d104096 rev m surgical training manual pdf
TRANSCRIPT
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MET Fully-Implantable Ossicular Stimulator D104096 M
Surgical Training Manual Page 1 of 69Otologics Confidential
Otologics LLCIn United States currently in Clinical Trials
CAUTION: Investigational Device. Limited by Federal Law (USA) to Investigational Use.
In Europe CE Marked
SURGICAL TRAINING MANUAL
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Contact Information
Worldwide Headquarters
Otologics LLC
5445 Airport BlvdBoulder, CO 80301US Tel: +1 (303) 448-9933
US Fax: +1 (303) 448-9955
EU Tel: +33 4 92 92 52 00
Website: www.otologics.com
E-Mail: [email protected]
E-Mail: [email protected]
European Representative
AR-MED Ltd
Runnymede Malthouse
Egham TW20 9BD
United Kingdom
Product: METTM (Middle Ear Transducer) Fully Implantable Ossicular Stimulator
Document: Surgical Training ManualDocument No: D104096
Copyright 2007 Otologics LLCNo part of this manual may be reproduced without permission.
All trademarks used in text are property of their respective owners.
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Contents
INTRODUCTION......................................................................................................................................... 4
OTOLOGISTS TRAINING FOR THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR..... 4
MET OSSICULAR STIMULATOR DESCRIPTION.................................................................................... 5
CANDIDACY CRITERIA............................................................................................................................. 8Technical Specifications.........................................................................................................................................9Implant....................................................................................................................................................................9Charger System.......................................................................................................................................................9Transducer Loading Assistant...............................................................................................................................10Remote..................................................................................................................................................................10Programming System............................................................................................................................................10
NEW IMPLANTATION OF THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR - FIMOS. 11Step 1: Pre-Surgical Implant Preparation.............................................................................................................12Step 2: Making the Incision .................................................................................................................................13Step 3: Drilling the Atticotomy............................................................................................................................14Step 4: Positioning the Mounting Bracket ...........................................................................................................15Step 5: Fastening the Mounting Bracket ..............................................................................................................19Step 6: Creating the Laser Hole ...........................................................................................................................20Step 7: Preparing the Bone Beds and Lead Channels ..........................................................................................22Step 8: Placing the MET Ossicular Stimulator ....................................................................................................23Step 9 Loading the MET Ossicular Stimulator and Diagnostics...........................................................................25Step 10: Attaching the Electronics Capsule to the Transducer .............................................................................27Step 11. Securing the Electronics Capsule and Closing the Incision...................................................................30Step 12. Post Surgical Care and Activation .........................................................................................................32
UPGRADE IMPLANTATION FROM THE SEMI-IMPLANTABLE OSSICULAR STIMULATOR (SIMOS)TO THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS)....................................... 33
Step 1: Pre-Surgical Preparation for the SIMOS to FIMOS Implantation............................................................34Step 2: Making the Incision and Removal of the Semi-Implantable Electronics.................................................35Step 3: Connector Disassembly ...........................................................................................................................36Step 4: Attaching the Electronics Capsule to the Transducer ...............................................................................37Step 5: Enlarging the Bone Bed for the Electronics Capsule, Pendant Microphone, and Closing.......................40Step 6: Post Surgical Care and Activation ...........................................................................................................41
SURGICAL STEPS FOR REPLACING THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR(FIMOS) WITH THE FULLY-IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS).................... 42
Step 1: Pre-Surgical Preparation for FIMOS to FIMOS Surgery .........................................................................43Step 2: Making the Incision and Removal of the FIMOS Electronics Capsule ...................................................44Step 3: Connector Disassembly ...........................................................................................................................45Step 4: Attaching the New FIMOS Electronics Capsule to the Old Transducer...................................................46
Step 5: Securing the Electronics Capsule, Pendant Microphone, and Closing ....................................................49Step 6: Post Surgical Care and Activation ...........................................................................................................50
APPENDICES........................................................................................................................................... 52Appendix 1: Otologics Surgical Equipment ........................................................................................................52Appendix 2: Troubleshooting an Implanted Device During Surgery ..................................................................57Appendix 3: Surgical Training Checklist.............................................................................................................58Appendix 4: Surgical Revision Training Checklist .............................................................................................64Appendix 5: Surgical Procedure Step By Step ....................................................................................................66
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INTRODUCTION
This manual describes the surgical procedure for the
implantation of the MET Fully-Implantable
Ossicular Stimulator, both for a new implantationand for an upgrade implantation from the MET
Semi-Implantable Ossicular Stimulator. Before
implanting the device for the first time, the
implanting surgeon and clinical staff responsible forthe implantation must participate in a surgical course
provided by Otologics, LLC and obtain certification.
Certification training consists of a temporal bone
course review of the Otologics device, surgical tools,and surgical procedure. An Otologics
representatives presence is mandatory for at least
the first two implantations. Surgical/Hospital stafftraining is also provided by Otologics. In addition to
this manual, there is a surgical video available. It is
strongly recommended that surgeons review this
video before performing surgery.
The surgical steps section of this manual gives keypoints and detailed steps to follow when implanting
the device. Pictures and descriptions of the required
surgical tools are included in each step. Safetyinstructions are also listed with each step. The
Appendices contain detailed drawings of the surgical
kits and instructions in case corrective action isrequired during the surgery.
At the fitting, the patient also receives instructions
on the use of the MET Fully-Implantable OssicularStimulator and its accessories, the Charger system
and Remote Control.
OTOLOGISTS TRAINING
FOR THE FULLY-
IMPLANTABLE MET
OSSICULAR STIMULATOR
The objective of the Otologists Training is toprovide an effective and consistent method for
training otologists so they can perform the
implantation of the MET Ossicular Stimulatorsuccessfully. Only otologists should be performing
the implantation procedure and receiving the
Otologists Training for the MET Ossicular
Stimulator.
In order to accomplish this objective, the following
protocol has been created:
1. Each implanting Otologic surgeon will gothrough an information protocol and hands on
training including information on:
a. the Otologics device
b. the Otologics surgical instrumentsc. the Otologics implantation procedure
2. An Otologics Representative will review theabove information through a temporal bone
session or a half skull model demonstration,after which a surgical training checklist is
completed and signed. This review session must
be successfully completed before the firstimplantation surgery and returned to Otologics.
3. Two tools have been created to assist in thetraining session:
a. The Otologics Surgical TrainingManual (D104096 This manual)
b. The Surgical Procedure TrainingChecklist and Signature Page(Appendix 3)
NOTE: If more than six months passes without
participation in a MET Ossicular Stimulator
implantation surgery, the otologist will be
required to go through another review session
with an Otologics Representative to review the
tools and procedure and to be updated on any
new information. The review core will consist of,
at a minimum:
1. A review of the tools and procedure using ahalf skull model and the actual surgicaltools. An additional temporal bone session
can be scheduled, if requested.
2. The Surgical Procedure Checklist will befilled out in full and signed again.
3. Any new information will be reviewed indetail
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MET OSSICULAR STIMULATOR DESCRIPTION
The MET Fully-Implantable Ossicular Stimulator is
a fully implantable device intended for patients withmoderate to severe sensorineural hearing loss. The
device is designed to eliminate the receiver found in
conventional hearing aids and drive the ossicles
directly. The potential benefits include eliminatingouter ear canal occlusion, improving sound quality,
and providing greater gain without feedback for
optimal speech recognition.
