NuvoMed DigiEars PLUS 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 IPLUS
Digital Behind-The-Ear
Hearing Aid
Model: HBE-4/0144
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.
• If the 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 with right hand side ear tube (red "28" marker
installed)
Left hand side ear tube (blue "28" marker)
Ear Tips x 3
(1
pc each for small, medium & large)
ZincAirA
13
Battery x 2
Cleaning
Tool
Storage Case
Carrying Pouch
Instruction Manual
Features
Traditional Behind-the-Ear Design
Ergonomic Fit
Active Noise Reduction
Minimal Noise Interference
Two (2) Built-In Microphones for Increased Hearing
Adjustment Simple +/- Volume Adjustment
Four (4) Program Presents: Standard, Restaurant, Outdoor and Music
Powered by ZincAirA13 Battery
*Replaceable Battery Included*
07
DESCRIPTION OF PARTS
1
2
3
4
5
6
7
8
1
---
-+
2
---
1-+
3
----+
-+
4
---+-
5
---
-
Front microphone input
Up
button+
Down button -
Rear microphone input
Battery compartment
Stable line
Ear tip
Ear tube
08
INSTRUCTIONS FOR USE
1.
Choose and install the ear tips
Choose: If the medium size
is
too tight/loose for you, adjust with the
small/large size
to
see
if
other
is
a better fit.
Install: Push the ear tip over the ridges
on
the thin tube. Make sure it
is
properly and securely mounted.
2.Loading
of
battery
Remove the sticker from a new battery (included)
and wait for two or three minutes.
Open the battery compart-
ment. Place the battery
in
the
battery door with the "+"
symbol facing upwards.
ffi
WARNING
This product contains a Button Cell Battery. A swallowed Button Cell
Battery can cause internal chemical burns leading to death
in
as little
as two hours. Dispose
of
used batteries immediately. Keep new and
used batteries away from children. If you think batteries might have
been swallowed or placed inside any part
of
the body, seek immediate
medical attention. Do not mix with used or other types
of
batteries.
09
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
of
the hearing aid is 11.5mm.
So the distance from the ear tip to the tympanic membrane afterwearing
the hearing aid is at least 11.5mm, 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.
ON/OFF the device
To
turn ON -Gently open the
battery compartment, insert
battery, and close the compart-
ment. Then, the device will be
set to turn on after a short delay,
in
order to give you enough time
to set it
in
your ear comfortably
before it turns on.
To
turn OFF -Simply open the
battery compartment a crack.
Store it
in
a safe & dry place.
10
Insertion depth=11.5mm
(MAX)
5.
Putting on/off the hearing aid
Putting
on
the hearing aid:
a.Place the hearing aid behind your
ear.
b.lnsert the earpiece into your ear canal.
c.Tuck the anchor into the bowl
of
your earto secure your hearing aid.
Putting offthe hearing aid:
Pull
on
the bend of the tube and remove the hearing aid from behind the
ear.
6. Volume control (volume levels & volume memory)
Short press + button once, the volume will increase one level. Short
press the -button one once, the volume will decrease one level.
Note:
-
You
would hear one (1) "beep" sound when the volume
is
decreased/increased by one level.
-Three (3) "beep" sounds would be heard when the volume reaches
maximum or minimum volume level.
-Next time when you use the machine, you don't need to adjust it
again because it will memorize your setting.
11
7. Program switching
Long press the +/- button 3 seconds to change the program.
Note:
There are four (4) programs:
-Normal program:
You
would hear a single "beep" sound. Restaurant
program:
You
would hear two (2) "beep" sounds. Outdoor program:
You
would hear three (3) "beep" sounds. Music program:
You
would
hear four (4) "beep" sounds.
-Program memory: The hearing aid will enter Normal program when
you use
ii
for the first lime. After that, every lime you power
ii
back on
(from powered off state), the program would be same as your last
used preference.
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 Forvery noisy environments, such
as: bar
or
crowded places.
12
8. Maintenance and cleaning
1.To ensure optimal use, it
is
necessary to regularly clean your hearing
aid, ear tube & ear tips from time to time.
-Please use a soft & dry tissue
or
cloth to clean the hearing aid.
Never use chemicals or hard abrasives.
-Please use the provided brush to clean the ear tips with care.
-Please use the provided cleaning tools to clean the ear tube. If it
is
very dirty, please use a soft & dry tissue
or
soft cloth for cleaning.
2.lt is important to keep your device clean and dry. On a daily basis,
clean the hearing aid using a soft cloth
or
tissue.
3.Clean up earwax adhered to the ear tips by using the thin side
of
included tool. Remove ear tips from the hearing aid before cleaning and
push the ear tips rim membrane outward.
Clean the ear tips with alcohol and 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 three (3) months.
-
If
the tips get stiff, brittle,
or
discolored over time, please change
them as soon as possible.
4.ln order to avoid damage due to humidity
or
excessive perspiration,
the use
of
a drying kit is recommended.
5.0perate
the controls with care, do not press very hard.
