Cochlear Baha 6 Max User manual

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Cochlear™Baha® 6 Max
Sound Processor
User manual part A
ZONE 2
EN-GB English 3
ES Español 23
EL Ελληνικά 43
PT Português 63
HE תירבע 83

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21 3
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English
Cochlear™Baha® 6 Max
Sound Processor
User manual part A
This guide is intended for recipients and caregivers using the
Cochlear™ Baha®6 Max Sound Processor as part of the Cochlear Baha System.

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Contents
1. Introduction. . . . . . . . . . . . . . . . . . . . . .5
1.1 Overview . . . . . . . . . . . . . . . . . . . . . . .5
1.2 Intended use . . . . . . . . . . . . . . . . . . .5
1.3 Indications . . . . . . . . . . . . . . . . . . . . .5
1.4 Clinical benefit . . . . . . . . . . . . . . . . . .6
1.5 Warranty . . . . . . . . . . . . . . . . . . . . . . .6
2. Use. . . . . . . . . . . . . . . . . . . . . . . . . . . . . .6
2.1 Turn on and off . . . . . . . . . . . . . . . . .6
2.2 Sound processor indicators. . . . . . .6
2.3 Change programs . . . . . . . . . . . . . .6
2.4 Adjust volume . . . . . . . . . . . . . . . . . .7
2.5 Share the experience . . . . . . . . . . . .7
3. Power . . . . . . . . . . . . . . . . . . . . . . . . . . .8
3.1 Battery type . . . . . . . . . . . . . . . . . . . .8
3.2 Low battery indication . . . . . . . . . . .8
3.3 Change the battery . . . . . . . . . . . . . .8
3.4 Tamper-resistant battery door . . . .9
4. Wear . . . . . . . . . . . . . . . . . . . . . . . . . . .10
4.1 Safety line . . . . . . . . . . . . . . . . . . . . 10
4.2 Flight mode . . . . . . . . . . . . . . . . . . 10
4.3 For users with two sound
processors. . . . . . . . . . . . . . . . . . . . . . . 10
4.4 Wireless devices. . . . . . . . . . . . . . . 11
4.5 Made for iPhone (MFi) . . . . . . . . . 11
4.6 Android streaming . . . . . . . . . . . . 11
5. Audio and visual indicators. . . . . . . .12
5.1 General audio and visual signals 12
5.2 Wireless audio and visual signals 13
5.3 Paediatric mode . . . . . . . . . . . . . . 13
6. Care . . . . . . . . . . . . . . . . . . . . . . . . . . . .14
6.1 Care and maintenance. . . . . . . . . 14
6.2 IP classification. . . . . . . . . . . . . . . . 14
7. Troubleshooting . . . . . . . . . . . . . . . . .15
7.1 Processor will not turn on . . . . . . 15
7.2 Sound is too quiet or muffled . . . 15
7.3 Sound is too loud or
uncomfortable . . . . . . . . . . . . . . . . . . . 15
7.4 You experience feedback
(whistling) . . . . . . . . . . . . . . . . . . . . . . . 15
8. Other information . . . . . . . . . . . . . . .16
8.1 Sound processor and parts. . . . . 16
8.2 Serious incidents . . . . . . . . . . . . . . 17
8.3 Environmental conditions . . . . . . 17
8.4 Environmental protection . . . . . . 17
8.5 Magnetic Resonance Imaging
(MRI). . . . . . . . . . . . . . . . . . . . . . . . . . . . 17
8.6 Electromagnetic compatibility
(EMC) . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
9. Regulatory information . . . . . . . . . . .19
9.1 Equipment classification and
compliance . . . . . . . . . . . . . . . . . . . . . . 19
9.2 Certification and applied
standards . . . . . . . . . . . . . . . . . . . . . . . 20
10. Key to symbols . . . . . . . . . . . . . . . . .21

