oticon Companion 1.0.0 App Instruction Manual

Instructions for use
Oticon Companion
Instruction Manual

Introduction

The following instructions for use are valid for Oticon Companion 1.0.0 or later.
Oticon Companion is designed for easy control of your hearing aids sound settings and allows you to control the sound streamed to them. The app also allows for remote communication between you and your hearing care professional.
The Remote Care feature of this app allows you to have follow-up visits from the comfort of your home. This feature allows you to see and hear your hearing care professional, as well as send text messages during your remote visit. The Remote Care feature also enables data communication between your hearing aids and your hearingcare professional through a stable Internet connection. In certain cases, you may have to attend follow-up visits in person at your hearing care professional’s practice.
Ensure you read this booklet carefully, including the Warnings section, before using the app. This will help you get the most benefit out of the app.
Warnings
Text marked with a warning symbol must be read before using the app.
When this guide mentions device(s), it refers to your Apple iOS device, for example, an iPhone® or iPad®, or your Android™ device such as a phone or tablet.
The app runs on your Apple iOS or Android device. Ensure that you always update the app to the newest compatible version. Also ensure that you update your device to the
latest version of iOS or Android OS.
Apple, the Apple logo, iPhone, iPad, and iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
In case of any additional questions regarding the use of the app, contact your hearing care professional.
Be aware that some settings are dependent on the fitting done by the hearing care professional.
This guide helps you with:

• Getting started with the app
• Using the app on your device

How to use this guide

Be aware that you must download the app on your device before you follow the procedures in this guide.
To use most features of this app you will need to pair your hearing aids to your device first. If you need help pairing your device to your hearing aids, visit: www.oticon.global/
pairing When using the Remote Care feature, ensure that you follow the procedures in the Remote Visit section of this guide in chronological order. In most cases, the procedures are the same for all devices on both operating systems (iOS and Android).

Intended use

Intended use| Oticon Companion* is intended to give the user wireless access to the hearing aid through
a mobile device for control of functionality and update of the hearing aid remotely. The product is intended to be used together with the given hearing solution.
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Indications for use| There are no indications for use (diagnoses) for Oticon Companion itself.
Intended user| Persons with hearing loss using a wireless hearing aid and their caregivers. Children below 10 years of age are expected to be assisted by responsible caregivers.
Intended user group| Infants, children, and adults.
Use environment| Indoor or outdoor.
Contraindications| No contraindications.
Clinical benefits| See clinical benefits of the hearing aid.

*Oticon Companion is an accessory to a medical device (wireless hearing aid).

Disclaimer for Oticon Companion

The manufacturer does not take responsibility for the consequences of using this app outside its intended use or warnings.
Your hearing care professional is responsible for the fitting through the app.
The manufacturer does not take any responsibility for hearing aid fitting.
The manufacturer reserves the right to discontinue the app service without prior notice.

IMPORTANT NOTICES

The Remote Care feature of this app connects you to your hearing care professional who sends updated settings to your hearing aids. If it is not possible to make all the changes remotely, then a physical visit to your hearing care professional is necessary.
The app should only be operated by the user of the hearing aid or responsible caregivers or hearing care professionals. Other third parties should be prevented from controlling the app.
The connection between hearing aids and mobile phone may be lost due to signal interference, low battery, distance between phone and hearing aids etc. If this occurs and affects the expected functionality of the hearing aids, you are advised to reboot the hearing aids.
For details on the functionality of your specific hearing aid, refer to your hearing aid’s Instructions for use.
The hearing care professional is responsible for obtaining the license needed to use the Remote Care feature with the clients.
If you have additional questions about the use of the app, contact your hearing care professional.

