oticon Oticon Opn 1 BTE13 PP, Opn 2 BTE13 PP, Opn 3 BTE13 PP, Siya 1 BTE, Siya 2 BTE Instructions For Use Manual

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Page 1
Instructions for use
BTE13 PP BTE - BTE PP
Oticon Opn Oticon Siya
Page 2
Model overview
Oticon Opn 1 BTE13 PP Oticon Opn 2 BTE13 PP Oticon Opn 3 BTE13 PP
Oticon Siya 1 BTE Oticon Siya 2 BTE Oticon Siya 1 BTE PP Oticon Siya 2 BTE PP
 LED light (Oticon Opn) for visual indication
The LED light is used to help users, caregivers, parents, and teachers to operate the hearing aid and to give instructions on relevant functions and modes (see relevant information throughout the booklet).
Introduction to this booklet
This booklet gives you guidance on how to use and maintain your new hearing aid. Please read the booklet carefully, including the Warning 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 Startup Handling Options Tinnitus Warnings More info
For your convenience, this booklet contains a navigation bar to help you easily navigate through the different sections.
Page 3
Intended use
The hearing aid is intended to amplify and transmit sound to the ear, and thereby compensate for impaired hearing within mild to severe-to-profound hearing loss. This power hearing aid is intended for use by adults and children older than 36 months.
IMPORTANT NOTICE
The hearing aid amplification is uniquely adjusted and optimised to your personal hearing capabilities during the hearing aid fitting performed by your hearing care professional.
Table of contents 1/2
About
Identify your hearing aid and earpiece 8 Identify left and right hearing aid 12 MultiTool for handling batteries and cleaning 13
Start up
Turn the hearing aid on and off 14 When to replace the battery 15 How to replace the battery (size 13) 16
Handling
Caring for your hearing aid 18 Put on the hearing aid with sound hook 19 Clean the mould 20 Put on hearing aid with thin tube (Corda miniFit) 22 Clean the thin tube 23 Standard earpieces: Replace dome or Grip Tip 24 Customised earpieces: Clean Micro mould/LiteTip 26 Replace ProWax filter 27
Continues on next page
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Options
Optional features and accessories 28 Flight mode 29 Change programs 30 Change volume 32 Mute 34 Use hearing aids with iPhone, iPad, and iPod touch 35 Pair hearing aids with iPhone 36 Wireless accessories 38 Tamper-resistant battery drawer 40 Other options 42
Tinnitus
Tinnitus SoundSupport™ (optional) 44 Guidelines for tinnitus sound generator users 45 Sound options and volume adjustment 46 Limitation on use time 49 Warnings related to Tinnitus 52
Warnings
General warnings 54
More info
Troubleshooting guide 58 Water and dust resistant (IP68) 60 Conditions of use 61 Warranty 62 Technical information 64 Your individual hearing aid settings 70
Table of contents 2/2
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Identify your hearing aid and earpiece
There are two different attachments and several different earpieces available for the hearing aid.
Mould
Tube
Sound hook
About
With sound hook and
mould earpiece
With thin tube
(Corda miniFit)
Ear grip (optional)
Thin tube
(0.9 mm
0.13 mm)
Standard earpieces: Customised earpieces:
Please see details for replacing the dome in chapter “Replace dome or GripTip”
Power dome
Grip Tip
Available in small and large, left and right, with or without vent.
Bass dome, single vent
Bass dome, double vent
The thin tube uses one of the following earpieces:
LiteTip
VarioTherm® LiteTip
Micro mould
VarioTherm® micro mould
® VarioTherm is a registered trademark
of Dreve
Open dome
* only as open dome for speaker 60
6 mm5 mm* 8 mm 10 mm 12 mm
Dome sizes
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Push button
Mute, change volume and programs
LED light
(only optional for Opn) Program, volume, and battery status
Microphone openings
Sound in
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With sound hook and mould
What it is and does
Push button
Mute, change volume and programs
LED light
(only optional for Opn) Program, volume, and battery status
Nail grip
Open the battery drawer
Battery drawer
Contains the battery.
