Interton RD4CIC-UP, RD6CIC-MP, RD4CIC-HP, RD4CIC-MP, RD4CIC-LP User Manual

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Page 1
User guide
Custom hearing aids
Interton Ready
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32
Left Hearing Aid Right Hearing Aid
Model number Model number
Battery size & design
CIC size 10A ITC size 312 ITE size 13
Programme Beep Description
1
2
3
4
Specific features supported by your hearing system:
Power-on Delay on page 16 AutoPhone on page 25 Telecoil on page 27 Tinnitus Sound Generator on page 30
Hearing aid type designations for models included in this user guide are:
DA312i, FCC ID: X26DA312i, IC: 6941C-DA312i; and DA13i, FCC ID: X26DA13i, IC: 6941C-DA13i. Please see page 8 for a list of models referring to these types.
This device includes an RF transmitter which operates in the frequency band of 2.4 GHz – 2.48 GHz. Nominal RF output power transmitted is 0 dBm.
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1 Introduction
Congratulations on the purchase of your new hearing aids. Interton’s innovative sound technology and design, combined with the customized programming selected by your hearing care professional, will make hearing a more enjoyable experience.
Please read this manual carefully in order to fully benefit from the use of your hearing aids. With proper care, maintenance, and usage, your hearing aids will serve you in better communication for many years.
This product is a custom-made device.
Ask your hearing care professional if you have any questions.
2 Intended use
Generic air-conduction hearing aids are wearable sound-amplifying devices intended to compensate for impaired hearing. The fundamental operating principle of hearing aids is to receive, amplify, and transfer sound to the eardrum of a hearing impaired person.
3 Becoming accustomed to amplification
While purchasing hearing aids is a major step, it is only one step in a process toward more comfortable hearing. Successfully adapting to the amplification your hearing aid provides takes time and consistent use.
You will enjoy more benefits from your Interton hearing aids by taking the following actions:
• Wear the hearing aids regularly in order to get comfortable with using them
• It takes time to get used to hearing aids. It may help to begin by wearing your hearing aid for short periods – even as little as 15 minutes – and then gradually increasing your wearing time. In a way, it is no different from adjusting to contact lenses. Speak to you hearing care professional, who can design a schedule tailored just for you.
• As you get more comfortable with them, increase the wearing time and wear your hearing aids in multiple types of listening environments.
It may take as long as several months for your brain to get used to all the “new” sounds around you. Following these suggestions will give your brain time to learn how to interpret amplification and in­crease the benefits you get from using Interton hearing aids.
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4 Statement
This device complies with part 15 of the FCC rules and ISED rules. 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.
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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 and ISED rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, uses and can radiate radio frequency energy and, if not installed and used in accord­ance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures:
• Reorient or relocate the receiving antenna.
• Increase the separation between the equipment and receiver.
• Connect the equipment into an outlet on a circuit different from the one in which the re­ceiver is connected.
• Consult the dealer or an experienced radio/TV technician for help.
Changes or modifications can void the user´s authority to operate the equipment.
The products are in compliance with the following regulatory requirements:
• In EU: the device conforms to the Essential Requirements according to Annex I of Council Direc­tive 93/42/EEC for medical devices (MDD).
• Hereby, Interton A/S declares that the radio equipment types DA312i and DA13i are in compliance with Directive 2014/53/EU. The full text of the EU declaration of conformity is available at the following internet address: www.interton.com/legal
• In US: FCC CFR 47 Part 15, subpart C.
• Other identified applicable international regulatory requirements in countries outside the EU and US. Please refer to local country requirements for these areas.
• In Canada: these hearing aids are certified under the rules of ISED.
• Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is granted pursuant to the Japanese Radio Law (電波法) and the Japanese telecommunications Business Law (電気通信事業法) This device should not be modified (otherwise the granted desig­nation number will become invalid).
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Completely-in-the-canal (CIC) hearing aids with size 10A battery are available in the following variants: RD6CIC-UP, RD6CIC-HP, RD6CIC-MP, RD6CIC-LP, RD4CIC-UP, RD4CIC-HP, RD4CIC-MP, RD4CIC-LP, RD3CIC-UP, RD3CIC-HP, RD3CIC-MP, RD3CIC-LP, RD2CIC-UP, RD2CIC-HP, RD2CIC-MP, RD2CIC-LP
In-the-canal (ITC) hearing aids (including type DA312i with FCC ID X26DA312i, IC number 6941C-DA312i models designated by a “W”) with size 312 are available in the following variants: RD6ITC-DW-UP, RD6ITC-DW-HP, RD6ITC-DW-MP, RD6ITC-D-UP, RD6ITC-D-HP, RD6ITC-D-MP, RD6ITC-W-UP, RD6ITC-W-HP, RD6ITC-W-MP, RD6ITC-UP, RD6ITC-HP, RD6ITC-MP, RD4ITC-DW-UP, RD4ITC-DW-HP, RD4ITC-DW-MP, RD4ITC-D-UP, RD4ITC-D-HP, RD4ITC-D-MP, RD4ITC-W-UP, RD4ITC-W-HP, RD4ITC-W-MP, RD4ITC-UP, RD4ITC-HP, RD4ITC-MP, RD3ITC-DW-UP, RD3ITC-DW-HP, RD3ITC-DW-MP, RD3ITC-D-UP, RD3ITC-D-HP, RD3ITC-D-MP, RD3ITC-W-UP, RD3ITC-W-HP, RD3ITC-W-MP, RD3ITC-UP, RD3ITC-HP, RD3ITC-MP, RD2ITC-DW-UP, RD2ITC-DW-HP, RD2ITC-DW-MP, RD2ITC-D-UP, RD2ITC-D-HP, RD2ITC-D-MP, RD2ITC-W-UP, RD2ITC-W-HP, RD2ITC-W-MP, RD2ITC-UP, RD2ITC-HP, RD2ITC-MP
In-the-ear (ITE) hearing aids (including type DA13i with FCC ID X26DA13i, IC number 6941C-DA13i mod­els designated by a “W”) with size 13 battery are available in the following variants: RD6ITE-DW-UP, RD6ITE-DW-HP, RD6ITE-DW-MP, RD4ITE-DW-UP, RD4ITE-DW-HP, RD4ITE-DW-MP, RD3ITE-DW-UP, RD3ITE-DW-HP, RD3ITE-DW-MP, RD2ITE-DW-UP, RD2ITE-DW-HP, RD2ITE-DW-MP
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5 Contents
1 Introduction ........................................................ 4
