Brio 5 I
User Guide
Phonak Brio™ 5 I-312/10 NW O
3
Wireless model
Phonak Brio 5 I-312
This user guide is valid for:
Non wireless model
Phonak Brio 5 I-10 NW O
4 5
Your hearing aids have been developed by Phonak —
the world leader in hearing solutions based in Zurich,
Switzerland.
These premium products are the result of decades of
research and expertise and are designed with your
well-being in mind. We thank you for making such a
great choice and wish you many years of listening
pleasure.
Please read the user guide carefully to make sure that
you understand and get the best out of your device.
Training is not required for handling of this device. A
hearing care professional will help set up this device
according to your individual preferences during the
tting consultation.
For more information regarding features, benets,
set up, use, maintenance or repairs of your hearing
aid and accessories, please contact your hearing care
professional or the manufacturer representative.
Additional information can be found in the data sheet
of your product.
If no box is checked and you do not know the
model of your hearing aid, please ask your hearing
care professional.
Your Brio 5 I-312 hearing aids operate between
2.4 GHz–2.48 GHz frequency range. When ying
please check if ight operator requires devices to
be switched into ight mode, see chapter 14.
Your hearing aid details
Model
c Phonak Brio 5 I-312
c Phonak Brio 5 I-10 NW O
Battery size
312
10
7
Contents
Your hearing aid
1. Quick guide
2. Parts of the hearing aid
Using the hearing aid
3. Left and right hearing aid markings
4. On/O
5. Batteries
6. Putting on the hearing aid
7. Removing the hearing aid
8. Push button
9. Volume control
10. Adjusting Brio 5 I-10 NW O with MiniControl
11. Connectivity overview Brio 5 I-312
12. Initial pairing Brio 5 I-312
13. Phone calls Brio 5 I-312
14. Flight mode Brio 5 I-312
8
10
12
13
14
16
17
19
20
21
23
24
27
31
Further Information
15. Care and maintenance
16. Operating, transport and storage conditions
17. Service and warranty
18. Compliance information
19. Information and description of symbols
20. Troubleshooting
21. Important safety information
22. For the US market only, complies with the
FDAregulations
33
35
37
39
45
52
54
69
8 9
1. Quick guide
Left and right hearing aid markings
Changing batteries
Blue marking for left
hearing aid.
Red marking for right
hearing aid.
1.
Remove the
sticker from the
new battery
and wait
twominutes.
Left Right
2.
Open the
battery door.
3.
Place battery in
the battery door
with the “+” symbol
facing upwards.
On/O
Flight mode Brio 5 I-312
Push button
Volume control
Models with this option only:
The push button on your hearing aid
can have various functions.
Models with this option only:
To increase the volume, turn the volume
control forwards. To decrease the volume,
turn the volume control backwards.
OOn
To enter ight mode press the push
button for 7 seconds while closing the
battery door. To exit ight mode, simply
open and close the battery door again.
10 11
2. Parts of the hearing aid
The following pictures show the models described in this
user guide. You can identify your personal model by:
• Checking “Your hearing aid details” on page 5.
• Or comparing your hearing aid with the following
shown models. Pay attention to the shape of the
hearing aid and if a volume control is present.
Brio 5 I-312
Battery door
Custom
made shell
Push button
Sound outlet / wax protection system
Volume control
(optional)
Brio 5 I-10 NW O
Custom made shell
Push button
(optional)
Removal handle
Sound outlet / wax protection system
Battery door
12 13
3. Left and right hearing
aid markings
There is a red or blue marking to tell you if it is a left or a
right hearing aid. The color mark is located on the
battery door, on the shell (text printed in red or blue) or
shell is colored red or blue.
Blue marking for left hearing aid.
Red marking for right hearing aid.
4. On/O
The battery door is also the on/o switch.
1.
Closed battery door =
hearing aid is on
2.
Opened battery door =
hearing aid is o
When you switch on the hearing aid you may hear a
start-up melody.
14 15
5. Batteries
1.
Remove the
sticker from the
new battery
and wait
twominutes.
2.
Open the
battery door.
3.
Place battery in
the battery door
with the “+” symbol
facing upwards.
Low power: You will hear two beeps when the battery
is low. You will have approximately 30 minutes to
change the battery (this can vary, depending on the
hearing aid settings and battery). We recommend
that you always have a new battery on hand.
Model
Phonak Brio 5
I-312
I-10 NW O
Zinc air
battery
size
312
10
Color
marking on
package
brown
yellow
IEC
code
PR41
PR70
ANSI
code
7002ZD
7005ZD
Replacement battery
This hearing aid requires zinc-air batteries. Identify
the correct battery size (312 or 10) by:
• Checking “Your hearing aid details” on page 5.
