
Instructions for use miniRITE
miniRITE T
Oticon Opn™
Oticon Opn S™
Oticon Opn Play™
Oticon Siya
Oticon Ruby
WARNING: People younger than
18 should go to a doctor before
using this.
People younger than 18 years old
need specialized care, and using this
without a medical evaluation may
worsen impairment or disability.
A hearing aid user who is younger
than 18 should have a recent medical
evaluation from a doctor, preferably
an ear-nose-throat doctor (an ENT).
Before using this, a doctor should
determine that the use of a hearing
aid is appropriate.
WARNING to Hearing Aid Dispensers:
You should advise a prospective hearing
aid user to consult promptly with a doctor,
preferably an ear specialist such as an
ENT, before dispensing a hearing aid if
you determine through inquiry, actual ob-
servation, or review of any other available
information concerning the prospective
user, that the prospective user has any of
the following conditions:
• Visible deformity of the ear, either
congenital or traumatic
• Fluid, pus, or blood coming out of the
ear within the previous 6 months
• Pain or discomfort in the ear
• History of excessive ear wax or
suspicion that something is in the ear
canal
• Dizziness, either recent or long-
standing
• Sudden, quickly worsening, or
fluctuating hearing loss within the
previous 6 months
• Hearing loss or ringing (tinnitus) only
in one ear or a noticeable difference in
hearing between ears
• Audiometric air-bone gap equal to or
greater than 15 dB at 500 Hz, 1000 Hz,
and 2000 Hz
WARNING to Hearing Aid Dispenser,
Outputs over 132 d8 SPL:
You should exercise special care in
selecting and fitting a hearing aid with
a maximum output that exceeds 132 dB
SPL because it may impair the remaining
hearing of the hearing aid user.
Caution: This is not hearing protection.
You should remove this device if you
experience overly loud sounds, whether
short or long-lasting. If you’re in a loud
place, you should use the right kind of
hearing protection instead of wearing
this device. In general, if you would use
ear plugs in a loud place, you should
remove this device and use ear plugs.
Caution: The sound output should not
be uncomfortable or painful.
You should turn down the volume or
remove the device if the sound output
is uncomfortably loud or painful. If you
consistently need to turn the volume
down, you may need to further adjust
your device.
Caution: You might need medical help
if a piece gets stuck in your ear.
If any part of your hearing aid, like the
eartip, gets stuck in your ear, and you
can’t easily remove it with your fingers,
get medical help as soon as you can. You
should not try to use tweezers or cotton
swabs because they can push the part
farther into your ear, injuring your ear-
drum or ear canal, possibly seriously.
Note: What you might expect when you
start using a hearing aid
A hearing aid can benefit many people
with hearing loss. However, you should
know it will not restore normal hearing,
and you may still have some difficulty
hearing over noise. Further, a hearing
aid will not prevent or improve a medical
condition that causes hearing loss.
People who start using hearing aids
sometimes need a few weeks to get used
to them. Similarly, many people find that
training or counseling can help them get
more out of their devices.
If you have hearing loss in both ears, you
might get more out of using hearing aids
in both, especially in situations that make
you tired from listening —for example,
noisy environments.
Note: Tell FDA about Injuries,
malfunctions, or other adverse events.
To report a problem involving your
hearing aid, you should submit Informa-
tion to FDA as soon as possible after the
problem. FDA calls them “adverse events,”
and they might include: skin irritation in
your ear, injury from the device (like cuts
or scratches, or burns from an overheated
battery), pieces of the device getting
stuck in your ear, suddenly worsening
hearing loss from using the device, etc.
Instructions for reporting are available at
https://www.fda.gov/Safety/MedWatch,
or call 1-800-FDA-1088. You can also
download a form to mail to FDA.
Note: Hearing loss in people younger
than 18
• People younger than 18 should see a
doctor first, preferably an ear-nose-
throat doctor (an ENT), because they
may have different needs than adults.
• The doctor will identify and treat
medical conditions as appropriate.
