Related Manuals for GN Hearing Flyte DA312r
Summary of Contents for GN Hearing Flyte DA312r
- Page 1 User Guide User Guide Flyte Custom Flyte BTE 400847011US-17.10-Rev.A 1 02-10-2017 14:14:51 Flyte BTE User Guide...
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Page 2: Statment
Hearing instrument type designations for models included in this user guide are: DA312r, FCC ID: X26DA312r, IC: 6941C-DA312r; DA13r, FCC ID: X26DA13r, IC: 6941C-DA13r; DA312i, FCC ID: X26DA312i, IC: 6941C-DA312i; and DA13i, FCC ID: X26DA13i, IC: 6941C-DA13i. Please see page 10, 12 and 14 for lists of models referring to these types. -
Page 3: Intended Use
The products are in compliance with the following regulatory requirements: • In the EU: the device conforms to the Essential Requirements according to Annex I of Council Directive 93/42/EEC for medical devices (MDD) and essential requirements and other relevant provisions of Direc- tive 2014/53/EU (RED). -
Page 4: Prescription Use Of A Tinnitus Sound Generator (Tsg) Hearing Instrument
Prescription use of a Tinnitus Sound Generator (TSG) hearing instrument The TSG module should be used as prescribed by your doctor, audiologist or hearing healthcare profes- sional. In order to avoid permanent hearing damages, the maximum daily usage depends on the level of the generated sound. - Page 5 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 programme to relieve patients suffering from tinnitus.
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Page 6: Introduction
Introduction Congratulations on the purchase of your new hearing instruments. The innovative sound technology and design, combined with the customised device programming selected by your hearing care professional, will make hearing a more enjoyable experience. Hearing instruments will enable you to hear sounds that you may not have heard in years because of your hearing loss. - Page 7 Hearing instrument model: Model IIC: Battery size 10 Model CIC: Battery size 10 Model ITC: Battery size 13 or 312 (circle one) Model ITE: Battery size 13 or 312 (circle one) Model MIH: Battery size 13, 312, or 10 for MIH-S (circle one) Left serial number: Right serial number: 400847011US-17.10-Rev.A 7...
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Page 8: Table Of Contents
Contents Statment ....... 2 Telecoil ......25 Intended use.. - Page 9 TSG warnings ......38 TSG precautions ..... . . 38 TSG warning to hearing healthcare professionals.
- Page 10 Mic in Helix (MIH-S) hearing instrument models Mic in Helix (MIH) hearing instruments with size 10A battery are available in the following (including type DA312r with FCC ID X26DA312r, variants: IC number 6941C-DA312r models designated by a “W”) with size 312 battery and Custom Mic in FL9MIH-S-UP, FL9MIH-S-HP, FL9MIH-S-MP, Helix hearing instruments (including type DA13r FL9MIH-S-LP...
- Page 11 Program button (optional) Battery compartment and On/Off switch Removal cord (optional) Sound outlet Wax filter Vent Microphone sound inlet Remote microphone and tubing (for remote microphone devices) Volume control (optional) 10. Model 11. Manufacturer 12. Serial number 400847011US-17.10-Rev.A 11 02-10-2017 14:14:56...
- Page 12 FL9ITC-D-UP, FL9ITC-D-HP, FL9ITC-D-MP, Invisible-in-the-canal (IIC) and FL9ITC-D-LP, FL9ITC-UP, FL9ITC-HP, completely-in-the-canal (CIC) hearing FL9ITC-MP, FL9ITC-LP, FL7ITC-D-UP, FL7ITC- instruments with size 10A battery are available in D-HP, FL7ITC-D-MP, FL7ITC-D-LP, FL7ITC-UP, the following variants: FL7ITC-HP, FL7ITC-MP, FL7ITC-LP FL9IIC, FL9CIC-UP, FL9CIC-HP, FL9CIC-MP, FL9CIC-LP, FL7CIC-UP, FL7CIC-HP, FL7CIC-MP, FP9ITC-D-UP, FP9ITC-D-HP, FP9ITC-D-MP, FL9CIC-LP FP9ITC-D-LP...
