Earlens Contact Hearing Solution User manual

Earlens®Contact Hearing Solution User Manual

1
Earlens®Contact Hearing Solution User Manual

Warnings
Before using the Earlens®Contact Hearing Solution, make sure you read and
understand each of the following safety warnings:
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exposure. Only physicians trained in Ear, Nose & Throat procedures should place or
remove the Lens.
• You should not use therapeutic or medical diathermy using electromagnetic radiation (magnetic
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• Should any part of the Device 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.
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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
Solution. Keep all components of the Earlens Hearing Solution out of the reach of children,
pets and others, to avoid risk of swallowing.
• Do not incinerate any component of the Earlens Hearing Solution or use near an open
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Precautions
4 5
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and Ear Tip.
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• The Lens and Ear Tip were tested for nickel leaching and found to be compliant and within
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may be visible on the Lens surface following prolonged wear. Testing indicated the oxidation
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expected life.
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• If you have known nickel sensitivity/allergy, please be aware that the Lens and Ear Tip
components contain nickel that is coated with a parylene barrier. If you develop an allergic
reaction, the Lens and Ear Tip should be promptly removed.
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Before using the Earlens Hearing Solution, make sure you read and understand each
of the following safety precautions.
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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.
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.
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.
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•Earplugs or headphones can be used with the Lens in place as long as they are not over-
inserted and do not protrude deeply into the ear canal.
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Ear plugs or headphones can be used with the Lens in place as long as they are not over-
Only healthcare professionals trained in the fitting of hearing aids may fit the Processor and Ear Tip.
•Earlens is custom designed and intended to be used only by a single patient.
•The Ear Tip is designed to sit a set distance from the Lens. Sound output may deviate if
the Ear Tip is not inserted to the proper depth. If the sound output does deviate, you can
reposition the Ear Tip until optimal sound output is achieved.
•Earplugs or headphones can be used with the Lens in place as long as they are not over-
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•Handle the components carefully and prevent hard knocks. Do not drop them as it may
damage the Earlens Hearing Solution.
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proximity or to clean the Processor.
•Keep Charger cord out of reach of individuals who may be at risk of strangulation.
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detectors, microwaves, RFID systems and commercial theft detection systems (also known
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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.
If the Earlens Processor fails to operate or if it appears damaged, including the presense of battery
leakage or swelling, promptly remove the Processor, discontinue use and contact your hearing
professional.
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•Use only the Earlens Charger and AC wall adaptor provided. Although other adapters may
look similar, they may cause damage to the Earlens Hearing Solution.
•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
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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 Ear 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.
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•You may experience a reduction in your hearing levels when the Lens is in place but the
Processor is not activated.
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ears, as this may cause the Lens to become dislodged or cause damage to the device.
•Failure to oil your ear canal daily may result in Lens displacement.
•Do not place any component of the Earlens Hearing Solution into a microwave, or near a
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) into your

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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.
Notices
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.
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.
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32
Welcome
Thank you for choosing the Earlens Hearing Solution. This user manual is designed
to show you how to use and care for your new Earlens. We encourage you to carefully
read this entire booklet including the Warnings and Precautions sections to achieve
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If you have further questions that are not answered in this manual, please contact
your hearing professional or call the Earlens Concierge at 1-844-264-5367. You
can always access the most up-to-date version of the Earlens Patient Instructions for
Use (IFU) at www.earlens.com/IFU. The IFU contains results from Earlens clinical
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Getting to Know Your Earlens ................................4
The Lens ...................................................................6
The Processor and Ear Tip ....................................7
The Charger .............................................................8
Mineral Oil .............................................................10
Using your Earlens Hearing Solution................. 11
7XUQLQJWKH3URFHVVRU2....................................11
Turning the Processor On....................................12
Identifying Left or Right Device ...........................13
Putting on the Processor and Ear Tip................14
Removing the Processor and Ear Tip.................16
Changing Volume and Program ........................17
Processor Alerts.....................................................22
Telephone and Cellphone Use ............................24
Charging and Battery Life ...................................26
&OHDQLQJDQG0DLQWHQDQFH .................................. 27
Daily Care...............................................................27
Oiling Instructions.................................................29
Avoiding Moisture & Heat....................................32
Warranty................................................................33
Troubleshooting...................................................... 34
Warnings................................................................... 37
Precautions .............................................................. 39
Technical Information............................................ 43
Device Labeling Symbols ...................................... 44
Contents
read this entire booklet including the Warnings, Precautions, and Notices sections
to achieve the maximum benefit from your new hearing technology.
can always access the most up-to-date version of this user manual and the Earlens
Patient Instructions for Use (IFU) at www.earlens.com/IFU.
10 11
234
Telephone and Cellphone Use 32
47
Pairing and Connecting your Apple Device
Cleaning and Maintenance
Charging and Battery Life
Daily Care
Oiling Instructions
34
37
36
37
39
Avoiding Moisture & Heat
Warranty
42
43
Troubleshooting 44
Technical Information
61
67
Clinical Study information
Device Labeling Symbols
Getting to Know Your Earlens
The Lens
The Processor and Ear Tip
The Charger
Mineral Oil
Warnings, Precautions, Notices
Using your Earlens Hearing Solution
Turning the Processor Off
Turning the Processor On
Identifying Left or Right Device
Putting on the Processor and Ear Tip
Removing the Processor and Ear Tip
Changing Volume and Program
12
14
15
16
18
2
19
19
20
21
22
24
25
Processor Alerts 30

