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Tinnitus Management

Tinnitus Sound Generator module

Your ReSound hearing aids include the Tinnitus Sound Generator (TSG) module. The Tinnitus Sound
Generator (TSG) Module is a software tool that generates sounds to be used in tinnitus management
programs to relieve suffering from tinnitus. The TSG can generate sounds adjusted to your personal
preference and your specific therapeutic needs as determined by your doctor, audiologist or hearing
care professional. Depending on the selected hearing aid program and the environment you are in,
you may hear the therapeutic sound of a continuous or fluctuating noise.

Indications for use of the TSG module - (US only)

The Tinnitus Sound Generator module is a tool to generate sounds to be used in a Tinnitus
Management Program to temporarily 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.

TheTinnitus 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.

Tinnitus Management

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Содержание ReSound Key CSI12

Страница 1: ...User guide ReSound Custom hearing aids ...

Страница 2: ...n Left hearing aid Right hearing aid Serial number Serial number Model number Model number Battery type CIC size 10A o ITC ITE size 312 ITE size 13 Program Beep Description 1 One beep 2 Two beeps 3 Three beeps 4 Four beeps 2 ...

Страница 3: ...ids from your ears 15 How to use your hearing aids 17 Using a telephone 23 Advanced options 28 Wireless accessories 33 How to clean and maintain your hearing aids 35 General warnings and precautions 38 Hearing aid expectations 41 Troubleshooting 42 Warnings to Hearing Aid Dispensers US only 44 Tinnitus Management 47 Regulatory information 62 Additional information 70 3 ...

Страница 4: ...4 ...

Страница 5: ...ring 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 For devices including a Tinnitus Sound Generator module The Tinnitus Sound Generator module is a tool to generate sounds to be used in a Tinnitus Management Program to tem...

Страница 6: ... 1 Push button optional 2 7 10 4 1 3 5 Manufacturer XXXX 8 9 3 6 10 2 Battery door and On Off switch 3 Removal cord optional 4 Sound outlet 5 Wax filter 6 Vent 7 Microphone inlets 8 Manufacturer 9 Model designation and Serial number 10 Antenna 6 Your hearing aid ...

Страница 7: ...Your hearing aid In The Canal ITC In The Ear ITE 1 Microphone sound inlets 2 1 1 5 4 3 2 Push button optional 3 Battery door 4 Volume control optional 5 Vent Your hearing aid 7 ...

Страница 8: ...e battery door completely by using your fingernail Remove the used battery if present 2 Prepare the new battery Remove the protective foil to activate the battery Wait for 2 minutes before inserting the battery into the hearing aid 8 How to get your hearing aid ready for use ...

Страница 9: ... hearing aid is not in use open the battery door to turn it off Open the battery door completely to allow moisture to evaporate and prolong the hearing aids lifespan If the hearing aids are experiencing frequent loss of connection to wireless accessories contact your hearing care professional for a list of low impedance batteries Battery warnings Zinc air batteries can be harmful to your health Do...

Страница 10: ...atteries may build up heat If this happens please remove the batteries Do not attempt to dispose of batteries by burning them Used batteries are harmful to the environment Please dispose of them according to local regulations or return them to your hearing care professional NOTE Always use new zinc air batteries that have a minimum remaining shelf life of one year Low battery warning When the batt...

Страница 11: ...wer 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 hearing aid functions are affected as the power level declines If the hearing aids are experiencing frequent loss of connection to wireless accessories contact your hearing care professional for a list of low impedance batteries How to get your h...

Страница 12: ...Hearing aid Remote control Streaming Fully charged P P P Low 4 even tones P P x Depleted 3 even tones and 1 longer tone P x x These will work again when you insert a new battery 12 How to get your hearing aid ready for use ...

Страница 13: ...sert Completely In The Canal CIC In The Canal ITC and In The Ear ITE 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 Openin...

Страница 14: ...ver an easier method With proper insertion hearing aids should fit snugly but comfortably NOTE It may be helpful to pull your ear up and outward with your opposite hand during insertion 14 How to place the hearing aids in your ears ...

Страница 15: ...aring aids 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 index finger and pull out and slightly upward while slightly rotating your hand forward How to remove the hearing aids from your ears 15 ...

Страница 16: ... edges of the hearing aid with your thumb and index finger and pull out and slightly upward while slightly rotating your hand forward CAUTION Never attempt to modify the shape of the hearing aid yourself 16 How to remove the hearing aids from your ears ...

