OTC Audien BTE Manuale utente
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OTC
Audien BTE
U S E R M A N U A L
2.WARNING:When to see a doctor
If you 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 saw 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 in your ear.
● You get really dizzy or have a feeling of spinning or swaying (called vertigo).
This OTC hearing aid is for users who are 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 professional fitting and continuing care are also important.
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.
WARNING
●Your hearing changed suddenly in the past 6 months.
● Your hearing changes: 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. To try again,
make sure to follow the instructions. If you feel pain or discomfort again, contact the manufacturer. If your
pain or discomfort doesn't go away, contact your hearing healthcare professional. You can also report this to
FDA as an adverse event according to the instructions that appear later.
4.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.
5.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.
WARNING
6.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.
7.Note: If you remain concerned, consult a professional.
If you try this device and continue to struggle with or remain concerned about your hearing, you should
consult with a hearing healthcare professional.
8.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 situa-
tions that make you tired from listening — for example, noisy environments.
Follow all the facility rules and posted instructions in areas where wireless network use its prohibited.
9.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 download a form to mail to FDA.
10. Intended use
●The Hearing Aids are used for hearing compensation of patients with mild to moderate air conduction
hearing loss.
11. Contraindication
●The device is unsuitable and should not be used in the following situations:
(1) Patients with chronic suppurative otitis media, congenital ear atresia to banned use.
(2) This hearing aids only be used for compensating the patients with hearing impairment, do not have
hearing therapeutic value.
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It’s time to
hear again.
Device Diagram
Package Contents
Setting Up Your Device
Fitting Your Ear Domes
Switching Between Modes
Adjusting Volume
Inserting Into Ear
Power On/Off
Charging Your Device
Light Key
Cleaning Your Device
Dome & Product Cleaning
Product Care
Precautions
TA B L E OF C ONTENT S
1, 2
3
4-8
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5
6
7
8
9
10
11-16
11, 12
13-16
17,18
19
Regulatory and Legal Information 20-30
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DEVICE DIAG R AM
Charging Case Cover
Left Charging Port
Right Charging Port
Charging Indicator
Light for Left Ear
(Light 1)
Charging Indicator
Light for Right Ear
(Light 3)
Charging Indicator
Light for Charging
Case (Light 2)
Ear Tube
Ear Dome
Receiver
Microphone 1
Microphone 2
Magnetic Charging
Connection Point
Volume Up
(Press for 1 second)
Mode Switch (Press for 3 seconds)
Volume Down
(Press for 1 second)
Turn On/Off (Press for 3 seconds)
Red = Right Ear
SE TTING UP YOUR D E VICE
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PACKAGE CONTENT S
Fitting Your Ear Domes
Your Audien BTE comes with small, medium and large sizes of
Ear Domes. To remove an EarDome from your device, simply
pull with enough force until it pops off. To attach, hold on to the
fastened securely.
Replace the domes as needed. Choosing the dome size most suitable for your needs will
provide a much better experience using your Audien BTE.
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5
ADJUSTING THE VOLUME
Switching between Modes Adjusting Volume
To change between the 4 environmental modes on your Audien
BTE, press on the volume up button for 3 seconds. The amount of
beeps that you hear after the 3 seconds indicates which mode you
are on.
Higher volume:
Press the volume up button for 1 second to increase the volume.
Lower volume:
Press the volume down button for 1 second to decrease the volume.
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Mode
M1 Conversation 1 Beep
M2 Restaurant 2 Beeps
M3 Outdoor 3 Beeps
M4 Music 4 Beeps
Suitable for Indicator
There are 11 volume levels. You will hear 1 beep each time you move up
or down a level. You will hear 2 beeps when you reach the highest/lowest
setting.
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SE TTING U P YOUR DEVICE
Step 1: Insert the ear dome into your ear canal.
Step 2: Gently wrap the Audien BTE over your ear
until it rests securely behind your ear.
Step 3: Push the ear tube into your ear canal until it is
snug and comfortable.
Inserting Into Ear
Powering ON/OFF
There are two methods to turn the Audien BTE on or off.
Turn on: Remove the Audien BTE from the charging case, and it will
automatically turn on.
Turn off: Place the Audien BTE back into its charging port, and it
will automatically turn off.
Press the volume down button for 3 seconds to turn the Audien
BTE on or off. You will hear an indicator sound saying, “Power On”
or “Power Off.”
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2
3
1.
2.
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CHARGING YOURDEVICE
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Step 1
Plugthe chargingcase
and USBcable into a
standard outlet. Light
2 will flash blue to
indicate the product
is charging.
Step 2
Insert the Audien BTE units
into the charging port.
The left ear unit should be
inserted into left charging
port. The right ear unit should
be in right charging port. Light
1 and light 3 will turn blue to
indicate charging.
Step 3
It will take around 2 hours
to fully charge both Audien
BTE units and their charging
case. On average, a full charge
lasts 20 hours. The case has
an internal battery so you can
charge your devices on the go.
Charging Your Device
CHARGE TIME: 2 HOURS
Blue lights indicate charging
(Light 1 & 3 )
LIGHT KEY:
Light 1
solid white =
Left ear fully charged
Light 3
solid white =
Right ear fully charged
Light 2 solid blue =
Charging case fully charged
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CLEANING YOURDEVICE
Cleaning Your Device
Dome Cleaning
Use the included cleaning brush to remove earwax, dust, and any
other debris from domes.
Audien BTE Cleaning
Use a soft cloth or tissue to clean the body of the Audien BTE,
including the push buttons, charging contacts, shell, etc. Do not use
alcohol, water, or other cleaning solvents to clean the Audien BTE
as it may damage them.
Regular cleaning is necessary. You may contact
us by email at: support@audienhearing.com to
order new domes and other accessories.
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