MED EL Elektro Ger te WL700 Remote Control User Manual Titel

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Document Description	UserManual.pdf
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Document Type	User Manual
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Date Submitted	2017-03-08 00:00:00
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Document Author:	Dorit Buschmann

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Description of Change
Initial draft
FCC Compliance information added
FCC Compliance information modified
Originator
D. Buschmann
D. Buschmann
P. Lampacher
Bonebridge
Samba audio processor
Model BB Left (51559) and BB Right (51560)
Instructions for use
Table of contents
Contents of the package
Introduction
Part One – General information
Device description
Samba audio processor overview
Intended use – Indications – Contraindications
Intolerances
Maintenance
Cleaning
Storage, handling and disposal
Part Two – User information
Switching the Samba on/off
Activating the Bonebridge System
Fitting the Samba to the implant
Changing the program
Batteries
Changing the cover
Using the hair clip
Troubleshooting
Part Three – Audiologist information
Supplementary equipment to program and handle the Samba
Information for audiologists and recommended training
Programming the Samba audio processor
Changing the magnet assembly
Advanced troubleshooting
Effective Date
15. Feb. 2017
21. Feb. 2017
TW#
TW138726
TW139413
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Part Four – Warnings and Precautions
Warnings
Precautions
Possible adverse events
Interference with other equipment
Initial activation
Warranty statement
Part Five – Clinical trial description
Part Six – Samba technical data
Symbols
Guidance and manufacturer’s declaration
Part Seven – The remote control
Contents of the package
•
Samba audio processor
•
Remote control
•
Instructions for use
•
Audio processor Registration Card and envelope
•
Audio processor batteries (Type 675 zinc-air button cell) in 1 dial card package
•
Remote control batteries (Type AAA), 2 pieces
•
Attachments: Hair clip (large and small)
•
Activity Clip
•
8 additional interchangeable design covers
•
Samba case
Introduction
This user manual covers operation and maintenance of the Samba audio processor for the Bonebridge System.
You should read this manual carefully and completely so that you are familiar with the operation and
maintenance of your audio processor. Please do not hesitate to contact your audiologist, clinic or MED-EL
representative with any additional questions you may have.
Part One – General information gives information on indications, contraindications, maintenance and storing of the
audio processor.
Part Two – User information is intended to complement information provided by your doctor or audiologist. This
includes basic information of how to use, maintain and troubleshoot your device.
Part Three – Audiologist information is intended for audiologists and provides additional detailed instructions on
fitting, adapting and programming the Samba audio processor. An advanced troubleshooting-section in the end of part
three will help to detect the causes of malfunctions and give instructions to resolve them.
Part Four - Warnings and precautions contains all relevant warnings and precautions, as well as information on the
warranty and the registration card.
Part Five – Clinical trial description describes the clinical trial and gives details on clinical studies and their results.
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Part Six – Samba technical data includes technical data, explanation to symbols used in this manual and
manufacturer‘s declaration.
Part Seven – The remote control contains information on the remote control.
Read carefully the section “Part Four – Warnings and precautions”!
Information particularly relevant for parents of implanted children is added, wherever necessary,
in this font and with this symbol.
Caution
The Samba audio processor is only to be used with a Bonebridge Bone Conduction Implant (BCI 601)!
Part One – General information
Device description
The Bonebridge is an osseointegrated bone conduction implant system intended to provide a level of useful sound
perception to individuals with hearing loss.
The Bonebridge System consists of two major components: The Bone Conduction Implant, called the BCI, and the
external audio processor, e.g. the Samba.
The externally worn audio processor is attached to the patient’s head, behind the ear. A magnet in the audio processor
is attracted to an opposing magnet within the implant. The audio processor includes two microphones to pick up sound
from the environment, a sound processing circuitry to modify the output signal to the customer’s specific requirements,
and a digital compression processor. The device is powered by a single standard battery. The Bonebridge System is
activated by simply fitting the audio processor.
The implanted part of the Bonebridge System consists of the internal coil and the Bone Conduction Floating Mass
Transducer™ (BC-FMT). A signal from the audio processor is transferred across the skin to the internal coil. The
internal coil then relays the signal to the BC-FMT. The BC-FMT converts the signal to vibrations, which are interpreted
by the customer as sound. The implanted portion of the Bonebridge System is not operated directly by the user and
has no specific maintenance requirements. The user does, however, have operation and maintenance responsibilities
for the Samba audio processor and its accessories.
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Samba audio processor overview
Microphone openings
Exchangeable cover
Battery compartment
Figure 1: Samba audio processor overview (opened position)
Intended use – Indications – Contraindications
Intended use
The Samba audio processor is an external part of the Bonebridge. The Bonebridge is intended to improve hearing for
patients with conductive or mixed hearing losses, bilateral fitting, and single sided deafness.
The Bonebridge augments hearing by providing acoustic information to the inner ear via bone conduction. This is
achieved by actuating a vibratory transducer, which is implanted in the mastoid bone.
Indications
Patients who have received a BCI 601 are indicated to use the Samba audio processor.
Because the Samba is a component of the Bonebridge System, all indications for the Bonebridge are applicable.
Contraindications
Because the Samba is a component of the Bonebridge System, all contraindications for the Bonebridge are
applicable.
NOTE
Important information related to indications, contraindications, warnings and risks for your implant are
shipped in a separate document (instructions for use of the implant) to your clinic together with the
implant. If you want to review this information, please contact your clinic or MED-EL.
Intolerances
Persons known to be intolerant of the materials used in the implant or the audio processor should not receive a
Bonebridge System. Please refer to Part Five – Samba technical data of this manual for materials of the Bonebridge
System in tissue contact.
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Maintenance
Your Samba audio processor is designed for durability and reliability. When handled with sufficient care, it will function
for a long time. The expected service life of your audio processor is 5 years.
Other than replacing the battery, there are no serviceable features on the audio processor. If your device does not
work properly, check the section Troubleshooting in Part Two – User information. If you cannot solve the problem
following the recommended actions in the troubleshooting section, please return to your audiologist for advice.
Please have your Samba checked by your audiologist at least every two years.
Cleaning
MED-EL recommends to clean the Samba weekly for hygienic reasons. Only clean the outside of the device. Do not
clean the Samba in or under water. Use a damp cloth to gently clean your audio processor. If necessary, use
nonabrasive household soap together with a damp cloth. Do not use aggressive cleaning agents. Prevent water from
running into the Samba via the microphone openings or the battery compartment.
Storage, handling and disposal
When not in use, the Samba should be kept in the Samba case provided. You can remove the battery from the Samba
for storage to extend battery life and you can store the battery in the Samba case. For doing this, place the battery in
the recess of the Samba case. The positive (+) pole (i.e. the flat side of the battery) must face downward (see Figure
2).
Figure 2: Samba case with Samba audio processor and its battery (with positive pole (+) in downward position)
If you live in a humid climate or perspire heavily, the audio processor should be placed in a drying container instead of
in the Samba case when it is not worn. Drying containers are effective for a limited period of time, depending on the
humidity in your area. Follow the instructions provided with the drying container.
NOTE
Please store the Samba in a dry place and protect it from direct sunlight.
The external components of your Bonebridge System must not be disposed of with your other household waste. You
are responsible for disposing all external components of your Bonebridge System by returning them to MED-EL or a
local representative.
Part Two – User information
This section is intended for users of Samba audio processors and contains important information on handling and
operation.
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Switching the Samba on/off
To switch the Samba on, insert a battery and close the battery compartment completely. To switch the Samba off,
open the battery compartment. It is sufficient to open the battery compartment about 5 mm (1/4 in.).
The Samba audio processor transmits sound information even when it is not attached to the head. To extend battery
life, the battery compartment should be opened whenever the audio processor is not in use. This disconnects the
battery and thus switches the audio processor off.
Activating the Bonebridge System
The Bonebridge System is activated when the Samba is switched on and placed over the internal coil of the implant.
Fitting the Samba to the implant
The Samba audio processor is kept in position over the implant by magnetic force. Magnets of different strength can
be used to offer best comfort for every individual.
If wearing the audio processor causes redness or discomfort to your skin, or if the audio processor seems to fall off
frequently, return to your audiologist to have the magnet exchanged.
NOTE
Please check your skin over the implant regularly during the first month of use.
Make sure the audio processor marked with the symbol
is used on the left side,
and the audio processor marked with the symbol
on the right side. The mark can
be found on the bottom of the Samba audio processor (see Figure 3).
Figure 3: Bottom of the Samba
audio processor (marked for
the right side)
NOTE
The functionality of the audio processor is influenced by its orientation.
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Figure 4: Placing the Samba on the head
The best results are achieved when the Samba is placed with the microphone openings
facing towards the top (as shown in Figure 4).
Hair trimming
Occasionally you may need to trim or shave your hair to about 6 mm (1/4 in.) in the area directly over the implant. In
most cases the patch of trimmed hair can be easily concealed by the remainder of your hair.
Using the Activity Clip
The Activity Clip is an optional magnetic accessory that can be used for additional fixation of the audio processor (also
named Single-Unit Processor) to the hair. Improved fixation may be desirable for example during sports activities. The
instructions for use for the Activity Clip are included in the clip's packaging.
Changing the program
The Samba audio processor offers up to five programs to choose from.
