NuvoMed DigiEars PRO User manual

getting

' •
Place Zinc AirA13 Battery
in yourdevice.
•
Try out all ear bud sizes
beforeturning the device on.
You want a comfortable, snug fit.
•
You're ready to use your
hearing aids!
- +
I P" tf"O,
•
Clean wax out of your
ears, excess earwax
can clog your hearing aids.
•
Start at the lowest volume
setting increases needed.
This is onlya guide for getting started, 1
so be sure to read thefull usermanual.

NuvoMed®
DigiEars IPRO
Digital True Wireless
Hearing Aid
Model: HAA-4/0141
INSTRUCTION MANUAL
PLEASE READ ALL INSTRUCTIONS CAREFULLY
& RETAIN THIS COPY FOR FUTURE USE

WARNINGS
& 1. WARNING: If you are younger than 18, do not use this.
You should go to a doctor, preferably an ear-nose-throat doctor (an ENT),
because your condition needs specialized care. Over-the-counter hearing aids
are only for users who are age 18
or older.
This OTC hearing aid is for users who are age 18 and older.
People who are younger than 18 with hearing loss should see a doctor,
(preferably an ENT), because they may need medical testing and
management. Hearing loss can affect speech and learning, so profes-
sional fitting and continuing care are also important.
2. WARNING: When to see a doctor
Ifyou have any of the problems listed below, please see a doctor,
preferably an ear-nose-throat doctor (an ENT).
•Your ear has a birth defect or
an unusual shape. Your ear was
injured or deformed
in an accident
•You have seen blood, pus, or fluid coming out
of your ear in the
past 6 months
•Your ear feels painful or uncomfortable
•
You have a lot of ear wax, or you think something could be lodged
in your ear
•You get really dizzy or have a feeling
of spinning or swaying
(called vertigo)
•Your hearing changed suddenly in the past 6 months
•Your hearing changes and/or varies, i.e., it gets worse then gets
better again
•You have worse hearing
in one ear
•You hear ringing or buzzing
in only one ear
3. WARNING: This hearing aid should not cause pain when inserting
it.
Remove this device from your ear if it causes pain or discomfort when
you insert or place
it. If you decide to try inserting the device again, make
sure
to follow the instructions. Ifyou feel pain or discomfort again, contact
the manufacturer.
If your pain and/or discomfort doesn' t go away,
contact your hearing healthcare professional.
You can also report this to
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FDA as an adverse event. To do this, please follow the instructions that
will appear later
in this manual.
4. WARNING: do not use if any of the followings apply to you
• Congenital atresia of external ear or deformity of any part of the
ear canal
• Deafness is unstable, and the degree
of hearing loss often
fluctuates
• Persistent headaches, dizziness, earaches, tinnitus or other
symptoms that are not suitable for adaptation
• Sudden onset
of hearing loss within the past 3 months; rapid
progressive deafness; unilateral hearing loss or other acute ear
disease
• Effusion (secretions/discharge)
in the ear and/or frequent
purulence (pus).
• Central deafness (central nervous system) or non-organic
deafness.
• Patients with acute otitis externa and tympanitis.
• Patients with acute and chronic suppurative otitis media
(in the period of purulent infection).
• Patients who are allergic to the materials
of this product.
5. WARNING: Important Safety Instruction
• Keep small parts (hearing instrument, ear tips, battery or other
detachable parts)that can
be swallowed out of children's reach.
• Dropping, immersing
in liquid, exposure to strong electromagnetic
fields or excessive heat will damage the hearing aid. Remove
devices prior to any type
of X-ray, MRI, or CT scan.
• If parts become stuck
in the ear canal, seek medical assistance-do
not attempt to remove by yourself.
•
Do not use at high volume for extended periods of time. Ear injury
can result.
• Ifyou experience any pain or strong discomfort using the devices,
remove and consult a doctor.
• Routine maintenance to keep the device clean is required. Ensure
that ear tips are free
of debris and moisture at all times.
•
Do not store or use the product in environments of high humidity or
temperature (such as a sauna or steam room), to avoid damage.
• Batteries should be properly recycled and not disposed
in the trash.
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• Keep the devices away from children. Injury or damage may result.
•
Do not share your hearing aids with others. Using a hearing aid
configured for someone else can result
in hearing damage or
injury.
• Monitor for any unusual skin reaction. Ifyou notice any allergic
reaction (itchiness, swelling, or rash), stop wearing the hearing
aids and consult a medical specialist.
• Stay away from strong electromagnetic fields when using
hearing aid to avoid unexpected damage. Your hearing aids are
delicate electronic instruments and may be damaged by contact
with strong magnetic equipment such as electromagnetic ovens,
microwave ovens, ultrasonic cleaners, etc.
• Ifthe Bluetooth function
is available for your device, do not con-
nect the hearing aid and headsets to the mobile phone via Blue-
tooth simultaneously. Noise, distortion or any other unexpected
problems may occur to your hearing aid.
• If needed, please contact the manufacturer for assistance
in
stepping up, using or maintaining your devices or to report any
unexpected operation or events.
• Contact your hearing professional for assistance if needed.
•
Do NOT fix your devices by yourself. Doing so will not only void the
warranty but also cause further damage easily -Check the
"TROUBLESHOOTING GUIDE" first when failures occur to your
devices.
CAUTIONS AND NOTICES
1. 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.
