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User instrUctions cMe15-ite
•
cMe10-ite cMe5-ite
•
cMe3-ite in-the-ear
Your melodia™ hearing aid
(To be filled out by the hearing care professional)
date: ______________________________________
Battery size: _________________________________
Cme15
Cme10
Cme5
Cme3
Vent:
Vent
No vent
2
Contents
sYmBols . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 the hearing aid . . . . . . . . . . . . . . . . . . . . . . . . . . 5
Right/left identification . . . . . . . . . . . . . . . . . . . . . . . 8
Acoustic indicators . . . . . . . . . . . . . . . . . . . . . . . . . . 8
The battery . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9
Inserting the battery . . . . . . . . . . . . . . . . . . . . . . . 9
Low battery indication . . . . . . . . . . . . . . . . . . . . . 11
Turning the hearing aid on and off . . . . . . . . . . . . . 12
Positioning the hearing aid . . . . . . . . . . . . . . . . . . . 13
Removing the hearing aid . . . . . . . . . . . . . . . . . . . 14
Volume adjustment . . . . . . . . . . . . . . . . . . . . . . . . 15
Listening programs . . . . . . . . . . . . . . . . . . . . . . . . 16
Switching between the listening programs . . . . . . 17
Cleaning . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
The hearing aid . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
The sound outlet . . . . . . . . . . . . . . . . . . . . . . . . . . 21
The microphone openings . . . . . . . . . . . . . . . . . . . 22
The vent . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 nanoCare wax guard . . . . . . . . . . . . . . . . . . . 24
Changing the NanoCare wax guard . . . . . . . . . . . . 25 aCCessories . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28 in Case of malfunCtion . . . . . . . . . . . . . . . . . 29
Caring for Your hearing aid . . . . . . . . . . . . . 32 warnings . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 adViCe . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 regulatorY information . . . . . . . . . . . . . . . . . 38
3
sYmBols
The following symbols will be used throughout the manual:
warning
Messages with this heading indicate serious adverse reactions, potential safety hazards and inadequate performance of device .
Caution
Messages with this heading indicate/include information regarding any special care to be exercised .
Non-ionizing radiation .
Not for general waste .
4
the hearing aid
1 . microphone openings
2 . on/off function
3 . nail grip
4 . sound outlet
5 . nanoCare wax guard
6 . Vent (Not in all versions) .
5
warning
This booklet contains important information and instructions .
Please read this booklet carefully before you start using the hearing aid .
note
Your hearing aid and accessories may not look exactly as illustrated in this booklet . we also reserve the right to make any changes considered necessary .
6
intended use
The Melodia hearing aids are intended as air conduction amplification devices to be used in everyday listening environments .
indications for use
The devices are indicated for individuals with a range of hearing loss severity from minimal (10 dB HL) to moderately severe (85 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 .
description of device
The hearing aid uses a proprietary wireless technology to enable communication between the left and the right hearing aids, as well as between the hearing aids and its accessories .
7
right/left identification
The Coselgi name is in red on a rightear hearing aid and in blue on a leftear hearing aid .
acoustic indicators
The hearing aid may be set to produce tones to indicate the use of certain functions .
function
Adjusting volume via remote control* default setting tone
Changing program via remote control tones
Starting up the hearing aid
Warning about low battery
* Remote control not available for CMe3 alternative setting
Off
Off tone Off
4 tones Off
8
the battery
We recommend zinc-air batteries . Use a size 312 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 . 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 .
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 .
9
Use the nail grip to push the battery compartment cover downwards and open the cover . Do not press the battery compartment cover beyond the open position .
Place the battery so that the plus (+) sign of the battery faces upwards .
You can use the battery magnet provided to steer the battery into place .
If the battery compartment cover 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 .
10
low battery indication
An acoustic indicator will sound when the battery is nearly exhausted, unless this function has been disabled (see page 8) . 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 .
11
turning the hearing aid on and off
The battery compartment cover of your hearing aid also functions as the on/off switch .
Close the battery compartment cover and push it upwards to turn the hearing aid on . An acoustic indicator will indicate that the hearing aid has been switched on unless this function has been disabled .
Push the battery compartment cover downwards to turn the hearing aid off .
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 .
12
Positioning the hearing aid
Close the battery compartment cover completely .
Hold your hearing aid with your thumb and fore finger . Slowly guide the hearing aid into your ear canal until you feel resistance .
Let go of the hearing aid and use the tip of your forefinger to gently push it into your ear until it rests comfortably in your ear canal .
To help position the hearing aid properly you could pull the outer ear backwards and upwards with the opposite hand .