Страница 17: ...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 pitch beep How to use your hearing aids 17 ...

Страница 18: ...ontrol 2 or the ReSound Smart 3D app to adjust e g the volume Push button optional Your hearing aid has a push button allowing you to use up to four different listening programs The list on page 2 tells which programs have been enabled 1 Push the program button to switch between programs 2 You will then hear one or more beeps The number of beeps indicates which program you have selected one beep p...

Страница 19: ...ecrease The volume changes to one hearing aid are repeated on the other side to keep levels the same Telecoil Optional for ITC ITE models only Your hearing aid may have a telecoil The Telecoil function may help to improve understanding of speech with Hearing Aid Compatible HAC telephones and in theatres cinemas houses of worship etc that have a teleloop installed When you select the Telecoil progr...

Страница 20: ...ting correctly The sound from the teleloop and the hearing aids microphones can be mixed according to your preference Ask your hearing care professional for more details How to use the telecoil program To use your telecoil program with hearing loop systems follow these steps 1 Switch your hearing aids to the Telecoil program 2 Find a good spot Reception is not clear in all locations as it depends ...

Страница 21: ...sound To use a HAC phone follow these steps 1 Switch your hearing aid to the Telecoil program 2 Pick up the phone and make a call or answer a call 3 Hold the phone close to the hearing aid and tilt it slightly outwards 4 Listen to the dial tone and move the telephone to get the best reception 5 If needed adjust the volume 6 When you hang up switch back to your preferred program How to use your hea...

Страница 22: ...me in your hearing aids If you see a M3 M4 T3 or T4 on the box then the smartphone is HAC compliant If you find it difficult to obtain a good result while using your smartphone your hearing care professional will be able to give you advice on available wireless accessories to enhance listening capabilities Ask your hearing care professional for advice regarding HAC smartphones 22 How to use your h...

Страница 23: ...to your ear canal or hold it close to the hearing aid microphones as illustrated 2 If you hear whistling try holding the telephone in the same position for a few seconds The hearing aid may be able to cancel the whistling 3 You can also try holding the telephone slightly away from the ear NOTE Depending on your needs your hearing care professional may activate a function specifically for telephone...

Страница 24: ...s accessories to enhance listening capabilities Phone Now optional By placing a magnet on the telephone receiver your hearing aids automatically switch the telephone program 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 program NOTE Ask your hearing care professional to enable Phone Now as one of...

Страница 25: ...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 Phone Now precautions If you experience frequent signal loss or noise during calls move the magnet to another place on the telephone receiver Only use magnets supplied by ReSou...

Страница 26: ...ation of the Phone Now function In order to place the magnet properly 1 Clean the telephone thoroughly 2 Remove foil from magnet 3 Place the magnet NOTE If you are not satisfied with the strength of Phone Now you can reposition the magnet or add additional magnets 26 Using a telephone ...

Страница 27: ...on and a good hearing experience on the telephone If your hearing aids have enabled the Comfort Phone functionality the hearing aid on the non phone ear automatically attenuates Do not cover the phone loudspeaker opening with the magnet If the function does not work to your satisfaction moving the magnet to another position may improve ease of use and comfort If your hearing aids do not switch to ...

Страница 28: ...ids to be adjusted remotely without having to visit your hearing care professional This service also includes ReSound Assist Live With this service you can get face to face assistance from your hearing care professional from home All you need is a smart device with Internet enabled This allows you to 1 Request assistance remotely to adjust your hearing aids to be a better fit for you 2 Keep your h...

Страница 29: ... device is connected to the Internet Your hearing care professional will provide information regarding this option and how it works with the ReSound Smart 3D app Streaming from an Android smartphone Some Android smartphones can stream audio directly to the advanced models of our hearing aids Your device must be running Android 10 or newer and it must have the Android Streaming for Hearing Aids fea...

Страница 30: ... aids for which they were designed and we take no responsibility if the app is used with other hearing aids Do not disable app notifications Install updates to keep the app working correctly The app must only be used with ReSound hearing aids for which they are intended and ReSound takes no responsibility if the app is used with other hearing aids If you want a printed version of the smart phone a...

Страница 31: ...ontrol this option can be added by your hearing care professional However in some areas you are requested to turn off wireless communication CAUTION When boarding a flight or entering an area where RF transmitters are prohibited wireless functionality must be deactivated Turning off wireless communication enter Flight Mode 1 Open and close the battery door on each hearing aid three times within 10...