54
Getting to Know Your Earlens
The Earlens Hearing Solution uses a small Lens placed in your ear by a physician to
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and transfers it to the Ear Tip, which converts the sound signal into an energy signal.
The Lens collects energy pulses that power the Lens to vibrate and gently activate
your natural hearing system.
There are important components to your Earlens that will be described in this
section: the Lens, the Processor, the Ear Tip, the Charger and mineral oil.
1Sound enters the microphone on the Processor,
which processes the audio signal based on your
hearing needs.
2The audio signal is then converted into pulses
of energy that are transmitted by the Ear Tip.
3When the energy signal reaches the Lens,
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frequencies — resulting in rich, natural sound.
1
2
3
Charger, and mineral oil. frequencies resulting in rich, natural sound.
12 13

76
The Lens
The Lens is powered by pulses of energy that contain sound information. When the
Lens detects the signal, it gently activates your natural hearing system, allowing you to
hear sound. To keep your Lens functioning properly, you must apply mineral oil every
other day, or as directed by your provider, and avoid placing foreign objects in your
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The Processor and Ear Tip
The Processor sits comfortably behind your ear. It collects and sends audio signals
through the Ear Tip. Those signals are received by the Lens.
Ear Tip
Processor
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Cable
Transmitter
Vent
User Controls
14 15

98
The Charger
The Charger can hold one or two devices. It features a USB-based AC wall power
adapter as its power source. The Charger includes an LED indicator display to let you
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Power Supply
Plug-in
Back View of Charger
Lid
Charging
Status
Indicators
Lid Release
Button
Front View of Charger
Charging Status Indicators
Charging Status Indicators What It Means
One ȵDVKLQJ light Charger connecting to Processor, it may take
up to 20 seconds to connect.
One solid light Battery charging and below 33% charged
Two solid lights Battery charging and above 33% charged
Three solid lights Battery charging and above 66% charged
Four solid lights Battery fully charged
Four ȵDVKLQJ lights
Processor not charging; remove from
Charger, re-insert into charging slot and
immediately press the top user control
No lights Check that Charger is plugged in and
Processors are correctly in slots
Slot Slot
16 17
Processor not charging; remove from Charger;
re-insert into charging slot and immediately
press the top user control (see page 45)

1110
Mineral Oil
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and properly working. Apply one pump of mineral oil to each ear
every other day, or as directed by your provider. 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
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Using your Earlens Hearing Solution
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When you remove your Processor from a plugged-in Charger, it will be ON.
To turn the Processor OFF,
push and hold the bottom
user control for 3 seconds.
Bottom User Control
3 Seconds
18 19

1312
Turning the Processor On
To turn the Processor ON, push and hold the top user control for 3 seconds.
Identifying Left or Right Device
To identify a left or right device, look at the color of the indicator in the Ear Tip.
Left
Blue indicates a
Left device
Right
Red indicates a
Right device
Top User Control
3 Seconds
20 21

