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BEB60 BEB80 User manual 401244000GB-19.10-Rev.A-WEB | Users Manual | 926.24 KiB | January 28 2020 / April 27 2020 | delayed release | ||
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1 | BEB60 BEB80 User manual 401244000GB-19.10-Rev.A-WEB | Users Manual | 926.24 KiB | January 28 2020 / April 27 2020 | delayed release |
User guide ReSound Behind-The-Ear hearing aids resound.com Hearing aid information Left hearing aid Right hearing aid Serial number Model number Battery type 312 13 Serial number Model number Program Beep Description 1 2 3 4 One beep Two beeps Three beeps Four beeps 2 Table of Contents Introduction Your hearing aid How to get your hearing aid ready for use How to place the hearing aids in your ears How to remove the hearing aids from your ears How to use your hearing aids Direct Audio Input (optional) Advanced options Wireless accessories Tinnitus Management How to clean and maintain your hearing aids 3 5 6 7 13 16 17 23 25 33 39 41 Warnings to hearing care professionals (US only) General warnings Troubleshooting Regulatory information Hearing aid variants Technical specifications Additional information 51 54 57 60 65 66 69 4 Introduction Thank you for choosing our hearing aids. We recommend that you use your hearing aids every day -
this way you will fully benefit from them. NOTE: Read this booklet carefully before you start using your hearing aids. Intended use Generic air-conduction hearing aids are wearable sound-amplifying devices intended to compensate forimpaired hearing.The fundamental operating principle of hearing aids is to receive, amplify, and transfersound 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 Programme 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 12 years of age or older. 5 Your hearing aid New entry 3 New entry 4 6 How to get your hearing aid ready for use Battery warnings WARNING: Batteries contain dangerous substances and should be disposed of carefully in the interest of your safety and for the environment. Please note:
1. Keep batteries away from pets, children and mentally challenged persons. 2. 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. 3. Do not attempt to recharge batteries (Zinc-Air) which are not specifically designated as rechargeable because they may leak or explode. 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. WARNING: Batteries may leak. Remove the battery if you leave the hearing aids unused for longer periods. 7 WARNING: 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. How to change the battery 1. Prepare the new battery. Remove the protective foil to activate the battery -
wait for 2 minutes before inserting the battery into the hearing aid 2. Open the battery door completely using your fingernail 3. Remove the used battery 4. Insert the new battery with the positive side (+) facing upwards. Always insert the battery in the door, never directly into the hearing aid. 5. Close the battery door Please observe the following:
1. To save battery power, turn off your hearing aids when they are not in use. 8 2. At night, switch off the hearing aid and open the battery door completely to allow moisture to evaporate. This prolongs the hearing aid's lifespan. 3. If the hearing aid frequently looses connection with wireless accessories, contact your hearing care professional for a list of appropriate batteries. Battery door lock If the hearing aid is going to be used by a child or a mentally disabled person, you can ask your hearing care professional to make a battery door lock available for you. You can turn the hearing aid on and off as you usually do, but you will have to unlock the battery door every time you need to change the battery. How to use the battery door lock For model 88:
9 To lock the battery door:
1. Open the battery door to the OFF position. 2. Use the tool provided with your battery door lock to push the slider from the left side to the rigth side. To unlock the battery door simply repeat the same procedure but pushing the slider to the right instead. You can now change the battery as described in How to change the battery. NOTE: The battery lock is not available for 67 models. For model 98:
10 To lock the battery door:
1. Insert the tool straight into the battery door lock. 2. Slide lock to the left. 3. An indication mark shows that the battery door is in the locked position (you will be able to see a white dot). To unlock the battery door simply repeat the same produce but sliding the lock to the right instead. You can now change the battery as described in How to change the battery. Low battery warning 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. 11 Low battery indicator when paired with wireless accessories (optional) The batteries drain faster when you use wireless functionalities like direct streaming from your iPhone or streaming sound from your TV with our TV Streamer. When the batteries deplete, the support of some wireless accessories shut down. Full functionality returns when you insert a new battery. The table below shows how the functionality changes with the battery level. Battery level Signal Hearing aid Remote control Streaming Fully charged Low Depleted (change battery) P P x P x x P P P 12 How to place the hearing aids in your ears How to tell right from left If you have two hearing aids, they may be tuned differently. One for your left ear, the other for your right. Do not swap them. Please pay attention to this when cleaning, storing and inserting the hearing aids. You might want to ask your hearing care practitioner to mark your hearing aids with a coloured Left and Right indication: Left is blue and Right is red. 13 How to place your hearing aids behind your ears How to insert the earmould in your ear:
