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
01
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.
02
• 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.
03
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.
04
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.
05
• 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-
06
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*
07
DESCRIPTION OF PARTS
Hearing aids
2
1 Microphones
2 Multi-function buttons
3 Ear tips
4 Charging contacts
5 In
ear
detection sensor
Charging case
1
2
3
4
5
6
7
3
-
~~~~
4
--~
---L
Upper
cover
Charging slots
7
---------'
Charging indicator
of
hearing aid (L)
Charging indicator
of
charging case
Charging indicator
of
hearing aid (R)
Charging port
Battery check button
08
INSTRUCTIONS
FOR
USE
1. Choose and install the
ear
tips
a: If the medium size
is
too tighUloose for you, you can adjust the
small/large size to see
if
other
is
a better fit.
b: Push the ear tip
rim
membrane outward.
c:
Hold on to the end ofthe hearing aid and push firmly to ensure that the
ear tip
is
fastened securely.
Note: Please pull the tip gently to check if it
is
firmly attached and ensure
the ear tip won't fall off easily.
2. Left & right hearing aid markings
There
is
a
Lor
R marking
on
the hearing aid.
The
L marking
is
for left hearing aid,
and
the R marking
is
for right hearing
aid.
J
.!,
~
ro
~&
left hearing
aid.
09
~w
~
R marking for
right hearing
aid.
3. Instruction
for
insertion depth
For adults, the average length of the ear canal has been estimated to be
23-28mm and the maximum insertion size ofthe hearing aid
is
9.2mm.
So the distance from the ear tip to the tympanic membrane after wearing
the hearing aid
is
at least 13.8mm, which
is
greater than the lower limit
of
10mm specified by OTC.
Therefore, the device
is
safe and complies with OTC regulations.
23-28mm
(adult)
4. Wearing & removing hearing aid
Insertion depth=9.2mm
(MAX)
Your hearing aids are equipped with in-ear detection sensor.
a: The hearing aids will enter the standby status automatically when
removed from your ear.
b: The hearing aids will turn
on
automatically when placed back
in
your
ear.
Wearing:
Step
1:
Hold the hearing aid body (hard
~
part), place
in
the ear (make sure
ii
is
in
right direction like picture).
Step
2:
Move the body slightly into ear
lobe for holding until feeling comfortable.
Removing: Grasp the protruding part of [i]
~
the hearing aid and remove
ii
from your
~
0)
ear lobe gently.
10
Note:
• The creak sound can be used as a reference to determine whether
the hearing aid is secured.
• Ifthe hearing aid gives out squeaking, please check if it
is
inserted
correctly. If inserted correctly, but the squeaking remains, please
replace with the other size
of
ear tip. When the hearing aid is not
in
use, please turn it off without delay.
• When the hearing aid is not functioning properly, please check
the "TROUBLESHOOTING" guide. If none
of
the solutions work,
please contact the Nuvomed Inc. Expert Care Team.
5.
Turning on/offthe hearing aids
Turning
on
the hearing aid:
The hearing aid will turn on automatically
in
about three (3) seconds when
it
is
worn correctly.
You
will hear prompt tone according
to
the hearing
program (refer
to
"HEARING PROGRAM CHANGE")
Turning offthe hearing aids:
The hearing aid will enter the standby status automatically when it
is
removed from your
ear.
When placed back into the correct slot
of
the
charging case, hearing aids will turn off and start charging automatically.
Turn On
Standby
Tum Off
6. Volume adjustment
• The hearing aid has six (6) volume levels.
•
You
could increase the volume by short pressing the"+" button.
•
You
could decrease the volume by short pressing
the"-
"button.
• The hearing aid will give out the prompt tone "Beep" when you
increase or decrease the volume.
• The hearing aid will give out the prompt tone "Beep-Beep-Beep" at
maximum or minimum volume.
L
-tt?1/-
-----1
"+"
button
button
11
7. Hearing program change
• There are four (4) preset programs
in
the hearing aid.
• You could change the hearing program by long-pressing the "+"
or
"-"
button for about three (3) seconds.
• The hearing aid is designed with a memory function: The hearing aid
can recognize the previous hearing program automatically.
• You're hearing aid beeps to indicate which hearing program you are in.
Hearing program Prompt tone
1 Standard One (1) Beep
2 Restaurant
Two
(2) Beeps
3 Outdoor Three (3) Beeps
4 Music Four (4) Beeps
Program Application situation
Standard program For quiet environments, such as:
home and office.
Restaurant program Forvery quiet environments, such
as: meeting, restaurant.
Outdoor program For outdoor environments, such
as road
or
supermarket.
Music program For very noisy environments, such
as: bar or crowded places.
8. Charging the hearing aid
• The hearing aid will turn off and start charging automatically when
placed back into the correct slot
of
the charging case.
• The blue indicator light indicates that the hearing aid is properly
charging, and the white indicator light indicates that the hearing aid is
fully charged.
• The indicator lights
of
the hearing aid will go out
in
about five (5)
minutes afterthe hearing aids are fully charged.
• Low battery warning: You will hearfive (5) Beeps every 10 minutes
when the remaining battery capacity is at a critical level.
12
9. Charging case
• The charging case will charge the hearing aid whenever the upper
cover is opened or closed. The charging process will stop
automatically when the case and hearing aids are fully charged.
• Check the "TROUBLESHOOTING" section when failure occurs to
your devices.
a: Turn on/off
With the hearing aids inside the charging case, you can turn the
charging case on or check the battery status by press and hold the
battery check button for about two (2) seconds. Then, you can also
press and hold the battery check button for about five (5) seconds to
turn off the charging case.
b: How to charge the charging case
Connect the included USB cable to the charging port
of
the charging
case and attach the other end of the cable to your computer USB port
or any other USB enabled power source.