1514
Putting on the Processor and Ear Tip
It is important
that the
Ear Tip
is placed
properly in
your ear.
1 2
Place the Processor
behind your ear, where it
should rest comfortably.
Hold the Ear Tip between your thumb
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pointing up and the Positioning Lip
pointing toward the back of the head.
3 4
Slowly insert the Ear Tip into your ear
canal. Gently pulling your outer ear up
and back may help with insertion.
Gently push the Ear Tip into your
ear canal, pushing it as far as it will
comfortably go, to ensure it is seated
in the correct position.
22 23
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Removing the Processor and Ear Tip
To remove the Processor and Ear Tip, grasp the Cable between your thumb and
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Changing Volume and Program
Your hearing professional can customize your user
controls based on your preferences and needs. Your user
controls can be set up to change volume, change programs
or to change both the volume and programs. Please speak
to your hearing professional how your user control settings
have been customized. The tables on the next few pages
can also serve as a helpful reference for instructions.
Your hearing professional can customize your user controls
based on your preferences and needs. Your user controls can
be set up to change volume, change programs or to change
both the volume and programs. Please speak to your hearing
professional about how your user control settings have been
customized. The tables on the next few pages can also serve
as a helpful reference.
24 25
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1918
User Control
Options Action/Press
Volume &
Program
Volume
Increase = Short Press Up
Cycle
to Next
Program
Volume
Increase
Power
2
Volume
Decrease
Volume
Decrease =Short
Press Down
Cycle to Next
Program =Long Press Up
VHFRQGV
3RZHU2 =Long Press Down
VHFRQGV
User Control
Options Action/Press
Volume
Only
Volume
Increase = Short Press Up
Power
2
Volume
Increase
Power
2
Volume
Decrease
Volume
Decrease =Short
Press Down
3RZHU2 =Long Press Up
VHFRQGV
3RZHU2 =Long Press Down
VHFRQGV
26 27
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2120
User Control
Options Action/Press
Program
Only
Cycle to
Next Program = Short Press Up
Power
2
Cycle
to Next
Program
Power
2
Cycle to
Previous
Program
Cycle to
Previous
Program
=Short
Press Down
3RZHU2 =Long Press Up
VHFRQGV
3RZHU2 =Long Press Down
VHFRQGV
User Control
Options Action/Press
No Volume
or Program
Control
Enabled
Disabled = Short Press Up
Power
2
Disabled
Power
2
Disabled
Disabled = Short
Press Down
3RZHU2 =Long Press Up
VHFRQGV
3RZHU2 =Long Press Down
VHFRQGV
28 29
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Remove and re-insert the Ear Tip
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2322
Processor Alerts
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description of each alert.
Alert Type Description of Alert What it Means
Power On 3 tone melody The Processor has powered on.
3RZHU2 4 descending tone melody 7KH3URFHVVRUKDVSRZHUHGR
Battery
6 tone melody OR a voice
alert that states “Battery”
The battery is low and the
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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 The volume is at the default
programmed level.
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.
30 31

Remove and re-insert the Ear Tip
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2524
Telephone and Cellphone Use
There are a few ways you can try to use your phone with your Earlens.
1Hold the upper portion of the phone over the microphones
on your Processor, with the mouthpiece pointed towards
your mouth.
2If available, use the speaker phone feature on your phone.
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For the latest iOS and Apple device compatibility information, please go to
www.earlens.com/connectivity.
32 33

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34 35
With the Made for iPhone feature, you can connect your Earlens Hearing Solution to your Apple
device. This connection, along with the Earlens Control App, allows you to easily and discretely
change your hearing aid programs and volume. You can also take phone calls and stream
media from your iPhone, iPad, and iPod touch directly to your hearing aids.
To pair your hearing aids to your Apple device, follow these steps:
Turn your hearing aids off and back on.
1
On your Apple device, tap the Settings icon > Accessibility > Hearing Devices.
2
Ensure Bluetooth is enabled. The Apple device will start searching for your hearing aids (Fig.1).
3
Once your hearing aids are discovered, your First Name + Hearing Aids and R+L will display*
4
Tap on your name.
5
A pairing request window
will appear for each device.
Select Pair* (Fig.3).
6
When your hearing aids
are paired and connected,
you will see the word
“Connected” (Fig.4) in the
main Hearing Devices
screen.
7
* If you connect one hearing aid, an L or R will display and only one pairing request window will appear.
Figure 1. Searching for hearing aids Figure 2. Hearing aids discovered
Figure 3. Pairing request window Figure 4. Hearing aids paired and connected
Pairing and Connecting your Apple Device

2726
Charging and Battery Life
The Processor battery will last an average of 20 hours. It takes 4 hours in the Charger
to completely recharge a fully depleted Processor battery. We highly recommend
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1To charge, place the Processor and Ear Tip into the Charger.
2Wait until the indicator light turns solid to ensure the Processor is successfully
charging.
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from the Charger, place it back into the charging slot and immediately press the
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hearing professional.
Cleaning and Maintenance
Daily Care
1Check that there is no wax or debris on the Ear Tip. If wax
or debris is present, use a soft cloth, a baby wipe or other
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2If there is wax or debris in the Ear Tip vent or covering
the emitter, use a soft-bristle toothbrush, a pipe-cleaner
or a hearing aid cleaning tool to gently clear the debris. Only
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not use a sharp brush or tool when cleaning the Ear Tip.
wipe, or other
If there is a wax or debris in the Ear Tip vent or on the end of
the transmitter, use a soft-bristle toothbrush, a pipe-cleaner
36 37
, refer to page 45
before contacting your hearing professional.
Other manuals for Contact Hearing Solution
1
Table of contents
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