User manual

FCC ID: X26CSX10

Users Manual

Download: PDF

FCCID_4165812

Left Hearing Aid Right Hearing Aid Specific features supported by your hearing system:
Serial number Serial number Smart Start on page 16
Phone Now on page 26
Model number Model number Telecoil on page 27
Battery size & form IIC CIC ITC size 10A ITC ITE size 13 ITC ITE size 312 Tinnitus Sound Generator on page 30
factor MIH size 13 MIH size 312 MIH-S size 10A
Hearing aid 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; CSX10; FCC
Programme Beep Description ID:X26, IC:6941C-CSX10. Please see page 8 - 9 for a list of models referring to these types.
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This device includes an RF transmitter that operates in the range of 2.4 GHz - 2.48 GHz.
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3
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1 Introduction 3 Becoming accustomed to amplification
Congratulations on the purchase of your new hearing aids. ReSound’s innovative sound technology and While purchasing hearing aids is a major step, it is only one step in a process toward more comfortable
design, combined with the customized programming selected by your hearing care professional, will hearing. Successfully adapting to the amplification your hearing aid provides takes time and consistent
make hearing a more enjoyable experience. use.

Please read this manual carefully in order to wholly benefit from the use of your hearing aids. With You will enjoy more benefits from your ReSound hearing aids by taking the following actions:
proper care, maintenance, and usage, your hearing aids will serve you in better communication for many • Wear the hearing aids regularly in order to get comfortable with using them
years. • It takes time to get used to hearing aids. It may help to begin by wearing your hearing aid for short
periods – even as little as 15 minutes – and then gradually increasing your wearing time. In a way,
Ask your hearing care professional if you have any questions. it is no different from adjusting to contact lenses. Speak to you hearing care professional, who can
design a schedule tailored just for you.
2 Intended use • As you get more comfortable with them, increase the wearing time and wear your hearing aids in
multiple types of listening environments.
Generic air-conduction hearing aids are wearable sound-amplifying devices intended to compensate for
impaired hearing. The fundamental operating principle of hearing aids is to receive, amplify, and transfer It may take as long as several months for your brain to get used to all the “new” sounds around you. Fol-
sound to the eardrum of a hearing-impaired person. lowing these suggestions will give your brain time to learn how to interpret amplification and increase
the benefits you get from using ReSound hearing aids.

4 5

4 Statement • In EU: the device conforms to the Essential Requirements according to Annex I of Council Direc-
tive 93/42/EEC for medical devices (MDD) .
This device complies with part 15 of the FCC rules and ISED rules.
• Hereby, GN ReSound A/S declares that the radio equipment types DA312r, DA13r, DA312i, DA13i
Operation is subject to the following two conditions:
and CSX10 are in compliance with Directive 2014/53/EU. The full text of the EU declaration of
1. This device may not cause harmful interference.
conformity is available at the following internet address: www.declarations.resound.com
2. This device must accept any interference received, including interference that may cause unde-
• In US: FCC CFR 47 Part 15, subpart C.
sired operation.
• Other identified applicable international regulatory requirements in countries outside the EU and
US. Please refer to local country requirements for these areas.
i 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
• In Canada: these hearing aids are certified under the rules of ISED.
• Japanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is
reasonable protection against harmful interference in a residential installation. This equipment
granted pursuant to the Japanese Radio Law (電波法) and the Japanese telecommunications Busi-
generates, uses and can radiate radio frequency energy and, if not installed and used in accordance
ness Law (電気通信事業法) This device should not be modified (otherwise the granted designation
with the instructions, may cause harmful interference to radio communications. However, there
number will become invalid).
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.
Changes or modifications can void the user´s authority to operate the equipment.

