Widex U-FS User Instructions

WIDEX UNIQUE

USER INSTRUCTIONS

THE WIDEX UNIQUE™ FAMILY

U-FS model

Receiver-in-the-ear

YOUR WIDEX® HEARING AID

(To be filled out by the hearing care professional)

Your hearing aid series:

PROGRAMS

 Universal  Audibility Extender
 Quiet  Audibility Extender
 Transport  Audibility Extender
 Urban  Audibility Extender
 Party  Audibility Extender
 Music  Audibility Extender
 T  Audibility Extender
 M+T  Audibility Extender

SPECIAL PROGRAMS

 Zen  Audibility Extender
 Phone  Audibility Extender

2

SMARTTOGGLE PROGRAMS

 Zen+  Audibility Extender
 Phone+  Audibility Extender

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.

NOTE

Read this booklet and the booklet "Ear-sets for Widex hearing aids" carefully
before your start using your hearing aid.

3

CONTENTS

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

Welcome to Widex..........................................................................................6

Your hearing aid at a glance.......................................................................6

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

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

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

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

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

Low battery indication...............................................................................10

Changing the battery.................................................................................10

Tamper-resistant battery drawer..............................................................11

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

Lost partner ................................................................................................ 12

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

Turning the hearing aid on and off...............................................................13

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

Programs.........................................................................................................14

Changing programs....................................................................................16

The Zen program........................................................................................ 17

Sound and program adjustment.................................................................20

4

Using a phone with hearing aids..................................................................21

CLEANING................................................................................................22

Tools................................................................................................................22

Cleaning the hearing aid...............................................................................22

ACCESSORIES.......................................................................................... 24

TROUBLESHOOTING................................................................................ 25

REGULATORY INFORMATION...................................................................27

EC directives...................................................................................................45

Directive 2014/53/EU................................................................................45

Information regarding disposal................................................................45

FCC and IC statements..................................................................................46

SYMBOLS.................................................................................................49

5

YOUR WIDEX HEARING AID

3

1/2

4

Welcome to Widex

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

The illustration shows your hearing aid without the ear-set. For further in­formation on the ear-set, see the ear-set manual. The ear-set consists of an
earwire and an ear-tip, and it is the part of your hearing aid that you wear
inside your ear.

1. On/off switch

2. Battery drawer with nail grip

3. Program button

4. Left/right identification. Blue indicates
your left hearing aid, while red is for
your right hearing aid.

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 call 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 or an allergic reaction.

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

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.

7

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

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.

Your hearing aid is very powerful and it can play sounds that exceed a
level of 132 dB. There may therefore be a risk of damaging your remain­ing hearing.

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.

Your hearing aids are designed to operate within the temperature, humidity
and atmospheric pressure ranges of 0°C (32°F) to 50°C (122°F), 10%-95% rH
and 750 to 1060 mBar.

You can find technical data sheets and additional information on your hear­ing aids on https://global.widex.com.

8

THE HEARING AID

Indications for use

The hearing aids are indicated for individuals with a range of hearing loss
from minimal (10 dB HL) to severe-to-profound (100 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.

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 who desire to listen to such a back­ground in the quiet.

The battery

Use a type 312 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 a zinc-air hearing aid battery, as it could ex­plode.

Never leave a weak 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:

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.

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

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.

Tamper-resistant battery drawer

If the hearing aid is going to be used by a child or a mentally disabled per­son, you can ask your hearing care professional to provide it with a tamper­resistant battery drawer.

To open battery drawer, use the special tool you've
received, and do as illustrated.

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

11

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.

Lost partner

(Only available in selected models)
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.

12

Turning the hearing aid on and off

1

2

To turn the hearing aid on, close the battery door. 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, pull the battery door
downwards.

NOTE

Don't forget to turn off the hearing aid when it is not in use.

Putting on and removing your hearing aid

Putting on the hearing aid

Your hearing aid can be fitted using different types of ear-sets. See the sep­arate ear-set manual for more information about your ear-set.

