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Widex CUSTOM User Instructions
WIDEX UNIQUE
USER INSTRUCTIONS
THE WIDEX UNIQUE™ FAMILY
U-IM/U-IP model
In-the-canal/In-the-ear
YOUR HEARING AID
To be filled out by the hearing care professional)
 Vent
 No vent
 Extraction cord
 Volume control
 Push button
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
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 carefully before your start using your hearing aid.
3
CONTENTS
YOUR HEARING AID...................................................................................6
Welcome...........................................................................................................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
Changing the battery................................................................................. 10
Low battery indication................................................................................ 11
Sound signals...................................................................................................11
Lost partner ................................................................................................ 12
How to tell right from left..............................................................................12
Turning the hearing aid on and off...............................................................12
Putting on and removing your hearing aid.................................................13
Removing the hearing aid......................................................................... 13
Programs.........................................................................................................14
The Zen program........................................................................................ 15
Program and sound adjustment.................................................................. 19
CLEANING................................................................................................ 22
4
Tools................................................................................................................ 22
Cleaning the hearing aid...............................................................................22
Changing the microphone filters.................................................................24
The wax guard............................................................................................... 26
ACCESSORIES.......................................................................................... 29
TROUBLESHOOTING................................................................................ 30
REGULATORY INFORMATION...................................................................33
EU directives................................................................................................... 51
Directive 2014/53/EU................................................................................. 51
Information regarding disposal.................................................................51
FCC and IC statements..................................................................................52
SYMBOLS................................................................................................. 55
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
2
1. Microphone openings
2. Push button (optional)
3. Volume control (optional)
4. Vent (optional)
5. Extraction cord (optional)
6. Battery compartment
6
3
4
5
7
8
10
9
7. Sound outlet
8. Wax guard
9. Vent (optional)
10. 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 (202) 625-3333.
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.
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 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 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.
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. Place the new
battery in the battery compartment with the "+"sign facing in the same direction as the "+" sign on
the battery compartment door, as shown on the illustration.
10
Close the battery compartment door. If it doesn't
close easily, the battery is not placed correctly.
If you are not using the hearing aid for a few days,
keep the battery compartment open.
NOTE
Avoid dropping your hearing aid - hold the hearing aid above a soft surface
while changing the battery.
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.
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
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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.
Turning the hearing aid on and off
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.
Open the battery door to turn the hearing aid off.
12
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.
Putting on and removing your hearing aid
Close the battery lid 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.
Removing the hearing aid
Hold the hearing aid with your thumb and forefinger and
pull carefully.
NOTE
If you find it difficult to take out the hearing aid, move it carefully from side to
side.
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Programs
PROGRAMS
USE
Universal
For everyday use
Quiet
Special program for listening in quiet environments
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
talking at the same time
Music
For listening to music
SPECIAL PROGRAMS
USE
Zen
Plays tones or noise for a relaxing sound
background
Phone
This program is designed for listening to
phone conversations
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SMARTTOGGLE PROGRAMS
USE
Zen+
This program is similar to Zen but allows
you to listen to different types of tones or
noise
Phone+
This program lets you listen to the phone
and avoid the surrounding sounds. One of
your hearing aids transmits the phone conversation to the other, so that you can listen
with both ears
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 in 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.
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
15
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.
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
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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
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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
Program and sound adjustment
Adjusting the sound level using the volume control
Your hearing aid adjusts the sound level automatically according to your
sound environment, but you can also adjust it manually depending on your
needs and preferences. To do so, turn the volume control towards the front
to increase the volume and turn it towards the rear to reduce it.
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.
NOTE
Your hearing aid will also play a tone when you reach the default sound level
programmed for you by your hearing care professional. In this way you can easily return to the optimal setting for most listening situations.
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You can also mute your hearing aid if you need to. Do as follows:
● Keep turning the volume control towards the rear until you can hear the
steady sound
To turn the sound on again:
● Turn the volume control towards the front or
● Change program
Any adjustment of the volume will be cancelled when you turn off your
hearing aid or if you change program.
Using the push button to change programs and adjust the sound level:
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:
Tap the button on your 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 hearing aid.
A long push on either of your hearing aids will mute and unmute the sound
(this setting is optional).
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As a combined program and sound adjustment button:
If you have this option, tap the button on your 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 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.
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CLEANING
Tools
You will receive the following cleaning tools with your hearing aid:
1. Cloth
2. Brush
3. Long wax-removing tool
4. Short wax-removing tool
5. Battery magnet
1.