2 Intended use ....................................................... 4
3 Becoming accustomed to amplification ........ 5
4 Statement ........................................................... 6
5 Contents ............................................................10
6 Descriptions ......................................................12
6.1 Your hearing aid - Completely In the Canal
(RD CIC) ...................................................................12
6.2 Your hearing aid - In the Canal (RD ITC) .........13
6.3 Your hearing aid - In the Ear (RD ITE)............. 14
7 Getting started ................................................ 16
7.1 On/Off function .................................................... 16
7.1.1 Power-on Delay .................................................... 16
7.2 Inserting/Replacing the battery ....................... 16
7.3 Low battery indicator ......................................... 18
7.3.1 Low battery indicator when paired with
wireless accessories only (optional) ................ 18
7.4 Insert/remove hearing aids ............................... 19
7.4.1 Insert Completely-In-Canal, In-The-Canal,
and In-The-Ear ...................................................... 19
7.4.2 Remove Completely-In-Canal ...........................20
7.4.3 Remove In-The-Canal and In-The-Ear ............. 20
7.5 Operation of the hearing aid ..............................21
7.5.1 Volume control (optional) ...................................21
7.5.2 Push button (optional) ........................................22
8 Telephone use .................................................. 23
8.1 Using Interton Hearing Aids with
iPhone, iPad, and iPod touch (optional) .........23
8.2 Using Interton hearing aids with
Smartphone apps (optional) .............................24
8.3 Cellular phones .....................................................24
8.4 AutoPhone .............................................................25
8.4.1 Place the AutoPhone magnet ...........................25
8.4.2 How to use AutoPhone .......................................26
8.5 Telecoil (optional) ................................................27
8.5.1 Teleloop systems ................................................ 28
8.5.2 HAC Telephone .................................................... 28
8.6 Flight mode (optional) ........................................29
9 Tinnitus Sound Generator (TSG) module ....30
9.1 indication for use of the TSG module ............ 30
9.2 User instructions for the TSG module ........... 30
9.2.1 Description of the device ..................................30
9.2.2 Explanation of how the device functions ........31
9.2.3 The scientific concepts that form the basis for
the device ...............................................................31
9.2.4 TSG volume control ..............................................31
9.2.5 Using TSG with smartphone apps .................... 32
9.3 Technical Specifications .....................................33
9.3.1 Audio signal technology .....................................33
9.3.2 Available sounds ..................................................33
9.3.3 Prescription use of a Tinnitus Sound
Generator (TSG) hearing aid ............................34
9.3.4 Important notice for prospective sound
generator users ...................................................34
9.4 Tinnitus Sound Generator warnings ................35
9.4.1 Tinnitus Sound Generator precautions ..........35
9.4.2 Tinnitus Sound Generator warning to hearing
care professionals ............................................... 36
10 Wireless accessories ....................................... 37
11 Care and maintenance ....................................37
11.1 Daily maintenance .............................................. 38
11.2 Replacing wax filters ...........................................39
11.2.1 Change HF3 wax filters .......................................39
11.2.2 Change Cerustop (white) wax filters ..............40
12 General warnings ..............................................41
13 Using Interton hearing aids with
Interton apps for smartphones ....................43
13.1 Intended use of Interton apps for
smartphones: ....................................................... 43
13.2 General precautions ........................................... 43
14 AutoPhone warnings.......................................44
14.1 AutoPhone precautions.....................................44
15 Battery warnings .............................................45
16 Hearing aid expectations ...............................47
17 Warning to hearing care professionals
(US Only) ...........................................................47
18 Important notice for prospective hearing
aid users (US Only) .........................................48
19 Children with hearing loss (US Only) ...........49
20 Technical Specifications.................................49
21 Troubleshooting guide ....................................50
22 Warranties and repairs ...................................54
23 Temperature test, transport and storage
information .......................................................54
24 Advisories .........................................................55
25 Acknowledgments ...........................................57
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6 Descriptions
6.1 Your hearing aid
- Completely In the Canal (RD CIC)
1. Push button (optional)
2. Battery door and On/Off switch
3. Removal cord (optional)
4. Sound outlet
5. Wax filter
6. Vent
7. Microphone sound inlet(s)
8. Volume control (optional)
9. Model
10. Manufacturer
11. Serial number
6.2 Your hearing aid
- In the Canal (RD ITC)
1. Push button (optional)
2. Battery door and On/Off switch
3. Removal cord (optional)
4. Sound outlet
5. Wax filter
6. Vent
7. Microphone sound inlet(s)
8. Volume control (optional)
9. Model
10. Manufacturer
11. Serial number
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6.3 Your hearing aid
- In the Ear (RD ITE)
1. Push button
2. Battery door and On/Off switch
3. Sound outlet
4. Wax filter
5. Ve nt
6. Microphone sound inlet(s)
7. Volume control (optional)
8. Model
9. Manufacturer
10. Serial number
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7 Getting started
Once you have placed the hearing aids in your ears, you can turn them on.
The hearing aid always starts in programme 1 (one) and with the preset volume.
