oticon Xceed 1, Xceed 2, Xceed 3, Xceed Play 1, Xceed Play 2 Instructions For Use Manual

Page 1
Instructions for use
BTE SP BTE UP
Oticon Xceed Oticon Xceed Play
Page 2
Model overview
BTE SP (Battery size 13)
BTE UP (Battery size 675)
FW 8
Oticon Xceed 1 GTIN: (01) 05707131357571
Oticon Xceed 2 GTIN: (01) 05707131357564
Oticon Xceed 3 GTIN: (01) 05707131357557
FW 8
Oticon Xceed Play 1 GTIN: (01) 05707131357540
Oticon Xceed Play 2 GTIN: (01) 05707131357533
LED light for visual indication. Helps caregivers, parents, and teachers to
operate the hearing aid and to give instructions on relevant functions and modes (see relevant information throughout the booklet).
Page 3
Introduction to this booklet
Intended use
This booklet gives you guidance on how to use and maintain your new hearing aid. Please read the booklet carefully, including the Warnings section. This will help you to get the most out of your new hearing aid.
Your hearing care professional has adjusted the hearing aid to meet your needs. If you have additional questions, please contact your hearing care professional.
About Start-up Handling Options Tinnitus Warnings More info
For your convenience, this booklet contains a navigation bar to help you easily navigate through the different sections.
The hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing within moderate-to-severe to profound hearing loss. The hearing aid is intended to be used by adults, children and infants.
IMPORTANT NOTICE
The hearing aid amplification is uniquely adjusted and optimized to your personal hearing capabilities during the hearing aid fitting performed by your hearing care professional.
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Table of contents
About
Hearing aid parts and functions 8 Identify left and right hearing aid 10 MultiTool for handling batteries and cleaning 11
Start-up
Turn the hearing aid ON and OFF 12 When to replace the battery 13 How to replace the battery 14
Handling
Put on the hearing aid 16 Caring for the hearing aid 17 Flight mode 20
Options
Optional features and accessories 21 Change program 22 Change volume 23 Mute 24 Use the hearing aid with iPhone and iPad 25 Pair with iPhone 26
Wireless accessories 28 Other options 30 Tamper-resistant battery drawer 32
Tinnitus
Tinnitus SoundSupport™ (optional) 34 Guidelines for tinnitus sound generator users 35 Sound and volume adjustment 36 Limitation on use time 39
Warnings
Tinnitus SoundSupport warnings 42 General warnings 43
More info
Troubleshooting 52 Water and dust resistant (IP68) 54 Conditions of use 55 Technical information 56 Warranty 61 Mobile phone 62 Your individual hearing aid settings 64 Sound and LED indicators 66 Technical Data 70
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Hearing aid parts and functions
LED (optional)
Program, volume,
and battery status
Volume button
Change volume
and mute
Microphone openings
Sound in
Sound hook
Tube
Brings sound into the ear
The handling of BTE SP and BTE UP is the same. Therefore the illustrations in this booklet only show the BTE SP.
Push button
Change program,
flight mode
Nail grip
Open the
battery drawer
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Battery drawer
Contains the battery and
functions as an on/off switch
Mold
Holds the hearing aid in the ear
Sound out
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Identify left and right hearing aid
MultiTool for handling batteries and cleaning
It is important to distinguish between the left and the right hearing aid as they may be programmed differently.
The MultiTool contains a magnet that makes it easier to replace the battery in the hearing aid. It also contains a brush and wire loop for cleaning and removing earwax. If you need a new MultiTool, please
You can find left/right color indicators in the battery drawer. Indicators
contact your hearing care professional.
can also be found on the molds.
Wire loopMagnet
A BLUE indicator marks the LEFT hearing aid
Brush
A RED indicator marks the RIGHT hearing aid
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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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Turn the hearing aid ON and OFF
When to replace the battery
The battery drawer is used to turn the hearing aid ON and OFF. To save battery life, make sure your hearing aid is turned OFF when you are not
When it is time to replace the battery, you will hear three alternate
tones repeated in moderate intervals until the battery runs out. wearing it. When you turn ON the hearing aid, it will play a jingle. When you turn it OFF, it will play four descending tones.
Three alternate tones*
= The battery is running low
Four descending tones
= The battery has run out
If you wish to return to the standard settings of the hearing aid, simply open and close the battery drawer.
Battery tip
Keep a spare battery on you at all times to ensure your hearing aid
Optional LED
always works. Two long green flashes indicate that the hearing aid is turned on.