1. Hold the earmould 3. Turn the top part of the 5. Place the hearing aid firmly behind the ear and make sure it sits securely. between your thumb and index finger and position its sound outlet in your ear canal. 2. Slide the earmould all the earmould gently backwards and forwards so that it tucks behind the fold of skin above your ear canal. way into your ear with a gentle, twisting movement. 4. Move the earmould up and down and gently press it to place it correctly in the ear. 14 NOTE: It may be helpful to pull your ear up and outward with your opposite hand during insertion. By experimenting, you may discover an easier method. NOTE: For comfort, always turn off your hearing aids before you insert or remove them. CAUTION: Never attempt to modify the shape of the hearing aid, earmoulds or tubing yourself. 15 How to remove the hearing aids from your ears How to remove your hearing aid 1. Lift the hearing aid from behind the ear. 2. Using your thumb and index finger, take hold of the earmould (not the hearing aid or the tubing) 3. Gently twist and pul the earmould to remove it from the ear. 16 How to use your hearing aids How to adjust the volume Your hearing aid automatically adjusts the volume depending on your listening situation. However, if your hearing aid has a volume control, you can adjust the volume according to your preferences. 1. To increase the volume, press the top part of the volume 2. To decrease the volume, press the bottom part of the volume control. control. 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. NOTE: Not available for 67 models. 17 NOTE: If you have two hearing aids with the Synchronised Volume Control function enabled, volume control adjustments to one hearing aid automatically repeat in the second hearing aid. When you change the volume in one of the hearing aids, it responds with one or more beeps. A beep in the second hearing aid follows. NOTE: Your hearing care professional can disable the volume control or replace it with a non-functional cover. How to change program Your hearing aid has a push button which allows you to select from several listening programs. Push the button to change program. You will then hear one or more beeps. The number of beeps indicates which program you have selected (one beep = program one, two beeps = program two and so on). You can also change programs using our wireless acessories and smartphone apps. NOTE: If your hearing aids have Synchronised Push Button enabled, changing program on one hearing aid automatically repeats in the second hearing aid. A beep in both hearing aids will follow each adjustment. 18 NOTE: When you turn the hearing aids off and on again, they always start up in program one and your preset volume level. Telephone use Your hearing aid allows you to use your telephone as you normally do. Finding the optimal position for holding a telephone may require practice. The following suggestions may be helpful:
1. Dependent on your fitting and hearing status, either hold the telephone up to your ear canal or hold it close to the hearing aid microphones as illustrated. 2. If whistling occurs, try holding the telephone in the same position for a few seconds as the hearing aid may be able to cancel the whistling. 3. Holding the telephone slightly away from the ear can also stop any whistling. NOTE: Depending on your individual needs, your hearing care professional may activate a programme specifically for telephone use. Telecoil Your hearing aid a telecoil. The Telecoil program may help to improve speech understanding with Hearing Aid Compatible (HAC) telephones and in theaters, cinemas, houses of worship, etc. that 19 have a hearing loop installed. When you select the Telecoil program, your hearing aid picks up signals from the hearing loop or HAC telephone. Your hearing care professional can activate the Telecoil program. NOTE: The telecoil cannot work without a hearing loop (aka induction-loop) or a HAC telephone. NOTE: If you are having trouble hearing with the hearing loop, ask you hearing care professional to adjust the program. NOTE: If there is no sound from the hearing aids in a hearing loop system and an active Telecoil program, the hearing loop system may not be turned on or is not operating correctly. NOTE: The sound from the hearing loop and the hearing aids' microphones can be mixed to your preference. Ask your hearing care professional if this could be useful for you. HAC telephone Some smartphones are hearing aid compatilbe (HAC). The HACphone establishes a small hearing loop that your hearing aids can connect to. The telecoil picks up the HAC phone's signal and converts it to sound. To use a HAC phone, follow these steps:
20 1. Switch your hearing aid to the Telecoil program. 2. Pick up the pohne and make a call or answer a call. 3. Hold the phone close to the hearing aid and tilt it slightly outwards. Listen to the dial tone and move the telephone to get the best reception. 4. 5. If needed, adjust the volume. 6. When you hang up, switch to your preferred program. 21 NOTE: If the phone has a poor telecoil signal, use the microphone program. To avoid whistling, do not hold the handset too tightly against your ear. NOTE: Ask your hearing care professional to enable the Telecoil programme in your hearing aids. NOTE: If you see a M3, M4, T3, or T4 on the box, then the smartphone is HAC compliant. If you find it dicult 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. 2. Find a good spot. Reception is not clear in all locations, it depends on the iduction loop. Look Hearing loop systems To use tele loop systems, follow these steps:
1. Switch your hearing aid to the telecoil program for signs or find another spot 3. If needed, adjust the volume 4. When you leave, swith to program 1. 22 Direct Audio Input (optional) You can connect a DAI (Direct Audio Input) adapter to the bottom of your hearing aid. Once connected, the hearing aid automatically switches to DAI. The sound is then sent directly to your hearing aid using a cable or a wireless FM system. If you want to be able to hear what happens around you, you can combine the DAI input with the sounds picked up by your hearing aid's microphones. NOTE: Your hearing aid's battery will drain faster if you use the DAI functionality. How to connect a DAI adapter 1. Align the tip of your DAI adapter with the groove on top of the battery door. 2. Move the adapter towards the battery door. 3. Click the adapter onto the hearing aid. How to disconnect a DAI adapter 1. Press the small lacth downwards. 23 2. Remove the adapter from the hearing aid. 24 Advanced options Phone Now (optional) 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. NOTE: Ask your hearing care professional to enable Phone Now as one of your programmes. 25 Place the Phone Now magnet Place Phone Now magnet on your telephone receiver to allow operation of the Phone Now function. In order to place magnet properly:
