Earlens Photon User manual
Earlens Photon Hearing Aid
User Manual
1
Welcome
Thank you for choosing the Earlens Light-Driven Hearing Aid. This user manual
is designed to show you how to use and care for your new Earlens Hearing Aid.
We encourage you to carefully read this entire booklet including the Warnings
and Precautions sections to achieve the maximum benet from your new
hearing technology.
If you have further questions that are not answered in this manual, please contact
your hearing professional or call Earlens Customer Service at 1
-844-234-LENS.
You should always access the most up-to-date version of the Earlens Light Driven
Hearing Aid Patient Instructions for Use (IFU) at www.earlens.com/IFU. The IFU contains
detailed warnings, precautions, results from Earlens Hearing Aid clinical studies and
information regarding safe and eective EMC use.
32
Getting to Know Your Earlens Hearing Aid
The Earlens Hearing Aid uses a small Lens placed in your ear by a physician to
activate your natural hearing system.The behind-the-ear Photon™Processor
collects sound and transfers it to the Light Tip, which converts the sound signal
to non-visible light. The Lens collects this light and gently activates your natural
hearing system.
There are important components to your Earlens Hearing Aid that will be described
in this section: the Lens, the Photon™Processor, the Light Tip, the Charger and
mineral oil. The components that you will interact with include the Processor,
Light Tip, Charger and mineral oil.
Getting to Know Your Earlens Hearing Aid .........3
The Lens ...................................................................5
The Photon™Processor and Light Tip..................6
The Charger .............................................................7
Mineral Oil ...............................................................9
Using your Earlens Hearing Aid .......................... 10
Turning the Processor On/O.............................10
Identifying Left or Right Device ...........................12
Putting on the Processor and Light Tip.............13
Removing the Processor and Light Tip..............16
Changing Volume and Program ........................17
Processor Alerts.....................................................22
Telephone and Cellphone Use ............................24
Charging and Battery Life ...................................25
Cleaning and Maintenance .................................. 26
Daily Care...............................................................26
Weekly Oiling .........................................................28
Avoiding Moisture & Heat....................................31
Warranty................................................................32
Troubleshooting...................................................... 33
Warnings................................................................... 35
Precautions .............................................................. 37
Device Labeling Symbols ...................................... 41
Contents
54
The Lens
The Lens is driven by light waves that contain sound information. When the Lens
detects light waves, it gently activates your natural hearing system allowing you to
hear sound. To keep your Lens functioning properly, you must apply mineral oil
weekly and do not put foreign objects in your ear (such as Q-tips, bobby pins, and
your ngernails).
1Sound enters the microphone on the Earlens
Photon Processor, which transforms the sound
and sends the audio signal to the Light Tip.
2The Light Tip converts the audio signal into light
and then projects the light wave to the Lens, which
makes direct contact with the eardrum.
3When the Lens is activated by the light wave,
it vibrates the eardrum gently at dierent
frequencies—resulting in rich, natural sound.
1
2
3
76
The Charger
The Charger can hold one or two devices. It features a USB-based AC wall power
adaptor as its power source. The Charger includes an LED indicator display to let
you know the charging status of your devices.
The Photon™Processor and Light Tip
The Processor sits comfortably behind your ear. It collects and sends sound signals
to the Light Tip, which then converts the sound signals into non-visible light that is
projected by the emitter. The light from the emitter is collected by the Lens.
Light Tip
Processor
Microphones
Ear Tube
Emitter
Vent
User Controls Micro-USB
Power Supply
Plug-in
Back View of Charger
Lid
Charging
Status
Indicators
Processor
Slot Processor
Slot
Lid Release
Button
Front View of Charger
98
Mineral Oil
Mineral oil plays an important role in keeping the Lens in position and
properly working. Apply two drops of mineral oil to each ear once a week,
or follow the instructions of your physician if you are asked to use mineral
oil more frequently. If you forget to apply the mineral oil to your ear as
advised, your Lens may stop working or fall out. In the event that you
forget to oil as scheduled, apply oil as soon as possible and then resume
as advised.
Detailed mineral oil use instructions are available in the Care and
Maintenance section of this manual.
Charger Indicator Lights
Charger Indicator Lights What It Means
Single ashing blue light Charger is attempting to connect with
the Processor
One solid blue light Battery is charging and less than 33% charged
Two solid blue lights Battery is charging and is 33% charged
Three solid blue lights Battery is charging and is 66% charged
Four solid blue lights Battery is fully charged
Four ashing blue lights Charger is unable to connect with the
Processor and is not charging
1110
2To turn the Processor OFF, push and hold the bottom user control for 3 seconds.
Using your Earlens Hearing Aid
Turning the Processor On/O
When you remove your Processor from a plugged-in Charger, it will be OFF.
1To turn the Processor ON,
push and hold either user
control for 3 seconds.
Bottom User Control
3 Seconds
User Control
3 Seconds
1312
Putting on the Processor and Light Tip
It is important that the Light
Tip is placed properly in your
ear to optimally aim the light
towards the Lens.
1
Place the Processor behind your ear,
where it should rest comfortably.