• Checking the marking on the inner side of the
battery door.
• Checking the following table.
If it is dicult to close the battery door: Check that
the battery is inserted correctly and the “+” symbol
is facing upwards. If the battery is not inserted
correctly, the hearing aid will not work and the
battery door can be damaged.
Please ensure you use the correct type of battery in
your hearing aids (zinc-air). Please also read chapter
21.2 for further information on product safety.
16 17
6. Putting on the hearing aid
(all models)
1.
Take your hearing aid up
to your ear and place
the ear canal part into
your ear canal.
7. Removing the hearing aid
7.1 Removing the hearing aid with a removal handle
1.
Hold the removal handle
and carefully pull the
hearing aid up and out
of the ear.
18 19
1.
Put your thumb behind your
lobe and gently press your ear
upward to push the hearing aid
out of the canal. In order to
help it along, make chewing
movements with your jaw.
2.
Grasp the protruding hearing
aid and remove it.
7.2 Removing the hearing aid without a
removal handle
8. Push button
Models with this option only:
The push button on your
hearing aid can have various
functions or is not active. This
depends on the programming
of the hearing aid, which is
indicated in your individual
“Hearing aid instructions.”
Please ask your hearing care
professional for this printout.
Brio 5 I-312:
If your hearing aid is paired
with a Bluetooth® enabled
phone, a short press on the
push button will accept an
incoming call and a long press
will reject an incoming call —
refer to chapter 13.
20 21
9. Volume control
Models with this
option only:
To increase the volume,
turn the volume control
forwards (towards nose).
To decrease the volume,
turn the volume control
backwards (towards back
of head). The volume
control can be disabled
by the hearing
care professional.
10. Adjusting Brio 5 I-10 NW O
with MiniControl
The MiniControl contains a magnet that functions
like a remote control to change the settings of your
Brio 5 I-10 NW O.
Your Brio 5 I-10 NW O in combination with MiniControl
can have various functions or can remain inactive. This
depends on your individual settings, which are indicated
in your individual “Hearing aid instructions.” Please ask
your hearing care professional for this print out.
To use the MiniControl,
unscrew the magnet from the
keychain housing and hold it
inside the ear canal without
touching the hearing aid.
MiniControl magnet
Keychain housing
22 23
While the hearing aid is on,
hold the magnet inside the ear
canal without touching the
hearing aid. Promtly remove
the magnet as soon as your
Brio 5 I-10 NW O is in
the desired program or the
volume is ideal for you.
If you use a medical device like a pacemaker or ICD
device (implantable cardioverter debrillator), please
read the specic user guide to clarify possible
impact of magnetic elds to your medical device.
Do not place the MiniControl (neither open nor
closed) in your breast pocket. Keep a distance of
at least 15 cm (6 inches) between the MiniControl
and any medical device.
11. Connectivity overview
Brio 5 I-312
The illustration below shows the connectivity options
available for your hearing aid.
* The TV Connector can be connected to any audio source such as a TV, PC or hi- system.
Cell phone
TV Connector connected to TV*
24 25
12.1 Initial pairing to Bluetooth® enabled device
It is only necessary to perform the pairing procedure
once with each device featuring Bluetooth wireless
technology. After the initial pairing, your hearing
aids will connect automatically to the device. This
can take up to 2 minutes.
1.
On your device (e.g. a phone), ensure that Bluetooth
wireless technology is enabled and search for Bluetooth
enabled devices in the connectivity setting menu.
12. Initial pairing Brio 5 I-312
2.
Switch on both hearing
aids. You now have 3
minutes to pair your hearing
aids with your device.
3.
Select the hearing aid in the list of Bluetooth enabled
devices. This will pair both hearing aids simultaneously.
A beep conrms successful pairing.
For more information about pairing instructions for
Bluetooth wireless technology, specic to some of
the most popular phone manufacturers, contact
your hearing care professional.
26 27
12.2 Connecting to the device
After your hearing aids have been paired to your device,
they will automatically connect again when switched on.
The connection will be maintained as long as the
device remains ON and within range.
Your hearing aids can be paired to up to two devices.
Your hearing aids can be connected to one device
at a time.
13. Phone calls Brio 5 I-312
Your hearing aids connect directly with Bluetooth®
enabled phones. When paired and connected to your
phone, you will hear the caller’s voice directly in your
hearing aids. Your hearing aids pick up your voice
through their own microphones.
