unitron Ativo BTE Hearing Aid User Guide

User Guide for unitron models including: Ativo M, Ativo SP, Ativo UP, Ativo BTE Hearing Aid, Hearing Aid, Aid

Unitron Ativo™BTE Hearing aid user guide

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[PDF] Unitron Ativo™BTE Hearing aid user guide

The button has several functions. It functions as a volume control and/or a program change depending on the hearing aid programming.

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UH UserGuide Ativo-M-SP-UP 92x125 EN 029-6869-02

Unitron AtivoTM BTE Hearing aid user guide
Unitron Ativo M Unitron Ativo SP Unitron Ativo UP
A Sonova brand

This user guide applies to the following models:
Hearing aids
Unitron Ativo M Unitron Ativo SP Unitron Ativo UP

Your hearing aid details
If no box is checked and you do not know the model of your hearing aid, please ask your hearing care professional.
Hearing aid models c Unitron Ativo M c Unitron Ativo SP c Unitron Ativo UP
Battery size
312 13 675
Earpieces c Classic earmold c Universal eartip c Dome* c SlimTip*
* Not compatible with Unitron Ativo UP

Quick guide
Changing batteries

1. Remove the sticker from the new battery and wait 2 minutes.

2. Open the 3. Place battery door. battery in the battery door with the flat side facing upwards.

Left & right hearing aid markings

Blue marking for Red marking for left hearing aid. right hearing aid.

On/Off

Off

Battery size

312, 13, 675

Multi-function button

Low battery warning
2 beeps every 30 minutes

The button has several functions. It functions as a volume control and/or a program change depending on the hearing aid programming. This is indicated in your individual hearing aid instructions. If paired with a Bluetooth enabled phone, a short press will accept and a long press will reject an incoming call.
Enter flight mode: To enter flight mode press the lower part of the button for 7 seconds while closing the battery door. To exit flight mode, simply open and close the battery door again.

Thank you for choosing these hearing aids. Unitron is a hearing solution brand that believes people should feel great about the entire hearing care experience, start to finish. Our ingenious products, technologies, services and programs offer a level of personalization you can't get anywhere else. Get ready to Love the experience.TM
Please read this user guide carefully to make sure that you understand and get the best out of your hearing aids. Training is not required for the handling of this device. A hearing care professional will help setup the hearing aids to your individual preferences during the sales consultation.
For more information regarding features, benefits, setup, use and maintenance or repairs of your hearing aid and accessories contact your hearing care professional or manufacturer representative. Additional information can be found in the Data Sheet of your product.

Table of contents
1. Parts of your hearing aids ...................................................... 4 2. Left and right hearing aid markings........................................ 6 3. On and off .............................................................................. 7 4. Batteries.................................................................................8 5. Putting your hearing aids on your ears................................. 10 6. Removing the hearing aids from your ears............................12 7. Multi-function button ............................................................14 8. Connectivity overview...........................................................17 9. Initial pairing ........................................................................ 18 10. Phone calls ......................................................................... 20 11. Flight mode.......................................................................... 25 12. Using the Unitron Remote Plus app .................................... 27 13. Listening in public places ...................................................28 14. Environmental conditions .................................................. 29 15. Care and maintenance .........................................................31 16. Exchanging the earpiece .................................................... 34 17. Exchanging the earwax protection of your SlimTip ............. 37 18. Service and warranty..........................................................38 19. Compliance information .....................................................40 20. Information and explanation of symbols........................... 46 21. Troubleshooting guide........................................................ 50 22. Important safety information............................................. 55

1. Parts of your hearing aids
1 Earhook - your custom made earmold attaches to your hearing aids using the earhook
2 Microphone - sound enters your hearing aids through the microphones.
3 Multi-function button - switches between listening programs, changes the volume level, and accepts or rejects mobile phone calls depending on your customized fitting
4 Battery door (on & off) - close the door to turn on your hearing aids, open the door all the way to turn off your hearing aid or to change the battery
5 Tubing - part of the earmold that attaches it to the earhook
6 Earmold - allows the sound to pass from the hearing aids to the ear and holds the hearing aids in place
7 Slim tube - sound travels down the slim tube to the ear canal
8 Dome - holds the slim tube in place in your ear canal
9 Retention piece - helps prevent the dome and
speaker unit from moving out of the ear canal
Possible earpieces

Classic earmold Universal eartip
4 * Not compatible with Unitron Ativo UP

Dome*

SlimTip*

Unitron Ativo hearing aids with earmold

2 3

2
5 5

6 6

Unitron Ativo hearing aids with Slim tube

9 4
5

2. Left and right hearing aid markings
There is a blue or red marking on the back of the hearing aid to indicate if it is a left or a right hearing aid.

Blue marking for left hearing aid.

Red marking for right hearing aid.

3. On and off
The battery door acts as an on and off switch.

1. On: Close the battery door 1. fully.

Note: It may take 5 seconds before the hearing aid turns on. Your hearing care provider can additionally increase the start up delay if required.

When you switch on the

hearing aid you might hear

a start-up melody.

