Cochlear Nucleus 8 User manual

for Nucleus®8 System
and Nucleus®7 System
Hybrid™User Guide

ii Hybrid User Guide

1Hybrid User Guide
Contents
Introduction
About this guide . . . . . . . . . . . . . . . . . . . . . . . . . 2
Hybrid system . . . . . . . . . . . . . . . . . . . . . . . . . . 3
Use your Hybrid system
Wear your Hybrid system. . . . . . . . . . . . . . . . . . . .8
Care for your Hybrid system . . . . . . . . . . . . . . . . . .9
Change the dome . . . . . . . . . . . . . . . . . . . . . . . 10
Change the speaker unit wax filter. . . . . . . . . . . . . . 11
Troubleshoot
Check the Hybrid system . . . . . . . . . . . . . . . . . . . 12
Warnings
For parents and carers. . . . . . . . . . . . . . . . . . . . . 14
Hybrid system . . . . . . . . . . . . . . . . . . . . . . . . . 15
Other information
Materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15
Serious incidents . . . . . . . . . . . . . . . . . . . . . . . 23
Equipment classification . . . . . . . . . . . . . . . . . . . 24
Legal statement . . . . . . . . . . . . . . . . . . . . . . . . 24
Trademark legal statement. . . . . . . . . . . . . . . . . . 24

2Hybrid User Guide
Introduction
About this guide
This guide is intended for Cochlear implant recipients and their
carers, who use their Cochlear™ Nucleus® 8 system or
Cochlear™ Nucleus® 7 system in Hybrid™ mode. The Cochlear
Nucleus 8 system consists of the Nucleus 8 Sound Processor
(model number CP1110) in Hybrid mode. The Cochlear Nucleus 7
system may consist of the Nucleus 7 Sound Processor (model
number CP1000) or Cochlear Nucleus 7 SE Sound Processor
(model number CP1001) or Cochlear Nucleus 7 S Sound Processor
(model number CP1002) in Hybrid mode.
This guide can also be used as a reference by hearing healthcare
professionals.
For more information, refer to the Nucleus 8 Sound Processor User
Guide, Nucleus 7 Sound Processor User Guide, Nucleus 7 SE Sound
Processor User Guide or Nucleus 7 S Sound Processor User Guide.
Note
• Please also refer to your Important Information document for
essential advice that applies to Cochlear implant systems.
• Refer to the Warnings section for warnings relating to the use
of the Hybrid system.
• Not all products are available in all countries.
Symbols used in this guide
Note
Important information or advice.
Tip
Time saving hint.
Caution (no harm)
Special care to be taken to ensure safety and
effectiveness. Could cause damage to equipment.
Warning (harmful)
Potential safety hazards and serious adverse reactions.
Could cause harm to person.

3Hybrid User Guide
Hybrid system
The Nucleus 8, Nucleus 7, Nucleus 7 SE and Nucleus 7 S
Hybrid systems include:
• The Cochlear Hybrid Earhook–replaces your normal
earhook, and connects the Cochlear Hybrid Receiver to
your sound processor.
• The Cochlear Hybrid Receiver–a cable with a speaker unit
that fits in your ear. It has a replaceable wax filter.
• A dome–fits over the speaker unit to hold it in place and
protect your ear. It is disposable and has a built-in wax
filter.
Caution
• Your clinician will select the receiver and dome that you
should use. Do not substitute any other parts.
• Your clinician will attach and remove the receiver for you. Do
not attempt to do this yourself.
1. Hybrid Earhook
2. Cable
3. Speaker unit (under dome)
4. Dome
5. Hybrid Receiver

4Hybrid User Guide
Hybrid mode
When using the Nucleus Sound Processor in Hybrid mode, the
hybrid system is worn in the outer ear canal of the respective
ear.
In Hybrid mode, your sound processor delivers two types of
sound signals:
• The usual electric signals to the cochlear implant
• Extra acoustic signals to the Hybrid system
Intended purpose
Device Intended purpose
Cochlear Hybrid Receiver The Hybrid Receiver is intended to be
used in combination with other devices
as part of a hearing implant system to
deliver amplified sound via the ear canal
for recipients with residual hearing.
Cochlear Hybrid Open
Dome, Cochlear Hybrid
Bass Single Dome,
Cochlear Hybrid Bass
Double Dome
The dome is intended to be used as an
accessory to the Hybrid Receiver to
allow a Hybrid Receiver to fit
comfortably and securely within the ear
canal. The dome is also used to assist
with delivering sound from the receiver.
Cochlear Hybrid Ear Lock
(size 60 and 85)
The Cochlear Hybrid Ear Lock is
intended to be used as an accessory to
the Hybrid Receiver to assist with
securing the Hybrid Receiver within the
ear canal.
Cochlear Hybrid Earhook
with Removal Tool
The Hybrid Earhook with removal tool
is intended to be used to assist with
wearing the sound processor as part of a
hearing implant system.