13
removing the hearing aid
Hold the hearing aid with your thumb and forefinger and pull gently .
If it is difficult, you can try to move the hearing aid carefully from side to side . It may also help to pull the outer ear backwards and upwards with the opposite hand .
14
Volume adjustment
The hearing aid volume is adjusted automatically in accordance with your sound environment .
If you have a remote control*, you can also adjust the volume manually or mute your hearing aid . Any adjustment of the volume setting will be canceled when your hearing aid is turned off, or when you change program .
In the default setting, any volume adjustment via the remote control will affect both hearing aids .
If you have a remote control, please also refer to the user instructions for this .
to mute the hearing aid with a remote control:
Keep pressing the volume down key on the remote control until the long beep-tone has sounded . Pressing one of the volume keys briefly will bring back the sound .
Caution
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 .
* Not available for CMe3
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listening programs
By default, your hearing aid has one listening program .
However, if you have a remote control*, a number of additional programs can be made available; how many depends on your specific hearing aid .
main
music
tV
relax
rearview
Phone
t
m+t
Standard
For listening to music
For listening to the TV
Attenuates background noise
Focus on sounds from behind
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 .
In this program you listen via the hearing aid microphones (M) and the telecoil (T) .
If your needs change over time, the combination of listening programs can be altered .
* Not available for CMe3
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switching between the listening programs
Each time you change program via a remote control, an acoustic indicator will sound unless this function has been disabled .
Program 1: One short beep
Program 2: Two short beeps
Program 3: Three short beeps
Program 4: One long and one short beep
Program 5: One long and two short beeps
In the default setting, both your hearing aids will be affected when you change programs .
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Cleaning
The following cleaning accessories are available for the hearing aid .
1 . Cloth
2 . Brush
3 . long wax removing tool
4 . short wax removing tool
1.
2.
3.
4.
Contact your hearing care professional if you need additional supplies of cleaning accessories .
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the hearing aid
It is very important for the hearing aid’s performance that it is kept free from earwax and dirt .
Clean your hearing aid after use with the cloth provided .
warning never clean the hearing aid with water or cleaning solutions, as this may cause it to malfunction .
When the hearing aid is not in use, the battery compartment cover should be left open to ventilate the hearing aid and allow it to dry .
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We recommend that every time you take the hearing aid out of your ear, you inspect the sound outlet and the microphone and vent openings to ensure that no earwax or dirt has gathered there . Below is an example of how the sound outlet and the microphone and vent openings may be positioned . The positions can be slightly different on your hearing aid .
1 . sound outlet
2 . Vent opening
3 . microphone openings
3
1
2
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the sound outlet
It is important that the sound outlet is not blocked by earwax . If it is blocked, do as follows:
Remove any visible earwax from around the sound outlet with the small brush or cloth . Do not attempt to clean the wax guard .
If the sound outlet is still blocked, you should change the wax guard (see pages 24-27) .
warning
If you cannot clean the sound outlet completely, you should contact your hearing care professional . Do not insert anything into the sound outlet, as this could damage the hearing aid .
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the microphone openings
If dirt or earwax has gathered around the microphone openings on the hearing aid front, do as follows:
Open the battery compartment cover and turn the hearing aid so the cover is facing downwards (see drawing) .
Guide the short wax removing tool (no . 4) through the microphone opening on the battery compartment cover from the inside as illustrated .
warning
If you suspect that earwax or dirt has migrated through the microphone opening and into the actual microphone inside the hearing aid, contact your hearing care professional . Do not insert anything into the actual microphone .
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the vent
If earwax has accumulated in and/or around the vent opening, do as follows:
Clean any earwax from the vent by passing the long wax removing tool
(no . 3) all the way through the vent .
warning
It is important for the performance of the hearing aid that the vent is never blocked by earwax . Make it a habit to clean the vent every day! In rare cases so much earwax can accumulate in the vent that the hearing aid sound is affected . In that case you should see your hearing care professional .
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nanoCare wax guard
The NanoCare wax guard helps to protect the hearing aid against earwax . Always use NanoCare wax guards with your hearing aid . Otherwise the warranty for your hearing aid will be void .
The NanoCare wax guard consists of the following parts:
1 . holder
2 . removal hook
3 . wax guard
Caution
The wax guard is disposable and for one-time use only . Do not attempt to clean or reuse a wax guard . This could damage your hearing aid and/or cause the wax guard to become dislodged in your ear .
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Changing the nanoCare wax guard
Insert the removal hook into the used wax guard placed in the sound outlet . Pull the wax guard straight out .
