Audifon rega pico User manual
IN-THE-EAR HEARING AIDS
sino
kami
rega
User Manual
3
Intended purpose
Hearing aids reduce the eects of hearing loss as much as
possible. Personal discomfort thresholds in loud noises are also
taken into account.
In quiet environments as well as in situations with background
noise, speech intelligibility should be improved and hearing
eort reduced.
The hearing aids are designed to last 6 years. Further
restrictions on use are listed in section 9 Safety instructions.
Hearing aids and the noiser module must be individually
fitted by a hearing care professional or an ENT doctor.
Updated: 09.08.2021
CONTENTS
INTRODUCTION ...............................................................
YOUR HEARING AID ..........................................................
. Type ............................................................................
. Technical features........................................................
. Batteries......................................................................
.. Information on batteries .....................................
.. Low battery warning ...........................................
OPERATION SINO, KAMI, REGA......................................
. Construction ...............................................................
. Inserting batteries .......................................................
. Removing batteries .....................................................
. Switching hearing aids on and o.................................
. Inserting and removing hearing aids ............................
. Volume control and program selection ........................
.. Volume control ....................................................
.. Selecting hearing programs.................................
TINNITUS FUNCTION........................................................
MAKING PHONE CALLS .....................................................
. Telephone loop TCoil ................................................
. Automatic program change .........................................
.. Auto TCoil...........................................................
.. Auto Phone..........................................................
.. Attaching magnet ...............................................
ACCESSORIES....................................................................
CARE INSTRUCTIONS .......................................................
. General .......................................................................
. Changing earwax protection filter...............................
. Drying hearing aids......................................................
TROUBLESHOOTING ........................................................
SAFETY INFORMATION.....................................................
. Important warnings....................................................
. Information about product safety ...............................
54
INTRODUCTION
Congratulations on the purchase of your new audifon hearing
aids. Your hearing care professional has adjusted the hearing
aids to your individual requirements. These instructions
are therefore intended to help you use your audifon hearing
aids properly.
Please read through the following operating and care
instructions carefully to avoid malfunctions and faults.
If you follow these instructions, your hearing aids will prove
an invaluable help in day-to-day communication with your
surroundings and other people.
The specific model of your hearing aids is shown on the sticker
on the packaging, on the warranty card or printed on the
hearing aids themselves.
Please take note of the following:
Your hearing aid will not make your hearing normal again,
nor will it prevent or improve any physical hearing loss. If you fail
to wear your hearing aid regularly, you will not benefit fully from
it. Use of a hearing aid only accounts for part of your hearing
ability and may need to be supplemented by auditory training
and instruction in lip reading.
If you have any further questions, please contact your hearing
care professional.
SIDE EFFECTS AND CONTRAINDICATIONS .......................
OPERATING CONDITIONS.................................................
TRANSPORT AND STORAGE CONDITIONS .......................
ENVIRONMENTALLY COMPATIBLE DISPOSAL ...................
OTHER INFORMATION .....................................................
SERVICE ............................................................................
KEY TO SYMBOLS ..............................................................
WARRANTY CARD
76
2.3 Batteries
To start your hearing aids, first insert a battery in the battery
compartment.
Make sure you only use zinc air batteries. Please follow the
instructions on the battery packaging. For the exact type of
battery in your hearing aid please see the overview table.
Please dispose of used batteries in the appropriate containers at
the premises of your hearing care professional.
Always switch your hearing aids OFF after use. To avoid damage,
remove the battery if you do not intend to use the hearing aids
for a long time.
2.3.1 Information on battery
A zinc air battery is used to supply the power for your hearing
aids. This type of battery is only activated when oxygen comes
through the air holes into the button cell and a chemical
reaction is initiated. During production, the air holes are sealed
with a protective strip.
This ensures the battery remains fresh until use and lasts longer
when it is sealed. Removing the protective strip allows oxygen
to enter and the chemical reaction is initiated.
Refitting the strip when the battery is not in use will not
extend its service life.
YOUR HEARING AID
2.1 Type
Your hearing aids are in-the-ear hearing aids.
2.2 Technical features
This user manual applies to the following types:
The detailed acoustic data of your hearing aid can be found in
a separate data specification. This and further information are
available from your hearing care professional or
www.audifon.com.