7.1 On/Off function
1. Close the battery door to turn on the hearing aid in programme 1 (one).
2. Open the battery door to turn off the hearing aid. Use your fingernail to pull it open.
7.1.1 Power-on Delay
Power-on Delay delays the time before the hearing aid turns on after you close the battery door. With Power-on Delay, you will hear a beep ( etc.) for each second of the delay period (5 or 10 seconds delay). If you do not want to turn on the hearing aids prior to placing them on your ear, ask your hearing care professional to deactivate Power-on Delay.
7.2 Inserting/Replacing the battery
1. Open the battery door completely by using your fingernail. Remove the used battery if present.
2. Prepare the new battery (please refer to page 2 for information on appro­priate battery type/size for your hearing aid). Remove the protective foil to activate the battery.
On Off
3. Wait for 2 minutes before inserting the battery into the hearing aid.
4. Insert the new battery with the positive side in the correct position. Always insert the battery in the door: never directly into the hearing aid.
5. Gently close the battery door.
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1. Always use new Zinc-Air batteries that have a minimum remaining shelf life of 1 year.
2. Whenever the hearing aids are not in use, remember to turn them off to avoid unnecessary battery consumption.
3. At night, switch off the hearing aid and open the battery door completely to allow moisture to evaporate and prolong the hearing aid’s lifespan.
4. If the hearing aid is experiencing frequent loss of connection to Interton wireless accessories, contact your hearing care professional for a list of low impedance batteries.
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WARNING: Batteries contain dangerous substances and should be disposed of carefully in the interest of your safety and for the environment. Also, keep batteries away from pets, children and mentally disabled persons.
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7.3 Low battery indicator
When the batteries are low on power, your hearing aids reduce the volume, and play a melody every 15 minutes until they are empty and turn off.
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NOTE: Keep spare batteries on hand.
7.3.1 Low battery indicator when paired with wireless accessories only (optional)
The batteries drain faster when you use wireless functionalities like streaming from your smartphone or from your TV via our TV Streamer 2.
As the battery power goes down, the wireless functions stop working. A short melody every five min­utes indicates that battery power is too low.
The table below shows how the functionality shifts with the power level of the battery.
Battery level Signal Hearing aid Remote Control Streaming
Fully charged
P P P
Low
P P O
Depleted (change battery)
P O O
7.4 Insert/remove hearing aids
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CAUTION: Never attempt to modify the shape of the hearing aid, ear-moulds, or tubing yourself.
7.4.1 Insert Completely-In-Canal, In-The-Canal, and In-The-Ear
1. Hold the hearing aid between your thumb and index finger, either above and below or on the sides.
2. Place the sound outlet portion into your ear canal. Turn the top part of the hearing aid gently backwards and forwards so that it tucks behind the fold of skin above your ear canal.
3. Insert the hearing aid into your ear canal. Opening and closing your mouth may ease insertion.
By experimenting, you may discover an easier method. With proper insertion, hearing aids should fit snugly but comfortably.
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NOTE: It may be helpful to pull your ear up and outward with your opposite hand during inser­tion.
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7.4.2 Remove Completely-In-Canal
1. Hold the removal cord with your thumb and index finger and pull outward.
2. Hold the edges of the hearing aid with your thumb and forefinger and pull outward while slightly rotating your hand forward.
7.4.3 Remove In-The-Canal and In-The-Ear
1. Hold the edges of the hearing aid with your thumb and forefinger.
2. Pull outward while slightly rotating your hand forward.
7.5 Operation of the hearing aid
7.5.1 Volume control (optional)
Your hearing aid has automatic volume control, which is individually set during the fitting session. However, the volume control (if present) allows you to adjust the volume of your hearing aids to your liking.
1. To increase the volume, turn the volume control up.
2. To decrease the volume, turn the volume control down.
When you change the volume, the hearing aid responds with a beep. When you reach the upper or lower limits, the hearing aid responds with a low-pitched beep.
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NOTE: If you have two hearing aids with the Synchronised Volume Control function enabled, volume control adjustments to one hearing aid automatically repeats in the second hearing aid. When you change the volume on one of the hearing aids, it responds with one or more beeps. A beep in the second aid follows. NOTE: If your hearing aids support wireless Remote Control, you may use the Interton Remote Control or the smartphone app to adjust e.g. the volume.
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7.5.2 Push button (optional)
Your hearing aid has a programme button allowing you to use up to four different listening pro­grammes. The list on page 2 tells which programs have been enabled.
1. Tap the programme button to switch between programmes.
2. You will then hear one or more beeps. The number of beeps indi­cates which programme you have selected (one beep = programme one, two beeps = programme two, etc.).
3. When you turn the hearing aids off and then back on, they always return to the default setting (programme one and preset volume).
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NOTE: If you have two hearing aids with the Synchronised Push Button enabled, programme changes to one hearing aid automatically repeats in the second hearing aid. When you change a programme in one hearing aid, it responds with one or more beeps. The same number of con­firmation beeps in the second aid follow. This Synchronised Push Button can also be configured to allow one side to control volume increase and the other side to control volume decrease. The volume changes to one hearing aid are repeated on the other side to keep the levels the same.
8 Telephone use
Your hearing aid allows you to use the telephone as you ordinarily do. Finding the optimal position for holding a telephone may require practice. One or more of the following suggestions may be helpful:
1. Hold the telephone up to your ear.
2. Hold the telephone towards the top of the ear (closer to where the microphones are).
3. If whistling occurs, it may take a few seconds of holding the tel­ephone in the same position before the hearing aid eliminates the feedback.
4. Whistling may stop by holding the telephone slightly away from the ear.
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NOTE: Depending on your individual needs, your hearing care professional may activate a pro­gramme specifically for telephone use.
8.1 Using Interton Hearing Aids with iPhone, iPad, and iPod touch (optional)
Interton Ready are Made for Apple* and allow for direct communication and control with an iPhone, iPad, or iPod touch.
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NOTE: For assistance with pairing and using these products with your Interton Ready hearing aids, please contact your hearing care professional.