1 . Vent opening
2 . sound outlet
3 . used wax guard
25
Turn the holder around so that the new wax guard is in position to be inserted .
Insert the holder into the opening of the sound outlet and gently press the wax guard into the opening .
Then pull the holder straight out .
The new wax guard will automatically detach from the holder . Press the hearing aid gently against a flat surface to ensure that the wax guard remains in place .
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Discard the holder with the used wax guard .
The frequency with which the NanoCare wax guard should be changed varies from one individual to another .
If you have any questions regarding your NanoCare wax guard, please contact your hearing care professional .
warning
If the wax guard fits loosely, discard it and insert another . If the wax guard becomes dislodged from the hearing aid while in the ear canal, please contact your physician . Do not try to remove the wax guard from your ear canal yourself .
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aCCessories
A number of assistive listening devices may be available for your hearing aid .
rC remote control* tV-Control*
For help in determining whether you could benefit from a remote control or other accessories, please consult your hearing care professional .
* Not available for CMe3
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in Case of malfunCtion
The following pages contain some quick advice on what to do if your hearing aid stops working or performs unsatisfactorily . If the problems persist, contact your hearing care professional for assistance .
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
The sound outlet is blocked
The microphone opening is blocked solution
Make sure the battery is placed correctly and the battery compartment cover is closed correctly .
See page 12
Insert a new battery in the hearing aid
See page 21
See page 22 .
If you suspect that earwax or dirt has migrated through the microphone opening and into the actual microphone inside the hearing aid, contact your hearing care professional . Do not insert anything into the actual microphone .
See page 21 The sound outlet is blocked
Your ear is blocked by earwax
Your hearing may have changed
Contact your ENT doctor/physician
Contact your hearing care professional
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Problem
The hearing aid whistles continuously
If the hearing aid is uncomfortable to wear
Possible cause
Your ear is blocked by earwax
The hearing aid is not correctly placed in your ear canal
The hearing aid fits loosely in your ear canal solution
Contact your ENT doctor/physician
Take the hearing aid out and reinsert it
Contact your hearing care professional
The hearing aid is not correctly placed in your ear canal .
The hearing aid does not fit your ear properly
Consult your hearing care professional on how to place the hearing aid correctly in your ear canal
Contact your hearing care professional
Your outer ear or ear canal is sore
Contact your hearing care professional
Your hearing aids are not working in synchrony
The connection between the hearing aids is lost
Turn the hearing aids off and on again
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Problem
The hearing aids do not respond with a corresponding change in volume or program to the RC
Possible cause
The RC is used beyond the transmission range
Strong electro- magnetic interference in the vicinity
The RC battery is dead or does not work
The RC and the hearing aids are not matched solution
Move the RC closer to the hearing aids
Move away from known source of
EM interference
Change the RC battery
Make sure RC is matched with hearing aids (see User instructions for RC) .
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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:
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, perfume, hair and body sprays or gels such as suntanning lotions or creams .
• In environments with high humidity, a drying kit may be used daily to reduce the amount of moisture inside the hearing aid .
See the instructions enclosed with the drying kit .
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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 .
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warning
• Risk of explosion if battery is replaced by an incorrect type or recharged . Dispose of used batteries according to the instructions .
• 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 .
• Be aware that the use of any type of hearing aid may involve a slightly increased risk of infection in the ear canal . An infection can arise as a result of inadequate ventilation of the ear . We therefore recommend that you remove the hearing aid from your ear at night to allow the ear canal to be ventilated . Make sure that you clean and inspect your hearing aid as required .
If an infection occurs, you should seek medical attention and contact your hearing care professional for advice on how to disinfect the hearing aid . Do not under any circumstances use alcohol, chlorine or similar substances .
• Do not use the hearing aids in mines or other areas with explosive gases .
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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 . 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 .
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 .)
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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 (Only to be performed by authorized personnel) .
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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 .
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regulatorY information
REGULATORY INFORMATION
The following Table summarizes the technical details of the
WidexLink technology as it is implemented in the Melodia™ hearing aids.
Antenna type
Hearing aids RC remote
Inductive antenna control
Inductive antenna
TM-DEX
Inductive antenna
Ø6 mm,
L - 8 mm
Bluetooth* -
NOAHlink
Embedded ceramic antenna
NA Antenna dimensions
Ø1.8 mm,
L - 6.55 mm
Modulation FSK
Ø8 mm,
L – 20 mm
FSK FSK FHSS/GFSK,
π/4 DPSK, 8
DPSK
-26 dBμA/m NA Magnetic
Field
Strength
(at 10 m distance)
Output power
(EIRP**)
Range
-54 dBμA/m -13
29 pW dBμA/m
21 nW 1.2 nW
Center frequency
< 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
+4dB re.