5Hybrid User Guide
Indications
Cochlear Hybrid Receiver
The Cochlear Hybrid Receiver is indicated for use with the
Nucleus 8 Processing Unit, Nucleus 7 Processing Unit,
Nucleus 7 SE Processing Unit, and Nucleus 7 S Processing
Unit.
The sound processor in Hybrid mode, regardless of associated
implant, is indicated for recipients with residual hearing at
frequencies between 125 Hz and 2 kHz.
Cochlear Hybrid Domes and Earhook
This section applies to the following devices (all variants, and
sizes unless otherwise listed):
• Cochlear Hybrid Earhook with Removal Tool
• Cochlear Hybrid Open Dome
• Cochlear Hybrid Bass Single Dome
• Cochlear Hybrid Bass Double Dome
• Cochlear Hybrid Power Dome.
The devices listed above are indicated for use with the
Cochlear Hybrid Receiver.
Cochlear Hybrid Ear Lock
The Cochlear Hybrid Ear Lock is indicated for use with the
Cochlear Hybrid Receiver, size 60 and 85.

6Hybrid User Guide
Contraindications
Cochlear Hybrid Receiver
The Cochlear Hybrid Receiver is not indicated for use with
processing units other than those listed in the Indications.
The sound processor in Hybrid mode is not indicated for
recipients who have no residual hearing at frequencies
between 125 Hz and 2 kHz.
Cochlear Hybrid Domes and Earhook
The Cochlear Hybrid Domes and Earhook are not indicated for
use with devices other than those listed in the Indications.
Cochlear Hybrid Ear Lock
The Cochlear Hybrid Ear Lock is not indicated for use with
devices other than those listed in the Indications.

7Hybrid User Guide
Intended patient population
There are no restrictions for the intended patient population
of the Nucleus 8 Sound Processor, Nucleus 7 Sound Processor,
Nucleus 7 SE Sound Processor and Nucleus 7 S Sound
Processor in terms of age, weight, health or other condition.
Benefits
The Nucleus 8, Nucleus 7, Nucleus 7 SE and Nucleus 7 S
Sound Processors operate in conjunction with a compatible
Cochlear implant system. Potential benefits of receiving a
Cochlear implant system include:
• Better understanding of speech in quiet.
• Better understanding of speech in noise.
• Increased satisfaction based on hearing capabilities.
Intended users
Intended users of the Nucleus 8, Nucleus 7, Nucleus 7 SE and
Nucleus 7 S Sound Processors in Hybrid mode are:
• Recipients of a compatible Cochlear Nucleus implant.
• Carers of recipients, who carry out recipient functions as
needed. Carers may include parents of paediatric recipients
who are less than 12 years old, nurses or other carers of
otherwise dependant recipients.
• Audiologists/clinicians.

8Hybrid User Guide
Use your Hybrid system
Wear your Hybrid system
Caution
• Recipients or carers should not fit the Hybrid system to the
sound processor, or remove it. This should only be done by
your clinician.
• Keep the Hybrid receiver away from the coil magnet.
• Do not twist the receiver cable.
1. Hold the coil in
one hand and
place the sound
processor on
your ear with
the other.
2. Place the coil
on your head.
3. Place your dome in your ear as instructed by your
clinician.
Remove the Hybrid system
When removing your coil and sound processor, remove
your dome from your ear as instructed by your clinician.

9Hybrid User Guide
Care for your Hybrid system
Note
Your Nucleus 8, Nucleus 7, Nucleus 7 SE or Nucleus 7 S Hybrid
system is not compatible with any parts that can be used with
Freedom, CP800 Series or CP900 Series Sound Processors (e.g.
domes, earmoulds, receivers or earhook).
Caution
• Handle and store the Hybrid system very carefully.
• Do not drop the Hybrid system.
The Nucleus 8, Nucleus 7, Nucleus 7 SE or Nucleus 7 S Hybrid
system provides the benefit of two wax filters:
1. An in-built wax filter in the disposable dome.
2. A replaceable wax filter fitted in the receiver’s speaker
unit.
Every day
• Check all parts and any Hybrid accessories you use for dirt
or moisture. Wipe the accessories with a soft dry cloth.
• Check the dome and its filter. Change the dome whenever
its filter is clogged with wax, or whenever the dome is dirty,
discoloured or losing shape.
• When changing the dome, also check the wax filter in the
speaker unit. Change the speaker unit filter whenever it is
clogged with wax or if the sound from the speaker unit
does not sound normal.

10 Hybrid User Guide
Change the dome
1. Pull the dome off,
using your
fingernails if
necessary, and
discard.
2. Push the new dome
directly onto the
speaker unit.
3. Click it securely into
place.

11Hybrid User Guide
Change the speaker unit wax filter
Caution
• Wax filters must always be used with the Hybrid system and
replaced regularly.
• Keep the Hybrid receiver away from the coil magnet.
1. Remove a new
ProWax tool from
its shell. One point
on the tool has a
removal tool and
the other point has
the new filter.
2. Insert the removal
tool into the
existing wax filter
and gently move
the filter from side
to side and remove
it from the speaker
unit.
3. Push the new filter
into the speaker
unit.
4. Dispose of the tool
and used wax filter.