Optional LED
Continuous orange flashes indicate low battery.
Turn ON
Close the battery drawer with the battery in place.
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Turn OFF
Open the battery drawer.
* Bluetooth® will be turned off and it will not be possible to use wireless accessories.
Note: Batteries need to be replaced more often if you are streaming to your hearing aid.
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How to replace the battery
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
Close the battery drawer. The
hearing aid will play a jingle through
the earpiece.
The MultiTool can be used to change the battery. Use the magnetic end to remove and insert batteries.
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.
Hold the earpiece close to your ear
to hear the jingle.
The MultiTool is provided by your hearing care professional.
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Put on the hearing aid
Caring for the hearing aid
Step 1 Step 2
When handling the hearing aid, hold it over a soft surface to avoid
damage in case you drop it.
Clean the microphone openings
Use the brush of the MultiTool to
carefully brush debris away from the
openings. Carefully brush the surface
around the openings.
The mold is customized for you and fits your ear shape. The molds are unique for the left or the right ear.
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Gently pull your ear outwards and press the mold in the direction of the ear canal, twisting it slightly.
Place the hearing aid behind your ear.
Make sure that no parts of the
MultiTool are squeezed into the
microphone openings by force. This
may damage the hearing aid.
IMPORTANT NOTICE
Use a soft, dry cloth to clean the hearing aid. The hearing aid must never be washed or immersed in water or other liquids.
Microphone openings
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Clean the mold
The mold should be cleaned regularly. Use a soft cloth to clean its surface. Use the MultiTool wire loop to clean the opening.
Replace the tube
The tubing between the mold and the hearing aid should be replaced if it becomes yellow or stiff. Consult your hearing care professional about this.
Wash the mold
Step 1
Step 2 Step 3
Make sure you are
able to identify which
mold is for which
hearing aid before
disconnecting them
from the hearing aid.
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Disconnect the tube and mold from the hook. Hold the hook firmly when pulling off the tube. Other­wise the hearing aid may be damaged.
Wash the mold and tube using mild soap. Rinse and dry completely before reconnecting to the hearing aid.
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Flight mode
Optional features and accessories
When flight mode is activated, Bluetooth® is turned off. The hearing aid will still be working. Pressing the push button on one hearing aid will activate flight mode on both hearing aids.
Optional LED
When flight mode is activated, the LED continuously flashes green,
The features and accessories described in the following pages are
optional. Please contact your hearing care professional for more
information about features and accessories.
If you experience difficult listening situations, a special program may
be helpful. These are programmed by your hearing care professional. orange and orange.
Write down any hearing situations in which you may need help.
To activate and deactivate
Press button for at least seven seconds. A short jingle confirms your action.
Opening and closing the battery drawer will also deactivate flight mode. A short jingle confirms your action.
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Change program
Change volume
Your hearing aid can have up to four different programs. You will hear one to four tones when you change program depending on the program.
Optional LED
The number of green flashes indicates the selected program.
The volume button allows you to adjust the volume.
You will hear a beep when you increase or decrease the volume.
Optional LED
A green flash confirms a change of volume. A long green flash indicates
that start-up volume has been reached. An orange flash will appear
when you reach the minimum or maximum level.
Press the push button to switch between programs.
The program cycle switches one program forward, for example program 1 to 2 or program 4 to 1.
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Press button to increase volume
Press button to decrease volume
MAXIMUM
START-UP VOLUME
MINIMUM
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Mute
Use the hearing aid with iPhone and iPad
Use the mute function if you need to turn off the sounds temporarily, while wearing the hearing aid. The mute function only mutes the microphones on the hearing aid.
Your hearing aid is Made for iPhone® and allows for direct
communication and control with iPhone, iPad® or iPod touch®.
For assistance in using these products with your hearing aid, please
contact your hearing care professional.
Optional LED
Continuous orange and green flashes indicate mute.
To mute the hearing aid
Press either end of the volume button for at least four seconds.
To reactivate, press either end of the button briefly.
IMPORTANT NOTICE
Do not use the mute function as an off switch, as the hearing aid still draws current from the battery in this mode.
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For information on compatibility,
please visit www.oticon.com/support/compatibility
Use of the Made for Apple badge means that an accessory has been designed to connect specifically to the Apple
product(s) identified in the badge, and has been certified by the developer to meet Apple performance standards.
Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards.
Please note that use of this Accessory with iPod, iPhone, or iPad may affect wireless performance.