Functions as an on/off switch
Sound hook
Tube
Brings sound
into the ear
Mould
Hold the
hearing aid
in the ear
Microphone openings
Sound in
With thin tube (Corda miniFit)
What it is and does
Battery drawer
Contains the battery.
Functions as an on/off switch
Thin tube
Brings sound
into the ear
Nail grip
Open the battery drawer
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Identify left and right hearing aid
It is important to distinguish between the left and the right hearing aid as they may be programmed differently.
You can find left/right colour indicators in the battery drawer. Indicators can also be found on Micro moulds (optional).
A RED indicator marks the RIGHT hearing aid
A BLUE indicator marks the LEFT hearing aid
IMPORTANT NOTICE
Your MultiTool has a built-in magnet. Keep the MultiTool at least 30 cm away from credit cards and other magnetically sensitive devices.
MultiTool for handling batteries and cleaning
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 contact your hearing care professional.
Brush
Wire loopMagnet
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Turn the hearing aid on and o
The battery drawer is also used to switch the hearing aid on and off. To save battery life, make sure your hearing aid is switched off when you are not wearing it. If you wish to return to the standard settings of the hearing aid, simply open and close the battery drawer (quick reset).
Turn ON
Close the battery drawer with the battery in place.
Turn OFF
Open the battery drawer.
Start up
When to replace the battery
When it is time to replace the battery, you will hear three beeps repeated in moderate intervals until the battery runs out.
Three beeps**
= The battery is running low
Four beeps
= The battery has run out
Warning Visual* - Continuously repeated
Battery running low
Red, short blink
Battery tip
To make sure the hearing aid is always working, bring spare batteries with you, or replace the battery before you leave home.
* Only optional for Opn ** 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 aids.
State Visual* - One sequence only
Quick reset
Green, long blink
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How to replace the battery (size 13)
2. Uncover 3. Insert
Fully open the battery drawer. Remove the battery.
Remove the sticky label from the
+ side
of the new battery.
Tip: Wait 2 minutes so that the battery can draw air, to ensure optimal functioning.
Insert the new battery into the battery drawer. Insert it from above, NOT from the side.
Make sure the
+ side
is facing up.
1. Remove
MultiTool
Close the battery drawer. The hearing aid will play a jingle through the earpiece.
Hold the earpiece close to your ear to hear the jingle.
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.
4. Close Tip
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Handling
Put on the hearing aid with sound hook
Read the following pages if you have a hearing aid with a sound hook and mould.
The mould is customised for you and fits your ear shape. The moulds are unique for the left or the right ear.
Gently pull your ear outwards and press the mould in the direction of the ear canal, twisting slightly.
Place the hearing aid behind your ear.
Step 1 Step 2
Caring for your hearing aid
When handling your hearing aid, hold it over a soft surface to avoid damage in case you drop it.
Clean the microphone openings
Carefully brush any debris away from the openings. Gently brush the surface. Make sure the brush is not pressed into the openings.
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 mould
The mould should be cleaned regularly. Use a soft cloth to clean the surface of the mould. Use the MultiTool wire loop to clean the opening.
Replace the tube
The tubing between the mould and the hearing aid should be replaced if it becomes yellow or stiff. Consult your hearing care professional about this.
Wash the mould
Make sure you are able to identify which mould is for which hearing aid before disconnect­ing them from the hearing aid.
Disconnect the tube and mould from the hook. Hold the hook firmly when pulling it off the tube. Otherwise the hearing aid may be damaged.
Wash the mould and tube using mild soap. Rinse and dry completely before reconnecting to the hearing aid.
Step 1
Step 2 Step 3
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Put on hearing aid with thin tube (Corda miniFit)
Read the following pages if your hearing aid has a thin tube.
Place the hearing aid behind your ear.
The thin tube should only be used with an attached ear­piece. Use only parts designed for your hearing aid.
Hold the bend of the tube between your thumb and index finger. The earpiece should point towards the ear canal opening.
Gently push the earpiece into your ear canal until the thin tube sits close to your head. If the thin tube has an ear grip, place it in the ear so it follows the contour of the ear.