DESCRIPTION:
The Otologics MET Fully-Implantable Ossicular
Stimulator consists of four primary components: theimplant, the programming system, the charger, and
the remote control. The implant component of the
MET Fully-Implantable Ossicular Stimulator
consists of two primary parts: the electronics capsule
and the Middle Ear Transducer (Figure 1). Theelectronics capsule contains the microphone, battery,
magnet, digital signal processor and connector.
Figure 1
Sounds are picked up by a sensitive microphone,
amplified according to the wearers needs, andconverted into an electrical signal. The signal is sent
down the lead and into the transducer. The tip of the
MET Fully-Implantable Ossicular Stimulator
transducer is mounted in a laser-drilled hole in the
body of the incus. Thetransducer translates theelectrical signals into a mechanical motion that
directly stimulates the ossicles and enables thewearer to perceive sound.
For upgrading from the MET Semi-ImplantableOssicular Stimulator to the MET Fully-Implantable
Ossicular Stimulator (not approved in the US), the
size of the bone bed is increased to accommodate thefully implantable electronics capsule, which is then
attached to the transducer. The fully implantable
electronics capsule is secured, and the wound isclosed. Two to six weeks after surgery and medical
clearance the device can be programmed and
activated.
The Otologics Programming System (Figure 2)
consists of fitting and diagnostic software, a radiofrequency coil that, when placed over the implant
site, magnetically adheres to the side of the wearers
head, and the NOAHlink programming interface,
which is worn around the neck. Using OtoFitFitting Software, the NOAHlink interface receives
signals from the computer through the wireless
connection and sends the signals to the implant viathe radio frequency coil.
Programming the implant is done in the same
manner as programming traditional digital hearingaids. In addition, the Otologics Programming System
provides the ability for extensive testing and
diagnostics of the MET Fully-Implantable Ossicular
Stimulator.
Figure 2The charger system consists of the base station,
charging coil, and charger body. To charge the
implant, the wearer removes the charger body from
the base station and places the coil on the skin, over
the implant site (Figure 3). The charger bodycontains a clip that allows the charger to be attached
to the belt or waistband of the wearer duringcharging (Figure 4). Typically, charging time will be
about one hour if performed daily. While rechargingthe implant, the wearer can perform normal daily
activities, turn the implant on and off, and adjust the
volume.
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Figure 3
Figure 4
A remote is used for controlling the MET Fully-
Implantable Ossicular Stimulator when the device is
not being charged. The remote allows the wearer toturn the implant on and off, and to adjust the volume.
To use the remote control, the wearer simply holds
the remote against the skin over the implant (Figure
5).
Figure 5
SURGERY OVERVIEW:
The transducer is implanted through an extended
atticotomy approach that exposes the incus body andmalleus head and is intended to minimize thesurgical risk. This technique circumvents any need
to dissect close to the facial and chorda tympani
nerves, associated with the facial recess approach.
The implant surgery is a relatively simple procedure
and not difficult in practiced hands. It does require a
set of proprietary surgical instruments. The
instruments are detailed in Appendix 1 of thismanual. Also, each surgical step lists the
instruments required for that step and has pictures
where applicable.
The basic steps of the surgery are as follows: non-
sterile preparation, patient preparation and incision,
atticotomy drilling, mounting bracket placement,laser hole creation, device placement and closing.
The surgery, from opening incision to closing,
typically can take up to 2-2.5 hours for surgeons
familiar with the procedure.
Upgrading a wearer who already has the semi-
implantable device to a fully-implantable device is
approved in the EU, This procedure is not approvedfor the US Clinical Trial. This is a simple surgical
procedure which may be performed under local
anesthesia. To upgrade, the semi-implantableelectronics capsule is disconnected from the
transducer via the IS-1 connector, leaving the
transducer and mounting bracket in place.
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PROCEDURAL RISKS:
The implantation of the MET Fully- Implantable
Ossicular Stimulator requires a surgical procedure
involving removal of tissue and bone. As with anysurgical procedure involving a general anesthetic,
certain risks exist.
Risks that may occur during surgery:The risks involved in surgery and complicationsrelated to surgery include the normal risks of the
operative procedure and general anesthesia. Theseinclude pain, blood clots, and/or circulatory problems,infection, cardiac arrest, cholesteatoma, and even
death. Specific risks related to operating on themastoid include infection, inflammation, numbness orstiffness about the ear, disturbance of taste or balanceand noticeable change in head noise.
The potential risks related to inserting the implantinclude disarticulation of the ossicles and increased
pressure on the ossicular chain. Increased pressure
during insertion may cause damage to the inner earand increased hearing loss.
Risks that may occur after surgery:Potential risks after surgery include inflammation,facial paralysis and perilymph fistula with the
possible development of meningitis, tinnitus andcomplications associated with general anesthesia.Other postoperative problems to consider arelabyrinthitis, vertigo, puncture or displacement of the
eardrum, and otitis media.
Potential risks related to the implant followingsurgery include infection, reparative granuloma and
inflammatory reaction.
It is possible that dislocation of the implant, a reactionto the implant materials, and/or failure of theimplanted device can occur and may necessitate anoperation to remove and/or replace the implant.
SAFETY INSTRUCTIONS HIGHLIGHTED INTHIS MANUAL
Important Information!
Special information that supports correct handling of
the implants components and helps avoid
operational errors is denoted as importantinformation and printed in italics.
Important Information!
This is an example of information that helps avoid
intraoperative errors.
CAUTION!Important information that helps prevent damage
occurring to the implants components is signaled by
the word CAUTION! and printed in bold type.
CAUTION!
This is an example that helps avoid damaging the
implants components.
DANGER:
If the instructions have to be followed strictly to
exclude the possibility of damage or injury to the
MET Ossicular Stimulator, patient or to a third party,
this is signaled by the word DANGER and framed
for emphasis.
DANGER:
This is an example of instructions that help avoid
damage to the implant or injury to the patient.
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CANDIDACY CRITERIA
Selection Criteria for the MET Fully-
Implantable Ossicular Stimulator1
18 years of age or older
Bilateral moderate to severe sensorineuralhearing loss within the Candidacy Audiogram
range shown below2 (Figure 6)
Unaided NU-6 or W-22 score 40% at 80 dBHL or 40 dB SL in the ear to be implanted
Post linguistic onset of hearing loss
Non-fluctuating, stable hearing loss
Normal middle ear anatomy
Realistic expectations for the middle ear implant
3 months experience over the past year withappropriate hearing aids (either binaural
amplification or a monaural fitting in the ear tobe implanted).3 (Note: This criteria applies to
the US Clinical Trial only.)
1 See Audiologists Manual for further detailed informationon candidacy.2 Moderate to severe loss is defined in terms of the puretone average (PTA) at three frequencies; 500, 1000, and2000 Hz or a high frequency pure tone average (HFPTA =average of 1000, 2000, 3000, and 4000 Hz) of 40-80 dB HL.3 The hearing aid(s) meet the insertion gain prescriptivetarget for an appropriate prescriptive formula for the hearingaid circuitry within 10 dB at 500, 1000, and 2000 Hz andwithin 15 dB at 4000 Hz for a 70-dB SPL input signal.