- Page 13 Program button (optional) Battery compartment and On/Off switch Removal cord (optional) Sound outlet Wax filter Vent Microphone sound inlet(s) Volume control (optional) Model 10. Manufacturer 11. Serial number 400847011US-17.10-Rev.A 13 02-10-2017 14:14:59...
- Page 14 In-the-ear (ITE) hearing instruments (including FP9ITE-DW-UP, FP9ITE-DW-MP, FP9ITE-DW-MP FP9ITE-D-UP, FP9ITE-D-HP, FP9ITE-D-MP type DA13i with FCC ID X26DA13i, IC number FP9ITE-W-UP, FP9ITE-W-MP, FP9ITE-W-MP 6941C-DA13i models designated by a “W”) with size 13 battery and In-the-ear (ITE) hearing instruments FP9ITE-UP, FP9ITE-MP, FP9ITE-MP (including type DA312i with FCC ID X26DA312i, IC number 6941C-DA312i models designated by a “W”) FP7ITE-DW-UP, FP7ITE-DW-MP, FPITE-DW-MP...
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Page 15: Program Button (Optional)
W-MP Program button (optional) Battery compartment and On/Off switch Sound outlet Wax filter Vent W-MP Microphone sound inlet(s) Volume control (optional) Model Manufacturer 10. Serial number 400847011US-17.10-Rev.A 15 02-10-2017 14:15:01... -
Page 16: Getting Started
Getting started On/Off function 1. When the battery door is closed, the hearing instrument will turn on, and the default program will be activated. 2. To turn the hearing instrument off, open the battery door. Many individuals can use their fingernail to pull it open. Tip: Whenever the hearing instruments are not in use, remember to open the battery doors to avoid unnecessary battery consumption. -
Page 17: Inserting/Replacing The Battery
Inserting/Replacing the battery 1. Open the battery door completely by using your fingernail. Remove the used battery if present. 2. Prepare the new battery (please refer to page 5 for information on appropriate battery type/size for your hearing instrument). Remove the protective foil and wait 2 minutes before inserting the battery into the hearing instrument to allow activation of the battery. -
Page 18: Low Battery Indicator
Low battery indicator When the batteries are low on power, your hearing aids reduce the volume, and play a melody every 15 minutes until they are empty and turn off. NOTE: Keep spare batteries on hand. Low battery indicator when paired with wireless accessories only The batteries drain faster when you use wireless functionalities like streaming from your smart phone or from your TV. -
Page 19: Inserting/Removing Hearing Instruments
Inserting/Removing hearing instruments Insertion (Mic in Helix) 1. Hold the hearing instrument 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 instrument gently backwards and forwards so that it tucks behind the fold of skin above your ear canal. - Page 20 Insertion (IIC, CIC, ITC, and ITE) 1. Hold the hearing instrument between your thumb and index finger, either above and below or on the sides. For IIC, there is a dot on the top side of the shell to show orientation for insertion.
- Page 21 Removal options (IIC, CIC and Mic in Helix) 1. Hold the removal cord with your thumb and index finger and pull outward. 2. Hold the edges of the hearing instrument with your thumb and forefinger and pull outward while slightly rotating your hand forward. 3.
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Page 22: Operation Of The Hearing Instrument
Operation of the hearing instrument Volume control (Optional) The volume control will allow the volume of hearing instruments to be increased or decreased. 1. To increase the volume, rotate the volume control forward (towards your face when you are wearing the hearing instruments). -
Page 23: Program Button (Optional)
Programbutton (Optional) Depending on your experience level with hearing instruments, individual hearing needs, and the type of lis- tening environments you experience, your hearing care professional may activate additional programs in the hearing instrument. If additional programs have been activated, the following list explains how they work. 1. -
Page 24: Flight Mode
Flight mode* When boarding a flight or entering an area where RF transmitters are prohibited, wireless functio- nality must be deactivated, as it is not allowed to radiate radio signals during flights or in otherwise restricted areas. For wireless hearing instruments follow the following steps to enter and leave flight mode: It is possible to disable wireless operation by opening and closing the battery compartment three times within a ten second period (open-close, open-close, open-close). -
Page 25: Telephone Use
Telephone use Finding the optimal position for holding a tele phone may require practice for some individuals, and one or more of the following suggestions may be helpful. • Hold the telephone as you would normally. • Hold the telephone towards the top of the ear (closer to where the micro- phones are). -
Page 26: Listen To Radio Or Tv
• The app must only be used with GN Hearing devices for which it is intended, and GN Hearing takes no responsibility if the app is used with other devices. -
Page 27: Cellular Phones
Cellular phones Your hearing instrument is designed to comply with the most stringent Standards of International Electromagnetic Compatibility. However, not all cell phones are hearing instrument compatible. The vary- ing degree of disturbance can be due to the nature of your particular cellular phone or of your wireless telephony service provider. - Page 28 1. High distortion during dialing or phoning may mean that the magnet is not in the optimal position relative to the telephone receiver. To avoid the issue, please move the magnet to another place on the telephone receiver. 2. Only use magnets supplied by GN Hearing. 400847011US-17.10-Rev.A 28 02-10-2017 14:15:23...
