Widex U-CIC, U-CIC-M User Instructions

USER INSTRUCTIONS

THE WIDEX UNIQUE™ FAMILY

U-CIC/U-CIC-M model

Completely-in-canal

YOUR WIDEX® HEARING AID

(To be filled out by the hearing care professional)
Vent:  Short  Full length  None

 CIC  CIC-M

Your hearing aid series:

PROGRAMS

 Universal  Audibility Extender
 Quiet  Audibility Extender
 Transport  Audibility Extender
 Urban  Audibility Extender
 Party  Audibility Extender
 Music  Audibility Extender

SPECIAL PROGRAMS

 Phone  Audibility Extender
 Zen  Audibility Extender

SMARTTOGGLE PROGRAMS
 Zen+  Audibility Extender

2

NOTE

The CIC-M is not a wireless hearing aid, which means that the hearing aids
cannot communicate with each other or with any accessory. Consequently,
you cannot adjust the sound and you will only have one listening program.

NOTE

The program names in the table are the default names. If you have chosen to
use some of the other names available, write the new names in the table. That
way you will always know which programs you have in your hearing aids.

3

CONTENTS

YOUR HEARING AID...................................................................................6

Welcome...........................................................................................................6

Important safety information.........................................................................7

THE HEARING AID......................................................................................9

Indications for use........................................................................................... 9

Intended use.....................................................................................................9

The battery.......................................................................................................9

Sound signals...................................................................................................11

How to tell right from left..............................................................................12

Turning the hearing aid on and off...............................................................12

Putting on and removing your hearing aid.................................................13

Sound adjustment..........................................................................................14

Programs.........................................................................................................15

CLEANING.................................................................................................21

Tools.................................................................................................................21

Cleaning the hearing aid................................................................................21

The wax guard............................................................................................... 23

ACCESSORIES..........................................................................................26

TROUBLESHOOTING.................................................................................27

REGULATORY INFORMATION.................................................................. 30

4

FCC and IC statements..................................................................................48

EC directives....................................................................................................51

SYMBOLS................................................................................................. 52

5

YOUR HEARING AID

Welcome

Congratulations on your new hearing aid.
Use your hearing aid regularly, even if it takes some time getting used to it.

Infrequent users don’t usually get the full benefit of a hearing aid.

NOTE

Your hearing aid and its accessories may not look exactly as illustrated in this
booklet. We also reserve the right to make any changes we consider necessary.

Your hearing aid at a glance

1. Microphone opening

2. Battery lid (on/off function)

3. Nail grip

4. Sound outlet

5. Wax guard

6. Extraction cord

7. Relief vent (short) / 8. Relief vent (full length)

6

Important safety information

Read these pages carefully before you begin using your hearing aid.

Hearing aids and batteries can be dangerous if swallowed or used im­properly. Swallowing or improper use can result in severe injury or even
fatalities. In case of ingestion, contact a doctor immediately and the 24
Hour National Button Battery Ingestion Hotline at [phone].

Take your hearing aids out when you are not using them. This will help to
ventilate the ear canal and prevent ear infections.

Contact your doctor or hearing care professional immediately if you sus­pect you may have an ear infection.

Remove your hearing aids before showering, swimming or using a hair
dryer.

Do not wear your hearing aids when applying perfume, spray, gels, lotion
or cream.

Do not dry your hearing aid in a microwave oven - this will ruin it.

Never use other people’s hearing aids and never allow others to use
yours, as this could damage your hearing.

Never use your hearing aids in environments where there may be explo­sive gases, such as in mines, etc.

Keep hearing aids, their parts, accessories and batteries away from chil­dren.

7

Never try to open or repair the hearing aid yourself. Contact your hearing
care professional if you need to have your hearing aid repaired.

Your hearing aids contain radio communication technology. Always ob­serve the environment in which you are using them. If any restrictions ap­ply, you must take precautions to comply with these.

Do not expose your hearing aids to extreme temperatures or high humid­ity, and dry them quickly if they get wet, or if you perspire heavily.

Your hearing aids should be stored and transported within the temperature and
humidity ranges of -20°C to +55°C (-4°F to 131°F) and 10%-95% rH.

Storage and transportation up to 60°C (140°F) with 10%-95% rH can be accepted
in shorter periods (duration of max. of 2 weeks).

Your hearing aids are designed to operate from 0°C (32°F) to 50°C (122°F).
For more information about your hearing aids, visit: www.widex.com.

8

THE HEARING AID

Indications for use

The hearing aids are indicated for individuals older than 36 months with a
range of hearing loss from minimal (10 dB HL) to severe (90 dB HL) and all
hearing loss configurations.

They are to be programmed by licensed hearing care professionals (audiol­ogists, hearing aid specialists, otolaryngologists) who are trained in hearing
(re)habilitation and tinnitus management.

Intended use

The hearing aids are intended as air conduction amplification devices to be
used in everyday listening environments. The hearing aids may be equipped
with the Zen program intended to provide a relaxing sound background (i.e.
music/noise source) for adults older than 21 years who desire to listen to
such a background in quiet.

The battery

Use a type 10 zinc-air battery for your hearing aid.
Always use a fresh, new battery that is precisely the kind recommended by

your hearing care professional.