0
20
40
60
80
100
0.25 0.5 1 1.5 2 3 4 6
Frequency [kHz]
Hearing
loss[dBH
L]
Figure 6
Contraindications
Vestibular disorder, including MenieresDisease
Osteodegenerative disorders, including PagetsDisease
Middle ear pathology, including a history ofrecurrent otitis media
Conductive or mixed hearing loss4(Note: This
applies to the US Clinical Trial only. Patientswith a MEI in the contra lateral ear or patients
that are to be upgraded from the Otologics
semi-implantable device to the fully-implantable
device will often exhibit conductive components)
Non-organic hearing loss
Retrocochlear hearing loss / central auditorynervous system disorder
Pre-linguistic onset of hearing loss
Medical contraindications to surgery or use ofthe device
4 Air-bone gap no greater than 10 dB, 500-4000 Hz
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Technical Specifications
Implant
Figure 7
Nominal Operating Parameters
Battery life: > 5 years
Battery recharge time: 60 minutes (typical for dailycharge)
Battery recharge frequency: Daily (up to 3 days
possible, but longer recharging time needed)
Peak Output: 121 dB MET Frequency Range: < 200 to 6250 Hz
Processor Type: 12 Band, 2 Channel Digital
Processor Materials: Biocompatible titanium, gold, ceramic,
epoxy, silicone elastomer, platinum-iridium alloy,
ruby
Connector Technology: IS-1
Charger System
Figure 8
Charger Body recharges implant battery
Charger Base recharges Charger Bodybattery
Turns implant on and off
Adjusts implant volume control
Implant functions normally during batterycharging
Charger battery life: > 5 years
Charging Coil
Charger Body
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Transducer Loading Assistant
Assists the surgeon in loading the
transducer by providing an indication of tip
contact Monitors current to the transducer to
determine tip contact
Powered via USB from the computer thatshows graphical loading information
Remote
Figure 9
Turns implant on and off
Adjusts implant volume
Range: Skin contact
Keychain sized
Programming System
Performs diagnostics to assess implant andbattery status
Programs implant according to hearing
needs of the wearer with flexibility to adjustgain, compression, and crossover frequency
Uses OtoFit Fitting Software inconjunction with NOAHlink.
Figure 10
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NEW IMPLANTATION OF THE FULLY-IMPLANTABLE MET
OSSICULAR STIMULATOR - FIMOS
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Step 1: Pre-Surgical Implant Preparation
Required Equipment Purpose
Implant To charge prior to implantation
Charger System For charging implant prior to implantation
Important Information!The MET Fully-Implantable Ossicular Stimulator must be charged prior to surgery. This should be done the day
before surgery.
Charging the Implant:
Plug in the Charger Base Station, and make sure that the Base Station indicator light is green, verifying that the
charger system is connected to a power source.
Confirm that the charging system is fully charged by checking to see if the charger power indicator is green.
(The charger indicator is the light on the far left side of the charger). A full recharge time for the charger body
is 6 hours.
To charge the implant, place the charging coil over the implant while it is still in its sterile packaging. The
charging will take place through the sterile packaging. Fully charging an implant can take up to 3 hours
(Figure 11). Once the implant is fully charged the Implant charger indicator will turn green. (The Implant
charger indicator is the light on the far right side of the charger.) Consult the Charger User Guide foradditional information (D105809).
Figures 11. Charging through the external packaging or through the internal packaging
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Step 2: Making the Incision
Required Equipment Purpose
Capsule Template (included in MET-1050) Determine size of incision required to allow placement
Key points:
1. Ensure that the incision is large enough to permit placement of the electronics capsule.2. Make the incision so that the Charging Coil will not rest directly on it.
Important Information!Review of a CT Scan taken prior to surgery is helpful to indicate the width of the attic space. The transducer is
6 mm in width and at least this much width is required for implantation of the device.
Prior to Surgery:
Prior to surgery an implant model or capsuletemplate is used to identify the optimal implant
placement and location of the incision. See dottedline in Figure 12. The optimal position of the
implant capsule typically lies between lines of 30
and 90 degree angle relative to the horizontal with
the silicone charging coil superior to the titanium
capsule body (see Figure 12) and where the capsuleand coil will sit flat on the patients skull. Although
the implant capsule and coil have been designed
for long term implantation, care must be takenwhen inserting the coil into a tissue pocket.
Excessive manipulation or bending of the coil can
damage it. In addition, the coil should be placed
such that it is not bent more than 10 relative to theimplant capsule.
Prior to starting the surgery, an implant template
can be placed over the skin and a sterile penmarker used to trace the shape of the implanttemplate. Then, the incision line can be drawn with
the sterile pen to assist in making sure the incision
will avoid the electronics and the MET Fully-Implantable Ossicular Stimulator.
Preoperative Preparation of the Patient:
Place the patient on the operating room table in the
standard manner for otologic surgery. Induce
anesthesia. Prophylactic antibiotics can beadministered at this time. The patients head may be
shaved over the incision site.
Any standard cochlear implant incision may be
applied (Figure 13).
Retract the auricular flap inferiorly and incise and
retract the periosteum. Define the lower border of thetemporalis muscle and retract it to expose the base of
the zygoma anteriorly and to identify the superior edgeof the canal wall and the spine of Henle. It is
important to extend the incision anterior to the pinna
for adequate visualization of the ossicles whiledrilling.
Use the Capsule Template (Figure 14) to determine the
extent of the incision required to properly place theelectronics capsule. This template represents the size
of the entire implant, including the microphone and
integral fixation strap.
Figure 13 Incision Patterns
Figure 14 Implant Template
Figure 12 Implant Placement
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Step 3: Drilling the Atticotomy
Required Equipment Purpose
Atticotomy Template (SUR-1110) Determine if size of atticotomy is sufficient
Key Points:1. Ensure that the incus body and malleus head is exposed.2. Create as wide a space as possible between the ear canal and the dura by thinning the bone down over both
structures.3. The atticotomy must extend 20-25 mm beyond the incus body posteriorly.4. Remove bony ledges deep in the atticotomy since they will impede placement of the transducer.
The atticotomy is started with a 6 mm burr at 12
oclock superior to the bony external ear canal at the
root of the zygoma (Figure 15). This 12 oclock
position is defined by extending a vertical tangent upfrom the anterior canal wall. The atticotomy should be
extended anteriorly to expose the head of the malleus
and posteriorly along the temporal (dural) line,
approximately 20-25 mm beyond the incus body, to awidth of 10-12 mm. It is not necessary to expose the
dura, only to define the plane and maintain the
atticotomy inferior to that plane. If the anterior edge
of the atticotomy does not adequately expose the
malleus head, visualization of the laser hole andplacement of the probe tip will be difficult. Keep the
atticotomy borders vertical in order to preserve the
surrounding cortex for the mounting bracket screws.