12 Hybrid User Guide
Troubleshoot
Check the Hybrid system
Problem Resolution
You do not hear
sound through the
Hybrid system
1. Change the sound processor
batteries.
2. Check your dome. If there is wax
buildup, change the dome. See Care
for your Hybrid system on page 9.
3. Check your speaker unit wax filter. If
there is wax buildup, change the filter.
See Care for your Hybrid system on
page 9.
4. Check that the receiver is properly
connected to your sound processor.
5. If the problem continues, contact
your clinician.
You experience
discomfort when
using the Hybrid
system
1. Check that your dome is properly
fitted to the speaker unit.
2. If the problem continues, contact
your clinician.

13Hybrid User Guide
Problem Resolution
You hear intermittent
or distorted sound, or
sound is too soft
1. Check that your dome is properly
fitted to the speaker unit.
2. Check that the receiver is properly
connected to your sound processor.
3. Check your dome. If there is wax
buildup, change the dome. See Care
for your Hybrid system on page 9.
4. Check your speaker unit wax filter. If
there is wax buildup, change the filter.
See Care for your Hybrid system on
page 9.
5. Your receiver cable may be too long
or too short. If in doubt, contact your
clinician.
6. Your dome may be the wrong type or
the wrong size. If in doubt, contact
your clinician.
7. If the problem continues, contact
your clinician.
Sound is too loud Remove the sound processor and coil from
your head immediately and contact your
clinician.

14 Hybrid User Guide
Warnings
For parents and carers
• Contact your clinician for advice on choosing the most
suitable Hybrid system for children.
• Do not allow children to replace a Hybrid system.
• Keep all parts of the Hybrid system out of reach of
children. Removable parts (e.g. domes, earlocks and wax
management systems) can be lost or may be a choking or
suffocation hazard.
• Carers should routinely check for signs of discomfort. See
your clinician if you are concerned that the Hybrid system
is not working at a comfortable sound level.
MR
The Nucleus 8 Sound Processor, Nucleus 7 Sound
Processor, Nucleus 7 SE Sound Processor and
Nucleus 7 S Sound Processor, remote and related
accessories (such as the Wireless Programming Pod)
in Hybrid mode, are MR Unsafe.
Full MRI safety information is available at
www.cochlear.com/warnings or by calling your
regional Cochlear office (contact numbers available at
the end of this document).

15Hybrid User Guide
Hybrid system
• Refit and replace domes regularly to ensure optimal fitting
and retention. Consult your clinician for advice on Hybrid
system misfits or signs of discomfort.
• Remove your sound processor if there is any discomfort or
pain (e.g. sound level is uncomfortably loud) and inform
your clinician.
If the dome is not securely attached to your Hybrid system, it
could fall off in your ear canal. If this happens, see your
medical practitioner.
Other information
Materials
• Hybrid Earhook is made from polyamide (PA) and liquid
silicone rubber (LSR).
• Receiver cable outer sheathing is made from polyamide.
• Hybrid Earlock is made of Polyether block amide
copolymer (PEBA).
• Domes are made of silicone.

16 Hybrid User Guide
Nucleus 7 Hybrid receiver - speaker unit 60 85 100 units Frequency Range < 200 – 2200 Hz OSPL90 Peak 105 112 119 dB SPL Reference Test Gain 25 30 38 dB Full-On Gain Peak 31 43 52 dB Total Harmonic Distortion
250 Hz @ 70dB SPL 1.4 0.7 0.5 % 400 Hz @ 70dB SPL 1.3 0.8 0.6 % 625 Hz @ 65dB SPL 0.9 0.5 0.7 %
ETLS * (vertical field) 0 0 1 dB Equivalent Input Noise (EIN) 23 23 22 dB SPL
Operating characteristics
Measurements according to IEC 60118-0:2015.
Nominal data. Tolerances, where applicable, according to IEC
60118-7:2005.

17Hybrid User Guide
Nucleus 8 Hybrid receiver - speaker unit 60 85 100 units Frequency Range < 200 – 2200 Hz OSPL90 Peak 105 111 117 dB SPL Reference Test Gain 27 32 40 dB Full-On Gain Peak 37 50 59 dB Total Harmonic Distortion
250 Hz @ 70dB SPL 1.6 0.6 0.6 % 400 Hz @ 70dB SPL 1.5 0.6 0.6 % 625 Hz @ 65dB SPL 1.2 0.6 0.7 %
ETLS * (vertical field) 1 1 1 dB Equivalent Input Noise (EIN) 25 24 24 dB SPL

18 Hybrid User Guide
Environmental conditions
Condition Minimum Maximum
Storage and transport
temperature
-10° C (+14° F) +55° C (+131° F)
Storage and transport
humidity
0% RH 90% RH
Operating temperature
(sound processor)
+5° C (+41° F) +40° C (+104° F)
Operating relative
humidity
0% RH 90% RH
Operating pressure 700 hPa 1060 hPa
Product components
Hybrid receiver - speaker
unit Cable sizes
60 1, 2, 3, 4
85 1, 2, 3, 4
100 1, 2, 3, 4