oticon CROS, BiCROS Instruction Manual

Page 1
Instructions for use
Oticon CROS
Page 2
Model overview
This booklet is valid for Oticon CROS and covers both CROS and BiCROS.
CROS
Oticon CROS is to be used with a compatible Oticon hearing aid that has either a single push button or a double push button for volume control.
Single push button
Double push button
For an overview of which hearing aids Oticon CROS is compatible with, please go to www.oticon.com
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Introduction to this booklet
Intended use
This booklet gives you guidance on how to use and maintain your new transmitter. Please read the booklet carefully, including the Warnings section. This will help you get the full benefit of your new transmitter.
Your hearing care professional has adjusted the transmitter to meet your needs. If you have further questions, please contact your hearing care professional.
About Start-up Handling Features Warnings More info
For your convenience, this booklet contains a navigation bar to help you easily navigate through the different sections.
The transmitter is intended to transmit sound from the poorer ear to a hearing aid placed on the better ear.
The transmitter is intended to be used by adults and children older than 36 months together with a hearing aid.
IMPORTANT NOTICE
For details on the functionality of the hearing aid, please refer to the hearing aid’s Instruction for use.
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Table of contents
About
Start-up
Handling
CROS solution 8 Your transmitter 10 Left/right identification 12 MultiTool for handling batteries and cleaning 13
Turn the transmitter ON and OFF 14 When to replace the battery 15 How to replace the battery (size 312) 16 Put on the transmitter 18
Caring for the transmitter 19 Replace the earpiece 20 ProWax miniFit filter 22 Change volume on the transmitter 23 Mute 26 Sound indicators 27
Warnings
General warnings 28
More info
Troubleshooting 36 Water & dust resistant (IP68) 38 Conditions of use 39 Warranty 40 Technical information 42
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CROS solution
A CROS or BiCROS solution consists of a transmitter and a hearing aid. The transmitter is placed on the poorer ear. It wirelessly sends sound
Sound transmission
from the poorer ear surroundings to the hearing aid placed on the better ear. The transmitter only works with certain Oticon hearing aids.
CROS (Contralateral Routing of Signals) is a solution for people with limited or no hearing in one ear combined with normal hearing in the opposite ear.
BiCROS (Bilateral Contralateral Routing of Signals) is a solution for people with limited or no hearing in one ear and hearing loss in the opposite ear.
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Hearing aidTransmitter
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Your transmitter
What it is and what it does
Microphones
Sound in
Push button
Change volume
and mute
Ear grip
Holds the dummy
speaker in place
(optional)
Wax filter
Wax protection
The dummy speaker has no acoustic purpose. The choice of size depends on what fits best in your ear.
Dummy speakers
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The dummy speaker uses an open dome as shown below. This helps the transmitter stay in your ear.
Earpiece
Open dome
Dummy speaker
No sound
Battery drawer
Nail grip
Open the
battery drawer
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Contains the battery and functions as an on/off switch
Dome sizes
6 mm5 mm* 8 mm 10 mm
* Only for dummy speaker 60
Please see details for replacing the dome in section: Replace the earpiece.
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Left/right identication
MultiTool for handling batteries and cleaning
It is important to distinguish between the transmitter and the hearing aid. The left/right color indicator helps you distinguish between left and right.
The MultiTool contains a magnet that makes it easier to replace the battery in the transmitter. It also contains a brush and wire loop for cleaning and removing earwax. If you need a new MultiTool, please
contact your hearing care professional. On the transmitter, you can find left/right color indicators in the battery drawer. On the dummy speaker it is located as shown.
Wire loopMagnet
RED indicates RIGHT
BLUE indicates LEFT
IMPORTANT NOTICE
The MultiTool has a built-in magnet. Keep the MultiTool at least 12 inches away from credit cards and other magnetically sensitive devices.