1. Insert the ear-set in the ear while holding the lower
part of the tube/earwire. Pulling the outer ear upwards
and backwards at the same time can be helpful.

2. Then place the hearing aid behind the ear. The hearing
aid should rest comfortably on the ear, close to your
head.

13

Removing the hearing aid

Start by removing the hearing aid from behind the
ear.
Then take the ear-set carefully out of the ear canal
while you hold the lower part of the tube/earwire.

Programs

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

Transport For listening in situations with noise from cars,

Urban For listening in situations with changing sound

Party For listening in situations with many people talk-

Music For listening to music

ments

trains, etc.

levels (in supermarkets, noisy workplaces or sim­ilar)

ing at the same time

14

PROGRAMS USE
T With this program you listen through the hearing

M+T This program is a combination of the hearing

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

Phone This program is designed for listening to phone

SMARTTOGGLE PRO­GRAMS

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

Phone+ This program lets you listen to the phone and

aid's telecoil, which allows you to listen directly
to the sound without background noise (requires
a teleloop system)

aid's microphone and the telecoil. You listen to
the sound source, but can also hear other sounds

ground

conversations

USE

listen to different types of tones or noise

avoid the surrounding sounds. One of your hear­ing aids transmits the phone conversation to the
other, so that you can listen with both ears

15

NOTE

The names in the list of programs are the default names. Your hearing care pro­fessional can also select an alternative program name from a preselected list.
Then it is even easier for you to select the right program in each listening situa­tion.

NOTE

You can only have one SmartToggle program on your hearing aid.

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 button.

NOTE

The Phone+ program can't be accessed using a remote control.

Zen+

To access this program, press and hold the program button 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 button
for more than one second.

16

Phone+

To access this program, press and hold the program button for more than
one second. To leave it repeat the same procedure.

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 using the latest Fractal technology. These sounds are shaped
according to your hearing loss so you can listen to them at any time and at
any place with a simple push of the program button.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.

17

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
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.

18

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
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

19

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.

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

Sound and program adjustment

If you have two hearing aids, the push button can be programmed in several
ways:

As a dedicated program button:

To change programs, just tap the button. To access and exit SmartToggle
programs, push and hold the push button down for more than one second
(this setting is optional). Once you have accessed the SmartToggle pro­gram, you can change among the different Zen styles selected for you by
short taps on the button.

As a dedicated sound adjustment button:

20

Tap the button on your right hearing aid if you’d like more audibility and
more volume. If you need to decrease the volume or you’d like more com­fort, tap the button on your left hearing aid.

A long push on either of your hearing aids will mute and unmute the sound
(this setting is optional).

As a combined program and sound adjustment button:

If you have this option, tap the button on your right hearing aid if you’d like
more audibility and more volume. If you need to decrease the volume or if
you’d like more comfort, just tap the button on your left hearing aid. A long
push on either of your hearing aids will change programs.

If you only have one hearing aid, a short tap will change programs and a
long tap will allow you to access the SmartToggle programs.

Using a phone with hearing aids

When you use a phone, hold it against your head at an an­gle above your ear, rather than directly against the ear.

21

CLEANING

1. 2. 3. 4. 5.

Tools

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

Cleaning the hearing aid

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

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

Wipe the hearing aid with a soft cloth (for example
the cloth you received from your hearing care profes­sional).
If the microphone openings are blocked, contact your
hearing care professional.

1. Cloth

2. Brush

3. Long wax-removing tool

4. Short wax-removing tool

5. Battery magnet

22

NOTE

It is recommended to remove the batteries from the hearing aids before placing
the hearing aids in a dehumidifier.

When not in use leave the battery compartment open to ventilate the hear­ing aid. For information on how to clean your ear-set, see the ear-set man­ual.

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.