System requirements

To use the app, you need the following:

• Compatible hearing aids with Bluetooth® Low Energy technology*
• A compatible iOS or Android device*
• For iOS devices
  • iOS operating system software running version 15.0 or later. To find out which version of iOS you have, on your iPhone or iPad, go to: Settings > General > About > Software Version
• For Android devices
  • Android operating system software running version 8.0 or later. To find out which version of Android you have, on your Android device, go to: Settings > About phone > Software information
• To use the Remote Care feature: A stable Internet connection suitable for both sound and video streaming, with a recommended minimum speed of 1 Mbps (upload/download)

Change volume and mute

You can change the volume in both hearing aids at the same time or in each hearing aid independently.
Changing the volume only applies to the selected program.
To access volume and mute controls

• On the tab bar, tap Sound.

A. Volume level indicator. The value 0 is the start-up volume as prescribed and set by your hearing care professional.
B. To increase or decrease the volume, move the slider(s) up or down or press the +/- buttons.
C. To switch between volume control in one or both hearing aids, tap the slider button .
D. To mute or unmute the hearing aid microphones, tap the mute button.
E. Tab bar
F. Navigation bar
G. Program selector

Change program

A program is a preset sound adjustment for your hearing aids. Each program is optimized for specific sound environments or remote sound sources.
Volume is adjusted independently for each program.
To change programs

1. On the tab bar, tap Sound.
2. On the navigation bar, in the program selector, tap the down arrow to see your available programs.
3. Tap the desired program to select it.

You can also toggle between your available programs by tapping the right and left arrows in the navigation bar.
Your hearing care professional can define up to four different listening programs at your fitting session.
Additional programs for TV Adapter, Connect Clip, Endemic and/or Tinnitus Sound Support™ may also be available.

Accessories and your app

If your hearing aids have been paired with one or more devices (TV Adapter, Endemic and/or Connect Clip), corresponding programs are available in the program selector.
TV Adapter/ Endemic
If your hearing aids are paired with a TV Adapter you can use the app to control the sound streamed from your TV to your hearing aids.
If your hearing aids are paired with Endemic you can use the app to control the sound streamed from the device to your hearing aids.
Connect Clip
With your Connect Clip you can make hands-free phone calls and stream sound from any Bluetooth device to your hearing aids. Your ConnectClip also functions as a remote microphone.
To adjust the volume of sound streamed from your paired device

1. On the tab bar, tap Sound.
2. On the navigation bar, in the program selector, tap the down arrow, then tap TV Adapter/Endemic or Connect Clip.
3. On the navigation bar, tap the Streaming tab.
4. Move the slider(s) up or down.

To adjust the volume of ambient environmental sounds picked up by your hearing aids

1. On the navigation bar, select the Surroundings tab.
2. Move the slider(s) up or down.

To switch between streaming sources
If you have more than one TV and a compatible device (TV Adapter/Endemic) paired to your hearing aids, you can use the app to switch between streaming sources.

1. On the tab bar, tap Sound.
2. On the navigation bar, in the program selector, tap the down arrow, then tap TV Adapter/Endemic.
3. On the bottom, above the tab bar, tap the Devices button . The highlighted device is the one currently streaming.
4. Select the desired streaming source from the list.

To rename a connected device

1. On the bottom, above the tab bar, tap the Devices button.
2. Tap the pencil icon for the device you want to rename.
3. In the text box enter the desired name.
4. Click Save.

Streaming equalizer

Streaming equalizer lets you adjust the loudness of frequency bands for the sound streamed from your mobile devices, TV Adapter, Endemic and/or Connect Clip.
Streaming equalizer is not available on any Tinnitus program.
Note
The streaming equalizer button is always visible on Apple and selected Android devices. On all other Android devices, the button appears the first time you stream sound from your phone or other connected devices.
To adjust the streaming equalizer

1. On the tab bar, tap Sound.
2. Above the tab bar, in the middle, tap the streaming equalizer button .
3. Move the slider(s) up or down.
   • Low equalizes bass tones.
   • Mid equalizes mid-range tones.
   • High equalizes treble tones.

The default settings are always 0 dB and the range is between +6 dB and -12 dB.

