ReSound Alera TS User Manual

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USER GUIDE
RESOUND ALERA™ TS HEARING INSTRUMENT
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ReSound Alera™ TS
Congratulations on your new ReSound Alera
TS hearing instrument! Wearing ReSound Alera™ TS hearing instruments enables you to hear sounds that you may not have heard in years, in addition to assisting in your tinnitus treatment programme. While some people adjust quickly to wearing hearing instruments and hearing the lost sounds again, others may need more time. By wearing the instruments regularly you will get accustomed to the new world of hearing more quickly and soon experience the full benefit of quality listening and interaction. ReSound Alera™ TS can also be a part of your tinnitus treatment programme. A Tinnitus Sound Generator (TSG) feature emits soothing sounds that can help reduce the unwanted effects of tinnitus. ReSound Alera™ TS instruments have been adjusted according to your individual hearing loss and tinnitus needs. Familiarising yourself with the functions of your new hearing instruments will help you get optimal benefit.
ReSou nd is a registered t rade mar k of GN ReS ound A /S
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Hearing instrument model:
Battery size:
Tube type: Dome size:
Left serial number: Right serial number:
This user guide is valid for ReSound Alera™ devices including Tinnitus Sound Generator (TSG) and describes the TSG related topics.
The user guide is only valid in connection with the ReSound BTE user guide, ref. number 17483300, or ReSound RIE user guide, ref. number 17332100.
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Standard/Power BTE
ALT987-DVIW ALT977-DVIW Open - ALT977-DVIW ALT78 7- D V I W ALT777-DVIW Open - ALT777-DVIW ALT5 8 7- DV IW ALT577-DVIW Open - ALT577-DVIW
Mini-BTE
ALT967-DIW Open - ALT967-DIW ALT767-DIW Open - ALT767-DIW
1. Programme button
2. Battery compartment & On/Off switch
3. Sound outlet
4. Front microphone inlet
5. Back microphone inlet
6. Volume control (optional)
7. Direct audio input
8. Left/Right indicator (Left=Blue/Right=Red)
9. Battery lock (optional)
10. Model
11. Manufacturer
12. Serial number
13. Sports lock
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RIE Mini-BTE ALT960-DR RIE BTE ALT961-DRW ALT962 - DV IRW, ALT76 2 - D V I R W
1. Receiver tube
2. Receiver Open Dome
3. Receiver Tulip Dome
4. Receiver Power Dome
5. RIE mould
6. Sports lock
7. Battery compartment
8. Receiver
9. Push button
10. Volume Control (optional)
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10. NP receiver tube
11. HP receiver tube
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12. Left/right indicator
13. Model, and serial number
14. Direct audio input
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DESCRIPTION OF THE DEVICE
The Tinnitus Sound Generator (TSG) Module is a software tool generating sounds to be used in tinnitus management programs to relieve suffering from tinnitus.
EXPLANATION OF HOW THE DEVICE FUNCTIONS
The TSG Module is a frequency and amplitude shaped white noise generator. Noise signal level and frequency characteristics can be adjusted to the specific therapeutic needs as de­termined by your doctor, audiologist, or hearing care practitioner. Your doctor, audiologist, or hearing care practitioner can modulate the generated noise with the purpose of making it more pleasant. The noise can then resemble, for example, crashing waves on a shore. Modulation level and speed can also be configured to your likes and needs.
If your tinnitus troubles you only in quiet environments, your doctor, audiologist, or hearing
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care practitioner can set the TSG Module so that it becomes audible exclusively in such surroundings. The overall sound level can be adjusted via an optional volume control. Your doctor, audiologist, or hearing care practitioner will review with you the need for having such a control.
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.
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SIGNIFICANT PHYSICAL CHARACTERISTICS
Audio signal technology
Digital
Available sounds
White noise signal which can be shaped with the following configurations: High-pass filter: 500 Hz Low-pass filter: 2 kHz High-pass filter: 750 Hz Low-pass filter: 3 kHz High-pass filter: 1 kHz Low-pass filter: 4 kHz High-pass filter: 1.5 kHz Low-pass filter: 5 kHz High-pass filter: 2 kHz Low-pass filter: 6 kHz The white noise signal can be modulated in amplitude with an attenuation depth of up to 14dB.
PRESCRIPTION USE OF THIS DEVICE
The TSG Module should be used as prescribed by your doctor, audiologist, or hearing care practitioner. In order to avoid permanent hearing damages, the maximum daily usage depends on the level of the generated sound.
