oticon Opn, Opn Play, Opn S, Siya, Opn 1 Instruction Manual

...
Page 1
Instructions for use
BTE PP BTE
Oticon Opn™ Oticon Opn S™ Oticon Opn Play™ Oticon Siya
Page 2
Model overview
This booklet is valid for Oticon Opn™, Oticon Opn S™,Oticon Opn Play™, and Oticon Siya families, in the following hearing aid models:
Oticon Opn FW6
Oticon Opn 1 BTE13 PP GTIN: (01) 05707131335227
Oticon Opn 2 BTE13 PP GTIN: (01) 05707131335234
Oticon Opn 3 BTE13 PP GTIN: (01) 05707131335241
Oticon Opn S FW7
Oticon Opn S 1 BTE PP GTIN: (01) 05707131349811
Oticon Opn S 2 BTE PP GTIN: (01) 05707131349828
Oticon Opn S 3 BTE PP GTIN: (01) 05707131349835
Oticon Opn Play FW7
Oticon Opn Play 1 BTE PP GTIN: (01) 05707131349842
Oticon Opn Play 2 BTE PP GTIN: (01) 05707131349859
Oticon Siya FW1
Oticon Siya 1 BTE PP GTIN: (01) 05707131340887
Oticon Siya 2 BTE PP GTIN: (01) 05707131340894
Oticon Siya 1 BTE GTIN: (01) 05707131340887
Oticon Siya 2 BTE GTIN: (01) 05707131340894
Page 3
LED light for visual indication. Not available for Oticon Siya.
The LED light is used to help, caregivers, parents, and teachers to operate the hearing aid and to give instructions on relevant functions and modes (see relevant information throughout the booklet).
5
Page 4
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 Warnings section. This will help you to get the most out of your new hearing aid.
Intended use Oticon Opn, Oticon Opn S, and Oticon Siya
The hearing aid is intended to amplify and transmit sound to the ear, and thereby compensating for impaired hearing within mild to severe-to-profound hearing loss.
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.
6 7
Intended use Oticon Opn Play
The hearing aid is intended to amplify and transmit sound to the ear, and thereby compensate for impaired hearing within mild to severe hearing loss. This hearing aid is intended for use by infants, children and adolescents/young adults.
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.
Page 5
Table of contents
About
Your hearing aid and earpiece 12 Identify left and right hearing aid 16 MultiTool for handling of batteries and cleaning 17
Start-up
Turn the hearing aid on and off 18 When to replace the battery 19 How to replace the battery (size 13) 20
Handling
Put on the hearing aid with sound hook 22 Caring for your hearing aid 23 Clean the earmold 24 Put on hearing aid with thin tube 26 Clean the thin tube 27 Replace standard earpieces 28 Clean customized earpieces 30
Continues on next page
Page 6
Table of contents
Replace ProWax filter 31 Flight mode 32
Options
Optional features and accessories 33 Change program 34 Change volume 36 Mute 38 Use hearing aid with iPhone and iPad 39 Pair with iPhone 40 Wireless accessories 42 Other options 44 Tamper-resistant battery drawer 46 Sound and LED indications 48
Tinnitus
Tinnitus SoundSupport™ (optional) 52 Guidelines for tinnitus sound generator users 53
Sound and volume adjustment 54 Limitation on use time 57 Tinnitus SoundSupport warnings 60
Warnings
General warnings 62
More info
Troubleshooting 70 Water and dust resistant (IP68) 72 Conditions of use 73 Warranty 74 Mobile phone 76 Technical information 78 Your individual hearing aid settings 84 Technical Data 86
Page 7
Your hearing aid and earpiece
The thin tube uses one of the following earpieces:
There are two different attachments and several different
Standard earpieces: Customized earpieces:
earpieces available for the hearing aid.
Open dome
With sound hook and
earmold earpiece
Sound
With thin tube
(Corda miniFit)
Bass dome, single vent
Bass dome, double vent
hook
Power dome
Tube
Mold
Thin tube
Grip Tip
Available in small and large, left and right, with or without vent.
Dome sizes
Ear grip (optional)
6 mm5 mm 8 mm 10 mm 12 mm
12 13
About Start-up Handling Options Tinnitus Warnings More info
Please see details for replacing the dome in chapter “Replace dome or GripTip”
MicroMold
LiteTip
VarioTherm® MicroMold
VarioTherm® LiteTip
® VarioTherm is a registered trademark
of Dreve
Page 8
With sound hook and earmold
What it is and does
Sound hook
Microphone openings
Sound in
With thin tube
What it is and does
Microphone openings
Sound in
Push button
Mute, change
Brings sound
hearing aid
14 15
Tube
into the ear
Earmold
Hold the
in the ear
Battery drawer
Contains the battery.