Caller’s voice
Your voice
Bluetooth® is a registered trademark owned by the Bluetooth SIG, Inc.
28 29
13.1 Making a call
Enter the phone number and press the dial button.
You will hear the ring tone through your hearing aids.
Your hearing aids pick up your voice through their own
microphones.
13.2 Accepting a call
When receiving a call, a calling notication will be heard
in the hearing aids. The call can be accepted by a short
press on the push button on the hearing aid (less than
2seconds) or directly on your phone.
short press
< 2 sec
13.3 Ending a call
A call can be ended by a long press on the push button
on the hearing aid (more than 2seconds) or directly on
your phone.
long press
> 2 sec
30 31
Your hearing aids operate between 2.4 GHz–2.48 GHz
frequency range. When ying some operators require all
devices to be switched into ight mode. Entering ight
mode will not disable normal hearing aid functionality,
only the Bluetooth connectivity functions.
14.1 Enter ight mode
To disable the wireless function and
enter ight mode in each hearing aid:
1.
Open battery door.
2.
Hold down the push button on
the hearing aid for 7 seconds while
closing the battery door.
In ight mode, your hearing aid cannot connect directly
to your phone.
13.4 Rejecting a call
An incoming call can be rejected by a long press on
the push button on the hearing aid (more than
2seconds) or directly on your phone.
long press
> 2 sec
14. Flight mode Brio 5 I-312
32 33
14.2 Exit ight mode
To enable the wireless function and exit ight mode in
each hearing aid:
1.
Open battery door.
2.
Close the battery door again.
15. Care and maintenance
Diligent and routine care of your hearing aid contributes
to outstanding performance and a long service life.
To ensure a long service life, Sonova AG provides a
minimum of a ve year service period after phase out
of the respective hearing aid.
Please use the following specications as a guideline.
For further information regarding product safety, see
chapter 21.2.
General information
Before using hair spray or applying cosmetics, you
should remove your hearing aid from your ear, because
these products may damage it.
34 35
Daily
Daily cleaning and the use of a drying system is highly
recommended. C&C line from Phonak is a complete set
of cleaning products. Your hearing care professional will
be glad to advise you. Never use household cleaning
products (washing powder, soap, etc.) to clean your
hearing aids.
If your hearing aid is performing weakly or fails to
operate, clean or replace the wax guard system. If your
hearing aid fails to operate after you have correctly
cleaned or replaced your wax protection system and
inserted new batteries, contact your hearing care
professional for advice.
Weekly
For more in depth maintenance instructions or for
more than basic cleaning, please see your hearing
care professional.
16. Operating, transport and
storage conditions
The product is designed such that it functions without
problems or restrictions if used as intended, unless
otherwise noted in this user guide.
Please ensure to use, transport and store the hearing
aids according to the following conditions:
Use Transport Storage
Temperature 0° to +40°C
(32° to 104°F)
-20° to +60°C
(-4° to 140°F)
-20° to +60°C
(-4° to 140°F)
Humidity 0% to 85%
(non condensing)
0% to 70%
(non condensing)
0% to 70%
(non condensing)
Atmospheric
pressure
500 to 1060 hPa 500 to 1060 hPa 500 to 1060 hPa
36 37
Phonak Brio 5 I-10 NW O hearing aids are classied as
IP68. This means that they are water and dust resistant
and designed to withstand daily life situations. It can be
worn in the rain but should not be fully submerged in
water or used when taking a shower, swimming or other
water activities. The hearing aids should never be
exposed to chlorinated water, soap, salt water or other
liquids with a chemical content.
17. Service and warranty
Local warranty
Please ask the hearing care professional where you
purchased your hearing aid about the terms of the
local warranty.
International warranty
Sonova AG oers a one year limited international
warranty, valid starting from the date of purchase.
This limited warranty covers manufacturing and material
defects in the hearing aid itself, but not accessories
such as batteries, tubes, earmolds and external receivers.
The warranty only comes into force if a proof of
purchase is shown.
The international warranty does not aect any legal
rights that you might have under applicable national
legislation governing sale of consumer goods.
38 39
Warranty limitation
This warranty does not cover damage from improper
handling or care, exposure to chemicals or undue stress.
Damage caused by third parties or non-authorized
service centers renders the warranty null and void. This
warranty does not include any services performed by a
hearing care professional in their oce.
