Widex SUPER VSD 440/220 User Instructions

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Widex SUPER VSD 440/220 User Instructions | Manualzz

USER INSTRUCTIONS

THE SUPER™440, 220 SERIES

S4-VSD/S2-VSD model RIC/RITE

Receiver-in-canal/Receiver-in-the-ear

YOUR HEARING AID

(To be filled out by the hearing care professional)

… … S4-VSD

… … S2-VSD

Programs:

… Master

… Music

… TV

… Comfort

… Reverse focus

… Audibility Extender

… Phone

… T

… M+T

… Zen

2

… Classic

… Master + Zen

… Master + Reverse focus

… Master + Audibility Extender

… Master + T

… Master + M+T

… Master + Phone

… Zen+

… Phone+

Date Your hearing care professional

3

CONTENTS

THE…HEARING…AID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6

Acoustic indicators . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

The battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Inserting the battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12

Low battery indication . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

Turning the hearing aid on and off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17

Right/left identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19

Positioning the hearing aid in the ear . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20

Removing the hearing aid . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22

Volume adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Manual volume adjustment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24

Lost partner alarm . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27

Programs . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28

Switching between the listening programs . . . . . . . . . . . . . . . . . . . . . . . 35

Zen+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Phone+ . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36

Using a telephone . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

CLEANING . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

4

ACCESSORIES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

IN…CASE…OF…MALFUNCTION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47

CARING…FOR…YOUR…HEARING…AID . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 51

WARNINGS… . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53

ADVICE . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59

REGULATORY…INFORMATION . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60

SYMBOLS . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97

5

THE HEARING AID

The illustration below shows the hearing aid without the ear-set .

The ear-set consists of an earwire and an ear-tip or earmold, in which the receiver is placed .

1 . Program button

2 . LED

3 . On/off switch

4 . Battery drawer with nail grip

5 . Volume control (in standard versions)

6 . Cover plate

7 . Right/left identification

6

5

1/2

7

3/4

6

If you need help to identify the serial number (usually six or seven digits) on the product, please contact your hearing care professional .

7

NOTE

In addition to these user instructions, a separate user manual is provided describing the various ear-set solutions available for your hearing aid: “Ear-sets for Widex BTE hearing aids” .

WARNING

This booklet and the manual “Ear-sets for Widex BTE hearing aids” contain important information and instructions . Read these booklets carefully before you start using the hearing aid .

NOTE

Your hearing aid, ear-set and accessories may not look exactly as illustrated in this booklet . We also reserve the right to make any changes considered necessary .

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Intended use

The SUPER™ hearing aids are intended as air conduction amplification devices to be used in everyday listening environments .

The SUPER hearing aids may be provided 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 quiet .

Indications for use

The devices are indicated for individuals with a range of hearing loss severity from moderate (40 dB HL) to severe-to-profound

(120 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 as well as tinnitus management .

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Description of device

Your SUPER™ hearing aid is used with an ear-set which consists of an earwire and an ear-tip or earmold, in which the receiver is placed . The hearing aid uses a proprietary wireless technology,

WidexLink, to enable communication between the left and the right hearing aid, as well as between the hearing aids and the DEX accessories . Your hearing aid is to be powered by a 675 type battery .

Your hearing aid may be provided with an optional listening program called Zen . It makes musical tones (and sometimes a rushing noise) in the background . These sounds are shaped according to your hearing loss .

WARNING

This hearing aid is capable of producing a sound pressure level exceeding 132 dB SPL . There may be a risk of damaging your residual hearing . Please follow the recommendations of your hearing care professional .

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Acoustic indicators

The hearing aid may be set to produce a signal to indicate the use of certain functions . The signal may be a spoken message or tones . The signal can also be deactivated .

Functions

Adjusting volume

Confirming program button use

Changing program

Starting up the hearing aid

Warning about low battery

Warning about lost partner*

Service reminder

*Only available in SUPER440

Default settings

Tone

Clicking sound

Tones

Tone

4 tones

Off

Off

Other settings

Off

Off

Message/off

Message/off

Message/off

Message

Message

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The battery

We recommend zinc-air batteries . Use a size 675 battery for the hearing aid .