9

NOTE

Check that the battery is completely clean and free of any residue before insert­ing it in the hearing aid. Otherwise your hearing aid may not function as expec­ted.

Never attempt to recharge your hearing aid batteries, as they could ex­plode.

Never leave a flat battery in the hearing aids while storing them. It could
leak and ruin your hearing aid.

Dispose of used batteries as indicated on the packaging and take note of
the expiry date.

Low battery indication

When the battery is weak, a sound signal will play. If the battery drains sud­denly there may however be no warning. We recommend carrying a spare
battery with you wherever you go.

Changing the battery

To change the battery, do as follows:

Use the nail grip to gently swing the battery door
open and remove the old battery.

Take the adhesive tab off the new battery and make
sure there is no sticky substance left on it. Let it
"breathe" for 60 seconds.

10

Now place the new battery in the drawer as shown.
Close the drawer. If it doesn't close easily, the battery
is not placed correctly. If you are not using the hear­ing aid for a few days, remove the battery.

NOTE

Avoid dropping your hearing aid - hold the hearing aid above a soft surface
while changing the battery.

Sound signals

Your hearing aid plays sounds to inform you that certain features have been
activated or that you have changed programs. These sounds may be spoken
messages or tones, depending on your needs and preferences.

Program 1 Message/one short beep
Program 2 Message/two short beeps
Program 3 Message/three short beeps
Program 4 Message/one short and one long beep
Program 5 Message/one long beep and two short beeps
Zen+ Message/tone

Ask your hearing care professional to turn these sounds signals off if you
don't need them.

11

Lost partner

(Only available in 440-series)
Your hearing care professional can turn on a feature in your hearing aid that

warns you whenever it loses contact with the hearing aid in the opposite
ear. You will hear a spoken message in your ear.

How to tell right from left

The hearing aid for your right ear has a red mark. The hearing aid for your
left ear has a blue mark.

Turning the hearing aid on and off

To turn the hearing aid on, close the battery cover and
push it upwards. The hearing aid will play a sound sig­nal to indicate that it is on, unless your hearing care
professional has deactivated this function.

To turn off the hearing aid, push the battery cover
downwards.

NOTE

You can also cup the hearing aid in your hand to verify that it is turned on. If it's
on, it will whistle. Don't forget to turn off the hearing aid when it is not in use.

12

Putting on and removing your hearing aid

To put on your hearing aid:

Close the battery cover completely.
Hold the hearing aid with your thumb and forefinger
and insert it slowly into your ear until you feel resist­ance. Then use the tip of your forefinger to gently push
the hearing aid into your ear until it feels comfortable.
Pulling the outer ear upwards and backwards while you
insert the hearing aid can be helpful.

NOTE

If the hearing aid doesn't feel comfortable, or if it doesn't fit properly, causing
irritation, redness or the like, contact your hearing care professional.

Removing the hearing aid

Use the extraction cord to take the hearing aid out of your
ear.

NOTE

If you find it difficult to take out the hearing aid, move it carefully from side to
side while pulling on the extraction cord.

13

Sound adjustment

Your hearing aid adjusts the sound automatically according to your sound
environment.

If you have a remote control, you can also adjust the sound manually to ach­ieve more comfort or more audibility, depending on your needs and prefer­ences. For more information on how this works, consult your hearing care
professional.

Depending on the hearing aid settings and features, any sound adjustment
you make will affect both hearing aids.

Each time you operate the volume control, you will hear a beep-tone unless
your hearing care professional has deactivated this function. When you
reach the maximum or minimum setting, you will hear a steady tone.

To mute your hearing aid do as follows:

● Keep pressing the lower part of the volume key on the remote control
until you can hear the steady sound

To turn the sound on again:

● Press the upper part of the volume key or

● Change program

Any adjustment of the volume will be canceled when you turn off your
hearing aid or if you change program.

14

Programs

PROGRAMS USE
Universal For everyday use
Quiet Special program for listening in quiet environ-

ments

Transport For listening in situations with noise from cars,

trains, etc.

Urban For listening in situations with changing sound

levels (in supermarkets, noisy workplaces or sim­ilar)

Party For listening in situations with many people talk-

ing at the same time

Music For listening to music

SPECIAL PROGRAMS USE
Zen Plays tones or noise for a relaxing sound back-

ground. For more information, see under "The
Zen program"

Phone This program is designed for listening to phone

conversations

15

SMARTTOGGLE PRO­GRAMS

USE

Zen+ This program is similar to Zen but allows you to

listen to different types of tones or noise

NOTE

The program names in the table are the default names. If you have chosen to
use some of the other names available, write the new names in the table. That
way you will always know which programs you have in your hearing aids.

Depending on your hearing loss, your hearing care professional can activate
the Audibility Extender feature. Ask your hearing care professional if you
could benefit from this.

If your needs and preferences change over time, your hearing care profes­sional can easily change your program selection

Changing programs

To change programs, simply push the program key on your remote control.

Zen+

To access this program, press and hold the program key for more than one
second. A quicker press then allows you to cycle through the available Zen
styles. To exit the program, press and hold down the program key for more
than one second.