1. Clean the telephone 2. Remove foil from magnet 3. Place the magnet thoroughly NOTE: If you are not satisfied with the strength of Phone Now, you can reposition the magnet or add additional magnets. Prior to placing the magnet on the telephone or cell phone, use a recommended cleaning agent to clean the telephone. 26 How to use Phone Now 1. Lift the telephone to your ear. 2. When you hear a short melody, the phone programme is active. NOTE: You may need to move the telephone receiver slightly to find the best position for reliable Phone Now activation 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 turns down the volume. Ask your hearing care professional to enable Phone Now as one of your programmes. Do not cover the loudspeaker opening with the magnet. If the programme does not work to your satisfaction, moving the magnet to another position may improve ease of use and comfort while speaking. If the hearing aids do not switch to the telephone programme every time, you can reposition the magnet or add additional magnets. Use a recommended cleaning agent. 27 Phone Now warnings 1. If a magnet is swallowed, seek immediate assistance from a medical practitioner. 2. Keep magnets out of reach of pets, children and people with mental disabilities. If a magnet is swallowed, please seek advice from a medical practitioner. 3. The magnet may affect some medical devices or electronic systems. The manufacturer of any magnetically sensitive devices (e.g. pacemakers) should advise you regarding appropriate safety precautions when using your hearing aid and magnet in close proximity to the medical device or electronic system 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 original magnets supplied by the manufacturer. Flight Mode (optional) Your hearing aid allows you to control it from your smartphone or Remote Control. However, in some areas you are requested to turn off wireless communication. 28 When boarding a flight or entering an area where RF transmitters are prohibited, wireless functionality must be deactivated. 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. NOTE: Both hearing aids must be set in Flight mode - even with synchronisation enabled. 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. How to use your hearing aids with iPhone, iPad and iPod touch (optional) Your hearing aids are Made for iPhone, iPad and iPod touch, which allow for direct audio streaming and control from these devices. 29 NOTE: For assistance with pairing and using these products with your hearing aids, contact your hearing care professional. Using your hearing aid with smartphone apps (optional) Our smartphone apps are intended to be used with our wireless hearing aids. The smartphone apps send and receive signals from the hearing aids via smartphones. Do not disable app notifications. Install updates to keep the app working correctly. Only use the app with hearing aids from the same manufacturer. We take 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 or consult customer support. NOTE: For assistance with pairing and using these products with your hearing aids, please contact your hearing care professional or visit our support site. 30 NOTE: If you have a Bluetooth enabled Android smartphone, you are able to answer the telephone if you use ReSound Phone Clip+. ReSound Assist (optional) If you have signed up to use ReSound Assist available with your hearing aids, you can allow your hearing aids to be adjusted remotely without having to go to your hearing care professional: all you need is a smart device with Internet enabled. This allows you to experience unprecedented freedom and flexibility:
1. Request assistance remotely to adjust your hearing aids to be a better fit for you. 2. Keep your hearing aids up to date with the latest software to ensure the best performance possible. NOTE: Your hearing aids shut down during the install and update process. For optimum performance, make sure the hearing aids are connected to the ReSound Smart 3D app and placed close to the iPhone, iPad, iPod touch or the Android smartphone before applying the changes. 31 This service only works if your smart 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. 32 How to clean and maintain your hearing aids 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 on cosmetics, perfume, aftershave, hairspray, 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. 33 NOTE: 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. Daily maintenance Cleaning tools 1. Soft cloth 1. Brush for cleaning. Use the brush on all surfaces and orifices. Also use your brush for daily cleaning and battery handling 2. Wire loop. Use the wire loop to clean the earmould 3. Magnet. Use the magnet to lift and replace the battery 34 If the microphone inlets are clogged, gently brush across the microphone inlets with the brush NOTE: Do not use the wire loop to clean the microphone inlets. If the microphone inlets are clogged, ask your hearing care professional to help you clean them. NOTE: The wire loop is only intended for earmoulds. How to clean your hearing aid Wipe your hearing aid clean with a soft cloth after use. 35 The earmould 1. Remove the earmould and tubing from the hearing aids prior to cleaning 2. Clean the earmould using a mild soap, and rinse with lukewarm water. 3. After cleaning, dry earmoulds thouroughly and remove any residual water and debris form the tubing utilising a small blower and wire loop. 36 NOTE: Your earmould tubing may become stiff, brittle or discoloured over time. Contact your hearing care professional regarding tube changes. Thin tubes and domes 1. Remove thin tubes from the hearing aids by unscrewing them counterclokwise 2. Wipe down thin tubes and domes with a damp cloth 3. In order to clear the thin tube of moisture and debris, push the black cleaning thread through the thin tube, beginning at the end opposite the dome 37 NOTE: We recommend that you change the thin tube and dome systems every three months. If the components get stiff or brittle, change them sooner. 38 Wireless accessories Wireless accessories ReSounds wireless eco-system features a comprehensive range of seamlessly integrated wireless accessories. This allows you to control and stream high quality stereo sound and speech directly to your hearing aids. Please find the list of available wireless accessories below:
ReSound 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. ReSound 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. ReSound Phone Clip+ streams phone conversations and stereo sound directly to both hearing aids, and it doubles as a simple remote control. ReSound Micro Mic is a body worn microphone for your friend or colleague. It significantly improves speech understanding in noisy situations. 39 ReSound Multi Mic works like the ReSound 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. 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. 40 Tinnitus Management Tinnitus Sound Generator module Your hearing aid includes the Tinnitus Sound Generator (TSG) module, a tool for generating sounds to be used in tinnitus management programmes to temporarily 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 program and the environment you are in, you will sometimes hear the therapeutic sound resembling 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 Programme 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 Programme. 41 User instructions for the TSG module Description of device The Tinnitus Sound Generator (TSG) Module is a software tool that generates sounds to be used in tinnitus management programmes to temporarily relieve suffering from tinnitus. Explanation on 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 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. 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. 42 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. 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. 43 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. The tinnitus sound generator volume can only be adjusted within the range set by the hearing care professional. The volume control is an optional feature in the TSG module used for adjusting the sound generator output level. 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 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. Technical specifications Audio signal technology Digital. 44 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 750 Hz 1000 Hz 1500 Hz 2000 Hz
2000 Hz 3000 Hz 4000 Hz 5000 Hz 6000 Hz 8000 Hz Prescription use of a Tinnitus Sound Generator hearing aid The TSG 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. 45 To adjust TSG, please consult your hearing care professional. 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. 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. 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. 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. 46 The sound generator instrument is a tool to generate sounds to be used with appropriate counselling and/or in a tinnitus management programme to relieve patients suffering from tinnitus. 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. 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 physician if you experience one of the following conditions:
a. Visible congenital or traumatic deformity of the ear. 47 b. History of active drainage from the ear within the previous 90 days. c. History of sudden or rapidly progressive hearing loss within the previous 90 days. d. Acute or chronic dizziness. e. Unilateral hearing loss of sudden or recent onset within the previous 90 days. f. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal. g. Pain or discomfort in the ear. 3. Discontinue use of the sound generator and consult promptly with your hearing care professional, if you experience changes in the tinnitus perception, discomfort or interrupted speech perception, while using the Tinnitus Sound Generator. 4. 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. 5. Children and physically or mentally disabled users will require guardian supervision while wearing the TSG hearing aid. 48 6. Adjustment of the Tinnitus Sound Generator settings, using a smartphone app, should only be performed by the parent or legal guardian in cases where the user is minor.Use of the ReSound Assist for remote settings of the tinnitus sound generator, should only be performed by the parent or legal guardian in cases where the user is minor. 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. 49 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. 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. 50 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 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. 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. 51 7. Warning to hearing care professionals: Special care should be exercised in selecting and fitting hearing aids with maximum sound pressure level that exceeds 132dB SPL with an IEC 60711:1981 occluded ear simulator. There may be a risk of impairment of the remaining hearing. 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. 10. 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 IEC 60950-1, as appropriate (wired connection, for example HI-PRO), SpeedLink). NOTE: For use of wireless functionality, only use supported wireless accessories. For further guidance regarding e.g. pairing, please refer to the user guide of the relevant wireless accessory. 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. Use only original parts from the manufacturer, e.g. wax guards. 52 3. Only connect your hearing aids to accessories intended and qualified to be used with your hearing aids. 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. 53 Troubleshooting Issue Feedback,
"whistling"
Potential cause Potential solution Is your earmould or dome inser-
ted correctly?
Put it in again. Is the volume very loud?
Reduce the volume. Are you holding an object (e.g. a hat or a phone) close to a hear-
ing aid?
Move your hand away to create more space between the hear-
ing aid and the object. Is your ear full of wax?
Visit your physician. 54 Issue No sound Potential cause Potential solution Is the hearing aid turned on?
Turn it on. Sound is distorted, spluttering or weak Is the hearing aid in telecoil mode?
Switch to the microphone pro-
gram. Is there a battery in the hearing aid?
Insert a new battery. Is the battery still good?
Replace with a new battery. Is the plastic tube or earmould clogged or broken?
Consult your hearing care professional Is your ear full of wax?
Visit your physician. The battery is flat Replace it with a new one. Is the battery dirty?
Clean it or replace it with a new one. Is the plastic tube or earmould clogged or broken?
Consult your hearing care professional Did your hearing aid get moist?
Use a dessicant. 55 Issue Potential cause Potential solution Battery drains very quickly Did you leave your hearing aid on for long periods of time?
Always turn off your hearing aid when you are not using it Is the battery old?