To obtain replacement batteries, please consult your hearing care professional . It is important to take note of the expiration date and the recommendations on the battery pack regarding disposal of used batteries . Otherwise there is a risk that the battery life may be reduced .

Inserting the battery

Before inserting a new battery into the hearing aid, remember to remove the adhesive tab . Once the tab has been removed, wait 60 seconds before placing the battery into the hearing aid .

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CAUTION

Do not use batteries if there is a sticky residue from the tab or other unwanted substance, as this can cause the hearing aid to malfunction .

Use the nail grip to gently swing the battery drawer completely open . Do not press the drawer beyond the open position .

13

Place the battery in the drawer, so that the plus (+) sign on the battery faces upward . You can use the battery magnet provided to steer the battery into place .

If the battery drawer does not close easily, the battery is incorrectly inserted .

When changing battery, it is a good idea to hold the hearing aid over a table .

14

The hearing aid may be provided with a battery drawer without a nail grip . A special tool for opening the drawer may be included with this drawer .

The battery drawer is opened as illustrated .

15

Low battery indication

A spoken message or beep tones will sound when the battery is nearly exhausted . If the battery drains suddenly there may however be no warning . We recommend that you always have a spare battery with you .

WARNING

Never leave an exhausted battery in the hearing aid . Exhausted batteries may leak, damaging the hearing aid .

WARNING

Your hearing aid may stop functioning, for instance if the battery is exhausted . You should be aware of this possibility, in particular when you are in traffic or are otherwise dependent on warning signals .

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Turning the hearing aid on and off

The battery drawer of the hearing aid also functions as the on/off switch .

Close the battery drawer completely to turn on the hearing aid . An acoustic indicator will indicate that the hearing aid has been switched on, unless this function has been disabled .

17

To turn off the hearing aid, open the battery drawer slightly to the first position where a click is felt .

Note: Another way to verify that the hearing aid is turned on is to cup it in your hand . If it is on, it will whistle .

Please remember to turn off the hearing aid when it is not in use .

Remove the battery if the hearing aid will not be used for several days .

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Right/left identification

If you wear hearing aids on both ears, the hearing aids can be provided with colored marks (red mark = right and blue mark = left) .

The arrow shows the position of the identification mark .

19

Positioning the hearing aid in the ear

Hold the earmold with your thumb and forefinger and slowly guide it into your ear canal until you feel resistance . Let go of the earmold and use the tip of your forefinger to gently push it into your ear until it rests comfortably in your ear canal .

20

To help position the earmold properly you could pull the outer ear backwards and upwards with the opposite hand .

Place the hearing aid behind the ear, so that the earwire rests comfortably on the ear, close to your head .

The illustrations show an earmold . For further information on eartip/earmold types and procedures, see the separate ear-set user manual provided .

If the ear-set does not fit or sit properly, causing discomfort, irritation, redness or the like, contact your hearing care professional .

21

Removing the hearing aid

Remove the hearing aid from its position behind the ear .

Hold the earmold with your thumb and forefinger and pull gently .

22

WARNING

Do not pull the earwire to remove the earmold, as this may damage the earwire .

If it is difficult, you can try to move the earmold carefully from side to side . It may also help to pull the outer ear backwards and upwards with the opposite hand .

23

Volume adjustment

The hearing aid volume is adjusted automatically in accordance with your sound environment .

Manual volume adjustment

Furthermore, your hearing aid is provided with a volume control, shaped like a small lever (unless your hearing care professional has removed it for you) .

Push the lever upwards to gradually raise the volume .

Push the lever downwards to gradually lower the volume .

In the default setting, any volume adjustment will affect both hearing aids .

24

To alter the increments in which the volume is increased or decreased, consult your hearing care professional .

Each time you operate the volume control, you will hear a beeptone, unless this function has been disabled . When the maximum or minimum adjustment level is reached, a steady tone will sound .

WARNING

If the volume in the hearing aid is generally too loud or too weak, or the reproduced sounds are distorted, or if you would like any further information, consult your hearing care professional .

To turn off the sound completely:

• Keep pressing the volume control lever downwards after the steady tone has sounded .

25

To turn the sound on again:

• Press the lever upwards or

• Change listening program

Any adjustment of the volume setting will be canceled when your hearing aid is turned off, or when you change program .