Step 1 Step 2 Step 3
Clean the thin tube
The thin tube should be cleaned to keep it clear of moisture and wax. If not cleaned, it may become blocked with wax, which stops sound from coming out.
Pull the thin tube out of the hearing aid.
Push the cleaning tool all the way through the thin tube.
Reconnect the thin tube to the hearing aid.
Step 1 Step 2 Step 3
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Standard earpieces: Replace dome or Grip Tip
The standard earpiece should not be cleaned. If the earpiece is filled with wax, replace it with a new one. Grip Tips should be replaced at least once a month.
Hold on to the end of the thin tube and then pull off the earpiece.
Insert the thin tube exactly into the middle of the earpiece to obtain a secure attachment.
Push firmly to ensure that the earpiece is fastened securely.
Step 1 Step 2 Step 3
IMPORTANT NOTICE
If the earpiece is not on the thin tube 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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Wax filter
Customised earpieces: Clean Micro mould/LiteTip
The earpiece should be cleaned regularly. The earpiece has a white wax filter*that keeps wax and debris from damaging the hearing aid.
Replace the filter when clogged, or if the sound is not normal, or contact your hearing care professional.
Clean the vent by pressing the brush through the hole, twisting it slightly.
Ven t
New filter
Replace ProWax lter
2. Remove 3. Insert
Remove the tool from the shell. The tool has two pins, one empty for removal and one with the new wax filter.
Push the empty pin into the wax filter in the earpiece and pull it out.
Insert the new wax filter using the other pin, remove the tool, and throw it out.
1. Tool
New
filter
Old filter
IMPORTANT NOTICE
Always use the same type of wax filter as was originally supplied with the hearing aid. If you are in any doubt about the use or replacement of wax filters, contact your hearing care professional.
* VarioTherm Micro mould and LiteTip do not have a wax filter
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Options
Optional features and accessories
The features and accessories described in the following pages are optional. Please contact your hearing care professional to find out how your hearing aid is programmed.
If you experience difficult listening situations, a special program may be helpful. These are programmed by your hearing care professional.
Write down any hearing situations in which you may need help.
Flight mode
When boarding an airplane or entering an area in which it is prohibited to radiate radio signals, flight mode must be activated. The hearing aid will still be working. It is only necessary to activate flight mode on one hearing aid; this will turn off Bluetooth® on both hearing aids.
To activate and deactivate Press
the push button for at least 7 seconds. A jingle confirms your action.
Opening and closing the battery drawer will also deactivate flight mode.
Listening state Visual* - Continuously repeated
Flight mode active
Green, short blink Red, short blink Pause
* Only optional for Opn
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Press up or down between programs.
Note that you can change continuously between programs - both up and down in the program order. For example, if you want to go from program 1 to 4, you can press the down button once instead of pressing the up button 3 times.
Change programs
Your hearing aid can have up to 4 different programs. These are programmed by your hearing care professional.
To be filled out by the hearing care professional
Program Sound
when activated
When to use Visual*
Continuously repeated
1
1 beep
2 2 beeps
3 3 beeps
4 4 beeps
Green, short blink Pause
Program change:
LEFT RIGHT Short press Long press
* Only optional for Opn
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Press button to turn volume up
You will hear 2 beeps at start-up level
Press button to turn volume down
Change volume
The push button allows you to adjust the volume. You will hear a click when you turn the volume up or down.
MAXIMUM
START-UP LEVEL
MINIMUM
To be filled out by the hearing care professional
Volume state Visual* - One sequence only
Start-up level
Minimum / maximum volume
Volume up / down
Green, short blink Green, long blink Red, short blink
Volume change
LEFT RIGHT Short press
* Only optional for Opn
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Mute
Use the mute function if you need to silence the hearing aid.
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.
Apply a very long press (4 seconds) to either end of the button to mute the hearing aid.
To reactivate the hearing aid, push the button briefly.
NOTE: the mute function only mutes the microphone(s) on the hearing aids.