2. 3. 4. 5.
Cleaning the hearing aid
Cleaning your hearing aid every day will make it more efficient and more
comfortable to wear.
The hearing aid
Wipe it with a soft cloth (for example the cloth you
received from your hearing care professional).
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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.
NOTE
If you cannot clean the sound outlet, contact your hearing care professional.
Never insert anything into the sound outlet as this can ruin your hearing aid.
The vent
Clean the vent every day by passing the long wax removing tool (no. 4) all
the way through the vent. When you are done, 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 and the like. Clean it every day after use and consult your hearing care professional if the vent is blocked.
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.
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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.
Changing the microphone filters
The microphone filters help to protect the hearing aid microphones against dirt and earwax. Always use microphone filters supplied by Widex with your hearing aid.
Open the case as illustrated.
The microphone filter tool consists of the following parts:
1. Removal hook
2. New microphone filter
24
Insert the removal hook into the used filter.
Keep the holder at a right angle.
Pull the used filter straight out.
Insert the new filter into the microphone opening.
Pull the holder straight out while turning it slightly to
make sure the filter remains in place.
Ask your hearing care professional about how often you should change the
microphone filters.
25
The filters are for one-time use only and are not intended to be cleaned.
If the filter fits loosely, discard it and use a new one.
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
The wax guard consists of the following parts:
1. Removal hook
2. New wax guard
1
Insert the removal hook into the used wax guard.
26
Keep the holder at a right angle.
Pull the used wax guard straight out.
Insert the new wax guard into the opening of the
sound outlet and press it gently.
27
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.
28
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
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 for helping hearing aid users hear speech in difficult
Mic
listening situations
Available in some countries only.
29
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
completely 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 open- See the cleaning section
ing is blocked
The hearing aid volume is not powerful
enough
The sound outlet is
blocked
See the cleaning section
Your ear is blocked by Contact your doctor
earwax
Your hearing may
have changed
30
Contact your hearing care
professional/doctor
Problem
Possible cause
Solution
The hearing aid whis- Your ear is blocked by Contact your doctor
tles continuously
earwax
It is not correctly
Take it out and reinsert it
placed in your ear canal
It fits loosely in your
ear canal
Contact your hearing care
professional
The hearing aid is un- It is not correctly
Consult your hearing care
comfortable to wear placed in your ear ca- professional
nal.
It does not fit your ear Contact your hearing care
properly
professional
Your outer ear or ear
canal is sore
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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
Problem
Possible cause
Solution
Your hearing aids are The connection beTurn them off and on again
not working in syntween the hearing aids
chrony
is lost
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
You hear “interrupted”
speech (on and off)
from the hearing aids
or no speech (muted)
from the opposite
hearing aid.
a. The battery in one of a. Replace battery in one or
the hearing aids has both hearing aids
expired
b. Move away from known
b. Strong electromag- source of EM interference
netic interference in
the vicinity
32
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
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- Inductive an- Inductive an- Embedded
na
tenna
tenna
ceramic antenna
Antenna di- Ø1.8 mm,
mensions 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 -54 dBμA/m
Field
Strength (at
10 m distance)
-13 dBμA/m
-26 dBμA/m
NA
Output
power
(EIRP**)
21 nW
1.2 nW
+4dB re.
1mW
29 pW
33
Hearing aids
Range
TM-DEX
< 1 m remote
< 1 m remote < 30 cm beunit to hearing unit to hearing tween hearing
aid
aid
aid and TM< 30 cm beDEX
tween hearing
aids or Hearing
aid to TM-DEX
Center fre- 10.6 MHz
quency
Channel
RC-DEX
10.6 MHz
10.6 MHz
Bluetooth* NOAHlink
< 10 m between PC
and NOAHlink
2.4 GHz
Single channel - Single channel Single channel - 5 logical
radio
radio
radio
channels
Bandwidth 660 kHz (-15
dB)
660kHz (-15
dB)
660kHz
(-15 dB)
1 MHz
Data-rate
212 kbit/second 212 kbit/sec- 212 kbit/sec- 2.1 Mbps
(raw channel ca- ond (raw
ond (raw chanpacity)
channel ca- nel capacity)
pacity)
Data flow
Simplex or
Simplex capa- Simplex or
semi-duplex ca- bility
semi-duplex
pability
capability
34
Time division
duplex
(TDD)
Hearing aids
Protocol
RC-DEX
TM-DEX
Random Access Random Ac- Random Ac– no collision
cess – no colli- cess – no colliavoidance
sion avoid- sion avoidance
ance
Bluetooth* NOAHlink
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.