If you wish to have the volume control disabled or removed, please consult your hearing care professional .

26

Lost partner alarm

(Note: Only applicable if this feature has been activated by your hearing care professional) .

If one of your hearing aids falls off your ear, and/or the battery is exhausted, a tone signal and a spoken message will sound two times in the other hearing aid, and a diode will flash on both hearing aids .

When the lost hearing aid is repositioned, and/or the battery is exchanged, the diodes stop flashing .

27

Programs

Your hearing aid may be provided with several of the following programs, plus either the special Zen program called Zen+, or the

Phone+ program .

Master

Music

TV

Comfort

Reverse focus

Audibility Extender

Phone

T

Standard

For listening to music

For listening to the TV

Attenuates background noise

Focus on sounds from behind

Makes high-frequency sounds audible

For listening to the telephone

In this program you listen via the telecoil (T) and not via the hearing aid microphones (M) .

The telecoil is used where a loop system is installed . If you activate the telecoil program, you listen to a specific sound source and shut out surrounding sounds .

28

M+T

Zen

(optional in S2-VSD)

Classic

Compound programs

Zen+

(optional in S2-VSD)

Phone+

In this program you listen via the hearing aid microphones (M) and the telecoil (T) .

Generates different kinds of tones or noise .

Designed for long-term users of super power hearing aids . Imitates the sound quality of a traditional super power hearing aid .

The Master program in one ear and Zen,

Reverse focus, Audibility Extender, T, MT or

Phone in the other .

Special Zen program with up to three different Zen styles

For phone use only . Transmits the telephone sound received in one hearing aid to the other hearing aid . Note that the microphones on the hearing aid to which the sound is transmitted are turned off .

29

If your needs change over time, the combination of listening programs can be altered .

CAUTION

When selecting Phone+ as listening program, please remember that there are situations in which it is particularly important to be able to hear the surrounding sounds .

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 . These sounds are shaped according to your hearing loss . 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 both the surrounding sounds and the generated sounds (fractal tones and noise) are heard together .

30

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 (i .e ., music/noise source) for adults 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 prescribed by a hearing care professional (audiologists, hearing aid specialists, otolaryngologists) who is trained in tinnitus management .

31

Directions for use

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 .

32

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

33

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 .

CAUTION

If you perceive a decrease in loudness, tolerance of sounds, speech not as clear, or worsening tinnitus, contact your hearing care professional .

34

Switching between the listening programs

Each time you switch to another program, an acoustic indicator will sound unless this function has been disabled .

Program 1: One short beep or message

Program 2: Two short beeps or message

Program 3: Three short beeps or message

Program 4: One long and one short beep or message

Program 5: One long and two short beeps or message

Zen+ or Phone+: Tone or message

In the default setting, both your hearing aids will be affected when you change programs .

35

Zen+

This program is accessed via a long press (more than 1 sec .) on the program button on the hearing aid or RC-DEX remote control . A short press then allows you to cycle through the available

Zen styles .

You can exit Zen+ by pressing and holding the program button for more than one second .

Phone+

This program is accessed via a long press (more than 1 sec .) on the program button . Please note that the program cannot be accessed via the RC-DEX .

You can exit Phone+ by pressing and holding the program button for more than one second .

If you wish to have the program button disabled, please consult your hearing care professional .

36

Using a telephone

When using a telephone, we recommend that you hold the telephone against your head at an angle above your ear, rather than directly against the ear . If the sound is not optimal, try moving the telephone earpiece to a slightly different position .

37

CLEANING

The following cleaning accessories are available for the hearing aid and ear-set .* For cleaning the ear-set, see the user manual

“Ear-sets for Widex BTE hearing aids .”

1 . Cloth

2 . Brush

3 . Wax removing tool

1 2 3

Contact your hearing care professional if you need additional supplies of cleaning accessories .

*Selection depends on ear-set type

38

Clean the hearing aid with the soft cloth after use .

If the microphone openings are still blocked, contact your hearing care professional .

WARNING

Never use water or cleaning solutions to clean the hearing aid, as this may cause it to malfunction .

When the hearing aid is not in use, keep it in a warm, dry place with the battery drawer open to ventilate the hearing aid and allow it to dry .

