Medel SONNET (Me1310) User manual

User Manual for
SONNET (Me) and SONNET EAS (Me)
audio processors
AW_. (English)
Cochlear Implants

Table of contents

. Table of contents
. TABLE OF CONTENTS 
. INTRODUCTION 
. INTENDED USE  INDICATIONS  CONTRAINDICATIONS 
Intended use 
Indications 
Contra-indications 
. SONNET AUDIO PROCESSOR 
The parts of the system 
The concept of EAS 
ON/OFF switch 
FineTuner 
Battery pack 
Coil 
Coil cable 
Earhook 
Microphone cover 
Connecting assistive listening devices 
. SPECIAL CONSIDERATIONS FOR YOUNG CHILDREN 
. GENERAL PRECAUTIONS AND WARNINGS 
General precautions for your MED-EL Cochlear Implant System 
Precautions for medical procedures 
. CARE AND MAINTENANCE 
Maintenance 
Weekly maintenance of your audio processor 
Batteries 
. TROUBLESHOOTING 
Speech Processor Test Device 
FineTuner 
SONNET indicator light 
Private alert 
FineTuner indicator functions 

Table of contents

. TECHNICAL DATA 
Audio processor 
FineTuner 
Symbols 
Speech Processor Test Device 
Guidance and manufacturer’s declaration 
. APPENDICES 
Warranty, guarantee and registration card 
Manufacturer address 
. CONTACT MEDEL 

Introduction

. Introduction
This user manual provides information and instructions regarding the MED-EL Cochlear
Implant (CI) System with the two variants of the SONNET audio processor: SONNET (Me)
and SONNET EAS (Me). It includes descriptions of available parts, wearing options, and
accessories for the SONNET, as well as instructions for troubleshooting and proper care of
the external cochlear implant equipment.
Your MED-EL Cochlear Implant System consists of the Mi SYNCHRONY (hereafter referred
to as SYNCHRONY), Mi CONCERTO (hereafter referred to as CONCERTO), PULSAR,
SONATA, C+ or C implants, the external SONNET audio processor (including
FineTuner and D Coil), the external components and accessories, and any external hardware
and software used by your audiologist: MAX Programming Interface, MAX Coil S, MAX Coil,
MAESTRO System Software.
This symbol indicates information that is particularly relevant for parents of implanted
children.
IMPORTANT
You are the operator of your / your child‘s SONNET audio processor, therefore we recommend
that you read this manual in its entirety. Do not perform any maintenance activities other
than those described in this manual (e.g. changing batteries). When performing these
maintenance activities, always remove the audio processor from the ear.
The adjustment to a cochlear implant and adequate tting of the device are gradual processes
that occur over time. It is important to remember that your ability to hear with your new
MED-EL system may take a little time while you become accustomed to this new method of
hearing. You may choose to work with an aural rehabilitation specialist or other clinician to
help you maximize your communication skills using the device.
After your initial tting, you will need to return to your CI centre on a regular basis for
reprogramming. Frequent reprogramming may be required during the rst year of implant
use. This is normal and necessary, and it reects a learning process that occurs as you
become more and more accustomed to stimulation through the implant. As more time
passes, you will likely nd that you may require fewer and fewer sessions. Most patients
continue to require occasional adjustments for as long as they use their implant.
Please contact your CI centre or MED-EL with any additional questions you may have.