35
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
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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 frequency 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.
37
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
38
Electromagnetic emissions
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.
Emissions test Compli- Electromagnetic environment - guidance
ance
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
Harmonic
Not
low‑voltage power supply network that supplies
emissions
applica- buildings used for domestic purposes.
IEC 61000-3-2 ble *)
Voltage fluctu- Not
ations/ flicker applicaemissions IEC ble *)
61000-3-3
*) Battery powered equipment
Electromagnetic immunity
39
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
Compliance Electromagnetic
Test level
level
environment –
guidance
Immunity Test
IEC 60601
Test level
Compliance Electromagnetic
level
environment –
guidance
Electrostatic discharge (ESD)
IEC
61000-4-2
± 6 kV contact
± 8 kV air
± 6 kV con- Floors should be
tact
wood, concrete or
± 8 kV air 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 Not
Not
supplies
applicable *) applicable *)
± 1 kV for input/output lines
Not
applicable *)
40
Immunity Test
Surge
IEC
61000-4-5
Voltage dips, short
interruptions and
voltage variations
on power supply
input lines
IEC
61000-4-11
IEC 60601
Test level
Compliance
level
Electromagnetic
environment –
guidance
± 1 kV line(s) to
line(s)
Not
Not
applicable *) applicable *)
± 2 kV line(s) to
earth
Not
applicable *)
<5 % UT
Not
Not
(>95 % dip
applicable *) applicable *)
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
41
Immunity Test
Power frequency
(50/60 Hz) magnetic field
IEC
61000-4-8
IEC 60601
Test level
Compliance
level
3 A/m
3 A/m
Electromagnetic
environment –
guidance
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
Compliance Electromagnetic environTest level
level
ment – guidance
42
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
Radiated RF
IEC
61000-4-3
3 Vrms
3 Vrms
Recommended separation distance
d = 1.2 ÖP
150 kHz to 80
MHz
3 V/m
3 V/m
d = 1.2 ÖP
80 MHz to 800 MHz
d = 2.3 ÖP
800 MHz to 2.5 GHz
80 MHz to 2.5
GHz
43
Immunity Test
IEC 60601
Test level
Compliance Electromagnetic environlevel
ment – 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:
44
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 mo45
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 Separation distance according to frequency of transoutput power of mitter (m)
transmitter (W)
150 kHz to 80
80 MHz to 800 800 MHz to 2.5
MHz
MHz
GHz
d = 1.2 ÖP
d = 1.2 ÖP
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
46
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 Commission (FCC) requirements for intentional
radiators.
EN 300 330-2
V1.6.1
RF emissions EMC and radio spectrum matters for
incl. Spurious Short Range Devices in the frequency
emission
range 9 kHz – 25 MHz
47
IEC
EMC emission
60601-1-2:2007 Immunity, RF
*adapted proto- and ESD
col
Medical electrical equipment.
General requirements for basic safety
and essential performance.
Electromagnetic compatibility.
EN 301 489-3
V1.6.1
Immunity, RF Standard for Low Power Transmitters in
and ESD
the frequency range 9 kHz – 40 GHz
IEC 6011813:2011
Immunity
International Product std. for hearing
RF Near Field aids to ensure adequate immunity to raimmunity test dio interference from cell telephones.
ANSI
C63.19-2007
Immunity
American National Standard Methods of
RF Near Field measurement of Compatibility between
immunity test 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:
48
(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.
49
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
50
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.
EU directives
Directive 2014/53/EU
Hereby, Widex A/S declares that this U-IM/U-IP is in compliance with the
essential requirements and other relevant provisions of Directive
2014/53/EU.
The U-IM/U-IP contains a radio transmitter operating at 10.6 MHz, -54
dBμA/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.
51
FCC and IC statements
FCC ID: TTY-UI
IC: 5676B-UI
Hardware Version Identification Number (HVIN): U-IP L, U-IP R, U-IM L, U-IM
R
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:
52
— 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.
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
53
(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.
54
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.
55
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.
56
57
58
59
WIDEX A/S
Nymoellevej 6, DK-3540 Lynge, Denmark
https://www.global.widex.com
Manual no.:
9 514 0398 041 #02
CIB number:
CIB380
9 514 0398 041 #02
Issue: 2019-03
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