Earlens Light Driven Instructions Manual

Wireless Earlens Light-Driven Hearing Aid Physician Instructions

1. Introduction ......................................................................................................... 2

2. Wireless Earlens Light-Driven Hearing Aid Device Description ..................... 2

3. Indications for Use .............................................................................................. 3

4. Fitting Range ....................................................................................................... 3

5. Contraindications ................................................................................................ 3

6. Warnings .............................................................................................................. 4

7. Precautions .......................................................................................................... 4

8. Clinical Study Results ......................................................................................... 5

9. Operating Instructions ........................................................................................ 7

10. Operating Specifications .................................................................................... 9

11. Glossary of Terms ............................................................................................. 10

12. Graphic Symbols Contained in Device Labeling ............................................ 10

13. Laser Certification ............................................................................................. 11

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1. Introduction

Figure 1: Earlens component schematic

Figure 4: Light Tip large vent opening

CAREFULLY READ ALL INSTRUCTIONS PRIOR TO USE.
Rx ONLY
For patient instructions, please see Earlens Light-Driven Hearing Aid Patient Instructions. For hearing

professional instructions, please see Earlens Light-Driven Hearing Aid Hearing Profes s ion al Instructions.

2. Wireless Earlens Light-Driven Hearing Aid Device Description

The wireless Earlens Light-Driven Hearing Aid uses non-visible light
to send sound information to a customized Tympanic Lens (Lens).
The Lens converts the light into vibrations that are directly applied to
the eardrum and are perceived as sound (Figure 1). The Earlens
Hearing Aid System includes the following:

• Lens

• Photon™ Processor

• Light Tip

• Earlens Fitting Software (ELF)

• Charger with Power Adapter

• Earlens Impression System

• Mineral Oil

• Earlens Control Mobile Application

2.1. Tympanic Lens

The Lens (Figure 2) is designed to receive light signals from the
Light Tip and convert the light signals into mechanical vibrations
of the tympanic membrane (TM). The Lens is customized for
each patient and is placed in to position by a trained physician. It
is placed at the end of the ear canal on the skin around the TM.

2.2. Photon™ Processor and Light Tip

The Processor is directly connected to the Light Tip via the cable
(Figure 3). The Processor is designed to pick-up sounds via the
microphones, apply signa l proc ess ing and trans mit the signal via
the cable to the Light Tip. The Processor should be placed in the
Charger for recharging every day.

The Processor features a wireless antenna that allows for direct
connectivity with select smartphones and tablets. The use of this
feature is optional. Information on settings and use of the
wireless functionality can be found in t he hear ing pr of es sional
and patient Instructions for Use. For additional information,
please contact your Earlens support team or visit

www.earlens.com

The Light Tip is connected to the Processor via the cable and
can be physically modified by a hearing professional to improve
fit. The Light Tip shell features a large opening or vent, which is
designed to allow the ear canal to have an open, non-occluding
feel (Figure 4). The Light Tip is specifically designed to stabilize
and aim the emitter at the Lens.

/connectivity.

Processor

Light Tip

Figure 2: Lens

Figure 3: Processor & Light Tip

Lens

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2.3. Earlens Fitting Software (ELF)

Figure 6: Earlens Fitting Range

ELF is used to program the Processor, enabling the hearing professional to calibrate and program the
Processor specific to the patient’s needs.

2.4. Earlens Charger and Power Adaptor

The Charger is designed to recharge the Processors
(Figure 5). When connected to the wall power
adaptor, the Charger houses and chargers either
one or two Processors simultaneo usly. An AC wall
power adaptor is include d.

2.5. Earlens Impression System

The Earlens Impression System is used by the
physician to collect a deep ear canal impression. The
impression is used to manufacture the customized
Lens and Light Tip.

2.6. Mineral Oil

White mineral oil (food grade) is used to lubricate the
eardrum to keep the Lens in place and functioning
properly. To maintain the devices, it is recommended
that patients apply at least two pumps of mineral oil
to their ears twice a week.