The five program settings are freely programmable by the audiologist. One possibility is that the five programs feature
five different volume settings. Another possibility is that programs can be used to switch between certain features of
the signal processing (e.g. Program 1 – ambient sound, Program 2 – optimized for noisy environment, Program 3 –
optimized for music, Program 4 and 5 – inactive). Programs are activated / deactivated by your audiologist during
programming.
Your Samba audio processor is equipped with wireless technology and can therefore be controlled by a remote
control. Please refer to section Part Six – The remote control for further information.
NOTE
After turning the audio processor on, the first program is always active.
NOTE
In case of a loss of the remote control the audio processor still can be used for best benefit. However, it is
not possible to change or modify the selected program without the remote control. It is recommended to
set program 1 for the most commonly used hearing situation. Just remove and insert the battery to run
the settings of program 1.
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Alternative remote control
Apart from the remote control distributed by MED-EL and explained in the section Part Six – The remote control, the
Siemens miniTEK is compatible for the use with your Samba audio processor. It can be purchased separately.
Please refer to the appertaining user guide for information about the miniTEK. This user guide is provided by the
manufacturer of the respective remote control.
NOTE
Wireless connectivity feature is available with the Siemens miniTEK, sold separately. Sivantos is not
responsible for the operation with the Samba or its compliance with safety and regulatory standards in
operation with the Samba.
Batteries
Battery status
The Samba is designed to be very energy-efficient and has a battery life of approximately three days. This is based on
an average daily use of 16 hours at an average volume level. The battery life of the audio processor may vary
depending on selected program, environment, and duration of use. The battery should be replaced regularly or when
the sound level of the Bonebridge System drops off dramatically.
If the battery is low, it must be replaced when you hear a series of beeps. The loudness and pitch of the beeps can be
preset by your audiologist. Additionally, if you notice a change in sound quality, it is recommended that you replace the
battery as your first troubleshooting step. If the problem persists, contact your audiologist.
Changing the battery
Caution
Use only size 675 zinc–air batteries (also called PR44 batteries). Using batteries of other sizes, voltages, or
power levels may cause irreparable damage to the audio processor and will void the warranty.
Never try to recharge 675 zinc–air batteries. Do not throw batteries into fire or try to open them.
Open battery compartment
•
Hold the Samba between your fingers. Place one
finger on the top of the audio processor and
another on the bottom.
First open one side of the battery compartment, then
open the other side.
NOTE
It does not matter which side is opened first.
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Open the battery compartment until the battery is
completely visible.
Remove battery
•
Turn the Samba upside-down carefully, allowing
the battery to drop out.
Do not apply force if the battery gets stuck in the
battery compartment, but push it back down and
try again.
Insert new battery
•
Take a new 675 zinc-air battery and remove the
foil covering the battery to activate the battery.
•
Place the battery in the audio processor’s battery
compartment
•
Make sure that the battery’s polarity matches the
marking on the battery compartment.
•
The positive (+) pole (i.e. the flat side of the
battery) must be on top.
•
If the battery does not slide in smoothly, it may be
upside down. Do not force the battery into the
battery compartment.
Close battery compartment
•
Slide the battery compartment into the audio
processor.
•
Do not force the battery compartment to close,
check for the correct position of the battery and
try again.
Spare battery
It is recommended that you keep a spare battery with you, but it must be carried in its original packaging or in another
container that will keep it clean and away from metal. Be sure not to remove the foil covering the battery until just prior
to inserting it in the audio processor.
Disposal of battery
Always remove used batteries immediately to avoid battery leakage and possible damage to the audio processor. To
avoid environmental pollution, do not throw batteries into household trash. Recycle or dispose of used batteries
according to local regulations.
Parents are advised to regularly change the battery as necessary and, if in doubt, check the status
of the battery.
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Warning
To prevent children and mentally challenged people from swallowing or choking on batteries, always keep
new and used batteries out of the reach of children and mentally challenged people.
NOTE
If you are the parent/guardian/carer of a Bonebridge System user and the user refuses to wear the
system or indicates uncomfortable hearing sensations, remove the audio processor immediately and
have the user’s system checked at the clinic.
Changing the cover
The Samba is provided with different exchangeable covers, which you can change easily. The different covers can be
used to change and customize the appearance of your Samba.
Open the battery compartment and remove the battery
(see Changing the battery).
To remove the cover:
•
Place the Samba on an even surface (e.g. table)
and put one finger on top.
•
The cover should be opened from the sides.
•
First, lift one side of the cover, then lift the other
side.
NOTE
It does not matter which side is opened first.
Open
cover here
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Remove the cover completely from the audio processor.
Place the new cover on the Samba. First, place the back
side of the cover on the audio processor.
Place the Samba on an even surface (e.g. table) and
press the cover down. Make sure that it snaps into place.
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Press the sides just below the cover and behind the
opened battery compartment together to ensure that the
cover is in the correct position.
Insert a battery and close the battery compartment (see
Changing the battery).
NOTE
Always attach the cover before you close the
battery compartment
Using the hair clip
You can use the provided attachment eyelet or replace it with one of the hair clips to prevent an accidental loss of the
Samba. Simply attach the hair clip to a strand of hair after fitting the audio processor to the implant.
The attachment eyelet is attached to the Samba on delivery. If necessary, you can replace or reattach it as follows:
Remove the cover and the battery of your audio
processor (see Changing the cover).
Pass the attachment eyelet under the battery
compartment and insert it in the small notch under
the battery compartment.
Notch for the
attachment eyelet
Attachment
eyelet
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Press the attachment eyelet down to fixate it in the
audio processor. Use a small pointed object like a
pencil for doing this.
Insert a battery and reattach the cover (see
Changing the cover).
Troubleshooting
Problem in your audio
processor
Possible cause
Recommended action
No sound
No battery inserted
Insert a new battery (see Changing the battery in Part
Two – User information)
Battery empty
Replace the battery (see Changing the battery in Part
Two – User information)
Foil covering the battery
still in place
Remove the foil covering the battery (see Changing the
battery in Part Two – User information)
Battery inserted upsidedown
Check polarity, flat side (+) must be on top (see
Changing the battery in Part Two – User information)
Microphone inlets
blocked
Carefully try to remove any dirt /obstructions from the
microphone inlets. If you cannot remove the obstruction
easily, contact your audiologist and/or MED-EL
representative.
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Problem in your audio
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Possible cause
Recommended action
Loss of electrical
connection due to
draggled battery
contacts
Remove the cover (see Changing the Cover in Part
Two – User information), check visible battery contacts
and clean carefully if necessary. Use a cotton swab and
a small amount of cleaning alcohol. Gently wipe dry after
cleaning.
No air flow to battery
Check battery compartment for gap, remove
dirt/obstruction
Device damaged (e.g.
by moisture/shock)
Contact your audiologist and/or MED-EL representative
Device turned off
unknowingly via the
remote control
Turn on the Samba using the remote control (see Part
Six – The remote control)
Battery low
Replace battery (see Changing the battery in Part Two
– User information)
Microphone inlets
blocked
Carefully try to remove any dirt /obstructions from the
microphone inlets. If you cannot remove the obstruction
easily, contact your audiologist and/or MED-EL
representative.
Incorrect position of
audio processor
Adjust the orientation of the audio processor (see Fitting
the Samba to the implant in Part Two – User
information)
Volume is turned too
low
Use the remote control to reset the Samba to the default
volume program (see Part Six – The remote control)
Volume is turned too
high
Use the remote control to reset the Samba to the default
volume program (see Part Six – The remote control)
Internal signal
processing defective
If you cannot turn down the volume with the remote
control, stop using the audio processor and contact your
audiologist and/or MED-EL representative
Audio processor
cannot be switched on
Battery compartment
blocked
Check for correct battery position, carefully push down
the battery when closing the battery compartment (see
Changing the battery in Part Two – User information)
Battery insertion not
possible
Wrong battery type
Use 675 zinc–air batteries (PR44 batteries) only
Battery upside-down
Turn battery, flat side (+) must be on top (see Changing
the battery in Part Two – User information)
Audio processor falls
off frequently
Hair over implant too
long
Shave hair over implant to about 6 mm (1/4 in.)
Magnet too weak
Contact your audiologist
Allergic reaction
Stop wearing your audio processor and contact your
audiologist. Please refer to Part Five – Samba
technical data of this manual for materials of the
Bonebridge System in tissue contact.
Attachment force too
high
Contact your audiologist
Only one program
activated
Contact your audiologist
Remote control not
working
If program selection is not possible, refer to the solutions
provided under Remote control not working (see
Troubleshooting in Part Two – User information)
Sound weak
Sound too loud
Skin irritation over
implant
Program selection not
possible
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Problem in your audio
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Remote control not
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Possible cause
Recommended action
Electrical problems
If all other options listed in this table fail, contact your
audiologist and/or MED-EL representative
Distance between audio
processor and remote
control exceeds
operating distance
Bring the remote control closer to the audio processor
and/or change the orientation of the remote control (see
Part Six – The remote control)
Key lock activated
Check if the key lock is activated and deactivate it, if
necessary (see Part Six – The remote control)
Batteries empty
Replace the batteries (see Part Six – The remote
control)
Another remote control
affects your audio
processor
Contact your audiologist
Caution
Never try to open or repair the Samba yourself. Always contact your audiologist or your local MED-EL
representative.