• The doctor may refer the person to
an audiologist for a separate test, a
hearing aid evaluation.
• The hearing aid evaluation will help
the audiologist select and fit the
appropriate hearing aid.
A person who is younger than 18
years old with hearing loss should have a
medical evaluation by a doctor, preferably
an ENT, before buying a hearing aid. The
purpose of a medical evaluation is to iden-
tify and treat medical conditions that may
aect hearing but that a hearing aid won’t
treat on its own.
Following the medical evaluation and
if appropriate, the doctor will provide a
written statement that the hearing loss
has been medically evaluated and the
person is a candidate for a hearing aid.
The doctor may refer the person to an
audiologist for a hearing aid evaluation,
which is different from the medical evalu-
ation and is intended to identify
the appropriate hearing aid.
The audiologist will conduct a hearing
aid evaluation to assess the person’s abil-
ity to hear with and without a hearing aid.
This will enable the audiologist to select
and fit a hearing aid for the person’s
individual needs. An audiologist can also
provide evaluation and rehabilitation
since, for people younger than 18, hear-
ing loss may cause problems in language
development and educational and social
growth. An audiologist is qualified by
training and experience to assist in the
evaluation and rehabilitation of hearing
loss in people younger than 18.
Model overview
This booklet is valid for Oticon Opn™, Oticon Opn S™,
Oticon Opn Play™, Oticon Siya and Oticon Ruby families,
in the following hearing aid models:
miniRITE
miniRITE T
Oticon Opn FW 6
Oticon Opn 1 GTIN: (01) 05707131340795
Oticon Opn 2 GTIN: (01) 05707131340818
Oticon Opn 3 GTIN: (01) 05707131340801
Oticon Opn S FW 8
Oticon Opn S 1 GTIN: (01) 05707131374967
Oticon Opn S 2 GTIN: (01) 05707131374974
Oticon Opn S 3 GTIN: (01) 05707131374981
Oticon Opn Play FW 8
Oticon Opn Play 1 GTIN: (01) 05707131374998
Oticon Opn Play 2 GTIN: (01) 05707131375001
Oticon Siya FW 1
Oticon Siya 1 GTIN: (01) 05707131340887
Oticon Siya 2 GTIN: (01) 05707131340894
Oticon Ruby FW 1
Oticon Ruby 1 GTIN: (01) 05707131378491
Oticon Ruby 2 GTIN: (01) 05707131378507
Model overview
LED light (Oticon Opn Play) for visual indication
The LED light helps caregivers, parents, and teachers to operate
the hearing aid and to give instructions on relevant functions and
modes (see relevant information throughout the booklet).
The following speakers are available for the above models:
Speaker 60
Speaker 85
Speaker 100 (Power Instrument)
Power Receiver Mold speaker 100 (Power Instrument)
Power Receiver Mold speaker 105 (Power Instrument)
Introduction to this booklet
This booklet gives you guidance on how to use and maintain your
new hearing aid. Please read the booklet carefully, including the
Warnings section. This will help you to get the most out of your
new hearing aid.
Your hearing care professional has adjusted the hearing aid to meet
your needs. If you have further questions, please contact your
hearing care professional.
About Start-up Handling Options Tinnitus Warnings More info
For your convenience, this booklet contains a navigation bar to help
you easily navigate through the different sections.
Intended use
Intended use The hearing aid is intended to amplify and transmit
sound to the ear.
Indications for use Impaired hearing within mild to severe-to-profound
hearing loss.
Intended user Adults and children older than 36 months.
User environment Indoor and outdoor.
Contraindications Users of active implants must pay special attention
when using the hearing aid. For more information read
the Warnings section.
Clinical benefits The hearing aid is designed to provide better speech
understanding to help ease communication with the
aim of improving quality of life.
IMPORTANT NOTICE
The hearing aid amplification is uniquely adjusted and optimized
to your personal hearing capabilities during the hearing aid fitting
performed by your hearing care professional.
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