Serial number
(left side):
Serial number
(right side):
Date of purchase:
Authorized hearing care
professional (stamp/signature):
Europe:
Declaration of Conformity
Hereby Sonova AG declares that this product meets the
requirements of the the Medical Devices Regulation(EU)
2017/745 as well as the Radio Equipment Directive
2014/53/EU. The full text of the EU Declaration of
Conformity can be obtained from the manufacturer or
the local Phonak representative whose address can be
taken from the list on www.phonak.com/us/en/
certicates (Phonak worldwide locations).
18. Compliance information
Australia/New Zealand:
Indicates a device’s compliance with applicable
Radio Spectrum Management’s (RSM) and
Australian Communications and Media Authority
(ACMA) regulatory arrangements for the legal
sale in New Zealand and Australia.
The compliance label R-NZ is for radio products
supplied in the New Zealand market under
conformity level A1.
40 41
The wireless models listed on page 2 are
certied under:
Phonak Brio 5 I-312, models M / P / SP / UP
USA FCC ID: KWC-VTP
Canada IC: 2262A-VTP
Notice 1:
This device complies with Part 15 of the FCC Rules
and with RSS-210 of Industry Canada. Operation is
subject to the following two conditions:
1) this device may not cause harmful interference, and
2) this device must accept any interference received,
including interference that may cause undesired
operation.
Notice 2:
Changes or modications made to this device not
expressly approved by Sonova AG may void the FCC
authorization to operate this device.
Notice 3:
This device 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 ICES-003 of Industry Canada.
These limits are designed to provide reasonable
protection against harmful interference in a residential
installation. This device generates, uses and can radiate
radio frequency energy and, if not installed and used in
42 43
accordance with the instructions, may cause harmful
interference to radio communications. However, there
is no guarantee that interference will not occur in a
particular installation. If this device does cause harmful
interference to radio or television reception, which can
be determined by turning the equipment o 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 device
and receiver.
• Connect the device into an outlet on a circuit
dierent from that to which the receiver is connected.
• Consult the dealer or an experienced radio/TV
technician for help.
Radio information of your hearing aid
Emission standards EN 60601-1-2
IEC 60601-1-2
EN 55011
CISPR11
CISPR32
Compliance with emission and immunity standards
Resonant loop antenna
2.4 GHz – 2.48 GHz
GFSK, Pi/4 DPSK, GMSK
< 1 mW
~1m
4.2 Dual-Mode
HFP (Hands-free prole), A2DP
Antenna type
Operation frequency
Modulation
Radiated power
Bluetooth®
Range
Bluetooth
Proles supported
44 45
Immunity standards EN 60601-1-2
IEC 60601-1-2
EN 61000-4-2
IEC 61000-4-2
EN IEC 61000-4-3
IEC 61000-4-3
EN 61000-4-4
IEC 61000-4-4
EN 61000-4-5
IEC 61000-4-5
EN 61000-4-6
IEC 61000-4-6
EN 61000-4-8
IEC 61000-4-8
EN 61000-4-11
IEC 61000-4-11
IEC 60601-1
19. Information and description
of symbols
With the CE symbol, Sonova AG conrms
that this product — including accessories
— meets the requirements of the Medical
Devices Regulation 2017/745 as well as the
Radio Equipment Directive 2014/53/EU. The
numbers after the CE symbol correspond to
the code of certied institutions that were
consulted under the above-mentioned
regulation and directive.
This symbol indicates that the products
described in these user instructions adhere to
the requirements for an applied part of Type
B of EN 60601-1. The surface of the hearing
aid is specied as an applied part of Type B.
Indicates the medical device manufacturer,
as dened in the Medical Devices Regulation
2017/745.
46 47
Indicates the date when the medical device
was manufactured.
Indicates the Authorized representative in
the European Community. The EC REP is also
the importer to the European Union.
This symbol indicates that it is important for
the user to read and take into account the
relevant information in these user guides.
This symbol indicates that it is important
for the user to pay attention to the relevant
warning notices in these user guides.
This symbol indicates that it is important
for the user to pay attention to the relevant
warning notices related to batteries in these
user guides.
Important information for handling and
product safety.
This symbol confers that the electromagnetic
interference from the device is under limits
approved by the US Federal Communications
Commission.
Indicates a device’s compliance with
applicable Radio Spectrum Management’s
(RSM) and Australian Communications and
Media Authority (ACMA) regulatory
arrangements for the legal sale in New
Zealand and Australia.
The Bluetooth® word mark and logos are
registered trademarks owned by Bluetooth
SIG, Inc. and any use of such marks by
Sonova AG is under license. Other trademarks
and trade names are those of their respective
owners.
48 49
The Compliance Identication Mark indicates
that the device is in accordance with
Brazilian conformity assessment
requirements for equipment under health
surveillance system. OCP indicates the
certication body.