Model
rega pico
rega CIC
kami CIC
sino CIC
rega ITE V
kami ITE V
sino ITE V
rega ITE V
kami ITE V
sino ITE V
rega ITE V
kami ITE V
sino ITE V
Size
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
/
Average service life
(zinc air)
in h Gain
in dB
Battery
Minor to moderate
hearing loss
Minor to moderate
hearing loss
Minor to severe
hearing loss
Moderate to severe
hearing loss
Indication range
98
5
4
4
5
3
2
1
OPERATION SINO, KAMI, REGA
Your hearing aid consists of the following elements:
Your hearing aids may dier from the illustrations as they
have been made according to an individual impression taken
of your ear.
Depending on the model, your hearing aids have markings
for the sides: blue = left, red = right
Depending on which type of hearing aid you have, it may
not feature the elements marked with an *.
Microphone inlets
Battery compartment
Volume control*
Program switch*
Drawstring*
3.1 Construction
1
2
3
1
2
3
4
Battery should be stored at room temperature. Avoid
keeping them in hot places or rooms with high humidity
(e.g. bathroom). Storage in a cooled location is not
necessary.
Used batteries are considered hazardous materials and
contain toxic materials, should never be disposed of in the
trash. Ask about recycling programs in your area where
you live or return them to your hearing care professional to
dispose them appropriately.
Further safety instructions can be found on the battery
packaging.
2.3.2 Low battery warning
The hearing aids are equipped with a low battery signal which
can be heard as a series of beeps approximately 30 minutes
before the end of the battery life.
1110
Open the battery compartment carefully
with your fingernail at the edge for opening
and swing it right out.
Then remove the battery from the battery
compartment.
3.3 Removing battery
Remove a battery from its packaging.
If the battery has a protective film, remove
and wait a few minutes before inserting the
battery.
Open the battery compartment carefully
with your fingernail at the edge for opening
and swing it right out.
Then insert the battery in the battery
compartment. Make sure the (+) symbol on
the battery matches the (+) symbol on the
battery compartment.
Note: Do not force the battery into the
battery compartment. If it does not
fit, check whether you are inserting it
correctly and that it is the correct type of
battery (see Section 2.2).
3.2 Inserting battery
1312
Inserting
Insert your hearing aids in the outer part of the ear so that the
tip points towards the ear canal. To insert, pull your earlobe
down slightly and at the same time press the hearing aid into
your ear. Your hearing aid will then slide into the right position.
Removing
Take your hearing aid out by pulling your earlobe with one hand
and pushing gently behind the ear. This will release the hearing
aid from the ear canal.
If your hearing aid has a drawstring, use it to carefully pull the
hearing aid out of your ear.
3.5 Inserting and removing hearing aids
Depending on the model, your hearing aids have markings
for the sides: blue = left, red = right
Before use, check that your hearing aids are clean. After use,
earwax and other residues may be present on your hearing aids.
Remove before using again.
After a preset delay and a start-up jingle, the first program will
activate and the hearing aids are ready for use.
Switching o
The hearing aids are switched o as soon as
the battery compartment is opened.
If the devices are going to be out of use for a
long time, open the battery compartment
fully and remove the battery.
o
Switching on
Your hearing aids are switched on and o via
the battery compartment.
The hearing aids are now switched on as
soon as the battery compartment is closed.
3.4 Switching hearing aids on and o
on
1514
3.6.2 Selecting hearing programs
(for hearing aids with a program switch)
Press the program switch on your devices
to run through the various hearing
programs.
Each time you press the program switch,
the next hearing program will be activated.
An audible signal confirms each program
change.
Hearing program
Description of setting
When you switch your hearing aids on,
they will be at the volume set for you.
•Increase volume
Slowly turn the controller forwards.
•Reduce volume
Slowly turn the controller
backwards.
Once you have reached the upper or
lower volume limit, you will hear a
clear signal.
3.6.1 Volume selection
3.6 Volume control and program selection
right ear
left ear
1716
MAKING PHONE CALLS
5.1 Telephone loop (T-Coil)*
A telephone loop receives the magnetic signal from telephones
and converts it to sound. This optional telephone program
may help you to understand better what people are saying on
the telephone.