Listening state Visual* - Continuously repeated
Mute
Green, short blink Red, short blink Pause
Use hearing aids with iPhone, iPad, and iPod touch
Your hearing aids are Made for iPhone® and allow for direct communication and control with iPhone, iPad® or iPod touch®. For assistance in using these products with your hearing aids,
please contact your hearing care professional or visit: www.oticon.global/connectivity
For information on compatibility, please visit www.oticon.global/connectivity
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.
Apple, the Apple logo, iPhone, iPad, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
* Only optional for Opn
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Pair hearing aids with iPhone
2. General 3. Accessibility1. Settings
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”.
6. Confirm pairing5. Select
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 3 minutes.
Your 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.
4. Prepare
Bluetooth
General
Accessibility
MFi Hearing Devices
William’s Hearing Aids
Oticon Opn
Bluetooth Pairing
Request
“William’s Hearing Aids” would
like to pair with your iPhone
Cancel Pair
On
When you turn o your hearing aids or Apple® device, they will no longer be connected. To connect them again, turn on your hearing aids by opening and closing the battery door. The hearing aids will then automatically reconnect to your Apple device.
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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 your mobile phone, you can use the hearing aids as a hands-free headset or as remote microphone.
TV Adapter 3.0
Wireless transmitter of sound from TV and electronic audio devices. TV Adapter streams sound directly to your hearing aids.
FM
Your hearing aids supports the option of attaching an FM system. The FM system allows you to receive speech or audio signals directly to your hearing aids from a dedicated transmitter.
For more information contact your hearing care professional.
Remote Control 3.0
Offers the ability to change program, adjust volume, or mute your hearing aids.
Oticon ON App
Offers an intuitive and discreet way to control your hearing aids. For iPhone, iPad, iPod touch, and Android™ devices.
Listening state Visual* - Continuously repeated
Wireless accessories incl. hearing aid
microphone
Wireless accessories
Green, short blink Green, long blink Pause
For more information visit: www.oticon.global/connectivity
* Only optional for Opn
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2
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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.
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 tamper-resistant effectiveness or locking ability is damaged.
Close the battery door completely and make sure it is 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
To lock the battery drawer
Tool to unlock the battery drawer
Unlock the battery drawer
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Direct Audio Input (DAI)
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 hearing aid and via a cable connected to an external sound source.
For more information contact your hearing care professional.
Other options
Telecoil
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 theatres, churches, or lecture rooms. This symbol or a similar sign is shown wherever a teleloop has been installed.
Autophone
The autophone can automatically activate a phone program in the hearing aid, if you place a dedicated magnet on your phone.
For more information, please contact your hearing care professional.
IMPORTANT NOTICE
Only connect hearing aids with DAI to electrically powered devices that comply with EN 60950-1, EN 60065 or equivalent safety standards. The external signal source determines the safety of hearing aids with DAI.
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Tinnitus
Tinnitus SoundSupport (optional)
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.
Guidelines for tinnitus sound generator users
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 a person reporting tinnitus have 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 options 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 the hearing aid”.
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:
A) Change volume in each ear separately or B) Change volume in both ears simultaneously.
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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 button repeatedly. To decrease volume, use a short press on the lower part of the push button repeatedly.
To be filled out by your hearing care professional.
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.
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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.
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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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.
As with any device, misuse of the sound generator feature could present some potentially harmful effects. Care should be taken to prevent the unauthorised 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.
Warnings related to Tinnitus
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You should familiarise yourself fully with the following general warnings before using your hearing aid for your personal safety and to ensure correct usage.
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.
General warnings
Warnings
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.
If a battery or hearing aid is swallowed, see a doctor immediately.
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 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
Caution must be taken with active implants. In general, follow the guide­lines recommended by manufacturers of implantable defibrillators and pacemakers regarding use with mobile phones and magnets.
The Autophone magnet and MultiTool (which has a built-in magnet) should be kept a least 30 cm away from the implant, e.g. do not carry it in a breast pocket.
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If you have an active brain implant, please contact the manufacturer of your implantable device for information about the risk of disturbance.
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 fields.
Heat and chemicals
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.
General warnings
Possible side effects
Hearing aids and earpieces may cause an accelerated accumulation of earwax.