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Pair with iPhone
Bluetooth
General
On
2. General 3. Accessibility1. Settings
Accessibility
MFi Hearing Devices
4. Prepare
William’s Hearing Aids
Oticon Xceed
6. Confirm pairing5. Select
Bluetooth Pairing
Request
“William’s Hearing Aids” would
like to pair with your iPhone
Cancel Pair
Open your iPhone and go to “Settings”. Make sure Bluetooth is on. Then choose “General”.
On the “General” screen, choose “Accessibility”.
On the “Accessibility” screen, choose “MFi Hearing Devices”.
Open and close the
battery drawer on
both hearing aids,
and place them close
to your iPhone. The
hearing aids remain in
pairing mode for
The iPhone will detect the hearing aids for pairing. Detected devices will appear in your iPhone list. Choose your hearing aids.
Confirm pairing. If you have two hearing aids, pairing confirmation is needed for each hearing aid.
3 minutes.
Your hearing aids and iPhone will no longer be connected if either of them is turned o. Open and close the battery drawer of your hearings aids
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to reconnect them with your iPhone.
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Wireless accessories
As an enhancement to your wireless hearing aids, a range of accessories is available. These can enable you to hear and communicate better in many everyday situations.
ConnectClip
When paired with ConnectClip, your hearing aids can be used as a hands-free headset. ConnectClip can also be used as a remote
Phone Adapter 2.0
Connects wirelessly to the hearings aids via ConnectClip allowing for use of landline phones.
Oticon ON App
Intuitive and discreet control of
your hearing aid. For iPhone, iPad,
iPod touch, and Android™ devices.
microphone.
For more information visit www.oticon.com/support or contact your
hearing care professional.
TV Adapter 3.0
Streams sound directly from a TV or electronic audio device to your
Remote Control 3.0
Offers the ability to change program, adjust volume, or mute your hearing aid.
hearing aid.
Apple, the Apple logo, iPhone, iPad, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other
countries. App Store is a service mark of Apple Inc. Android, Google Play, and the Google Play logo are trademarks
of Google LLC.
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Other options
Telecoil program
Telecoil helps you hear better when using a telephone with a built-in loop, or when you are in buildings with teleloop systems such as theaters, churches, or lecture
FM
Allows you to receive speech or audio signals directly to your hearing aid
from a dedicated transmitter. To attach an FM receiver or an FM adapter
your HCP needs to replace the battery drawer.
rooms. This symbol or a similar sign is shown wherever a teleloop has been installed.
Direct Audio Input (DAI)
Allows your hearing aid to receive signals directly from external sources such as TV, radio, music players, etc. The DAI adaptor is mounted to your
CROS
Solution for people with an unaidable hearing loss in one ear. A
transmitter on the poorer ear transmits sound to a hearing aid on the
better ear.
hearing aid and via a cable connected to an external sound source. To attach a DAI adapter your HCP needs to replace the battery drawer.
IMPORTANT NOTICE
When the DAI is connected to an audio source plugged into a wall outlet, the audio source must comply with IEC 62368 or equivalent safety standards.
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For more information, please contact your hearing care professional.
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Tamper-resistant battery drawer
To keep the battery out of reach of infants, small children, and people with learning difficulties, a tamper-resistant battery drawer should be used.
Lock the battery
drawer
Tool to unlock the battery drawer
Unlock the battery drawer
1
2
Close the battery
drawer completely
and make sure it is
IMPORTANT NOTICE
Avoid excessive force when opening the battery drawer in the locked position. Do not force the battery drawer beyond its fully opened position. Make sure to insert the battery correctly.
Please contact your hearing care professional if you suspect the tamper­resistant effectiveness or locking ability is damaged.
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locked.
Use this small tool provided by your hearing care professional.
Insert the tip of the tool into the small hole at the back of the battery drawer.
1. Move it to the right and hold it.
2. Open the battery drawer.
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Tinnitus SoundSupport (optional)
Guidelines for tinnitus sound generator users
Intended use of Tinnitus SoundSupport
Tinnitus SoundSupport is a tool intended to generate sounds to provide temporary relief for patients suffering from tinnitus as part of a tinnitus management program.
The target population is the adult population (over 18 years old).
Tinnitus SoundSupport is targeted to licensed hearing care professionals (audiologists, hearing aid specialists, or otolaryngologists) who are familiar with the evaluation and treatment of tinnitus and hearing loss. Fitting of Tinnitus SoundSupport must be done by a hearing care professional participating in a tinnitus management program.