The products comply with the following regulatory requirements:

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Mic in Helix (MIH-S) hearing aid models with size 10A battery are available in the following variants: In-the-canal (ITC) hearing aids (including type DA312i with FCC ID X26DA312i, IC number 6941C-
LT9MIH-S-UP, LT9MIH-S-HP, LT9MIH-S-MP, LT9MIH-S-LP, LT7MIH-S-UP, LT7MIH-S-HP, LT7MIH-S-MP, DA312i models designated by a “W”) with size 312 battery and In-the-canal (ITC) hearing aids (including
LT7MIH-S-LP, LT5MIH-S-UP, LT5MIH-S-HP, LT5MIH-S-MP, LT5MIH-S-LP type DA13i with FCC ID X26DA13i, IC number 6941C-DA13i models designated by a “W”) with size 13
battery are available in the following variants:
Mic in Helix (MIH) hearing aids (including type DA312r with FCC ID X26DA312r, IC number 6941C- LT9ITC-DW-UP, LT9ITC-DW-HP, LT9ITC-DW-MP, LT9ITC-DW-LP, LT9ITC-D-UP, LT9ITC-D-HP, LT9ITC-D-MP,
DA312r models designated by a “W”) with size 312 battery and Custom Mic in Helix hearing aids (includ- LT9ITC-D-LP, LT9ITC-W-UP, LT9ITC-W-HP, LT9ITC-W-MP, LT9ITC-W-LP, LT9ITC-UP, LT9ITC-HP, LT9ITC-MP,
ing type DA13r with FCC ID X26DA13r, IC number 6941C-DA13r models designated by a “W”) with size LT9ITC-LP, LT7ITC-DW-UP, LT7ITC-DW-HP, LT7ITC-DW-MP, LT7ITC-DW-LP, LT7ITC-D-UP, LT7ITC-D-HP,
13 battery are available in the following variants: LT7ITC-D-MP, LT7ITC-D-LP, LT7ITC-W-UP, LT7ITC-W-HP, LT7ITC-W-MP, LT7ITC-W-LP, LT7ITC-UP,
LT9MIH-W-UP, LT9MIH-W-HP, LT9MIH-W-MP, LT9MIH-W-LP, LT9MIH-UP, LT9MIH-HP, LT9MIH-MP, LT7ITC-HP, LT7ITC-MP, LT7ITC-LP, LT5ITC-DW-UP, LT5ITC-DW-HP, LT5ITC-DW-MP, LT5ITC-DW-LP,
LT9MIH-LP, LT7MIH-W-UP, LT7MIH-W-HP, LT7MIH-W-MP, LT7MIH-W-LP, LT7MIH-UP, LT7MIH-HP, LT5ITC-D-UP, LT5ITC-D-HP, LT5ITC-D-MP, LT5ITC-D-LP, LT5ITC-W-UP, LT5ITC-W-HP, LT5ITC-W-MP,
LT7MIH-MP, LT7MIH-LP, LT5MIH-W-UP, LT5MIH-W-HP, LT5MIH-W-MP, LT5MIH-W-LP, LT5MIH-UP, LT5ITC-W-LP, LT5ITC-UP, LT5ITC-HP, LT5ITC-MP, LT5ITC-LP
LT5MIH-HP, LT5MIH-MP, LT5MIH-LP
In-the-ear (ITE) hearing aids (including type DA13i with FCC ID X26DA13i, IC number 6941C-DA13i
Invisible-in-the-canal (IIC) and Completely-in-the-canal (CIC) hearing aids with size 10A battery (includ- models designated by a “W”) with size 13 battery and In-the-ear (ITE) hearing aids (including type
ing type CSX10 with FCC ID X26CSX10, IC number 6941C-CSX10 models designated by a “W”) are DA312i with FCC ID X26DA312i, IC number 6941C-DA312i models designated by a “W”) with size 312
available in the following variants: battery are available in the following variants:
LT9IIC, LT7IIC, LT9CIC-UP, LT9CIC-HP, LT9CIC-MP, LT9CIC-LP, LT7CIC-UP, LT7CIC-HP, LT7CIC-MP, LT7CIC- LT9ITE-DW-UP, LT9ITE-DW-HP, LT9ITE-DW-MP, LT9ITE-D-UP, LT9ITE-D-HP, LT9ITE-D-MP, LT9ITE-W-UP,
LP, LT5IIC, LT5CIC-UP, LT5CIC-HP, LT5CIC-MP, LT5CIC-LP, LT9CIC-W-MP, LT9CIC-W-HP, LT7CIC-W-MP, LT9ITE-W-HP, LT9ITE-W-MP, LT9ITE-UP, LT9ITE-HP, LT9ITE-MP, LT7ITE-DW-UP, LT7ITE-DW-HP,
LT7CIC-W-HP, LT5CIC-W-MP, LT5CIC-W-HP LT7ITE-DW-MP, LT7ITE-D-UP, LT7ITE-D-HP, LT7ITE-D-MP, LT7ITE-W-UP, LT7ITE-W-HP, LT7ITE-W-MP,
LT7ITE-UP, LT7ITE-HP, LT7ITE-MP, LT5ITE-DW-UP, LT5ITE-DW-HP, LT5ITE-DW-MP, LT5ITE-D-UP,
In-the-canal (ITC) hearing aids with size 10A battery are available in the following variants: LT5ITE-D-HP, LT5ITE-D-MP, LT5ITE-W-UP, LT5ITE-W-HP, LT5ITE-W-MP, LT5ITE-UP, LT5ITE-HP, LT5ITE-MP
LT9ITC-D-UP, LT9ITC-D-HP, LT9ITC-D-MP, LT9ITC-D-LP, LT9ITC-UP, LT9ITC-HP, LT9ITC-MP, LT9ITC-LP,
LT7ITC-D-UP, LT7ITC-D-HP, LT7ITC-D-MP, LT7ITC-D-LP, LT7ITC-UP, LT7ITC-HP, LT7ITC-MP, LT7ITC-LP,
LT5ITC-D-UP, LT5ITC-D-HP, LT5ITC-D-MP, LT5ITC-D-LP, LT5ITC-UP, LT5ITC-HP, LT5ITC-MP, LT5ITC-LP