2. Off: Open battery door.

4. Batteries
Insert battery with a standard battery door

1. Remove the 2. Open the 3. Place battery

sticker from the battery in the battery

new battery

door.

door with the

and wait 2 minutes.

flat side facing upwards.

If it is difficult to close the battery door: check that the battery is inserted correctly and that the flat side is facing upwards. If the battery is not inserted correctly, the hearing aid will not work and the battery door can be damaged. The flat side is marked with a "+" symbol either on the
sticker or on the battery.

Low power: You will hear two beeps when the battery is low. You will have approximately 60 minutes to change the battery (this can vary, depending on the hearing aid settings and battery). We recommend that you always have a new battery on hand.

Replacement battery

Model
Unitron Ativo BTE-UP BTE-SP BTE-M

Zinc-air battery size 675 13 312

Color marking on package blue orange brown

IEC code
PR44 PR48 PR41

ANSI code
7003ZD 7000ZD 7002ZD

Please ensure that you use the correct type of battery in your hearing aid (zinc-air). Please also read chapter 22 for further information on
product safety.

5. Putting your hearing aids on your ears
5.1 Putting on the hearing aid with classic earmold
1.
1. Take the earmold up to your ear and place the ear canal part into your ear canal.
2. 2. Place the hearing aid behind
your ear.
3. 3. Insert the upper part of the
earmold into the upper part of the bowl of your ear.
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5.2 Putting on the hearing aid with dome, SlimTip or universal eartip
1. 1. Place the hearing aid behind
your ear.
2. 2. Insert the earpiece into your
ear canal.
3. 3. If there is an anchor attached
to the earpiece, tuck it into the bowl of your ear to secure your hearing aid.

6. Removing the hearing aids from your ears
6.1 Removing the hearing aid with classic earmold
1. Lift the hearing aid above 1. the upper part of your ear.
2. Grasp the earmold with 2. your fingers and gently remove it.

6.2 Removing the hearing aid with dome, SlimTip or universal eartip.
Pull on the bend of the tube and remove the hearing aid from behind the ear.

Please try to avoid gripping the tube to remove the hearing aid.
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7. Multi-function button
The multi-function button has several functions.
It functions as a volume control and/or a program change depending on the hearing aid programming. This is indicated in your individual Getting Started Guide. Please ask your hearing care professional for a printout.
If the hearing aid is paired with a Bluetooth® enabled phone, a short press on the upper or the lower part of the button will accept an incoming call and a long press will reject an incoming call refer to chapter 10.

Program control
Each time you push the upper part of the button on either hearing aid for longer than 2 seconds, you will move to the next hearing aid program. Your hearing aids beep to indicate which program you are in.

Program setting Program 1 (e.g. quiet)

Beeps 1 beep

Program 2 (e.g. noise)

2 beeps

Program 3 (e.g. telephone)

3 beeps

Program 4 (e.g. music)

4 beeps

Volume control To adjust the volume of your environment:
· Push the upper part of the button on the hearing aid to increase the volume, and
· Push the lower part of the button on the hearing aid to decrease the volume
As you change the volume, your hearing aids will beep.

Volume setting Suggested volume level

Beeps 1 beep

Turning volume up

short beep

Turning volume down

short beep

Maximum volume level

2 beeps

Minimum volume level

2 beeps

8. Connectivity overview
The illustration below shows some of the connectivity options available for your hearing aid. Please see the user guide that came with your accessory for more information.
Bluetooth® enabled devices

PartnerMic

Remote control

TV Connector connected to TV*

*The TV Connector can be connected to any audio source such as a TV, PC or hi-fi system.

9. Initial pairing
9.1 Initial pairing to a Bluetooth® enabled device
It is only necessary to perform the pairing procedure once with each device featuring Bluetooth wireless technology. After the initial pairing, your hearing aid will connect automatically to the device. Initial pairing can take up to 2 minutes.
1. On your device (e.g. a phone), ensure that Bluetooth wireless technology is enabled and search for Bluetooth enabled devices in the connectivity setting menu.
2. Switch on both hearing aids. You now have 3 minutes to pair your hearing aids with your device.
3. Your device shows a list of Bluetooth enabled devices. Select the hearing aid from the list to simultaneously pair both hearing aids. A beep confirms successful pairing.
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Consult your phone user guide for instructions on pairing a Bluetooth device with your phone. 9.2 Connecting to the Bluetooth enabled device After being paired to your device, your hearing aid will automatically connect again when switched on. The connection will be maintained as long as the device remains ON and within range Your hearing aid can be connected to up to two devices and paired to up to eight devices.
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10. Phone calls
Your hearing aid connects directly with Bluetooth enabled phones. When paired and connected to your phone, you will hear notifications and the caller's voice directly in your hearing aid. Phone calls are "hands free", this means that your voice is picked up by the hearing aid microphones and transmitted back to the phone.
Your voice

Making a call
Enter the phone number and press the dial button. You will hear the dialing tone through your hearing aid. Your voice is picked up by the hearing aid microphones and transmitted to the phone.