*
Feature is only available in Interton Ready 6 and 4 wireless models.
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8.2 Using Interton Ready with smartphone apps (optional)
Intended use of smartphone apps:
The app must only be used with Interton hearing aids for which they are intended, and Interton takes no responsibility if the app is used with other hearing aids.
Use with smartphone apps:
• Do not disable app notifications.
• Install updates to keep the app working correctly.
• Only use the app with Interton hearing aids. Interton takes no responsibility if the app is used with other hearing aids.
• If you want a printed version of the smartphone app user guide, please go to our website at www. interton.com/get-going-customs or consult customer support.
8.3 Cellular phones
Your hearing aid complies with the most stringent Standards of International Electromagnetic Compat­ibility. However, not all cell phones are hearing aid compatible (HAC).
Any degree of disturbance can be due to the nature of your particular cellular phone or of your wireless telephone service provider.
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NOTE: If you find it difficult to obtain a good result while using your cellular phone, your hearing care professional will be able to give you advice on available wireless accessories to enhance listening capabilities.
8.4 AutoPhone
By placing a magnet on the telephone receiver, your hearing aids automatically switch the telephone programme on when the receiver is close to your ear.
When you remove the receiver from your ear, the hearing aids automatically return to the previous listening programme.
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NOTE: Ask your hearing care professional to enable AutoPhone as one of your programmes.
8.4.1 Place the AutoPhone magnet
Follow these steps in order to place the AutoPhone magnet properly:
Clean the telephone thoroughly. Remove foil from magnet. Place the magnet.
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WARNING: IF A MAGNET IS SWALLOWED, SEEK IMMEDIATE ASSISTANCE FROM A MEDICAL PRACTITIONER.
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NOTE: Ask your hearing care professional to enable AutoPhone as one of your programmes. NOTE: Do not cover the loudspeaker opening with the magnet. NOTE: If AutoPhone does not work to your satisfaction, moving the magnet to another
position may improve ease of use and comfort while speaking. NOTE: If the hearing aids do not switch to the telephone programme every time, you can reposition the AutoPhone magnet or add additional magnets. NOTE: Use a recommended cleaning agent.
8.4.2 How to use AutoPhone
1. Lift the telephone to your ear.
2. When you hear a short melody, the phone programme is active.
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NOTE: You may need to move the telephone receiver slightly to find the best position for reliable AutoPhone activation and good hearing on the telephone.
NOTE: If your hearing aids have enabled the Comfort Phone functionality, the hearing aid on the non-phone ear automatically turns down the volume.
8.5 Telecoil (optional)
Your hearing aid may be equipped with a telecoil. The Telecoil programme may help to improve speech understanding with Hearing Aid Compatible telephones and in theatres, cinemas, houses of worship etc. that has teleloop installed.
The telecoil cannot work without a teleloop (a.k.a. induction-loop) or a Hearing Aid Compatible (HAC) telephone. When you switch on the Telecoil programme, your hearing aids pick up signals from the teleloop or HAC telephone.
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NOTE: If you are having trouble hearing with the teleloop, ask you hearing care professional to adjust the programme. NOTE: If there is no sound from the hearing aids in a teleloop system and an active Telecoil pro­gramme, the teleloop system may not be turned on or is not operating correctly.
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8.5.1 Teleloop systems
To use teleloop systems, follow these steps:
1. Switch your hearing aid to the Telecoil programme.
2. Find a good spot. Reception is not clear in all locations; it depends on the induction loop. Look
for signs or find another spot to sit.
3. If needed, adjust the volume.
4. When you leave, switch to programme 1.
8.5.2 HAC Telephone
The telecoil picks up the HAC telephone’s telecoil signal and converts it to sound.
To use the HAC telephone, follow these steps:
1. Switch your hearing aid to the Telecoil programme.
2. Pick up the telephone and place a call or answer a call.
3. Hold the telephone behind your ear – close to the hearing aid, and tilt it slightly outwards.
4. Listen to the dialling tone and move the telephone to get the best reception.
5. If needed, adjust the volume.
6. When you hang up, switch to programme 1.
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NOTE: If the phone has a poor telecoil signal, use the microphone programme. To avoid whistling, do not hold the handset too tightly against your ear.
8.6 Flight mode (optional)
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WARNING: When boarding a flight or entering an area where RF transmitters are prohibited, deactivate wireless functionality.
Your Interton Ready hearing aid allows you to control it from your smartphone or Interton Remote Control. However, in some areas you are requested to turn off wireless communication.
Follow these steps to turn off wireless mode:
1. For each hearing aid, open and close (open-close, open-close, open-close) the battery door three times within a 10-second period.
2. Double-dings for ten seconds ( etc.) indicate that your hearing aid is in Flight mode.
Follow these steps to activate wireless mode:
1. For each hearing aid, open and close the battery door once.
2. Your hearing aids are in wireless mode after 10 seconds.
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NOTE: Both hearing aids must be set in Flight mode - even with synchronisation enabled. NOTE: It is important to wait an additional 15 seconds after wireless function resumes before
opening and closing the battery door again for any reason. Flight mode will resume if you open and close the battery door during this 15-second window.
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9 Tinnitus Sound Generator module
Your Interton hearing aid includes the Tinnitus Sound Generator (TSG) module, a tool for generating sounds to be used in tinnitus management programmes to relieve suffering from tinnitus. The TSG can generate sounds adjusted to the specific therapeutic needs and your personal preference as determined by your doctor, audiologist, or hearing care professional. Depending on the selected hearing aid programme and the environment you are in, you will sometimes hear the therapeutic sound resembling a continuous or fluctuating noise.
9.1 Indication for use of the TSG module
The Tinnitus Sound Generator Module is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from Tinnitus. The target population is primarily the adult popula­tion over 18 years of age. This product may also be used with children 5 years of age or older.