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These instructions contain information about Tinnitus SoundSupport, which may have been enabled in your hearing aids by your hearing care professional.
Tinnitus SoundSupport is a tinnitus management device intended to generate sound of sufficient intensity and bandwidth to help manage tinnitus.
Your hearing care professional will also be able to offer the appropriate follow-up care. It is important to follow his/her advice and directions regarding such care.
Prescription use only
Good health practice requires that the person reporting tinnitus has a medical evaluation by a licensed ear physician before using a sound generator. The purpose of such an evaluation is to ensure that any medically treatable condition that may cause tinnitus is identified and treated prior to using a sound generator.
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Sound and volume adjustment
Tinnitus SoundSupport is programmed by your hearing care professional to match your hearing loss and preferences for tinnitus relief. It offers a number of different sound options. Together with your hearing care professional, you can select your preferred sound(s).
Tinnitus SoundSupport programs
Together with your hearing care professional, you can decide for which programs you may want to have Tinnitus SoundSupport activated. The sound generator can be activated in up to four different programs.
Mute
If you are in a program for which Tinnitus SoundSupport is activated, the mute functionality will mute only the environmental sounds, and not the sound from Tinnitus SoundSupport. See chapter: Mute.
Volume adjustments with Tinnitus SoundSupport
When you select a hearing aid program for which Tinnitus SoundSupport is activated, your hearing care professional can only set the push button on your hearing aid to work as a volume control for the tinnitus relief sound.
Your hearing care professional will set the volume control for the sound generator in one of two ways:
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A) How to change Tinnitus SoundSupport volume in each ear separately
To increase volume (on one hearing aid only), use a short press on the upper part of the push button repeatedly until desired level is reached. To decrease volume (on one hearing aid only), use a short press on the lower part of the push button repeatedly until desired level is reached.
B) How to change Tinnitus SoundSupport volume in both ears simultaneously
You can use one hearing aid to increase/decrease the sound in both hearing aids. When changing the volume in one hearing aid, the volume on the other hearing aid will follow. To increase volume, use a short press on the upper part of the push
Limitation on use time
Daily use
The volume levels of Tinnitus SoundSupport can be set to a level which could lead to permanent hearing damage when used for a prolonged period of time. Your hearing care professional will advise you of the maximum amount of time per day you should use Tinnitus SoundSupport. It should never be used at uncomfortable levels.
See table “Tinnitus SoundSupport: Limitation on use” in section ”Your individual hearing aid settings” at the end of this booklet to learn how many hours per day you can safely use the relief sound in your hearing aids.
button repeatedly. To decrease volume, use a short press on the lower part of the push button repeatedly.
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Important information for hearing care professionals about Tinnitus SoundSupport
Device description
Tinnitus SoundSupport is a module function that can be enabled in the hearing aids by a hearing care professional.
Maximum wearing time
The wearing time of Tinnitus SoundSupport will decrease as you increase the level above 80 dB(A) SPL. The fitting software will automatically display a warning when the hearing aid exceeds 80 dB(A) SPL. See “Max wearing time indicator” next to the tinnitus fitting graph in the fitting software.
The volume control is deactivated
By default, the volume control for the sound generator is deactivated in the hearing aid. Risk of noise exposure increases when the volume control is activated.
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If the volume control is activated
A warning may be displayed if you activate the tinnitus volume control in the “Buttons & Indicators” screen. This occurs if the relief sound can be listened to at levels that may cause hearing damage. The “Max wearing time” table in the fitting software displays the number of hours the patient can safely use Tinnitus SoundSupport.
• Note the max wearing time for each program for which Tinnitus SoundSupport is activated.
• Write those values in the table “Tinnitus SoundSupport: Limitation on use”, found in the back of this booklet.
• Instruct your patient accordingly.
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Tinnitus SoundSupport warnings
If your hearing care professional has activated the sound generator Tinnitus SoundSupport, please pay attention to the following warnings.
There are some potential concerns associ­ated with the use of any sound generated by a tinnitus management device. Among them are the potential for worsening of tinnitus and/or a possible change in hearing thresholds.
Should you experience or notice a change in hearing or tinnitus, or any dizziness, nausea, headaches, heart palpitations or possible skin irritation at the point of contact with the device, you should imme­diately discontinue use of the device and seek a consultation with a medical, audiol­ogy, or other hearing care professional.
