Earlens Photon Hearing Aid User Manual

Earlens Photon Hearing Aid
User Manual
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 benefit 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 effective EMC use.
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Contents
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/Off..............................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
2
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
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.
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The Lens
1 Sound enters the microphone on the Earlens
1
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 fingernails).
Photon Processor, which transforms the sound
and sends the audio signal to the Light Tip.
2 The Light Tip converts the audio signal into light
and then projects the light wave to the Lens, which
makes direct contact with the eardrum.
3 When the Lens is activated by the light wave,
2
3
it vibrates the eardrum gently at different
frequencies—resulting in rich, natural sound.
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5
The Photon™ Processor and Light Tip
The Charger
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.
Ear Tube
Microphones
Light Tip
User Controls
Emitter
Vent
6
Processor
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.
Lid
Charging
Status
Indicators
Processor
Slot
Processor
Slot
Micro-USB
Power Supply
Plug-in
Lid Release
Button
Front View of Charger
Back View of Charger
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Charger Indicator Lights
Charger Indicator Lights
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What It Means
Single flashing 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 flashing blue lights
Charger is unable to connect with the
Processor and is not charging
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.
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Using your Earlens Hearing Aid
2 To turn the Processor OFF, push and hold the bottom user control for 3 seconds.
Turning the Processor On/Off
When you remove your Processor from a plugged-in Charger, it will be OFF.
1 To turn the Processor ON,
push and hold either user
control for 3 seconds.
3 Seconds
3 Seconds
Bottom User Control
User Control
10
11
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
Blue writing indicates
a Left device
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Right
Red writing indicates
a Right device
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.
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14
2
3
4
Hold the Light Tip between your thumb
and index finger, 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.
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.
15
Removing the Processor and Light Tip
1
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.
Grasp the Ear Tube between your thumb and
index finger near the Light Tip and gently pull it
out of the ear canal.
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17
User Control
Options
Short Press Up =
Volume &
Program
Volume
Increase
Volume
Short
=
Press Down
Decrease
Long Press Up
Cycle to Next
=
(3 seconds)
Program
Long Press Down
= Power Off
(3 seconds)
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User Control
Options
Button Press / Button Action
Button Press / Button Action
Short Press Up =
Volume
Increase
Volume
Decrease
Cycle
to Next
Program
Power
Off
Volume
Increase
Short
Volume
=
Press Down
Decrease
Volume
Only
Long Press Up
= Power Off
(3 seconds)
Volume
Increase
Volume
Decrease
Power
Off
Power
Off
Long Press Down
= Power Off
(3 seconds)
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User Control
Options
Short Press Up =
Program
Only
Cycle to
Next Program
Cycle to
Short
= Previous
Press Down
Program
Long Press Up
= Power Off
(3 seconds)
Long Press Down
= Power Off
(3 seconds)
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User Control
Options
Button Press / Button Action
Button Press / Button Action
Short Press Up = Disabled
Cycle
to Next
Program
Cycle to
Previous
Program
Power
Off
Power
Off
No Volume
or Program
Control
Enabled
Short
= Disabled
Press Down
Long Press Up
= Power Off
(3 seconds)
Disabled
Power
Off
Disabled
Power
Off
Long Press Down
= Power Off
(3 seconds)
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Processor Alerts
Your hearing professional can program your Processors to have a number of sound
alerts that indicate a specific function. The following table provides a description of
each alert.
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Alert Type
Description of Alert
What It Means?
Power On
3 tone melody
The Processor has powered on.
Power Off
4 descending tone melody
The Processor has powered off.
Battery
6 tone melody OR a voice
alert that states “Battery”
The battery is low and the
Processor will shut off in either
15 or 60 minutes.
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
The program has changed.
OR voice alerts that say the
name of the program
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Telephone and Cellphone Use
Charging and Battery Life
There are a few ways you can try to use your phone with your Earlens Hearing Aid.
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.
1 To charge, place the Processor and Light Tip into the Charger.
2 Wait until the indicator light turns solid to ensure the Processor is successfully
charging.
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1
2
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.
3 If the indicator lights flash, 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 flash, contact your
hearing professional.
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Cleaning and Maintenance
Daily Care
1 Check 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.
2 If 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 off of the ear and do not use a sharp brush or tool when
cleaning the Light Tip.
3 If 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 fingernails. Insertion
of foreign objects could result in pain, may damage your ear
and may cause damage to the Lens.
4 Wipe the Processor with a soft cloth if you notice any
moisture or debris.
5 Never use chemicals on the Processor or Light Tip.
6 Use a soft cloth to wipe the Charger when necessary.
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27
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
different schedule. If you have difficulty 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.
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1 Minute
1
2
Tilt your head to the side. Many users
find 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.
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Avoiding Moisture & Heat
• After oiling, your ears may feel a little stuffy. 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 fill with water.
3
Repeat for the opposite ear.
• Use only the mineral oil and container provided
and/or recommended by your hearing provider
or Earlens.