Страница 32: ...ommunication will be activated after 10 seconds NOTE It is important to wait an additional 15 seconds after wireless function resumes before opening and closing the battery compartment again for any reason Flight mode will resume if you open and close the battery compartment during this 15 second window 32 Advanced options ...

Страница 33: ...e to your hearing aids at a volume level that suits you ReSound Remote Control allows you to adjust the volume mute your hearing aids and change programs ReSound Remote Control 2 allows you to adjust the volume or mute your hearing aids change programs and see settings at a glance on its display ReSound Phone Clip streams phone conversations and stereo sound directly to both hearing aids and it do...

Страница 34: ...for streaming audio from a computer or music player NOTE Ask your hearing care professional for more information on the range of ReSound wireless accessories For use of wireless functionality only use ReSound wireless accessories For further guidance please refer to the user guide of the relevant ReSound wireless accessory 34 Wireless accessories ...

Страница 35: ... coating will be damaged Care and maintenance Please follow the advice below to have 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 your hearing aids when you are not wearing them 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 o...

Страница 36: ...eded 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...

Страница 37: ...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 NOTE Pressing on the new filter with the flat side of the wax filter tool can ensure that the filter is correctly in place If a different type of wax filter is used for your hea...

Страница 38: ...s 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 the 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 Hear...

Страница 39: ...ere radio frequency emission is prohibited 9 If a hearing aid is broken do not use it 10 A power hearing aid can produce very loud sound to compensate for a severe or profound hearing loss There is therefore a risk of further impairing the remaining hearing 11 External devices connected to the electrical input must be safe according to the requirements of IEC 60601 1 IEC 60065 EN IEC 62368 1 or IE...

Страница 40: ...ireless devices Although unlikely nearby electronic devices may be affected In that case move the hearing aid away from the affected electronic device 2 Use only original parts from the manufacturer e g wax guards 3 Only connect your hearing aids to accessories intended and qualified to be used with your hearing aids 40 General warnings and precautions ...

Страница 41: ...ting from organic conditions Consistent use of the hearing aid is recommended In most cases infrequent use does not permit you to get 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 Hearing aid expectations 41 ...

Страница 42: ...at a telephone receiver close to the 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 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 42 Troubleshooting ...

Страница 43: ...t or replace it with a new one Did your hearing aid get moist Use a desiccant drying kit Battery drains very quickly Did you leave your hearing aid switched on for longer 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 pack Troubleshooting 43 ...

Страница 44: ...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...

Страница 45: ...ian 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 w...

Страница 46: ...s 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 Children with hearing loss 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 because hearing loss may cause problems in language development and...

Страница 47: ...r the therapeutic sound of a continuous or fluctuating noise Indications for use of the TSG module US only The Tinnitus Sound Generator module is a tool to generate sounds to be used in a Tinnitus Management Program to temporarily 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...

Страница 48: ...unds to be used in tinnitus management programs to relieve suffering from tinnitus Explanation of how the device works 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...

Страница 49: ... 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 monito...

Страница 50: ...tus 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 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 There...

Страница 51: ... 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 supported hearing aids when a hearing care professional has enabled the TSG functionality during fitting of the hearing aid NOTE To use smartphone apps the hearing aid must be connected with the smartphone or mobile device Tinnitus Management 51 ...

Страница 52: ...gnal which can be shaped with the following configurations High pass filter Low pass filter 500 Hz 2000 Hz 750 Hz 3000 Hz 1000 Hz 4000 Hz 1500 Hz 5000 Hz 2000 Hz 6000 Hz 8000 Hz The white noise signal can be modulated in amplitude with an attenuation depth of up to 14 dB 52 Tinnitus Management ...

Страница 53: ...rceived decrease in auditory function or increase in tinnitus perception you should discontinue use of sound generator and seek medical evaluation Children and physically or mentally challenged users will require training by a doctor audiologist hearing care professional or the guardian for the insertion and removal of the hearing aid containing the TSG module Important notice for prospective soun...

Страница 54: ...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 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 counselling and or in a tinnitus management pro...

Страница 55: ...perly used Sound generators should be used only as advised by your doctor audiologist or hearing care professional Sound generators are not toys and should be kept out of reach of anyone who might cause themselves injury especially children and pets Tinnitus Management 55 ...