Functions as an on/off switch
About Start-up Handling Options Tinnitus Warnings More info
Nail grip
Open the battery drawer
volume and programs
LED
(optional) Program, volume, and battery status
Thin tube
Brings sound
into the ear
Battery drawer
Contains the battery.
Functions as an on/off switch
Push button
Mute, change volume and programs
LED
(optional) Program, volume, and battery status
Nail grip
Open the battery drawer
Page 9
Identify left and right hearing aid
MultiTool for handling of 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,
You can find left/right color indicators in the battery drawer.
please contact your hearing care professional.
Indicators can also be found on MicroMolds (optional).
Wire loopMagnet
Brush
A BLUE indicator marks the LEFT hearing aid
16 17
About Start-up Handling Options Tinnitus Warnings More info
A RED indicator marks the RIGHT hearing aid
IMPORTANT NOTICE
Your MultiTool has a built-in magnet. Keep the MultiTool at least 12 in. away from credit cards and other magnetically sensitive devices.
Page 10
Turn the hearing aid on and o
When to replace the battery
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 it is time to replace the battery, you will hear three beeps
repeated in moderate intervals until the battery runs out. 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).
Optional LED
Two long green blinks indicate that the hearing aid is turned on.
Three beeps*
= The battery is running low
Battery tip
To make sure the hearing aid is always working, bring spare
Four descending tones
= The battery has run out
batteries with you, or replace the battery before you leave home.
Turn ON
Close the battery
Turn OFF
Open the battery drawer.
Optional LED
Red blinks, continuously repeated, to indicate battery low.
drawer with the battery in place.
18 19
About Start-up Handling Options Tinnitus Warnings More info
* 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.
Page 11
How to replace the battery (size 13)
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.
Close the battery drawer. The
hearing aid will play a jingle
through the earpiece.
Insert it from above,
Tip: Wait 2 minutes so that the battery can draw air, to ensure optimal functioning.
20 21
About Start-up Handling Options Tinnitus Warnings More info
NOT from the side.
Make sure the
+ side
is facing up.
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.
Page 12
Put on the hearing aid with sound hook
Caring for your hearing aid
Read the following pages if you have a hearing aid with a sound hook and earmold.
Step 1 Step 2
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.
The earmold is customized for you and fits your ear shape. The earmolds are unique for the left or the right ear.
22 23
About Start-up Handling Options Tinnitus Warnings More info
Gently pull your ear outwards and press the earmold in the direction of the ear canal, twisting slightly.
Place the hearing aid behind your ear.
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
Page 13
Clean the earmold
The earmold should be cleaned regularly. Use a soft cloth to clean the surface of the earmold. Use the MultiTool wire loop to clean the opening.
Replace the tube
The tubing between the earmold and the hearing aid should be replaced if it becomes yellow or stiff. Consult your hearing care professional about this.
Wash the earmold
Step 1
Step 2 Step 3
Make sure you are
able to identify
which earmold is for
which hearing aid
before disconnect-
ing them from the
hearing aid.
24 25
About Start-up Handling Options Tinnitus Warnings More info
Disconnect the tube and earmold from the hook. Hold the hook firmly when pulling it off the tube. Otherwise the hearing aid may be damaged.
Wash the earmold and tube using mild soap. Rinse and dry completely before reconnecting to the hearing aid.
Page 14
Put on hearing aid with thin tube
Clean the thin tube
Read the following pages if your hearing aid has a thin tube.
Step 1 Step 2 Step 3
Ear grip
(optional)
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.
26 27
About Start-up Handling Options Tinnitus Warnings More info
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.
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 into your ear.
.
Step 1 Step 2 Step 3
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.
Page 15
Replace standard earpieces
The standard earpiece (dome or Grip Tip) 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.
Step 1 Step 2 Step 3
Hold on to the end of the thin tube and then pull off the earpiece.
28 29
About Start-up Handling Options Tinnitus Warnings More info
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.
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.
Page 16
Clean customized earpieces
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.
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 MicroMold and LiteTip do not have a wax filter
30 31
About Start-up Handling Options Tinnitus Warnings More info
Clean the vent by pressing the brush through the hole, twisting it slightly.