Accepting a call When receiving a call, an incoming-call notification will be heard in the hearing aid. The call can be accepted by a short press on the upper or lower part of the multi-function button on the hearing aid (less than 2 seconds) or directly on your phone.
short press < 2 sec

Ending a call A call can be ended by a long press on the upper or lower part of the multi-function button on the hearing aid (more than 2 seconds) or directly on your phone.
long press > 2 sec

Rejecting a call An incoming call can be rejected by a long press on the upper or lower part of the multifunction button on the hearing aid (more than 2 seconds) or directly on your phone.
Long press >2 sec
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11. Flight mode

Your hearing aids operate in the frequency range of 2.4 GHz2.48 GHz. When flying, some airlines require all devices to be switched into flight mode. Entering flight mode will not disable normal hearing aid functionality, only the Bluetooth connectivity functions.

Entering flight mode

To disable the Bluetooth wireless function and enter flight mode in each hearing aid:

1. Open the battery door.

2. Hold down the lower

part of the multi-function

button on the hearing aid

for 7 seconds while closing

the battery door.

In flight mode, your hearing

aid cannot connect directly to

your phone.

Exiting flight mode To enable the Bluetooth wireless function and to exit flight mode: 1. Open the battery door. 1. 2. Close the battery door.
2.
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12. Using the Unitron Remote Plus app
Compatibility information The Unitron Remote Plus app can be used on phones with Bluetooth Low Energy (LE) capability. Please find phone compatibility details on: https://www.unitron.com/global/en_us/help-andsupport/bluetooth-support/phone-compatibility. html
Please find the instruction for use on: https://www.unitron.com/ca/en_ca/help-andsupport.html?tabItem=userguides
Install Unitron Remote Plus app for iPhone users, please scan the code:
Install Unitron Remote Plus app for Android OS users, please scan the code:
iPhone® is a trademark of Apple Inc., registered in the U.S. and other countries. iOS® is a registered trademark or trademark of Cisco Systems, Inc. and/or its affiliates in the United States and certain other countries. AndroidTM is a trademark of Google LLC.
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13. Listening in public places
Telecoils pick up electromagnetic energy and convert it into sound. Your hearing aid has a telecoil option that can help you hear in various public spaces such as churches, concert halls, train stations and government buildings.
When you see this symbol, a loop system is present and is compatible with your hearing aids. Please contact your hearing care professional for further information and activation of the telecoil function.
How to use your telecoil function Accessing the telecoil function that your hearing care professional has set up is possible in two ways.
Direct access to the telecoil program is possible via a long press of the multi-function button on your hearing aid.
Alternatively it is possible to access the telecoil program via the Remote Plus app.
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Ensure that you are standing or are seated within the designated loop system area as noted by the official telecoil symbol.

14. Environmental conditions

This product is designed such that it functions without problems or restrictions if used as intended, unless otherwise noted in this user guide.
Please ensure to use, transport and store the hearing aid according to the following conditions:

Operating

Temperature +5 to +40 °C (+41 to +104 °F)

Humidity

0% to 85%

(non condensing)

Atmospheric

pressure

500 to 1060 hPa

Transport -20 to +60 °C (-4 to +140 °F) 0% to 93%
500 to 1060 hPa

Storage -20 to +60 °C (-4 to +140 °F) 0% to 93%
500 to 1060 hPa

Temperature and humidity shall not exceed the ranges described in the table above for extended periods of time during transport and storage.
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Remove the battery if you are not using your hearing aid for a long period of time. These hearing aids are classified as IP68. This means that they are water and dust resistant and designed to withstand daily life situations. They can be worn in the rain but should not be fully submerged in water or used when taking a shower, swimming or other water activities. These hearing aids should never be exposed to chlorinated water, soap, salt water or other liquids with a chemical content.
If the device has been subject to storage and transport conditions outside of the recommended use conditions, wait 15 minutes before starting the device after recommended environmental conditions are restored.
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15. Care and maintenance
Expected Service Life: The hearing aids have the expected service life of five years. The devices are expected to remain safe for use for this duration.
Commercial service period: Routine and diligent care of your hearing aids will contribute to the outstanding performance for the duration of the expected service life of your devices.
Sonova AG will provide a minimum of a five year repair service period after the respective hearing aid and essential components have been phased out of the manufacturer's product portfolio.
Please use the following specifications as a guideline. For further information regarding product safety, see chapter 22.
General information Before using hair spray or applying cosmetics, you should remove your hearing aid from your ear, because these products may damage it. 31