Japanese mark for certified radio equipment.
Indicates the manufacturer’s serial number
so that a specic medical device can be
identied.
Indicates the manufacturer’s serial number
so that a specic medical device can be
identied.
Indicates that the device is a medical device.
This symbol indicates that it is important for
the user to read and take into account the
relevant information in this user guide.
Ingress Protection Rating. IP68 rating
indicates that the hearing aid is water and
dust resistant. It survived continuous
immersion in 1 meter of water for 60minutes
and 8 hours in a dust chamber as per the
IEC60529 standard.
Temperature during transportation and
storage: –20° to +60° Celsius (–4° to +140°
Fahrenheit).
Humidity during transportation and storage:
0% to 70%, if not in use. See instruction in
chapter 21.2 regarding drying the hearing aid
after use.
50 51
Atmospheric pressure during transportation
and storage: 500 hPa to 1060 hPa
During transportation keep dry.
The symbol with the crossed-out garbage bin
is to make you aware that this hearing aid
may not be thrown away as normal
household waste. Please dispose of old or
unused hearing aids, at waste disposal sites
intended for electronic waste, or give your
hearing aid to your hearing care professional
for disposal. Proper disposal protects the
environment and health.
52 53
20. Troubleshooting
Causes
Dead battery
Blocked sound outlet
Battery not inserted correctly
Hearing aid switched o
Hearing aid not inserted correctly
Earwax in ear canal
Volume too loud
Low battery
Blocked sound outlet
Volume too low
Physical hearing condition has changed
Indication for low battery
Moisture on battery or hearing aid
Hearing aid is in ight mode
Hearing aid not paired to the phone
Problem
Hearing aid not functioning
Hearing aid whistles
Hearing aid too loud
Hearing aid not loud enough
or distorted
Hearing aid plays two beeps
Hearing aid switches on and o
(intermittent)
Phone call function does not work
(Brio 5 I-312 only)
If the problem persists, contact your hearing care professional
for assistance.
What to do
Change battery (chapter 5)
Clean sound outlet
Insert battery correctly (chapter 5)
Switch hearing aid on by completely closing the battery door (chapter 4)
Insert hearing aid correctly (chapter 6)
Contact your ENT/GP or hearing care professional
Decrease volume if volume control available (chapter 8 + 9)
Change battery (chapter 5)
Clean sound outlet
Turn volume up if volume control available (chapter 8 + 9)
Contact your hearing care professional
Change battery within the next 30 minutes (chapter 5)
Wipe battery and hearing aid with dry cloth
Open and close battery door (chapter 14.2)
Pair it to the phone (chapter 12)
54 55
Any serious incident that has occurred in relation to the
hearing aid, should be reported to the manufacturer
representative and the competent authority of the state of
residence. The serious incident is described as any incident
that directly or indirectly led, might have led or might lead
to any of the following:
• the death of a patient, user or other person
• the temporary or permanent serious deterioration of
a patient’s, user’s or other person’s state of health
• a serious public health threat
To report an unexpected operation or event, please contact
the manufacturer or a representative.
Please read the information and limitations-of-use
information on the following pages before using your
hearing aid.
A hearing aid will not restore normal hearing and will not
prevent or improve a hearing impairment resulting from
organic conditions. Infrequent use of a hearing aid does
not permit a user to attain full benet from it. The use of a
hearing aid is only part of hearing habilitation and may
need to be supplemented by auditory training and
instruction in lipreading.
Hearing aids are suitable for the home healthcare
environment and due to their portability it may happen
that they are used in professional healthcare facility
environments like physician oces, dental oces, etc.
Feedback, poor sound quality, too loud or too soft sounds,
inadequate tting or problems when chewing or
swallowing, can be resolved or improved during the
ne-tuning process at the tting procedure by your
hearing care professional.
21. Important safety information
56 57
Indications:
General clinical indications for the use of hearing aids and
Tinnitus software feature are:
• Presence of hearing loss
• Uni- or bilateral
• Conductive, sensorineural or mixed
• Mild to profound
• Presence of a chronic tinnitus (only applicable for
devices which provide the Tinnitus software feature)
Contraindications:
General clinical contra-indications for the use of hearing
aids and Tinnitus software feature are:
• Hearing loss is not in the tting range of the hearing
aid (i.e. gain, frequency response)
• Acute tinnitus
• Deformity of the ear (i.e. closed ear canal)
• Neural hearing loss
Intended use:
The hearing aid is intended to amplify and transmit sound
to the ear and thereby compensate for impaired hearing.