Ven t
Wax filter
Replace ProWax lter
1. Tool
New filter
Remove the tool
from the shell. The
tool has two pins,
one empty for
removal and one
with the new wax
filter.
2. Remove 3. Insert
New
filter
Push the empty pin into the wax filter in the earpiece and pull it out.
Old filter
Insert the new wax filter using the other pin, remove the tool, and throw it out.
Page 17
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 hearning aid will activate flight mode on both hearing aids.
Optional LED
The LED will blink green, red, and red a few times. This confirms that flight mode is activated.
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.
To activate and deactivate Press the push button for at least 7 seconds. An audible jingle confirms your action.
Opening and closing the battery drawer will also deactivate ight mode.
32 33
About Start-up Handling Options Tinnitus Warnings More info
Page 18
Change program
Your hearing aid can have up to 4 different programs. These are programmed by your hearing care professional.
Optional LED
The number of green blinks indicate the selected program.
To be filled out by the hearing care professional
Program Activation sound When to use
1
2
“1 beep”
“2 beeps”
3
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.
34 35
About Start-up Handling Options Tinnitus Warnings More info
4
Program change:
“3 beeps”
“4 beeps”
LEFT RIGHT Short press Long press
Page 19
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
Press button to turn volume up
Press button to turn volume down
36 37
About Start-up Handling Options Tinnitus Warnings More info
START-UP LEVEL
MINIMUM
You will hear 2 beeps at start-up level.
Optional LED
The LED will blink green to confirm changes in volume, and a long
green blink at start-up level. The LED will show a red blink when
the volume reaches the minimum or maximum level.
To be filled out by the hearing care professional
Volume change
LEFT RIGHT Short press
Page 20
Mute
Use hearing aid with iPhone and iPad
Use the mute function if you need to silence the hearing aid. The mute function only mutes the microphone(s) 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,
Optional LED
Green and red blinks, continuously repeated, to indicate mute.
Apply a long press (4 seconds) to either end of the button to mute the hearing aid.
please contact your hearing care professional or visit:
www.oticon.com/support.
For information on compatibility,
To reactivate the hearing aid, push 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.
38 39
About Start-up Handling Options Tinnitus Warnings More info
please visit www.oticon.com/support.
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 pelformance.
Apple, the Apple logo, iPhone, iPad, and iPod touch are trademarks of Apple Inc., registered in the U.S.
and other countries.
Page 21
Pair with iPhone
4. Prepare
6. Confirm pairing5. Select
2. General 3. Accessibility1. Settings
William’s Hearing Aids
Oticon Opn S or Oticon Opn Play
Bluetooth
General
On
Open your iPhone and go to “Settings”. Make sure Bluetooth is on. Then choose “General”.
Accessibility
On the “General” screen, choose “Accessibility”.
MFi Hearing Devices
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
Your iPhone will detect the hearing aids for pairing. Detected devices will appear in your iPhone list. Choose your hearing aids.
Bluetooth Pairing
Request
“William’s Hearing Aids” would
like to pair with your iPhone
Cancel Pair
Confirm pairing. If you have two hearing aids, pairing confir­mation is needed for each hearing aid.
mode for 3 minutes.
40 41
About Start-up Handling Options Tinnitus Warnings More info
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.
Page 22
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 aid as a hands-free headset; ConnectClip can also be used as a remote microphone.
TV Adapter 3.0
Wireless transmitter of sound from TV and electronic audio
FM
Your hearing aid supports the option of attaching an FM receiver. The FM system allows you to receive speech or audio signals directly to your hearing aid from a dedicated transmitter.
Remote Control 3.0
Offers the ability to change
program, adjust volume, or
mute your hearing aid.
Phone Adaptor 2.0
Connects your traditional home
phone to the ConnectClip via
Bluetooth allowing for hands-
free phone calls.
Oticon ON App
Offers an intuitive and discreet way to control your hearing aid. For iPhone, iPad, iPod touch, and Android™ devices.
devices. TV Adapter streams sound directly to your hearing aid.
For more information visit www.oticon.com/support or contact
your hearing care professional.
42 43
About Start-up Handling Options Tinnitus Warnings More info
Page 23
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, houses of worship, or lecture rooms. This symbol or a similar sign is shown wherever a teleloop has been installed.
Auto Phone - optional for Oticon Opn and
Oticon Siya
The Auto Phone can automatically activate a phone program in the hearing aid, if you place a dedicated magnet on your phone.