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8 Telephone use • The app must only be used with ReSound devices for which it is intended, and ReSound take no
responsibility if the app is used with other devices.
Your hearing aid allows you to use the telephone as you ordinarily do. Finding the optimal position for
• If you would like a printed version of the user guide for a smart phone app, please consult cus-
holding a telephone may require practice. One or more of the following suggestions may be helpful:
tomer support or go to our website at www.resound.com/support.
1. Hold the telephone up to your ear.
2. Hold the telephone towards the top of the ear (closer to where the
8.3 Cellular phones
microphones are).
3. If whistling occurs, it may take a few seconds of holding the telephone Your hearing aid complies with the most stringent Standards of International Electromagnetic Compat-
in the same position before the hearing aid eliminates the feedback. ibility. However, not all cell phones are hearing aid compatible (HAC).
4. Whistling may stop by holding the telephone slightly away from the
ear. Any degree of disturbance can be due to the nature of your particular cellular phone or of your wireless
telephone service provider.

i NOTE: Depending on your individual needs, your hearing care profes-
sional may activate a programme specifically for telephone use.
i NOTE: If you find it difficult to obtain a good result while using your cellular phone, your hearing
care professional will be able to give you advice on available wireless accessories to enhance listen-
8.1 Using ReSound Smart Hearing Aids with iPhone, iPad, and iPod touch (optional) ing capabilities.
ReSound LiNX 3D are Made for iPhone, and allow for direct communication and control with an
iPhone, iPad, or iPod touch.

i NOTE: For assistance with pairing and using these products with your ReSound LiNX 3D hearing
aids, please contact your hearing care professional.