When making calls with the telephone loop program, hold the
handset as normal.
To find the correct position for optimum reception,
move the handset backwards and forwards slightly.
Depending on which type of hearing aid you have, it may
not feature the elements marked with an *.
5.2 Automatic program change*
The hearing aids belonging to the kami and rega families feature
automatic telephone program activation. The hearing aids can
automatically switch either to telephone loop (Auto T-Coil) or to
a microphone program for telephony (Auto Phone).
To prevent the hearing aids from accidentally switching
programmes during a telephone call, the program switch is
disabled during this time.
TINNITUS FUNCTION
Combi hearing aids from audifon play an eective part in
tinnitus therapy.
Your hearing care professional would have adjusted the combi
hearing aids to your individual hearing situation with you.
Information on operating devices with active tinnitus modules
can be found in Section 3 on this user manual.
4.1 Intended purpose
The integrated noiser module can be optionally activated and
can be used to support tinnitus therapy.
In combination with other therapeutic measures, the noise is
intended to help reduce the perception of tinnitus.
Activation of the noiser module as part of a tinnitus therapy
is suitable for adults aged 18 and over.
1918
5.2.3 Attaching magnet
To attach the magnet, proceed as follows:
. Clean the telephone handset thoroughly.
. Attach the magnet as shown in the illustration.
. If necessary, you can reposition the magnet.
5.2.1 Auto T-Coil
Automatic switchover to the telephone loop program is
designed for landline phones and only works with older
telephones or phones which have been specially designed
for use with telephone loops. Attaching the optional magnet
sticker increases the reliability of the switching function.
Familiarise yourself with how the automatic telephone loop
switching function works before making a call.
When you move the telephone handset away from your ear
again, your hearing aids will return to the program previously in
use.
5.2.2 Auto Phone
Automatic switchover to an acoustic telephone program can
be used with conventional landline and mobile phones and
optimises playback for telephony.
Attaching the optional magnet sticker increases the reliability
of the switching function. Familiarise yourself with how the
automatic telephone program switching function works before
making a call.
When you move the telephone handset away from your ear
again, your hearing aids will return to the program previously in
use.
Auto Phone and Auto T-Coil are optional functions.
Your hearing care professional will adjust your devices to
your individual requirements.
2120
CARE INSTRUCTIONS
audifon hearing aids will improve your hearing ability as well as
your quality of life. To ensure your hearing aids function perfect-
ly and so make hearing a pleasant experience for years to come,
audifon oers special care products designed to enable optimum
cleaning of your devices.
Protect your hearing aids against moisture (e.g. showers, sweat,
rain), and take your hearing aids out before using hairspray or
similar cosmetic products.
No matter what type of hearing aid you use, we also recommend
carrying out daily care on them as these devices are exposed to
moisture and dust through intended use, even when handled
with care: Each one is in direct contact with the skin. Resulting
perspiration may damage your hearing aid in the long term un-
less dried on a daily basis. The hearing aids are coated with a
water-repellent finish to prevent any damage from moisture.
Wearing a hearing aid or insertion of the ear adapter piece in the
ear canal will always involve soiling with earwax. For this reason
we recommend regular cleaning. Do not use a damp cloth to
clean your hearing aids. Always use a soft, dry cloth.
Should your hearing aid still not function correctly despite regu-
lar care, call on your hearing care professional.
Do not try under any circumstances to repair your hearing aid
yourself.
7.1 GeneralThe hearing aids from the rega, kami and sino families oer the
following accessories, which are available from your hearing
care professional. For further information please contact your
hearing care professional.
ACCESSORIES
Accessories
Earwax filter Small filter that stops the sound outlet of your hearing aid
getting blocked and should be replaced regularly.
Description
2322
dry star UV 2
The audifon dry star UV will dry your devices gently yet
thoroughly through a constant circulation of uniformly warm
air inside the casing.
The audifon dry star UV is not only automatic but also
consumes very little power, switching itself o at the end of the
drying program. The drying station is simple to operate using a
single sensor button.
7.3 Drying hearing aids
Your hearing aids should be dried after use at the end of the day
and above all after cleaning. If you take care of your hearing
aids by drying them carefully, this will significantly increase
their service life. There are two ways of doing this. If you
have an audifon drying station of the type dry star UV or
dry go, use this for drying. Take note of the individual product
instructions for further details. Alternatively, you can dry your
hearing aids in the audifon pro care Drying-Tub with an audifon
Drying-Capsule.