Check the date on the battery package. 56 Warnings to 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. 57 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. 58 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. 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 because 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 hearing loss. 59 Regulatory information Warranties and repairs The manufacturer 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, the manufacturer pledges to secure functionality at least equivalent to the original hearing aid. As a signatory to the United Nations Global Compact initiative, the manufacturer is committed to doing this in line with environment-friendly best practices. Hearing aids therefore, at the manufacturers 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. 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. Temperature test, transport and storage information Our hearing aids are subjected to various tests in temperature and damp heating cycling between -
25C (-13F) and +70C (+158F) according to internal and industry standards. 60 During normal operation the temperature should not exceed the limit values of 0C (+32F) to
+45C (+113F), and relative humidity of 90% RH, non-condensing. Air pressure between 500hPa and 1100hPa is appropriate. During transport or storage, the temperature should not exceed the limit values of -20C (-4F) to
+60C (+140F) and relative humidity of 90% RH, non-condensing (for limited time). The air pressure between 500hPa and 1100hPa is appropriate. 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. It is designed not to exceed the emission limits for exposure to radio frequency (RF) energy set by the Federal Communications Commission and ISED. 61 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 Reorient or relocate the receiving antenna Increase the separation between the equipment and receiver 62 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:
T he device conforms to the Essential Requirements 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 BEB60, BEB70 and BEB80 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 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. 63 Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is granted pursuant to the Japanese Radio Law ( ) and the Japanese telecommunications Business Law ( ). This device should not be modified (otherwise the granted designation number will become invalid). Type designations Hearing aid type designations for models included in this user guide are:
BEB60, FCC ID: X26BE60, IC: 6941C-BE60; BEB70, FCC ID: X26BE70, IC: 6941C-BE70; BEB80, FCC ID: X26BEB80, IC: 6941C-BEB80. This device operates in the frequency range of 2.4 GHz - 2.48 GHz. This device includes an RF transmitter that operates in the range of 2.4 GHz - 2.48 GHz. 64 Hearing aid variants Behind-the-ear (BTE) hearing aids of type BEB60 with FCC ID X26BEB60, IC number 6941C-BEB60 and size 312 battery are available in the following variants:
Behind-the-ear (BTE) hearing aids of type BEB70 with FCC ID X26BEB70, IC number 6941C-BEB70 and size 13 battery are available in the following variants:
Behind-the-Ear (BTE) hearing aids type BEB80 with FCC ID X26BEB80, IC number 6941C-BEB80 and size 13 battery are available in following variants:
RE567-DWT RE767-DWT RE967-DWT . Nominal RF output power transmitted is: -1 dBm. RE577-DWT RE777-DWT RE977-DWT . Nominal RF output power transmitted is: -2 dBm. RE588-DWT RE788-DWT RE988-DWT. Nominal RF output power transmitted is: -2 dBm. 65 Technical specifications Mini BTE Models: RE567-DWT RE767-DWT RE967-DWT Reference test gain (60 dB SPL input) Full-on gain (50 dB SPL input) Maximum output (90 dB SPL input) Total harmonic distortion Telecoil sensitivity(1 mA/m input) HFA- SPLIV@31.6 mA/m (ANSI) Full-on telecoil sensitivity@1mA/m Equivalent input noise Noise reduction Frequencyrange (DIN 45605) Current Drain HFA Max. HFA Max. 1600Hz/HFA 500 Hz 800 Hz 1600 Hz 3200 Hz Max. HFA 1600 Hz/HFA Open Closed 36 52 47 123 113 0.4 0.1 0.4 0.2 81 96 77 22 10 39 56 49 121 116 0.7 0.6 0.6 0.2 85 99 79 23 10 100-7800 100-6800 1.17/1.22 1.18/1.34 dB dB
dB SPL dB SPL Hz mA dBSPL Data in accordance with ANSI S3.22-2014, IEC 60118-0:2015 66 Maximum Output (OSPL 90) 2cc Coupler t u p t u O
) L P S B d
140 130 120 110 100 90 80 Frequency (Hz) i n a G
) B d
80 70 60 50 40 30 20 Full-On and Reference Test Gain 2cc Coupler Full-on gain 50dB SPL input Reference test gain 60dB SPL input Frequency (Hz) BTE Models: RE577-DWT RE777-DWT RE977-DWT Reference test gain (60 dB SPL input) Full-on gain (50 dB SPL input) Maximum output (90 dB SPL input) Total harmonic distortion Telecoil sensitivity(1 mA/m input) HFA- SPLIV@31.6 mA/m (ANSI) Full-on telecoil sensitivity@1mA/m Equivalent input noise Noise reduction Frequencyrange (DIN 45605) Current Drain Open Closed HFA Max. HFA Max. 1600Hz/HFA 500 Hz 800 Hz 1600 Hz 3200 Hz Max. HFA 1600 Hz/HFA 40 52 49 128 117 0.5 0.1 0.6 0.2 83 101 79 22 10 45 57 52 126 122 0.7 0.9 0.6 0.2 88 105 83 22 10 100-7170 100-6170 1.18/1.2 1.2/1.29 dB dB