8.2 Using ReSound hearing aids with smart phone apps (optional)
Use with smart phone apps:
• Notifications of app updates should not be disabled, and it is recommended that you install up-
dates to ensure that the app will function correctly and will be kept up to date.
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9 Tinnitus Sound Generator (TSG) module 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
9.1 Intended use for the TSG module sounds from nature, such as breaking waves or running water.
Your ReSound hearing aid includes the Tinnitus Sound Generator function, a tool for generating sounds
to be used in tinnitus management programmes to relieve suffering from tinnitus. If you have two wireless hearing aids that support ear-to-ear synchronisation this functionality can be
enabled by your hearing care professional. This will cause the Tinnitus Sound Generator to synchronise
The Tinnitus Sound Generator can generate sounds adjusted to the specific therapeutic needs and your the sound in both hearing aids.
personal preference as determined by your doctor, audiologist, or hearing care professional. Depending
on the selected hearing aid programme and the environment you are in, you will sometimes hear the If your tinnitus troubles you only in quiet environments, your doctor, audiologist or hearing care profes-
therapeutic sound resembling a continuous or fluctuating whistling. sional 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
9.2 User instructions for the TSG module professional will review with you the need for having such a control.
9.2.1 Description of the device
For hearing aids where ear to ear synchronisation is enabled your hearing care professional can also
The Tinnitus Sound Generator (TSG) Module is a software tool that generates sounds to be used in tin-
enable environmental monitoring synchronisation so that the TSG noise level is automatically adjusted
nitus management programmes to relieve suffering from tinnitus.
simultaneously in both hearing aids dependent on the background sound level. Additionally if the hearing
aid has a volume control then the background noise level monitored by the hearing aid and the volume
9.2.2 Explanation of how the device functions
control can be used simultaneously to adjust the generated noise level in both hearing aids.
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, 9.2.3 TSG volume control
audiologist or hearing care professional.
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
Your doctor, audiologist or hearing care professional can modulate the generated noise with the purpose
control the volume (loudness) manually. However, the volume control provides the ability to adjust the
of making it more pleasant. The noise can then resemble, for example, crashing waves on a shore.
volume, or amount of stimulus, to the liking of the user.