16

The Zen program

Your hearing aid may be provided with a unique optional listening program
called Zen. It makes musical tones (and sometimes a rushing noise) in the
background. The Zen program may be used alone (without amplification) in
quiet when you are not required to hear surrounding sounds. Or, it may be
used with amplification so that both the surrounding sounds and the gener­ated sounds (fractal tones and noise) are heard together.

CAUTION

Use of the different Zen programs may interfere with hearing surrounding
sounds including speech. The programs should not be used when hearing such
sounds is important. Switch the hearing aid to a non-Zen program in those sit­uations.

The duration of the Zen play time can be set by your hearing healthcare pro­fessional according to your needs.

Benefits

The Zen program may provide a relaxing listening background for some
people. When the Zen program is used in a tinnitus management program,
its wearer may experience some relief from tinnitus.

Indications for use

The Zen program is intended to provide a relaxing sound background for
adults (21 years and older) who desire to listen to such a background in qui­et. It may be used as a sound therapy tool in a tinnitus treatment program

17

that is programmed by a licensed hearing healthcare professional (audiolo­gists, hearing aid specialists, otolaryngologists) who is trained in tinnitus
management.

Directions for use

The Zen program can be activated with a simple push of the program but­ton on the hearing aid (or on the remote control). Depending on how your
hearing care professional has set up the program, you can access the Zen
program by a "short-press" of the program button or a "long-press" of the
program button.

● "Short-press" option - the program button is pressed for less than a sec­ond. At most two listening programs can be programmed for Zen.

● "Long-press" option - the program button is pressed and held for more
than 1 second. Up to three Zen styles are available. A "short-press" of
the program button in the long-press mode will allow you to cycle
through the available Zen styles. You can exit the "long-press" mode by
pressing and holding the program button for more than one second.

Because of the unique ways in which Zen is programmed in your hearing
aid, please follow the recommendations of your hearing care professionals
as to how to use the program, when to use the program and/ or how long to
use the program.

Precautions

To ensure the safety and effectiveness of the Zen program when used as a
sound therapy tool for tinnitus, the tinnitus management program must be
designed and conducted by hearing care professionals who are trained in

18

tinnitus management. A tinnitus management program should include a
complete audiological evaluation, tinnitus diagnosis, counseling, use of
proper amplification and/or sound therapy tools.

Prior to any tinnitus management program, it is advisable that you seek
medical attention to exhaust any medical or surgical treatment options.

Use your hearing aid and the Zen program according to the directions and
schedule recommended by your hearing care professionals.

Contraindications

The following symptoms are contraindicated for the use of hearing aids. In­cluding the Zen program

● Congenital or traumatic deformity of the ear

● Active drainage from the ear within 90 days

● History of rapid progressive hearing loss within previous 90 days

● Acute or chronic dizziness

● Sudden unilateral hearing loss in previous 90 days

Warnings

Use of the Zen program may interfere with hearing everyday sounds includ­ing speech. It should not be used when hearing such sounds is important.
Switch the hearing aid to a non-Zen program in those situations.

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Risks

There are no known risks or side effects associated with the use of the Zen
program. However, consistent with our recommendations on the use of
conventional hearing aids, stop using the hearing aids (and the Zen pro­gram) and seek attention from your hearing care professional if any of the
following symptoms are noted:

● Skin irritation

● Perceived decrease in loudness, tolerance of sounds, speech not as

clear, or worsening tinnitus

20

CLEANING

Tools

You will receive the following cleaning tools with your hearing aid.

1. 2. 3. 4. 5.

1. Cloth

2. Brush

3. Long wax removing tool

4. Short wax removing tool

5. Battery magnet

Cleaning the hearing aid

Cleaning your hearing aid every day will make it more efficient and more
comfortable to wear.

The hearing aid

Just wipe it with the a soft cloth (for example the cloth
you received from your hearing care professional).

The sound outlet

Remove any visible earwax from around the sound outlet
with the small brush or cloth. Never try to clean the wax
guard.

21

NOTE

If you can't clean the sound outlet, contact your hearing care professional. Never
insert anything into the sound outlet as this can ruin your hearing aid.

The microphone openings

Open the battery lid and turn the hearing aid so the lid is
facing downwards (see illustration). Guide the short wax
removing tool (no. 4 ) through the microphone openings
on the lid from the inside (see illustration).

NOTE

If you suspect that earwax or dirt has got into the microphone inside the hearing
aid, contact your hearing care professional. Do not insert anything into the mi­crophone.

The vent

Short vent: clean the vent as far as the long end of the
wax removing tool (no. 3) can reach.
Long vent: clean the vent every day by passing the long
wax removing tool (no. 3) all the way through the vent.

Leave the hearing aid open to ventilate it.

NOTE

It is important for the performance of your hearing aid that you keep the vent
clean and free of earwax, dirt or the like. Clean it every day after use and consult
your hearing care professional if the vent is blocked.

22

Dry your hearing aid quickly if it gets wet, or if you perspire heavily. Some
people use a special dehumidifier like Widex Dry-Go to help keep their hear­ing aids dry and clean. Ask your hearing care professional if this is right for
you.

