Cochlear Nucleus 8 Manuale utente

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.

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