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As with any device, misuse of the sound generator feature could present some potentially harmful effects. Care should be taken to prevent the unauthorized use and to keep the device out of the reach of children and pets.
Maximum wearing time
Always follow the maximum wearing time per day of the Tinnitus SoundSupport advised by your hearing care professional. Prolonged use may lead to worsening of your tinnitus or of your hearing loss.
General warnings
For your personal safety and to ensure correct usage, you should familiarize yourself fully with the following general warnings before using your hearing aid.
Please note that a hearing aid 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 a hearing aid does not permit a user to attain its full benefits.
Consult your hearing care professional if you experience unexpected operations or events with your hearing aid.
Usage of hearing aids
Hearing aids should be used only as directed and adjusted by your hearing care professional. Misuse can result in sudden and permanent hearing loss.
Never allow others to wear your hearing aid as incorrect usage could cause permanent damage to their hearing.
Choking hazards & risk of swallowing batteries and other small parts
Hearing aids, their parts, and batteries 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.
Children younger than 36 months must always use a tamper-resistant battery drawer. Please talk to your hearing care professional about the availability of this option.
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General warnings
If a battery or hearing aid 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.
Use in explosive environments – only applies to BTE UP hearing aid
The hearing aid is safe to use under normal usage conditions. The BTE UP hearing aid with size 675 battery has not been tested for compliance with international standards concerning explosive environments.
Therefore, do not use BTE UP in envi­ronments with danger of explosions e.g. mines, oxygen rich environments or areas where flammable anaesthetics are handled.
Dysfunction
Be aware of the possibility that your hearing aid may stop working without notice. Keep this in mind when you depend on warning sounds (e.g. when you are in traffic). The hearing aids may stop functioning, for instance if the batteries have expired or if the tubing is blocked by moisture or earwax.
Active implants
The hearing aid has been thoroughly tested and characterized 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.
Cochlear implants
If you are using a cochlear implant (CI) on one ear and a hearing aid on the other ear, make sure to always keep your CI antenna and magnets at a safe distance from your hearing aid. The magnetic field from the CI magnets may permanently damage the speaker unit in your hearing aid.
Never place the devices close together on a table e.g. when cleaning or changing bat­teries. Do not carry the CI system and the hearing aid together in the same box.
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General warnings
X-ray/CT/MR/PET scanning, and electrotherapy
Remove your hearing aid before X-ray/CT/ MR/PET scanning, electrotherapy, surgery, etc. as your hearing aid may be damaged when exposed to strong electromagnetic fields.
The hearing aid must never be exposed to extreme heat, e.g. left inside a parked car in the sun.
The hearing aid 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 hearing aid. Always remove your hearing aid before applying such products and allow time to dry before use.
Power instrument
Special care should be exercised when selecting, fitting and using a hearing aid when the maximum sound pressure capability exceeds 132 dB SPL (IEC 711), as there may be risk of impairing the re­maining hearing of the hearing aid user.
Possible side effects
Hearing aids and earpieces may cause an accelerated accumulation of earwax.
The non-allergenic materials used in hearing aids may in rare cases cause a skin irritation or other side effects.
Please consult a physician if these conditions occur.
Interference
The hearing aid has been thoroughly tested for interference, in accordance with the most stringent international stand­ards. However, interference between the hearing aid 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 hearing aid and the interfer­ing device.
Use on aircraft
Your hearing aid has Bluetooth. On board an aircraft, flight mode must be activated, unless Bluetooth is permitted by the flight personnel.
Connection to external equipment
The safety of the use of hearing aids when connected to external equipment (with an auxiliary input cable, USB cable or directly) is determined by the external equipment. When connected to external equipment plugged into a wall outlet, this equipment must comply with IEC 62368 or equivalent safety standards.
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 hearing aids is not allowed
Changes or modifications not expressly approved by the manufacturer will void the warranty of the equipment.
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General warnings
Warning 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.
(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.
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(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.
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 purchase-option 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 a medical evaluation from a licensed physician.
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General warnings
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.