Intended use – Indications – Contra-indications

. Intended use – Indications –
Contra-indications
INTENDED USE
The SONNET audio processor is an external part of the MED-EL Cochlear Implant System.
The MED-EL Cochlear Implant System is intended to evoke auditory sensation via electrical
stimulation of the auditory pathways for severely to profoundly hearing impaired individuals
who obtain little or no benet from acoustic amplication in the best aided condition.
Additionally, the MED-EL Cochlear Implant System used in combination with the FLEX ()
or FLEX electrode is intended to evoke auditory sensations via electrical stimulation or
via combined electric-acoustic stimulation (EAS) of the auditory pathways for partially deaf
individuals, who obtain benet from acoustic amplication in the lower frequencies only.
The MED-EL Cochlear Implant System is also intended to evoke auditory sensations via
electrical stimulation of the auditory pathways for individuals with single–sided deafness,
which is dened as severe to profound hearing impairment in one ear and normal hearing or
mild to moderate hearing impairment in the other ear.
INDICATIONS
Patients who received one or two MED-EL SYNCHRONY, CONCERTO, PULSAR, SONATA,
C+ or C cochlear implants are indicated to use the SONNET in typical everyday
environments (home, ofce, outdoor etc.). The SONNET is appropriate for patients of any
age.
The hearing aid functionality of the SONNET is intended to be used by patients with
functional low frequency hearing. Post-operative acoustic amplication (i.e. use of combined
electric-acoustic stimulation) is indicated for hearing losses between dBHL and dBHL
(when using the half gain tting rule) in the frequency range between  Hz and Hz.
The SONNET is intended to be used every day during a patient’s waking hours.
 The FLEX electrode was formerly marketed as the FLEXEAS electrode. Implementation of the FLEXEAS name change
to FLEX may depend on regulatory approval and the electrode may therefore still be marketed as FLEXEAS in some
markets.

Intended use – Indications – Contra-indications

The user of a SONNET does not need any special skills or elevated level of education,
however, the user (or custodian if the user is a child or a handicapped person not able to
perform the actions listed below) shall at minimum be able to perform the following actions:
• Switching ON/OFF
• Changing batteries
• Placing/removing SONNET on/from the ear
• Placing/removing coil over/from the implant site
As the SONNET is a component of the MED-EL Cochlear Implant System, all indications stated
for the MED-EL Cochlear Implant System are applicable.
To obtain optimal benet from the cochlear implant, candidates shall be sufciently motivated
and shall understand the importance of returning to the CI centre for regular processor
programming, assessment sessions and training.
CONTRAINDICATIONS
A patient must not receive a SONNET if the individual is known to be intolerant of the
materials used in the SONNET. Combined electric-acoustic stimulation (EAS) is contra-
indicated for patients unable to use acoustic amplication. For details, please refer to
chapter , Technical data.
The SONNET and any external wireless device (e.g. FineTuner) are not intended to be used in
environments where RF transmissions are prohibited (e.g. operating theatre).
As the SONNET is a component of the MED-EL Cochlear Implant System, all contra-indications
stated for the MED-EL Cochlear Implant System are applicable.
NOTE:
Important information related to indications, contra-indications, warnings and risks for
your cochlear implant are shipped in a separate document (instruction for use of the
implant) to your clinic together with the cochlear implant. If you want to review this
information, please contact your clinic or MED-EL.

SONNET audio processor

. SONNET audio processor
THE PARTS OF THE SYSTEM
The MED-EL Cochlear Implant System is an active medical device that has internal (implanted)
and external parts. The internal part of the device is surgically implanted behind the ear in
the skull, while the external components are worn behind the ear or on the body.
Implants with titanium housing: SYNCHRONY (shown), CONCERTO and SONATA
Implants with ceramic housing: PULSAR (shown), C+ and C
Fig.  The MED-EL cochlear implants
The external parts include the SONNET audio processor and the audio processor accessories.
In its basic conguration, the SONNET audio processor consists of the control unit with
the earhook attached, the battery pack (consisting of frame and cover), the coil and the
coil cable. A separate device called FineTuner facilitates access to various audio processor
functions.
The coil is held in place by magnetic attraction to the implant.
The audio processor uses batteries that provide sufcient power for both the external and
the implanted electronics. The implanted part does not contain batteries.