When you are not using your hearing aid, leave the battery door open so that any moisture can evaporate. Make sure that you always completely dry your hearing aid after use. Store the hearing aid in a safe, dry and clean place. Your hearing aid is resistant to water, sweat and dust under the following conditions:
· The battery door is fully closed. Ensure that no foreign object such as hair is caught in the battery door when it is closed.
· After exposure to water, sweat or dust, the hearing aid is cleaned and dried.
· The hearing aid is used and maintained as described in this user guide.
Use of your hearing aid around water can restrict air flow to the batteries causing it to stop working. Should your hearing aid stop working after coming into contact with water, refer to the troubleshooting steps in chapter 21.
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Daily Inspect the earpiece and tube for earwax and moisture deposits. Clean the surfaces with a lint-free cloth. Never use cleaning agents such as household detergents, soap, etc. for cleaning your hearing aid. It is not recommended to rinse these parts with water, as this could cause moisture to be trapped in the tube. If you need to clean your hearing aid intensively, ask your hearing care professional for advice and information on filters or drying capsules.
Weekly Clean the earpiece with a soft, damp cloth or with a special cleaning cloth for hearing aids. For more in depth maintenance instructions or for more than basic cleaning, please see your hearing care professional.
Monthly Inspect your hearing tube for color changes, hardening, or cracks. In the case of such changes, the hearing tube has to be replaced. Please see your hearing care professional.
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16. Exchanging the earpiece
Your hearing aid is fitted with an earpiece, which can be a dome, an earmold, a SlimTip or a universal eartip.
Please check the earpiece regularly and exchange or clean it if it looks dirty or if the hearing aid volume or sound quality is reduced.
If a dome is used, it should be exchanged every 3 months. If an earmold is used please refer to chapter 15 of this user guide. If a SlimTip is used please follow the instructions in chapter 17 to exchange the earwax protection.

16.1 Removing the earpiece or dome from the Slim tube
1. Remove the earpiece from 1. the Slim tube by holding the Slim tube in one hand and the earpiece in the other.
2. 2. Gently pull off the earpiece
to remove.

3. Clean the Slim tube with a 3. lint-free cloth.

16.2 Attaching the earpiece or dome to the Slim tube
1. Hold the Slim tube in one 1. hand and the earpiece the other.
2. Slide the earpiece over the 2. tip of the Slim tube.

3. The Slim tube and the earpiece should fit perfectly

together.

17. Exchanging the earwax protection of your SlimTip
1. Insert the removal side of the 1. exchange tool into the used earwax protector. The shaft of the holder should touch the rim of the earwax protector.
2. Carefully pull and remove 2. the earwax protector straight out. Do not twist the earwax protector when removing.

1. To insert the new earwax

protector, gently push the

insertion side of the exchange

tool straight into the hole of

the SlimTip until the outer ring

is perfectly aligned.

2. Pull the tool straight out.

The new earwax protector will

remain in place.

18. Service and warranty
Local warranty
Please ask the hearing care professional where you purchased your hearing aids about the terms of the local warranty.
International warranty
Sonova AG offers a one year limited international warranty, valid from the date of purchase. This limited warranty covers manufacturing and material defects in the hearing aid, but not accessories such as tubes, wires, earpieces, or external speaker. The warranty only comes into force if a proof of purchase is shown.
The international warranty does not affect any legal rights that you might have under applicable national legislation governing sale of consumer goods.

Warranty limitation
This warranty does not cover damage from improper handling or care, exposure to chemicals or undue stress. Damage caused by third parties or non-authorized service centers renders the warranty null and void. This warranty does not include any services performed by a hearing care professional in their office.
Serial numbers Hearing aid left side: Hearing aid right side:
Date of purchase:
Authorized hearing care professional (stamp/ signature):

19. Compliance information
Declaration of conformity for the hearing aid
Hereby, Sonova AG declares that this product meets the requirements of the Medical Devices Regulation MDR 2017/745 and complies with Radio Equipment Directive 2014/53/EU. The full text of the EU Declarations of Conformity can be obtained from the manufacturer via the following web address: www.sonova.com/en/certificates.

Australia/New Zealand: Indicates a device's compliance with applicable Radio Spectrum Management's (RSM) and Australian Communications and Media Authority (ACMA) regulatory arrangements for the legal sale in New Zealand and Australia. The compliance label R-NZ is for radio products supplied in the New Zealand market under conformity level A1

The hearing aid described in this user guide is certified under: Standard hearing system

USA - FCC ID:

Canada - IC:

Unitron Ativo M KWC-ARNEM 2262A-ARNEM

Unitron Ativo SP Unitron Ativo UP

KWC-ARNESP KWC-BPZ

2262A-ARNESP 2262A-BPZ

Notice 1: This device complies with Part 15 of the FCC Rules and with RSS210 of Industry Canada. Operation is subject to the following two conditions: 1) this device may not cause harmful interference, and 2) this device must accept any interference received, including interference that may cause undesired operation. Notice 2: Changes or modifications made to this device not expressly approved by Sonova AG may void the FCC authorization to operate this device. Notice 3: This device has been tested and found to comply with the limits for a Class B digital device, pursuant to Part 15 of the FCC Rules and ICES-003 of Industry Canada.
These limits are designed to provide reasonable protection against harmful interference in a residential installation. This device 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.
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However, there is no guarantee that interference will not occur in a particular installation. If this device 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 device and receiver.
· Connect the device into an outlet on a circuit different from that to which the receiver is connected.
· Consult the dealer or an experienced radio/TV technician for help

Radio information of your wireless hearing aid

Antenna type

Resonant loop antenna

Operation frequency 2.4 GHz 2.48 GHz

Modulation

GFSK, Pi/4 DQPSK, GMSK

Radiated power

< 1 mW

Bluetooth® Range Bluetooth Profiles supported

~1m 4.2 Dual-Mode HFP (Hands-free profile), A2DP

Electromagnetic emissions
Manufacturer's Declaration: The hearing aids are intended for use in the electromagnetic environments listed below. The user should assure that they are used in such environments.