Figure 5: Earlens Charger

3. Indications for Use

The wireless Earlens Light Driven Hearing Aid (a.k.a. Earlens Hearing Aid) transmits amplified sound by
vibrating the eardrum through direct contact. It is indicated for individuals 18 years and older with a mild
to severe sensorineural hearing impairment who can benefit from amplification. The device can provide
the full spectrum of amplification that includes 125 Hz – 10,000 Hz.

4. Fitting Range

The Earlens Light Driven Hearing Aid provides the full spectrum
of amplification that includes 125 Hz – 10,000 Hz. The
audiometric fitting range for the Earlens Hearing Aid is sho wn in
Figure 6.

5. Contraindications

The patient must not have any known or active medical issues
that would preclude having a hearing device, including:

a. an abnormal TM (deemed perforated, inflamed or has

dimeric or monomeric area, or in any other way
abnormal);

b. an abnormal middle ear or a history of prior middle ear

surgery other than tympanostomy tubes;

c. an ear canal anatomy that prevents the physician from

seeing an adequate amount of the TM;

d. an anatomical configuration of the external auditory canal that

prevents satisfactory placement of the Lens;
e. a history of chronic and recurrent ear infections in the past 24 months;
f. a rapidly progressive or fluctuating hearing impairment;
g. diagnosed with having a compromised immune system which may impact the tissue of the auricle

or ear canal, such as keratosis obturans, ichthyosis, eczema of the auricle or ear canal, or

received radiation of the head ever or chemotherapy for cancer within the last six years.

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Note: Once the otologic and audiologic indications for use were met, approximately 95% of patients were

Class 1 Laser

Product

successfully fit with the Earlens Hearing Aid (5% were unable to anatomically accommodate the Lens).

6. Warnings

Before using the Earlens Hearing Aid, make sure you read and underst and each o f 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.

• The patient 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 Earlens Hearing Aid become damaged, the patient should discontinue

use and contact their hearing professional.

• If the patient experiences discomfort or pain in their ear, they should contact their ENT physician

immediately. Only physicians trained in Ear, Nose & Throat procedures should place or remove

the Lens.

• The patient should not insert foreign objects into the 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 improper l y.

• The patient should contact their hearing professional if they experience discharge from the ear or

persistent discomfort or any other problems.

• Should the Processor become unusually warm or hot, the patient should promptly remove it,

discontinue use and contact their hearing professional.

• Do not crush, short circuit, modify or disassemble any component of the Earlens Heari ng 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 open flame. Handle

waste from electronic equipment per local regulations.

7. Precautions

Before using the Earlens Hearing Aid, make sure you and the patient read and unders tand each
of the following safety precautions.

• Individuals with known nickel sensitivity/allergy should be informed that the Lens component

contains nickel that is coated with a parylene barrier. If an allergic reaction develops, the Lens

should be promptly removed.

• 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 expec t ed lif e.

• Only hearing healthcare professionals trained in the fitting of hearing aids may fit the Earlens

Processor and Light Tip.

• The Earlens Hearing Aid is custom designed and intended to be used for 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, the patient can

reposition the Light Tip until optimal sound output is achieved.

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• 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.

• The patient may shower, bathe or swim with the Lens in place. Ear plugs may be used to prevent

water from entering the 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.

• If the patient has small or unusually shaped ear canals, they may be at greater risk for ear canal

abrasions, either from the ear impression procedure or from Light Tip use.

• The patient should avoid getting the Proces s or wet, a s it may damage the device. The patient

must remove the Processor prior to showering, swimming, or bathing.

• The patient may experience a reduction in their 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 ears, as

this may cause the Lens to become dislodged or cause damage to the device.

• Failure to oil the ear canal may result in Lens displacement.

• Do not place any component of the Earlens Hearing Aid into a microwave, or near a significant

source of static electricity.

• Use only the Earlens Charger and AC wall adapter provided. Although other adapters may look

similar, they may cause damage to the Earlens Hearing Aid.

• 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, the patient should promptly remove the Processor, discontinue use

and contact their hearing professional.

• 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

the patient perceives unexp ec ted noise or interference in the presence of the Earlens Hearing

Aids, move away from the source to mitigate the potential interference. If the patient has further

concerns they should remove the Processors and contact their hearing professional.