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English
1. Introduction
Congratulations on your choice of the Cochlear™ Baha®6 Max Sound Processor.
This manual is full of tips and advice on how to best use and care for your
Baha sound processor. Be sure to discuss any questions or concerns that you
may have regarding your hearing or use of this system with your hearing care
professional.
1.1 Overview
NOTE
Additional illustrations, figures 1-9, can be found on the inside of the cover of this user
manual.
1.2 Intended use
The Cochlear Baha System uses bone
conduction to transmit sounds to the
cochlea (inner ear) with the purpose
of enhancing hearing. The Baha 6 Max
Sound Processor is intended to be used
as part of the Cochlear Baha System to
pick up surrounding sound and transfer
it to the skull bone via a Baha Implant,
Baha Softband or Baha SoundArc™ and
can be used unilaterally or bilaterally.
1.3 Indications
The Cochlear Baha System is indicated
for patients with conductive hearing loss,
mixed hearing loss and SSD (single-sided
sensorineural deafness). The Baha 6 Max
Sound Processor is indicated for patients
with up to 55 dB SNHL (sensorineural
hearing loss).
Battery door
Snap coupling
Indicator light
Control button
Microphone ports
Attachment hole
for safety line

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1.4 Clinical benefit
Most recipients of a bone conduction
hearing solution will experience improved
hearing performance and quality of life
compared to unaided listening.
1.5 Warranty
The warranty does not cover defects or
damage arising from, associated with,
or related to the use of this product with
any non-Cochlear processing unit and/
or any non-Cochlear implant. See the
“Cochlear Baha Global Limited Warranty
card” for more details.
2. Use
2.1 Turn on and off
See figure 1
The battery door is used to turn the sound
processor on and off.
1. To turn on your sound processor,
close the battery door completely.
2. To turn off your sound processor,
gently open the battery door until you
feel the first “click”.
When your sound processor is turned
off and back on again, it will return to
Program 1 and default volume level. If
enabled, audio and/or visual signals will
let you know that the device is starting up.
See chapter 5, “Audio and visual indicators”.
2.2 Sound processor indicators
See figure 2
Audio signals and the visual indicator
will alert you of changes to your sound
processor. For a complete overview see
chapter 5, “Audio and visual indicators”.
2.3 Change programs
See figure 3
You can choose between programs to
change the way your sound processor
deals with sound. You and your hearing
care professional will have selected up
to four pre-set programs for your sound
processor.
Program 1 __________________________________
Program 2 __________________________________
Program 3 __________________________________
Program 4 __________________________________

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These programs are suitable for different
listening situations. Ask your hearing
care professional to fill in your specific
programs on the lines in the previous
page.
1. To change the program, press and
release the control button located on
the top of your sound processor once.
2. If enabled, audio and visual signals
will let you know which program you
have changed to. See chapter 5, “Audio
and visual indicators”.
3. To change to any of the other
programs pre-set by your clinician,
repeat above steps until you get
confirmation that you are in the
desired program.
NOTE
If you are a bilateral recipient,
program changes you make to one
device will automatically apply to the
second device. This function can be
enabled or disabled by your hearing
care professional.
2.4 Adjust volume
Your hearing care professional has set the
volume level for your sound processor.
NOTE
You can change the program
and adjust the volume using the
optional Cochlear Baha Remote
Control, Cochlear Wireless Phone
Clip, Baha Smart App or from your
compatible smart phone or smart
device. See section 4.4, “Wireless
devices”.
2.5 Share the experience
See figure 4
Family members and friends can “share
the experience” of bone conduction
hearing using the Cochlear test rod,
provided with the sound processor.
1. Turn on your sound processor and
attach it on the test rod by tilting
it into place. You will feel the snap
coupling “click” into the notch on the
test rod.
2. Hold the test rod against the skull
bone behind an ear. (Ensure you are
holding the test rod, and not the
sound processor). Plug both ears and
listen.