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Brush
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Turn the transmitter ON and OFF
When to replace the battery
The battery drawer is used to switch your transmitter on and off. To save battery life, make sure the transmitter is switched off when you are not wearing it. If you wish to return to the standard settings, simply open
When it is time to replace the battery in the transmitter, you will hear
three alternate high pitch tones in the hearing aid. They will be repeated
in moderate intervals until the battery runs out. and close the battery drawer.
Three alternate tones
= The battery is running low
Four descending tones
= The battery has run out
Battery tip Turn ON
Close the battery
Turn OFF
Open the battery drawer.
Keep a spare battery on you at all times to ensure your transmitter
always works.
drawer with the battery in place.
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How to replace the battery (size 312)
1. Remove
2. Uncover 3. Insert
4. Close Tip
MultiTool
Fully open the battery drawer. Remove the battery.
Remove the sticky label from the
+ side
of the new battery.
Insert the new battery into the battery drawer. Make sure the + side is facing up.
Tip:
Wait 2 minutes for the battery to draw air to en­sure optimal functioning.
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Insert it from above, NOT from the side.
Close the battery drawer.
If the transmitter is within range of
the hearing aid, you will hear a jingle
in the hearing aid.
The MultiTool can be used to change the battery. Use the magnetic end to remove and insert batteries.
The MultiTool is provided by your hearing care professional.
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Put on the transmitter
Step 1 Step 2 Step 3
Caring for the transmitter
When handling your transmitter, hold it over a soft
surface to avoid damage if you drop it.
Clean the microphone openings
Ear grip
(optional)
Use the brush of the MultiTool to
carefully brush debris away from the
openings. Carefully brush the surface
Microphone
openings
around the openings.
Place the transmitter behind your ear.
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Hold the bend of the dummy speaker wire between your thumb and index finger. The earpiece should point towards opening of the ear canal.
Gently push the earpiece into your ear canal until the dummy speaker wire sits close to your head. If the dummy speaker has an ear grip, place it in the ear so it follows the contour of the ear.
Make sure that no parts of the
MultiTool are squeezed into the
microphone openings by force. This
may damage the transmitter.
IMPORTANT NOTICE
Use a soft, dry cloth to clean the transmitter. The transmitter must never be washed or immersed in water or other liquids.
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Replace the earpiece
The earpiece should not be cleaned. If it is filled with wax, replace it with a new one.
Step 1 Step 2 Step 3
Hold on to the dummy speaker and then pull off the earpiece.
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Insert the dummy speaker into the exact center of the earpiece for a secure attach­ment.
Push firmly to ensure that the earpiece is securely fastened.
IMPORTANT NOTICE
If the earpiece is not on the dummy speaker when removed from the ear, the earpiece may still be in the ear canal. Consult your hearing care professional for further instructions.
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ProWax miniFit lter
Change volume on the transmitter
The dummy speaker has a white wax filter attached to the end with the earpiece. The wax filter keeps wax and debris out of the
The push button on the transmitter allows you to adjust the volume of
the transmitted sound. You will hear a high pitch beep in the hearing aid
when you increase or decrease the volume. dummy speaker. It has no acoustic purpose. Replace the filter for hygienic reasons when clogged.
Remove the earpiece from the dummy
Wax filter
MAXIMUM
speaker before replacing the wax filter.
Press button to increase volume
Press button to
IMPORTANT NOTICE
Always use the same type of wax filter as was originally supplied with the transmitter. If you are in any doubt about the use or replacement of wax filters, contact your hearing care professional.
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decrease volume
START-UP VOLUME
MINIMUM
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Page 13
CROS users only
The microphones on the hearing aid are deactivated. This means that there is no sound coming from the hearing aid.
BiCROS users only
The sound from the hearing aid remains the same when you adjust the
volume of the transmitted sound.
Hearing aid with single push button
The push button on the hearing aid has no volume functionality. To adjust the transmitted sound, you need a ConnectClip, Oticon ON App, Remote Control or iPhone®.
Hearing aid with double push button
If your hearing care professional has activated the volume control, the push button on the hearing aid will adjust the transmitted sound.