Note: If a universal DAI adaptor is used, wipe it with the soft cloth after use .

39

ACCESSORIES

A variety of assistive listening devices are available for your hearing aid .

For help in determining whether you could benefit from a remote control or other accessories, please consult your hearing care professional .

Direct audio input

The hearing aid can be furnished with a universal DAI adaptor .

This allows direct connection to different kinds of accessories

(FM), as well as external audio equipment (radio, TV, etc .) .

On the form on page 43, your hearing care professional can mark the audio programs you have access to and where they are located .

40

Attaching the universal DAI adaptor:

1 . Use the tip of your finger to slide off the cover plate at the bottom of the hearing aid .

2 . Slide the DAI adaptor onto the hearing aid until it clicks into place .

3 . Lock it into place by sliding the locking button downwards, as illustrated .

1 .

2 .

3 .

A compatible device with a universal three-pin plug can now be attached .

41

Removing the universal DAI adaptor:

Remove the universal three-pin plug device attached to the DAI adaptor

1 . Unlock the DAI adaptor by sliding the locking button upwards, as illustrated .

2 . Slide the DAI adaptor off the hearing aid .

3 . Slide the cover plate on .

1 .

2 .

3 .

For more information on the use of audio input consult your hearing care professional .

42

Program order

3

4

2

1

5

DAI

…

…

…

…

…

M-DAI

…

…

…

…

…

43

WARNING

If the hearing aid is connected to equipment which is connected to the electrical mains, this equipment must comply with IEC 60065, IEC

60950-1, IEC 60601-1 or equivalent UL safety standards .

Do not connect the hearing aid to sockets that are labelled with one or more of the following symbols:

FM systems

The Widex FM system, SCOLA, consists of a wireless microphone and a receiver integrated in an FM shoe . The Widex receiver suitable for your hearing aid is called SCOLA FLEX-i .

The system can be set according to your needs .

44

Attaching the SCOLA FLEX-i:

1 . Use the tip of your finger to slide the cover plate at the bottom of the hearing aid off .

2 . Slide the SCOLA FLEX-i onto the hearing aid until it clicks into place .

3 . Lock it into place by sliding the locking button downwards, as illustrated .

1 .

2 .

3 .

45

Removing the SCOLA FLEX-i:

1 . Unlock the SCOLA FLEX-i by sliding the locking button upwards, as illustrated .

2 . Slide the SCOLA FLEX-i off the hearing aid .

3 . Slide the cover plate on .

1 .

2 .

3 .

For more information on the SCOLA FM system, consult the

SCOLA™ FM system and the SCOLA FLEX/SCOLA FLEX-i user instructions .

46

IN CASE OF MALFUNCTION

Problem

The hearing aid is completely silent

The hearing aid volume is not powerful enough

Possible cause

The hearing aid is not turned on

The battery does not work

Your ear is blocked by earwax

Your hearing may have changed

The earwire is not properly connected to the hearing aid

Solution

Make sure the battery drawer is completely closed

Insert a new battery in the hearing aid

Contact your ENT doctor/ physician

Contact your hearing care professional

Check that the earwire connector in the hearing aid is completely inserted

47

Problem

The hearing aid whistles continuously

Your two hearing aids are not working in synchrony

Possible cause

Your ear is blocked by earwax

The connection between the hearing aids is lost

Solution

Contact your ENT doctor/ physician

Turn the hearing aids off and on again

48

Problem

The hearing aids do not respond with a correspond ing change in volume or program to the

DEX

Possible cause

The DEX is used beyond the transmission range

Solution

Move the DEX closer to the SUPER hearing aids

Strong electromagnetic interference in the vicinity

Move away from known source of EM interference

The DEX and the SUPER hearing aids are not matched

Check with hearing care professional to make sure

DEX is matched with

SUPER hearing aids

49

Problem Possible cause

You hear

“interrupted” speech (on and off) from the hearing aids or no speech (muted) from the transmitting ear

No sound from the FM system when using a DAI adaptor

The battery in one of the hearing aids has expired

Strong electromagnetic interference in the vicinity

Defective or dirty contact points

Solution

Replace battery in one or both hearing aids

Move away from known sources of interference

Contact your hearing care professional

Note: This information covers only the hearing aid . See the “Earsets for Widex BTE hearing aids” user manual for information specific to your ear-set and the SCOLA FM system manual for information on your SCOLA devices .