The otherwise non-allergenic mate­rials used in hearing aids may in rare cases cause 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 have 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 hearing aid when connected to external equipment (via auxiliary input cable, via 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-60065, IEC-60950 or equivalent safety standards.
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Troubleshooting guide
More info
Symptom Possible causes Solutions
No sound
Dead battery Replace the battery
Clogged earpieces (dome, Grip Tip, mould or Micro mould)
Clean mould or Micro mould or replace wax filter
Consider to replace dome, or GripTip
Hearing aid microphone muted Unmute the hearing aid microphone
Intermittent or reduced sound
Clogged sound outlet Clean mould or Micro mould, replace wax filter or change dome or GripTip
Moisture Wipe battery with a dry cloth
Dead battery Replace the battery
Squealing noise
Hearing aid earpiece inserted incorrectly Re-insert the earpiece
Earwax accumulated in ear canal Have ear canal examined by your doctor
Beeping/LED blinking (only optional for Opn)
If your hearing aid plays 8 beeps, 4 times consecutively, and repeatedly blink red 4 times with small pauses, your hearing aid needs a microphone service check
Red, long blink
Contact your hearing care professional
Pairing issue with Apple device
Bluetooth connection failed
1) Unpair your hearing aids (Settings➝GeneralAccessibilityHearing DevicesDevices
Forget this device). 2) Turn Bluetooth off and on again. 3) Open and close hearing aid
battery drawer. 4) Re-pair hearing aids (see chapter: “Pair hearing aids with iPhone”)
Only one hearing aid paired
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
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.
Conditions of use
Operating conditions
Temperature: +1°C to +40°C Relative humidity: 5% to 93%, non-condensing
Storage and transport conditions
Temperature and humidity shall not exceed the below limits for extended periods during transport and storage:
Temperature: -25°C to +60°C Relative humidity: 5% to 93%, non-condensing
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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 unauthorised 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 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.: _________________________
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Technical information
The hearing aid contains two radio technologies, which are described below:
The hearing aid contains a radio transceiver using short-range magnetic induction technology working at 3.84 MHz. The magnetic field strength of the transmitter is very weak and is always below
-40 dBμA/m at a 10 metre distance.
The hearing aid also contains a radio transceiver using Bluetooth Low Energy (BLE) and a proprietary short­range radio technology both working at 2.4 GHz. The 2.4 GHz radio trans­mitter is weak and is always below 4 dBm EIRP in total radiated power.
The hearing aid complies with international standards concerning electromagnetic compatibility and human exposure.
Due to the limited space available on the hearing aid, relevant approval markings can be found in this document.
Additional information can be found in the “Technical Data sheet” on www.oticon.global
USA and Canada
The hearing aid contains a radio module with the following certification ID numbers:
FCC ID: U28AUBTEP IC: 1350B-AUBTEP
The device complies with Part 15 of the FCC Rules and with Industry Canada’s licence-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 hearing aid is in compliance with the essential requirements and other relevant provisions of Directive 2014/53/EU.
Declaration of Conformity is available from the manufacturer.
Manufactured by:
Denmark
Waste from electronic equipment must be handled according to local regulations.
This Class B digital apparatus complies with Canadian ICES-003.
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 manufacturer or an
experienced radio/TV technician for help.
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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/A1:2002. IP6X indicates total dust protection. IPX8 indicates the protection against the eects of continuous immersion in water.
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.
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.
Catalogue number
Indicates the manufacturer’s catalogue 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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Your individual hearing aid settings
To be filled out by your hearing care professional.
Tinnitus SoundSupport: Limitation on use
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
187195UK / 2018.04.24
Settings overview for your hearing aid
Left Right
Yes No
Volume control
Yes No
Yes No
Program shift
Yes No
Yes No
Mute
Yes No
Yes No
Tinnitus SoundSupport
Yes No
Volume control indicators
On Off
Beeps at min/max volume
On Off
On Off
Clicks when changing volume
On Off
On Off
Beeps at preferred volume
On Off
Battery indicators
On Off
Low battery warning
On Off
187195UK / 2018.04.24
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187195UK / 2018.04.24 / Opn Firmware 6.0 or earlier / Siya Firmware 1.0
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