When drilling the atticotomy, skeletonize the bony
external canal and tegmen down to Krners septumjust superior to the incus. Krners septum forms the
roof of the middle ear, is approximately 10 to 12 mmdeep from the cortex. Once Krners septum isidentified, it is carefully removed using a diamond
burr to expose the epitympanum, proximal antrum,
the incus and head of the malleus. Malleus head
exposure is important in order to obtain a clear view
of the incus body during laser use and probe tip
placement (Figure 16).
If required, use the Oval Fitment Gauge (Figure 17)
as a guide to approximate the size and shape of the
atticotomy. The oval fitment gauge represents theminimum atticotomy size. Typically the atticotomy
will extend further anterior for good visualization of
the incus body and malleus head. It is possible to
test the width of the bottom of the atticotomy by
ensuring that a 5mm burr will fit into the opening.
Important Information!
It is important to create as wide a space aspossible between the dura and the ear canal
for device insertion.
Remove bony ledges near the incus. Theymay hamper advancement of the transducer
and the probe tip into the laser hole.
Figure 16 - Atticotomy
Figure 15 - Atticotomy location (Left Ear)
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DANGER: While it is important to create as
wide a space as possible between the dura and the
ear canal, it is also important to avoid penetrating
the dura and to mitigate any penetration of the
external ear canal.
Step 4: Positioning the Mounting Bracket
Required Equipment Purpose
Mounting bracket with Bending Template attached.
(included in MET-1050)
Affix MET Ossicular Stimulator to skull
Laser Guide Assembly (SUR-1140) Assess size and location of atticotomyDetermine optimal placement for laser hole drilling
Bending Pliers (SUR-1120) Used to bend legs of mounting bracket (if necessary)
Cutting Pliers (SUR-1130) Used to remove mounting bracket legs (if necessary)
Key Points:
1. The mounting bracket must be placed so that the tip of the Laser Guide assembly points directly at thelocation on the incus where the laser hole will be made (Figures 19 and 20).
2. The Laser Guide tip angle may be altered by loosening the locking ring and moving the handle.3. The mounting bracket legs can be bent or removed (with the cutting pliers) to allow flush placement
against the patients cortex.
The Laser Guide Assembly, which reproduces the geometry and dimensions of the transducer assembly, is
used to position the optical fiber on the body of the incus. The hospital surgical staff will place the Laser
Guide Assembly (Figure 18a) in the mounting bracket assembly (Figure 18b). Test fit the mounted LaserGuide Assembly in the atticotomy (Figure 19).
If necessary, enlarge the atticotomy until the mounting bracket fits in the hole and the Laser Guide Assembly
tip is just above the center of the body of the incus. The axis of the tip must be as perpendicular to the incusbody as possible. It is important to avoid the edge of the incus, or the connection may not be secure (Figure
20). The angle of the Laser Guide Assembly can be adjusted by slightly unscrewing the locking ring tool and
moving the Laser Guide tip both angularly and axially. The tip should point directly at the spot intended for
the laser hole and should be able to touch the incus. Once the tip has been properly aligned, retighten the
locking ring tool.
Figure 17 - AtticotomyTemplate
10 mm wide x 20 mm lon
Locking RingTool
Handle
Laser Guide Tip
Figure 18a Laser Guide Assembly.
Bending Template,
comes pre-assembled
on Bone Bracket.
Bone Bracket
Figure 18b Bone Bracket with Bending Template.
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While holding the Laser Guide assembly in position, bend the Surgical Bending Template legs (shown blue in
Figure 19) to conform to the surface of the skull. Once satisfied, remove the Mounting Bracket/Laser Guide
assembly and bend the legs on the mounting bracket to match the bends previously created on the template.(See Figure 21a)
Figure 20 Correct Position of Laser Hole
DANGER: When introducing the Laser Guide
Assembly, ensure that the tip does not make
contact with the incus to avoid the possibility of
disarticulating the ossicles.
Figure 19 - Placing Mounting Bracket (Right Ear)
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It will be necessary to bend the legs of the mounting bracket with the Bending Pliers to achieve a flush fit at
the mounting location on the cortex. (Figure 21a & 21c)
Once the Bone Bracket is fit to the surface of the cortex, the bending template (blue) can be removed from themounting bracket using the bending pliers. The center tab is bent upwards and the blue template is pulled off
the mounting bracket. (Figure 21b)
DANGER:
The Surgical Bending Template must be removed prior to securing the Mounting Bracket to the
cortex. It is not intended to be left inside the body, due to sharp edges, though it is of the same
titanium material as the bone bracket.
Figure 21a Bending Bone Bracket Legs to Match Template.
Figure 21b Removing Surgical Bending Template from Bone Bracket.
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The bone screws should not be used to pull a mounting bracket leg down to achieve a flush fit of the mountingbracket to the skull. The legs should be bent (using bending pliers) to achieve this purpose. If necessary, one
mounting bracket leg can be removed using the Cutting Pliers (Figure 22a & 22b).
Figure 22b
Cutting Pliers
Figure 21c Correct Fit of Bracket to Skull
Figure 22a Bending Pliers
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Step 5: Fastening the Mounting Bracket
Required Equipment Purpose
Drill bit (included in MET- 1050) Drill proper size and depth holes for mounting bracket
Mounting screwdriver (Blade, SUR-1160; Handle, SUR-
1170)
Screw mounting bracket to skull
4 mm Bone screws (included in MET-1050) Affix mounting bracket to skull
Oversize bone screws (included in MET-1050) Substitute for 4 mm bone screws (if necessary)
Key Points:
1. Ensure that the Laser Guides tip is aligned to the exact desired location for the incus laser hole beforedrilling bone screw holes.
2. Screw down each leg with at least one screw per leg.3. Use the oversize bone screws if necessary.
Once the Laser Guide tip points at the location forthe laser hole and the mounting bracket legs have
been adjusted to fit flush against the cortex, use
the drill bit provided in the surgical kit to drill a
hole through one of the mounting holes located atthe end of one of the mounting bracket legs. Use
the Otologics screwdriver (Figure 23) and a 4 mm
screw (Figure 24) to secure the mounting bracket
leg to the skull. Repeat this process for all of theremaining legs of the mounting bracket utilizing
one bone screw per leg.
It is not necessary to place more than one bonescrew per mounting bracket leg, but in order to
ensure a secure mount there should be at least one
screw in all four legs. If it is not possible to put ascrew in a particular leg, that leg should be
removed using the cutting pliers.
Important Information!
A minimum of 3 legs must be attached tothe skull. If 3 legs cannot be attached,
remove and reposition the mounting
bracket!
All legs must have at least one screwsecurely fastening the mounting bracket
to the skull. If a leg is not securely
fastened to the skull pressure on the leg
may cause probe tip movement and
decrease patient performance or
transducer damage (Figure 25)
If for any reason, the laser guide assembly tipcannot be properly aligned, the screws may be
removed and the mounting bracket repositioned.
In order to use the same hole again, it may be
necessary to use the oversize bone screw.
Alternatively, a new hole can be drilled into theskull through one of the other holes on the
mounting bracket leg.
Important Information!
As the screws are fastened, ensure thatthe mounting bracket does not move and
change the intended approach angle for
the tip of the Laser Guide Assembly.
The mounting bracket should be fastenedwith 4mm bone screws. The oversize
bone screws should be used if the bonescrewholes become stripped.