Emissions Test
RF emissions CISPR 11

Compliance Group 1

Electromagnetic environment guidance
The hearing aids generate or use RF energy only for their internal functioning. Therefore, the RF emissions are very low and are not likely to cause any interference to nearby electronic equipment.

RF emissions CISPR 11

Class B

The hearing aids are suitable for use in domestic establishment and in establishment directly connected to a low voltage power supply network which supplies buildings used for domestic purposes.

Electromagnetic immunity

Immunity Test

IEC 60601-1-2 Test Level

Compliance Level

Electrostatic Discharge (ESD) IEC 61000-4-2

+/- 8 kV contact
+/- 2 kV , +/- 4 kV, +/- 8 kV, +/- 15 kV air

Radiated RF

Electromag- 10 V/m 80 MHz 2.7 GHz

netic Field

80% AM at 1 kHz

Immunity

Test IEC

61000-4-3

10 V/m 80 MHz 2.7 GHz 80% AM at 1 kHz

9 V/m; 710, 745, 780 MHz; 9 V/m; 710, 745, 780 MHz; Pulse modulation 18 Hz Pulse modulation 18 Hz

9 V/m; 5240, 5500, 5785 MHz; Pulse modulation 217 Hz

Proximity Magnetic Field IEC 61000-4-3

27 V/m; 385 MHz;

Pulse modulation 18 Hz Pulse modulation 18 Hz

28 V/m; 450 MHz FM +/- 5 28 V/m; 450 MHz FM +/- 5 kHz deviation; 1 kHz sine kHz deviation; 1 kHz sine

28 V/m; 810, 870, 930 MHz; 28 V/m; 810, 870, 930 MHz; Pulse modulation 18 Hz Pulse modulation 18 Hz

28 V/m; 1720, 1845,

1970, 2450 MHz;

Pulse modulation 217 Hz Pulse modulation 217 Hz

Immunity Test
Rated power frequency magnetic fields IEC 61000-4-8

IEC 60601-1-2 Test Level
30 A/m 50 Hz or 60 Hz

Compliance Level
30 A/m 50 Hz or 60 Hz

Test frequency 30kHz, Test frequency 30kHz,

modulation: CW,

Enclosure

Immunity test level 8

Port

Test frequency

Immunity to

134, 2 kHz,

Proximity Pulse modulation: 2.1 kHz, Pulse modulation: 2.1 kHz,

Magnetic Immunity test level 65 Immunity test level 65

Fields IEC

61000-4-39 Test frequency 13.56 kHz, Test frequency 13.56 kHz,

Pulse modulation: 50kHz, Pulse modulation: 50kHz,

Immunity test level 7.5 Immunity test level 7.5

20. Information and explanation of symbols

xxxx

With the CE symbol, Sonova AG confirms that this product including accessories meets the requirements of the Medical Devices Regulation (EU) 2017/745 as well as the Radio Equipment Directive 2014/53/EU. The numbers after the CE symbol correspond to the code of certified institutions that were consulted under the abovementioned regulation and directive.
This symbol indicates that the products described in these user instructions adhere to the requirements for an applied part of Type B of EN 60601-1. The surface of the hearing aid is specified as applied part of Type B.
Indicates the medical device manufacturer, as defined in Medical Devices Regulation (EU) 2017/745.
Indicates the date when the medical device was manufactured.

Indicates the Authorized representative in the European Community. The EC REP is also the importer to the European Union.
This symbol indicates that it is important for the user to read and take into account the relevant information in these user guides.

This symbol indicates that it is important for the user to pay attention to the relevant warning notices in this user guide.
This symbol indicates that it is important for the user to pay attention to the relevant warning notices related to batteries in these user guides.
Important information for handling and product safety.

This symbol confers that the electromagnetic interference from the device is under limits approved by the US Federal Communications Commission.

Indicates a device's compliance with applicable Radio Spectrum Management's (RSM) and Australian Communications and Media Authority (ACMA) regulatory arrangements for the legal sale in New Zealand and Australia.

The Bluetooth® word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. and any use of such marks by Sonova is under license. Other trademarks and trade names are those of their respective owners.

This symbol indicates that this is a Prescription Device. CAUTION: U.S. Federal law restricts this device to sale by or on the order of a physician or hearing care professional (for US only).