The Tinnitus Balance software feature is intended for use by
people with tinnitus who also desire amplication. It
provides supplementary noise stimulation which can help
defocus the user’s attention from their tinnitus.
Intended patient population:
This device is intended for patients with unilateral and
bilateral, mild to profound hearing loss from 18 years of
age. The Tinnitus feature is intended for patients with
chronic tinnitus from 18 years of age.
Intended user:
Intended for people with hearing loss using a hearing
aid and their caregivers. A hearing care professional
is responsible for adjusting the hearing aid.
58 59
The hearing care professional may decide that referral
is not appropriate or in the best interest of the patient
when the following applies:
• When there is sucient evidence that the condition
has been fully investigated by a medical specialist
and any possible treatment has been provided;
• The condition has not worsened or changed
signicantly since the previous investigation
and / or treatment.
• If the patient has given their informed and competent
decision not to accept advice to seek a medical opinion,
it is permissible to proceed to recommend appropriate
hearing aid systems subject to the following
considerations:
• The recommendation will not have any adverse
eects on the patients health or general well being;
• The records conrm that all necessary
considerations about the patient’s best interest
have been made. If legally required, the patient has
signed a disclaimer to conrm that the referral
advice has not been accepted and that it is an
informed decision.
The primary criteria for the referral of a patient for a
medical or other specialist opinion and / or treatment
are as follows:
• Visible congenital or traumatic deformity of the ear;
• History of active drainage from the ear in the previous
90 days;
• History of sudden or rapidly progressive hearing loss
in one or both ears within the previous 90 days;
• Acute or chronic dizziness;
• Audiometric air-bone gap equal to or greater than
15dB at 500 Hz, 1000 Hz and 2000 Hz;
• Visible evidence of signicant cerumen accumulation
or a foreign body in the ear canal;
• Pain or discomfort in the ear;
• Abnormal appearance of the eardrum and ear canal
such as:
• Inammation of the external auditory canal
• Perforated eardrum
• Other abnormalities which the hearing care
professional believes are of medical concern
60 61
Your Brio 5 I-312 hearing aids operate between
2.4 GHz–2.48 GHz frequency range. When ying please
check if ight operator requires devices to be switched
into ight mode, see chapter 14.
Changes or modications to the hearing aid that were
not explicitly approved by Sonova AG are not permitted.
Such changes may damage your ear or the hearing aid.
Do not use the hearing aids in explosive areas (mines
or industrial areas with danger of explosions, oxygen-rich
environments or areas where ammable anesthetics
are handled). This device is not ATEX certied.
WARNING: Device batteries are hazardous and can cause
serious injuries if they are swallowed or placed inside any
part of the body, whether the battery is used or new! Keep
out of the reach of children, individuals with cognitive
impairment, or pets. If you suspect that a battery was
swallowed or placed inside any part of the body,
immediately consult your physician without any delay!
21.1 Hazard warningsClinical benet:
Hearing aid: Improvement of speech understanding.
Tinnitus feature: Tinnitus feature provides supplementary
noise stimulation which can help defocus the user’s
attention from their tinnitus.
Side eects:
Physiological side-eects of hearing aids like tinnitus,
dizziness, wax build up, too much pressure, sweating or
moisture, blisters, itching and/or rashes, plugged or
fullness and their consequences like headache and/ or ear
pain, may be resolved or reduced by your hearing care
professional.
Conventional hearing aids have the potential to expose
patients to higher levels of sound exposure, which might
result in threshold shifts in the frequency range aected
by acoustic trauma.
62 63
The following is only applicable for persons with active
implantable medical devices (i.e. pacemakers, debrillators,
etc.):
Keep the wireless device at least 15 cm (6 inches) away from
the active implant. If you experience any interference do not
use the wireless hearing aids and contact the manufacturer
of the active implant. Please, note that the interference can
also be caused by powerlines, electrostatic discharge, airport
metal detectors etc.
Keep magnets (i.e. battery handling tool, EasyPhone magnet,
etc.) at least 15 cm (6 inches) away from the active implant.
Use of accessories, transducers and cables other than those
specied or provided by the manufacturer of this equipment
could result in increased electromagnetic emissions or
decreased electromagnetic immunity of this equipment
and result in improper operation.
If you feel pain in or behind your ear, if it is inamed or if
skin irritation and accelerated accumulations of earwax
occur, please check with your hearing care professional or
physician.
In very rare cases if not securely attached, a cerumen stop
can remain in your ear canal when removing the hearing aid
from the ear. In the unlikely case that such part gets stuck in
your ear canal, it is strongly recommended to see a
physician for safe removal.