There are four (4) blue indicator lights (LED) to show the remaining
battery capacity
of
the charging case. Read the following table for
detailed information. Full charging time for charging the case is 2-3
hours.
-Blue light 1m1 Flashing blue light -Light
is
off
Charging Remaining
status of battery LED 1
LED2
LED 3
LED4
charging capacity
case
100%
- - - -
Charging
75%-100'¾
- - - -
case
is
50%-75%
- - - -
charging
25%-50%
- - - -
0%-25%
llmllll
- - -
75%-100%
- - - -
Charging 50%-
75%
- - - -
case
is
- - - -
not 25%-50%
charging 5%-25% - - - -
0%-5% - - - -
13
Maintenance and cleaning
1.Hearing Aid care
-Keep your hearing aid clean. Extreme temperature {heat or cold),
moisture, and foreign substances can result
in
poor performance.
-Use the included cleaning tool to clean debris that may collect
on
the buttons, microphones, and charging contact. Inspect the
receiver, ear tips, and charging case regularly.
-
DO
NOT clean your hearing aid with water, solvent, cleaning fluids
or oils.
-Charging contacts should always
be
kept clean and dry.
-Always store your hearing aid
in
the charging case when not
in
use.
2.Charging case care
-Keep your charging case clean. Extreme temperature (heat or cold),
moisture, and foreign substance can result
in
poor performance
-Use the included cleaning brush to keep the charging ports clear
of
debris at all times.
-
DO
NOT use water, solvents or cleaning fluids or oils to clean the
charging ports.
-Store your charging case
in
a clean and dry location.
3.Care and maintenance
-Keep your device away from children and pets.
-Keep your hearing aid away from high-temperature and/or high
humidity environments.
-
Do
not poke the microphone with any sharp objects to avoid
damage.
-
Do
not attempt to disassemble or repair your devices by yourself.
Doing
so
will void your warranty and cause further damage
-Clean the charging contact
of
the rechargeable hearing aid with dry
and soft cloth regularly to ensure the normal charging.
4.Cleaning tool
-Clean any earwax that collects
on
to the ear tips by using the thin
side
of
the included tool.
-Remove ear tips from the hearing aid before cleaning and push the
ear tips rim membrane outward.
14
-Clean the ear tips with alcohol and a dry cloth and wait for the ear
tips to dry before attaching them to the hearing aid.
Note:
-We recommend replacing the ear tips every 3 months.
-If the tips get stiff, brittle or discolored over time, please change
them as soon as possible.
5.Cleaning tool
Use a soft cloth or tissue to wipe any moisture or perspiration from the
surface
of
the cleaning tool.
Troubleshooting
Problem Possible cause Solution
1.ls the hearing aid 1.Reinsert the hearing
inserted correctly
in
aid
in
your ears.
your ears? 2.Reduce the volume.
2.ls the volume too loud? 3.Replace the ear tips.
Feedback 3.Are the ear tips broken 4.Move your hand away
or or clogged?
"whistling" to create more space
4.Are you holding
an
between the hearing
object (e.g. a hat or a aid and the object.
telephone mouthpiece) 5.Visit your physician.
close to the hearing
aid?
5.ls your ear full
of
wax?
1.ls the hearing aid 1.Charge the hearing
charged? aid.
No
sound
2.ls the charging case 2.Charge the charging
charged? case.
3.ls your ear full
of
wax? 3.Visit your physician.
Hearing
Is
the hearing aid Reconnect the charging
aid
is
not connected correctly to a cable.
charging USB power source?
15
Specification
Test Standard: ANSI 3.22-2014
Test Equipment: FONIX 8000
Test Coupler:
HA-1
The standard test ambient conditions shall
be:
Temperature: 23·c±5t: (73°±9°F)
Relative humidity:
0%
to 80%
Atmospheric pressure: 760(+37.5,-150)mm of
Hg
or 101.3(+5,-20)kPa
1
).
OTC Hearing aids technical specifications
Test Items Program Program Program Program
1 2 3 4
Max. Output (OSPLso) 109dB 106dB 110dB 104dB
The full-on gain value 25dB 25dB 28dB 23dB
(HFA FOG@50)
The total harmonic 0.4% 0.3% 0.5% 0.4%
distortion value {THO)
The self-generated 19dB 14dB 12dB 16dB
noise value {EIN)
The Latency value 14ms 14ms 14ms 14ms
Frequency response F1=210Hz F1=220Hz F1=230Hz F1=200Hz
bandwidth F2=5400Hz F2=5600Hz F2=5000Hz F2=5700Hz
Frequency response 5dB 4dB 5dB 3dB
smoothness
2). Battery life & Discharge time
of
the charging case
Test Items Value
Battery life
of
hearing aids 12h
A pair hearing aids charging time with 4 times
fully charging case
•
The
data are derived from the measured value
of
the product
at
the
laboratory, not guaranteed values.
16
Normalized symbols
0 Follow operating instructions
* B type applied part
+ Needs protection from moisture
0 Manufacturing date
..
Manufacturer information
[ill] Balch code
[ill
Serial number
~
USE BY
Lh
Warning/ Danger: Improper use might cause serious injuries.
~
Medical Device
Storage/Transport
%¢
Permissible storage and transport temperature and humidity
Operating
%¢ Permissible operating temperature and humidity
Maintenance, storage, and disposal
• Maintenance
1) We do not authorize any institution or individual to maintain and/or
repair the product. If you suspect that the products may be
in
question, please contact us immediately.
2) The user must not attempt any repairs to the device or any of its
accessories. Please contact
us
for any repair needs.
3) Opening
of
the equipment by unauthorized agencies is not allowed
and will terminate any claim to warranty. Warning: No modification
of
this equipment
is
permitted.
17
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