Identifying Left or Right Device
To identify a left or right device, look at the color of the serial number printed on the
Light Tip.
Left Right
Blue writing indicates
a Left device
Red writing indicates
a Right device
1514
4
Gently push the Light Tip into your ear canal,
pushing it as far as it will comfortably go, to
ensure it is seated in the correct position.
2 3
Hold the Light Tip between your thumb
and index nger, with the serial number
on the Light Tip oriented towards the
back of your head.
Slowly insert the Light Tip into your
ear canal. You may need to move the
outside of your earlobe up and down to
help with insertion.
1716
Changing Volume and Program
Your hearing professional can customize your user
controls based on your preferences and needs. User
controls can be set up to change volume, change programs
or have multi-functionality to change both the volume and
programs. Please discuss with your hearing professional
how your user control settings have been customized and
consult the tables on the next few pages for instructions.
Removing the Processor and Light Tip
1
Grasp the Ear Tube between your thumb and
index nger near the Light Tip and gently pull it
out of the ear canal.
1918
User Control
Options Button Press / Button Action
Volume
Only
Short Press Up = Volume
Increase
Power
O
Volume
Increase
Power
O
Volume
Decrease
Short
Press Down =Volume
Decrease
Long Press Up
(3 seconds) =Power O
Long Press Down
(3 seconds) =Power O
User Control
Options Button Press / Button Action
Volume &
Program
Short Press Up = Volume
Increase
Cycle
to Next
Program
Volume
Increase
Power
O
Volume
Decrease
Short
Press Down =Volume
Decrease
Long Press Up
(3 seconds) =Cycle to Next
Program
Long Press Down
(3 seconds) =Power O
2120
User Control
Options Button Press / Button Action
No Volume
or Program
Control
Enabled
Short Press Up = Disabled
Power
O
Disabled
Power
O
Disabled
Short
Press Down = Disabled
Long Press Up
(3 seconds) =Power O
Long Press Down
(3 seconds) =Power O
User Control
Options Button Press / Button Action
Program
Only
Short Press Up = Cycle to
Next Program
Power
O
Cycle
to Next
Program
Power
O
Cycle to
Previous
Program
Short
Press Down =
Cycle to
Previous
Program
Long Press Up
(3 seconds) =Power O
Long Press Down
(3 seconds) =Power O
2322
Alert Type Description of Alert What it Means?
Volume Change 1 quick beep The volume has increased/decreased.
Default
Volume Level 2 quick beeps You are at your home volume setting.
Min/Max Volume 3 quick beeps You are at the minimum or maximum
limits of your volume control.
Program Change
P1 = 1 beep
P2 = 2 beeps
P3 = 3 beeps
P4 = 4 beeps
OR voice alerts that say the
name of the program
The program has changed.
Processor Alerts
Your hearing professional can program your Processors to have a number of sound
alerts that indicate a specic function. The following table provides a description of
each alert.
Alert Type Description of Alert What It Means?
Power On 3 tone melody The Processor has powered on.
Power O 4 descending tone melody The Processor has powered o.
Battery
6 tone melody OR a voice
alert that states “Battery”
The battery is low and the
Processor will shut o in either
15 or 60 minutes.
2524
Charging and Battery Life
The Processor battery will last an average of 24 hours or more and a minimum of
16 hours on a full charge. It takes 4 hours in the Charger to completely recharge a
fully depleted Processor battery.
1To charge, place the Processor and Light Tip into the Charger.
2Wait until the indicator light turns solid to ensure the Processor is successfully
charging.
3 If the indicator lights ash, the Processor is not charging. Remove the Processor
from the Charger, re-insert the device into the charging slot and immediately short
press the top user control. If the indicator lights continue to ash, contact your
hearing professional.
Telephone and Cellphone Use
There are a few ways you can try to use your phone with your Earlens Hearing Aid.
12
Hold the upper portion of the phone over
the microphones on your Processor, with the
mouthpiece pointed towards your mouth.
If available, use the speaker phone
feature on your phone.
2726
3If you notice wax on the Light Tip, use a soft cloth to wipe
the bowl of your ear. Never insert foreign objects into the
ear, such as Q-tips, bobby pins or your ngernails. Insertion
of foreign objects could result in pain, may damage your ear
and may cause damage to the Lens.
4Wipe the Processor with a soft cloth if you notice any
moisture or debris.
5Never use chemicals on the Processor or Light Tip.
6Use a soft cloth to wipe the Charger when necessary.
Cleaning and Maintenance
Daily Care
1Check that there is no wax or debris on the Light Tip. If wax or debris is present, use
a soft cloth, a baby wipe or other Isopropyl Alcohol (IPA) based wipes to remove.
2If there is wax or debris in the Light Tip vent, use a soft-bristle toothbrush, a pipe-
cleaner or a hearing aid cleaning tool to gently clear the debris. Only perform
cleaning when the device is o of the ear and do not use a sharp brush or tool when
cleaning the Light Tip.
2928
1 Minute
12
Tilt your head to the side. Many users
nd that using a mirror or lying on their
side is helpful when applying oil.