Do not use any kind of liquid or disinfectant to clean your hearing aid.

Clean and inspect your hearing aid every day after use to check that it is
not broken. If the hearing aid breaks while you are wearing it, leaving
small fragments in your ear canal, contact your doctor. Never try to take
out the fragments yourself.

The wax guard

The wax guard helps to protect the hearing aid against earwax. Always use
wax guards supplied by Widex with your hearing aid.

Changing the wax guard

Open the wax guard case as illustrated.

2

1

The wax guard consists of the following parts:

1. Removal hook

2. New wax guard

23

Insert the removal hook into the used wax guard.

Keep the holder at a right angle.

Pull the used wax guard straight out.

24

Insert the new wax guard into the opening of the
sound outlet and press it gently.

Pull the holder straight out.

Ask your hearing care professional about how often you should change the
wax guard.

The wax guard is for one-time use only and is not intended to be cleaned.

If the wax guard fits loosely, discard it and use a new one.

If the wax guard falls off inside your ear, contact your doctor or hearing
care professional to have it removed. Do NOT attempt to remove the wax
guard yourself.

25

ACCESSORIES

You can use a variety of accessories with your hearing aid. To see whether
you could benefit from using these accessories, ask your hearing care pro­fessional.

Name Use
RC-DEX remote control
TV-DEX for listening to TV and audio
PHONE-DEX for easy landline use
FM+DEX for streaming audio and FM signals
UNI-DEX for connecting hearing aids to mobile phones
CALL-DEX for easy wireless connection to mobile phones
COM-DEX for wireless connection to mobile phones and other devices

via bluetooth

COM-DEX
Remote Mic

for helping hearing aid users hear speech in difficult listening
situations

Available in some countries only.

26

TROUBLESHOOTING

These pages contain advice on what to do if your hearing aid stops working
or if it doesn't work as expected. If the problem persists, contact your hear­ing care professional.

Problem Possible cause Solution
The hearing aid is com-

pletely silent

It is not turned on Make sure the battery is

placed correctly and the
battery compartment cover
is closed correctly.

The battery does not
work

Insert a new battery in the
hearing aid

The sound outlet is
blocked

See the cleaning section

The microphone open­ing is blocked

See the cleaning section

The hearing aid vol­ume is not powerful
enough

The sound outlet is
blocked

See the cleaning section

Your ear is blocked by
earwax

Contact your doctor

Your hearing may
have changed

Contact your hearing care
professional/doctor

27

Problem Possible cause Solution
The hearing aid whis-

tles continuously

Your ear is blocked by
earwax

Contact your doctor

It is not correctly
placed in your ear ca­nal

Take it out and reinsert it

It fits loosely in your
ear canal

Contact your hearing care
professional

The hearing aid is un­comfortable to wear

It is not correctly
placed in your ear ca­nal.

Consult your hearing care
professional

It does not fit your ear
properly

Contact your hearing care
professional

Your outer ear or ear
canal is sore

It is important that first­time users only wear the
hearing aid for short peri­ods of time at the begin­ning. Take 2-3 weeks to
gradually get used to the
hearing aid. If the soreness
continues, contact your
hearing care professional

28

Problem Possible cause Solution
Your hearing aids are

not working in syn­chrony

The connection be­tween the hearing aids
is lost

Turn them off and on again

The hearing aids do
not respond with a
corresponding change
in volume or program
to the device

a. The device is used
beyond the transmis­sion range
b. Strong electromag­netic interference in
the vicinity
c. The device and the
hearing aids are not
matched

a. Move the device closer to
the hearing aids
b. Move away from known
source of EM interference
c. Check with your hearing
care professional to make
sure device is matched with
the hearing aids

You hear “interrupted”
speech (on and off)
from the hearing aids
or no speech (muted)
from the transmitting
hearing aid.

a. The battery in one of
the hearing aids is
dead
b. Strong electromag­netic interference in
the vicinity

a. Replace battery in one or
both hearing aids
b. Move away from known
sources of interference

29

REGULATORY INFORMATION

The following Table summarizes the technical details of the WidexLink tech­nology as it is implemented in the UNIQUE™ hearing aids.

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Antenna
type

Inductive anten-naInductive an-

tenna

Inductive an­tenna

Embedded
ceramic an­tenna

Antenna di­mensions

Ø1.8 mm,
L - 4.85 mm

Ø8 mm,
L – 20 mm

Ø6 mm,
L - 8 mm

NA

Modulation FSK FSK FSK FHSS/GFSK,

π/4 DPSK, 8
DPSK

Magnetic
Field
Strength (at
10 m dis­tance)

-54 dBμA/m -13 dBμA/m -26 dBμA/m NA

Output
power
(EIRP**)

29 pW 21 nW 1.2 nW +4dB re.