Manual Drilling: If for any reason thedrill bit provided does not fit in the
otologic drill, the screwdriver blade can
be removed from the screwdriver handle
and the drill bit inserted in its place. The
proper sized hole can then be drilled by
twisting the drill bit/handle by hand.
Figure 23 - Screwdriver
Figure 24 - Bone Screw
Figure 25 Bend Leg to Skull
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Step 6: Creating the Laser Hole
Required Equipment Purpose
Laser guide tip Used to determine laser alignment to incus.
Laser fiber Used to deliver laser energy to precise point on theincus
Hypodermic Tube (included in MET-1050) Used to handle and align laser fiber
Hand auger (included in MET-1050) Used to remove debris from laser hole
Laser Used to produce energy to cut hole in incus
Laser fiber cutter (SUR-2110) May be required to prepare laser fiber tip
Laser fiber stripper (SUR-2120) May be required to prepare laser fiber tip
Key Points:1. Line up the Laser Guide Assembly with the exact position of the laser hole2. Verify the sheath on the end of the laser fiber has been stripped back a minimum of 2mm from then end.
If not, strip the sheath using the Laser Fiber Stripper Tool.
3. Generate a laser hole at least 0.75mm deep (measured to the shoulder of the hand auger)4. Wear appropriate eye protection.
Ensure the Laser Guide Assembly is locked into
position by tightening the locking ring tool. TheLaser Guide Assembly should be mounted so that
the tip is just touching the incus.
The Laser Guide tip is then removed from the LaserGuide Assembly (Figure 26). The Hypodermic Tube
(Figure 27) is placed over the end of the optical
fiber. The laser fiber should extend out of the
hypodermic tube no more than 1 mm (Figure 28).
The Hypodermic Tube and optical fiber are theninserted through the laser guide and the optical fiber
is used to deliver laser energy to the body of incus.
The laser fiber should be in contact with the incus forproper laser cutting. The laser fiber may be prepared
for cutting by test firing several pulses on a sterilewooden spatula.
Typical settings with a KTP 532 nm laser energy are
0.1 second pulse bursts at 0.5 second intervals with a
power setting of 2.4W. This laser should be run in
50 pulse sets and can take between 300 and 450
Figure 27Hypodermic Tube
Figure 26
Laser Guide (Separated)
Figure 28
Laser Fiber Protruding 1 mm out of
Hypodermic Tube
Laser Guide Tip
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pulses on average to complete the hole. Typicalsettings with a DIODE 810nm laser energy are 0.2
second pulse at 0.7 pulse rate with a power setting of
3W. This laser should be run in 20 pulse sets and
can take 60 to 80 pulses on average to
complete the hole. Consult your Laser representative
and your Otologics representative to determine the
correct settings for your laser model and type. It isrecommended that irrigation be used throughout the
creation of the laser hole. In order to remove the
char after sufficient laser pulses, the tube and fiberare removed from the laser guide and replaced by the
hand auger. Debris is removed using the manually
operated hand auger (Figures 29 and 30) and suction-
irrigation.
The hand auger is best utilized by rolling the handle
back and forth between the thumb and index finger.The laser ablation process is repeated until the hole
is approximately 0.75 mm deep at the 3:00 and 9:00
positions of the hole, as determined by the shoulder
at the tip of the hand auger (Figure 31). The holeshould be surrounded by bone at least 0.25 mm deep
on the shallowest side. The laser guide is thenremoved from the mounting bracket in preparation
for transducer placement.
DANGER: Ensure all personnel are aware of the
use of the laser and are taking proper
precautions.
DANGER: Ensure the correct diameter fiber is
in use to avoid creating an oversized laser hole.
Should the initial hole form a trench reposition the
laser guide and cut a second hole (Figure 32)
Figure 30Rotating the Hand Auger Between the
Thumb and Forefinger (Right Ear)
Figure 31
Correct Depth of Laser Hole
Figure 32
Second Hole Drilled After an Incorrect
Trench
Auger Tip
Figure 29
Hand Auger
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Step 7: Preparing the Bone Beds and Lead Channels
Required Equipment Purpose
Capsule Template (included in MET-1050) Determine size and location of bone bed
Key Points:
1. Cover the atticotomy during bone bed drilling2. Use the capsule template to assess proper location for the bone bed.
After removing the laser guide from the mounting
bracket, fill and/or cover the atticotomy with
protective material to keep the area free of debrisduring bone bed drilling.
Using the capsule template (Figure 33)for sizing,
bone-beds are created in the skull at the positionsdefined prior to surgery, keeping in mind the
recommended location for the microphone, shown in
the area without muscle, directly posterior to theexternal auditory canal (Figure 12, page 13).
The Capsule bone bed (Figure 34) should be drilledto the depth represented by the thickest portion of the
template, for the entire size of the implant, not
including the Antenna Coil area. The intent of thebone bed is to reduce the curvature of the skull,
providing the minimum attainable deflection of the
coil. The capsule placement shown in Figure 12
Implant Placement represents the portion of the
skull with the minimum curvature as a starting point.
The capsule must not be placed so that it touches anyof the other components or their mounting straps.
The Capsule Antenna Coil should be centered underthe position representing optimal placement of the
Charging Coil. If the total thickness of the tissue
flap, including skin and muscle, is greater than 6
mm, it must be thinned down to 6 mm to ensureproper magnetic fixation of the Charging Coil.
The bone bed for the microphone may be done one
of two (2) ways (Figure 34). (1) At a minimum, acircular depression may be made to accommodate
the raised portion on the under or back-side of the
microphone, or (2) A larger area to fit the shape for
the entire device may be drilled. A lead channel
should be drilled for the microphone lead in
either case. Also, a channel should be drilled to
accommodate the transducer lead. Forperformance reasons the microphone, and its straps,
must not touch any of the other implant components.
It is important to consider the placement of the
microphone, capsule, and leads relative to the temple
pieces of eyeglasses or other head gear. Themicrophone should not be placed under or adjacent
to muscle tissue, such as the temporalis muscle, as
the localized tension created by the muscle will
affect the performance of the microphone.
Adequate space is required to allow for the
installation of the silicone straps on the implant to
fit securely into the bone bed for the implant.
DANGER: Cover atticotomy during bone bed
drilling to prevent debris from entering the
atticotomy.
Figure 33- Capsule Template
Figure 34
MET Fully-Implantable Ossicular
Stimulator Bone Beds and Lead Channels
(Right Ear)
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Step 8: Placing the MET Ossicular Stimulator
Required Equipment Purpose
MET Ossicular Stimulator Implanted into atticotomy
Transducer Insertion Instrument (SUR-1190) To roughly position the MET Ossicular Stimulator tip
Locking ring tool (SUR-1150) To tighten locking ring in place when tip is alignedLocking Ring (included in MET-1050) Tightened by locking ring tool to hold MET Ossicular
Stimulator in place
Key Points:
1. When threading the MET Ossicular Stimulator into the mounting bracket, take great care with the probetip.
2. A flatter approach to the mounting bracket may make it easier to thread the device into the bracket.3. Position the probe tip within 2mm of the laser hole in the incus.
The Transducer Insertion Instrument, Locking ringtool and Locking Ring are assembled onto the
transducer (Figure 35 a & b).