8. Clinical Study Results

The Definitive Clinical Study of the Earlens Light Driven Hearing Aid confirmed the safety and
effectiveness of the Earlens Hearing Aid for individuals with a mild to severe sensorineural hearing
impairment between the frequencies of 125 Hz – 10,000 Hz. The prospective, single arm study assessed
48 subjects (96 ears) who wore the fully activated Earlens Hearing Aid in both ears in their daily lives for
four months per study protocol. Safety and effectiveness were assessed during the four months.

8.1. Study Demographics

The average age of the study population was 69 years with a gender ratio of 60% for males and 40% for
females. The subjects were seen across three clinical sites with the largest enrollment at Site 1 (Site 1=
21, Site 2=15 and Site 3=12). All participants were experie nc ed hearing aid users.

8.2. Safety Outcomes

The primary safety endpoint was intended to demonstrate that use of the Ear lens Hear i ng Aid did not
result in a change in residual hearing function. The objective was to identify any change in baseline
hearing after four months of device usage using a four frequency threshold criteria (500, 1000, 2000, and
4000 Hz, referred to as PTA4). A determination of clinically non-significant hearing threshold change was
made if calculated PTA4 hearing change of the subject population was less than 10 dB. After wearing the
Lens for 4 months, no decrease in hearing sensitivity of more than 10 dB was observed. A secondary
safety endpoint assessed any decrease in hearing sensitivity of >10 dB by subject per ear at each test
frequency. After four months of use no subjects exhibited a decrease of >10 dB for either ear at any

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frequency. In addition, no serious device or procedure-related adverse events were reported during the

Figure 7: Word Recognition

Figure 8: Sound-field thresholds

trial. There were 31 adverse events reported in 20 subjects for 22 ears. All but one of the adverse events
were temporary and resolved. One subject report of a ‘fullness’ sensation when wearing the Aid did not
change during the trial and effectiveness outcomes were not impacted. The subject continued use
throughout the study period of four months. Table 1 presents the adverse events by type, frequency of
occurrence and resolution status at the conclusion of the study.

Table 1: Adverse events across study period

8.3. Effectiveness Outcomes

The primary efficacy endpoint was intended to demonstrate device effectiveness by improving speech
recognition using the Northwestern Auditory Test No.6 (NU-6) test of word recognition with the Earlens
Hearing Aid at a speech level of 45 dB HL. The objective was to show that the Earlens Hearing Aid
provides a statistically significant improvement in mean aided word recognition at 30 days post placement
when compared to the baseline unaided condition measured prior to placement. The average baseline
unaided score was 52% and the average aided score was 85% (Figure 7); this improvement was
statistically significant (p<0.0001). A secondary measure of device effectiveness was defined as more
than 10 dB improvement (functional gain) in thresholds over the range of frequencies from 2,000 to
10,000 Hz for aided measured at 30 days post placement when compared to unaided measured prior to
placement. Mean functional gain was 30.5 dB (p<0.0001), indicat ing that the Earlens Hearing Aid was
able to deliver significant functional gain (Figure 8). Functional gain reached a maximum of 68 dB at 9-10
kHz.

Word Recognition (n = 78 ears)

100

90
80
70
60
50
40
30
20

Percent Correct (%)

10

0

Unaided baseline Aided 30-day

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Sound-field Threshholds (n = 78 ears)

Frequency (Hz)

100 1,000 10,000

-10
0

10
20
30
40
50

Hearing Level (dB HL)

100
110
120

60
70
80
90

Aided 30­day

Baseline
Unaided

6

An additional measure of device effectiveness was perceived benefit as measured by the Abbreviated
Profile of Hearing Aid Benefit (APHAB). The average baseline unaided percentage of communication
difficulties was 58% (standard deviation = 16%), the percentage of difficulties decreased to 30%
(standard deviation = 13%) with the subject’s own air conduction hearing aid, and for Earlens it was 29%
(standard deviation = 14%). 92% of subjects completing the study (35 out of 38) perceived a clinically
significant improvement for Earlens relative to unaided as measured by APHAB.