SONNET audio processor



















The SONNET audio processor is available in two variants: The rst variant (product code
Me) is an audio processor that supports electrical stimulation only, while the second
variant (product code Me) additionally features acoustic stimulation (amplication)
intended to be used by patients who have at least a certain degree of functional low frequency
hearing. Throughout this manual the term “SONNET” will be used when specically referring
to the rst variant, the term “SONNETeas” will be used for the second variant. “SONNET” will
be used in all other cases.
 Coil
 Coil cable
 SONNET control unit
 CI earhook
 Microphone cover
 Microphone openings
 Indicator light
 Battery pack
 Air inlets
SONNET audio processor
 Coil
 Coil cable
 SONNETeas control unit
 EAS earhook
 Microphone cover
 Microphone openings
 Indicator light
 Battery pack
 Air inlets
 Ear mould (not supplied by MED-EL)
SONNETeas audio processor with ear mould attached
Fig.  Your SONNET audio processor

SONNET audio processor

THE CONCEPT OF EAS
Cochlear implant users with low frequency hearing benet from additional acoustic
stimulation in the implanted ear as has been demonstrated in various scientic studies. This
combination of cochlear implant and acoustic stimulation is known as combined electric-
acoustic stimulation, or EAS. The term electric stimulation refers to the cochlear implant,
while acoustic stimulation refers to the acoustic amplication unit.
Especially in listening situations with background noise (background conversations, street
noise etc.), EAS can greatly improve speech understanding. Users of combined electric-
acoustic stimulation have also reported that sound quality and music perception are improved
compared to cochlear implant use alone.
Studies have also shown that it may take time for EAS use to show its full benet. If you are
an EAS user and do not experience an immediate benet, do not be discouraged.

SONNET audio processor

ON/OFF SWITCH
The battery pack cover functions as an ON/OFF switch.
You may select the following positions:
Battery pack cover pulled back: OFF
Battery pack cover completely moved over the frame: ON
IMPORTANT
When trying to pull back the battery pack cover, make sure that the battery pack cover lock
is in the unlocked position as shown in Fig. -. When it is not in the unlocked position, use
the screwdriver provided with your SONNET kit to turn it counter-clockwise into the unlocked
position.
There is no need to completely remove the battery pack cover to switch off the SONNET. It is
sufcient to pull it back to a position where you can see the whole labelling on the control
unit (see Fig. ).
OFF ON
Fig.  The SONNET audio processor in OFF
position
Fig.  The SONNET audio processor in ON
position
After switching on the SONNET audio processor, the indicator light will blink green up to four
times indicating the activated programme. For example, if the light blinks three times, then
programme  is currently active. The audio processor begins working as soon as the green
light comes on and blinks.

SONNET audio processor

In young children the battery pack cover lock must always be turned clockwise into
the locked position (see Fig. -) once the cover has been moved completely over the
frame to prevent the child from disassembling the audio processor.
To activate your CI system, switch on the SONNET, place it, i.e. control unit and battery pack,
behind the ear and the coil with the at side to the head over the site of the implant (see
Fig. ). As soon as the coil is approximately over the implant, it is automatically positioned
correctly by attraction to the implant magnet.
An ear mould may help keep the processor in position on the ear. Contact your CI
centre or audiologist for assistance.
Fig.  SONNET behind the ear and coil over the site of the implant
In the OFF position, the audio processor is turned off. No current is drawn in this position.
Make sure to pull back the battery pack cover of your audio processor when it is not in use,
as this prolongs the lifetime of the batteries (see also chapter , Care and maintenance).
If the processor is not worn behind the ear and turned off, i.e. the battery pack cover
pulled back, make sure that young children do not have access to the audio processor
to prevent disassembling the device.
The SONNET audio processor has an integrated telephone coil (telecoil). The telecoil picks up
magnetic sound signals coming from telephone receivers or loop systems which are installed
in some public buildings and converts them into audible signals.