44 45
About Start-up Handling Options Tinnitus Warnings More info
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
attached to your hearing aid and then connected via a cable to the
external sound source.
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.
Page 24
Tamper-resistant battery drawer
To keep the battery out of reach of infants, small children, and people with cognitive impairments, a tamper-resistant battery drawer should be used.
To lock the battery
drawer
Tool to unlock the battery drawer
Unlock the battery drawer
1
2
Close the battery
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.
46 47
About Start-up Handling Options Tinnitus Warnings More info
door completely
and make sure it
is locked.
Use this small blue tool provided by your hearing care professional.
Insert the tip of the blue tool into the small hole at the back of the battery drawer.
1. Move it to the right and push up
2. Open the battery drawer
Page 25
Sound and LED indications
Different sound and LED light indications help to show the hearing aid status. The different setting options are listed on the following pages.
Your hearing care professional can set sound and LED indications to match your preferences.
48 49
About Start-up Handling Options Tinnitus Warnings More info
Program status
Program 1 1 beep
Program 2 2 beeps
Program 3 3 beeps
Program 4 4 beeps
Wireless accessories 2 beeps
Wireless accessories incl. microphone
Flight mode Sound
Flight mode active 4 beeps
Flight mode inactive 4 beeps
Green, short blink Green, long blink Red, short blink
Sound LED
2 beeps
LED
LED comments
Continuously repeated or repeated 3 times with small pauses
Continues on next page
Page 26
On Sound LED LED comments
On
Volume Sound LED
Preferred volume
Minimum / maximum volume
Volume up / down
Mute
Green, short blink Green, long blink Red, short blink
50 51
About Start-up Handling Options Tinnitus Warnings More info
Start-up jingle
2 beeps
3 beeps
1 beep
Shown one time
Shown one time
Continuously repeated or repeated 3 times with small pauses
Warnings Sound LED LED comments
Battery low indication
Battery shut down
Microphone service check needed
Red, short blink Red, long blink
3 beeps
4 descending tones
8 beeps repated 4 times
Continuously repeated
Repeated 4 times with small pauses
Page 27
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.
52 53
About Start-up Handling Options Tinnitus Warnings More info
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.
Page 28
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 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.
54 55
About Start-up Handling Options Tinnitus Warnings More info
Page 29
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.
56 57
About Start-up Handling Options Tinnitus Warnings More info
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.
Page 30
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.
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.
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.
58 59
About Start-up Handling Options Tinnitus Warnings More info
• 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.
Page 31
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.
60
About Start-up Handling Options Tinnitus Warnings More info
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.
Page 32
General warnings
You should familiarize 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.
62 63
About Start-up Handling Options Tinnitus Warnings More info
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 cognitive impairments.
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 and contact the National Poison Center at 1-800­222-1222 or National Battery Ingestion Hotline at 202-625-3333.
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
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.
Continues on next page
Page 33
General warnings
If you have an active brain implant, please contact the manufacturer of your implantable device for information about the risk of disturbance.
The Auto Phone magnet and MultiTool (which has a built-in magnet) should be kept at least 12 in. away from the implant, e.g. do not carry it in a breast pocket.
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.
Heat and chemicals
The hearing aid must never be exposed to extreme heat, e.g. left inside a parked car in the sun.
64 65
About Start-up Handling Options Tinnitus Warnings More info
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.
For information of whether your hearing aid is a power instrument, see the model overview in the front of this booklet.
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 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 hearing aid when con­nected to external equipment with an auxiliary input cable, is determined by the external signal source. When con­nected to external equipment plugged into a wall outlet, this equipment must comply with IEC-62368 (or IEC-60065, IEC-60950 until June 20, 2019) or equivalent safety standards.
Page 34
General warnings
Warnings to hearing care professional
A hearing care professional should advise a prospective hearing aid user to consult immediately with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing care professional determines through inquiry, actual observation, or review of any other available informa­tion concerning the prospective user, that the prospective user has any of the following conditions:
(i) Visible congenital or traumatic
deformity of the ear.
(ii) History of active drainage from the
ear within the previous 90 days.
66 67
About Start-up Handling Options Tinnitus Warnings More info
(iii) History of sudden or rapidly
progressive hearing loss within
the previous 90 days. (iv) Acute or chronic dizziness. (v) Unilateral hearing loss of sudden
or recent onset within the
previous 90 days. (vi) Audiometric air-bone gap equal
to or greater than 15 decibels at
500 Hertz (Hz), 1,000 Hz, and
2,000 Hz. (vii) Visible evidence of significant
cerumen accumulation or a
foreign body in the ear canal. (viii) Pain or discomfort in the ear.
Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure capability exceeds 132 dB SPL as there may be risk of impairing the remaining hearing of the hearing aid user.
Important notice for prospective hearing aid users
Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as Otolaryngologists, Otologists or
Otorhinolaryngologists. The purpose of medical evaluation is to ensure that all medically treatable conditions that may affect hearing are identified and treated before the hearing aid is purchased. Following the medical evaluation, the physician will give you a written statement that states that your hearing loss has been medi­cally evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or a hearing aid dispens­er, as appropriate, for a hearing aid evaluation.
Page 35
General warnings
The audiologist or hearing care pro­fessional will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs. If you have reservations about your ability to adapt to amplification, you should inquire about the availabil­ity of a trial, rental or purchase­option program. Many hearing care professionals now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee, after which you may decide if you want to purchase the hearing aid. Federal law limits the sale of hearing aids to those individuals who have obtained
68 69
About Start-up Handling Options Tinnitus Warnings More info
a medical evaluation from a licensed physician.
Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a phy­sician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged. A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. A hearing aid is only part of hearing rehabilitation and may need to be supplemented by auditory training and lip reading.
Children with hearing loss
In addition to seeing a physician for medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation, since hearing loss may cause problems in language development and educational and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabil­itation of a child with a hearing loss. If the user is an infant, small child, or person with cognitive impairment, it is recommended that the hearing aid be modified with a tamper-resistant battery compartment.
Page 36
Troubleshooting
Symptom Possible causes Solutions
Dead battery Replace the battery
No sound
Intermittent or reduced sound
Squealing noise
Beeping/LED blinking (optional)
Pairing issue with Apple device
70 71
About Start-up Handling Options Tinnitus Warnings More info
Clogged earpieces (dome, Grip Tip, earmold or MicroMold)
Hearing aid microphone muted Unmute the hearing aid microphone
Clogged sound outlet Clean earmold or MicroMold, replace wax filter or change dome or GripTip
Moisture Wipe battery with a dry cloth
Hearing aid earpiece inserted incorrectly Re-insert the earpiece
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 blink red 4 times with small pauses, your hearing aid needs a microphone service check
Bluetooth connection failed
Only one hearing aid paired
Clean earmold or MicroMold or replace wax filter
Consider to replace dome, or GripTip
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 chapter: “Pair with iPhone”)
If none of the above solutions work, consult your hearing care professional.
Page 37
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.
72 73
About Start-up Handling Options Tinnitus Warnings More info
Page 38
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.: _________________________
74 75
About Start-up Handling Options Tinnitus Warnings More info
International warranty
Your hearing aid is covered by an international limited warranty issued by the manufacturer for a period of at least 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 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.
Page 39
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.
76 77
About Start-up Handling Options Tinnitus Warnings More info
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.
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.”
The immunity of this hearing aid 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.
Page 40
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 15 nW [typically below -40 dBμA/m at a 10meter/33 ft. distance].
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
78 79
About Start-up Handling Options Tinnitus Warnings More info
below 3 mW equal to 4.8 dBm 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.com
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 license-exempt RSSs.
Operation is subject to the following two conditions:
1. This device may not cause harmful interference.
2. This device must accept any interference received, including interference that may cause undesired operation.
Changes or modifications not expressly approved by the party responsible for compliance could void the user’s authority to operate the equipment.
Page 41
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
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.
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
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
80 81
About Start-up Handling Options Tinnitus Warnings More info
Waste from electronic equipment must be handled according to local regulations.
Page 42
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 60529:1991/A1:2002. IP6X indicates total dust protection. IPX8 indicates the protection against the eects of continuous immersion in water.
82 83
About Start-up Handling Options Tinnitus Warnings More info
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.