8.4. Temporary TM Damping

The Lens is designed to remain in place even when the Processor is not worn. When the Processor is
removed (swimming, bathing, sleeping), users may experience TM damping, which would be interpreted
as slight reduction of sound, due to the loading effect of the Lens. The effect on PTA (500 Hz, 1000 Hz
and 2000 Hz) averaged 4 dB, which is immediately reversed when the Lens is removed. When the
Processor is in place, the gain delivered by the Earlens Hearing Aid more than overcomes the TM
damping effect.

8.5. Summary of Extended Study

The safety and effectiveness of the Earlens Hearing Aid was monitored beyond the 4 months of the
Definitive Study. In the Extended Study, 24 subjects (48 ears) opted to continue wearing the Earlens
Hearing Aid after completing the Definitive study. At the conclusion of the Extended Study, 33 ears had at
least 12 months of cumulative Lens wear with no change in unaided air conduction hearing thresholds
under earphones. Of the 24 active subjects in the Extended Wear Study, 11 related AEs were
experienced by 8 subjects in 10 ears. All events were temporary and resolved. Nine of 11 AEs were
related to ear cleaning pre-impression (3 AEs), the impression procedure (4 AEs), or the inspection
process pre-impression (2 AE). Two of the related AEs were attributed to Light Tip fit and both were
resolved after Light Tip modification. One subject continues to report a sensation of fullness.

Driven on the results of the Definitive study, the Earlens Hearing Aid has been shown to be safe and
effective in delivering the full spectrum of amplification from 125 to 10,000Hz.

9. Operating Instructions

9.1. Ear Canal Impression

Before making the ear canal impression using the Earlens Impression System, please read and follow the
precautions and procedures found in the Earlens Impression System Instructions for Use.

9.2. Lens Placement

a. Visually inspect the Lens packaging. DO NOT use if there is any visible damage.
b. Explain to the patient that the ear will be inspected and cleaned, then lubricated with oil (which

may cause some sensations of stuffiness), and the device will be inserted. Instruct the patient to
remain still during the procedure.

c. With the patient in the supine position, use a binocular microscope to inspect the external

auditory canal and the tympanic membrane and determine if there are any contraindications for
Lens placement.

d. Remove all cerumen and epithelial debris from the ear canal, anterior sulcus and tympanic

membrane using the usual office instrumentation and small cotton swabs with mineral oil. If there
is any bleeding or development of contraindications as a result of cleaning of the ear canal, do

not place Lens.
e. Lubricate the ear canal and TM with mineral oil.
f. Read the package label to confirm that the device is for the right patient and ear (Left or Right).

The right device is identified by a red dot. The left device is identified by a blue dot. In addition to

the label, the Grasping Tab is located on the right side of the Photodetector for a right-ear de vice

and on the left side of the Photodetector for a left-ear device.
g. Grasp the Lens at the Grasping Tab (Figure 2) using smooth alligator forceps.

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h. Using alligator forceps, gently advance the Lens through a thin bladed nasal speculum to the

medial region of the ear canal.
i. Then, using an aural speculum and curved pick, gently advance the Lens onto the TM and

position it such that the Perimeter Platform is congruent with the anatomical contours of the

patient’s anatomical counterparts. At this point the Umbo platform will be in direct contact with

the TM.
j. Once satisfactory positioning is achieved, remove the speculum.
k. Verify functionality of the Lens after placement in the patient’s ear using the Earlens Light Pen.

Please read and follow the precautions and procedures found in the Earlens Light Pen

Instructions for Use.

9.3. Lens Removal

a. Explain to the patient that the ear will be inspected and cleaned, lubricated with mineral oil (which

may cause some sensations of stuffiness), and the device will be gently removed. Instruct the

patient to remain still during the procedure.
b. With the patient in the supine position use a binocular microscope to inspect the external auditory

canal and the TM, and determine the position of the device and the location of the grasping tab.
c. Lubricate the ear canal with mineral oil.
d. Using a right angle hook, use the Grasping Tab to capture the device to be removed and slowly

deliver it into the lateral canal. Withdraw the speculum, and use the curved pick to remove the

Lens.
e. Inspect the external auditory canal and the TM.