Remote microphone

This functionality lets you use your iPhone or iPad as a remote microphone.
For example, you can place your iPhone near a person speaking across a room and the sound is streamed to your hearing aids.
Remote microphone is not available on Tinnitus, Connect Clip or TV Adapter/Endemic programs.
To activate or deactivate the remote microphone

1. On the tab bar, tap Sound.
2. In the program selector, tap the down arrow and select one of the general programs.
3. On the bottom, on the right-hand side, tap the microphone button , then toggle the switch .

Note
The remote microphone functionality is currently only available for Apple devices.

Speech Booster*

Speech Booster helps you focus on speech in noisy environments. When activated, this feature enhances speech by suppressing non-speech sound sources from the sides and back.
To activate and deactivate Speech Booster

• Above the tab bar, on the right, tap the speech booster button , then toggle the switch.

The feature is deactivated when you change programs, open the battery drawer/place the hearing aids in the charger, or reconnect the hearing aids.

Note

• The exact name of the Speech Booster feature depends on the hearing aids you are using. The Speech Booster feature is only available for select hearing aids. For further information contact your hearing care professional.

Find my hearing aids

If you are unable to find your hearing aids, the app can show you, on a map, the last known location of your paired hearing aids when the app was running.
To locate your missing hearing aids

1. On the tab bar, tap Hearing aids.
2. Tap Find my hearing aids.

The hearing aid icons indicate how close you are to each connected hearing aid.
The green marker on the map indicates that there is connection between your hearing aid and device.
The red marker indicates that the connection is lost. Tap the icon to see the date, time and location of the last connection.
For best results, it is recommended to keep the app turned on, either actively being used, or running in the background.

Create account or sign in

To use some features of this app you will need to create an account or sign in with your existing user credentials.
If you already signed up to other Oticon registered services, you can reuse your credentials to sign in to your account. You can create an account either by using your Apple  ID, Facebook, or Google credentials or by using your email address.
To sign in with existing credentials

1. On your device, on the tab bar, tap More.
2. On the More benefits screen, tap My Profile.
3. Tap SIGN IN.
4. Follow the guidance in the app.
5. In the You are signed in screen, tap GO TO THE APP.
6. If using the Remote Care feature, continue to Prepare for your remote visit section of this booklet.

To create an account
Using Apple ID, Facebook, or Google

1. On your device, on the tab bar, tap More.
2.  On the More benefits screen, tap My Profile.
3. Tap CREATE ACCOUNT.
4. Follow the guidance in the app.

Create account or sign in (continued) Using an email address

1. On your device, on the tab bar, tap More.

2. On the More benefits screen, tap My Profile.

3. Tap CREATE ACCOUNT.

4. In the email address field, enter your email address.
   Tap CONTINUE.

5. In your email inbox, open the Welcome to our app email you received and click the Verify your email button. You are now directed to a webpage, where you must create a password. In the Password field, create a password. You will use this password when you sign into the app.

6. In the Confirm new password field, reenter the password. Tap CONTINUE.
   You will be redirected to a page informing you that your account is ready and that you must return to the app on your device and sign in.

7. Close your web browser, return to the app and then follow the guidance in the app.

Prepare for your remote visit

• Plug your device into power or ensure that your device is fully charged.
• Ensure that your hearing aids are paired with your device.
• Ensure that the Bluetooth on your device is enabled.
• Position yourself where there is a stable Internet connection.
• Insert new batteries in your hearing aids to ensure they are adequately powered. If you are using rechargeable hearing aids, make sure they are fully charged. Ensure that you have your charger nearby as you may need it to restart your hearing aids.

Alternatively, you can manually restart your hearing aids by turning them OFF and ON.
Note
In order to maintain a strong and reliable connection for the duration of the remote visit, your hearing aids must have new or fully charged batteries.

• Turn OFF any type of battery-saving mode on your phone/ tablet.
• Terminate other apps you are running to avoid disturbances.