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3. Power
3.1 Battery type
The Baha 6 Max Sound Processor uses a
312 size type hearing aid battery (1.45 Volt
zinc air, non-rechargeable). Batteries
should be replaced as needed, just as
you would with many other electronic
devices. Battery life will vary with e.g. daily
use, volume levels, wireless streaming,
sound environment, program setting, and
battery strength.
3.2 Low battery indication
If activated, the visual and audio signals
will alert you when there is approximately
one hour of battery power remaining
(at this time you may experience lower
amplification). If the battery runs down
completely, the sound processor will stop
working.
3.3 Change the battery
See figure 5
1. To replace the battery, remove your
sound processor from the head and
hold the sound processor with the
front facing down.
2. Gently open the battery door until it is
completely open.
3. Remove the old battery and dispose
of it according to local regulations.
4. Remove the new battery from the
packet and peel away the sticker on
the + side.
5. Insert the battery into the battery
compartment with the + side
facing up.
6. Gently close the battery door.
WARNING
Batteries can be harmful if swallowed,
put in the nose or in the ear. Be sure
to keep your batteries out of reach of
small children and other recipients in
need of supervision. Before use, verify
that the tamper-resistant battery
door is properly closed. In the event
a battery is accidentally swallowed, or
stuck in the nose or in the ear, seek
immediate medical attention at the
nearest emergency centre.

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English
NOTE
• To maximise battery life, switch off
the sound processor when it is not
in use.
• Battery life decreases as soon as
the battery is exposed to air (when
the plastic strip is removed), so be
sure to only remove the plastic strip
directly prior to use.
• If a battery leaks, replace it
immediately.
3.4 Tamper-resistant battery door
See figure 6
To prevent the accidental opening of
the battery door, an optional tamper-
resistant battery door is available. This is
particularly useful to prevent children, and
other recipients in need of supervision,
from accidentally accessing the battery.
Contact your hearing care professional for
a tamper-resistant battery door.
To use the tamper-
resistant battery door:
1. To unlock and turn off the device,
carefully insert the tamper resistant
tool or the tip of a pen in the small
hole on the battery door and gently
open the door.
2. To lock and turn on the device, gently
close the battery door until it is
completely closed.

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4. Wear
4.1 Safety line
See figure 7
The safety line is designed to reduce the
risk of dropping or losing your processor.
You can attach a safety line that clips onto
your clothing:
1. Pinch the loop on the end of the
safety line between your finger and
thumb.
2. Pass the loop through the attachment
hole in the sound processor from
front to back.
3. Pass the clip through the loop and
pull the line tight. Attach the clip to
your clothing.
NOTE
Cochlear recommends connecting the
safety line when engaging in physical
activities. Children should use the
safety line at all times.
4.2 Flight mode
See figure 8
Activate flight mode in situations when
you need to deactivate radio signals
(wireless functionality), such as when
boarding a flight or other areas where
radio frequency emission is prohibited.
To activate flight mode:
1. Open and close the battery door on
your sound processor three times
(open-close, open-close, open-close)
within a 10-second period.
2. If enabled, audio and visual signals
will confirm that flight mode is
activated. See chapter 5, “Audio and
visual indicators”.
Follow these steps to
deactivate flight mode:
1. Make sure your sound processor has
been running for at least 15 seconds
before you attempt to turn off flight
mode.
2. To turn off flight mode, open and
close the battery door once on your
sound processor.
3. Let the sound processor run for
another 15 seconds or more before
turning it off to be certain that flight
mode is deactivated.
4.3 For users with two
sound processors
To make identification easier, ask your
hearing care professional to mark your
left and right sound processor with the
coloured stickers provided (red for right,
blue for left).