7.2 Changing earwax protection filter
Your hearing aids have protection filters to prevent
earwax being deposited inside the receiver. It is necessary
to regularly change the filter to ensure your hearing aids
function perfectly. To replace the filter, proceed as follows:
Remove the replacement tool from the
filter dispenser and slide it into the filter.
Remove the filter.
Turn the replacement tool so the new filter
is at the bottom.
Press the new filter with the replacement
tool into the filter opening of the hearing
aid until it clicks into place. Then simply
pull out the replacement tool and dispose
of it.
2524
TROUBLESHOOTING
If you experience any malfunctions when using your hearing
aids, this does not necessarily mean that they are faulty.
Therefore first check your hearing aid to make sure that:
•the hearing aid is switched on (see “Switching on and o”
Section 3.4),
•the batteries are not weak or dead,
•the volume control is not at the lowest setting (increase the
volume slightly if necessary),
•the right program has been set (change program if
necessary),
•the earwax protection system is not blocked.
If this does not eliminate the fault, consult your hearing care
professional, who will be pleased to help you.
Note: Malfunctions!
Your devices may be subject to interference from other
electrical equipment despite their EMC-compatible design.
If this occurs, please consult your hearing care professional.
dry go
The audifon dry go is the perfect solution for drying your devices
when on trips or if out and about. Once connected, for example
to the USB port on your laptop, the drying program can be
conveniently started at the touch of a single button. A flow of
warm air inside the audifon dry go will then dry your devices
reliably. The drying station switches o automatically at the end
of the drying program.
2726
Warning: Skin irritation
If you are allergic to acrylic, symptoms of an allergy may
occur. In this case please consult your doctor.
Warning: Risk of injury!
Hearing aids are adjusted to the individual hearing loss
of each wearer and should therefore only be used by
this person.
If the hearing aid is worn by other persons, this may harm
their hearing.
Warning: Interference with active and inactive
implants!
If you have an active or inactive implant (e.g. defibrillator,
pacemaker), follow the implant manufacturer’s instructions
regarding the use of mobile devices. In the event of
malfunctions, stop using your hearing aid and contact your
doctor or the implant manufacturer.
If you have an active brain implant, ask your doctor or the
implant manufacturer for a risk assessment.
Warning: Risk of injury!
During the fitting process, please only use accessories (e.g.
measurement technology, in-situ hoses, sound hoses,
filters) that are approved in the EU for the respective
purpose and, thus, that are compliant with the “General
Requirements” of Directive 93/42 / EU or the Regulation
2017/745 / EU for medical devices, respectively. Please pay
attention to the corresponding CE marking. For example:
Anity 2.0 from Interacoustics and the Sanibel™ REM probe
tubes, type A from Sanibel Supplies. Unauthorized changes
or modifications that are not explicitly approved can – in the
worst case - lead to injuries.
Warning: Risk of suocation!
Batteries, hearing aids and other small parts (e.g. magnets)
may be swallowed. For this reason, these hearing aids are not
intended for use by children under 36 months of age.
Never leave children unattended with your hearing aids!
Should a battery, hearing aid or other small parts be accidentally
swallowed, please consult a doctor immediately.
Warning: Damage to hearing!
The maximum volume of the noiser modul is in a range that may
lead to hearing loss according to OSHA regulations. For users
without hearing loss, the noiser modul should not exceed sound
pressure levels above 70 dB SPL (as measured at a 2cc coupler).
For users with hearing loss, the hearing loss needs to be taken
into consideration when adjusting the noise levels. Under no
circumstances should the noiser module be used at a volume
that is uncomfortable to the user.
For sound pressure levels up to 80 db SPL (as measured at the
2cc coupler) the noiser module can be used for up to 8 hours
daily. For higher sound pressure levels, the uncritical duration of
applications is reduced. The noiser modul should not be used for
more than 2 hours daily at higher sound pressure levels. Higher
sound levels and/or longer times of application might harm the
hearing ability over time.
Warning: Risk of explosion!