NOTE
If the housing of the audio processor becomes damaged or a problem persists after trying the
recommended actions described in the troubleshooting section, contact your audiologist or MED-EL
representative.
Signal interference with other equipment
Sound is picked up by the microphones of the Samba and is then transmitted to the Bonebridge implant. A short-range
wireless technology called “Near Field Magnetic Induction (NFMI)” is used for this transmission. Transmissions of up
to approximately 10 mm (0.39 in.) are possible in the Bonebridge System with this technology. The system has been
tested to and complies with IEC 60601-1-2. Additionally, it has been tested for interference with commonly used
wireless devices.
Please keep the following precautions in mind:
•
Some devices such as hand-held computers, mobile telephones and theft and metal detection systems may cause
interference with the Bonebridge System.
•
Do not stay in areas where theft and metal detection systems are used.
•
Remove the audio processor when you are moving through security checkpoints. Alert the security personnel that
you have a Bonebridge implanted. It is advised that you carry your Bonebridge User Identification Card at all
times.
•
Move away from any possible source of interference when you experience any audible interferences.
If you experience any unusual sound and the condition persists, contact your audiologist or your local MED-EL
representative.
Part Three – Audiologist information
Caution
This section is intended for audiologists and other professionals like hearing aid programmers.
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If your patient refuses to wear the system or indicates uncomfortable hearing sensations, remove the audio processor
immediately and check the user’s system.
Please do not hesitate to contact your MED-EL representative for any information not provided in this manual.
Also refer to the section Samba audio processor overview in Part One – General information for more
details.
Supplementary equipment to program and handle the Samba
•
Programming cable CS64 (provided by MED-EL, catalogue number 51768)
•
Battery pill (provided by MED-EL, catalogue number 51769)
•
SYMFIT 7.0 (programming software provided by MED-EL, catalogue number 51529)
•
Connexx 6.5.5 (programming software provided by Sivantos)
•
ConnexxLink (wireless programming system provided by Sivantos)
•
Magnet lid driver (provided by MED-EL, catalogue number 51771)
•
Magnets of different strengths (provided by MED-EL, check the current catalogue numbers in MED-EL’s
catalogue)
Information for audiologists and recommended training
Audiologists should be experienced in the fitting of hearing aids and the application of standard audiological tests and
measures. It is recommended that audiologists receive specific training regarding the evaluation of candidates and
fitting of the Bonebridge System in adults as well as in children.
Supplementary equipment to be connected to the Samba audio processor for fitting by the audiologist, the
programming cable and the battery pill (both available separately) must be compliant with Type BF of the electrical
safety standard IEC 60601-1 / EN 60601-1, indicated by the symbol
. Anyone who connects additional equipment
to the audio processor's programming interface configures a medical system, and is, therefore, responsible that the
system complies with the requirements of IEC 60601-1 electrical safety standard. If there are any questions, please
consult with MED-EL or the regional representative.
Also refer to the hearing aid programmer's manual (e.g. HI-PRO, NOAHLink).
Programming the Samba audio processor
The Samba can be programmed either wired or wireless.
NOTE
The remote control is not activated by default and has to be activated with the programming software
(SYMFIT 7.0 or higher).
Wired programming
Follow these steps for the wired programming of the Samba:
Caution
Battery pills and programming cables not intended to be used with the Samba can cause irreparable damage
to the device. Only use the battery pill and the programming cable provided.
•
Open the battery compartment and remove the battery. Refer to section Changing the battery in Part Two –
User Information for information regarding opening the battery compartment.
•
Insert the battery pill straight into the battery compartment (see Figure 5).
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Figure 5: Samba with battery pill inserted
•
Close the battery compartment. Do not force the battery compartment to close, check for the correct position
of the battery pill and try again.
•
Connect the programming cable CS64 to the battery pill.
•
Connect the programming cable CS64 to the hearing aid programmer.
•
Place the audio processor over the implant.
•
Program the audio processor. Follow the instructions in the SYMFIT 7.0 or higher software manual.
•
After programming, remove the programming cable CS64 and the battery pill from the audio processor. Insert
a new type 675 zinc-air button cell battery into the audio processor.
•
Close the battery compartment.
Wireless programming
The use of ConnexxLink is necessary for the wireless programming of the Samba. ConnexxLink is not provided with
the audio processor and has to be purchased separately. Please follow the instructions provided with the user manual
of ConnexxLink.
Changing the magnet assembly
The Samba is held in place only by magnetic attraction. The magnet assembly is exchangeable. In some cases it may
be necessary to use a stronger or weaker magnet.
To change the magnet assembly, follow these steps:
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Remove the cover (see section Changing the cover in
Part Two – User information)
Use the provided magnet lid driver to remove the magnet
lid together with the magnet.
•
Place the tip of the magnet lid driver into the
groove of the magnet lid and turn the magnet lid
driver anti-clockwise. Magnet lid driver and
magnet attract each other magnetically and thus
hold the magnet lid too.
Use the provided magnet lid driver to insert the chosen
magnet together with the magnet lid:
•
Place the magnet lid between the magnet and the
magnet lid driver. The tip of the magnet lid driver
must be placed into the groove of the magnet lid.
Magnet lid driver and magnet attract each other
magnetically and thus hold the magnet lid too.
•
Turn the magnet lid driver clockwise to tighten the
magnet and the magnet lid in the correct position.
Attach the cover again (see section Changing the cover
in Part Two – User information).
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Advanced troubleshooting
This section only deals with problems not covered in the section Troubleshooting in Part Two – User information.
Problem
Possible cause
Recommended action
No sound or sound too
weak
Microphone inlets
blocked
Remove obstruction/dirt, or contact your MED-EL
representative
Sound too loud
Internal signal
processing defective
Stop patient from using the audio processor and adapt the
characteristics of the affected program. See Part Three –
Audiologist information, Programming the Samba audio
processor for further details. Otherwise contact your MEDEL representative
Audio processor falls
off frequently
Magnet too weak
Exchange the magnet assembly with a stronger version
(see Part Three – Audiologist information, Changing the
magnet assembly for more details)
Magnet positioning
incorrect
Check for correct magnet position in housing (see Part
Three – Audiologist information, Changing the magnet
assembly for more details)
Skin irritation over
implant
Attachment force too
high
Exchange the magnet assembly with a weaker version (see
Part Three – Audiologist information, Changing the
magnet assembly for more details)
Program selection not
possible
Electrical problems
Exchange the remote control. If problem persists, contact
your MED-EL representative
Insertion of battery pill
not possible
Battery pill not inserted
correctly
Insert the battery pill straight into the battery compartment
(see Part Three – Audiologist information, Programming
the Samba audio processor for more details)
Programming contacts
blocked/dirty/corroded
Remove obstruction/dirt, or contact your MED-EL
representative
Connection of
programming cable
CS64 to battery pill not
possible
Programming contacts
blocked/dirty/corroded
Remove obstruction/dirt using a cotton swab and a small
amount of cleaning alcohol, or contact your MED-EL
representative
Device failure
during/after
programming
Intermittence during
programming
If problem persists after reset of audio processor, contact
your MED-EL representative
Remote control not
working
Another remote control
affects the audio
processor
Change the wireless address to avoid interference.
NOTE
If the audio processor becomes damaged or a problem persists after trying the recommended actions
described in the troubleshooting sections, contact your MED-EL representative.
Part Four – Warnings and precautions
The following section describes warnings and general precautions that apply to your Bonebridge System. Read the
following section carefully. If you have any questions, consult the surgeon who performed your implant surgery.
Always inform any physician that you are visiting for medical treatment that you have a Bonebridge implanted. He or
she may not be aware that you have an implant, and this knowledge may affect your treatment.
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Warnings
The device must not be altered and may only be used as intended!
Electromagnetic compatibility
The Bonebridge System needs special precautions regarding electromagnetic compatibility (EMC) and needs to be
installed and put into service according to the EMC information provided in this manual.
Portable and mobile Radio Frequency (RF) communications equipment may affect the performance of your Samba
audio processor.
Precautions
The Samba audio processor contains complex electronic parts. These parts are durable but must be treated with care.
The audio processor must never be disassembled by anyone other than authorized service personnel or the warranty
will be void. The magnet compartment must be opened only by a trained audiologist or professional. All sound
adjustments shall be made only by a qualified audiologist.
The audio processor is specifically adjusted for each individual user. Never exchange your audio processor with
another Bonebridge or Vibrant Soundbridge System user.
If you are the parent/guardian/carer of a Bonebridge System user and the user refuses to wear the system or indicates
uncomfortable hearing sensations, remove the audio processor immediately and have the user’s system checked at
the clinic.
Before switching on the Samba audio processor, check it for proper mechanical condition, e.g. for loose or broken
parts and for the presence of the attachment eyelet. In case of problems, the audio processor should not be switched
on. Read the section Troubleshooting in Part Two – User information or contact your audiologist and/or MED-EL
representative.
Head trauma
A blow to the head may damage the implant and result in its failure. Implant recipients are strongly encouraged to use
head protection whenever possible during sports and activities in which head trauma is a risk (i.e., bicycling,
motorcycling, skiing) and should never participate in sports in which head trauma is part of the activity (i.e., boxing).