2. 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.
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3. Caution: You might need medical help if a piece gets stuck in
your ear.
Ifany part of your hearing aid, like the ear tip, 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.
4. Note: If you remain concerned, consult a professional.
Ifyou try this device and continue to struggle with or remain concerned
about your hearing, you should consult with a hearing healthcare
professional.
5. 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.
6. Note: Tell FDA about injuries, malfunctions, or other adverse
events.
To report a problem involving your hearing aid, you should submit infor-
mation 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 worsen-
ing 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.
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7.Note:lf you experience side effects, contact a hearing
care professional.
Possible side effects from wearing the hearing aid may be:
-Dizziness
-Tinnitus
-Perceived worsening of hearing loss
-Nausea
-Headache
-Skin reaction
-Excessive ear wax accumulation
8.Note:Tips for better communication
It will take practice, time, and patience for your brain to adapt to the new
sounds that your hearing aids provide. Hearing
is only part of how we
share thoughts, ideas and feelings.
Reading lips, facial expressions, and gestures can help the learning
process and add to what amplification alone may miss.
(1) Please review the following simple communication tips for you:
• Move closer to and look at the speaker.
• Sit face-to-face
in a quiet room if possible.
• Try out different locations to find the optimal places to listen.
• Minimize distractions.
• Background noises may be frustrating at first; remember, you have
not heard them for a while.
• Let others know what you need; keep
in mind that people cannot
"see" your hearing loss.
• Develop realistic expectations
of what your hearing aids can and
cannot do.
• Better hearing with hearing aids are a learned skill combining desire,
practice, and patience.
(2)
You will learn and adjust, it just takes a little time. Remem-
ber
to be patient with yourself.
(3) For Your Family and Friends:
Your family and friends are also affected by your hearing loss.
Request that they do the following:
• Get your full attention before beginning to speak.
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• Look at you or sit face-to-face.
• Speak clearly and at a normal rate and level; shouting can actually
make understanding more difficult.
• Rephrase rather than repeat the same words; different words may be
easier to understand.
• Minimize distractions while speaking.
9.Additional cautions:
• The use of accessories and cables other than those specified by
manufacturer (except for cables sold by manufacturer as replace-
ment parts for internal components) may result
in increased
emission or decreased immunity
of the device.
•
Do not use a mobile phone or other devices that emit electro
magnetic fields, near the unit. This may result in incorrect operation
of the unit.
• Do not bring the device into any MRI, CT, diathermy, RFID and
electromagnetic security systems such as metal detectors environ-
ment or near any of this equipment. Consult manufacturer if you
have any questions.
• This device should not be used adjacent to or stacked with other
equipment and that if adjacent or stacked use is necessary, this
device should be observed to verify normal operation in the
configuration
in which it will be used.
• Refer to further guidance below regarding the EMC
environment
in which the device should be used.
There
is no guarantee that interference will not occur in a particular
installation. Radiated or conducted electromagnetic signals can cause:
1) As to devices:
• Deviation
of the values of pulse duration, amplitudes, and repetition
frequencies, may impair the unit's essential performance. The
device has passed EMC highest interference level test, and the
parameters do not deviate the essential performance requirement.
• The device displays abnormally.
2) As to patients:
• The sensitivity of stimulation may be weaker or stronger, but it does
not produce safety issues.
• It cannot achieve expected effect.
Ifthis equipment is found to cause or respond to interfer-
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ence, attempt to correct the problem by one or more of the follow
ing measures:
• If feeling too
weak or too strong stimulation, adjust the strength
level to an acceptable level.
• Ifthe device display is abnormal,
power off and restart the device
and check whether it shows properly.
• Re-orient
or re-locate the affected device.
• Increase the separation between the unit and the affected device.
•
Power the equipment from a source other than that of the affected
device.
• Consult the service representative for further suggestions.
Getting Started
Remove the product from the box.
Please retain all packaging until you have thoroughly checked and
counted all the parts and the contents against the parts list.
Package Contents
Digital Hearing Aid
Ear tips x 3 pairs (2pcs each
for small, medium & large)
Charging Case
USB Cable
Cleaning Tool
Carrying Pouch
Instruction Manual
Features
Discreet True Wireless Earbud Design
Seamless In
Ear Detection Technology
Active Noise Reduction
Minimal Noise Interference
Bluetooth Connectivity for Streaming Music
Built-in
Mic for Hands-Free Calling
Simple +/- Volume Adjustment
4 Programmed presets: Standard, Restaurant,
Outdoor and Music
Charging time (Case): s
2hr
Working time: .!:12hr x 5 times= 60
*Full Charge Case Carries 4 Full Recharges for Up To 60 Hrs of
Usage*
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