1mW
< 10 m between PC and
NOAHlink
2.4 GHz
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REGULATORY INFORMATION
The following Table summarizes the technical details of the
WidexLink technology as it is implemented in the Melodia™ hearing aids.
Antenna type
Antenna dimensions
Hearing aids RC remote control
Inductive antenna
Inductive antenna
Ø1.8 mm,
L - 6.55 mm
Modulation FSK
Ø8 mm,
L – 20 mm
FSK
TM-DEX
Inductive antenna
Ø6 mm,
L - 8 mm
Bluetooth* -
NOAHlink
Embedded ceramic antenna
NA
-54 dBμA/m -13 dBμA/m
FSK FHSS/GFSK,
π/4 DPSK, 8
DPSK
-26 dBμA/m NA Magnetic
Field
Strength
(at 10 m distance)
Output power
(EIRP**)
Range
29 pW 21 nW 1.2 nW +4dB re.
1mW
Center frequency
< 1 m remote unit to hearing aid
< 30 cm between hearing aids or
Hearing aid to TM-DEX
< 1 m remote unit to hearing aid
10.6 MHz
< 30 cm between hearing aid and
TM-DEX
10.6 MHz 10.6 MHz
< 10 m between PC and
NOAHlink
2.4 GHz
Hearing aids RC remote control
Channel Single channel radio
Single channel radio
Bandwidth 660 kHz (-15 dB)
Data-rate 212 kbit/second (raw channel
capacity)
660kHz
(-15 dB)
212 kbit/ second
(raw channel capacity)
TM-DEX
Single channel radio
660kHz
(-15 dB)
212 kbit/second (raw channel
capacity)
Bluetooth* -
NOAHlink
5 logical channels
1 MHz
2.1 Mbps
Data flow Simplex or semi-duplex capability
Protocol Random Access – no collision avoidance
Simplex capability
Random
Access – no collision avoidance
Simplex or semi-duplex capability
Random Access – no collision avoidance
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 Melodia 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
Melodia 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.
(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
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(Benefits) The use of wireless transmission allows convenient and synchronized control of hearing aid functions. The Melodia 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
Melodia 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.
(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
RADIO TRANSMITTER / CABLES / TRANSDUCERS
The Melodia™ 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 dBμA/m @ 10 m
• Duty Cycle: < 5 % (averaged over 1 hour of operation)
• Simplex or semi duplex capability
The radio receiver in the Melodia™ 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 Melodia™ series hearing aid nor during programming of the hearing aid.
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QUALITY OF SERVICE FOR WIRELESS TECHNOLOGY IN
THE WIDEXLINK SYSTEM
WidexLink wireless technology enables communication between two partners of a binaural pair of Melodia 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.
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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QUALITY OF SERVICE FOR WIRELESS TECHNOLOGY IN
THE WIDEXLINK SYSTEM
WidexLink wireless technology enables communication between two partners of a binaural pair of Melodia 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.
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 communication protocol which checks the package numbers during each transmission.
• A Cyclic Redundancy Check (CRC) to check data validity and correct errors.
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GUIDANCE AND MANUFACTURER’S DECLARATION
Electromagnetic emissions
The Melodia™ series hearing aids are intended for use in the electromagnetic environment specified below. The customer or the user of a Melodia™ 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 Melodia™ 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
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC
61000-3-3
Class B
Not applicable *)
Not applicable *)
The Melodia™ 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.
*) Battery powered equipment
44
GUIDANCE AND MANUFACTURER’S DECLARATION
Electromagnetic emissions
The Melodia™ series hearing aids are intended for use in the electromagnetic environment specified below. The customer or the user of a Melodia™ 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 Melodia™ 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
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/ flicker emissions IEC
61000-3-3
Class B
Not applicable *)
Not applicable *)
The Melodia™ 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.
*) Battery powered equipment
Electromagnetic immunity
The Melodia™ series hearing aids are intended for use in the electromagnetic environment specified below. The customer or the user of a Melodia™ series hearing aid should assure that it is used in such an environment.
Immunity
Test
Electrostatic discharge
(ESD)
IEC
61000-4-2
Electrical fast transients/burst
IEC
61000-4-4
Surge
IEC
61000-4-5
IEC 60601
Test level
± 6 kV contact
± 8 kV air
Compliance level
± 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 %.