Ingestion of small parts
The audio processor contains small parts that may be hazardous if swallowed. Children should be instructed not to
swallow or put any components of the Bonebridge System into their mouths and not to play with any components.
Use your own audio processor
Patients should use only the audio processor that has been specifically programmed for them by their clinician. Use of
a different audio processor may cause distorted or uncomfortably loud sounds.
Water damage
Protect the audio processor from water or perspiration. Never bathe or shower while wearing the audio processor. The
warranty is void when damage is caused by moisture. When playing sports or engaging in other activities in which you
may perspire a lot, it is recommended that you wear a sweatband to absorb moisture near the audio processor. The
use of a drying container (not provided with your device) in high humidity or moist conditions is also recommended.
If the Samba gets wet, switch it off as quickly as possible, remove the battery from the battery compartment and gently
wipe the outside dry, using a soft absorbent cloth. Then allow the audio processor to dry out (preferably overnight). If
in doubt, repeat the drying process.
If the problem persists, return the audio processor to your audiologist or MED-EL representative for repair or
replacement.
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Dirt damage
Avoid getting sand or dirt into any part of the audio processor. If the audio processor is not working, try the actions
recommended in the section Troubleshooting in Part Two – User information. If the problem persists, return the
audio processor to your audiologist or MED-EL representative for repair or replacement.
Range of benefits
The Bonebridge System does not restore normal hearing and benefits may vary from one patient to another. The
correlation between the degree of benefit obtained from an implant and the cause or degree of hearing impairment has
not yet been evaluated. There are no definitive tests that can be administered prior to implantation to estimate the
degree of benefit a patient may receive.
Possible adverse events
The following are known to be possible adverse events associated with middle ear surgery: Implant patients are
exposed to the usual risks of surgery and general and/or local anesthesia, which include, but are not limited to,
bleeding, local skin numbness or pain, infection, transient tinnitus, vertigo or headache. If these occur, they are usually
transient and resolve within a few weeks after the surgery. Please consult or contact your clinic for further information.
Other complications that may occur include: post-surgery displacement of the implant; post-surgical translocation of
the BC-FMT due to trauma or inferior surgical positioning and extrusion of the implant.
Interference with other equipment
Samba audio processor
•
Mobile phones, Cordless telephones (DECT): The Bonebridge System has been tested for wireless device
compatibility. The Bonebridge System is in near field category “M4”. This is the best possible category and
ensures usable performance with any portable phone. For further details please refer to Part Five – Samba
technical data.
•
Wireless LAN (WLAN): To avoid interferences, a distance of 70 cm (27.56 in.) shall be observed to
transmitters.
•
Other radio frequency transmitters: Portable and mobile RF communications equipment should be used no
closer to any part of the Samba than the recommended separation distance given in Table 6 in the section
Guidance and manufacturer’s declaration in Part Five – Samba technical data.. Please contact the
operator of a specific radio frequency transmitter to obtain transmission frequency and rated power.
•
Other electronic equipment: The Samba uses radio frequency only for its internal function. Therefore, its
radio frequency emissions are very low and are not likely to cause any interference in nearby electronic
equipment. The Samba is suitable for use in all establishments.
•
Theft and metal detection systems: Commercial theft detection systems and metal detectors produce
strong electromagnetic fields. Patients with an implant should be advised that passing through security metal
detectors may activate the detector alarm. For this reason, it is advised that patients carry their Bonebridge
User Identification Card at all times.
•
Ionizing Radiation Therapy: It is recommended not to wear an audio processor during irradiation.
•
Magnetic Resonance Imaging (MRI):
an MRI examination.
The audio processor is MR unsafe and shall not be worn during
Bone Conduction Implant (BCI 601):
•
Surgical diathermy: Electrosurgery instruments can produce radio frequency voltages that might result in
direct coupling between the instrument and the implant. Monopolar electrosurgical instruments must not be
used within the vicinity of the implant. The induced currents could cause damage to the implant or the patient’s
hearing.
•
Ionizing radiation therapy: Radiation therapy does not harm the implant. It is recommended not to wear an
audio processor during irradiation.
•
X-ray, CT, cobalt treatment, PET scan, diagnostic ultrasound: No restriction within clinically useful
exposures.
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Monopolar electrocautery, therapeutic ultrasound, transcranial magnetic stimulation,
electroconvulsive therapy: May never be applied directly over the implant because these procedures may
damage it.
Magnetic Resonance Imaging (MRI):








MR Conditional
Non-clinical testing has demonstrated the “Bonebridge hearing implant, single (68 x 28 x 10 mm)” is
MR conditional.
The audio processor shall not be worn during an MRI examination, however, it is still possible that
audible interference can occur.
It can be scanned safely under the following conditions:
 static magnetic field of 1.5 Tesla or less, with
 spatial gradient field of 118 T/m or less
 spatial gradient field product of 141 T /m or less
 theoretically estimated maximum whole body averaged (WBA) specific absorption rate (SAR)
of < 1.6 W/kg at 1.5 Tesla, (local SAR < 5.6 W/kg), for 15 minutes of continuous MR scanning.
In non-clinical testing the “Bonebridge hearing implant" produced a temperature rise of less than 2.0 °C
(with a background temperature increase of ≈ 1.6 °C) at a maximum whole body averaged specific
absorption rate (SAR) of ≈ 2.3 W/kg assessed by calorimetry for 15 min. of continuous MR scanning
with body coil in a 1.5 Tesla Intera, Philips Medical System (PMS) (Software: Release 12.6.1.3, 201012-02) MR Scanner.
General notice: the whole body or head averaged SAR is inappropriate to scale exact local
temperature increases. Local SAR can deviate and result in much higher values than the WBA-SAR
software displayed.
Gradient magnetic fields: stimulation level parameter PNS = 47 % (1.5 T Intera, Philips Medical
Systems (PMS)) was used during RF heating tests. No tests have been performed regarding possible
nerve or other tissue stimulation.
The “Bonebridge hearing implant” has not been tested in simultaneous combination with other devices.
MR image quality is compromised. Worst-case image artifacts are expected to affect the image in a
surrounding area with a radius of 15 cm measured from the geometrical center of the implant.
Therefore, it may be necessary to optimize MR imaging parameters for the presence of this implant.
Initial activation
The patient should return for medical clearance and initial activation of the audio processor after the swelling of the
skin flap has reduced.
Warranty statement
MED-EL’s warranty is in agreement with mandatory local statutory warranty provisions.
Any extension of the statutory warranty is subject to agreement between MED-EL and the purchaser. Therefore these
extensions may be different in various countries. Please contact your clinic or local MED-EL representative for
information on your individual warranty rights.
Extension of statutory warranties shall not be granted unless the audio processor is properly registered. You can
register your audio processor either by completing the provided registration card and sending it to MED-EL or by using
MED-EL’s online registration website (upon availability). Ask your clinic or local MED-EL representative for help if you
need assistance in the registration process.
Extensions of statutory warranties exclusively cover product failures. This does not apply to any MED-EL product
subjected to physical or electrical abuse or misuse, or operated in any manner inconsistent with the applicable
MED-EL instructions.
NOTE
Please make sure to receive your Bonebridge User Identification Card from your surgeon.
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Part Five – Clinical trial description
The purpose of this multi-center, non-randomized, non-blinded, repeated-measures clinical study was to demonstrate
the safety and effectiveness of the MED-EL Bonebridge system consisting of the Bone Conduction Implant (BCI) and
the externally worn audio processor (AP). The MED-EL Bonebridge is a medical device designed to provide benefit in
speech perception and sound quality to individuals who demonstrate a Mixed Hearing Loss (MHL) or Conductive
Hearing Loss (CHL), with stable inner ear function.
Six tests were evaluated in order to determine safety and effectiveness of the MED-EL Bonebridge System preoperatively and 1, 3, and 12 month post-operatively:
Word Recognition Score
Speech Reception Threshold
Warble Tones
Bone Conduction
Air Conduction
Hearing Device Satisfaction Scale
(WRS; Freiburger Monosyllables)
(SRT; OLSA)
(WT)
(BC)
(AC)
(HDSS)
In total, 57 subjects were enrolled in the study. The data presented here covers all 53 subjects who had reached 12month post-operative evaluation at the time of data analysis. Subjects were fitted approx. 1 month postoperatively with
the audio processor.
Primary Study Endpoint
The primary effectiveness endpoint was the improvement in speech perception in the post-activation aided condition
compared to the pre-operative unaided condition. A change of at least 15 % in the Freiburger Monosyllable Test was
considered clinically significant and was the primary endpoint for this study. To underline this test, the Oldenburger
Satztest (OLSA) was analyzed post hoc. For this analysis an improvement of 15 dB SPL in OLSA was considered
clinically significant.
Secondary Study Endpoints
The secondary effectiveness endpoint was the improvement in sound perception (Warble Tones: WT) in the postactivation aided condition compared to the pre-operative unaided condition for audiometric test frequencies 500-8000
Hz. A more than 10 dB improvement (Functional Gain: FG) at one or more test frequencies was considered significant.
The secondary safety endpoints were stable hearing thresholds for Bone Conduction characterized by no difference
between pre- and post-operative Bone Conduction thresholds for audiometric test frequencies 500-4000 Hz. A
decrease of 5 dB or less at a particular frequency is within test-retest reliability and was not considered clinically
significant.
