ReSound Alera TS Manual de usuario

USER GUIDE

RESOUND ALERA™ TS

HEARING INSTRUMENT

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.

ReSound is a registered trade mark of GN ReSound A/S

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.

Hearing instrument model:

Battery size: Tube type: Dome size:

Left serial number: Right serial number:

8/9

Standard/Power BTE

ALT9 87- DVI W

ALT977-DVIW Open - ALT977-DVIW

ALT787- DVI W

ALT777-DVIW Open - ALT777-DVIW

ALT587-DV I W

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

10 11

10. NP receiver tube

11. HP receiver tube

12. Left/right indicator

13. Model, and serial number

14. Direct audio input

RIE Mini-BTE ALT960-DR

RIE BTE ALT961-DRW

ALT962- DVI RW, ALT762- DVI RW

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)

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 de-

termined 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

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.

10 11

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 percep-

tion, 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 men-

tally 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.

12 13

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 pro-

vide 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 percep-

tion, 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.

14 15

(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.

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

generator if the hearing care practitioner determines through inquiry, actual observation, or

review or any other available information concerning the prospective user that the prospec-

tive 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.

16 17

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 identi-

ﬁed and treated before the sound generator instrument is used. The sound generator instru-

ment 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)

18 19

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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