Japanese mark for certified radio equipment.
Indicates the manufacturer's serial number so that a specific medical device can be identified. Indicates the manufacturer's catalogue number so that the medical device can be identified. Indicates that the device is a medical device.
This symbol indicates that it is important for the user to read and take into account the relevant information in this user guide. IP Rating = Ingress Protection Rating. IP68 rating indicates that the hearing aid is water and dust resistant. It survived continuous immersion in 1 meter of water for 60 minutes and 8 hours in a dust chamber as per the IEC60529 standard. Indicates the temperature limits to which the medical device can be safely exposed.
Indicates the range of humidity to which the medical device can be safely exposed.
Indicates the range of atmospheric pressure to which the medical device can be safely exposed.
48

During transportation keep dry.
The symbol with the crossed-out garbage bin is to make you aware that this device may not be thrown away as normal household waste. Please dispose of old or unused devices, at waste disposal sites intended for electronic waste, or give your device to your hearing care professional for disposal. Proper disposal protects the environment and health. This symbol indicates a device that is not safe to use in magnetic resonance (MR) environment (e.g. during an MRI scan).
49

21. Troubleshooting guide

Cause Issue: No sound Not turned on Low/dead battery Poor battery contact
Battery upside down
Earmolds blocked with ear wax
Plugged microphone shield

Possible remedy
Turn on Replace battery Consult your hearing care professional Insert battery plus (+) side up Clean earmolds. See "Care and maintenance". Consult your hearing care professional Consult your hearing care professional

Cause

Possible remedy

Issue: Not loud enough

Low volume

Turn up volume; see hearing care professional if problem persists

Low battery

Replace battery

Earmolds not inserted properly

See "Putting your hearing aids on your ears". Reinsert carefully

Change in hearing

Consult your hearing care professional

Earmolds blocked with ear wax

Clean earmolds. See "Care and maintenance". Consult your hearing care professional

Plugged microphone shield

Consult your hearing care professional

Cause Issue: Intermittent Low battery Dirty battery contact

Possible remedy
Replace battery Consult your hearing care professional

Issue: Two long beeps

Low battery

Replace battery

Issue: Whistling Earmolds not inserted properly
Hand/clothing near ear
Poorly fitting earmolds

See "Putting your hearing aids on your ears". Reinsert carefully
Move hand/clothing away from your ear
Consult your hearing care professional

Cause

Possible remedy

Issue: Not clear, distorted

Poorly fitting earmolds Consult your hearing care professional

Earmolds blocked with ear wax

Clean earmolds. See "Care and maintenance". Consult your hearing care professional

Low battery

Replace battery

Plugged microphone shield

Consult your hearing care professional

Issue: Earmolds falling out of ear

Poorly fitting earmolds Consult your hearing care professional

Earmolds not inserted properly

See "Putting your hearing aids on your ears". Reinsert carefully

Cause

Possible remedy

Issue: Weak on the telephone

Telephone not positioned properly

Move telephone receiver around ear for clearer signal.

Hearing aid requires adjustment

Consult your hearing care professional

Issue: mobile phone calls not being heard through hearing aids

Hearing aids are in flight Exit flight mode: open

mode

battery door, then close

battery door

Hearing aids are not paired to the phone

Pair your hearing aids to your mobile phone (again)

For any problems not listed in the guide, contact your hearing care professional.

22. Important safety information
Please read the relevant safety information and limitations-of-use information on the following pages before using your hearing aid.
Intended use The hearing aid is intended to amplify and transmit sound to the ear and thereby compensate for impaired hearing.
Intended user Intended for:
· People with hearing loss
· Caregivers of the person with hearing loss
· Hearing care professional responsible for adjusting the hearing aid

Intended medical indication Presence of hearing loss:
· Unilateral or bilateral · Hearing loss type: conductive,
sensorineural or mixed · Grades of hearing loss:
· Unitron Ativo BTE-UP: - Severe, - Profound
· Unitron Ativo BTE-SP: - Mild - Severe
· Unitron Ativo BTE-M: - Mild, - Moderate
Medical contraindications Medical contraindications for the use of hearing aids are:

· Deformity of the ear (i.e. closed ear canal; absence of the auricle)
· Neural hearing loss (i.e. retro-cochlear pathologies such as absent/ non-viable auditory nerve)
· Hearing loss is not in the fitting range of the hearing aid (i.e. gain, frequency response)
Intended patient population The device is intended for patients from 36 months of age who fulfill the clinical indication for this product.
Clinical benefit: Improvement in speech understanding.