A decrease of more than 10 dB in subject individual PTA4 (0.5, 1, 2, 4 kHz) at the 12 month interval was reported as
an adverse event.
Safety was further evaluated by tabulations of all adverse events (AEs) / serious adverse events (SAEs). Safety data
was collected on all implanted subjects.
Subject device satisfaction and benefit, determined by the HDSS (Hearing Device Satisfaction Scale) was either
preserved or improved from 3 to 12 months post operatively.
The HDSS (German language version) is comprised of 21 categories and is scored using the Likert 1 scale. Items are
presented in a phrase related to an aspect of hearing implant use. The rate of satisfaction for each question category
is calculated and summarized using descriptive statistics.
Inclusion criteria
Subjects were eligible for enrollment in the study if they fulfilled the following criteria:
General Inclusion Criteria:
a. geographical and physical ability to return to the investigational center for scheduled evaluations and
follow-up appointments
Likert (1932-1933). "A technique for the measurement of attitudes." Archives of Psychology Vol 22 (No. 140): 5-55.
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b. reasonable travel distance to the study center
(arrival, study appointment and departure should be accomplishable within 1 day)
c. fluentness in the language used in the investigational center and used for evaluation
d. age of 5 years or older
e. psychological and emotional stability with realistic expectations of the benefits and limitations of the BB
f. emotional and psychological ability to understand and perform on required study procedures
g. the patient should have tried any means of hearing amplification before (medical and/or audiological
feasibility preconditioned)
Audiological /Medical Inclusion Criteria:
h. feasibility of the reliable testing of target parameters (e.g. proper masking of the contralateral side) as
listed in the protocol (WRS, SRT etc.)
i. presence of a conductive or mixed hearing loss as indicated by audiometric testing. That is, presence
of an air-bone gap of at least 10 dB at three or more of the frequencies 500, 1000, 2000, and 3000 Hz.
j. all audiometric evaluations should be indicative of a conductive or mixed hearing loss.
k. pure-tone bone-conduction threshold levels at or within the levels stated in the Table 3.
Frequency (kHz)
0.5
1.0
2.0
3.0
BC Upper Limit (dB HL)
45
45
45
45
1. Table 3: Indication range
2. Upper limits (dB HL) of bone conduction thresholds as a function of frequency for persons with conductive or
mixed hearing loss
Exclusion criteria
Subjects were excluded from the study for any of the following reasons:
l. chronic or non-revisable vestibular or balance disorders
m. abnormally progressive hearing loss
n. evidence that hearing loss is of retrocochlear or central origin
o. evidence of conditions that would prevent good speech recognition potential as determined by good
clinical judgment
p. chronic headache or pain in the head region
q. non-responsive ear infection that could impair success with a bone conduction device
r. skin or scalp conditions that may preclude attachment of the audio processor or that may interfere with
the use of the audio processor
s. abnormal skull size or any other abnormality that would preclude appropriate placement of the BCI as
determined by CT scan.
t. impossibility to undergo general or local anesthesia.
u. single-sided sensorineural deafness, that is severe to profound sensorineural deafness in one ear
while the other ear has normal hearing
v. Pathological conditions causative for inner ear hearing instability (threshold fluctuation) or progressive
inner ear hearing loss.
w. Allergy or intolerance to one or more of the materials of the device, that are in contact with the body
x. In patients bilaterally implanted with the BB, only one ear needs to be chosen to be tested in the study.
Description of tests
Speech Perception testing
The following tests were conducted in a sound field with the speaker at 0° azimuth and 1 meter from and at level with
the subject’s head in a sound-attenuated room.
1. Word Recognition Score
Open-set, monosyllabic words were tested using the Freiburger Monosyllables Word Recognition test. Testing
was completed in quiet at 65 dB SPL in the sound field and results were reported as a percent correct for words.
This test was performed in quiet.
2. Speech Reception Threshold
Open-set sentences were tested using the OLSA (Oldenburger Satztest). The OLSA was administered and the
speech level in dB SPL for 50% correct recognition was determined. This test was performed in quiet.
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Audiometric Tests (sound field)
The following test was conducted in a sound field with the speaker at 0° azimuth and 1 meter from and at level with the
subject’s head in a sound-attenuated room.
Warble Tones
Were applied in the sound field and thresholds were measured using a standard bracketing procedure at 500,
1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Audiometric Tests (basic test battery)
The following tests were conducted, using insert earphones or traditional headphones, on each ear individually.
Bone Conduction
Were tested by pure tones applied in the sound field and thresholds were measured using a standard bracketing
procedure at 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Air Conduction
Was tested by pure tones applied in the sound field and thresholds was measured using a standard bracketing
procedure at 500, 1000, 2000, 3000, 4000, 6000 and 8000 Hz.
Device Satisfaction & Benefit
Hearing Device Satisfaction Scale
Subjective Device Satisfaction was tested by means of the Hearing Device Satisfaction Scale (HDSS)/ Hearing
Device Satisfaction Scale - Parent (HDSS-P, for parents of implantees) a self-assessment questionnaire. HDSS
measures parameters such as comfort, handling, and changes in quality of life. The HDSS consists of 21
questions/categories regarding the subjective device satisfaction with response options transformed into a
percentage ranging from very satisfied (100 %), satisfied (75 %), sometimes satisfied/dissatisfied (50 %),
dissatisfied (25 %), to very dissatisfied (0 %) based on the answers given.
Clinical trial results
Of the 57 total subjects implanted, 53 had reached the 12 month post-operative time point on the date of analysis. One
subject withdrew from the study after implantation; therefore, safety results for 53 subjects and audiometric results for
52 subjects were analyzed. The table below provides details on the number of subjects for each interval completed.
# of Subjects
Pre-operative
1 Month post-operative (Initial Activation)
3 Month post-operative
12 Month post-operative
Total
53
52
52
50
Demographics
The table below provides information on subject demographics, including gender, age at implantation, average of
previous ear surgeries and number of subjects with previous ear surgeries.
Parameter/Category or Statistic
Gender
Male %
Female %
Age (years) mean (min-max)
Implant Side
Left %
Right %
Previous Ear Surgeries
Total (N=53)
Adult (N = 45)
Pediatric (N=8)
58.5 % (N=22)
41.5 % (N=31)
41 (5-76) (N=53)
37.7 % (N=17)
62.3 % (N=28)
47 (18-76) (N=45)
62.5 % (N=5)
37.5 % (N=3)
11 (5-17) (N=8)
41.5 % (N=22)
58.5 % (N=31)
42.2 % (N=19)
57.8 %(N=26)
37.5 % (N=3)
62.5 % (N=5)
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Average surgeries per subject
3.66
3.61
Previously operated subjects
60.38 % (N=32)
68.89% (N=31)
Parameter/Category or Statistic
Disease Etiology
Chronic Otitis Media
Atresia
Cholesteatoma
Ear Dysplasia
Malformation
Ear Dysplasia /
Franceschetti Syndrome
Chronic Mastoiditis
Stenosis
Anomalius Bar
Congenital Syndromic Malformation
Otosclerosis
Glomus Tumor
Osteogenesis Imperfecta Otosclerosis
Microtia
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Only one pediatric
subject was
previously
operated with five
previous ear
surgeries.
Total (N=53)
30.19
16
22.64
12
20.75
11
7.55
1.89
1.89
Adult (N = 45)
15
28.30
16.98
11
20.75
5.66
1.89
1.89
1.89
1.89
1.89
1.89
1.89
1.89
1.89
1.89
1.89
1.89
1.89
1.89
1.89
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Pediatric (N=8)
1.89
5.66
1.89
1.89
1.89
1.89
Speech Perception Results (primary endpoints)
For the primary endpoint of improvement on Freiburger monosyllabic words in quiet the average unaided preoperative
score was 19.57 % (±21.7 %) correct. At 12 months post-operative, in the BB aided condition, subjects scored 82.9 %
(±18.1 %) correct. This represents an improvement with BB of 63.3 percentage points. Statistical analysis revealed a
significant improvement in WRS in the BB aided condition, as compared to the preoperative unaided condition.
Freiburger
Word Recognition Score
Total (N=52)
Adult (N = 44)
Pediatric (N=8)
Score [%]
19.57
Std.
21.70
46
Score [%]
20.00
Std.
21.64
39
Score [%]
17.14
Std.
23.60
1 month post-operative
74.51
21.01
51
75.00
21.73
44
71.43
16.76
3 month post-operative
83.75
15.84
52
84.66
15.72
44
78.75
16.64
12 month post-operative
82.90
18.10
50
82.91
18.68
43
82.86
15.24
pre-operative
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Figure 6: Word recognition scores for all subjects. Box Plots: median = horizontal lines; + = mean; ANOVA p < 0.05; *
= significance; red circles depict distribution of individual values
Additionally, improvement in speech understanding in quiet was assessed with OLSA sentences in quiet. Subjects
improved from 63.69 dB SPL (±11.81 dB SPL) pre-operative unaided to 39.71 dB SPL (±8.84 dB SPL) at 12 months
post-operatively aided with the BB. Statistical analysis showed a significant improvement in speech perception of 24
dB SPL.
OLSA
Speech Reception Threshold
Total (N=52)
Adult (N = 44)
Pediatric (N=8)
dB SPL
63.69
Std.