If the problems persist, contact your hearing care professional for assistance .

50

CARING FOR YOUR HEARING AID

The hearing aid is a valuable object and should be treated with care . Here are some things you can do to prolong the life of your hearing aid:

51

CAUTION

• Turn off your hearing aid when it is not in use . Remove the battery if the hearing aid will not be used for several days .

• When the hearing aid is not in use, keep it in its case in a dry location out of reach of children and pets .

• Do not expose the hearing aid to extreme temperatures or high humidity . Make sure to dry the hearing aid thoroughly after heavy perspiration such as that which may occur during intense physical activity, e .g . playing sports .

• Avoid dropping your hearing aid – perform cleaning and battery changes while holding the hearing aid above a soft surface .

• Do not wear your hearing aid while in the shower or swimming, or when using a hair dryer, and avoid let ting the hearing aid come into contact with sticky or greasy substances, such as hair spray or sunscreen .

52

WARNINGS

WARNING

Hearing aids and batteries can be dangerous if swal lowed or used improperly . Swallowing or improper use can result in severe injury or even fatalities . In case of ingestion, contact a physician immediately and the 24 Hour National Button Battery Ingestion Hotline at (202)

625-3333 .

• Keep hearing aids and their parts, accessories and batteries out of reach of children and anyone else who might swallow such items or otherwise cause injury to themselves . Do not change batteries in front of them and do not let them see where you keep your battery supply .

Discard used batteries carefully .

• Batteries are very small and can easily be mistaken for pills or the like .

Never put a battery or hearing aid in your mouth for any reason as you may risk swallowing it .

• Clean and inspect your hearing aid after use to check that it is intact .

If the hearing aid or the ear-set breaks while in the ear canal, contact your hearing care professional immediately . Do not try to remove the parts yourself .

53

WARNING

• Risk of explosion if battery is replaced by an incorrect type or recharged . Dispose of used batteries according to the instructions on the battery pack .

• Never allow others to wear your hearing aid, as this could cause permanent damage to their hear ing .

• When selecting a listening program, please remember that there are situations in which it is particularly important to be able to hear the surrounding sounds (e .g . traffic, warning signals) .

• The hearing aid is made of modern non-allergenic materials . Nonetheless, in rare cases skin irritation may occur . If you notice skin irritation in or around your ear or ear canal, contact your hearing care professional .

54

WARNING

• Please note that when using any type of hearing aid, you must allow regular ventilation of the ear . If the ear is not adequately ventilated, there may be a slightly increased risk of infection or disease in the ear canal . We therefore recommend that you remove the hearing aid and ear-set from your ear when you go to bed, to allow the ear canal to be ventilated . If possible, you should also remove your hearing aid and ear-set during the day if there are any periods when you do not need them . Make sure that you clean and inspect your hearing aid and ear-set as required . If an ear infection or disease occurs, you should seek medical attention and contact your hearing care professional for advice on how to disinfect the various hearing aid parts .

Do not under any circumstances use alcohol, chlorine or similar substances for this purpose .

• Regular use of a de-humidifier is recommended to help avoid malfunction of the hearing aid .

• Do not use Widex hearing aids in mines or other areas with explosive gases .

55

WARNING

• Do not wear your hearing aid during radiation, X-rays,

MRIs, CT or other medical treatments and scans . The emissions from these procedures as well as from other types of radiation, such as that in a microwave oven, can damage your hearing aid and the hearing aid can become very hot .

Radiation from, for example, room surveillance equipment, burglar alarms and cell phones is weaker and will not damage the hearing aid, but may create audible interference .

56

WARNING

Interference with active Implants

• In order to show caution, we advise to follow the guidelines recommended by manufacturers of defibrillators and pacemakers regarding use of cell phones:

• If you wear an active implantable device keep the Wireless Hearing

Aids and Hearing Aid Accessories such as wireless remote controls or communicators at least 15 cm/6 inches away from the implant .