Side effects: Physiological side-effects of hearing aids like tinnitus, dizziness, wax build up, too much pressure, sweating or moisture, blisters, itching and/or rashes, plugged or fullness and their consequences like headache and/or ear pain, may be resolved or reduced by your hearing care professional. Conventional hearing aids have the potential to expose patients to higher levels of sound exposure, which might result in threshold shifts in the frequency range affected by acoustic trauma.
The primary criteria for the referral of a patient for a medical or other specialist opinion and / or treatment are as follows:
· Visible congenital or traumatic deformity of the ear;
· History of active drainage from the ear in the previous 90 days;
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· History of sudden or rapidly progressive hearing loss in one or both ears within the previous 90 days;
· Acute or chronic dizziness; · Audiometric air-bone gap equal to or
greater than 15 dB at 500 Hz, 1000 Hz and 2000 Hz; · Visible evidence of significant cerumen accumulation or a foreign body in the ear canal; · Pain or discomfort in the ear; · Abnormal appearance of the eardrum and ear canal such as: · Inflammation of the external auditory
canal · Perforated eardrum · Other abnormalities which the hearing
care professional believes are of medical concern
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Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels (dB SPL) because there may be risk of impairing the remaining hearing of the hearing aid user. (This provision is required only for those hearing aids with a maximum sound pressure capability greater than 132 dB SPL).* The hearing care professional may decide that referral is not appropriate or in the best interests of the patient when the following applies:
· When there is sufficient evidence that the condition has been fully investigated by a medical specialist and any possible treatment has been provided;
· The condition has not worsened or changed significantly since the previous investigation and / or treatment.
*Only relevant for Unitron Ativo SP and Unitron Ativo UP.
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If the patient has given their informed and competent decision not to accept advice to seek a medical opinion, it is permissible to proceed to recommend appropriate hearing aid systems subject to the following considerations:
· The recommendation will not have any adverse effects on the patients health or general well being;
· The records confirm that all necessary considerations about the patient´s best interests have been made.
If legally required, the patient has signed a disclaimer to confirm that the referral advice has not been accepted and that it is an informed decision. The hearing aid is suitable for the home healthcare environment and due to their portability it may happen that it is used in professional healthcare facility environment like physician offices, dental offices etc.
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A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Infrequent use of a hearing aid does not permit a user to attain full benefit from it. The use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lipreading.
Feedback, poor sound quality, too loud or too soft sounds, inadequate fitting or problems when chewing or swallowing, can be resolved or improved during the fine-tuning process at the fitting procedure by your hearing care professional.

Any serious incident that has occurred in relation to the hearing aid, should be reported to the manufacturer representative and the competent authority of the state of residence. The serious incident is described as any incident that directly or indirectly led, might have led or might lead to any of the following:
a) the death of a patient, user or other person
b) the temporary or permanent serious deterioration of a patient's, user's or other person's state of health
c) a serious public health threat
To report an unexpected operation or event, please contact the manufacturer or a representative.