SONNET audio processor

To use the telecoil proceed as follows:
• Activate the telecoil by pressing the key T(only signals picked up by the telecoil will be
audible) or MT (signals picked up by the microphone and the telecoil will be audible) on
your FineTuner as described in chapter , SONNET audio processor, FineTuner, FineTuner
controls.
• When you are using a telephone, position the telephone so that its earpiece is centred
over the SONNET control unit. Move the telephone slightly up or down as necessary to
optimize the signal quality.
• When you are in an environment with a loop system, try to find a spot where the signal
quality is best for you.
• To deactivate the telecoil when you do not need it anymore, press the key Mon your
FineTuner as described in chapter , SONNET audio processor, FineTuner, FineTuner
controls.
When you switch on the audio processor, the microphone is active even if you had the
telecoil selected before you switched off the audio processor. When the telecoil is active,
you may hear buzzing sounds when operating a FineTuner key. The buzzing is normal and
indicates that a command is being sent. To reduce interference with various electronic and
electrical equipment when the telecoil is active, we recommend you reduce audio sensitivity
(see chapter , SONNET audio processor, FineTuner, FineTuner controls).

SONNET audio processor

FINETUNER
Your audiologist will program your SONNET audio processor to suit your needs. The FineTuner
is provided to help you optimally use your audio processor in changing daily listening
situations.
The SONNET audio processor itself has only an ON/OFF switch. All other functions are
accessed with a separate device, the FineTuner, which transmits commands to your SONNET
audio processor via a radio frequency (RF) link. Its ergonomic design and larger size keys
facilitate changing the settings of your SONNET audio processor, just like a remote control
allows you to change channels on your television.
Keeping the FineTuner out of the reach of children prevents them from inadvertently
changing the settings of their audio processor.
The FineTuner is not necessary for the function of your audio processor. When switched on,
the audio processor activates the same programme, volume and audio sensitivity setting it
had when it was switched off.
The FineTuner is congured for its designated target audio processor, i.e. only the target
audio processor will execute the desired command when a certain key is pressed on the
FineTuner. The typical maximum operating distance between the FineTuner and the audio
processor is approximately  cm. This range might be less if you are close to electronic and
electrical equipment even if this equipment complies with all applicable electromagnetic
emission requirements.

SONNET audio processor

How to congure your FineTuner
The FineTuner is congured for your individual audio processor and cannot be used by
another cochlear implant user. Your audiologist or clinical staff will congure the FineTuner
to suit your needs. Sometimes it may be necessary for you to synchronise your FineTuner
and audio processor (e.g. if you purchase a backup FineTuner). To do so, rst switch off your
audio processor and place the coil on the keyboard of the FineTuner (approx. over key MT).
Then switch on your audio processor. The audio processor and FineTuner will be synchronised
automatically. Successful synchronisation is indicated by a short blinking signal of the two
amber indicator lights on your FineTuner.
For bilaterally implanted users
One FineTuner can be congured for use with both audio processors. If you want to use your
FineTuner for both audio processor systems, your audiologist or clinical engineer has received
the MED-EL application software manual with detailed programming information and will
assign two audio processors to your dataset. Once your audio processors are programmed
correctly, the synchronisation procedure described above should be performed with both
audio processors.

SONNET audio processor

FineTuner controls
Fig.  FineTuner
All FineTuner functions can be selectively disabled by your audiologist or clinical staff by
disabling the respective command in the control unit (via the MED-EL application software).
Your FineTuner will still be able to transmit all commands, but your control unit will not
execute disabled commands.
DEFAULT KEY
This key sets overall volume and audio sensitivity to predened
values determined by your audiologist or clinical staff. Pressing
the default key on your FineTuner only affects volume and audio
sensitivity. The programme position does not change.
SENSITIVITY KEY
Increases audio sensitivity
SENSITIVITY KEY
Decreases audio sensitivity
VOLUME KEY
Increases overall loudness
PROGRAMME
SELECTION KEYS
Four keys to access four
different programmes
INPUT SELECTION KEY
Selects the microphone
INPUT SELECTION KEY
Selects the telecoil
INPUT SELECTION KEY
Selects microphone + telecoil
PROCESSOR SELECTION KEY
(for bilateral patients only)
Selects the left processor
PROCESSOR SELECTION KEY
(for bilateral patients only)
Selects both processors
PROCESSOR SELECTION KEY
(for bilateral patients only)
Selects the right processor
VOLUME KEY
Decreases overall loudness