Moisture and heat can damage your Earlens Hearing Aid. You can avoid this by
taking these steps:
1 Do not leave your device in extreme heat.
2 Do not wear your device in heavy rain, steam baths or showers.
3 Do not dry your device in a microwave or any other heat source.
4 Take off your device when applying hairspray, perfume, aftershave, insect repellent
or any other harsh chemical as it can damage your device.
5 Wipe off your device if there is moisture on it.
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31
Troubleshooting
Warranty
Your hearing aid is covered by a warranty. Please talk to your hearing provider about
the details of your warranty.
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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.
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Issue
Possible Causes
Possible Remedy
Issue
Possible Causes
Possible Remedy
Damage to Light
Tip or Ear Tube
Wear and tear.
Contact your hearing professional.
Whistling
(feedback)
The Light Tip is not
properly inserted.
Sound distorted/
not clear
Battery is low.
Charge the Processor until at least 2 solid
lights appear.
Remove and reinsert the Light Tip
and check the position in a mirror if
possible. If the issue persists, contact
your hearing professional.
Hearing aid is damaged.
Contact your hearing professional.
Hearing aid setting is
not optimal.
Contact your hearing professional.
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
flash, contact your hearing professional.
Charger lights
flashing
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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.
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• 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.
• Should the Processor become unusually warm or hot, promptly remove it, discontinue use
and contact your hearing healthcare professional.
• 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.
• 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.
• 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 fingernails.
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.
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• Do not incinerate any component of the Earlens Hearing Aid or use near an open flame.
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.
37
• The Lens was tested for nickel leaching and found to be compliant and within the safe levels
identified in European standard EN1811. Traces of oxidation (discoloration) may be visible
on the Lens surface following prolonged wear. Testing indicated the oxidation was not likely
to affect the structural integrity of the Lens within the 1 year expected life.
• Only healthcare professionals trained in the fitting of hearing aids may fit the Processor
and Light Tip.
• The Earlens Hearing Aid is custom designed and intended to be used only by a single patient.
• The Light Tip is designed to sit a set distance from the Lens. Sound output may deviate if
the Light Tip is not inserted to the proper depth. If the sound output does deviate, you can
reposition the Light Tip until optimal sound output is achieved.
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• If you have small or unusually shaped ear canals, you may be at greater risk for ear canal
abrasions, either from the ear impression procedure or from Light Tip use.
• You should avoid getting the Processor wet, as it may damage the device. You must remove
the Processor prior to showering, swimming, or bathing.
• You may experience a reduction in your hearing levels when the Lens is in place but the
Processor is not activated.
• Do not direct streams of liquid (i.e. isopropyl alcohol, hydrogen peroxide, DeBrox) into your
ears, as this may cause the Lens to become dislodged or cause damage to the device.
• Failure to oil your ear canal weekly may result in Lens displacement.
• Earplugs or headphones can be used with the Lens in place as long as care is taken not to
over-insert them and they do not protrude deeply into the ear canal.
• Do not place any component of the Earlens Hearing Aid into a microwave, or near a
significant source of static electricity.
• You may shower, bathe or swim with the Lens in place. Ear plugs may be used to prevent
water from entering your ears so long as care is taken to not over-insert them. Removing
water from ears may be more difficult with the Lens in place.
• Use only the Earlens Charger and AC wall adaptor provided. Although other adaptors may
look similar, they may cause damage to the Earlens Hearing Aid.
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Device Labeling Symbols
• Handle the components carefully and prevent hard knocks. Do not drop them as it may
damage the Earlens Hearing Aid.
• If the Earlens Processor fails to operate or if it appears damaged, including the presence of
battery leakage or swelling, promptly remove the Processor, discontinue use and contact
your hearing professional.
Refer to Instruction Manual
Catalog Code
Serial Number
Dispose Electronic
Waste Properly
Date of Manufacture
Caution
Keep Dry
Product is a Type BF Part
MR Unsafe
• Only clean the Processor with a soft cloth. Do not use chemicals (i.e. hairspray) in close
proximity or to clean the Processor.
• Keep Charger cord out of reach of individuals who may be at risk of strangulation.
• Electromagnetic fields produced by other electrical equipment such as cell phones, metal
detectors, microwaves, RFID systems and commercial theft detection systems (also known as
electronic article surveillance [EAS]) may interfere with the Earlens Hearing Aid. In the event
that you perceive unexpected noise or interference in the presence of these devices, move
away from the source to mitigate the potential interference. If you have further concerns you
should remove the Processors and contact your hearing healthcare professional.
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By Prescription Only
Storage Temperature Limit
FCC Approved Equipment
CE Mark
Class 1 Laser Product
Batch Code
Humidity Limitation
42
Atmospheric Pressure
Limitation
Manufactured by:
Earlens Corporation, Inc.
4045A Campbell Ave.
Menlo Park, CA 94025 USA
+1 (844) 234-LENS
www.earlens.com
European Authorized
Representative:
Medimark® Europe SARL
11, Rue Emile Zola, B.P. 2332
F-38033 Grenoble Cedex 2 – France
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©2016 Earlens, Inc. All rights reserved. LBL00092vA February 2016
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