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 43
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
84
About Start-up Handling Options Tinnitus Warnings More info
Settings overview for your hearing aid
Left Right
Yes No
Yes No
Yes No
Yes No
On Off
On Off
On Off
On Off
Volume control
Program shift
Mute
Tinnitus SoundSupport
Volume control indicators
Beeps at min/max volume
Beeps when changing volume
Beeps at preferred volume
Battery indicators
Low battery warning
Yes No
Yes No
Yes No
Yes No
On Off
On Off
On Off
On Off
Page 44
Technical Data BTE13 PP
Opn1BTE13PP_OSPL90_2cc − 02−05−2017 − taje − 09:02:09
Opn2+3BTE13PP_FOG_2cc − 02−05−2017 − taje − 13:31:47
Opn1BTE13PP_FOG_2cc − 02−05−2017 − taje − 09:03:26
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
Opn 1, Opn S 1, & Opn Play 1
Opn 2, Opn 3, Opn S 2, Opn S 3,
Opn Play 2, Siya 1, & Siya 2
Oticon
OSPL90 – Output Sound Pressure Level
Input: 90 dB SPL. Technical setting: A0
Full-on Gain
Input: 50 dB SPL. Technical setting: A0
Sound Hook
Thin tube (size 1/1.3)
86 87
About Start-up Handling Options Tinnitus Warnings More info
dB SPL
130
120
110
100
Hz 500 1000 2000 Hz 5000 10000
100 200
dB
70
60
50
40
Hz 500 1000 2000 Hz 5000 10000
100 200
dB SPL
130
120
110
100
100 200
dB
70
60
50
40
100 200
Oticon
Hz 500 1000 2000 Hz 5000 10000
Hz 500 1000 2000 Hz 5000 10000
0 dB SPL ref. 20 mPa
Peak OSPL90 131 (1291) dB SPL 131 (129*) dB SPL 131 (129*) dB SPL
HF Average OSPL90 126 (118
Peak Full-on Gain 66 (66
HF Average Full-on Gain 61 (54
Reference Test Gain 50 d B 50 dB 50 dB
Frequency Range 120-7000 Hz 120-7000 Hz 120-7000 Hz
Total Harmonic Distortion 500 Hz 3 % 3 % 3 %
Total Harmonic Distortion 800 Hz <2% <2% <2%
Total Harmonic Distortion 1600 Hz <2 % <2 % <2 %
Battery Consumption 1.9 mA 1.9 mA 1.9 mA
Equivalent Input Noise Level (omni/dir) 14/27 dB SPL 14/27 dB SPL 14/27 dB SPL
HF Average SPLITS (left/right ear) 109/ 109 dB SPL 109/ 109 dB SPL 10 9/109 dB SPL
Attack Time <5 ms <5 ms <5 ms
Release Time <50 ms <50 ms <50 ms
* For instruments fitted with thin tube
Oticon
Opn 1, Opn S 1,
& Opn Play 1
1
) dB SPL 126 (118*) dB SP L 126 (118 *) dB SPL
1
) dB 66 (66*) dB 66 (66*) d B
1)
dB 61 (54*) dB 61 (54*) dB
Oticon
Opn 2, Opn S 2 &
Siya 1
Oticon
Opn 3, Opn S 3, Opn
Play 2, & Siya 2
Page 45
Technical Data BTE
100 200 500 1000 2000 5000 10000Hz Hz
100
110
120
130
100 200 500 1000 2000 5000 10000Hz 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
OSPL90 – Output Sound Pressure Level
Input: 90 dB SPL. Technical setting: A0
Full-on Gain
Input: 50 dB SPL. Technical setting: A0
88 89
Sound Hook
Thin tube (size 1/0.9)
About Start-up Handling Options Tinnitus Warnings More info
dB SPL
60
50
40
30
Siya 1 & 2
2CC Coupler
0 dB SPL ref. 20 mPa Oticon Siya 1 & Siya 2
Peak OSPL90 120 (121*) dB SPL
HF Average OSPL90 115 (105*) d B SPL
Peak Full-on Gain 57 (54*) dB
HF Average Full-on Gain 50 (41*) dB
Reference Test Gain 39 dB
Frequency Range 100-7000 Hz
Total Harmonic Distortion 500 Hz <2 %
197869US / 2019.01.10
Total Harmonic Distortion 800 Hz <2 %
Total Harmonic Distortion 1600 Hz <2 %
Battery Consumption 1.7 mA
Equivalent Input Noise Level (omni/dir) 18/28 dB SPL
HF Average SPLITS (left/right ear) 97/97 dB SPL
Attack Time <5 ms
Release Time <30 ms
* For instruments fitted with thin tube
197869US / 2019.01.10
Page 46
0000197869000001
Oticon Opn Firmware 6.0 or earlier, Oticon Siya Firmware 1.0
197869US / 2019.01.10 : Oticon Opn S & Oticon Opn Play Firmware 7.0,
Loading...