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English
4.4 Wireless devices
You can use Cochlear True Wireless™
devices to enhance your listening
experience. To learn more about the
options available, ask your hearing care
professional or visit www.cochlear.com.
To pair your sound processor
to a wireless device:
1. Press the pairing button on your
wireless device.
2. Turn off your sound processor by
opening the battery door.
3. Turn on your sound processor by
closing the battery door.
4. You will hear an audio signal in your
sound processor as a confirmation of
a successful pairing.
To activate wireless audio streaming:
The following instructions are applicable
for the Cochlear Wireless Mini
Microphone 2/2+ and Cochlear Wireless
TV Streamer.
Press and hold the control button on your
sound processor until you hear an audio
signal. See chapter 5, “Audio and visual
indicators”.
If your sound processor is paired with
more than one wireless device, you
can toggle between the devices in the
different channels by pressing the control
button (long press) on your sound
processor once, twice or three times, until
you have selected the accessory you want.
To end wireless audio streaming:
Press and release (short press) the
control button on your sound processor.
The sound processor will return to the
previously used program.
NOTE
For additional guidance regarding e.g.
pairing, please refer to the user guide
of the relevant Cochlear wireless
device.
4.5 Made for iPhone (MFi)
Your sound processor is a Made for
iPhone (MFi) hearing device. This allows
you to control your sound processor
and stream audio directly from your
Apple®devices. For full compatibility
details and more information, visit
www.cochlear.com/compatibility.
4.6 Android streaming
Your sound processor is compatible
with the ASHA (Audio Streaming
for Hearing Aid) protocol. This
allows you to use the direct audio
streaming functions of compatible
Android devices. For full compatibility
details and more information, visit
www.cochlear.com/compatibility.

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5. Audio and visual indicators
Your hearing care professional can set up your sound processor to show the
following audio and visual signals.
5.1 General audio and visual signals
Status/action Audio signal Visual signal Comment
Start up
5 beeps 4 seconds steady
light
Your hearing care
professional can set up the
audio signal to be 1, 5 or
10 beeps.
Start up in
flight mode
10x dual beeps
4 x dual flashes
Change program
1-4 beeps 1-4 flashes
The number of flashes and
beeps indicates the number
of the current program.
Volume up/down
1 beep 1 short flash
Maximum/
minimum volume 1 long beep 1 long flash
Low battery
indication
2 x 4 beeps
Repeated series
of rapid flashes

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English
5.2 Wireless audio and visual signals
Status/action Audio signal Visual signal Comment
Wireless streaming
activated or change
from one wireless
device to another
Ripple tone upward
melody
1 long flash
followed by
1 short flash
Confirmation wireless
device paring
Ripple tone in
upward melody
N/A
5.3 Paediatric mode
This optional continuous mode is primarily intended for parents and carers who want to
receive a visual feedback from their child’s sound processor. It can be activated by your
hearing care professional. As the child gets older the mode can also be switched off by your
hearing care professional.
Status/action Visual signal Comment
Low battery indication
Repeated series of rapid flashes
Continuously repeated
or repeated with small
pauses.
Flight mode
4 x dual flashes
Program 1-4
1-4 flashes depending on the chosen
program
Streaming active
1 long flash followed by 1 short flash

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6. Care
6.1 Care and maintenance
Your sound processor is a delicate
electronic device. Follow these guidelines
to keep it in proper working order:
• For cleaning your sound processor
and snap coupling, remove the sound
processor from your head and use
the Baha sound processor cleaning
kit and accompanying instructions.
The kit is provided by Cochlear in the
sound processor box.
• After exercise, wipe your processor
with a soft cloth to remove sweat or
dirt.
• If the sound processor gets wet
or is exposed to a very humid
environment, dry it with a soft cloth,
remove the battery and let the
processor dry out before inserting a
new one.
• Remove your sound processor before
applying any hair conditioners,
mosquito repellent or similar
products.
• Turn off and store the sound
processor away from dust and dirt.
• A storage case is provided by
Cochlear in the sound processor box.
• Avoid exposing your sound processor
to extreme temperatures.
• For long-term storage, remove the
battery.
CAUTION
Do not use other cleaning methods
than recommended by Cochlear.
6.2 IP classification
The electronics compartment in your
sound processor is protected against
damage by dust and by immersion in
water. Without the battery, the sound
processor was tested for immersion in
water for 35 minutes at 1.1 meters depth
and achieved an IP68 rating. This means
that if you, for example, accidentally
drop your sound processor in water, the
electronics in the device are protected
against malfunction due to water ingress.
However, your sound processor has a
battery that requires air to operate and
malfunctions if wet. The sound processor
with battery achieves an IP42 rating. This
means there is a possibility that if you,
for example, are out in rain or in other
humid environments, water can block air
supply to the battery causing a temporary
malfunction. To avoid temporary
malfunction, avoid exposing the sound
processor to water and always remove it
before swimming or bathing.