9.4. Cleaning and Preparing the Lens for Reinsertion

If a Lens is removed the device and canal must be cleaned prior to reinsertion of the device.

a. Remove the Lens per the Lens Removal instructions and carefully place the device in a dish of

mineral oil for soaking.
b. Thoroughly clean the ear canal, anterior sulcus and TM using cotton swabs, mineral oil and

suction as needed. Remove any debris, including epithelial tissue that may have built up in the

anterior sulcus or on the TM.

I. Hydrogen peroxide solution can be used to loosen hard epithelium or cerumen adhered

to the TM or anterior sulcus. Before placement of the Lens ensure all of the hydrogen
peroxide is completely suctioned out, and the applied area is cleaned with mineral oil, to
avoid device contact with the hydrogen peroxide solution.

c. Inspect the umbo of the TM and the area where the Perimeter Platform of the Lens was resting to

ensure it is free of debris or epithelial tissue.
d. After soaking, grasp the Lens at the Grasping Tab using alligator forceps under visual

magnification. Carefully suction any debris remaining from the Perimeter Platform and/or

Photodetector.

I. Avoid directly contacting the support springs and Umbo Platform while cleaning the Lens.

II. Holding the Grasping Tab of the Lens with the alligator forceps prevents the Lens from

being suctioned up, dropped to the floor or experiencing undue pressure on the Umbo
Platform. It also aids to control the suction to the Lens.

e. Following the cleaning carefully inspect the Lens to ensure it is free of debris and is not damaged.

I. Replacing a Lens that is not free of debris or is damaged may cause the device to

displace.

f. Proceed with device placement per the Lens Placement operati ng ins truc ti ons .

9.5. Troubleshooting

The expected life for the Lens is one year. The Lens is expected to exhibit the same failure modes
regardless of the duration of wear. The Lens can become displaced from the tympanic membrane,
blocked by debris or degrade over time. This may cause the sound output of the Earlens Hearing Aid to

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cease, become reduced or become intermittent. Perform the following troubleshooting steps to assess

Battery Charger Input

100-240 VAC, 50-60Hz, 0.2A

Battery Charger Output

5.0 VDC, 1.0A

Lens function:

a. Inspect the ear canal and Lens

removal or reinsertion is required, follow Lens Removal and Cleaning and Preparing Lens for

Reinsertion instructions above.
b. Verify functionality of the Lens on the patient’s ear using the Earlens Light Pen. Please read and

follow the precautions and procedures found in the Earlens Light Pen Instructions for Use. If

removal or reinsertion of the Lens is required, follow Lens Removal and Cleaning and Preparing

Lens for Reinsertion i ns truc tions abo ve.
c. Inspect the position of the Lens on ear. If the perimeter platform does not appear to be in contact

with the wall of the ear canal, the Lens may be displaced.

I. In the event of displacement of the Lens, remove the device per Lens Removal

instructions and replace following the Cleaning and Preparing Lens for Reinsertion
operating instructions.

d. Inspect the appearance of the Lens on ear. If the Lens appears damaged or abnormal, remove

using the Lens Removal instructions and contact Earlens.
e. If there is a suspected performance is sue with the Le n s that otherwise appears fine visually (e.g.

significant elevation of system Light Calibration), remove the device per Lens Removal

instructions and replace following the Cleaning and Preparing Lens for Reinsertion operating

instructions. Once Lens is replaced assess if the suspected performance issue is resolved (e.g.

system Light Calibration is no longer elevated).

If after performing the troubleshooting steps listed above, the Lens still does not function, remove it using
the Lens Removal operating instructions and contact Earlens.

. If the Lens is blocked by debris, carefully clean the ear canal. If

9.6. Care & Maintenance

a. Store the Earlens Hearing Aid in a clean, dry location out of direct sunlight.
b. The expected life of the Lens is one year. As for any patient with a hear i ng assist dev ic e, it is

recommended that the patient return annually to their hearing professional(s) to monitor their

audiologic and otologic status.

10. Operating Specifications

• For technical details about the Earlens Light Dri ven He ar ing Aid and compliance to applicable
standards, please consult the Hearing Professional Instructions for Use.

• Certain components of the Earlens Hearing Aid, including the Processor and the Light Tip are
classified as a Type BF applied parts as described in the international standard IEC 60601-1:2005,
Medical Electrical Equipment-Part 1:General Requirements for Basic Safety and Essential
Performance.