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9.3 Using TSG with smart phone apps The white noise signal can be modulated in amplitude with an attenuation depth of up to 14dB.
The Tinnitus Sound Generator control via hearing aid push buttons can be enhanced with wireless High-pass filter Low-pass filter
control from a TSG control app on a smart phone or mobile device. This functionality is available in sup-
500 Hz 2000 Hz
ported hearing aids when a hearing care professional has enabled the TSG functionality during fitting of
the hearing aid. 750 Hz 3000 Hz
1000 Hz 4000 Hz
To use smart phone apps the hearing aid must be connected with the smart phone or mobile device.
1500 Hz 5000 Hz
9.4 The scientific concepts that form the basis for the device 2000 Hz 6000 Hz
The TSG module provides sound enrichment with the aim of surrounding the tinnitus sound with a neu-
tral 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 9.6 Prescription use of a Tinnitus Sound Generator (TSG) hearing aid
needs to be audible. The ideal level of the TSG module, therefore, should be set so that it starts to blend The TSG module should be used as prescribed by your doctor, audiologist or hearing care professional.
with the tinnitus, and so that you can hear both your tinnitus as well as the sound used. In order to avoid permanent hearing damages, the maximum daily usage depends on the level of the
generated sound.
In a majority of instances, the TSG module can also be set to mask the tinnitus sound, so to provide tem-
porary relief by introducing a more pleasant and controllable sound source. Should you develop any side effects from using the sound generator, such as dizziness, nausea, head-
aches, perceived decrease in auditory function or increase in tinnitus perception, you should discontinue
9.5 Technical Specifications use of the sound generator and seek medical evaluation.
9.5.1 Audio signal technology
The target population is primarily the adult population over 18 years of age. This product may also be
Digital
used with children 5 years of age or older. However, children and physically or mentally disabled users will
require training by a doctor, audiologist, hearing care professional or the guardian for the insertion and
9.5.2 Available sounds
removal of the hearing aid containing the TSG module.
White noise signal which can be shaped with the following configurations:
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12 i Care and maintenance 12.1 i Daily maintenance
Please follow the instructions below to have the best user experience and to prolong the durability of It is important to keep your hearing aid clean and dry. On a daily basis, clean the hearing aids using a soft
your hearing aids: cloth or tissue. In order to avoid damage due to humidity or excessive perspiration, the use of a drying kit
1. Keep your hearing aid clean and dry. Wipe the case with a soft cloth or tissue after use to remove is recommended.
grease or moisture. Do not use water or solvents, as these can damage the hearing aid(s).
2. Never immerse hearing aids in water or other liquids, as liquids may cause permanent damage to 12.2 Replacing wax filters
the hearing aids. Custom hearing aids may have wax filters that protect against wax and moisture. It is recommended that
3. Avoid rough handling of hearing aids or dropping them on hard surfaces or floors. these are changed as needed.
4. Do not leave hearing aids in or near direct heat or sunlight, such as in a hot, parked car, as exces-
sive heat can cause damage or deform the casing. 12.2.1 Change HF3 wax filters
5. Do not wear your hearing aid while showering, swimming, in heavy rain or in a moist atmosphere
1. Brush the sound outlet area with the sound outlet pointed down.
such as a steam bath or sauna.
2. Insert the threaded end of the wax filter tool into the used wax filter, and gently rotate clockwise.
6. If your hearing aid does get wet, or if it has been exposed to high humidity or perspiration, it
3. Gently pull until the used filter is removed.
should be left to dry out overnight with the battery out and the battery door open. It is also a
4. Discard the used filter in the slot located in the wax filter kit by pressing it into the centre, sliding it
good idea to put the hearing aid and battery in a sealed container together with a drying agent
to one end of the slot, and pull until the filter is discarded.
(desiccator) overnight. Do not use the aid until it is completely dry. Consult your hearing care
5. Flip the wax filter tool around, locate a new filter in the dial, and press the tip of the tool into the
professional as to which drying agent to use.
center of the dial.
7. Remove your hearing aid when applying cosmetics, perfume, aftershave, hair spray, and suntan
6. Gently pull the new filter out of the dial.
lotion. These might get into the aid and cause damage.
7. Align the new filter to the sound outlet.
8. Press the new filter into the opening, and simultaneously pull and rock back and forth until the
new wax filter is in place.

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12.2.2 Change Cerustop (white) wax filters
1. To remove the old wax guard, insert the removal side of the wax guard tool into the used wax 13 i General warnings
guard so that the shaft of the tool is touching the rim of the wax guard. Slowly pull the wax guard 1. Consult a hearing care professional if you think there may be a foreign object in your ear canal, if
straight out. you experience skin irritation, or if excessive earwax accumulates with the use of the hearing aid.
2. To insert the new wax guard, gently press the replacement side of the wax guard tool straight into 2. Different types of radiation, from e.g. NMR, MRI, or CT scanners, may damage hearing aids. It is
the hole of the sound outlet until the outer ring lies flush with the outside of the receiver. Pull the recommended not to wear hearing aids during these or other similar procedures. Other types of
tool straight out -the new wax guard will remain in place. 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 mo-

i TIP: Pressing on the new filter with the flat side of the wax filter tool can ensure that the filter is
correctly in place.
mentarily affect the sound quality or temporarily create undesired sounds from hearing aids.
3. Do not wear hearing aids in mines, oil fields, or other explosive areas unless those areas are certi-
NOTE: If a different type of wax filter is used for your hearing aids, or if your hearing aids do not fied for hearing aid use.
use wax filters, consult your hearing care professional for guidance. 4. Do not allow others to use your hearing aids. This may cause damage to the hearing aids or to the
hearing of the other individual.

i CAUTION: Use only original ReSound consumables e.g. wax filters. 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.
7. Warning to hearing care professionals: Special care should be exercised in selecting and fit-
ting 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. Be careful when boarding flights to deactivate the wireless functionality. Turn off your wireless
functionality by using the flight mode in areas where radio frequency emission is prohibited.
9. If device is broken, do not use.