Apply the drops of mineral oil at the entrance
of the ear canal. Allow the drops to run down
to your eardrum by keeping your head tilted for
one minute. You may hear or feel the oil when it
reaches the eardrum.
Weekly Oiling
Oiling is required to keep the Lens in place and functioning properly. Apply
2 drops of mineral oil to your ear canal at a minimum of once per week.
Follow the instructions provided by your physician if he or she asks you to oil on a
dierent schedule. If you have diculty applying the mineral oil, consider having
another person assist you.
Instructions for Oiling:
We recommend you oil your ears at bedtime, after you have removed your Earlens
Hearing Aids for the day. After you oil, you may notice a slight decrease in your
hearing, which is temporary.
3130
Avoiding Moisture & Heat
Moisture and heat can damage your Earlens Hearing Aid. You can avoid this by
taking these steps:
1Do not leave your device in extreme heat.
2Do not wear your device in heavy rain, steam baths or showers.
3Do not dry your device in a microwave or any other heat source.
4 Take o your device when applying hairspray, perfume, aftershave, insect repellent
or any other harsh chemical as it can damage your device.
5 Wipe o your device if there is moisture on it.
3
Repeat for the opposite ear.
• After oiling, your ears may feel a little stuy. This
should subside on its own when the oil is absorbed.
• It is recommended that you reapply mineral oil after
you go swimming, take a bath or enjoy any other
activity that causes your ear canals to ll with water.
• Use only the mineral oil and container provided
and/or recommended by your hearing provider
or Earlens.
3332
Troubleshooting
Issue Possible Causes Possible Remedy
No sound Battery is
not charged.
Charge the Processor until at least 2 solid
lights appear. If 2 or more solid lights appear,
the battery is not the issue, contact your
hearing professional.
Not loud enough The Light Tip is
covered with wax.
Wipe down with a soft cloth, baby wipe or other
Isopropyl Alcohol based wipes to remove wax.
The Light Tip is
improperly inserted.
Remove and reinsert the Light Tip and check
the position in a mirror if possible.
Volume is set
too low.
If your device features volume user control
functionality, increase the volume. If you
still require more volume, contact your
hearing professional.
Warranty
Your hearing aid is covered by a warranty. Please talk to your hearing provider about
the details of your warranty.
3534
Issue Possible Causes Possible Remedy
Whistling
(feedback)
The Light Tip is not
properly inserted.
Remove and reinsert the Light Tip
and check the position in a mirror if
possible. If the issue persists, contact
your hearing professional.
Warnings
Before using the Earlens Hearing Aid, make sure you read and understand each of
the following safety warnings:
• The Earlens Hearing Aid is considered MR unsafe. The Lens should be removed prior to an
MRI exam or MRI exposure. Only physicians trained in Ear, Nose & Throat procedures
should place or remove the Lens.
Issue Possible Causes Possible Remedy
Damage to Light
Tip or Ear Tube
Wear and tear. Contact your hearing professional.
Sound distorted/
not clear
Battery is low. Charge the Processor until at least 2 solid
lights appear.
Hearing aid is damaged. Contact your hearing professional.
Hearing aid setting is
not optimal.
Contact your hearing professional.
Charger lights
ashing
Something is wrong
with the Charger
or Processor.
Remove the Processor from the Charger,
re-insert the device into the charging slot
and immediately short press the top user
control. If the indicator lights continue to
ash, contact your hearing professional.
3736
• You should not use therapeutic or medical diathermy using electromagnetic radiation (magnetic
induction coils or microwave) from the shoulders up with Earlens Hearing Aid in place.
• The Processor and Light Tip unit contain a Class 1 laser product. It is safe to use under
normal operating conditions. The Class 1 laser light is NOT visible. Do NOT look directly
into the laser or aim directly into the eyes. Should any part of the Aid become damaged,
discontinue use and contact your hearing professional.
• If you experience discomfort or pain in your ear, you should contact the ENT physician
immediately. Only physicians trained in Ear, Nose & Throat procedures should place or
remove the Lens.
• Do not insert foreign objects into your ear, such as Q-tips, bobby pins or ngernails.
Insertion of foreign objects could result in pain and damage to the ear, damage to the Lens
or cause it to operate improperly.
• Contact your hearing professional if you experience discharge from the ear or persistent
discomfort or any other problems.
• Should the Processor become unusually warm or hot, promptly remove it, discontinue use
and contact your hearing healthcare professional.
• Do not crush, short circuit, modify or disassemble any component of the
Earlens Hearing Aid. Keep all components of the Earlens Hearing Aid out of
the reach of children, pets and others, to avoid risk of swallowing.
• Do not incinerate any component of the Earlens Hearing Aid or use near an open ame.
Handle waste from electronic equipment per local regulations.
Precautions
Before using the Earlens Hearing Aid, make sure you read and understand each of
the following safety precautions.
• If you have known nickel sensitivity/allergy, please be aware that the Lens component
contains nickel that is coated with a parylene barrier. If you develop an allergic reaction, the
Lens should be promptly removed.
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