During the visit, do not:

• place your hearing aids more than 3 meters (approx. 10 feet) away from your device
• Turn OFF your hearing aids
• Turn OFF Bluetooth on your device
• Enable Flight mode on your hearing aids or your device
• Turn OFF your device
•  Switch between Wi-Fi and data plan
• Terminate the app or switch to another app
• Enable any kind of battery-saving mode on your device

Begin visit
After you have gone over the Prepare for your remote visit checklist on the previous page, you must launch the Remote Care feature in the app.
If you are not already signed in or if you do not have an account, follow the steps in the Create account or sign in section of this booklet before proceeding.
To begin your Remote Care visit

1. On the tab bar, tap More
2. In the More benefits screen, at the top, tap Remote Care.
3. On the Remote Care screen, at the bottom, tap GO TO VISIT*.
4. In the Connect your hearing aids screen, tap CONNECT.
5. In the following Before the visit screens, follow the guidance in the app and tap CONTINUE whenever prompted.
   • If you have not paired your hearing aids to your device, you will be taken to the Pair your hearing aids screen.

If this happens:

•  Click PAIR and follow the steps on the screen to pair your device to your hearing aids.

Waiting room

• In the Waiting room screen, wait for your hearing care professional to connect and join the visit. While you wait, you see a video stream of yourself.

• If this is your first time using the app, ensure you read and agree to the Data & Privacy notice. To activate the services in the app, tap AGREE.

Your RemoteCare visit
When your hearing care professional joins the remote visit, they appear on your screen in a video stream.
A. Camera: Turn your own camera ON/OFF.
B. Audio: Turn your own audio ON/OFF.
C. Chat: Write a text message to your hearing care professional.
Hearing aids connected
When your hearing care professional establishes a remote connection to your hearing aids, the L and R graphics change from blinking to steady green.

Hearing evaluation (In-situ audiometry)
This is an optional function of the Remote Care feature which enables your hearing care professional to remotely check if your hearing loss has changed and to fine tune the settings of your hearing aids accordingly.
To ensure a successful hearing evaluation

•  make sure you are in a quiet place with little or no background noise. Too much background noise can affect the results, possibly requiring the hearing evaluation to be redone.
• Wear your hearing aids correctly and as advised during your first fitting.
• Do not turn off or unpair your hearing aids during the visit.

IMPORTANT NOTICE
If your internet connection is lost during the hearing evaluation visit, you will receive an on-screen notification and the app will attempt to reestablish the connection.
If you hear a tone in your hearing aids after the internet connection is lost

• Remove and restart your hearing aids if they are muted or still playing sound.

In some cases, during a Remote Care visit, the app goes into recovery mode and updates your hearing aids with the latest settings from your hearing care professional.
Applying settings
When your hearing care professional uploads new settings or configurations to your hearing aids, the L and R graphics change color and blink orange.
Settings saved
When the new settings have been successfully saved to your hearing aids, the L and R graphics change color to steady green again.
Restarting hearing aids
When you and your hearing care professional agree to end the visit, then the hearing care professional restarts your hearing aids (by turning them OFF and ON). If enabled,  your hearing aids play a melody or jingle.
End visit
When your hearing care professional ends the visit, and the Visit ended screen appears, tap OK. At this point, you can begin using your hearing aids.

Intended use of Tinnitus Sound Support

Tinnitus Sound Support 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 adults (over 18 years old).
Tinnitus Sound Support 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 Sound Support must be done by a hearing care professional participating in a tinnitus management program.
Tinnitus Sound Support is a sound generator that can be integrated into your hearing aids. Specially designed programs in the hearing aids allow you to play various sounds that can help you move your attention away from your tinnitus.
During the fitting session, your hearing care professional can enable the Tinnitus Sound Support in one or more programs. They can be accessed along with the other programs on top of the screen.
For information about limitation of use of these programs, ensure you read your hearing aid’s Instructions for use, or contact your hearing care professional.
Note
The Tinnitus Sound Support feature is only available in the app if Tinnitus has been activated by the hearing care professional in your hearing aids.