The Tinnitus Sound Generator module is targeted for healthcare professionals, which are treating patients suffering from Tinnitus, as well as conventional hearing disorders. The fitting of the Tinnitus Sound Generator module must be done by a hearing professional participating in a Tinnitus Manage­ment Program.
9.2 User instructions for the TSG module
9.2.1 Description of device
The Tinnitus Sound Generator (TSG) Module is a software tool that generates sounds to be used in tin­nitus management programmes to relieve suffering from tinnitus.
9.2.2 Explanation of how the device functions
The TSG module is a frequency and amplitude shaped white-noise generator. Noise signal level and fre­quency characteristics can be adjusted to the specific therapeutic needs as determined by your doctor, audiologist or hearing care professional.
Your doctor, audiologist or hearing care professional can modulate the generated noise with the pur­pose of making it more pleasant. The noise can then resemble, for example, breaking waves on a shore.
9.2.3 The scientific concepts that form the basis for the device
The TSG module provides sound enrichment with the aim of surrounding the tinnitus sound with a neu­tral sound, which is easily ignored. Sound enrichment is an important component of most approaches to tinnitus management, such as Tinnitus Retraining Therapy (TRT).
To assist habituation to tinnitus, this needs to be audible. The ideal level of the TSG module, therefore, should be set so that it starts to blend with the tinnitus, and so that you can hear both your tinnitus as well as the sound used.
In a majority of instances, the TSG module can also be set to mask the tinnitus sound, so to provide temporary relief by introducing a more pleasant and controllable sound source.
9.2.4 TSG volume control
The sound generator is set to a specific loudness level by the hearing care professional. When switching the sound generator on, the volume will have this optimal setting. Therefore, it might not be necessary to control the volume (loudness) manually. However, the volume control provides the ability to adjust the volume, or amount of stimulus, to the liking of the user.
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The volume control is an optional feature in the TSG module used for adjusting the sound generator output level.
Modulation level and speed can also be configured to your likes and needs. An additional feature can be enabled by your hearing care professional that allows you to select predefined sounds that simulate sounds from nature, such as breaking waves or running water.
If you have two wireless hearing aids that support ear-to-ear synchronization, this functionality can be enabled by your hearing care professional. This will cause the Tinnitus Sound Generator to synchronize the sound in both hearing aids.
If your tinnitus troubles you only in quiet environments, your doctor, audiologist or hearing care profes­sional can set the TSG Module so that it becomes audible exclusively in such surroundings. The overall sound level can be adjusted via a volume control. Your doctor, audiologist or hearing care professional will review with you the need for having such a control.
For hearing aids where ear-to-ear synchronization is enabled your hearing care professional can also enable environmental monitoring synchronization so that the TSG noise level is automatically adjusted simultaneously in both hearing aids dependent on the background sound level. Additionally since the hearing aid has a volume control then the background noise level monitored by the hearing aid and the volume control can be used simultaneously to adjust the generated noise level in both hearing aids.
9.2.5 Using TSG with smartphone apps
The tinnitus sound generator control via hearing aid push buttons can be enhanced with wireless control from a TSG control app on a smartphone or mobile device. This functionality is available in sup-
ported hearing aids when a hearing care professional has enabled the TSG functionality during fitting of the hearing aid.
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NOTE: To use smartphone apps, the hearing aid must be connected with the smartphone or mobile device.
9.3 Technical specifications
9.3.1 Audio signal technology
Digital.
9.3.2 Available sounds
White noise signal which can be shaped with the following configurations: The white noise signal can be modulated in amplitude with an attenuation depth of up to 14 dB.
High-pass filter Low-pass filter
500 Hz 2,000 Hz
750 Hz 3,000 Hz
1,000 Hz 4,000 Hz
1,500 Hz 5,000 Hz
2,000 Hz 6,000 Hz
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The purpose of medical evaluation is to assure that all medically treatable conditions that may affect tinnitus are identified and treated before the sound generator instrument is used.
The sound generator instrument is a tool to generate sounds to be used with appropriate counseling and/or in a tinnitus management programme to relieve patients suffering from tinnitus.
9.4 i Tinnitus Sound Generator warnings
1. Sound generators should be used only as advised by your doctor, audiologist, or hearing care professional.
2. Sound generators are not toys and should be kept out of reach of anyone who might cause themselves injury (especially children and pets).
3. Sound generators can be dangerous if improperly used.
9.4.1 i Tinnitus Sound Generator precautions
1. Should the user develop any side effects from using the sound generator, such as dizziness, nausea, headaches, perceived decrease in auditory function or increase in tinnitus perception, the user should discontinue use of the sound generator and seek medical evaluation.
2. The volume control is a feature in the TSG module used for adjusting the sound generator output level. To prevent unintended usage by paediatric or physically or mentally disabled us­ers, the volume control must be configured to only provide a decrease of the sound generator output level.
3. Children and physically or mentally disabled users will require guardian supervision while wear­ing the TSG hearing aid.
9.3.3 i Prescription use of a Tinnitus Sound Generator hearing aid
The TSG module should be used as prescribed by your doctor, audiologist or hearing healthcare profes­sional. In order to avoid permanent hearing damages, the maximum daily usage depends on the level of the generated sound.
Should you develop any side effects from using the sound generator, such as dizziness, nausea, head­aches, perceived decrease in auditory function or increase in tinnitus perception, you should discon­tinue use of sound generator and seek medical evaluation.
The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. However, children and physically or mentally challenged us­ers will require training by a doctor, audiologist, hearing healthcare professional or the guardian for the insertion and removal of the hearing instrument containing the TSG module.
9.3.4 Important notice for prospective sound generator users
A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and band­width to mask internal noises. It is also used as an aid in hearing external noises and speech.
Good health practice requires that a person with a tinnitus condition have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before using a sound generator. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryn­gologists, otologists or otorhinolaryngologists.