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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 of mental incapacity, 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
No sound
Intermittent or reduced sound
Squealing noise
Beeping/orange flashes (optional)
Pairing issue with Apple device
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Clogged mold Clean mold
Microphones muted Unmute microphones
Clogged sound outlet Clean mold
Moisture Wipe battery with a dry cloth
Dead battery Replace the battery
Mold inserted incorrectly Re-insert the mold
Earwax accumulated in ear canal Have ear canal examined by your doctor
Ear has grown Contact your hearing care professional
If your hearing aid plays 8 beeps, 4 times consecutively, and/or repeatedly flashes orange 4 times with small pauses, your hearing aid needs a microphone service check
Bluetooth connection failed
Only one hearing aid paired
Contact your hearing care professional
1) Unpair your hearing aid (Settings➝GeneralAccessibilityHearing DevicesDevices Forget this device). 2) Turn Bluetooth off and on again. 3) Open and close battery drawer on
hearing aid. 4) Re-pair hearing aid (see section: Pair with iPhone)
If none of the above solutions work, consult your hearing care professional.
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Water and dust resistant (IP68)
Your hearing aid 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 hearing aid come into contact with water and stop working, please follow these guidelines:
1. Gently wipe off any water
2. Open the battery drawer, remove the battery, and gently wipe off any water in the battery drawer
3. Let the hearing aid 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 shall not exceed the below 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 hearing aid while showering or participating in water activities. Do not immerse your hearing aid in water or other liquids.
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Page 29
Mobile phone
Some hearing aid users have reported a buzzing sound in their hearing aid when they are using mobile phones, indicating that the mobile phone and hearing aid may not be compatible.
The ANSI C63.19 standard determines the prediction of compatibility between a specific hearing aid and a mobile phone by: adding the numerical value of the rating for the hearing aid immunity to the numerical value of the rating for the mobile phone emissions. A sum of 4 would indicate that the combination of wireless device and hearing aid is usable; a combined rating that equals at least 5 would provide normal use; a combined rating of 6 or greater would indicate excellent performance.
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Whereas all hearing aids have acoustic coupling, only the larger hearing aids have the physical space for telecoil (inductive) coupling. These two types of coupling have different rating scales (M1-M4 for acoustic coupling and T1-T4 for telecoil coupling, respectively) and both ratings are therefore relevant when predicting the compatibility of a particular hearing aid.
For a hearing aid with both acoustic coupling and telecoil coupling with a rating of M4/T2 and with a telephone rating of M3/T3), the combined rating is 7 (M4 + M3) for the acoustic coupling and 5 (T2 + T3) for the telecoil coupling. According to the guidelines given above, both types of coupling will thereby be
acceptable, with the acoustic coupling indicating excellent performance and the telecoil coupling indicating normal use.
The above equipment performance measurements, categories and system classifications are based upon the best information available, but it cannot be guaranteed that all users will be satisfied.
The immunity of BTE SP and BTE UP is at least M2/T2.
The equipment performance measurements, categories and system classifications are based upon the best information available but cannot guarantee that all users will be satisfied.
IMPORTANT NOTICE
The performance of individual hearing aids may vary with individual mobile phones. Therefore, please try this hearing aid with your mobile phone or, if you are purchasing a new phone, be sure to try it with your hearing aid prior to purchase. For additional guidance, please ask your mobile phone provider for the booklet entitled “Hearing Aid Compatibility with Digital Wireless Cell Phones.”
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Technical information
The hearing aid contains two radio technologies, which are described below:
The hearing aid complies with interna­tional standards concerning electromag­netic compatibility and human exposure.
The manufacturer declares that this hearing aid is in compliance with the essential requirements and other
relevant provisions of Directive The hearing aid contains a radio trans­ceiver that uses short-range magnetic induction technology working at
Due to the limited space available on the hearing aid, relevant approval markings can be found in this booklet.
2014/53/EU.
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 10 meter distance).
Additional information can be found in the “Technical Data sheet” on www.oticon.com
The hearing aid also contains a radio transceiver using Bluetooth Low Energy (BLE) and a proprietary short-range radio technology both working at ISM band 2.4 GHz. The radio transmitter is weak and always below 3 mW equal to
4.8 dBm in total radiated power.
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Waste from electronic equipment must be handled according to local regulations.
Declaration of Conformity is available from the manufacturer.
Manufactured by:
Denmark
Page 31
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-digit 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. IP6X indicates total dust protection. IPX8 indicates the protection against the eects of continuous immersion in water.
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Bluetooth logo
Registered trademark of Bluetooth SIG, Inc. where any use of such requires a license.
Made for Apple badges
Indicates that the device is compatible with iPhone, iPad and iPod touch.
Hearing loop
This logo incorporates the universal symbol for hearing assistance. The “T” signies that a hearing loop is installed.
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.