Tinnitus Sound Support

To select a tinnitus program with relief sounds

1. On the tab bar, tap Sound.
2. On the navigation bar, in the program selector, tap the down arrow, then tap the tinnitus program you would like to use.

For more information about programs, see the Change program section.
To adjust tinnitus relief sound level

1. On the navigation bar, tap the Masker tab.
2. Move the slider(s) up or down.

You can do this for each hearing aid independently or both hearing aids at the same time.
For more information about volume control, see the
Change volume section.
To adjust the volume of ambient environmental sounds picked up by your hearing aids

1. On the navigation bar, tap the Surroundings tab.
2. Move the slider(s) up or down.

General warnings
For your personal safety and to ensure correct usage, you should familiarize yourself fully with the following general warnings before using your device. Consult your hearing care professional if you experience unexpected operations or serious incidents with your device during use or because of its use. Your hearing care professional will support you with issue handling and, if relevant, reporting to the manufacturer and/or the national authorities.
Using the app can distract you in situations where full concentration is required. Be aware of your surroundings while using the app.

Troubleshooting

This instruction for use document contains detailed guidance on the use of the app. If you experience unexpected behavior when using the app or have additional questions not covered by this document, you should consult the Troubleshooting section within the app.
To access the Troubleshooting section

1. On the tab bar, tap More
2. In the More benefits screen, near the middle, tap Help & Support.
3. In the Help & Support screen, at the top, tap Troubleshooting.

Troubleshooting Remote Care

I can only see myself, there is no video stream of my hearing care professional.

1. Let your hearing care professional know that you cannot see them. Your hearing care professional will attempt to refresh the video connection.
2. Wait for a short while, usually the video stream is reestablished automatically.

What do I do if I receive a phone call during the Remote Care visit?
It is recommended that you decline phone calls during the  Remote Care visit.
What do I do if my Internet connection suddenly stops working?
Attempting to reconnect happens automatically. If the reconnection fails, you have the option to END THE VISIT During a visit, I left the app and returned to it. Does that
have any impact?
While your app is not active, your hearing care professional cannot see you, and it may seem to them as if you have a connection issue.
I am having challenges with the visit with my hearing care professional, e.g. video is unstable.
This is most likely due to an unstable Internet connection.
Try to repeat the visit with a better Internet connection.
The visit suddenly ended without a mutual agreement with my hearing care professional.

• Try to reconnect to the visit or contact your hearing care professional.

The settings in my hearing aids cannot be recovered:

1. Ensure Bluetooth is enabled on your device.
2. Ensure you insert new batteries or that your rechargeable hearing aids are fully charged.
3. Ensure your hearing aids are paired with your phone or tablet.
4. Restart the app.

The app checks if your hearing aids are in working order. In some cases, the app goes into recovery mode and updates your hearing aids with the latest settings from your hearing care professional. Please follow the guidance in the app. If you still cannot recover the settings in your hearing aids, ensure you contact your hearing care professional.

Technical information

The following are definitions that may appear in the Instructions for use and on the About the app screen for Oticon Companion:

Description of symbols used in this booklet

| Warnings
Text marked with a warning symbol must be read before using the app.
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| Manufacturer
The device is produced by the manufacturer whose name and address are stated next to the symbol. Indicates the medical device manufacturer, as defined in EU Regulation 2017/745.
0123| CE mark
The device complies with all required EU regulations and directives. The four- digit number indicates the identification of the notified body.

Description of symbols and abbreviations used in the app

| Consult electronic instructions for use Indicates the need for the user to consult electronic instructions for use.
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| Medical Device
The device is a medical device.
| Global Trade Item Number
A globally unique 14-digit number used to identify medical device products including medical device software.

This medical device complies with Medical Device Regulation (EU) 2017/745.
Declaration of Conformity is available at the headquarters:
Oricon A/S
Kongebakken 9
DK-2765 Smarm
Denmark
www.oticon.global

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