6.lf
your hearing aid is dropped
in
water, wipe with dry cloth and allow
ample time for it to fully dry before attempting to use
or
have it tested by
Nuvomed Inc.
13
Troubleshooting
Problem Possible cause Solution
Cannot
hear Is the battery exhausted? Replace with a new battery.
sound
well
1.lfyou turn on the power. 1.Turn
on
the device.
2.lf
you fit the battery
in
2.Remove and re-install
correct direction. the batteries.
3.lf
the battery power has 3.Replace the new
been used up. battery.
4.lf
the earphone
is
4.Contact Nuvomed Inc.
damaged. 5.Contact Nuvomed Inc.
5.lf
the lead
is
broken. 6.Wipe off, then have it
6.What to do
if
the hearing tested.
No
sound aid was dropped
in
?.Carefully wipe it off
water? with a soft, dry cloth,
7.lf the hearing aid was let it dry and then have
accidentally dropped
in
it tested by Nuvomed
water or other liquid. Inc.
a.Never attempt to dry the a.Compliance with the
hearing aid
in
a user manual.
microwave oven, a dish
dryer, or with a hair
dryer. This may damage
the hearing aid.
1.Battery power isn't 1.Replace with new
The
sound
enough. batteries.
is
very
2.lf
something is wrong 2.Consult your distributor.
weak
and
with earphone. 3.Close the battery holder
vague 3.ls the battery holder properly
closed properly
14
If the receiver
of
the
Volume hearing aid does not fit
level too the ear properly, or a
high
whistling unpleasant
noise may be heard
(which is caused by
acoustic feedback).
Specification
Test Standard: ANSI 3.22-2014
Test Equipment: FONIX 8000
Test Coupler: HA-2
Turn the hearing aid off
and reposition it properly
in
the ear.
Or,
if
the
receiver does not fit your
ear properly, try replacing
it with another type. The
use
of
a correctly fitted ear
mold
is
recommended.
Please consult your
hearing aid dispenser.
The standard test ambient conditions shall be:
Temperature: 23'C±5'C(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 aid technical specifications
Test Items Program Program Program Program
1 2 3 4
Max. Output (OSPL•o) 110dB 111dB 111dB 110dB
The full-on gain value 31dB 27dB 33dB 24dB
(HFA FOG@50)
The total harmonic 0.3% 0.5% 0.4% 0.3%
distortion value (THD)
The self-generated 21dB 25dB 16dB 20dB
noise value (EIN)
The Latency value 6ms 6ms 6ms 6ms
Frequency response
F1=200Hz
F1=203Hz
F1=210Hz F1=200Hz
bandwidth
F2=5600Hz F2=5400Hz
F2=5300Hz F2=7500Hz
Frequency response 6dB ?dB 8dB 6dB
smoothness
15
2).
Battery life
The
battery life ofa hearing
aid
is
up
to 235 hours.
• The data are derived from the measured value ofthe product at the
laboratory, not guaranteed values.
Normalized symbols
0 Follow operating instructions
* B type applied part
-+
Needs protection from moisture
E] Manufacturing date
...
Manufacturer information
~
Batch code
ill] Serial number
il USE
BY
Lh
Warning/ Danger: Improper use might cause serious injuries.
~
Medical Device
Storage/Transport
%¢
Permissible storage and transport temperature and humidity
Openrting
%¢ 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. Ifyou suspect that the products may
be
in
question, please contact us immediately.
16
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.
• Storage
1) Always store your rechargeable devices
in
the Charging Case when
not in use.
2) Do not store
or
expose the devices and/or case to extreme hoUcold
temperatures, moist/humid environments,
or
shock/vibration.
3) Keep the devices and case in following environmental ranges:-10°C
-55°C,10%-90%RH, 700-1060hPa
4) The hearing aids should be fully charged before used for the first time.
The hearing aids should be charged at least every six (6) months if
they are not used for
an
extended period oftime.
Warranty
WARRANTY
DURATION:
All materials and workmanship are warrantied to
the original consumer and purchaser for a period
of
ninety (90) days
from the original date
of
purchase. Proof
of
purchase required to
ensure warranty coverage.
WARRANTY
COVERAGE:
This product is warranted against defective
materials
or
workmanship. This warranty is void
if
the product has been
damaged by accident,
in
shipment, unreasonable use, misuse, neglect,
improper service, commercial use, repairs by unauthorized personnel
or
other causes not arising out
of
defects in materials
or
workmanship.
This warranty is effective only
if
the product
is
purchased and operated
in
USAand does not extend to any units which have been used
in
violation of written instructions furnished by Nuvomed Inc.
or
to units
which have been altered
or
modified
or,
to damaged products
or
parts
thereof which have had the serial number removed, altered, defaced
or
rendered illegible.
WARRANTY
DISCLAIMERS:
This warranty
is
in lieu of all warranties
expressed
or
implied and no representative
or
person is authorized to
assume for Nuvomed Inc. any other liability
in
connection with the sale
of
our products. There shall be no claims for defects
or
failure under
17
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