Hearing aid with single push button
The push button on the hearing aid has no volume functionality. To
adjust the combined sound from the transmitter and hearing aid, you
need a ConnectClip, Oticon ON App, Remote Control or iPhone.
Hearing aid with double push button
If your hearing care professional has activated the volume control, the
push button on the hearing aid will adjust the combined sound from the
transmitter and the hearing aid.
Contact your hearing care professional for more information.
Apple, the Apple logo, iPhone, iPad, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
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Page 14
Mute
Sound indicators
Use the mute function if you need to temporarily turn off the transmission of sound to the hearing aid. The mute function mutes the
Different sound indicators help to communicate the status of your
transmitter. The sounds will be transmitted to your hearing aid. microphones on the transmitter.
Volume Sound
Start-up volume
Minimum / maximum volume
To mute the transmitter
Press either end of the push button for
Volume up / down
at least four seconds.
To reactivate, press either end of the
Warnings Sound
button briefly.
IMPORTANT NOTICE
Battery low indication
Battery shut down
Microphone service check needed
Do not use the mute function as an off switch, as the transmitter still draws current from the battery in this mode.
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About Start-up Handling Warnings More info
2 high pitch beeps
3 high pitch beeps
1 high pitch beep
3 high pitch alternate tones
4 high pitch descending tones
8 high pitch beeps repeated 4 times
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General warnings
For your personal safety and to ensure correct usage, you should familiarize yourself fully with the following general warnings before using your transmitter.
Please note that the transmitter will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Furthermore, note that in most cases, infrequent use of the transmitter does not permit a user to attain its full benefits.
Consult your hearing care professional if you experience unexpected operations or events with your transmitter.
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Choking hazards & risk of swallowing batteries and other small parts
The transmitter, its parts and the battery should be kept out of reach of children and anyone who might swallow these items or otherwise cause injury to themselves.
Batteries have occasionally been mistaken for pills. Therefore, check your medicine carefully before swallowing any pills.
Most hearing aids can be supplied with a tamper-resistant battery drawer upon request. This is strongly recommended for infants, small children, and people with learning difficulties.
If a battery is swallowed, see a doctor immediately and contact the National Poison Center at 1-800-222-1222 or National Battery Ingestion Hotline at 1-800-498-8666.
Battery use
Always use batteries recommended by
your hearing care professional. Low quality
batteries may leak and cause bodily harm.
Never attempt to recharge your batteries,
and never dispose of batteries by burning
them. There is a risk that the batteries will
explode.
Dysfunction
Be aware of the possibility that your trans-
mitter may stop working without notice.
Keep this in mind when you depend on
warning sounds (e.g. when you are in traf-
fic). The transmitter may stop functioning,
for instance if the batteries have expired.
Active implants
The transmitter has been thoroughly
tested and characterised for human health
according to international standards for
human exposure (Specific Absorption Ratio
- SAR), induced electromagnetic power and
voltages into the human body.
The exposure values are well below international accepted safety limits for SAR, induced electromagnetic power and voltages into the human body defined in the standards for human health and coex­istence with active medical implants, such as pacemakers and heart defibrillators.
If you have an active brain implant, please contact the manufacturer of your implanta­ble device for information about the risk of disturbance.
The MultiTool which has a built-in magnet should be kept at least 12 inches away from the implant, e.g. do not carry it in your breast pocket.
In general, please follow the guidelines recommended by the manufacturers of implantable defibrillators and pacemakers on use with magnets.
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General warnings
X-ray/CT/MR/PET scanning, and electrotherapy
Remove your transmitter before X-ray/CT/ MR/PET scanning, electrotherapy, surgery, etc. as it may be damaged when exposed to strong electromagnetic fields.
Heat and chemicals
The transmitter must never be exposed to extreme heat, e.g. left inside a parked car in the sun.
The transmitter must not be dried in microwave ovens or other ovens.