dB SPL dBSPL dB SPL Hz mA Data in accordance with ANSI S3.22-2014, IEC 60118-0:2015 67 Maximum Output (OSPL 90) 2cc Coupler t u p t u O
) L P S B d
140 130 120 110 100 90 80 Frequency (Hz) i n a G
) B d
80 70 60 50 40 30 20 Full-On and Reference Test Gain 2cc Coupler Full-on gain 50dB SPL input Reference test gain 60dB SPL input Frequency (Hz) Power BTE Models: RE588-DWT RE788-DWT RE988-DWT Reference test gain (60 dB SPL input) Full-on gain (50 dB SPL input) Maximum output (90 dB SPL input) Total harmonic distortion Telecoil sensitivity(1 mA/m input) HFA- SPLIV@31.6 mA/m (ANSI) Full-on telecoil sensitivity@1mA/m Equivalent input noise Noise reduction Frequencyrange (DIN 45605) Current Drain 1600 Hz/HFA Max 1600 Hz/HFA Max 1600 Hz/HFA 500 Hz 800 Hz 1600 Hz Max. HFA 1600 Hz/HFA 53 68 62 134 130 2.6 0.2 0.5 97 113 92 23 13 dB dB
dB SPL dB SPL dB SPL 100-5160 1.8/1.4 Hz mA Data in accordance with ANSI S3.22-2014, IEC 60118-0:2015 68 Maximum Output (OSPL 90) 2cc Coupler t u p t u O
) L P S B d
140 130 120 110 100 90 80 Frequency (Hz) i n a G
) B d
80 70 60 50 40 30 20 Full-On and Reference Test Gain 2cc Coupler Full-on gain 50dB SPL input Reference test gain 60dB SPL input Frequency (Hz) Additional information Mobile phones Your hearing aid complies with the most stringent Standards of International Electromagnetic Compatibility. Any degree of disturbance can be due to the nature of your particular mobile phone or of your wireless telephone service provider. NOTE: If you find it difficult to obtain a good result while using your mobile phone, your hearing care professional will be able to give you advice on available wireless accessories to enhance listening capabilities. Type designations Hearing aid type designations for models included in this user guide are:
BEB60, FCC ID: X26BE60, IC: 6941C-BE60; BEB70, FCC ID: X26BE70, IC: 6941C-BE70; BEB80, FCC ID: X26BEB80, IC: 6941C-BEB80. This device operates in the frequency range of 2.4 GHz - 2.48 GHz. This device includes an RF transmitter that operates in the range of 2.4 GHz - 2.48 GHz. 69 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 70 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. 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. 2019GN 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. Android, Google Play and the Google Play logo are trademarks of Google LLC. The Bluetooth word mark and logos are registered trademarks owned by Bluetooth SIG, Inc. 71 Manufactureraccording to EU Medical Device Directive 93/42/EEC:
Worldwide Headquarters GN ReSound A/S Lautrupbjerg 7 DK-2750 Ballerup Denmark Tel. +45 4575 1111 resound.com CVR no. 55082715 Singapore GN Hearing Pte. Ltd. 2 Kallang Avenue
#07-19 CT HUB Singapore - 339407 Tel: +65 6320 9388 resound.com United Kingdom GN Hearing UKLtd. Kirtlington Business Centre Portway, Kirtlington Oxon OX5 3JA Tel.: +44 1869 352 800 resound.com Australia GN Hearing Australia PtyLtd Gate C, 19-25 Khartoum Road Macquarie TechnologyPark Macquarie Park NSW 2113 Tel.: (free) 1800 658 955 resound.com New Zealand GN HearingNew Zealand Limited Ground Floor, North Entrance 4 Fred Thomas Drive Takapuna, Auckland, 0622 Tel.: (free) 0800 900 126 resound.com Anyissues relating to the EU Medical Device Directive 93/42/EEC orEU Radio Equipment Directive 2014/53/EU should be directed to GN ReSound A/S. A
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1 | InternalPictures | Internal Photos | 556.53 KiB | January 28 2020 / April 27 2020 | delayed release |
1 | External Photos ReSound | External Photos | 369.61 KiB | January 28 2020 / April 27 2020 | delayed release |
1 | 62138RRF007 photographs | Test Setup Photos | 835.76 KiB | January 28 2020 / April 27 2020 | delayed release |
1 | USA FCC DoC Declaration letter | Cover Letter(s) | 248.48 KiB | January 28 2020 |
Date: 15/01/2020 DEKRA Testing and Certification, S.A.U. Parque Tecnolgico de Andaluca C/ Severo Ochoa 2 & 6 29590 Campanillas Mlaga, Espaa Ref: sDoC declaration letter for equipment with FCC ID: X26BEB70 Pursuant to 15.101 of the Commissions Rules (47 C.F.R.), GN Hearing A/S hereby declare that the device above mentioned is classified under the following equipment class/classes:
JAB JAD JAV JBP JBC CXX CRR CYY HID Part 15 Class B Digital Device Part 15 Class A Digital Device Other Non-Digital SDoC Devices Part 15 Class B Computing Device/Personal Computer Part 15 Class B Computing Device/Personal Computer Communications Rcvr for use w/ licensed Tx and CBs Superregenerative Receiver Communications Receiver used w/Pt 15 Transmitter Part 15 TV Interface Device And will follow the Authorization procedure Suppliers Declaration of Conformity prior to the initiation of marketing. Sincerely, P.A. __________________________ By: Lars Hagander Title: Vice president, Corporate Quality Company: GN Hearing A/S, Lautrupbjerg 7, 2750 Ballerup, Denmark Telephone: +45 45 75 21 00 e-mail: lhagander@gnresound.dk FCB034_00 //DEKRA Testing and Certification, S.A.U. // www.dekra-product-safety.com/wireless
1 | US FCC Agent letter | Cover Letter(s) | 1.13 MiB | January 28 2020 |