The transducer is then threaded into the mounting
bracket (Figure 35 c & d) with the transducer in a
fully retracted position. Slightly loosen thelocking ring tool to allow the Transducer Insertion
Instrument to move. Using the Transducer
Insertion Instrument, make angular and grossdepth adjustments to align the transducer probe tip
with the laser-ablated hole in the body of the incus
(Figure 36). Position the probe tip of the
transducer 1-2 mm from the body of the incus.Using the locking ring tool, tighten the mountingsystem locking ring and lock the transducer in
place. Remove locking ring tool and Transducer
Insertion Instrument.
Figure 35 d
Installing MET Fully Implantable Ossicular
Stimulator in Mounting Bracket (Right Ear)
Figure 35 a
Assembling the Transducer Insertion Instrument,Locking Ring tool and locking ring onto the rear of
Figure 35 b
Figure 35 c
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Important Information!
Position the tip within 2mm of thelaser hole before attempting to
advance the tip into the hole with
the advancement screwdriver.Advancing the probe tip beyond
5mm (20 turns) may decouple the
transducer body from the
mounting shaft.
The transducer motor willdecouple from the mounting shaft
if the transducer is extended more
than 6mm (24 turns).
CAUTION!
The probe tip is extremely sensitive
and must not make contact with anyobject.
DANGER: To ensure probe tip protection, fully
retract the probe tip before threading the
transducer into the mounting bracket.
DANGER: While threading the transducer
into the mounting bracket, hold the Transducer
Insertion Instrument to prevent it from falling
into the atticotomy and contacting the incus.
Figure 36
Aligning Probe Tip to Hole in Incus (Right Ear)
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Step 9 Loading the MET Ossicular Stimulator and Diagnostics
Required Equipment Purpose
Adjustment Screwdriver (SUR-1180) Used to advance MET Ossicular Stimulator tip into hole in
incus
Transducer Loading Assistant (TLA) Used to promote appropriate loading
Diagnostic System Use to confirm operational state of the implant
Key Points:
1. Align the probe tip directly with the hole in the incus.2. Test mobility of the incus prior to and after inserting the probe tip into the incus hole.3. Advance the transducer probe tip until the incus moves and then advance the tip turn of the adjustment
screwdriver.4. If retraction is necessary, be sure to retract the probe tip AT LEAST TURN MORE than the stopping-
point desired, or completely retract probe tip out of the hole and begin process again.
5. Final transducer placement should always be an ADVANCING motion.
CAUTION!
When using the TLA, the coil must be
wrapped in a sterile bag to be placed over theimplant coil.
Prior to advancing the probe tip, the mobility of the incus should be tested by moving it gently with a surgical pick
(Figure 39). The degree of movement should be noted.
The Adjustment Screwdriver is fitted to the hex nut on top of the mounting shaft to make the final probe tipinsertion adjustment.
If using the Transducer Loading Assistant (TLA), refer to the TLA Instructions for Use (D107454-US or
D106317-EU) at this point for specific instructions for loading the transducer.
If not using the TLA, proceed as follows. To achieve proper loading of the ossicular chain with the transducer,the adjustment screwdriver (Figure 37) is turned clockwise to advance the transducer probe tip until it makes
contact with the bottom of the hole and the incus moves (Figure 38). The tip should then be advanced an additional turn of the adjustment screwdriver. A surgical pick should be used again to test mobility of the ossicles. Upon
final loading, the ossicles should demonstrate similar pre-placement mobility (Figure 39).
During normal use the transducer tip vibrates in and out 4 um, thus it is essential that the tip be in contact with the
bottom of the hole. If the transducer has been advanced too far, it must be retracted to avoid creating a conductive
hearing loss.
Figure 37
Adjustment Screwdriver
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When retracting the transducer, be sure to retract AT LEAST TURN MORE than the stopping-point desired.
That is, if the transducer has been over-advanced by turn, then the transducer must be retracted a minimum of
turn and then advanced turn to result in a net retraction.
CAUTION! Final transducer placement should always be anADVANCING motion.
Once the transducer is in its final position, a pick should again be used to test the mobility of the ossicles. If thereappears to be stiffening in the ossicular chain, the entire procedure should be repeated until there is minimal
stiffening of the ossicular chain (Figure 39).
Important Information!
Do not overextend the probe tip by trying to advance it more than 20 turns (5 mm).
One complete turn (360) of the screwdriver is equivalent to 0.25 mm of probe tip insertion or retraction.
The transducer mounting shaft has been designed for subsequent readjustment if necessary to obtainoptimum performance.
DANGER: Overloading may cause a conductive hearing loss, damage to the ossicles and/or damage to the
cochlea.
Figure 38
Advancing probe tip (right ear)
Figure 39
Incus Mobility Test
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Step 10: Attaching the Electronics Capsule to the Transducer
Required Equipment Purpose
Disposable Torque Wrench Used to tighten connector block set screws securing transducer lead to
electronics capsule
Transducer with lead To be attached to electronics capsule to form complete unit
Electronics Capsule To be attached to transducer to form complete unit
The transducer can now be attached to the
electronics capsule by inserting the male connectorof the transducer lead into the female connector of
the electronics capsule (Figure 40). Once the
connector has been fully inserted into the
electronics capsule, the two screws are tightened(clockwise) with the torque wrench provided using
the following procedure:
Figure 40
1. The electronics capsule is constructed so that
the male transducer connector may be insertedinto the female electronics connector.
Lubricate the male connecting pin with sterilesaline.
2. While firmly holding the electronics capsuleby the pin connector block between the thumband forefinger (taking care to not touch the
microphone), insert the male connecting pin
into the female connecting block until the pin
hits the positive stop on the inside of theconnector and can be seen protruding past the
pin connector block (Figure 41 & 42).
3. Two locking screws will be tightened with thetorque wrench to hold the connector in place.(Figure 44)
4. While firmly supporting the pin connectingblock between the thumb and forefingergently push on the torque wrench while
turning clockwise to engage the wrench headinto the screw.
5. Once the wrench has been felt to engage thescrew, turn the wrench clockwise until the
torque wrench clicks once. This will take
between and turn.6. While still firmly supporting the pin
connecting block between the thumb and
forefinger remove the torque wrench, and
gently pull on the lead to confirm contact.
7. Repeat steps 5-7 above for the ring lockingscrew while continuing to firmly support the
electronics capsule by holding the ring
connecting block between the thumb and
forefinger.8. Install the septum Plug into the connector
blocks by pressing each end of the molded
septum plug into the appropriate connectorblock.
Figure 41
Set Screws
torqued with
Torque Wrench
Tip protrusion
Figure 42
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Caution!
Over tightening may cause the screwhead to be stripped and may cause the
connector blocks to be pulled free from
the capsule.
Always support the connector blocks
while tightening or loosening thescrews. Failure to do so may damage
the electronics capsule.
Never attempt to turn the connectorscrews with anything other than the
supplied torque wrench. Failure to do
so may result in implant damage.
Failing to insert the transducerconnector fully into the connector
blocks may cause damage to the
transducer when the set screws are
secured.