• If you experience any interference, do not use the hearing aids and contact the manufacturer of the implant . Please note that interference can also be caused by power lines, electrostatic discharge, airport metal detectors etc .

• If you have an active brain implant, please contact the manufacturer of the implant for risk evaluation .

If you have an implantable device, we advise to keep magnets* at least

15 cm/6 inches away from the implant . (*= can be specified as Autophone magnet, hearing instrument case, magnet in a tool, etc .)

57

CAUTION

• Your hearing aid has been tested for interference according to international standards . Nevertheless, it is possible that unforeseen interference may occur in the hearing aid due to electromagnetic radiation from other products such as alarm systems, room surveillance equipment and cell phones .

• Although your hearing aid has been designed to comply with the most stringent international electromagnetic compatibility standards, the possibility cannot be excluded that it may cause interference with other equipment, such as medical devices .

• Never try to open or repair the hearing aid yourself .

58

ADVICE

NOTE

• The hearing aid will not restore normal hearing and will not prevent or improve a hearing loss resulting from organic conditions . However, the hearing aid can help you to make the best possible use of your remaining hearing ability . You should also bear in mind that it can take time to get used to a new hearing aid and new sounds .

• In most cases, using the hearing aid infrequently will not permit you to gain full benefit from it .

• The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading .

• The use of hearing aids increases the risk of accumulation of earwax .

Contact your physician/ENT doctor if you suspect that a plug of earwax has accumulated in your ear . Earwax may not only reduce your own hearing but also the effect of the hearing aid considerably . It is a good idea to ask your physician to clean your ears a couple of times a year .

59

REGULATORY INFORMATION

REGULATORY INFORMATION

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

Antenna type

Hearing aids RC-DEX

Inductive antenna

Inductive antenna

TM-DEX

Inductive antenna

Bluetooth* -

NOAHlink

Embedded ceramic antenna

Antenna dimensions

Ø1 .8 mm,

L - 6 .55 mm

Modulation FSK

NA

FHSS/GFSK,

π/4 DPSK, 8

DPSK

-54 dB μA/m -13 dBμA/m -26 dBμA/m NA Magnetic

Field

Strength (at

10 m distance)

Ø8 mm,

L – 20 mm

FSK

Ø6 mm,

L - 8 mm

FSK

60

Hearing aids RC-DEX TM-DEX

Output power

(EIRP**)

Range

29 pW 21 nW 1 .2 nW

< 1 m remote unit to hearing aid

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

DEX

10 .6 MHz

< 1 m remote unit to hearing aid

10 .6 MHz

< 30 cm between hearing aid and TM-DEX

10 .6 MHz Center frequency

Channel Single channel radio

Bandwidth 660 kHz (-15 dB)

Single channel radio

660kHz (-15 dB)

Single channel radio

660kHz

(-15 dB)

Bluetooth* -

NOAHlink

+4dB re .

1mW

< 10 m between PC and

NOAHlink

2 .4 GHz

5 logical channels

1 MHz

61

Data flow Simplex or

Protocol

Hearing aids RC-DEX

Data-rate 212 kbit/second (raw channel

capacity) semi-duplex capability

Random

Access – no collision avoidance

212 kbit/ second (raw channel capacity)

Simplex capability

Random

Access – no collision avoidance

TM-DEX

212 kbit/second (raw channel

capacity)

Simplex or semi-duplex capability

Random

Access – no collision avoidance

Bluetooth* -

NOAHlink

2 .1 Mbps

Time division duplex

(TDD)

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

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(Benefits) The use of wireless transmission allows convenient and synchronized control of hearing aid functions . The SUPER 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 SUPER 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 .

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 .

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Coordination of compression – The SUPER440 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 SUPER hearing aids distinguish between “true” hearing aid whistling (or feedback) and music sounds to prevent unnecessary feedback cancellation and preserve natural sound quality .

(Contraindications):

• 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

64

RADIO TRANSMITTER / CABLES / TRANSDUCERS

The SUPER™ 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

• Modulation: FSK

• Radiated output power: 29 pW / -75 dBm

• Magnetic field strength: -54 dB μA/m @ 10 m

• Duty Cycle: < 5 % (averaged over 1 hour of operation)

• Simplex or semi duplex capability

The radio receiver in the SUPER™ series hearing aid is using the same frequency and bandwidth as the transmitter .