Hearing programs in the directional microphone mode
reduce background noises. Please be aware that warning
signals or noises coming from behind, e. g. cars, are partially
or entirely suppressed.
This hearing aid is not for children below 36 months. The
hearing aid is a small device and contains small parts. Do
not leave children, individuals with cognitive impairment or
pets unsupervised with this hearing aid. If swallowed,
consult a physician or hospital immediately as the hearing
aid or its parts can be choking or poisonous hazard.
64 65
The hearing aids (specially programmed for each hearing loss)
must only be used by the intended person. They should not be
used by any other person as they could damage hearing.
Patients implanted with magnetic externally programmable
CSF shunt valves may have a risk of experiencing an
unintended change in their valve setting when exposed to
strong magnetic elds. The receiver (loudspeaker) of hearing
aids, the Lyric SoundLync, the Lyric programming wand and
the MiniControl contain static magnets. Keep a distance of
2inches (approx. 5 cm) or more between the magnets and
the site of the implanted shunt valve.
The majority of hearing aid users have a hearing loss for
which a deterioration in hearing is not to be expected with
regular use of a hearing aid in everyday situations. Only a
small group of hearing aid wearers with hearing loss, may be
at risk of deterioration in hearing after a long period of use.
64
Brio 5 I-312 only: Portable RF communications equipment
(including peripherals such as antenna cables and external
antennas) should be used no closer than 30 cm (12 inches)
to any part of the hearing aids, including cables specied by
the manufacturer. Otherwise, degradation of the
performance of this equipment could result.
Avoid strong physical impacts to the ear when wearing
in-the-ear hearing aids. The stability of in-the-ear shells is
designed for normal use. A strong physical impact to the ear
(e.g. during sports) may cause the in-the-ear shell to break.
This may lead to perforation of the ear canal or ear drum.
After mechanical stress or shock to the hearing aid, please
ensure that the hearing aid shell is intact before placing it in
the ear.
Use of this equipment adjacent to or stacked with other
equipment should be avoided because it could result in
improper operation. If such use is necessary, this equipment
and the other equipment should be observed to verify that
they are operating normally.
66 67
Phonak hearing aids are water resistant and not waterproof.
They are designed to withstand normal activities and
occasional accidental exposure to extreme conditions. Never
immerse your hearing aid in water! These hearing aids are
not specically designed for extended periods of water
submersion on a continual basis, that is worn in activities
such as swimming or bathing. Always remove your hearing
aid before these activities, as the hearing aid contains
sensitive electronic parts. Never wash the microphone inputs.
Doing so could cause it to lose its special acoustic features.
Protect your hearing aid from heat (never leave near a
window or in the car). Never use a microwave or other
heating devices to dry your hearing aid. Ask your hearing
care professional about suitable drying methods.
When you are not using your hearing aid, leave the battery
door open so that any moisture can evaporate. Make sure
that you always completely dry your hearing aid after use.
Store the hearing aid in a safe, dry and clean place.
21.2 Information on product safety Do not drop your hearing aid! Dropping onto a hard surface
can damage your hearing aid.
Always use new batteries for your hearing aid. In case a
battery is leaking, replace it immediately with a new one to
avoid any skin irritation. You can return used batteries to
your hearing care professional.
The batteries used in these hearing aids should not exceed
1.5 Volts. Please do not use silver-zinc or Li-ion (lithium-ion)
rechargeable batteries as these may cause severe damage to
your hearing aids.
Remove the battery if you are not using your hearing aid for
a long period of time.
6968
Special medical or dental examination including radiation
described below, may adversely aect the correct
functioning of your hearing aids. Remove and keep them
outside the examination room/area before undergoing:
Medical or dental examination with X-ray (also CT scan).
Medical examinations with MRI/NMRI scans, generating
magnetic elds.
Hearing aids don’t need to be removed when passing
security gates (airports etc.). If X-ray is used at all, it will be
in very low doses, and will not aect the hearing aids.
Do not use your hearing aid in areas where electronic
equipment is prohibited.
Do not kink or buckle the removal handle. Repeated stress to
the removal handle may cause it to break. In case of a
broken removal handle the battery door may exceptionally
be used to carefully pull the hearing aid out of the ear canal.
22. For the US market only, complies
with the FDA regulations
Important information: Cell phones
Some hearing aid users have reported a buzzing sound
intheir hearing aids when they are using cell phones.