GN Hearing A/S Date: 08.10.2019 DEKRA Testing and Certification, S.A.U. Parque Tecnoldgico de Andalucia C/ Severo Ochoa 2 & 6 29590 Campanillas Malaga, Espana Ref: Agent letter for FCC ID: X26BEB70 We, GN Hearing A/S, Lautrupbjerg 7, 2750 Ballerup, Denmark, hereby authorize DEKRA Testing and Certification S.A.U., C/Severo Ochoa n 2, 29590 Campanillas, Malaga, Spain, Mr. /Ms. Miguel Angel Cobo, e-mail: Miguelangel.cobo@dekra.com, Phone: +34 952 619 846 to act as our agent in the preparation of this application for equipment certification, including the signing of all documents relating to these matters. The present authorization considers the development of documents on behalf of the client, written under his own letterhead and related to the necessary information to be provided on his behalf to complete the certification process. We also hereby certify that neither we nor any party to this application are subject to a denial of U.S. Federal benefits, which include FCC benefits, pursuant to Section 5301 of the Anti-Drug Abuse Act of 1988, U.S.C. 862 because of conviction for possession or distribution of controlled substance. For instances where our authorized agent signs the application for certification on our behalf, | acknowledge that all responsibility for complying with the terms and conditions for Certification, as specified by DEKRA Testing and Certification, S.A.U., still resides with us. This agreement expires one year from the current date. Sincerely, ' ng A/S By Lars Hagafhder Title: Vige president, Corporate Quality Company: GN Hearing A/S, Lautrupbjerg 7, 2750 Ballerup, Denmark Telephone: +45 45 75 21 00 e-mail: |hagander@gnresound.dk GN Hearing A/S | Lautrupbjerg 7 | DK-2750 Ballerup | +45 45 75 00 00 Co. Reg. no. 55082715 | info@gn.com | www.gn.com
1 | US FCC confidentiality request | Cover Letter(s) | 1.68 MiB | January 28 2020 |
GN Hearing A/S Date: 08.10.2019 DEKRA Testing and Certification, S.A.U. Parque Tecnoldgico de Andalucia C/ Severo Ochoa 2 & 6 29590 Campanillas Malaga, Espana Ref: Confidentiality request for FCC ID: X26BEB70 To whom it may concern:
Pursuant to 0.457(d)(1)(ii) and 0.459 of the Commissions Rules (47 C.F.R.) and 552 (b)(4) of the Freedom of Information Act, GN Hearing A/S hereby request requests that a part of the subject FCC application be held confidential to avoid release of sensitive information of the product to the public. For the product stated above, we request that the following information be withheld from public disclose:
Type of Confidentiality Requested Exhibit L_] Short Term ><] Permanent Block Diagrams Dx] Short Term External Photos Dx] Short Term Internal Photos
[_] Short Term ><] Permanent Operation Description
[_] Short Term ><] Permanent Parts List & Placement/BOM
[_] Short Term [x] Permanent Tune-Up Procedure
[_] Short Term >x] Permanent Schematics x] Short Term Test Setup Photos x] Short Term Users Manual Permanent Confidentiality:
The above materials contain trade secrets and proprietary information not customarily released to the public. The public disclosure of these matters might be harmful to us and provide unjustified benefits to our competitors. Short-Term Confidentiality:
We hereby request short-term confidentiality for the product stated above to avoid premature release of sensitive information prior to marketing or release of the product to the public. Release date of short term confidentiality is:
45 days from grant date marked 90 days from grant date marked 135 days from grant date marked 180 days from grant date marked Specific date:
MOOI GN Hearing A/S | Lautrupbjerg 7 | DK-2750 Ballerup | +45 45 75 00 00 Co. Reg. no. 55082715 | info@gn.com | www.gn.com Page 1 of 2 GN GN Hearing A/S We are also aware that we are responsible to notify DEKRA in the event information regarding the product or the product is made available to the public. DEKRA will then release the documents listed above for public disclosure pursuant to FCC Public Notice DA 04-1705. GN Hearing A/S Lautrupbjerg /
DK-2750 Ballerup Denmark CVR: 55082715 Sincerely,
: Lars/Hagander ce President, Corporate Quality Company: GN Hearing A/S, Lautrupbjerg 7, 2750 Ballerup, Denmark Telephone: +45 4575 2100 e-mail: |hagander@gnresound.com GN Hearing A/S | Lautrupbjerg 7 | DK-2750 Ballerup | +45 45 75 00 00 Co. Reg. no. 55082715 | info@gn.com | www.gn.com Page 2 of 2
1 | FCC cover letter labeling | Cover Letter(s) | 147.58 KiB | January 28 2020 |
Ref: Justification for placing the FCC ID in the user manual and packaging for the following devices:
FCC ID: X26BEB60 FCC ID: X26BEB70 FCC ID: X26BEB80 FCC ID: X26LOB90 FCC ID: X26VER12 There are two main reasons why devices state above does not have FCC ID:
1) Due to the specific use of a typical hearing instrument, its external surface is in contact with the users skin in the ear. Therefore, it is not appropriate to permanently affix a label on the outer surface of the device to prevent skin irritations. 2) The only permanent location is the battery door, but it is too small to have the visible text
(smaller than 4-6 points). Therefore, the FCC ID information is included in the user manual and sales package together with the device.