38 39

10. External devices connected to the electrical input must be safe according to the requirements of
IEC 60601-1, IEC 60065, or IEC 60950-1, as appropriate (wired connection, for example HI-PRO), 14 i
Using ReSound hearing aids with ReSound apps for smart
SpeedLink). phones
14.1 Intended use of ReSound apps for smart phones:
i 1. ReSound wireless devices include a RF transmitter that operates in the range of 2.4 GHz - 2.48
GHz. ReSound smart phone apps are intended to be used with ReSound wireless hearing aids. ReSound smart
2. For hearing aid types DA13i, DA13r, DA312i and DA312r nominal RF output power transmit- phone apps send and receive signals from the ReSound wireless hearing aids via smart phones for which
ted is 0 dBm. the apps have been developed.
3. For hearing aid type CSX10 nominal RF output power transmitted is 2.5 dBm.
4. For use of wireless functionality only use ReSound wireless accessories. For further guidance
regarding e.g. pairing, please refer to the user guide of the relevant ReSound wireless acces-
14.2 i General precautions
1. When wireless function is activated, the device uses low-powered digitally coded transmissions
sory. 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. When using wireless functionality and the devices are affected by electromagnetic interference,
move away from the source.
3. Use only original ReSound consumables e.g. tubes and domes.
4. Only connect ReSound hearing aids to ReSound accessories intended and qualified to be used
with ReSound hearing aids.

40 41

2. History of active drainage from the ear within the previous 90 days. 5. Used batteries are harmful to the environment. Please dispose of them according to local regula-
3. History of sudden or rapidly progressive hearing loss within the previous 90 days. tions or return them to your hearing care professional.
4. Acute or chronic dizziness. 6. Remove the batteries to prevent leakage when the hearing aids are not in use for an extended
5. Unilateral hearing loss of sudden or recent onset within the previous 90 days. period of time.
6. Audiometric air-bone gap equal to or greater than 15dB at 500 hertz (Hz), 1000 Hz, and 2000 Hz.
7.
8.
Visible evidence of significant cerumen accumulation or a foreign body in the ear canal.
Pain or discomfort in the ear.
18 i 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,
i CAUTION: The maximum output of the sound generator falls into the range that can cause hear-
ing 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 set to a level of 85
infrequent use does not permit you to attain full benefit from it.

dB SPL or above. When the sound generator is set to levels of 90 dB SPL or above, the user should The use of a hearing aid is only part of hearing rehabilitation and may need to be supplemented by audi-
not use the sound generator for more than two (2) hours per day. In no case should the sound tory training and instructions in lip-reading.
generator be worn at uncomfortable levels.

17 i Battery warnings
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 recharge-
able because they may leak or explode.
4. DO NOT attempt to dispose of batteries by burning them.

44 45

19 i Warning to hearing aid hearing care professionals (US Only) 20 i Important notice for prospective hearing aid users (US Only)
A hearing care professional should advise a prospective hearing aid user to consult promptly with a Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed
licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing care physician (preferably a physician who specializes in diseases of the ear) before purchasing a hearing aid.
professional determines through inquiry, actual observation, or review of any other available information Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otolo-
concerning the prospective user, that the prospective user has any of the following conditions: gists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treat-
1. Visible congenital or traumatic deformity of the ear. able conditions that may affect hearing are identified and treated before the hearing aid is purchased.
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. Following the medical evaluation, the physician will give you a written statement that states that your
4. Acute or chronic dizziness. hearing loss has been medically evaluated and that you may be considered a candidate for a hearing
5. Unilateral hearing loss of sudden or recent onset within the previous 90 days. aid. The physician will refer you to an audiologist or a hearing care professional, as appropriate, for a
6. Audiometric air-bone gap equal to or greater than 15 decibels at 500 hertz (Hz), 1,000 Hz, and hearing aid evaluation. The audiologist or hearing care professional will conduct a hearing aid evalua-
2,000 Hz. tion to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable
7. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal. the audiologist or hearing care professional to select and fit a hearing aid to your individual needs. If you
8. Pain or discomfort in the ear. 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.