• Expected service life of the Earlens Hearing Aid include:

o Processor and Charger- thr ee years
o Light Tip- one year
o Lens- one year

• The Earlens Hearing Aid is designed for continuous use.

• The Processor is not designed to prevent the ingress of water.

10.1 Power Requirements

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10.2 Operating and Storage Conditions

IEC 60601-

M002

WEEE

Annex IX

International

tilted up to 15°

Caution: Federal law

practitioner)

Operating

5°C- 40°C

Storage

-20ºC to 55ºC
Use conditions

Avoid high temperatures
direct sunlight.

Frequency

100Hz to 10,000Hz
TM

Tympanic Membrane

Lens

Tympanic Lens

ELF

Earlens Fitting Software

EAS

Electronic Article Surveillance

AE

Adverse Event

Conditions

* If the system is stored at a temperature outside the operating temperature range, allow the system to
stabilize at room temperature for a minimum of 1 hour before use.

15-93% humidity
700 – 1060 hPa

and sustained exposure to

Conditions and
Temperature
Limit*

range

Maximum relative humidity of
93% non-condensing.

11. Glossary of Terms

12. Graphic Symbols Contained in Device Label i ng

Symbol Description Reference Symbol Description Reference

Refer to instruction
manual/booklet

Separate collection
for electrical and
electronic equipment

Keep Dry

restricts this device
to sale by or on
the order of a
(licensed healthcare

1:2005

ISO 7010-

Directive

2012/19/EU,

ISO 15223-

1:2012, 5.3.4

FDA Final

Rule 81 FR

38911

IP21

Temperature
limit

Atmospheric
pressure
limitation

Protection Code
against ingress
of solid foreign
objects ≥

12.5mm
diameter and
vertically falling
water drops
when enclosure

Serial number

ISO 15223-

1:2012, 5.3.7

ISO 15223-

1:2012, 5.3.9

IEC 60601-

1:2005

IEC 60529, 4.2

ISO 15223-

1:2012,5.1.7

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Humidity lim itat i on

FCC Guidelines

2014

0459

MDD

Annex XII

IEC 60601-

5333

IEC 60601-1-

04)

ISO 15223-

1:2012, 5.3.8

Caution

ISO 15223-

1:2012, 5.4.4

Class 1 laser
product

Batch code

Catalog number

Date of manufacture

Non-ionizing
radiation

IEC 60825­1:2007, 5.2

ISO 15223-

1:2012, 5.1.5

ISO 15223-

1:2012, 5.1.6

ISO 15223-

1:2012, 5.1.3

2:2007

IEC 60417-

5140 (2003-

MR unsafe

FCC Part 18
Declaration of
Conformity

CE conformity
marking

Type BF applied
part

ASTM F2503-

13

for

Labeling, Part

15 and Part 18,

93/42/EEC,

1:2005

IEC 60417-

13. Laser Certification

The Earlens Light-Driven Hearing Aid complies with 21CFR 1040.10 and 1040.11.

Manufacturer (Ref. ISO 15223-1:2012, 5.1.1):
Earlens Corporation, Inc.
4045A Campbell Ave.
Menlo Park, CA 94025

European Authorized Representative (Ref. ISO 15223-1:2012, 5.1.2):
Medimark® Europe SARL
11, Rue Emile Zola, B.P. 2332
F-38033 Grenoble Cedex 2 – France

0459

©2017 Earlens, Inc. All rights reserved.
Patent Protected/Pendin g: www.earlens.com/patents

TM

Earlens Photon

and the Earlens Control app are compatible with the following Apple devices:
iPhone 7 Plus, iPhone 7, iPhone SE, iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone
5s, iPhone 5c, iPhone 5, iPad Pro, iPad Air 2, iPad Air, iPad (4th generation), iPad mini 4, iPad
mini 3, iPad mini with Retina display, iPad mini, iPod touch (5th generation) using iOS 9 or later.

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Apple, the logo, AirPlay, iPhone, iPad, iPod are trademarks of Apple Inc., registered in the U.S.
and other countries.

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