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English
If your sound processor becomes
wet and malfunctions:
1. Remove your sound processor from
the head.
2. Open the battery door and remove
the battery.
3. Put your sound processor in a
container with drying capsules such
as a Dri-Aid Kit, etc. Let your sound
processor dry out before inserting a
new battery. Drying kits are available
from most hearing care professionals.
7. Troubleshooting
Contact your hearing care professional if you have any concerns regarding the
operation or safety of your sound processor, or if the solutions below do not
resolve your issue.
7.1 Processor will not turn on
1. Try turning the sound processor on
again. See section 2.1, “Turn on and
off”.
2. Replace the battery. See section 3.3,
“Change the battery”.
3. The battery requires air to operate.
Ensure that the battery air inlet and/or
the battery air holes are not covered.
4. Try a different program. See section
2.3, “Change programs”.
7.2 Sound is too quiet or muffled
1. Try turning up the volume using
a compatible smartphone or a
Cochlear wireless device.
2. Check that the sound processor is
not wet. If it is wet, let the sound
processor dry before use. See section
6.1, “Care and maintenance”.
7.3 Sound is too loud
or uncomfortable
1. Try turning down the volume of your
sound processor. See section 2.4,
“Adjust volume”.
7.4 You experience
feedback (whistling)
1. Check to ensure that the sound
processor is not in contact with items
such as glasses or a hat, or in contact
with your head or ear. See figure 9.
2. Try turning down the volume of your
sound processor. See section 2.4,
“Adjust volume”.
3. Check that there is no external
damage to the sound processor.
4. Check that there is no dirt in the
connection to the your sound
processor.

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8. Other information
8.1 Sound processor and parts
• The sound processor is suited for use
in a home healthcare environment.
The home healthcare environment
includes locations such as homes,
schools, churches, restaurants,
hotels, cars, and airplanes, where
equipment and systems are less likely
to be administered by healthcare
professionals.
• A sound processor will not restore
normal hearing and will not prevent
or improve a hearing impairment
resulting from organic conditions.
• Infrequent use of a sound processor
may not enable a recipient to attain
full benefit from it.
• The use of a sound processor is only
part of hearing rehabilitation and may
need to be supplemented by auditory
and lip reading training.
• The sound processor is a digital,
electrical, medical instrument
designed for specific use. As such,
due care and attention must be
exercised by the recipient at all times.
• A discharge of static electricity can
damage the electrical components
of the sound processor or corrupt
the program in the sound processor.
If static electricity is present (e.g.
when putting on or removing clothes
over the head or getting out of a
vehicle), you should touch something
conductive (e.g. a metal door handle)
before your sound processor
contacts any object or person. Prior
to engaging in activities that create
extreme electrostatic discharge, such
as playing on plastic slides, the sound
processor should be removed.
• If disruptions keep occurring, please
contact your clinician to resolve the
issue.
• For wireless functionality, only
use Cochlear Wireless devices or
compatible smart devices.
• No modification of this equipment is
allowed.
• Adult supervision is recommended
when the recipient is a child.
• Avoid exposing your sound processor
to X-ray radiation.
WARNING
The sound processor and removable
parts of the system (batteries, battery
door, safety line) can be lost or may
be a choking or strangulation hazard.
Keep out of reach of small children
and other recipients in need of
supervision.
WARNING
Do not use damaged product.