1mW

30

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Range < 1 m remote

unit to hearing
aid
< 30 cm be­tween hearing
aids or Hearing
aid to TM-DEX

< 1 m remote
unit to hearing
aid

< 30 cm be­tween hearing
aid and TM­DEX

< 10 m be­tween PC
and NOAH­link

Center fre­quency

10.6 MHz 10.6 MHz 10.6 MHz 2.4 GHz

Channel Single channel -

radio

Single channel
radio

Single channel ­radio

5 logical
channels

Bandwidth 660 kHz (-15

dB)

660kHz (-15
dB)

660kHz
(-15 dB)

1 MHz

Data-rate 212 kbit/second

(raw channel ca­pacity)

212 kbit/sec­ond (raw
channel ca­pacity)

212 kbit/sec­ond (raw chan­nel capacity)

2.1 Mbps

Data flow Simplex or

semi-duplex ca­pability

Simplex capa­bility

Simplex or
semi-duplex
capability

Time division
duplex
(TDD)

31

Hearing aids RC-DEX TM-DEX Bluetooth* -

NOAHlink

Protocol Random Access

– no collision
avoidance

Random Ac­cess – no colli­sion avoid­ance

Random Ac­cess – no colli­sion avoidance

Packet­based proto­col, time
divided; se­cure Serial
Port Profile
(SPP)

* Bluetooth specification v2.0 + EDR published by the Bluetooth Special In­terest Group (SIG).

** EIRP = Equivalent isotropically radiated power.

Bluetooth Identifier: B01837
Reference number of QPN: NOAHlinkV1.2_412832_QPN_E1
(Benefits) The use of wireless transmission allows convenient and

synchronized control of hearing aid functions. The UNIQUE wireless hearing
aids share input information between the two partner hearing aids. In so do­ing, the wearers would experience the following additional user benefits
(only when wearing binaural UNIQUE hearing aids).
Synchronization of volume control settings between hearing aids – The vol­ume in both hearing aids will change when the VC is adjusted on one ear.

32

Synchronization of listening programs between hearing aids – The same lis­tening program is used in both hearing aids when one is changed by the
user.
Surveillance of partner hearing aid – The hearing aid(s) will signal an alert
(“partner check”) when a hearing aid battery has expired, or that one of the
hearing aids has fallen off. In rare instances, a much stronger wireless source
nearby may activate this alert. This serves as an early warning to the wearer
of such service interruption. Coordination of compression – The UNIQUE
hearing aids maintain the intensity level difference between ears (inter-au­ral level difference, ILD). In some situations where speech is presented to
one side and noise the other side, this coordinated action could enhance the
relative loudness of the speech sounds to the noise background and im­prove speech understanding for some wearers.

More accurate identification of feedback – The UNIQUE hearing aids distin­guish between “true” hearing aid whistling (or feedback) and music sounds
to prevent unnecessary feedback cancellation and preserve natural sound
quality.

Radio transmitter / cables / transducers
The UNIQUE™ series hearing aid contains a radio transmitter / receiver with

the following

Radio transmitter parameters:

Frequency (range): 10.6 MHz (10.2 – 11.0 MHz)
Bandwidth (-15dB): 660 kHz
Channel: Single channel radio

33

Modulation: FSK
Radiated output power: 29 pW / -75 dBm
Magnetic field strength: -54 dBμA/m @ 10 m
Duty Cycle: < 5 % (averaged over 1 hour of operation)
Simplex or semi duplex capability
The radio receiver in the UNIQUE™ series hearing aid is using the same fre-

quency and bandwidth as the transmitter.

Cables and transducers:

No cables and transducers are used neither during normal use of the
UNIQUE™ series hearing aid nor during programming of the hearing aid.

Quality of Service for Wireless Technology in the WidexLink System

WidexLink wireless technology enables communication between two part­ners of a binaural pair of UNIQUE hearing aids and with their matched exter­nal devices. The requirements for the quality of service (QoS) vary among
the various components and their intended user scenarios.

For programming, these requirements include a BER (Bit Error Rate) better
than 10-3, at a bitrate of 212 kbits/s, a semi-duplex transmission with a re­quired acknowledge, a transmission latency in each direction (2x) and a re­ceive-to-transmit mode (RX to TX) time. The data are saved in the hearing
aid even when transmission is interrupted.

34

During daily use, the requirements on audio streaming between hearing
aids include a BER better than 10-3. The communication is simplex with a
bitrate of 212 kbits/s. The additional audio decoding in this mode results in a
longer latency which is less than 10 ms. For remote control commands the
QoS requirements include a BER better than 10-2. The lower BER require­ment results from redundant transmissions. Each key press results in trans­missions of 7 data packages of which only one is needed for a successful
communication.

For inter-ear communication between hearing aids, a BER better than 10-3
is required. The communication is updated every 50 ms (or 20 Hz). The
hearing aids continue to amplify based on the last saved settings even when
the transmission range is exceeded or when communication is interfered.

Wireless Security Measures

Security of the wireless signals is assured through device system design that
includes:

Individual MAC address for each unit which is checked during each transmis­sion.

A built-in pairing table which specifies valid and legitimate pairing among
units

A proprietary Widex communication protocol which checks the package
numbers during each transmission.

A Cyclic Redundancy Check (CRC) to check data validity and correct errors.

Guidance and manufacturer’s declaration

35

Electromagnetic emissions
The UNIQUE™ series hearing aids are intended for use in the electromagnet-

ic environment specified below. The customer or the user of a UNIQUE™ ser­ies hearing aid should assure that it is used in such an environment.