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10 Wireless accessories
With Interton wireless accessories, you can stream sound from your TV or music player directly to your Interton hearing aids and you can also control them without wearing an intermediary device around your neck.
Ask your hearing care professional for more information on the range of Interton wireless accessories.
TV Streamer 2 allows you to stream the audio from TV sets and virtually any other audio source to your hearing aids at a volume level that suits you. Remote Control 2 allows you to adjust the volume or mute your hearing aids, change programmes, and see all your settings at a glance on its display. Phone Clip 2 streams phone conversations and stereo sound directly to both hearing aids, and it dou­bles as a simple remote control. Micro Mic is a body worn microphone for your friend or colleague. It significantly improves speech understanding in noisy situations. Multi Mic works like the Micro Mic but doubles as a table microphone. Connects with loop and FM sys­tems , and has a mini-jack input for streaming audio from a computer or music player.
11 i Care and maintenance
Please follow the advices below to hearing aidve the best user experience and to prolong the life of your hearing aids.
1. Keep your hearing aids dry and clean.
2. Open the battery door to dry out your hearing aids when you are not wearing them.
9.4.2 i Tinnitus Sound Generator warning to hearing care professionals
A hearing care professional should advise a prospective sound generator user to consult promptly with a licensed physician (preferably an ear specialist) before getting a sound generator. 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:
1. Visible, congenital or traumatic deformity of the ear.
2. History of active drainage from the ear within the previous 90 days.
3. History of sudden or rapidly progressive hearing loss within the previous 90 days.
4. Acute or chronic dizziness.
5. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
6. Audiometric air-bone gap equal to or greater than 15 dB at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
i
CAUTION: The maximum output of the sound generator falls into the range that can cause hear­ing loss according to OSHA regulations. In accordance with NIOSH recommendations, the user should not use the sound generator for more than eight (8) hours a day when this is set to a level of 85 dB SPL or above. When the sound generator is set to levels of 90 dB SPL or above the user should not use the sound generator for more than two (2) hours per day. In no case should the sound generator be worn at uncomfortable levels.
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3. Wipe the hearing aids with a soft cloth after use to remove grease or moisture.
4. Do not wear your hearing aids when putting on cosmetics, perfume, after-shearing aidve, hear­ing aidir spray, suntan lotion etc. These might discolour the hearing aid or get into the hearing aid causing damage.
5. Do not immerse your hearing aid in any liquid.
6. Keep your hearing aids away from excessive heat and direct sunlight. The heat may deform the shell, damage the electronics and deteriorate the surfaces.
7. Do not swim, shower or steam bathe while wearing your hearing aids.
11.1 i Daily maintenance
It is important to keep your hearing aid clean and dry. On a daily basis, clean the hearing aids using a soft cloth or tissue. In order to avoid damage due to humidity or excessive perspiration, the use of a drying kit is recommended.
11.2 Replacing wax filters
Custom hearing aids may have wax filters that protect against wax and moisture. It is recommended that these are changed as needed.
11.2.1 Change HF3 wax filters
1. Brush the sound outlet area with the sound outlet pointed down.
2. Insert the threaded end of the wax filter tool into the used wax filter, and gently rotate clock­wise.
3. Gently pull until the used filter is removed.
4. Discard the used filter in the slot located in the wax filter kit by pressing it into the centre, sliding it to one end of the slot, and pull until the filter is discarded.
5. Flip the wax filter tool around, locate a new filter in the dial, and press the tip of the tool into the center of the dial.
6. Gently pull the new filter out of the dial.
7. Align the new filter to the sound outlet.
8. Press the new filter into the opening, and simultaneously pull and rock back and forth until the new wax filter is in place.
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12 i General warnings
1. Consult a hearing care professional if you think there may be a foreign object in your ear canal, if you experience skin irritation, or if excessive earwax accumulates with the use of the hearing aid.
2. Different types of radiation, from e.g. NMR, MRI, or CT scanners, may damage hearing aids. It is recommended not to wear hearing aids during these or other similar procedures. Other types of radiation, such as burglar alarms, room surveillance systems, radio equipment, mobile tel­ephones, contain less energy and will not damage hearing aids. However, they have the potential to momentarily affect the sound quality or temporarily create undesired sounds from hearing aids.
3. Do not wear hearing aids in mines, oil fields, or other explosive areas unless those areas are certified for hearing aid use.
4. Do not allow others to use your hearing aids.
5. Hearing aid usage by children or mentally disabled persons should be supervised at all times to ensure their safety. The hearing aid contains small parts that could be swallowed by children. Please be mindful not to leave children unsupervised with this hearing aid.
6. Hearing aids should be used only as prescribed by your hearing care professional. Incorrect use may result in sudden and permanent hearing loss.
7. Warning to hearing care professionals: Special care should be exercised in selecting and fitting hearing aids with maximum sound pressure level that exceeds 132 dB SPL with an IEC 60711:1981 occluded ear simulator. The remaining hearing may risk further impairment.
8. Turn off your wireless functionality by using the flight mode in areas where radio frequency emission is prohibited.
9. If a hearing aid is broken, do not use it.
11.2.2 Change Cerustop (white) wax filters
1. To remove the old wax guard, insert the removal side of the wax guard tool into the used wax guard so that the shaft of the tool is touching the rim of the wax guard. Slowly pull the wax guard straight out.
2. To insert the new wax guard, gently press the replacement side of the wax guard tool straight into the hole of the sound outlet until the outer ring lies flush with the outside of the receiver. Pull the tool straight out -the new wax guard will remain in place.
i
TIP: Pressing on the new filter with the flat side of the wax filter tool can ensure that the filter is correctly in place. NOTE: If a different type of wax filter is used for your hearing aids, or if your hearing aids do not use wax filters, consult your hearing care professional for guidance.
i
CAUTION: Use only original Interton consumables e.g. wax filters.