Page 32
International warranty
Your hearing aid 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 hearing aid itself, but not in accessories such as batteries, tubing, speakers, earpieces and filters, etc. Problems resulting from improper or incorrect handling or care, excessive use, accidents, repairs made by an un­authorized party, exposure to corrosive conditions, physical changes in your ear, 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
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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 hearing aid to your hearing care professional, who may be able to sort out minor problems and adjustments immediately.
Warranty
Certificate
Name of owner: _______________________________________________________
Hearing care professional: _______________________________________________
Hearing care professional’s address: _______________________________________
Hearing care professional’s phone: ________________________________________
Purchase date: ________________________________________________________
Warranty period: _______________ Month: ________________________________
Model left: ____________________ Serial no.: ______________________________
Model right: ___________________ Serial no.: ______________________________
Page 33
Your individual hearing aid settings
To be filled out by your hearing care professional.
Settings overview for your hearing aid
Left Right
Yes No
Yes No
Yes No
Yes No
On Off
On Off
On Off
On Off
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Change volume
Change program
Mute
Tinnitus SoundSupport
Volume control indicators
Beeps at min/max volume
Beeps when changing volume
Beeps at start-up volume
Battery indicators
Low battery warning
Yes No
Yes No
Yes No
Yes No
On Off
On Off
On Off
On Off
No limitation on use
Program Start-up volume (Tinnitus) Max volume (Tinnitus)
1 Max _______ hours per day Max _______ hours per day
2 Max _______ hours per day Max _______ hours per day
3 Max _______ hours per day Max _______ hours per day
4 Max _______ hours per day Max _______ hours per day
Tinnitus SoundSupport: Limitation on use
Page 34
Sound and LED indicators
Different sounds and LED lights indicate the hearing aid status. The different indicators are listed on the following pages.
Your hearing care professional can set sound and LED indicators to match your preferences.
Program
1 1 tone
2 2 tones
3 3 tones
4 4 tones
Green flash
1) LED continuous or repeated three times with small pauses
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Sound LED
1)
When to use
ON/OFF Sound LED LED comments
On
Volume Sound LED
Start-up volume
Minimum/maximum volume
Volume up/down
Mute
Unmute
Long green flash Green flash Orange flash
Jingle
2 beeps
3 beeps
1 beep
Descending
tone
Ascending
tone
Shown one time
Shown one time
Continuous or repeated three times
Continues on next page
Page 35
Accessories
FM and wireless programs
FM and wireless programs
Flight mode Sound
Flight mode active Short jingle
Flight mode inactive Short jingle
1) DAI/FM + hearing aid microphone, TV Adapter
2) DAI/FM signal only, ConnectClip remote microphone
3) Only available when three-time repetition is selected
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1)
2)
Long green flash Green flash Orange flash
Sound
2 different tones
2 different tones
LED
LED
3)
LED comments
Continuous or repeated three times
LED comments
Continuous or repeated three times
Warnings Sound LED LED comments
Low battery
Battery shut down
Microphone service check needed
Orange flash Long orange flash
3 alternate
tones
4 descending tones
8 beeps repeated 4 times
Continuously flashing
Repeated four times
Page 36
Technical Data BTE SP
Hz Hz
Hz Hz
dB
2CC Coupler measured according to American National Standard ANSI S3.22­2014 and ANSI S3.55-2014/Part 5. Supply voltage: Battery Zinc Air 1.4 Volt
0 dB SPL ref. 20 mPa Oticon Xceed
Oticon Xceed
OSPL90 – Output Sound Pressure Level
Input: 90 dB SPL. Technical setting: A0