The chemicals in cosmetics, hairspray, perfume, aftershave lotion, sunscreen lotion, and insect repellent can damage the transmitter. Always remove your trans­mitter before applying such products and allow time to dry before use.
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Possible side effects
The transmitter and earpiece may cause an accelerated accumulation of earwax.
The non-allergenic materials used in the transmitter may in rare cases cause a skin irritation or other side effects.
Please consult a physician if these conditions occur.
Interference
The transmitter has been thoroughly tested for interference, in accordance with the most stringent international stand­ards. However, interference between the transmitter and other devices (e.g. some mobile telephones, citizens band systems, shop alarm systems and other devices) may occur. If this occurs, increase the distance between the transmitter and the interfer­ing device.
Incompatible non-supplied accessories
Only use accessories, transducers or
cables supplied by the manufacturer of
this device. Incompatible accessories may
result in increased emission or decreased
immunity.
Modification of the transmitter is not
allowed
Changes or modifications not expressly ap-
proved by the manufacturer could void the
user’s authority to operate the equipment.
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General warnings
Warnings to hearing care professional
A hearing care professional should advise a prospective hearing aid user to consult immediately with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing care professional determines through inquiry, actual observation, or review of any other available informa­tion concerning the prospective user, that the prospective user has any of the following conditions:
(i) Visible congenital or traumatic
deformity of the ear.
(ii) History of active drainage from the
ear within the previous 90 days.
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(iii) History of sudden or rapidly
progressive hearing loss within
the previous 90 days. (iv) Acute or chronic dizziness. (v) Unilateral hearing loss of sudden
or recent onset within the
previous 90 days. (vi) Audiometric air-bone gap equal
to or greater than 15 decibels at
500 Hertz (Hz), 1,000 Hz, and
2,000 Hz. (vii) Visible evidence of significant
cerumen accumulation or a
foreign body in the ear canal. (viii) Pain or discomfort in the ear.
Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure capability exceeds 132 dB SPL as there may be risk of impairing the remaining hearing of the hearing aid user.
Important notice for prospective hearing aid users
Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as Otolaryngologists, Otologists or
Otorhinolaryngologists. The purpose of medical evaluation is to ensure 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.
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General warnings
The audiologist or hearing care pro­fessional 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 purchase­option program. Many hearing care professionals 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 limits the sale of hearing aids to those individuals who have obtained
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About Start-up Handling Warnings More info
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. A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. A hearing aid is only part of hearing rehabilitation and may need to be supplemented by auditory training and lip reading.
Children with hearing loss
In addition to seeing a physician for 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 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. If the user is an infant, small child, or person with cognitive impairment, it is recommended that the hearing aid be modified with a tamper-resistant battery compartment.
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Troubleshooting
Symptom Possible causes Solutions
Dead battery Replace the battery
Transmitter microphone muted Unmute the transmitter microphone
No sound from the transmitter
Intermittent or reduced sound
Beeping
If none of the above solutions work, consult your hearing care professional.
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Transmitter turned OFF Turn transmitter ON
Receiving hearing aid turned OFF Turn hearing aid ON
Receiving hearing aid muted Unmute hearing aid
Moisture on either the transmitter or hearing aid battery Wipe batteries with a dry cloth
If your transmitter plays 8 beeps, 4 times consecutively, it needs a microphone service check
Contact your hearing care professional
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Water & dust resistant (IP68)
Your transmitter is dust tight and protected against ingress of water, which means it is designed to be worn in all daily life situations. Therefore, you do not have to worry about sweat or getting wet in the rain. Should your transmitter come into contact with water and stop working, please follow these guidelines:
1. Gently wipe off any water.
2. Open the battery drawer and remove the battery and gently wipe off any water in the battery drawer.
3. Let the transmitter dry with the battery drawer left open for approximately 30 minutes.
4. Insert a new battery.
Conditions of use
Operating conditions
Storage and transport conditions
Temperature: +34 °F to +104 °F Relative humidity: 5% to 93%, non-condensing
Temperature and humidity should not exceed the following limits for extended periods during transport and storage:
Temperature: -13 °F to +140 °F Relative humidity: 5% to 93%, non-condensing
IMPORTANT NOTICE
Do not wear your transmitter while showering or participating in water activities. Do not immerse transmitter in water or other liquids.