Do not use hearing aids in environments where there is a risk of
explosion (e.g. in mines or industrial plants subject to such risk).
SAFETY INFORMATION
9.1 Important warnings
2928
Note: Interference with electronic devices!
If you are in an environment where use of electronic or
wireless devices is restricted, check whether your hearing
aids must be turned o.
Note: Leaking batteries can damage your hearing aid!
If you are not going to use your hearing aids for a long time,
remove the battery to increase its service life, to avoid
leakage and to prevent corrosion to the battery contacts.
Note: Interference with magnetic storage media!
Magnets pose a risk when they are placed close to magnetic
storage media. Please therefore keep magnets away from
such media (e.g. bank cards).
Note: Strong radiation can damage hearing aids!
Make sure you take out your hearing aids if you are
undergoing a CT or MRI scan, other magnetic field-based
examinations or radiotherapy.
Note: Damage to hearing aid!
Never leave your hearing aid in the sun, near a naked flame
or in a hot vehicle. Otherwise your hearing aids might
become damaged.
Note: Damage to hearing aid!
Never try to change the shape of your hearing aid yourself.
Otherwise your hearing aids might become damaged.
Note: Malfunctions!
Your devices may be subject to interference from other
electrical equipment despite their EMC-compatible design.
In this case move away from the source of interference.
Warning: Electric shock!
Audio devices supplied with mains power must comply with
IEC 60065, IEC 60601 or similar safety standards to ensure
that they can be connected to your hearing aids without any
risk to safety.
9.2 Information about product safety
Note: Damage to hearing aid!
Hearing aids are susceptible to impact, so avoid any hard
knocks (e.g. by dropping them).
Note: Modifications to the device!
No modifications should be made to the hearing aids unless
performed directly by the manufacturer.
Note: Damage to hearing aid!
To avoid damage to your hearing aids, please do not wear
them in the following situations:
•when swimming, in the shower or bath
•when washing or blow-drying your hair
•when using hair spray, perfume, aftershave or body lotion
• during high-frequency heat therapy treatment
• when it is very hot or raining heavily
Should your hearing aid become damp, remove the battery
and dry the hearing aid in one of the drying containers
specified by the manufacturer. Do not dry your hearing aid in
the microwave under any circumstances.
Note: Damage to hearing aid!
Do not force the battery into the battery compartment. If it
does not fit, check whether you are inserting it correctly and
that it is the correct type of battery.
3130
OPERATING CONDITIONS
•Relative humidity between 10% and 90%
•Operating temperature between 0 °C and 40 °C
•Air pressure between 500 and 1060 hPa
10.2 Contraindications
Hearing aids should not be used under the following
circumstances:
•Hearing loss due to mainly neural deficits
•Insucient size/shape of the ear canal or malformations at
the ear that do not allow for easy insertion and retrieval of
the respective device.
•Adverse medical conditions of the outer ear and the ear
canal e.g., chronic inflammations, chronic skin irritations,
cholesteatoma
•Known allergies to any materials that have skin contact
Patients who are unable to operate the devices independently
require competent assistance. The use of hearing aids for
mentally impaired persons and for children should only be
done on the recommendation of a doctor. A comprehensive
risk assessment should be performed for the specific individual
case. Close supervision by a caregiver is recommended to ensure
proper use of the hearing instruments and to avoid accidental
swallowing of hearing instruments or parts thereof.
Note: Leaking batteries can damage your hearing aid
hearing aid!
If you do not intend to use your hearing aids for a long time,
remove the battery to increase its service lifespan, to avoid
leakage and to prevent corrosion to the battery contacts.
Note: Age of user!
The hearing aids are not suitable for children and teenagers
under the age of 16 years.
Note: Reporting serious incidents!
All serious incidents that occur involving the product should be
reported to the manufacturer and the competent authorities
in the member state in which the user and/or the patient are
registered.
SIDE EFFECTS AND CONTRAINDICATIONS
10.1 Side Eects
Please consult a doctor at once if you notice the following side
eects:
•Sensation of a foreign body
•Build-up of earwax
•Skin irritation
•Dizziness
•Vomiting
•Headache
•Pain in or behind the ear
•Any subjective deterioration in your hearing or increase in the
tinnitus level
3332
OTHER INFORMATION
EU declaration of conformity
audifon hereby declares that the products listed in this user
manual comply with the following directive:
93/42/EEC for medical devices
2011/65/EU RoHs for the reduction of hazardous substances.