1. The recess above the screws will besealed with Septum Plug ) The SeptumPlug should be installed using the
following procedure:
a. Wipe the area with sterile wipeto assure it is dry of blood or
saline solution.
b. Align the septum plug with thetwo connector blocks..
c. Apply pressure to seat theseptum plug into the screw
holes. (Figure 43a and b)d. Verify septum plug is seated into
the connector block surface and
is covering the entire connector
block and screw surfaces.
Important Information!
Never tighten connector block screws without the
male connecting pin inserted into the female
connecting blocks.
Always lubricate the male connecting pin with
saline prior to insertion into the connector block.
Failure to do so will result in an improperconnection. Never fill the female connecting
block with fluid. To do so will result in an
improper connection.
Figure 43a Top View
Figure 43b Side View
After the Septum Plugs are firmly seated, a pair of Silicone Bands must be slid over the implant to secure them and
ensure a proper seal. As the Capsule is already connected to the Transducer, the Silicone Bands will need to be slid
over the Coil end. Care should be exercised not to bend the Coil portion of the Capsule more than a few degrees.Sterile saline may be used as a lubricant to allow the Bands to slide completely over the Septum Plugs (Figure 45a).
The bands should be placed so they do not lie on the curved portion of the Capsule. This is to prevent them from
slipping off (Figure 45b).
Figure 44 Torque Wrench
Figure 45a Silicone Bands Figure 45b Silicone Bands Installed
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Surgical Diagnostics:
Some tests should be performed during
implantation. These tests help to make sure that
the transducer and microphone are fully functionaland will help detect if the device has been
damaged, e.g. during handling or in the OR during
implantation. The data collected can be used laterin the clinic for diagnostics and troubleshooting.
These tests are:
Battery test (reads charge state)
SAFI test:Microphone functionality
Functional Test
Transducer Impedance
CAUTION!
For the surgical tests, the programming coil
must be wrapped in a sterile bag to be placed
over the implant coil.
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Step 11. Securing the Electronics Capsule and Closing the Incision
Required Equipment Purpose
Flap Thickness Gauge (SUR-1200) Used to measure skin flap thickness over the device to
ensure proper device function.
Key Points:
1. If the tissue flap is thicker than 6mm, it must be thinned down to ensure that the Charging Coil will remainattached to the patient during charging of the implant and the Programming Coil remains fixated during
the fitting process.
2. Only bi-polar cauterization is permitted once the implant has been placed.
Important Information!3. Integral straps are provided for securing the electronics capsule and the microphone pendant to the bone
bed. Additional bending and fitting of the straps may be required. The straps will constrain the implant
and the microphone in a fixed location following the installation of the bone screws. For this reason
each strap will require the use of two bone screws. The devices should be tested for movementfollowing the installation of the bone screws. If movement is present additional adjustment to the straps
must be performed. Additional bending and shaping of the strap may be performed using the surgical
pliers used to form the bone-mounting bracket. Precautions for bending are described in detail in the
Instructions for Use included with the Bone Bracket.
4. CAUTION! The leads of the Transducer and Microphone should not be placed in contact with the legs ofthe mounting bracket to avoid damage to the leads.
5. CAUTION! Place the Microphone in the recommended location as in figure below, directly posterior tothe external auditory canal and route the lead from the microphone to the Capsule so that there is no
tension on either end of the lead. DO NOT pull on the leads or create tight bends on them, especially inthe areas where they enter the Pendant and Capsule bodies.
Implant Location
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The thickness of the tissue flap is measured using
the flap measurement tool (Figure 44) and noted.
If it is thicker than 6mm, the tissue must be
thinned down. If it is too thick, the magnet in theCharging Coil may not be strong enough to remain
attached to the magnet in the electronics capsule
and it may result in poor conduction. The tissueflap is sutured down to cover the electronics
capsule and the wound is closed in layers (Figure45).
DANGER: Once the electronics capsule
and pendant microphone have been
implanted, only bi-polar cauterization is
allowed. The use of mono-polar cauterizing
equipment may damage the implanted
electronics.
Important Information! Make sure that the
implant is positioned with THIS SIDE OUT
facing away from the skull (lateral).
At the surgeon's discretion, the implant
electronics may be placed under or over themuscle to achieve a total tissue thickness over
the coil and magnet of 6mm (Figure 46).
At this point, tests should be conducted using
the Surgical Assistant FIMOS Implant software
(SAFI) to make sure that the transducer and
microphone are fully functional and whether thedevice has been damaged. Refer to the SAFI
Instructions for Use D107455.
Figure 47, Measuring Flap Thickness
Figure 48
Cross Section Showing Capsule
Placement
Figure 46, Flap Thickness Gauge
DANGER: Excessive manipulation or
bending of the coil can damage it. In addition,
the coil should be placed such that it is not
bent more than 10relative to the implant
ca sule.
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Step 12. Post Surgical Care and Activation
Post Surgery Care:
Follow up patient care is performed in the usual manner for otologic surgery. The patient is given the samepostoperative instructions provided after standard otologic surgery. If the patient was wearing amplification
prior to surgery, he or she may wear amplification in the non-implant ear, but should not wear amplification inthe implant ear until after the eight week healing period is complete and medical clearance is given.
Activation:
Following a 8-week healing period and medical clearance, the MET Fully-Implantable Ossicular Stimulator
will be programmed according to the hearing needs of the individual patient. Detailed procedures for fitting
the MET Fully-Implantable Ossicular Stimulator are provided in the MET Fully-Implantable Ossicular
Stimulator Fitting Guide.
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UPGRADE IMPLANTATION FROM THE SEMI-
IMPLANTABLE OSSICULAR STIMULATOR (SIMOS) TOTHE FULLY-IMPLANTABLE MET OSSICULAR
STIMULATOR (FIMOS)
(E.U. ONLY)
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Step 1: Pre-Surgical Preparation for the SIMOS to FIMOS
Implantation
Important Information!
The MET Fully-Implantable Ossicular Stimulator must be charged prior to surgery using the Charger and
instructions for use for the Charger.
Important Information!
A CAT scan or a lateral x-ray must be performed to determine location of the implanted lead and mounting
bracket.
Important Information!Integral straps are provided for securing the electronics capsule and the microphone to the bone bed.
Additional bending and fitting of the straps may be required. The straps should constrain the implant or the
microphone in a fixed location following the installation of the bone screws. For this reason, two bone
screws must be used in each strap. The devices should be tested for movement following the installation ofthe bone screws. If movement is present additional adjustment to the straps must be performed. Additional
bending and shaping of the Bone Bracket may be performed using the surgical pliers used to form the bone-
mounting bracket. Precautions for bending are described in detail in the Instructions for Use included with the
straps. The recommended locations for the straps are also indicated in the Instructions for Use provided withthe brackets.
CAUTION! The leads of the Transducer and Microphone should not be placed in contact with the legs of themounting bracket to avoid damage to the leads.
CAUTION! Place the Microphone in the recommended area (Figure 12 page 13), directly posterior to the
external auditory canal, and route the lead from the microphone to the Capsule so that there is no tension on
either end of the lead. DO NOT pull on the leads or create tight bends on them, especially in the areas wherethey enter the Pendant and Capsule bodies.
CAUTION: For an upgrade implantation, only bi-polar cauterization is permissible. The use
of mono-polar cauterizing equipment may damage the implanted transducer.
