oticon miniRITE R Manuale utente
Instructions for use miniRITE R
Oticon Opn S™
Oticon Opn Play™
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 deter-
mine through inquiry, actual observation,
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 dB 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 uncomfort-
ably 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 eardrum 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 Information 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 down-
load 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 identify 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 evaluation and is intended
to identify the appropriate hearing aid.
The audiologist will conduct a hearing
aid evaluation to assess the person’s ability
to hear with and without a hearing aid.
This will enable the audiologist to select
and fit a hearing aid for the person’s individ-
ual needs. An audiologist can also provide
evaluation and rehabilitation since, for peo-
ple younger than 18, hearing loss may cause
problems in language development and
educational and social growth. An audiolo-
gist 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 the Oticon Opn S™, Oticon Opn Play™ and
Oticon Ruby families in the following hearing aid models:
FW 8.0
Oticon Opn S 1 GTIN: (01) 05714464013166
Oticon Opn S 2 GTIN: (01) 05714464013173
Oticon Opn S 3 GTIN: (01) 05714464013180
Oticon Opn Play 1 GTIN: (01) 05707131374998
Oticon Opn Play 2 GTIN: (01) 05707131375001
FW 1.0
Oticon Ruby 1 GTIN: (01) 05714464013210
Oticon Ruby 2 GTIN: (01) 05714464013227
The following speakers are available for the above models:
Speaker 60
Speaker 85
Speaker 100 (Power Instrument)
Power receiver mold speaker 100
Power receiver mold speaker 105
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.
A hearing care professional (hearing aid professional, audiologist,
ENT (ear, nose and throat) doctor, and hearing aid dispenser) is a
person who is appropriately educated and has proven competency
in professionally assessing hearing, selecting, fitting, and
delivering hearing instruments and rehabilitation care to persons
with hearing loss.
The education of the hearing care professional is in accordance
with national or regional regulations.
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.
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.
Intended use
Intended use The hearing aid is intended to amplify and transmit
sound to the ear.
Indications for use Bilateral or unilateral impaired hearing of sensorineural,
conductive, or mixed type ranging from a slight
(16dB HL*) to profound (95dB HL*) degree of hearing
loss, with an individual frequency configuration.
Intended user Person with hearing loss using a hearing aid and their
caregivers. Hearing care professional responsible for
adjusting the hearing aid.
Intended user
group
Adults and children older than 36 months.
User environment Indoor and outdoor.
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