The declaration of conformity can be viewed at
audifon GmbH & Co. KG
Werner-von-Siemens-Straße 2
D-99625 Kölleda
and at www.audifon.com
All serious incidents involving the product that occur should
be reported to the manufacturer and to the responsible
authorities in the member state in which the user and/or
the patient are registered.
TRANSPORT AND STORAGE CONDITIONS
•Relative humidity between 10% and 60%
•Storage temperature must lie between -20 °C and 60 °C
•Remove battery for storage
•Store away from magnetic fields
ENVIRONMENTALLY COMPATIBLE
DISPOSAL
In accordance with European defaults used electrical and
electronics devices may no more be given to the unsorted waste.
The symbol of the waste bin on wheels refers to the necessity of
separate collection. Please help with environmental protection and
see to it that this device is given to the for this purpose designated
systems of waste sorting if you do not use it any longer.
GUIDELINE 2012/19/EU of the EUROPEAN PARLIAMENT AND THE
COUNCIL of July 04th 2012 about electrical and electronics old
devices.
Alternatively, you can return your worn-out hearing aids and
batteries to your hearing aid specialist for environmentally friendly
disposal. He is your contact in the disposal chain for electronic
waste.
3534
Date
Hearing care professional
Date
Hearing care professional
Date
Hearing care professional
SERVICE
Arrange for your hearing aids to be checked regularly by a
hearing care professional.
Date
Hearing care professional
Date
Hearing care professional
Date
Hearing care professional
3736
KEY TO SYMBOLS
Caution
Indicates a situation that may result in serious, moderate or minor
injury.
Indicates the need for the user to consult the instructions for use for
important cautionary information such as warnings and precautions
that cannot, for a variety of reasons, be presented on the medical
device itself.
Notice
Indicates possible damage to property.
Information
Additional information for better understanding of the device.
Manufacturer
Indicates the medical device manufacturer, as defined in the
EU Medical Devices Regulation (EU) 2017/745 and in EU Directives
90/385/EEC, 93/42/EEC and 98/79/EC.
Date of manufacture
Indicates the date when the medical device was manufactured.
Electronic waste (WEEE)
Recycle hearing aids, accessories or batteries according to local
regulations. Hearing aid users can also return electronic waste to
their hearing care professional for disposal. Electronic equipment
covered by Directive 2012/19/EU on waste and electrical equipment
(WEEE).
Consult instructions for use
Indicates the need for the user to consult the instructions for use.
Humidity limitation
Indicates the range of humidity to which the medical device can be
safely exposed.
Temperature limit
Indicates the temperature limits to which the medical device can be
safely exposed.
Medical device
Indicates the item is a medical device
Catalogue number
Indicates the manufacturer’s catalogue number so that the medical
device can be identified.
Serial number
Indicates the manufacturer’s serial number so that a specific medical
device can be identified.
Lot number, batch code
Indicates the manufacturer’s batch code so that the batch or lot can
be identified.
CE mark
The device complies with all required EU regulations and directives.
The four digit number indicates the identification of the notified body.
3938
WARRANTY CARD
You have chosen high-quality hearing aids from audifon.
Your hearing care professional oers a month warranty on our hearing
aids from the date of purchase (date of invoice). The warranty covers defects in
materials and manufacture. It does not cover batteries, chemical or
electrochemical eects, wear and tear or mechanical damage due to improper
handling. The right to claim under warranty is voided if you or any
unauthorised third persons perform modifications or improper repair.
Therefore please always follow the safety and care instructions. Proof of
purchase must be provided as proof of warranty. The date of purchase and the
serial number must be clearly visible. Warranty obligations will not result in
any extension of the warranty period, nor will they give rise to a new warranty
period for the hearing aid.
The warranty period for built-in spare parts ends at the same time as the
warranty period for the entire hearing aid.
Date of sale
Signature
Hearing aid type
Your hearing care professional
Stamp:
Name
No., street
Town, postcode
Telephone
Date of issue
Type Side
Serial number
Warranty Battery type
Type Side
Serial number
Warranty Battery type
R
L
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12
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