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Warranty
Certificate
Name of owner: __________________________________________________
Hearing care professional: __________________________________________
Hearing care professional’s address: __________________________________
Hearing care professional’s phone: ___________________________________
Purchase date: ___________________________________________________
Warranty period: _______________ Month: ___________________________
Model: _______________________ Serial no.: _________________________
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International warranty
Your transmitter is covered by an inter­national limited warranty issued by the manufacturer for a period of 12 months from the date of delivery. This limited warranty covers manufacturing and material defects in the device itself, but not in accessories such as e.g. batteries, cables, power supplies, etc. Problems arising from improper/incor­rect handling or care, excessive use, accidents, repairs made by an unau­thorized party, exposure to corrosive conditions, damage due to foreign objects entering the device or incorrect adjustments are NOT covered by the limited warranty and may void it. The above warranty does not affect any legal rights that you might have under appli­cable national legislation governing sale of consumer goods. Your hearing care professional may have issued a warranty
that goes beyond the clauses of this limited warranty. Please consult him/her for further information.
If you need service
Take your transmitter to your hearing care professional, who may be able to sort out minor problems and adjust­ments immediately.
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Technical information
The transmitter contains a radio transceiver that uses short-range magnetic induction technology working at 3.84 MHz. The magnetic field strength of the transmitter is very weak and is always below 15 nW (typically below -40 dBμA/m at a 33 feet/10 meter distance).
The transmitter complies with international standards concerning electromagnetic compatibility and human exposure.
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Due to the limited space available on the transmitter, relevant approval markings can be found in this booklet.
Additional information can be found in the “Technical Data sheet” on www.oticon.com
USA and Canada
Oticon CROS (Model: CROS01) contains a radio module with the following certification ID numbers:
FCC ID: U28AUMRTE IC: 1350B-AUMRTE
The device complies with Part 15 of the FCC Rules and with Industry Canada’s license-exempt RSSs.
Operation is subject to the following two conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
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The manufacturer declares that this transmitter is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU.
Waste from electronic equipment must be handled according to local regulations.
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Declaration of Conformity is available from the manufacturer.
Manufactured by:
Denmark
Description of symbols used in this booklet
Warnings
Text marked with a warning symbol must be read before using the device.
Manufacturer
The device is produced by the manufacturer whose name and address are stated next to the symbol. Indicates the medical device manufacturer, as dened in EU Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
CE mark
The device complies with Medical Device Directive 93/42/EEC. The four-digits number indicates the identication of the notied body.
Electronic waste (WEEE)
Recycle hearing aids, accessories or batteries according to local regulations. Hearing aid users can also return electronic waste to their hearing care professional for disposal. Electronic equipment covered by Directive 2012/19/EU on waste and electrical equipment (WEEE).
Regulatory Compliance Mark (RCM) The device complies with electrical safety, EMC and radio spectrum requirements for devices supplied to the Australian or New Zealand market.
IP code
Indicates the class of protections against harmful ingress of water and particulate matter according to EN 60529:1991. IP6X indicates total dust protection. IPX8 indicates the protection against the eects of continuous immersion in water.
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Description of symbols used on the regulatory packaging label
Keep dry
Indicates a medical device that needs to be protected from moisture.
Caution symbol
Consult instructions for use for warnings and cautions.
Catalog number
Indicates the manufacturer’s catalog number so that the medical device can be identied.
Serial number
Indicates the manufacturer’s serial number so that a specic medical device can be identied.
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210150US / 2019.06.06
210150US / 2019.06.06
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0000210150000001
210150US / 2019.06.06 / Oticon CROS Firmware 1.0
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