According to the ANSI 63.19 (American National
Standard Methods of Measurement of Compatibility
between Wireless Communications Devices and Hearing
Instruments) standard, the compatibility of a particular
hearing aid and cell phone can be predicted by adding
the rating for the hearing aid immunity to the rating for
the cell phone emissions. The sum of the hearing
aid rating (e.g. M2/T2=2) and the telephone rating
(e.g. M3/T3=3) is 5, and any combination that equals
5 will provide “normal use”; a sum of 6 or greater would
indicate “excellent performance”. The equipment
performance measurements, categories and system
classications are based upon the best information
available but cannot guarantee that all users will be
satised. The immunity of this hearing aid is at least
M2/T2.
70 71
Note: the performance of individual hearing aids may
vary with individual cell phones. Therefore, please try the
hearing aid with your cell phone or, if you are purchasing
a new phone, be sure to try it with your hearing aid prior
to purchase. For additional guidance, please ask your
hearing care professional for the booklet entitled “hearing
aid compatibility with digital wireless cell phones.”
Important information in case of battery ingestion
If a battery is swallowed, call the 24-hour National
Battery Ingestion Hotline at 202-625-3333 or consult
your physician immediately.
Warning to hearing aid dispensers
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 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.
(ii) History of active drainage from the ear within
theprevious 90 days.
(iii) History of sudden or rapidly progressive hearing loss
within the previous 90 days.
(iv) Acute or chronic dizziness.
72 73
(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 signicant cerumen
accumulation or a foreign body in the ear canal.
(viii) Pain or discomfort in the ear. Special care should
beexercised in selecting and tting a hearing aid
whose maximum sound pressure level exceeds
132decibels because there may be risk of impairing
the remaining hearing of the hearing aid user. (This
provision is required only for those hearing aids with
a maximum sound pressure capability greater than
132 decibels (dB).)
Important notice for prospective hearing aid users
Good health practice requires that a person with a
hearing loss have a medical evaluation by a licensed
physician (preferably a physician who specializes in
diseases of the ear) before purchasing a hearing aid.
Licensed physicians who specialize in diseases of the ear
are often referred to as otolaryngologists, otologists or
otorhinolaryngologists. The purpose of medical
evaluation is to assure that all medically treatable
conditions that may aect hearing are identied and
treated before the hearing aid is purchased.
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.
The audiologist or hearing aid dispenser will conduct
ahearing aid evaluation to assess your ability to hear with
74 75
and without a hearing aid. The hearing aid evaluation will
enable the audiologist or dispenser to select and t
ahearing aid to your individual needs.
If you have reservations about your ability to adapt to
amplication, you should inquire about the availability of a
trial-rental or purchase-option program. Many hearing aid
dispensers now oer programs that permit you to wear a
hearing aid for a period of time for a nominal feeafter 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
awaiver is not in your best health interest and its use
isstrongly discouraged.
Children with hearing loss
In addition to seeing a physician for a medical evaluation,
achild with a hearing loss should be directed to an
audiologist for evaluation and rehabilitation since hearing
loss may cause problems in language development
and theeducational and social growth of a child. An
audiologist is qualied by training and experience to
assist in the evaluation and rehabilitation of a child with
a hearing loss.
Australian Sponsor:
Sonova Australia Pty Ltd
Locked Bag 5006 Norwest,
NSW, 2153
Australia
Sonova Deutschland GmbH
Max-Eyth-Strasse 20
70736 Fellbach-Oengen
Germany
029-1172-03/V1.00/2021-12/hc © 2021 Sonova AG. All rights reserved.
Your hearing care professional:
Manufacturer:
Sonova AG
Laubisrütistrasse 28
CH-8712 Stäfa
Switzerland
07-Feb-2022
1
Document Detail
Type:
PDL
CURRENT
Status:
PDL-8821Document No.:
07-Feb-2022
Effective Date:
Rev.: 2
Title:
029-1172-03 User guide Brio 5 I (ITE)
Process:
Innovation Management
53TMARINIC Tiia MarinicOwner:
Attributes
Description
Attribute Type Value
Affected Site Stafa (CH)
1100
Affected Site
Product Family
Virto P
Project
Mozart ITE Product
Project
Project Phase
Finished Product
Project Phase
Approvals
Sign-off BySign-off DateJob TitleLevel Actor
11LBRAUNLora Braun 1 07-Feb-2022
Quality Assurance Manager
Marketing
11IMATTMANNIsabelle Mattmann 2 07-Feb-2022
Product Manager
Access Activity
Accessed By Accessed Date
Revision Notes
Note
Remark
02-Feb-202253TMARINIC
fixed emissions and immunity
standards to match
WI-112 [4]