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Page 29: Tele-Loop Systems
Tele-loop systems Many places, such as theaters, houses of worship, and schools are equipped with tele-loop systems. When using a telecoil program with tele-loop systems, sound is picked up directly and may improve speech understanding. If there is no sound from the hearing instruments in a tele-loop system and with a telecoil program activated, the tele-loop system may not be turned on or is not operating correctly. -
Page 30: Daily Maintenance
Daily maintenance It is important to keep your hearing instrument clean and dry. On a daily basis, clean the hearing instru- ments using a soft cloth or tissue. Remove any wax or debris from hearing instruments using a brush and/ or a wire loop. -
Page 31: General Precautions
4. Never attempt to modify the shape of the hearing instrument, earmolds, or tubing yourself. 5. For use of wireless functionality only use GN Hearing accessories. For further guidance please refer to the user guide of the relevant GN Hearing accessory. -
Page 32: General Warnings
General warnings 1. If a hearing aid is broken, do not use it 2. 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 3. - Page 33 • GN Hearing wireless devices operate in the frequency range of 2.4 GHz - 2.48 GHz. • GN Hearing wireless devices include a RF transmitter that operates in the range of 2.4 GHz - 2.48 GHz. • For use of wireless functionality only use GN Hearing accessories. For further guidance regarding e.g.
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Page 34: Tinnitus Sound Generator (Tsg) Module
Tinnitus Sound Generator (TSG) module Intended use for the TSG module Your ReSound hearing instrument includes the Tinnitus Sound Generator function, a tool for generating sounds to be used in tinnitus management programmes to relieve suffering from tinnitus. The Tinnitus Sound Generator can generate sounds adjusted to the specific therapeutic needs and your personal preference as determined by your doctor, audiologist, or hearing healthcare professional. - Page 35 Modulation level and speed can also be configured to your likes and needs. An additional feature can be enabled by your hearing healthcare 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 synchronisation this functionality can be ena- bled by your hearing healthcare professional.