Full-on Gain
Input: 50 dB SPL. Technical setting: A0
Acoustic input: 60 dB SPL
Magnetic input: 31.6 mA/m
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dB SPL
140
130
120
110
100 200 500 1000 2000 5000 10000
80
70
60
50
100 200 500 1000 2000 5000 10000
Peak OSPL90 139 dB SPL
HF Average OSPL90 130 dB SPL
Peak Full-on Gain 79 dB
HF Average Full-on Gain 70 dB
Reference Test Gain 53 dB
Frequency Range 100-6100 Hz
Total Harmonic Distortion 500 Hz 4 %
Total Harmonic Distortion 800 Hz <2%
Total Harmonic Distortion 1600 Hz <2%
Battery Consumption (Typical)
2.5 mA
Equivalent Input Noise Level (omni/dir) 19/34 dB SPL
HF Average SPLITS (left/right ear) 115 /115 dB SPL
Attack Time <5
Release Time <90
Page 37
Technical Data BTE UP
10000
Hz Hz
110
120
130
140
dB SPL
10000
Hz Hz
50
60
70
80
dB
2CC Coupler measured according to American National Standard ANSI S3.22­2014 and ANSI S3.55-2014/Part 5. Supply voltage: Battery Zinc Air 1.4 Volt
0 dB SPL ref. 20 mPa Oticon Xceed
Oticon Xceed
OSPL90 – Output Sound Pressure Level
Input: 90 dB SPL. Technical setting: A0
100 200 500 1000 2000 5000
Full-on Gain
Input: 50 dB SPL. Technical setting: A0
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Acoustic input: 60 dB SPL
Magnetic input: 31.6 mA/m
100 200 500 1000 2000 5000
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Peak OSPL90 142 dB SPL
HF Average OSPL90 130 dB SPL
Peak Full-on Gain 83 dB
HF Average Full-on Gain 69 dB
Reference Test Gain 53 dB
Frequency Range 100-5300 Hz
Total Harmonic Distortion 500 Hz 9 %
Total Harmonic Distortion 800 Hz <2%
Total Harmonic Distortion 1600 Hz 3 %
Battery Consumption (Typical) 4.1 mA
Equivalent Input Noise Level (omni/dir) 23/38 dB SPL
HF Average SPLITS (left/right ear) 112 /112 dB SPL
Attack Time <5
Release Time <90
Page 38
Technical Data BTE SP
Hz Hz
Hz Hz
dB
2CC Coupler measured according to American National Standard ANSI S3.22­2014 and ANSI S3.55-2014/Part 5. Supply voltage: Battery Zinc Air 1.4 Volt
0 dB SPL ref. 20 mPa Oticon Xceed Play
Oticon Xceed Play
OSPL90 – Output Sound Pressure Level
Input: 90 dB SPL. Technical setting: A0
Full-on Gain
Input: 50 dB SPL. Technical setting: A0
Acoustic input: 60 dB SPL
Magnetic input: 31.6 mA/m
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dB SPL
140
130
120
110
100 200 500 1000 2000 5000 10000
80
70
60
50
100 200 500 1000 2000 5000 10000
Peak OSPL90 139 dB SPL
HF Average OSPL90 130 dB SPL
Peak Full-on Gain 79 dB
HF Average Full-on Gain 70 dB
Reference Test Gain 53 dB
Frequency Range 100-6100 Hz
Total Harmonic Distortion 500 Hz 4 %
Total Harmonic Distortion 800 Hz <2%
Total Harmonic Distortion 1600 Hz <2%
Battery Consumption (Typical) 2.5 mA
Equivalent Input Noise Level (omni/dir) 19/34 dB SPL
HF Average SPLITS (left/right ear) 115 /115 dB SPL
Attack Time <5
Release Time <90
Page 39
Technical Data BTE UP
10000
Hz Hz
110
120
130
140
dB SPL
100 200 500 1000 2000 5000 10000
50
60
70
80
dB
2CC Coupler measured according to American National Standard ANSI S3.22­2014 and ANSI S3.55-2014/Part 5. Supply voltage: Battery Zinc Air 1.4 Volt
Oticon Xceed Play
OSPL90 – Output Sound Pressure Level
Input: 90 dB SPL. Technical setting: A0
100 200 500 1000 2000 5000
Full-on Gain
Input: 50 dB SPL. Technical setting: A0
76
Acoustic input: 60 dB SPL
Magnetic input: 31.6 mA/m
About Start-up Handling Options Tinnitus Warnings More info
0 dB SPL ref. 20 mPa Oticon Xceed Play
Peak OSPL90 142 dB SPL
HF Average OSPL90 130 dB SPL
Peak Full-on Gain 83 dB
HF Average Full-on Gain 69 dB
Reference Test Gain 53 dB
Frequency Range 100-5300 Hz
Total Harmonic Distortion 500 Hz 9 %
208033US / 2019.07.12
Total Harmonic Distortion 800 Hz <2%
Total Harmonic Distortion 1600 Hz 3 %
Battery Consumption (Typical) 4.1 mA
Equivalent Input Noise Level (omni/dir) 23/38 dB SPL
HF Average SPLITS (left/right ear) 112 /112 dB SPL
Attack Time <5
Release Time <90
208033US / 2019.07.12
Page 40
0000208033000001
208033US / 2019.07.12 / Firmware 8.0
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