frequency | equipment class | purpose | ||
---|---|---|---|---|
1 | 2020-01-28 | 2402 ~ 2480 | DXX - Part 15 Low Power Communication Device Transmitter | Original Equipment |
app s | Applicant Information | |||||
---|---|---|---|---|---|---|
1 | Effective |
2020-01-28
|
||||
1 | Applicant's complete, legal business name |
GN Hearing A/S
|
||||
1 | FCC Registration Number (FRN) |
0019433481
|
||||
1 | Physical Address |
Lautrupberg 7
|
||||
1 |
Ballerup, N/A
|
|||||
1 |
Denmark
|
|||||
app s | TCB Information | |||||
1 | TCB Application Email Address |
a******@dekra.com
|
||||
1 | TCB Scope |
A2: Low Power Transmitters (except Spread Spectrum) and radar detectors operating above 1 GHz
|
||||
app s | FCC ID | |||||
1 | Grantee Code |
X26
|
||||
1 | Equipment Product Code |
BEB70
|
||||
app s | Person at the applicant's address to receive grant or for contact | |||||
1 | Name |
L****** H****
|
||||
1 | Title |
Vice President, Corporate Quality
|
||||
1 | Telephone Number |
+45 4********
|
||||
1 | Fax Number |
+45 4********
|
||||
1 |
l******@gnresound.dk
|
|||||
app s | Technical Contact | |||||
n/a | ||||||
app s | Non Technical Contact | |||||
n/a | ||||||
app s | Confidentiality (long or short term) | |||||
1 | Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | Long-Term Confidentiality Does this application include a request for confidentiality for any portion(s) of the data contained in this application pursuant to 47 CFR § 0.459 of the Commission Rules?: | Yes | ||||
1 | If so, specify the short-term confidentiality release date (MM/DD/YYYY format) | 04/27/2020 | ||||
if no date is supplied, the release date will be set to 45 calendar days past the date of grant. | ||||||
app s | Cognitive Radio & Software Defined Radio, Class, etc | |||||
1 | Is this application for software defined/cognitive radio authorization? | No | ||||
1 | Equipment Class | DXX - Part 15 Low Power Communication Device Transmitter | ||||
1 | Description of product as it is marketed: (NOTE: This text will appear below the equipment class on the grant) | Wireless hearing instrument | ||||
1 | Related OET KnowledgeDataBase Inquiry: Is there a KDB inquiry associated with this application? | No | ||||
1 | Modular Equipment Type | Does not apply | ||||
1 | Purpose / Application is for | Original Equipment | ||||
1 | Composite Equipment: Is the equipment in this application a composite device subject to an additional equipment authorization? | No | ||||
1 | Related Equipment: Is the equipment in this application part of a system that operates with, or is marketed with, another device that requires an equipment authorization? | No | ||||
1 | Grant Comments | This device meets the SAR Test Exclusion threshold specified in KDB447498 and since then, it is authorized for portable operation. Multi-transmitter, supporting simultaneous transmission configurations, have not been evaluated and shall be evaluated according to KDB Publication 447498 and §2.947(f), §15.31(h) and §15.31(k) composite system and §2.1 product terms and concepts. | ||||
1 | Is there an equipment authorization waiver associated with this application? | No | ||||
1 | If there is an equipment authorization waiver associated with this application, has the associated waiver been approved and all information uploaded? | No | ||||
app s | Test Firm Name and Contact Information | |||||
1 | Firm Name |
DEKRA Testing and Certification, S.A.U.
|
||||
1 | Name |
F**** C******
|
||||
1 | Telephone Number |
34-95********
|
||||
1 | Fax Number |
34-95********
|
||||
1 |
f******@dekra.com
|
|||||
Equipment Specifications | |||||||||||||||||||||||||||||||||||||||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Line | Rule Parts | Grant Notes | Lower Frequency | Upper Frequency | Power Output | Tolerance | Emission Designator | Microprocessor Number | |||||||||||||||||||||||||||||||||
1 | 1 | 15C | 2402.00000000 | 2480.00000000 |
some individual PII (Personally Identifiable Information) available on the public forms may be redacted, original source may include additional details
This product uses the FCC Data API but is not endorsed or certified by the FCC