65

Cables…and…transducers:…

No cables and transducers are used neither during normal use of the

SUPER™ series hearing aid nor during programming of the hearing aid .

66

QUALITY OF SERVICE FOR WIRELESS TECHNOLOGY IN THE

WIDEXLINK SYSTEM

WidexLink wireless technology enables communication between two partners of a binaural pair of SUPER 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 .

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 .

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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 .

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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 .

69

GUIDANCE AND MANUFACTURER’S DECLARATION

Electromagnetic emissions

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

Emissions test Compliance Electromagnetic environment - guidance

RF emissions

CISPR 11

Group 1 The SUPER™ 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 .

70

RF emissions

CISPR 11

Harmonic emissions

IEC 61000-3-2

Voltage fluctuations/ flicker emissions IEC

61000-3-3

Class B

Not applicable *)

Not applicable *)

*) Battery powered equipment

The SUPER™ hearing aid is suitable for use in all establishments, including domestic establishments and those directly connected to the public low-voltage power supply network that supplies buildings used for domestic purposes .

71

Electromagnetic…immunity

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

Immunity

Test

IEC 60601

Test level

Compliance level

Electrostatic discharge

(ESD)

IEC

61000-4-2

± 6 kV contact

± 8 kV air

± 6 kV contact

± 8 kV air

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 % .

72

Immunity

Test

IEC 60601

Test level

Compliance level

Electrical fast transients/ burst

IEC

61000-4-4

Surge

IEC

61000-4-5

± 2 kV for power line supplies

± 1 kV for input/output lines

± 1 kV line(s) to line(s)

± 2 kV line(s) to earth

Not applicable *)

Not applicable *)

Not applicable *)

Not applicable *)

Electromagnetic environment – guidance

Not applicable *)

Not applicable *)

73

Immunity

Test

IEC 60601

Test level

Voltage dips, short interruptions and voltage variations on power supply input lines

IEC

61000-4-11

<5 % U

T

(>95 % dip in U

T

) for

0 .5 cycle

40 % U

T

(60 % dip in U

T

) for 5 cycles

70 % U

T

(30 % dip in U

T

) for 25 cycles

<5 % U in U

T

T

(>95 % dip

) for 5 s

Compliance level

Not applicable *)

Electromagnetic environment – guidance

Not applicable *)

74

Immunity

Test

IEC 60601

Test level

Compliance level

Electromagnetic environment – guidance

Power frequency

(50/60 Hz) magnetic field

IEC

61000-4-8

3 A/m 3 A/m Power frequency magnetic fields should be at levels characteristic of a typical location in a typical commercial or hospital environment

NOTE U

T

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

*) Battery powered equipment

75

Electromagnetic…immunity…–…cont.

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

76

Immunity

Test

IEC 60601

Test level

Conducted

RF

IEC

61000-4-6

3 Vrms

150 kHz to

80 MHz

Compliance level

3 Vrms

Electromagnetic environment – guidance

Portable and mobile RF communications equipment should be used no closer to any part of the

SUPER TM series hearing aid, including cables, than the recommended separation distance calculated from the equation applicable to the frequency of the transmitter .

Recommended separation distance d = 1 .2 √ P

77

Radiated RF

IEC

61000-4-3

3 V/m

80 MHz to

2 .5 GHz

3 V/m d = 1 .2 √ P

80 MHz to 800 MHz d = 2 .3 √ P

800 MHz to 2 .5 GHz

78

Immunity

Test

IEC 60601

Test level

Compliance level

Electromagnetic environment – guidance

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

Field strengths from fixed

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

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

79

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

SUPER™ series hearing aid is used exceeds the applicable RF compliance level above, the SUPER™ 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

SUPER™ series hearing aid .

b . Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m .