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English
8.2 Serious incidents
Serious incidents are rare. Any
serious incident in relation to your
device should be reported to your
Cochlear representative and to the
medical device authority in your country,
if available.
8.3 Environmental conditions
Condition Minimum Maximum
Operating temperature +5°C (41°F) +40°C (104°F)
Operating humidity 10% RH 90% RH
Operating pressure 700 hPa 1060 hPa
Transport temperature* -10°C (14°F) +55°C (131°F)
Transport humidity* 20% RH 95% RH
Storage temperature +15°C (59°F) +30°C (86°F)
Storage humidity 20% RH 90% RH
* Transport conditions require transport packaging used for sound processor.
NOTE
Battery performance deteriorates in temperatures below +5°C.
8.4 Environmental protection
Your sound processor contains electronic
components subject to the Directive
2012/19/EU on waste electrical and
electronic equipment.
Help protect the environment by not
disposing of your sound processor or
batteries with your unsorted household
waste. Please recycle your device,
batteries and electronic items in according
to your local regulations.
8.5 Magnetic Resonance
Imaging (MRI)
The sound processor and other external
accessories should never be brought
into a room with an MRI machine, as
damage to the sound processor or the
MRI equipment could occur. The sound
processor must be removed before
entering a room where an MRI scanner is
located.
If you are to undergo an MRI procedure,
refer to the MRI Reference Card included
in the document pack.

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8.6 Electromagnetic
compatibility (EMC)
Interference may occur in the vicinity of
equipment marked with the following
symbol:
Devices such as airport metal detectors,
commercial theft detection systems, and
Radio Frequency ID (RFID) scanners may
produce strong electromagnetic fields.
Some Baha users may experience a
distorted sound sensation when passing
through or near one of these devices. If
this occurs, you should turn off the sound
processor when in the vicinity of one
of these devices. The materials used in
the sound processor may activate metal
detection systems. For this reason, you
should carry the Security Control MRI
Information Card with you at all times.
WARNING
Portable RF communications
equipment (including peripherals
such as antenna cables and external
antennas) should be used no closer
than 30 cm (12 in.) to any part of
your sound processor, including
cables specified by the manufacturer.
Otherwise, degradation of the
performance of this equipment could
result.
WARNING
Use of accessories, transducers and
cables other than those specified or
provided by Cochlear could result in
increased electromagnetic emissions
or decreased electromagnetic
immunity of this equipment and result
in improper operation.

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English
9. Regulatory information
Not all products are available in all markets. Product availability is subject to
regulatory approval in the respective markets.
9.1 Equipment classification
and compliance
Your sound processor is internally
powered equipment Type B applied part
as described in the international standard
IEC 60601- 1:2005/A1:2012, Medical
Electrical Equipment– Part 1: General
Requirements for Basic Safety and
Essential Performance.
This device complies with part 15 of
the FCC (Federal Communications
Commission) Rules and with RSS of
ISED (Innovation, Science and Economic
Development) Canada. Operation is
subject to the following two conditions:
• This device may not cause harmful
interference.
• This device must accept any
interference received, including
interference that may cause
undesired operation.
Changes or modifications made to this
equipment not expressly approved by
Cochlear Bone Anchored Solutions AB
may void the FCC authorization to operate
this equipment.
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. These limits are designed
to provide reasonable protection against
harmful interference in a residential
installation.
This equipment generates, uses and
can radiate radio frequency energy and,
if not installed and used in 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 equipment does cause
harmful interference to radio or television
reception, which can be determined by
turning the equipment off and on, the
recipient 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
or a circuit different from that to
which the receiver is connected.
• Consult the dealer or an experienced
radio/TV technician for help.

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FCC ID: QZ3BAHA6MAX
IC: 8039C-BAHA6MAX
HVIN: Baha 6 Max
FVIN: 1.0
PMN: Cochlear Baha 6 Max Sound
Processor
The model is a radio transmitter and
receiver. It is designed not to exceed
the emission limits for exposure to
radio frequency (RF) energy set by the
FCC and ISED. The sound processor is
designed not to exceed the emission
limits according to CAN ICES-003 (B)/
NMB-003(B).
9.2 Certification and
applied standards
The products are in compliance with the
following regulatory requirements:
• In EU: the device conforms to the
Essential Requirements according to
Annex I of Council Directive 93/42/
EEC for medical devices (MDD) and
essential requirements and other
relevant provisions of Directive
2014/53/EU (RED).
• Other identified applicable
international regulatory requirements
in countries outside the EU and
US. Please refer to local country
requirements for these areas.