Emissions test Compli-

ance

Electromagnetic environment - guidance

RF emissions
CISPR 11

Group 1 The UNIQUE™ hearing aid uses RF energy only

for its internal function. Therefore, its RF emis­sions are very low and are not likely to cause any
interference in nearby electronic equipment.

RF emissions
CISPR 11

Class B The UNIQUE™ hearing aid is suitable for use in all

establishments, including domestic establish­ments and those directly connected to the public
low‑voltage power supply network that supplies
buildings used for domestic purposes.

Harmonic
emissions
IEC 61000-3-2

Not
applica­ble *)

Voltage fluctu­ations/ flicker
emissions IEC
61000-3-3

Not
applica­ble *)

*) Battery powered equipment

Electromagnetic immunity

36

The UNIQUE™ series hearing aids are intended for use in the electromagnet­ic environment specified below. The customer or the user of a UNIQUE™ ser­ies hearing aid should assure that it is used in such an environment.

Immunity Test IEC 60601

Test level

Compliance

level

Electromagnetic

environment –

guidance

Immunity Test IEC 60601

Test level

Compliance
level

Electromagnetic
environment –
guidance

Electrostatic dis­charge (ESD)
IEC
61000-4-2

± 6 kV contact
± 8 kV air

± 6 kV con­tact
± 8 kV air

Floors should be
wood, concrete or
ceramic tile. If floors
are covered with
synthetic material,
the relative humidi­ty should be at least
30%.

Electrical fast tran­sients/burst
IEC
61000-4-4

± 2 kV for power line
supplies
± 1 kV for input/out­put lines

Not
applicable *)

Not
applicable *)

Not
applicable *)

37

Immunity Test IEC 60601

Test level

Compliance

level

Electromagnetic

environment –

guidance

Surge
IEC
61000-4-5

± 1 kV line(s) to
line(s)

± 2 kV line(s) to
earth

Not
applicable *)

Not
applicable *)

Not
applicable *)

Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC
61000-4-11

<5 % UT
(>95 % dip
in UT) for

0.5 cycle
40 % UT
(60 % dip
in UT) for 5 cycles
70 % UT
(30 % dip
in UT) for 25 cycles
<5 % UT
(>95 % dip
in UT) for 5 s

Not
applicable *)

Not
applicable *)

38

Immunity Test IEC 60601

Test level

Compliance

level

Electromagnetic

environment –

guidance

Power frequency
(50/60 Hz) mag­netic field
IEC
61000-4-8

3 A/m 3 A/m Power frequency

magnetic fields
should be at levels
characteristic of a
typical location in a
typical commercial
or hospital environ­ment

NOTE UT is the a.c. mains voltage prior to the application of the test level.

*) Battery powered equipment

Electromagnetic immunity – cont.

The UNIQUE™ series hearing aids are intended for use in the electromagnet­ic environment specified below. The customer or the user of a UNIQUE™ ser­ies hearing aid should assure that it is used in such an environment.

Immunity Test

IEC 60601
Test level

Compliance
level

Electromagnetic environ­ment – guidance

39

Portable and mobile RF
communications equip­ment should be used no
closer to any part of the
UNIQUETM series hear­ing aid, including cables,
than the recommended
separation distance cal­culated from the equa­tion applicable to the fre­quency of the transmit­ter.

Conducted RF

IEC
61000-4-6

3 Vrms

150 kHz to 80
MHz

3 Vrms

Recommended separa­tion distance
d = 1.2 ÖP

Radiated RF

IEC
61000-4-3

3 V/m

80 MHz to 2.5
GHz

3 V/m d = 1.2 ÖP

80 MHz to 800 MHz

d = 2.3 ÖP
800 MHz to 2.5 GHz

40

Immunity Test IEC 60601

Test level

Compliance
level

Electromagnetic environ­ment – guidance

Where P is the maximum
output power rating of
the transmitter in watts
(W) according to the
transmitter manufacturer
and d is the recommen­ded separation distance
in meters (m).

Field strengths from
fixed RF transmitters, as
determined by an elec­tromagnetic site survey
a, should be less than the
compliance level in each
frequency range b.

Interference may occur in
the vicinity of equipment
marked with the follow­ing symbol:

41

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, ob­jects and people.

a. Field strengths from fixed transmitters, such as base stations
for radio (cellular/cordless) telephones and land mobile radios, amateur ra­dio, AM and FM radio broadcast and TV broadcast cannot be predicted the­oretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered.
If the measured field strength in the location in which the UNIQUE™ series
hearing aid is used exceeds the applicable RF compliance level above, the
UNIQUE™ series hearing aid should be observed to verify normal operation.
If abnormal performance is observed, additional measures may be necessa­ry, such as re-orienting or re-locating the UNIQUE™ series hearing aid.
b. Over the frequency range 150 kHz to 80 MHz, field strengths should be
less than 3 V/m.

Recommended separation distances

Recommended separation distances between portable and mobile RF com­munication equipment and the UNIQUE™ series hearing aids.