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Page 36: Using Tsg With Smart Phone Apps
Using TSG with smart phone apps The tinnitus sound generator control via hearing aid push buttons can be enhanced with wireless control from a TSG control app on a smart phone or mobile device. This functionality is available in supported hearing aids when a hearing healthcare professional has enabled the TSG functionality during fitting of the hearing aid. -
Page 37: Technical Specifications
Technical Specifications Audio signal technology Digital 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 14dB. High-pass filter Low-pass filter 500 Hz 2000 Hz 750 Hz... -
Page 38: Tsg Warnings
TSG warnings • Sound generators can be dangerous if improperly used. • Sound generators should be used only as advised by your doctor, audiologist, or hearing healthcare professional. • Sound generators are not toys and should be kept out of reach of anyone who might cause themselves injury (especially children and pets). -
Page 39: Tsg Warning To Hearing Healthcare Professionals
TSG warning to hearing healthcare professionals A hearing healthcare 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 healthcare 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: (i) Visible congenital or traumatic deformity of the ear. -
Page 40: Battery Warning Information
Battery warning information Batteries, although very small, contain dangerous substances, and should be disposed of carefully. This is for the safety of you and the environment. Please note: 1. DO NOT RECHARGE ZINK AIR BATTERIES – THEY MAY LEAK OR EXPLODE. 1. -
Page 41: Hearing Instrument Expectations
Hearing instrument expectations A hearing instrument will not restore normal hearing and will not prevent or improve a hearing impairment re- sulting from organic conditions. Consistent use of the hearing instrument is recommended. In most cases, infrequent use does not permit you to attain full benefit from it. The use of a hearing instrument is only part of hearing rehabilitation and may need to be supplemented by auditory training and instructions in lip-reading. -
Page 42: Warning To Hearing Aid Dispensers
Warning to hearing aid dispensers (US Only) A hearing aid dispenser 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 aid dispenser de- termines 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: Visible congenital or traumatic deformity of the ear. -
Page 43: Children With Hearing Loss
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 aid dispenser, as appropriate, for a hearing aid evaluation. -
Page 44: Troubleshooting Guide
Troubleshooting Guide SYMPTOM CAUSE Not turned on Dead battery No sound Battery door will not close Blocked wax filter Incorrect earmold placement Blocked sound outlet filter Change in hearing sensitivity Not loud enough Excessive ear wax Volume set too low 400847011US-17.10-Rev.A 44 02-10-2017 14:15:23... - Page 45 POSSIBLE REMEDY Turn on by closing the battery door Replace battery Insert battery properly Replace wax filter or consult your hearing care professional Reinsert hearing instrument carefully Change filter or consult your hearing care professional Consult your hearing care professional Consult your physician Increase the volume control if available or consult your hearing care professional 400847011US-17.10-Rev.A 45...
- Page 46 Troubleshooting Guide SYMPTOM CAUSE Incorrect custom placement in ear Excessive ear wax Excessive whistling / feedback Feedback control may need adjustment Hearing instrument settings not optimal Weak battery Improper fit Sound distorted / not clear Hearing instrument damaged Hearing instrument settings not optimal Possible Root Cause - Device is in flight mode Wireless does not work * If there are any other problems not mentioned in this guide, please contact your hearing care professional.
- Page 47 POSSIBLE REMEDY Re-insert custom product carefully Consult your hearing care professional Consult your hearing care professional Consult your hearing care professional Replace battery Consult your hearing care professional Consult your hearing care professional Consult your hearing care professional Open and close the battery compartment once. Wireless will reactivate 10 seconds later. (If Root Cause is device in flight mode) 400847011US-17.10-Rev.A 47 02-10-2017 14:15:24...
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Page 48: Technical Data
Technical Data MAXIMUM OUTPUT HEARING INSTRUMENT MODEL (2ccCoupler / IEC 60118-7 and ANSI S3.22-2009) 115 dB SPL (typical) All Low Power (LP) models including IIC All Medium Power (MP) models 119 dB SPL (typical) All High Power (HP) models 121 dB SPL (typical) All Ultra Power (UP) models 130 dB SPL (typical) 400847011US-17.10-Rev.A 48... -
Page 49: Warranty And Repairs
Warranty and repairs GN Hearing provides a warranty on hearing instruments in the event of defects in workmanship or materi- als, as described in applicable warranty documentation. In its service policy, GN Hearing pledges to secure functionality at least equivalent to the original hearing instrument. As a signatory to the United Nations Global Compact initiative, GN Hearing is committed to doing this in line with environment-friendly best practices. - Page 50 Be aware of information marked with the warning symbol WARNING points out a situation that could lead to serious injuries, CAUTION indicates a situation that could lead to minor and moderate injuries. Advice and tips on how to handle your hearing instrument better. Equipment includes RF transmitter.
- Page 51 Please ask your local hearing care professional concerning disposal of your hearing instrument 400847011US-17.10-Rev.A 51 02-10-2017 14:15:26...
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Page 52: Manufacturer
Manufacturer GN Hearing A/S 8001 E. Bloomington Freeway Bloomington, MN 55420-1036 Distributed by: TruHearing Inc. 12936 S. Frontrunner Blvd Draper, UT 84020 (844) 278-8672 400847011US-17.10-Rev.A 52 02-10-2017 14:15:42...
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