Страница 56: ...d discontinue use of the sound generator and seek medical evaluation To prevent unintended usage by paediatric or physically or mentally disabled users the volume control must if enabled be configured to only provide a decrease of the sound generator output level Children and physically or mentally disabled users will require guardian supervision while wearing the TSG hearing aid 56 Tinnitus Manag...

Страница 57: ...ive 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 o...

Страница 58: ...comfortable levels 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 Discontinue use of the sound generator and consult promptly with a licensed...

Страница 59: ...le 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 5 Children and physically or mentally disabled users will require guardian supervision while wearing the TSG hearing aid 6 Adjustment of the Tinnitus Sound Gener...

Страница 60: ...e 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 ...

Страница 61: ...ions 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 Tinnitus Management 61 ...

Страница 62: ... 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 Hearing aids that malfunction must be repaired b...

Страница 63: ...lues of 0 C 32 F to 45 C 113 F at a relative humidity of 90 non condensing During transport or storage the temperature should not exceed the limit values of 20 C 4 F to 60 C 140 F at a relative humidity of 90 RH non condensing for a limited time Regulatory information 63 ...

Страница 64: ...de 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 harmf...

Страница 65: ...irements according to Annex I of Council Directive 93 42 EEC for medical devices MDD Hereby GN ReSound A S declares that the radio equipment types CSX10 CSX12 CSX13 CSI12 and CSI13 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 declarations resound com In US FCC CFR 47 Part 15 subpart C Other identifi...

Страница 66: ...re CSX12 FCC ID X26CSX12 IC 6941C CSX12 CSX13 FCC ID X26CSX13 IC 6941C CSX13 CSI12 FCC ID X26CSI12 IC 6941C CSI12 CSI13 FCC ID X26CSI13 IC 6941C CSI13 and CSX10 FCC ID X26CSX10 IC 6941C CSX10 This device includes an RF transmitter which operates in the frequency band of 2 4 GHz 2 48 GHz Hearing aid variants Completely in the canal CIC hearing aids including type CSX10 with FCC ID X26CSX10 IC numbe...

Страница 67: ...DW HP KE4ITC DW UP KE3ITC DW UP KE2ITC DW UP In the ear ITE hearing aids including type CSI13 with FCC ID X26CSI13 IC number 6941C CSI13 models with size 312 or 13 battery are available in the following variants KE4ITE DW MP KE3ITE DW MP KE2ITE DW MP KE4ITE DW HP KE3ITE DW HP KE2ITE DW HP KE4ITE DW UP KE3ITE DW UP KE2ITE DW UP Nominal RF output power transmitted is CSI12 1 36 dBm CSI13 1 36 dBm CS...

Страница 68: ...structions for use Do not dispose of your hearing aids and batteries with ordinary household waste Your hearing aids and batteries should be disposed of at sites intended for electronic waste or returned to your hearing care professional for safe disposal Please ask your local hearing care professional concerning disposal of your hearing aid NOTE There may be specific regulations in your country P...

Страница 69: ...Complies with ACMA requirements Complies with IMDA Standards DA105282 Complies with IMDA standards Regulatory information 69 ...

Страница 70: ...C60118 0 Edition 3 0 2015 06 IEC60118 7 and ANSI S3 22 2009 supply Voltage 1 3V All Low Power LP models CIC models 114 dB SPL typical All Medium Power MP models 118 dB SPL typical All High Power HP models 120 dB SPL typical All Ultra Power UP models Not CIC models 129 dB SPL typical 70 Additional information ...

Страница 71: ...st 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 DISCLAIM...

Страница 72: ...r to meet Apple performance standards Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards 2020 GN Hearing A S All rights reserved ReSound is a trademark of GN Hearing A S Apple the Apple logo iPhone iPad iPod touch are trademarks of Apple Inc registered in the U S and other countries App Store is a service mark of Apple Inc registered in...

Страница 73: ...Notes Additional information 73 ...

Страница 74: ...Notes 74 Additional information ...

Страница 75: ...Notes Additional information 75 ...

Страница 76: ...stralia Tel free 1800 658 955 resound com New Zealand GN Hearing New Zealand Limited Ground Floor North Entrance 4 Fred Thomas Drive Takapuna Auckland 0622 Tel free 0800 900 126 resound com Singapore GN Hearing Pte Ltd 456 Alexandra Road 22 01 Singapore 119962 Tel 65 6320 9388 resound com Any issues relating to the EU Medical DeviceDirective 93 42 EEC or EU Radio Equipment Directive 2014 53 EU sho...

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