The UNIQUE™ series hearing aids are intended for use in the electromagnet­ic environment in which RF disturbances are controlled. The customer or the
user of the UNIQUE™ series hearing aid can help prevent electromagnetic
interference by maintaining a minimum distance between portable and mo-

42

bile RF communications equipment (transmitters) and the UNIQUE™ hear­ing aids as recommended below, according to the maximum output power
of the communications equipment.

Rated maximum
output power of
transmitter (W)

Separation distance according to frequency of trans­mitter (m)

150 kHz to 80
MHz
d = 1.2 ÖP

80 MHz to 800
MHz
d = 1.2 ÖP

800 MHz to 2.5
GHz
d = 2.3 ÖP

0.01 0.12 0.12 0.23

0.1 0.38 0.38 0.73
1 1.2 1.2 2.3
10 3.8 3.8 7.3
100 12 12 23

43

For transmitters rated at a maximum output power not listed above, the
recommended separation distance d in meters (m) can be estimated using
the equation applicable to the frequency of the transmitter, where P is the
maximum output power rating of the transmitter in watts (W) according to
the transmitter manufacturer.

NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.

NOTE 2 These guidelines may not apply in all situations. Electromagnetic
propagation is affected by absorption and reflection from structures, ob­jects and people.

This UNIQUE™ hearing aid may be interfered with by other equipment even
if that other equipment complies with CISPR emission requirements.

(EMI/EMC Compliance).

The UNIQUE™ hearing aid complies with the following EMC/EMI standards:
Standard

Test type Note

47 CFR Part 15,
subpart C

RF emissions USA Federal Communications Commis-

sion (FCC) requirements for intentional
radiators.

EN 300 330-2
V1.6.1

RF emissions
incl. Spurious
emission

EMC and radio spectrum matters for
Short Range Devices in the frequency
range 9 kHz – 25 MHz

44

IEC
60601-1-2:2007
*adapted proto­col

EMC emission
Immunity, RF
and ESD

Medical electrical equipment.
General requirements for basic safety
and essential performance.
Electromagnetic compatibility.

EN 301 489-3
V1.6.1

Immunity, RF
and ESD

Standard for Low Power Transmitters in
the frequency range 9 kHz – 40 GHz

IEC 60118­13:2011

Immunity
RF Near Field
immunity test

International Product std. for hearing
aids to ensure adequate immunity to ra­dio interference from cell telephones.

ANSI
C63.19-2007

Immunity
RF Near Field
immunity test

American National Standard Methods of
measurement of Compatibility between
wireless Communication Devices and
Hearing Aids

* The device was tested in only one orientation that represents the longest
length (or worst case scenario). This is acceptable because of the relative
small size of the device compared to the wavelength of the RF used in the
test.

Warning to hearing aid dispensers

A hearing aid dispenser should advise a prospective hearing aid user to con­sult promptly with a licensed physician (preferably an ear specialist) before
dispensing a hearing aid if the hearing aid dispenser determines through in­quiry, actual observation, or review of any other available information con­cerning the prospective user, that the prospective user has any of the fol­lowing conditions:

45

(i) Visible congenital or traumatic deformity of the ear.
(ii) History of active drainage from the ear within the previous 90 days.
(iii) History of sudden or rapidly progressive hearing loss within the previous

90 days.
(iv) Acute or chronic dizziness.
(v) Unilateral hearing loss of sudden or recent onset within the previous 90

days.
(vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500

hertz (Hz), 1,000 Hz, and 2,000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body

in the ear canal.
(viii) Pain or discomfort in the ear.
Special care should be exercised in selecting and fitting a hearing aid whose

maximum sound pressure level exceeds 132 decibels because there may be
risk of impairing the remaining hearing of the hearing aid user.

Important notice for prospective hearing aid users

Good health practice requires that a person with a hearing loss have a medi­cal evaluation by a licensed physician (preferably a physician who special­izes in diseases of the ear) before purchasing a hearing aid. Licensed physi­cians who specialize in diseases of the ear are often referred to as otolar­yngologists, otologists, or otorhinolaryngologists. The purpose of medical
evaluation is to assure that all medically treatable conditions that may affect
hearing are identified and treated before the hearing aid is purchased.

46

Following the medical evaluation, the physician will give you a written
statement that states that your hearing loss has been medically evaluated
and that you may be considered a candidate for a hearing aid. The physician
will refer you to an audiologist or a hearing aid dispenser, as appropriate, for
a hearing aid evaluation.

The audiologist or hearing aid dispenser will conduct a hearing aid evalua­tion to assess your ability to hear with and without a hearing aid. The hear­ing aid evaluation will enable the audiologist or dispenser to select and fit a
hearing aid to your individual needs.

If you have reservations about your ability to adapt to amplification, you
should inquire about the availability of a trial-rental or purchase-option pro­gram. Many hearing aid dispensers now offer programs that permit you to
wear a hearing aid for a period of time for a nominal fee after which you
may decide if you want to purchase the hearing aid.

Federal law restricts the sale of hearing aids to those individuals who have
obtained a medical evaluation from a licensed physician. Federal law per­mits a fully informed adult to sign a waiver statement declining the medical
evaluation for religious or personal beliefs that preclude consultation with a
physician. The exercise of such a waiver is not in your best health interest
and its use is strongly discouraged.