11.81
42
dB SPL
62.21
Std.
11.69
36
dB SPL
72.60
Std.
8.70
1 month post-operative
47.01
10.41
48
45.99
10.51
41
53.01
7.97
3 month post-operative
41.42
9.51
50
40.63
9.81
42
45.53
6.83
12 month post-operative
39.71
8.84
48
39.19
9.09
41
42.80
7.01
pre-operative
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Audiometric Results (secondary endpoints)
For the secondary endpoint of improvement on warble tones, the average unaided preoperative threshold improved
from 56.94 dB SPL (±12.57 dB SPL) to 29.33 dB SPL (±8.83 dB SPL) at 12 months post-operatively in the aided
condition. The functional gain of 28.89 dB SPL is significant in the BB aided condition, as compared to the
preoperative unaided condition.
WT
Warble tones
Total (N=52)
Adult (N = 44)
Pediatric (N=8)
pre-operative
dB HL
56.94
Std.
12.57
50
dB HL
57.64
Std.
12.89
42
dB HL
53.28
Std.
10.75
1 month post-operative
34.16
8.18
52
34.26
8.00
44
33.59
9.69
3 month post-operative
29.88
7.99
52
30.06
8.29
44
28.91
6.49
12 month post-operative
29.33
8.89
50
29.71
9.11
43
26.96
7.56
Figure 7: Warble tone thresholds using the pure-tone average: pre-operative (unaided) compared to the aided
condition at 1 month (Initial Activation), 3 and 12 months post-operatively for all subjects
The secondary endpoint of unchanged residual hearing was measured by unaided audiologic PTA4 thresholds from
preoperative unaided to the 12 month post-operative endpoint. The results of descriptive analyses of BC and AC
thresholds presented below show that BB treatment had no significant effect on residual hearing.
BC
Bone Conduction thresholds
Total (N=52)
Adult (N = 44)
Pediatric (N=8)
pre-operative
dB HL
16.03
Std.
9.70
52
dB HL
17.41
Std.
9.57
44
dB HL
8.44
Std.
6.71
1 month post-operative
17.17
10.39
52
18.59
10.27
44
9.38
7.53
3 month post-operative
15.66
8.63
52
16.88
8.63
44
8.91
4.88
12 month post-operative
17.03
10.24
50
18.11
10.25
43
10.36
7.83
AC
Air Conduction thresholds
Total (N=52)
dB HL
Std.
Adult (N = 44)
dB HL
Std.
Pediatric (N=8)
dB HL
Std.
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pre-operative
59.12
14.76
51
59.68
15.08
43
56.09
13.34
1 month post-operative
58.52
15.08
50
58.89
15.36
43
56.25
14.03
3 month post-operative
58.48
15.26
52
58.43
15.59
44
58.75
14.25
12 month post-operative
58.21
16.45
49
58.32
16.84
42
57.50
15.02
Figure 8: Mean residual Bone Conduction thresholds and area of standard deviation: pre-operative (dark grey), at
1 (green), 3 (yellow) and 12 (blue) months post-operatively for all subjects. The rectangular area (light grey) depicts the
indication range at 45 dB HL pre-operatively.
Subjective Device Satisfaction (secondary endpoints)
On average subjects were satisfied or very satisfied 3 months after the BB treatment (80.8 %) and this result remained
stable at the 12 month (80.2 %) post-operative appointment.
Only two adult subjects were just under 50 % satisfied at the 3 month evaluation time point (48.68 %, 48.75 %) with
both being more satisfied at the 12 month appointment (50 % ,67.11 %).
HDSS
Device Satisfaction
Total (N=52)
Adult (N = 44)
Pediatric (N=8)
3 month post-operative
80.80
Std.
12.61
44
79.40
Std.
12.30
37
88.50
Std.
12.29
12 month post-operative
80.20
10.93
39
79.60
10.52
36
87.90
15.43
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Safety
Adverse events were collected for all implanted subjects throughout the duration of the study. Adverse events were
classified as non-serious/serious, device/procedure related or unrelated. A total of 31 Adverse Events, one temporary
loss of residual hearing and one serious adverse event unrelated to the procedure or the device were reported up to
12 months after implantation.
The temporary loss of residual hearing was just 2.5 dB above the limit and was solved without treatment as the
residual hearing threshold recovered at a later time point. One serious adverse event unrelated to the device reports
on ear canal inflammation with subsequent cholesteatoma removal surgery and antibiotic treatment.
Eighteen adverse events occurring in 15 subjects were reported as related to either the device or the procedure, with
two reported as SADE (Device related Serious Adverse Events), 4 reported as device related Adverse Events and 12
reported as procedure related Adverse Events. One subject who experienced a SADE on skin infection and
subsequent explantation was excluded from the study analysis as the inclusion criteria were not met (the patient’s skin
was too thin already preoperatively).
Details on the type and number of device and procedure related adverse events can be found below:
Events Reported as Device- or Procedure-Related for No. of
53 subjects
Events
Itching at the implant side
Skin irritation at the implant side
Skin infection at the implant side
Headaches
Headaches and Skin irritation
Pain at the implant side
Pain at the implant side and skin infection
Pain due to post-operative scar formation
Occasional pain due to skin nerve cut
Postoperative subcutaneous seroma
Revision surgery to thin out the subcutaneous fascia.
Vertigo
Tinnitus
No. of
Subjects
% of
Subjects
1.89 %
5.66 %
3.77 %
1.89 %
1.89 %
3.77 %
1.89 %
1.89 %
1.89 %
1.89 %
1.89 %
1.89 %
1.89 %
% Re
solved
100 %
100 %
100 %
100 %
100 %
100 %
100 %
100 %
0%
100 %
100 %
100 %
100 %
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* Some subjects experienced more than one adverse event.
Part Six – Samba technical data
Dimensions
•
Primarily circular shape
•
Diameter ≤ 1.38 in. (battery compartment closed)
•
Height ≤ 0.43 in. (tallest point)
•
Weight ≤ 0.38 ounces (oz)
Material in tissue contact
•
Eastman Tritan Copolyester MX731
Power supply
•
Power supply of the audio processor:
One non-rechargeable 675 zinc-air button cell with a nominal 1.4-Volt supply and 600mA-Hrs of capacity
(IEC identifier: PR44)
Audio frequency range
•
250 Hz to 8 kHz
Signal processing
•
16-band Digital Equalizer
•
16 independent Compression Channels
•
Noise Reduction Control
•
Feedback Reduction
Controls
•
Remote control
•
Turn off the system by opening the battery compartment
Degrees of protection provided by enclosures
•
IP32
Operating Temperature
•
+5°C to +40°C
•
Relative humidity: 93 % max.
•
Atmospheric pressure: 70 to 106 kPa
Storage and shipping conditions
•
-25°C to +60°C
•
Relative humidity: 93 % max.
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Atmospheric pressure: 70 to 106 kPa
Removable parts
•
Cover
•
Magnet assembly
o Magnet lid
o Magnet
•
Battery (not inserted on delivery)
•
Attachment eyelet (has to be in place or can be replaced with the provided hair clips)
Wireless technology
Type:
NFMI (near field magnetic induction)
Frequency:
120 kHz
Modulation type:
Voice AM
Wireless range:
10 mm
Type:
NFMI (near field magnetic induction)
Frequency:
3.28 MHz
Modulation type:
FM
Wireless range:
1m
Quality of Service:
Once switched on, the Samba will automatically begin to transmit sound. When the Samba is magnetically attached to
the implant, the link is established.
The Bonebridge System has been tested for wireless device compatibility. According to ANSI C63.19:2011, the
Bonebridge System is in near field category M4.
To determine the system performance when a wireless device is present, obtain the near field category from the
wireless device, e.g. from the network operator or the wireless device manufacturer. Add the numerical part of the
near field category of the Bonebridge System and the wireless device. The result is interpreted as follows:
Hearing aid category (near field category of the Bonebridge System M4 = 4) + telephone category (M1 = 1) = 5:
Normal use
Hearing aid category (near field category of the Bonebridge System M4 = 4) + telephone category (M2 = 2) = ≥ 6:
Excellent performance
Security:
The Bonebridge System wireless technology is secure because:
•
No patient specific information is stored inside the Bonebridge implant.
•
The wireless link of the Bonebridge System is merely 10 mm (0.39 in.) so any intruder to the Bonebridge
system is required to be in very close range
FCC ID: VNP-WL700
NOTICE: This device complies with Part 15 of the FCC Rules. 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:
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Changes or modifications made to this equipment not expressly approved by (manufacturer name) may void the FCC
authorization to operate this equipment.
Symbols
Caution
Refer to instructions for use.
Information relevant for parents of implanted children
Type BF (IEC 60601-1 / EN 60601-1): The bottom surface of the Samba, which is in contact
with the patient, is a Type BF Applied Part.
Manufacturer
Serial number
Catalogue number
Temperature limit
Humidity limitation
MR conditional
MR unsafe
Protected against solid objects over 2.5 mm in diameter e.g. tools. Protection against water
drops falling vertically over a 15° range.