Not applicable *)
± 2 kV for power line supplies
± 1 kV for input/output lines
± 1 kV line(s) to line(s)
Not applicable *)
Not applicable *)
Not applicable *)
Not applicable *)
± 2 kV line(s) to earth
Not applicable *)
45
Immunity
Test
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC
61000-4-11
IEC 60601
Test level
<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 *)
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
46
Immunity
Test
Voltage dips, short interruptions and voltage variations on power supply input lines
IEC
61000-4-11
IEC 60601
Test level
<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 *)
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
Electromagnetic immunity – cont.
The Melodia™ series hearing aids are intended for use in the electromagnetic environment specified below. The customer or the user of a Melodia™ series hearing aid should assure that it is used in such an environment.
Immunity
Test
IEC 60601
Test level
Compliance level
Conducted
RF
3 Vrms 3 Vrms
Electromagnetic environment – guidance
Portable and mobile RF communications equipment should be used no closer to any part of the
Melodia
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
IEC
61000-4-6
Radiated
RF
150 kHz to
80 MHz
3 V/m 3 V/m
IEC
61000-4-3
80 MHz to
2.5 GHz d = 1.2 √
P
80 MHz to 800 MHz d = 2.3 √
P
800 MHz to 2.5 GHz
47
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:
48
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:
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 Melodia™ series hearing aid is used exceeds the applicable RF compliance level above, the Melodia™ 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 Melodia™ 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 Melodia™ series hearing aids.
The Melodia™ series hearing aids are intended for use in the electromagnetic environment in which RF disturbances are controlled. The customer or the user of the Melodia™ series hearing
49
aid can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Melodia™ 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
10
100
Separation distance according to frequency
150 kHz to
80 MHz d = 1.2
0.12
0.38
1.2
3.8
12
√
P
of transmitter (m)
80 MHz to
800 MHz d = 1.2
0.12
0.38
1.2
3.8
12
√
P
800 MHz to
2.5 GHz d = 2.3
0.23
0.73
2.3
7.3
23
√
P
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 Melodia™ hearing aid may be interfered with by other equipment even if that other equipment complies with CISPR emission requirements.
50
aid can help prevent electromagnetic interference by maintaining a minimum distance between portable and mobile RF communications equipment (transmitters) and the Melodia™ 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
10
100
Separation distance according to frequency
150 kHz to
80 MHz d = 1.2
0.12
0.38
1.2
3.8
12
√
P
of transmitter (m)
80 MHz to
800 MHz d = 1.2
0.12
0.38
1.2
3.8
12
√
P
800 MHz to
2.5 GHz d = 2.3
0.23
0.73
2.3
7.3
23
√
P
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 Melodia™ hearing aid may be interfered with by other equipment even if that other equipment complies with CISPR emission requirements.
(EMI/EMC Compliance).
The Melodia™ 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
IEC 60118-
13:2011
ANSI
C63.19:2007
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
Immunity
RF Near Field immunity test
Immunity
RF Near Field immunity test
Medical electrical equipment.
General requirements for basic safety and essential performance.
Electromagnetic compatibility.
Standard for Low Power Transmitters in the frequency range
9 kHz – 40 GHz
International Product std. for hearing aids to ensure adequate immunity to radio interference from cell telephones.
American National Standard
Methods of measurement of
Compatibility between wireless
Communication Devices and
Hearing Aids
* 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.
51
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.
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.
52
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.
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 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.
53
fCC id: ttY-C4xP iC: 5676B-C4xP federal Communications Commission statement
This device complies with part 15 of the FCC Rules . Operation is subject to the following two conditions:
(1) This device may not cause harmful interference, and
(2) this device must accept any interference received, including interference that may cause undesired operation .
NOTE:
This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules .
These limits are designed to provide reasonable protection against harmful interference in a residential installation . This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications . However, there is no guarantee that interference will not occur in a particular installation . If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
- Reorient or relocate the receiving antenna .
- Increase the separation between the equipment and receiver .
- 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 Coselgi could void the user’s authority to operate the equipment .
54
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 .
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 .
55
Hereby, Coselgi A/S declares that this CMe-ITE is in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC .
A copy of the Declaration of Conformity can be found at: http://www .coselgi .com/products/doc
56
Hearing aids, accessories and batteries should not be disposed of with normal household waste . Please consult your
national Coselgi distributor for advice on how to dispose of these items .
57
58
59
manufacturer
¡9 514 0132 001S¤ ¡#01v¤
Printed by Hto / 2013-09
9 514 0240 041 #01 coseLGi and MeLoDiA are trademarks of coselgi A/s
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