Children with hearing loss

In addition to seeing a physician for a medical evaluation, a child with a
hearing loss should be directed to an audiologist for evaluation and rehabili­tation since hearing loss may cause problems in language development and

47

the educational and social growth of a child. An audiologist is qualified by
training and experience to assist in the evaluation and rehabilitation of a
child with a hearing loss.

FCC and IC statements

FCC ID: TTY-UCIC
IC: 5676B-UCIC
Federal Communications Commission Statement
This device complies with part 15 of the FCC Rules. Operation is subject to

the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference

that may cause undesired operation.
NOTE:
This equipment has been tested and found to comply with the limits for a

Class B digital device, pursuant to part 15 of the FCC Rules. These limits are
designed to provide reasonable protection against harmful interference in a
residential installation. This equipment generates, uses and can radiate radio
frequency energy and, if not installed and used in accordance with the in­structions, may cause harmful interference to radio communications. How­ever, there is no guarantee that interference will not occur in a particular in­stallation. If this equipment does cause harmful interference to radio or tele-

48

vision reception, which can be determined by turning the equipment off and
on, the user is encouraged to try to correct the interference by one or more
of the following measures:

— Reorient or relocate the receiving antenna.
— Increase the separation between the equipment and receiver.
— Connect the equipment into an outlet on a circuit different from that to

which the receiver is connected.
— Consult the dealer or an experienced radio/TV technician for help.
NOTE:
This equipment complies with FCC radiation exposure limits set forth for an

uncontrolled environment. This transmitter must not be co-located or oper­ating in conjunction with any other antenna or transmitter.

Changes or modifications to the equipment not expressly approved by Wi­dex could void the user’s authority to operate the equipment.

Industry Canada Statement / Déclaration d’industrie Canada
Under Industry Canada regulations, this radio transmitter may only operate

using an antenna of a type and maximum (or lesser) gain approved for the
transmitter by Industry Canada.

To reduce potential radio interference to other users, the antenna type and
its gain should be so chosen that the equivalent isotropically radiated power
(e.i.r.p.) is not more than that necessary for successful communication.

49

This device complies with Industry Canada licence-exempt RSS standard(s).
Operation is subject to the following two conditions:

(1) this device may not cause interference, and
(2) this device must accept any interference, including interference that may

cause undesired operation of the device.
Conformément à la réglementation d’Industrie Canada, le présent émetteur

radio peut fonctionner avec une antenne d’un type et d’un gain maximal (ou
inférieur) approuvé pour l’émetteur par Industrie Canada.

Dans le but de réduire les risques de brouillage radioélectrique à l’intention
des autres utilisateurs, il faut choisir le type d’antenne et son gain de sorte
que la puissance isotrope rayonnée équivalente (p.i.r.e.) ne dépasse pas l’in­tensité nécessaire à l’établissement d’une communication satisfaisante.

Le présent appareil est conforme aux CNR d’Industrie Canada applicables
aux appareils radio exempts de licence. L’exploitation est autorisée aux
deux conditions suivantes :

(1) l’appareil ne doit pas produire de brouillage, et
(2) l’utilisateur de l’appareil doit accepter tout brouillage radioélectrique

subi, même si le brouillage est susceptible d’en compromettre le fonc­tionnement.

50

EC directives

Directive 1999/5/EC

Hereby, Widex A/S declares that these U-CIC, U-CIC-TR, U-CIC-M and U­CIC-M-TR are in compliance with the essential requirements and other rele­vant provisions of Directive 1999/5/EC.

A copy of the Declaration of Conformity according to 1999/5/EC can be
found at:

http://www.widex.com/doc

N26346

Information regarding disposal

Do not dispose of hearing aids, hearing aid accessories and batteries with
ordinary household waste.

Hearing aids, batteries and hearing aid accessories should be disposed of at
sites intended for waste electrical and electronic equipment, or given to
your hearing care professional for safe disposal.

51

SYMBOLS

Symbols commonly used by Widex A/S in medical device labelling (la­bels/IFU/etc.)

Symbol Title/Description

Manufacturer

The product is produced by the manufacturer whose name and
address are stated next to the symbol. If appropriate, the date of
manufacture may also be stated.

Catalog number

The product’s catalog (item) number.

Consult instructions for use

The user instructions contain important cautionary information
(warnings/precautions) and must be read before using the prod­uct.

Warning

Text marked with a warning symbol must be read before using
the product.

WEEE mark

“Not for general waste”
When a product is to be discarded, it must be sent to a designated
collection point for recycling and recovering to prevent the risk of
harm to the environment or human health as a result of the pres­ence of hazardous substances.

52

Symbol Title/Description

CE mark

The product is in conformity with the requirements set out in Eu­ropean CE marking directives.

RCM mark

The product complies with electrical safety, EMC and radio spec­trum regulatory requirements for products supplied to the Aus­tralian or New Zealand market.

Interference

Electromagnetic interference may occur in the vicinity of the
product.

53

54

55

WIDEX A/S Nymoellevej 6, DK-3540 Lynge, Denmark

www.widex.com

Manual no.:

9 514 0315 041 #03

CIB number:

CIB346/0117
Issue: 2017-01

9 514 0315 041 #03