23

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 2 for easy landline use
FM+DEX for streaming audio and FM signals
T-DEX for connecting hearing aids to mobile phones

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

COM-DEX Re­mote Mic

Available in some countries only.

via a telecoil

other devices via Bluetooth
for helping hearing aid users hear speech in dif-

ficult listening situations

24

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

The hearing aid volume
is not powerful enough

The hearing aid whistles
continuously

Your two hearing aids
are not working in syn­chrony

It is not turned on Make sure the battery

The battery does not
work

Your ear is blocked by
earwax

Your hearing may have
changed

Your ear is blocked by
earwax

The connection between
the hearing aids is lost

25

drawer is completely
closed

Insert a new battery

Contact your doctor

Contact your hearing
care professional/doctor

Contact your doctor

Turn them off and on
again

Problem Possible cause Solution
The hearing aids do not

respond with a corre­sponding change in vol­ume or program to the
control 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 the device is
matched with hearing
aids

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

NOTE

This information covers only the hearing aid. See the "Ear-sets for Widex hear­ing aids" user manual for information specific to your ear-set. If the problems
persist, contact your hearing care professional for assistance.

a. The battery in one of
the hearing aids has ex­pired
b. Strong electromag­netic interference in the
vicinity

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

26

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* -

Antenna
type

Antenna di­mensions

Modulation FSK FSK FSK FHSS/GFSK,

Magnetic
Field
Strength (at
10 m dis­tance)

Output
power
(EIRP**)

Inductive anten-naInductive an-

Ø1.8 mm,
L - 4.85 mm

-54 dBμA/m -13 dBμA/m -26 dBμA/m NA

29 pW 21 nW 1.2 nW +4dB re.

tenna

Ø8 mm,
L – 20 mm

27

Inductive an­tenna

Ø6 mm,
L - 8 mm

NOAHlink

Embedded
ceramic an­tenna

NA

π/4 DPSK, 8
DPSK

1mW

Hearing aids RC-DEX TM-DEX Bluetooth* -

Range < 1 m remote

Center fre­quency

Channel Single channel -

Bandwidth 660 kHz (-15

Data-rate 212 kbit/second

Data flow Simplex or

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

10.6 MHz 10.6 MHz 10.6 MHz 2.4 GHz

radio

dB)

(raw channel ca­pacity)

semi-duplex ca­pability

< 1 m remote
unit to hearing
aid

Single channel
radio

660kHz (-15
dB)

212 kbit/sec­ond (raw
channel ca­pacity)

Simplex capa­bility

28

< 30 cm be­tween hearing
aid and TM­DEX

Single channel ­radio

660kHz
(-15 dB)

212 kbit/sec­ond (raw chan­nel capacity)

Simplex or
semi-duplex
capability

NOAHlink

< 10 m be­tween PC
and NOAH­link

5 logical
channels

1 MHz

2.1 Mbps

Time division
duplex
(TDD)

Hearing aids RC-DEX TM-DEX Bluetooth* -

Protocol Random Access

– no collision
avoidance

* 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.

Random Ac­cess – no colli­sion avoid­ance

29

Random Ac­cess – no colli­sion avoidance

NOAHlink

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

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

30

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.

31

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

32

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-

RF emissions
CISPR 11

RF emissions
CISPR 11

Harmonic
emissions
IEC 61000-3-2

Voltage fluctu­ations/ flicker
emissions IEC
61000-3-3

*) Battery powered equipment

Electromagnetic immunity

Electromagnetic environment - guidance

ance
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.

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

establishments, including domestic establish­ments and those directly connected to the public

Not

low‑voltage power supply network that supplies

applica-

buildings used for domestic purposes.

ble *)
Not

applica­ble *)

33

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

Immunity Test IEC 60601

Electrostatic dis­charge (ESD)
IEC
61000-4-2

Electrical fast tran­sients/burst
IEC
61000-4-4

Test level

Test level

± 6 kV contact
± 8 kV air

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

Compliance
level

± 6 kV con­tact
± 8 kV air

Not
applicable *)

Not
applicable *)

34

Compliance

level

Electromagnetic

environment –

guidance

Electromagnetic
environment –
guidance

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

Not
applicable *)