SONNET audio processor

FineTuner functions
Automatic keyboard lock: To avoid unintentional operation of a key, the FineTuner features
an optional automatic keyboard lock. This function electronically locks the keyboard if no key
is pressed for more than  seconds.
To activate the keyboard lock feature of your FineTuner, hold down the  key for more
than  seconds to enter the programme mode (the red and both amber indicator lights on
your FineTuner will start blinking alternately indicating that you have successfully entered the
FineTuner’s programme mode) and then the key to activate the automatic keyboard lock
(the FineTuner will conrm successful activation of the automatic keyboard lock by a short
blinking signal of the two amber indicator lights).
To deactivate the automatic keyboard lock, press the  key twice to unlock the keyboard
for  seconds, then hold it down for more than  seconds to enter the programme mode.
Press the key to deactivate the keyboard lock. Just as described above, the FineTuner will
conrm successful deactivation of the automatic keyboard lock with a short blinking signal
of the two amber indicator lights.
To activate a certain function while the keyboard lock is active, press the desired function
key twice. The rst click temporarily unlocks the keyboard, the second click executes the
command. After  seconds without pressing another key, the keyboard is locked again.
Battery low warning: If you press a key and see the red indicator light on your FineTuner
ashing  times, then the voltage level of your FineTuner is critically low (see also chapter ,
Care and maintenance, Batteries, Changing the battery of your FineTuner).
Transmitter time-out: The FineTuner stops transmitting after  seconds to save energy, even
if the key is still pressed.
Your FineTuner does not have an ON/OFF switch.
Three indicator lights with different colours ( amber,  red) indicate various conditions of
the FineTuner. For a detailed description of their function see chapter , Troubleshooting.
The FineTuner does not affect connected assistive listening devices.

SONNET audio processor

BATTERY PACK
The SONNET battery pack (product code Ma) consists of the battery pack frame
holding two hearing aid batteries, and the battery pack cover. The battery pack cover which
also functions as the ON/OFF switch of the SONNET (see Fig.  and ) slides over the battery
pack frame. This conguration allows the entire audio processor to be worn on the ear.
Changing the batteries is described in chapter , Care and maintenance, Batteries, Changing
the batteries of your SONNET audio processor.
To remove the battery pack from the control unit (e.g. to connect a MAX programming
cable instead) proceed as follows:
. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig.
-. When it is not in the unlocked position, use the screwdriver provided with your
SONNET kit to turn it counter-clockwise into the unlocked position.
. Pull back and completely remove the battery pack cover.
. Press the release lever () on the battery pack frame as shown in Fig. – and separate
battery pack frame and control unit ().
To attach the battery pack to the control unit proceed as follows:
. Insert the rib on the control unit into the matching groove of the battery pack frame ()
as shown in Fig. -.
. Push the opposite end of the battery pack frame onto the control unit () until the
release lever engages.
. Make sure that the battery pack cover lock is in the unlocked position as shown in Fig.
-. When it is not in the unlocked position, use the screwdriver provided with your
SONNET kit to turn it counter-clockwise into the unlocked position.
. Slide the battery pack cover completely over the battery pack frame to switch on the
SONNET (see Fig. ). Mind the correct orientation of the battery pack cover when sliding
it over the frame and do not use excessive force. The orientation is correct when the air
inlets () on the battery pack cover are on the same side as the coil cable socket in the
control unit (see Fig. -).
In young children the battery pack cover lock must always be turned clockwise into
the locked position (see Fig. -) once the cover has been moved completely over the
frame to prevent the child from disassembling the audio processor.

SONNET audio processor

Fig.  Battery pack cover lock
 
unlocked locked

SONNET audio processor








Fig.  How to remove/attach the battery pack from/to the control unit
The battery pack cover is available in several colours allowing you to personalise your SONNET.
Only parents/adults should disassemble the device to change defective parts. Parents/
adults must check the device at least once a week for damages or missing parts.