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13 i Using Interton hearing aids with Interton apps for
smartphones
13.1 Intended use of Interton apps for smartphones:
Interton smartphone apps are intended to be used with Interton wireless hearing aids. Interton smart­phone apps send and receive signals from the Interton wireless hearing aids via smartphones for which the apps have been developed.
13.2 i General precautions
1. When wireless function is activated, the device uses low-powered digitally coded transmissions in order to communicate with other wireless devices. Although unlikely, nearby electronic devic­es may be affected. In that case, move the hearing aid away from the affected electronic device.
2. When using wireless functionality and the devices are affected by electromagnetic interference, move away from the source.
3. Use only original Interton consumables e.g. tubes and domes.
4. Only connect Interton hearing aids to Interton accessories intended and qualified to be used with Interton hearing aids.
10. External devices connected to the electrical input must be safe according to the requirements of IEC 60601-1, IEC 60065, or IEC 60950-1, as appropriate (wired connection, for example HI-PRO), SpeedLink).
i
For use of wireless functionality only use Interton wireless accessories. For further guidance regarding e.g. pairing, please refer to the user guide of the relevant Interton wireless accessory.
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15 i Battery warnings
Batteries contain dangerous substances and should be disposed of carefully in the interest of your safety and for the environment. Please note:
1. To save battery power, turn off your hearing aids when they are not in use.
2. Keep batteries away from pets, children and mentally challenged persons.
3. DO NOT place batteries in your mouth. Consult a physician immediately if a battery has been swallowed, as they can be harmful to your health.
4. DO NOT attempt to dispose of batteries by burning them.
5. Used batteries are harmful to the environment. Please dispose of them according to local regu­lations or return them to your hearing care professional.
6. Remove the batteries to prevent leakage when the hearing aids are not in use for an extended period of time.
i WARNING: BATTERIES MAY LEAK. REMOVE THE BATTERY IF YOU LEAVE THE HEARING AIDS
UNUSED FOR LONGER PERIODS. WARNING: DO NOT RECHARGE ZINC AIR BATTERIES – THEY MAY LEAK OR EXPLODE. WARNING: ZINC AIR BATTERIES CAN BE HARMFUL TO YOUR HEALTH:
• CONSULT A PHYSICIAN IMMEDIATELY IF A BATTERY HAS BEEN SWALLOWED
• DO NOT PLACE ZINC AIR BATTERIES IN YOUR MOUTH
• KEEP BATTERIES AWAY FROM CHILDREN, MENTALLY DISABLED PERSONS, AND PETS
DO NOT ATTEMPT TO DISPOSE OF BATTERIES BY BURNING THEM.
14 i AutoPhone warnings
1. If a magnet is swallowed, seek immediate advice from a medical practitioner.
2. Keep magnets out of reach of pets, children and mentally disabled persons.
3. The AutoPhone magnet may affect sensitive medical devices / electronic systems. Seek advice from the manufacturers regarding appropriate safety measures when using the AutoPhone solution near the sensitive device / equipment (pacemakers and defibrillators) in question. If the manufacturer cannot issue a statement, we recommend keeping the magnet or a telephone equipped with the magnet 30 cm (12") away from magnetically sensitive devices (e.g. pacemak­ers).
14.1 i AutoPhone precautions
1. If you experience frequent signal loss or noise during calls, move the AutoPhone magnet to another place on the telephone receiver.
2. Only use magnets supplied by Interton.
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16 i Hearing aid expectations
A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Consistent use of the hearing aid is recommended. In most cases, infrequent use does not permit you to obtain full benefit from it.
The use of a hearing aid is only part of hearing rehabilitation and may need to be supplemented by auditory training and instructions in lip-reading.
17 i Warning to hearing aid hearing care professionals (US Only)
A hearing care professional should advise a prospective hearing aid user to consult promptly 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:
1. Visible congenital or traumatic deformity of the ear.
2. History of active drainage from the ear within the previous 90 days.
3. History of sudden or rapidly progressive hearing loss within the previous 90 days.
4. Acute or chronic dizziness.
5. Unilateral hearing loss of sudden or recent onset within the previous 90 days.
6. Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
8. Pain or discomfort in the ear.
USED BATTERIES ARE HARMFUL TO THE ENVIRONMENT. PLEASE DISPOSE OF THEM ACCORD-
ING TO LOCAL REGULATIONS OR RETURN THEM TO YOUR HEARING CARE PROFESSIONAL.
IF THE BATTERIES ARE NOT INSERTED CORRECTLY, THE DEVICE WILL NOT WORK AND THE
BATTERIES MAY BUILD UP HEAT. IF THIS HAPPENS, PLEASE REMOVE THE BATTERIES.
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19 i Children with hearing loss (US Only)
In addition to seeing a physician for a 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 the 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.
20 Technical Specifications
Hearing aid model Maximum output
(Data in accordance with IEC60118-0 Edition3.0 2015­06, IEC60118-7 and ANSI S3.22-2009, supply Voltage
1.3V)
All Low Power (LP) models 115 dB SPL (typical)
All Medium Power (MP) models 119 dB SPL (typical)
All High Power (HP) models 121 dB SPL (typical)
All Ultra Power (UP) models 130 dB SPL (typical)
18 i Important notice for prospective hearing aid users (US Only)
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 assure 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 care professional, as appropriate, for a hearing aid evaluation. The audiologist or hearing care professional will conduct a hearing aid evalua­tion to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or hearing care professional to select and fit a hearing aid to your individual needs. If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial-rental or purchase-option programme. Many hearing care professionals now offer programmes 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 restricts the sale of hearing aids to those individuals who have obtained 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.
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21 Troubleshooting guide
SYMPTOM CAUSE POSSIBLE REMEDY
Feedback, “whistling”
Is your hearing aid sitting in the ear correctly? Put it in again.
Is the volume very loud? Reduce it.