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.

46 47

SYMPTOM CAUSE POSSIBLE REMEDY
Sound is distorted, splutter- Is the battery dead? Replace it with a new one.
ing or weak?
Is the battery dirty? Clean it or replace it with a new one.

Is the plastic tube or the earmould clogged or broken? Visit your hearing care professional.

Did your hearing aid get moist? Use a desiccant.
Battery drains very quickly Did you leave your hearing aid switched on for long periods of time? Always switch off your hearing aid when you are not using them, e.g. during the night.

Is the battery old? Check the date on the battery packaging.

52 53

24 Warranties and repairs 25 Temperature test, transport and storage information
ReSound provides a warranty on hearing aids in the event of defects in workmanship or materials, ReSound hearing aids are subjected to various tests in temperature and damp heating cycling between
as described in applicable warranty documentation. In its service policy, ReSound pledges to secure -25 °C and +70 °C according to internal and industry standards. During transport or storage, the tempera-
functionality at least equivalent to the original hearing aid. As a signatory to the United Nations Global ture should not exceed the limit values of -20 °C to +60 °C and relative humidity of 90% RH, non-con-
Compact initiative, ReSound is committed to doing this in line with environment-friendly best practices. densing (for limited time). The air pressure between 500 and 1100 hPa is appropriate.
Hearing aids therefore, at ReSound’s discretion, may be replaced by new products or products manufac-
tured from new or serviceable used parts, or repaired using new or refurbished replacement parts. The Be aware of information marked with the warning symbol:
warranty period of hearing aids is designated on your warranty card, which is provided by your hearing
care professional. i WARNING points out a situation that could lead to serious injuries.

For hearing aids that require service, please contact your hearing care professional for assistance.
ReSound hearing aids that malfunction must be repaired by a qualified technician. Do not attempt to i CAUTION indicates a situation that could lead to minor and moderate injuries.
open the case of hearing aids, as this will invalidate the warranty.
i Advice and tips on how to handle your hearing aid better.

Equipment includes an RF transmitter

PLEASE ASK YOUR LOCAL HEARING CARE PROFESSIONAL CONCERNING
DISPOSAL OF YOUR HEARING AID AND HEARING AID CHARGER.

i NOTE: Country specific regulations apply.

54 Follow instructions for use. 55

58 59

400620000GB-19.01-Rev.F
Manufacturer according to EU Medical
Device Directive 93/42/EEC:

Worldwide Headquarters United Kingdom Australia
GN ReSound A/S GN Hearing UK Ltd. GN Hearing Australia Pty Ltd.
Lautrupbjerg 7 Kirtlington Business Centre Gate C, 19-25 Khartoum Road
DK-2750 Ballerup Portway, Kirtlington Macquarie Technology Park
Denmark Oxon OX5 3JA Macquarie Park NSW 2113
Tel.: +45 4575 1111 Tel.: +44 1869 352 800 Tel.: (free) 1800 658 955
resound.com resound.com resound.com

CVR no. 55082715

New Zealand Singapore
GN Hearing Nw Zeeland Limited GN Hearing Pte. Ltd.
Ground Floor, North Entrance 2 Kallang Avenue
4 Fred Thomas Drive #07-19 CT HUB
Takapuna, Auckland, 0622 Singapore - 339407
Tel.: (free) 0800 900 126 Tel: +65 6320 9388
resound.com resound.com

Faceplate/Electronics by: GN ReSound A/S
Any issues relating to the EU Medical Device Directive 93/42/EEC or EU Radio
Equipment Directive 2014/53/EU should be directed to GN ReSound A/S

Document Created: 2019-01-14 12:28:21
Document Modified: 2019-01-14 12:28:21

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