Should you develop any side effects from using the sound generator, such as dizziness, nausea, headaches, perceived decrease in auditory function or increase in tinnitus percep­tion, you should discontinue use of sound generator and seek medical evaluation.
The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. However, children and physically or men­tally challenged users will require training by a doctor, audiologist, hearing care practitioner or the guardian for the insertion and removal of the device containing the TSG module.
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WARNING
Sound generators can be dangerous if improperly used.
Sound generators should be used only as advised by your doctor, audiologist, or hearing care practitioner.
Sound generators are not toys and should be kept out of reach of anyone (especially children and pets) who might cause themselves injury.
VOLUME CONTROL
The sound generator is set to a specific loudness level by the hearing care practitioner. 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 volume control is an optional feature in the TSG module used for adjusting the sound generator output level. To prevent unintended usage by paediatric or physically or mentally challenged users, the volume control must, if enabled, be configured to only pro­vide a decrease of the sound generator output level.
CAUTION
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, user should discontinue use of sound generator and seek medical evaluation.
Children and physically or mentally challenged users will require guardian supervision while wearing the device.
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WARNING TO HEARING CARE PRACTITIONER
A hearing care practitioner should advise a prospective sound generator user to consult promptly with a licensed physician (preferably an ear specialist) before setting a sound gene rator if the hearing care practitioner determines through inquiry, actual observation, or review or 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.
(ii) History of active drainage from the ear within the previous 90 days.
(iii) History of sudden or rapidly progressive hearing loss within the previous 90 days.
(iv) Acute or chronic dizziness.
(v) Unilateral hearing loss of sudden or recent onset within the previous 90 days.
(vi) Audiometric air-bone gap equal to or greater than 15 decibels at 500 Hertz (Hz),
1,000 Hz and 2,000 Hz.
(vii) Visible evidence of significant cerumen accumulation or a foreign body in the ear
canal.
(viii) 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. The user should not use the sound generator for more than eight (8) hours a day when this is set below 90dB SPL. Above that level, the device should not be used for more than two (2) hours per day. In no case should the sound generator be worn at uncomfortable levels.
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IMPORTANT NOTICE FOR PROSPECTIVE SOUND GENERATOR USERS
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 a 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 program to relieve patients suffering from tinnitus.
Technical Data
Hearing Instrument Tinnitus Sound Generator
Model Maximum Output (IEC 60118-7)
ALT960-DR & ALT961-DRW RIE HP Closed/Open 89 dB SPL (Typical)
ALT960-DR & ALT961-DRW RIE NP Closed/Open 88 dB SPL (Typical)
ALT962-DVIRW & ALT762-DVIRW RIE HP Closed/Open 88 dB SPL (Typical)
ALT962-DVIRW & ALT762-DVIRW RIE NP Closed/Open 88 dB SPL (Typical)
ALT967-DIW & ALT767-DIW Closed 91,9 dB SPL (Typical)
ALT967-DIW & ALT767-DIW Open 86 dB SPL (Typical)
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Technical Data
Hearing Instrument Tinnitus Sound Generator
Model Maximum Output (IEC 60118-7)
ALT977-DVIW, ALT777-DVIW & ALT577-DVIW Closed 92,3 dB SPL (Typical)
ALT977-DVIW, ALT777-DVIW & ALT577-DVIW Open 89,5 dB SPL (Typical)
ALT987-DVIW, ALT787-DVIW & ALT587-DVIW 91,7 dB SPL (Typical)
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
Product is a Type B applied part
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Worldwide Headquarters
ReSound A/S Lautrupbjerg 7 DK-2750 Ballerup, Denmark Tel.: +45 45 75 11 11 Fax: +45 45 75 11 19 www.resound.com
Any issues relating to the EU Medical Device Directive 93/42/EEC, or Council Directive 1999/5/EC on Radio Equipment and Telecom­munications terminal equipment should be directed to ReSound A/S
United Kingdom
GN ReSound Ltd. Kirtlington Business Centre Portway Kirtlington Oxon OX5 3JA Tel.: +44 1869 352 800 Fax: +44 1869 343 466 www.gnresound.co.uk
Australia
GN ReSound Pty. Ltd. Unit R1 Regents Park Estate 391 Park Road Regents Park NSW 2143 Tel.: (free) 1800 658 955 Fax: +61 2 9743 7472 www.gnresound.com.au
New Zealand
GN ReSound (NZ) Ltd. 12 Parkway Drive Mairangi Bay Auckland Tel.: (free) 0800 900 126 Fax: (free) 0800 007 695 www.gnresound.co.nz
17720500-GB -11.03 Rev. A
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