Immunity Test IEC 60601

Surge
IEC
61000-4-5

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

Test level

± 1 kV line(s) to
line(s)

± 2 kV line(s) to
earth

<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

35

Compliance

level

Not
applicable *)

Not
applicable *)

Not
applicable *)

Electromagnetic

environment –

guidance

Not
applicable *)

Not
applicable *)

Immunity Test IEC 60601

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

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

Test level

3 A/m 3 A/m Power frequency

IEC 60601
Test level

Compliance

Compliance
level

36

level

Electromagnetic

environment –

guidance

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

Electromagnetic environ­ment – guidance

Conducted RF

IEC
61000-4-6

Radiated RF

IEC
61000-4-3

3 Vrms

150 kHz to 80
MHz

3 V/m

80 MHz to 2.5
GHz

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.

Recommended separa­tion distance

3 Vrms

3 V/m d = 1.2 ÖP

37

d = 1.2 ÖP

80 MHz to 800 MHz

d = 2.3 ÖP
800 MHz to 2.5 GHz

Immunity Test IEC 60601

Test level

Compliance
level

38

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:

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-

39

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)

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

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

40

800 MHz to 2.5
GHz
d = 2.3 ÖP

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
47 CFR Part 15,

subpart C

EN 300 330-2
V1.6.1

Test type Note
RF emissions USA Federal Communications Commis-

RF emissions
incl. Spurious
emission

sion (FCC) requirements for intentional
radiators.

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

41

IEC
60601-1-2:2007
*adapted proto­col

EN 301 489-3
V1.6.1

IEC 60118­13:2011

ANSI
C63.19-2007

* 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:

EMC emission
Immunity, RF
and ESD

Immunity, RF
and ESD

Immunity
RF Near Field
immunity test

Immunity
RF Near Field
immunity test

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

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

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

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

42

(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.

43

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

44

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.

EC directives

Directive 2014/53/EU

Hereby, Widex A/S declares that this U-FS is in compliance with the essen­tial requirements and other relevant provisions of Directive 2014/53/EU.

The U-FS contains a radio transmitter operating at 10.6 MHz, 54dBmA/m
@10 m.

A copy of the Declaration of Conformity according to 2014/53/EU can be
found at:

http://global.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.

45

FCC and IC statements

FCC ID: TTY-UFS
IC: 5676B-UFS

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 television
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.

46

— 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 uncontrol-

led 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.

ISED Statement / Déclaration d’ISED

This device contains licence-exempt transmitter(s)/receiver(s) that comply with Inno­vation, Science and Economic Development Canada’s licence-exempt RSS(s). Opera­tion is subject to the following two conditions:

(1) This device may not cause interference.
(2) This device must accept any interference, including interference that may cause un-

desired operation of the device.
L’emetteur/recepteur exempt de licence contenu dans le present appareil est conforme

aux CNR d’Innovation, Sciences et Developpement economique Canada applicables aux
appareils radio exempts de licence. L’exploitation est autorisee aux deux conditions sui­vantes:

(1) L’appareil ne doit pas produire de brouillage;
(2) L’appareil doit accepter tout brouillage radioelectrique subi, meme si le brouillage

est susceptible d’en compromettre le fonctionnement.

47

ISED RADIATION EXPOSURE STATEMENT:
This equipment complies with ISED RF radiation exposure limits set forth for an uncon-

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

ISED EXPOSITION AUX RADIATIONS:
Cet equipement est conforme avec ISED les limites d’exposition aux rayonnements defi

nies pour un controle environnement. Cet emetteur ne doit pas etre co-localises ou
fonctionner en conjonction avec une autre antenne ou emetteur.

48

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.

Catalogue number

The product’s catalogue (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.

49

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
markets.

50

51

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

https://www.global.widex.com

Manual no.:

9 514 0317 041 #07

CIB number:

CIB350
Issue: 2019-03

9 514 0317 041 #07