CE Mark, applied in 2015 (0123 is the TÜV SÜD notified body code)
Non-ionizing radiation (refer to Guidance and manufacturer’s declaration Table 4)
Indicator for right side application
Indicator for left side application
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Guidance and manufacturer’s declaration
Tables according to IEC 60601-1-2
Table 1
Guidance and manufacturer’s declaration – electromagnetic emissions
The Samba is intended for use in the electromagnetic environment specified below. The customer or the
user of the Samba should assure that it is used in such an environment.
Emissions test
Compliance
Electromagnetic environment – guidance
RF emissions
Group 1
The Samba uses RF energy only for its internal
function. Therefore, its RF emissions are very low
and are not likely to cause any interference in
nearby electronic equipment.
Class B
The Samba is suitable for use in all establishments,
including domestic establishments and those directly
connected to the public low-voltage power supply
network that supplies buildings used for domestic
purposes.
CISPR 11
RF emissions
CISPR 11
Harmonic emissions
IEC 61000-3-2
Voltage fluctuations/
flicker emissions
IEC 61000-3-3
Not applicable
Not applicable
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Table 2
Guidance and manufacturer’s declaration – electromagnetic immunity
The Samba is intended for use in the electromagnetic environment specified below. The customer or the
user of the Samba should assure that it is used in such an environment.
IMMUNITY test
IEC 60601
Compliance level
Electromagnetic environment –
guidance
Floors should be wood, concrete or
ceramic tile. If floors are covered
with synthetic material, the relative
humidity should be at least 30 %.
test level
Electrostatic
± 6 kV contact
± 6 kV contact
discharge (ESD)
± 8 kV air
± 8 kV air
IEC 61000-4-2
Electrical
transient/burst
fast ± 2 kV for power Not applicable
supply lines
IEC 61000-4-4
±
kV
for
input/output lines
Surge
± 1 kV line(s) to
IEC 61000-4-5
line(s)
Mains power quality should be that
of a typical commercial or hospital
environment.
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
Not applicable
Mains power quality should be that
of a typical commercial or hospital
environment.
± 2 kV line(s) to
earth
Voltage
dips,
short <5 % UT
interruptions and voltage
(>95 % dip in UT)
variations on power
supply input lines
for 0.5 cycle
If the user of the Samba requires
continued operation during power
mains
interruptions,
it
is
recommended that the Samba be
powered from an uninterruptible
power supply or a battery.
IEC 61000-4-11
40 % UT
(60 % dip in UT)
for 5 cycles
70 % UT
(30 % dip in UT)
for 25 cycles
<5 % UT
(>95 % dip in UT)
for 5 s
Power frequency
(50/60 Hz)
magnetic field
IEC 61000-4-8
NOTE
3 A/m
3 A/m
Power frequency magnetic fields
should be at levels characteristic of
a typical location in a typical
commercial
or
hospital
environment.
UT is the a.c. mains voltage prior to application of the test level.
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Table 4
Guidance and manufacturer’s declaration – electromagnetic immunity
The Samba is intended for use in the electromagnetic environment specified below. The customer or the
user of the Samba should assure that it is used in such an environment.
IMMUNITY test
IEC 60601 TEST Compliance
LEVEL
level
Electromagnetic
guidance
environment
–
Portable
and
mobile
RF
communications equipment should be
used no closer to any part of the
Samba, including cables, than the
recommended
separation
distance
calculated from the equation applicable
to the frequency of the transmitter.
Recommended separation distance
Conducted RF IEC 61000- 3 Vrms
3V
4-6
150 kHz to 80 MHz
 3.5 
d =
 ∗ P
 V1 
Radiated RF IEC 61000-4- 3 V/m
80 MHz to 2.5 GHz
 3.5 
 ∗ P
d =
 E1 
3 V/m
80 MHz to 800 MHz
 7 
d =   ∗ P
 E1 
800 MHz to 2.5 GHz
where P is the maximum output power
rating of the transmitter in watts (W)
according
to
the
transmitter
manufacturer
and
is
the
recommended separation distance in
metres (m).
Field
strengths
from
fixed
RF
transmitters, as determined by an
electromagnetic site survey, should be
less than the compliance level in each
frequency range.
Interference may occur in the vicinity of
equipment marked with the following
symbol:
NOTE 1 At 80 MHz and 800 MHz, the higher frequency range applies.
NOTE 2 These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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Field strengths from fixed transmitters, such as base stations for radio (cellular/cordless)
telephones and land mobile radios, amateur radio, AM and FM radio broadcast and TV broadcast
cannot be predicted theoretically with accuracy. To assess the electromagnetic environment due to
fixed RF transmitters, an electromagnetic site survey should be considered. If the measured field
strength in the location in which the Samba is used exceeds the applicable RF compliance level
above, the Samba should be observed to verify normal operation. If abnormal performance is
observed, additional measures may be necessary, such as re-orienting or relocating the Samba
Over the frequency range 150 kHz to 80 MHz, field strengths should be less than 3 V/m.
Table 6
Recommended separation distances between
portable and mobile RF communications equipment and the Samba
The Samba is intended for use in an electromagnetic environment in which radiated RF disturbances are
controlled. The customer or the user of the Samba can help prevent electromagnetic interference by
maintaining a minimum distance between portable and mobile RF communications equipment (transmitters)
and the Samba as recommended below, according to the maximum output power of the communications
equipment.
Rated maximum
output power of
transmitter
Separation distance according to frequency of transmitter
150 kHz to 80 MHz
80 MHz to 800 MHz
800 MHz to 2.5 GHz
 3.5 
 ∗ P
d =
 V1 
 3.5 
 ∗ P
d =
 E1 
 7 
d =   ∗ P
 E1 
0.01
0.12
0.12
0.23
0.1
0.37
0.37
0.74
1.17
1.17
2.33
10
3.69
3.69
7.38
100
11.67
11.67
23.33
For transmitters rated at a maximum output power not listed above, the recommended separation distance d
in metres (m) can be estimated using the equation applicable to the frequency of the transmitter, where P is
the maximum output power rating of the transmitter in watts (W) according to the transmitter manufacturer.
NOTE 1
At 80 MHz and 800 MHz, the separation distance for the higher frequency range applies.
NOTE 2
These guidelines may not apply in all situations. Electromagnetic propagation is affected by
absorption and reflection from structures, objects and people.
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Part Seven – The remote control
Table of contents
Your remote control
Overview
Display
Power save mode
Control buttons
Key lock switch
Wireless compatibility between your Samba audio processor and the remote control
Batteries
Inserting batteries
Checking the battery status
Daily use
Adjusting the volume
Changing the hearing program
Turning on and off (mute)
Alarm clock
Setting the alarm
Ending the alarm
Turning the alarm clock off
Setup and service functions
Setting the time
Resetting volume and hearing program
Maintenance and care
Troubleshooting
Important Information
Intended use
Explanation of symbols
Disposal information
Technical information
Important safety information
Personal safety
Product safety
Your remote control
Your hearing instrument (your Samba audio processor) is equipped with wireless technology and can therefore be
controlled by a remote control.
The operating distance of the remote control is approximately 1 meter (40 in.).
 Make sure the distance between your remote control and your audio processor does not exceed the operating
distance.
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CAUTION
Read this user guide thoroughly and completely and follow the safety information in this
document to avoid damage or injury.
Overview
 Display
 Key lock switch
 Control buttons
 Program change button
 Volume up/down buttons
More functions are available in the menu. To enter or exit the menu, press the volume up button and
the volume down button simultaneously.
Display
All actions initiated with the remote control are immediately reflected on the display.
The remote control does not receive information from your hearing instruments. All actions that you initiate with the
controls of your hearing instruments are not reflected on the remote control’s display.
 Indicates change of volume
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 Indicates change of hearing program
 Alarm clock is activated
 Batteries of the remote control are low
 Function of control buttons
Power save mode
If the remote control is not used for some time, the display automatically turns black. The remote control is then in its
power save mode.
 Press the program change button to activate the display again.
Control buttons
You can quickly access two functions with the control buttons on the right hand side
of the remote control.
Basic functions:
Turn hearing instruments on or off.
Reset to default volume and hearing program.
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Key lock switch
To prevent any accidental operation while the remote control is in pockets or bags,
move the key lock switch to lock position (red color visible).
When the key lock is active, all buttons on the remote control are disabled. The
following icon is displayed.
Wireless compatibility between your Samba audio processor and the remote control
A good functionality of the wireless connection between your Samba audio processor and the remote control depends
to a great extent on the orientation of both devices. If you experience problems when using the remote control, try the
following recommendations:
•
Hold the remote control as close as possible to your body and on the body side where you wear your Samba.
•
Turn the remote control a little in such a way that the display and the buttons are not facing straight upwards
but that they are facing slightly to the left or to the right until the wireless connection is established.
•
In some cases, it could help to decrease the distance between the remote control and your Samba.
•
Do not cover the upper part of the remote control with your fingers or hand.
When the wireless connection is established, you can operate your Samba.
Batteries
The remote control uses two AAA batteries.
Inserting batteries
Slide the battery compartment cover in the direction of the arrow.
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Insert the batteries.
Make sure the "+" symbols on the battery and the compartment are aligned.
Attach the cover by sliding it onto the remote control.
The current time setting is displayed. If you want to change it, refer to section "Setting the time".
Checking the battery status
When the batteries of the remote control are low, this is indicated in the status bar.
Additionally, you can check the battery status at any time in the menu.