Is your hearing aid loose in your ear? Visit your hearing care professional.
Are you holding an object (e.g. a hat, a telephone receiver) close to a hearing aid?
Move your hand away to create more space between the hearing aid and the object.
Is your ear full of wax? Visit your physician.
No sound
Is the hearing aid turned on? Switch it on.
Is the hearing aid in telecoil mode? Switch to the microphone program.
Is there a battery in the hearing aid? Insert a new battery.
Is the battery still good? Replace with a new one.
Is your ear full of wax? Visit your physician.
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SYMPTOM CAUSE POSSIBLE REMEDY
Sound is distorted, splutter­ing or weak?
Is the battery dead? Replace it with a new one.
Is the battery dirty? Clean it or replace it with a new one.
Did your hearing aid get moist? Use a desiccant.
Battery drains very quickly
Did you leave your hearing aid switched on for long periods of time? Always switch off your hearing aid when you are not using them, e.g. during the night.
Is the battery old? Check the date on the battery packaging.
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22 Warranties and repairs
Interton provides a warranty on hearing aids in the event of defects in workmanship or materials, as described in applicable warranty documentation. In its service policy, Interton pledges to secure functionality at least equivalent to the original hearing aid. As a signatory to the United Nations Global Compact initiative, Interton is committed to doing this in line with environment-friendly best practices. Hearing aids therefore, at Interton’s discretion, may be replaced by new products or products manufac­tured from new or serviceable used parts, or repaired using new or refurbished replacement parts. The warranty period of hearing aids is designated on your warranty card, which is provided by your hearing care professional.
For hearing aids that require service, please contact your hearing care professional for assistance. Interton hearing aids that malfunction must be repaired by a qualified technician. Do not attempt to open the case of hearing aids, as this will invalidate the warranty.
23 Temperature test, transport and storage information
Interton hearing aids are subjected to various tests in temperature and damp heating cycling between
-25 °C and +70 °C according to internal and industry standards.
During transport or storage, the temperature should not exceed the limit values of -20 °C to +60 °C and relative humidity of 90% RH, non-condensing (for limited time). An air pressure between 500 and 1100 hPa is appropriate.
24 Advisories
Be aware of information marked with the warning symbol:
i WARNING points out a situation that could lead to serious injuries. i CAUTION indicates a situation that could lead to minor and moderate injuries.
i Advice and tips on how to handle your hearing aid better.
Equipment includes RF transmitter
Please ask your local hearing care professional concerning disposal of your hearing aid.
i NOTE: Country specific regulations apply.
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© 2018 GN Hearing GmbH. All rights reserved. Interton is a trademark of GN Hearing GmbH. Apple, the Apple logo, iPhone, iPad, iPod touch are trademarks of Apple Inc., registered in the U.S. and other countries.
i
Use of the Made for Apple badge means that an acces­sory has been designed to connect specifically to iPhone, iPad and iPod touch models, 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.
25 Acknowledgments
Portions of this software are written by Kenneth MacKay (micro-ecc) and licensed under the following terms and conditions:
Copyright ® 2014, Kenneth MacKay. All rights reserved.
Redistribution and use in source and binary forms, with or without modification, are permitted provided that the following conditions are met: * Redistributions of source code must retain the above copyright notice, this list of conditions and the
following disclaimer.
* Redistributions in binary form must reproduce the above copyright notice, this list of conditions and
the following disclaimer in the documentation and/or other materials provided with the distribution.
THIS SOFTWARE IS PROVIDED BY THE COPYRIGHT HOLDERS AND CONTRIBUTORS “AS IS” AND ANY EXPRESS OR IMPLIED WARRANTIES, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY AND FITNESS FOR A PARTICULAR PURPOSE ARE DISCLAIMED. IN NO EVENT SHALL THE COPYRIGHT HOLDER OR CONTRIBUTORS BE LIABLE FOR ANY DIRECT, INDIRECT, INCI­DENTAL, SPECIAL, EXEMPLARY, OR CONSEQUENTIAL DAMAGES (INCLUDING, BUT NOT LIMITED TO, PROCUREMENT OF SUBSTITUTE GOODS OR SERVICES; LOSS OF USE, DATA, OR PROFITS; OR BUSI­NESS INTERRUPTION) HOWEVER CAUSED AND ON ANY THEORY OF LIABILITY, WHETHER IN CON­TRACT, STRICT LIABILITY, OR TORT (INCLUDING NEGLIGENCE OR OTHERWISE) ARISING IN ANY WAY OUT OF THE USE OF THIS SOFTWARE, EVEN IF ADVISED OF THE POSSIBILITY OF SUCH DAMAGE.
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Page 31
400942000GB-18.04-Rev.A
Faceplate/Electronics by: Interton A/S Any issues relating to the EU Medical Device Directive 93/42/EEC or EU Radio Equipment Directive 2014/53/EU should be directed to Interton A/S.
Worldwide Headquarters
Interton A/S Lautrupbjerg 7 DK-2750 Ballerup Denmark Tel.: +45 4575 1111 interton.com
CVR no. 55082715
United Kingdom
GN Hearing Ltd. Kirtlington Business Centre Portway Kirtlington Oxon OX5 3JA Tel.: +44 1869 352 800 interton.com
Australia
GN Hearing Australia Pty. Ltd. Gate C, 19-25 Khartoum Road Macquarie Technology Park Macquarie Park NSW 2113 Tel.: (free) 1800 658 955 interton.com
Singapore
GN Hearing Pte. Ltd. 2 Kallang Avenue #07-19 CT HUB Singapore - 339407 Tel: +65 6320 9388 interton.com
New Zealand
GN Hearing NZ Ltd. Ground Floor, North Entrance 4 Fred Thomas Drive Takapuna, Auckland, 0622 Tel.: (free) 0800 900 126 interton.com
Manufacturer according to EU Medical Device Directive 93/42/EEC:
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