Hazard warnings
Your hearing aids operate between 2.4 GHz2.48 GHz frequency range. When flying please check if flight operator requires devices to be switched into flight mode, see chapter 11 regarding flight mode in this user guide.
The hearing aids (specially programmed for each hearing loss) must only be used by the intended person. They should not be used by any other person as they could damage hearing.
Changes or modifications to the hearing aid that were not explicitly approved by Sonova AG are not permitted. Such changes may damage your ear or the hearing aid.
Do not use the hearing aids in explosive areas (mines or industrial areas with danger of explosions, oxygen rich environments or areas where flammable anesthetics are handled). The device is not ATEX certified.
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If you feel pain in or behind your ear, if it is inflamed or if skin irritation and accelerated accumulations of earwax occur, please check with your hearing care professional or physician.
Hearing programs in the directional microphone mode reduce background noises. Please be aware that warning signals or noises coming from behind, e. g. cars, are partially or entirely suppressed.
This hearing aid is not for children below 36 months. The usage of this device by children and individuals with cognitive impairment should be supervised at all times to ensure their safety. The hearing aid is a small device and contains small parts. Do not leave children and individuals with cognitive impairment unsupervised with this hearing aid. If swallowed, consult a physician or hospital immediately as the hearing aid or its parts can cause choking!
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If you experience itching, redness, blisters, swelling, inflammation in or around your ears, inform your hearing care professional and contact your physician. WARNING: Device batteries are hazardous and can cause serious injuries if they are swallowed or placed inside any part of the body, whether the battery is used or new! Keep out of the reach of children, individuals with cognitive impairment, or pets. If you suspect that a battery was swallowed or placed inside any part of the body, immediately consult your physician without any delay!
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The following is only applicable for persons with active implantable medical devices (i.e. pacemakers, defibrillators, etc.):
· Keep the wireless hearing aid at least 15 cm (6 inches) away from the active implant. If you experience any interference, do not use the wireless hearing aids and contact the manufacturer of the active implant. Please, note that interference can also be caused by power lines, electrostatic discharge, airport metal detectors etc.
· Keep magnets (i.e. batteryhandling tool, IIC Remote Control, etc.) at least 15 cm (6 inches) away from the active implant.
Use of accessories, transducers and cables other than those specified or provided by the manufacturer of this equipment could result in increased electromagnetic emissions or decreased electromagnetic immunity of this equipment and result in improper operation.
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If the hearing aid is connected by wire to a fitting device, this fitting device must comply with the safety standard IEC 60601-1 to avoid electrical shock.
Portable RF communications equipment (including peripherals such as antenna cables and external antennas) should be used no closer than 30 cm (12 inches) to any part of the hearing aids, including cables specified by the manufacturer. Otherwise, degradation of the performance of this equipment could result.
Avoid strong physical impacts to the ear when wearing a hearing aid with customized earpiece. The stability of customized earpieces is designed for normal use. A strong physical impact to the ear (e.g. during sports) may cause the customized earpiece to break. This may lead to perforation of the ear canal or eardrum.
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After mechanical stress or shock to the hearing aid, please ensure the hearing aid shell is intact before placing it in the ear. Use of this equipment adjacent to or stacked with other equipment should be avoided because it could result in improper operation. If such use is necessary, this equipment and the other equipment should be observed to verify that they are operating normally. The majority of hearing aid users have a hearing loss for which a deterioration in hearing is not to be expected with regular use of a hearing aid in everyday situations. Only a small group of hearing aid wearers with hearing loss, may be at risk of deterioration in hearing after a long period of use.
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Hearing aids should not be fitted with domes / wax protection systems when used by clients with perforated eardrums, inflamed ear canals or otherwise exposed middle ear cavities. In these cases, we recommend the use of a custom earpiece. In the unlikely case that any part of this product should remain in the ear canal, it is strongly recommended to see a physician for safe removal. In very rare cases if not securely attached, an eartip or part of it can remain in your ear canal when removing the hearing aid from the ear. In the unlikely case that such part gets stuck in your ear canal, it is strongly recommended to see a physician for safe removal.
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Special medical or dental examination including radiation described below, may adversely affect the correct functioning of your hearing aids. Remove and keep them outside the examination room/area before undergoing:
· Medical or dental examination with X-ray (also CT scan).
· Medical examinations with MRI/NMRI scans, generating magnetic fields.
Hearing aids don't need to be removed when passing security gates (airports etc.). If X-ray is used at all, it will be in very low doses, and will not affect the hearing aids.
Hearing aids and their parts should be kept out of reach of children and anyone who might swallow, choke on or otherwise cause injury to themselves with them. If swallowed consult a physician or hospital immediately as the hearing aid or its parts can be poisonous. In the event of choking immediately administer treatment or contact emergency services.
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Information on product safety These hearing aids are water resistant and not waterproof. They are designed to withstand normal activities and occasional accidental exposure to extreme conditions. Never immerse your hearing aid in water! These hearing aids are not specifically designed for extended periods of water submersion on a continual basis, that is worn in activities such as swimming or bathing. Always remove your hearing aid before these activities, as the hearing aid contains sensitive electronic parts.
Never wash the microphone inputs. Doing so could cause it to lose its special acoustic features.
Protect your hearing aid from heat and sunlight (never leave near a window or in the car). Never use a microwave or other heating devices to dry your hearing aid. Ask your hearing care professional about suitable drying methods.
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When you are not using your hearing aid, leave the battery door open so that any moisture can evaporate. Make sure that you always completely dry your hearing aid after use. Store the hearing aid in a safe, dry and clean place.
Do not drop your hearing aid! Dropping onto a hard surface can damage your hearing aid.
The batteries used in these hearing aids should not exceed 1.5 Volts. Please do not use silver-zinc or Li-ion (lithium-ion) rechargeable batteries as these may cause severe damage to your hearing aids.
Always use new batteries for your hearing aid. In case a battery is leaking, replace it immediately with a new one to avoid any skin irritation. You can return used batteries to your hearing care professional.
Remove the battery if you are not using your hearing aid for a long period of time.
Do not use your hearing aid in areas where electronic equipment is prohibited.
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The dome should be changed every three months or when it becomes stiff or brittle. This is to prevent the dome from detaching from the tube spout during insertion into or removal from the ear.
If you are not using your hearing aid for a long period of time, store it in a box with a drying capsule or in a well ventilated location. This allows moisture to evaporate from your hearing aid and prevents a potential impact on its performance.
Important information in case of battery ingestion in the USA If a battery is swallowed, call the 24-hour National Battery Ingestion Hotline at 800-4988666 or consult your physician immediately.
Mobile phone compatibility rating
Some hearing aid users have reported a buzzing sound in their hearing aids when they are using mobile phones, indicating that the mobile phone and hearing aids may not be compatible.
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According to the ANSI C63.19 standard (ANSI C63.19-2011 American National Standard Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing Aids), the compatibility of particular hearing aids and a mobile phone can be predicted by adding the rating for the hearing aid immunity to the rating for the mobile phone emissions. For example, the sum of the hearing aid rating of 4 (M4) and a telephone rating of 3 (M3) would result in a combined rating of 7. Any combined rating that equals at least 5 would provide "normal use"; a combined rating of 6 or greater would indicate "excellent performance."
The immunity of these hearing aids is at least M4. The equipment performance measurements, categories and system classifications are based upon the best information available but cannot guarantee that all users will be satisfied.
The performance of the individual hearing aids may vary with individual mobile phones. Therefore, please try these hearing aids with your mobile phone or, if you are purchasing a new phone, please be sure to try it with your hearing aids prior to purchase.
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Your feedback Record your specific needs or concerns and bring to your first office visit after getting your hearing aids. This will help your hearing care professional to address your needs.
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Additional notes ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________ ___________________________________________
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Australian Sponsor : Sonova Australia Pty Ltd. 12 Inglewood Place, Norwest NSW 2153 Australia
And importer for European Union : Sonova Deutschland GmbH Max-Eyth-Str. 20 70736 Fellbach-Oeffingen, Germany Pat. www.sonova.com/en/intellectualproperty For a listing of Unitron group companies, please visit www.unitron.com

Distributor
Manufacturer: Sonova AG Laubisrütistrasse 28 CH-8712 Stäfa Switzerland unitron.com

References

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