 To enter the menu, press the volume up button and the volume down button simultaneously.
 Navigate to the menu entry Info by pressing the volume up button or the volume down button.
 Confirm your selection by pressing the program change button.
The battery status is displayed:
battery full
battery empty
 To return to the standard display, press the program change button.
Remove empty batteries immediately and dispose of them according to local regulations.
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Daily use
Adjusting the volume
If you are wearing two hearing instruments (in this case two Samba audio processors), the volume will be adjusted on
both instruments at the same time.
 Press the volume up button or the volume down button to adjust the volume by one step.
Changing the hearing program
If you are wearing two hearing instruments, the hearing program will be changed on both instruments.
 Press the program change button to switch to the next hearing program.
Turning on and off (mute)
You have several options to turn your hearing instruments on and off with your remote control. Both hearing
instruments are simultaneously turned on or off.
When you turn your hearing instrument off via remote control, the following icon is
displayed. It is displayed until you turn your hearing instrument back on.
After turning on, the previously used volume and hearing program are set.
Turning off via control button
Press the control button next to the following icon to turn your hearing instrument
on or off.
Turning on:
 To turn your hearing instruments back on, press any key or move the key lock switch to unlock position (green color
visible).
Alarm clock
You can set an alarm clock reminding you at the same time every day by a repeating signal tone and by an alarm
clock icon.
The alarm is initiated by the remote control but the acoustic signal is emitted by your hearing
instrument.
 Turn on your hearing instrument.
 Keep your hearing instrument within the remote control’s operating distance.
Otherwise you will not be able to hear the alarm.
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Setting the alarm clock
 To enter the menu, press the volume up button and the volume down button
simultaneously.
 Navigate to the menu entry Alarm by pressing the volume up button or the
volume down button.
 Confirm your selection by pressing the program change button. The entry field
for hours is highlighted.
 Set the hours by pressing the volume up button or the volume down button.
 Confirm your setting by pressing the program change button. The entry field for
minutes is highlighted.
 Set the minutes by pressing the volume up button or the volume down button.
 Confirm your setting by pressing the program change button. The alarm on/off
selection field is highlighted.
 Press the volume up button or the volume down button to position the cursor
next to alarm clock on:
 Confirm your selection by pressing the program change button.
When the alarm clock is turned on, this is indicated in the status bar.
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Ending the alarm
When the alarm clock rings, a corresponding icon is displayed on the remote
control.
If you do not end the alarm, it is repeated within the next minutes.
 To end the alarm, press the program change button.
The alarm clock will ring at the same time on the next day.
Turning the alarm clock off
 To enter the menu, press the volume up button and the volume down button
simultaneously.
 Navigate to the menu entry Alarm by pressing the volume up button or the
volume down button.
 Confirm your selection by pressing the program change button. The entry field
for hours is highlighted.
 Press the program change button twice to skip the entry fields for hours and
minutes. The alarm on/off selection field is highlighted.
 Press the volume up button or the volume down button to position the cursor
next to alarm clock off:
 Confirm your selection by pressing the program change button.
Setup and service functions
Setting the time
 To enter the menu, press the volume up button and the volume down button
simultaneously.
 Navigate to the menu entry Clock by pressing the volume up button or the
volume down button.
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 Confirm your selection by pressing the program change button. The entry field
for hours is highlighted.
 Set the hours by pressing the volume up button or the volume down button.
 Confirm your setting by pressing the program change button. The entry field for
minutes is highlighted.
 Set the minutes by pressing the volume up button or the volume down button
 Save the settings by pressing the program change button.
The time is displayed.
The time is always displayed in the header of the menu. To enter or exit the
menu, press the volume up button and the volume down button simultaneously.
Resetting volume and hearing program
If you have made changes to volume or program and do not know why the hearing instruments are acting the way
they are, you can manually set the default volume and hearing program for your hearing instruments.
You can reset the hearing instruments by pressing the control button next to the following
icon.
Maintenance and care
NOTICE
 Do not put your remote control in water!
 Do not clean your remote control with alcohol or
benzine.
 Clean the remote control as necessary with a soft cloth and use a nonabrasive household soap.
 Avoid abrasive cleaning liquids with additives such as citric acid, ammonia, etc.
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Troubleshooting
Problem and possible solutions
The remote control does not work.
•
Check, if the key lock is activated. Deactivate it, if necessary.
•
Change the batteries.
Another remote control affects your hearing instruments.
•
Return remote control and hearing instruments to your Hearing Care Professional. Your Hearing Care
Professional can change the wireless address to avoid interference.
Consult your Hearing Care Professional if you encounter further problems.
Important information
Intended use
The remote control is intended to operate hearing instruments (i.e. Samba audio processor).
Use the remote control only as described in this user guide.
Explanation of symbols
Points out a situation that could lead to serious, moderate, or minor injuries.
Indicates possible property damage.
Advice and tips on how to handle your device better.
Disposal information
NOTICE
 Recycle hearing instruments, accessories and packaging according to national regulations.
NOTICE
 To avoid environmental pollution, do not throw batteries into household trash.
 Recycle or dispose of batteries according to national regulations or return them to your Hearing
Care Professional.
Technical information
MED-EL remote control
Operating frequencies: Fc=3.28 MHz
Maximum field strength @ 10m: -7 dBμA/m
Maximum field strength @ 30m: 28.5 dBμV/m
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Important safety information
Personal safety
WARNING
Choking hazard!
Your device contains small parts which can be swallowed.
 Keep hearing instruments, batteries and accessories out of reach of children and mentally
disabled persons.
 If parts have been swallowed consult a physician or hospital immediately
WARNING
Risk of injury!
 Do not use obviously damaged devices and return them to point of sale.
WARNING
Note that any unauthorized changes to the product may cause damage to the product or cause
injury.
 Use only approved parts and accessories. Ask your Hearing Care Professional for support.
WARNING
Risk of affecting electronic equipment!
 In areas where the use of electronics or wireless devices are restricted, verify if your device has to
be turned off.
WARNING
Wireless systems may interfere with measuring devices and electronic equipment.
 Do not use your device in hospitals or airplanes.
WARNING
Risk of interference with active implants or life support systems!
If you wear a pacemaker:
 Carry the remote control at a safe distance of about 30 cm (12 in.) away from the pacemaker.
 Do not carry the remote control:
•
in your breast pocket,
•
with a lanyard around your neck,
•
or directly on the skin over the active implant.
For all other active implants or life support systems:
 Prior to use, have the electromagnetic compatibility verified.
WARNING
Risk of explosion!
 Do not use your remote control in explosive atmospheres (e. g. in mining areas).
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Radiofrequency radiation exposure information
The radiated output power of the device is far below the FCC radio frequency exposure limits.
Nevertheless, the device shall be used in such a manner that the potential for human contact during
normal operation is minimized.
Product safety
NOTICE
 Protect your devices from extreme heat. Do not expose them to direct sunlight.
NOTICE
 Protect your devices from high humidity.
NOTICE
 Do not dry your devices in the microwave oven.
NOTICE
Different types of strong radiation, e. g. during X-ray or MRI head examinations, may damage
devices.
 Do not use the devices during these or similar procedures.
Weaker radiation, e. g. from radio equipment or airport security, does not damage the devices.
In some countries restrictions for the usage of wireless equipment exist.
 Refer to local authorities for further information.
NOTICE
Your hearing instruments are designed to comply with international standards on electromagnetic
compatibility but interference with nearby electronic devices could occur. In this case, move away
from the source of interference.
NOTICE
 Your remote control is programmed to exclusively communicate with your hearing instruments. If
you experience problems with another person's remote control, consult your Hearing Care
Professional.
Please help us to improve the quality of this manual by making any suggestions or for further information regarding the
use of this MED-EL product, or to report any problems, please contact:
MED-EL Elektromedizinische Geräte GmbH
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Fürstenweg 77a
6020 Innsbruck
Austria
www.medel.com
or call +43 5 77 88
MED-EL Corporation, USA
2511 Old Cornwallis Road, Suite 100
Durham, NC 22713, USA
implants.us@medel.com
1-888-633-3524
Conformance Information
With the CE marking MED-EL confirms compliance with the European Directive 90/385/EEC concerning active
implantable medical devices and the European Directive 99/5/EC (R&TTE) concerning radio and telecommunications
terminal equipment.
MED-EL Elektromedizinische Geräte GmbH
Fürstenweg 77a
6020 Innsbruck
Austria
Distributed by:
MED-EL Corporation, USA
2511 Old Cornwallis Road, Suite 100
Durham, NC 22713, USA
implants.us@medel.com
1-888-633-3524
CAUTION: Federal law restricts this device to sale by or on the order of a physician or audiologist.
Copyright information:
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© 2017 MED-EL Elektromedizinische Geräte GmbH. Revision 0.2 (February 2017). All rights reserved.
The Bonebridge System is manufactured in Austria. Bonebridge, BCI, Samba and SYMFIT are trademarks of MED-EL
Elektromedizinische Geräte GmbH.
NOAHlink and NOAH are trademarks of Hearing Instrument Manufacturers Software Association (HIMSA A/S).
Hi-Pro is a trademark of GN Otometrics A/S.
CONNEXX and miniTEK are manufactured by Sivantos GmbH under Trademark License of Siemens AG.

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