80

Recommended…separation…distances

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

The SUPER™ series hearing aids are intended for use in the electromagnetic environment in which RF disturbances are controlled . The customer or the user of the SUPER™ series hearing aid can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the SUPER™ 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 .1

1

Separation distance according to frequency of

150 kHz to 80

MHz d = 1 .2

0 .12

0 .38

1 .2

√ P transmitter (m)

80 MHz to

800 MHz d = 1 .2

0 .12

0 .38

1 .2

√ P

800 MHz to 2 .5

GHz d = 2 .3

0 .23

0 .73

2 .3

√ P

81

10

100

3 .8

12

3 .8

12

7 .3

23

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

82

(EMI/EMC…Compliance).…

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

Standard

47 CFR Part 15, subpart C

EN 300 330-2

V1 .5 .1

IEC 60601-1-

2:2007

*adapted protocol

EN 301 489-3

V1 .4 .1

Test type Note

RF emissions USA Federal Communications Commission (FCC) requirements for intentional radiators .

RF emissions incl . Spurious emission

EMC and radio spectrum matters for

Short Range Devices in the frequency range 9 kHz – 25 MHz

EMC emission

Immunity, RF and ESD

Immunity, RF and ESD

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

83

IEC 60118-

13:2011

ANSI C63 .19-

2007

Immunity

RF Near Field immunity test

Immunity

RF Near Field immunity test

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

* 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.

84

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 .

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 .

85

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 .

86

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 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 .

87

FCC ID: TTY-S4VSD

IC: 5676B-S4VSD

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

88

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

— Reorient or relocate the receiving antenna .

— Increase the separation between the equipment and receiver .

— Connect the equipment into an outlet on a circuit different from that to which the receiver is connected .

— Consult the dealer or an experienced radio/TV technician for help .

NOTE:

This equipment complies with FCC radiation exposure limits set forth for an uncontrolled environment . This transmitter must not be co-located or operating in conjunction with any other antenna or transmitter .

Changes or modifications to the equipment not expressly approved by

Widex could void the user’s authority to operate the equipment .

89

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

(2) this device must accept any interference, including interference that may cause undesired operation of the device .

90

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 .

91

Directive 1999/5/EC

Hereby, Widex A/S declares that this S4-VSD and S2-VSD are in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC .

A copy of the Declaration of Conformity according to 1999/5/EC can be found at: http://www .widex .com/doc

92

Electrical and electronic equipment (EEE) contains materials, components and substances that can be hazardous and present a risk to human health and the environment when waste electrical and electronic equipment (WEEE) is not handled correctly .

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 . Proper disposal helps to protect human health and the environment .

93

YOUR HEARING AID

(To be filled out by the hearing care professional)

Date: _________________________________________

Battery size: 675

94

Programs available in your hearing aid:

Program 1:

Program 2:

Program 3:

Program 4:

Program 5:

Special program:

95

Programs available in your hearing aid:

Program 1:

Program 2:

Program 3:

Program 4:

Program 5:

Special program:

96

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 .

Date of manufacture

The date when the product was manufactured .

Use-by date

The date after which the product is not to be used .

Batch code

The product’s batch code (lot or batch identification) .

97

Symbol Title/Description

Catalog number

The product’s catalog (item) number .

Serial number

The product’s serial number .*

Keep away from sunlight

The product must be protected from light sources and/or

The product must be kept away from heat

Keep dry

The product must be protected from moisture and/or

The product must be kept away from rain

Lower limit of temperature

The lowest temperature to which the product can be safely exposed .

98

Symbol Title/Description

Upper limit of temperature

The highest temperature to which the product can be safely exposed .

Temperature limits

The highest and lowest temperatures to which the product can be safely exposed .

Consult instructions for use

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

Caution/Warning

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

99

Symbol Title/Description

WEEE mark

“Not for general waste”

When the product is to be discarded, it must be sent to a designated collection point for recycling and recovery .

CE mark

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

Alert

The product is identified by R&TTE Directive 1999/5/EC as an equipment Class 2 product with some restrictions on use in some CE member states .

C-Tick mark

The product complies with EMC and radio spectrum regulatory requirements for products supplied to the

Australian or New Zealand market .

100

Symbol Title/Description

Interference

Electromagnetic interference may occur in the vicinity of the product .

*The six- or seven-digit number on the product is the serial number .

Serial numbers may not always be preceded by

101

102

103

WIDEX A/S Nymoellevej 6, DK-3540 Lynge, Denmark www .widex .com

Manual no .:

9 514 0293 041 #02

CIB341/1114

Issue:

2015-10

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