Charging the Implant:
Plug in the Charger Base Station, and make sure
that the Base Station indicator light is green,verifying that the charger system is connected to a
power source.
Confirm that the charging system is fully charged
by checking to see if the charger power indicator isgreen. (The charger indicator is the light on the far
left side of the charger). A full recharge time for
the charger body is 6 hours.
To charge the implant, place the charging coil over
the implant while it is still in its sterile packaging.The charging will take place through the sterile
packaging. Fully charging an implant can take up
to 3 hours. Once the implant is fully charged the
Implant charger indicator will turn green. (The
Implant charger indicator is the light on the far right
side of the charger.) Consult the Charger User
Guide for additional information.
Determine location of implanted electronics:
The surgeon should determine the location of the
implanted electronics using a CAT scan or x-ray
and manual palpation. Once the location of theelectronics has been identified, the patient may be
prepared for surgery.
Preoperative Preparation of the Patient:
The patient is placed on the operating room tablein the standard manner for otologic surgery and
anesthesia is induced. Prophylactic antibiotics can
be administered at this time as well. The patients
head may be shaved over the incision site.
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Step 2: Making the Incision and Removal of the Semi-
Implantable Electronics
The original incision site should be utilized (Figure 48), and should allow for adequate access to the implant
electronics capsule.
DANGER: Care must be taken to not cut the electronics capsule during the incision or
dissection.
Figure 49
Once the implant electronics has been located, incise the sheath covering the implant electronics, and cut any
sutures that may be holding the capsule in place.
Remove the implant from its tissue bed taking care not to stress the transducer lead.
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Step 3: Connector Disassembly
Required Equipment Purpose
Disposable Torque Wrench Used to tighten or loosen septum screw securing transducer lead to electronics capsule
Transducer with lead To be attached to electronics capsule to form complete unit
Electronics Capsule To be attached to transducer to form complete unit
Using a scalpel, cut around the front and rear
septums to expose the allen-head screws of the
front and rear connector blocks (Figure 49).
Place the head of the torque wrench (Figure 53page 35) into the allen slot in the front connector
block and turn counter clockwise to loosen the
screw.
Grasp the lead strain relief and gently pull the
male connecting pin (Figure 49) from theelectronics capsule.
Take care not to damage the male connecting pin
in any way. Clean tissue and blood from theconnecting pin and inspect the front and rear seals
for cracks and tears.
Measure, record and report to Otologics the tissue
thickness. If the tissue that over-lies the
electronics capsule is thicker than 6 mm, thin the
tissue to 6mm prior to connecting the new
electronics capsule.
Figure 49 (left ear) Figure 50
Pin connector
block
Ring Connector block
Male connector pin
Female connector
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Step 4: Attaching the Electronics Capsule to the Transducer
Required Equipment Purpose
Disposable Torque Wrench Used to tighten or loosen septum screw securing transducer lead to electronics capsule
Transducer with lead To be attached to electronics capsule to form complete unit
Electronics Capsule To be attached to transducer to form complete unitBone Wax Minimally
Resorbable (E.U. Only)
If used in place of provided Septum plug and bands, to create a moisture barrier on
outside of Implant connector block set screws
The transducer can now be attached to theelectronics capsule by inserting the male connector
of the transducer lead into the female connector of
the electronics capsule (Figure 51). Once the
connector has been fully inserted into the
electronics capsule, the two screws are tightened(clockwise) with the torque wrench provided using
the following procedure:
Figure 51
1. The electronics capsule is constructed so thatthe male transducer connector may be inserted
into the female electronics connector.
Lubricate the male connecting pin with sterilesaline.
2. While firmly holding the electronics capsuleby the pin connector block between the thumband forefinger (taking care to not touch the
microphone), insert the male connecting pin
into the female connecting block until the pin
hits the positive stop on the inside of theconnector and can be seen protruding past the
pin connector block (Figure 52 & 53).
3. Two locking screws will be tightened with thetorque wrench to hold the connector in place.(Figure 55)
Figure 52
4. While firmly supporting the pin
connecting block between the thumb andforefinger gently push on the torque
wrench while turning clockwise to
engage the wrench head into the screw.
5. Once the wrench has been felt to engagethe screw, turn the wrench clockwiseuntil the torque wrench clicks once. This
will take between and turn.
6. While still firmly supporting the pinconnecting block between the thumb andforefinger remove the torque wrench, and
gently pull on the lead to confirm contact.
7. Repeat steps 5-7 above for the ringlocking screw while continuing to firmly
support the electronics capsule by holding
the ring connecting block between the
thumb and forefinger.8. Install the septum Plug into the connector
blocks by pressing each end of the
molded septum plug into the appropriate
connector block.
Tip protrusion
Figure 53
Set Screws
torqued with
Torque Wrench
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Caution!
Over tightening may cause the screwhead to be stripped and may cause the
connector blocks to be pulled free from
the capsule.
Always support the connector blockswhile tightening or loosening the
screws. Failure to do so may damagethe electronics capsule.
Never attempt to turn the connectorscrews with anything other than the
supplied torque wrench. Failure to do
so may result in implant damage.
Failing to insert the transducerconnector fully into the connector
blocks may cause damage to the
transducer when the set screws are
secured.
2. The recess above the screws will be
sealed with Septum Plug ) The SeptumPlug should be installed using the
following procedure:
a. Wipe the area with sterile wipeto assure it is dry of blood orsaline solution.
b. Align the septum plug with thetwo connector blocks..
c. Apply pressure to seat theseptum plug into the screwholes. (Figure 54a and b)
d. Verify septum plug is seated intothe connector block surface and
is covering the entire connector
block and screw surfaces.
Important Information!
Never tighten connector block screws without the
male connecting pin inserted into the female
connecting blocks.
Always lubricate the male connecting pin with
saline prior to insertion into the connector block.
Failure to do so will result in an improperconnection. Never fill the female connecting
block with fluid. To do so will result in an
improper connection.
Figure 54a Top View
Figure 54b Side View
After the Septum Plugs are firmly seated, a pair of Silicone Bands must be slid over the implant to secure them and
ensure a proper seal. As the Capsule is already connected to the Transducer, the Silicone Bands will need to be slid
over the Coil end. Care should be exercised not to bend the Coil portion of the Capsule more than a few degrees.Sterile saline may be used as a lubricant to allow the Bands to slide completely over the Septum Plugs (Figure 56a).
The bands should be placed so they do not lie on the curved portion of the Capsule. This is to prevent them from
slipping off (Figure 56b).
Figure 55 Torque Wrench
Figure 56a Silicone Bands Figure 56b Silicone Bands Installed
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Important information:
Never tighten connector block screws without the male connecting pin inserted into the female connecting blocks.
Always lubricate the male connecting pin with saline prior to insertion into the connector block. Failure to do so
will result in an improper connection.
Never fill the female connecting block with fluid. To do so will result in an improper connection.
Surgical Diagnostics:
Some tests should be performed during implantation.
These tests help to make sure that the transducer and
microphone are fully functional and will help detectif the device has been damaged, e.g. during handling
or in the OR during implantation. The data collected
can be used later in the clinic for diagnostics and
troubleshooting.
These tests are:
Battery test (reads charge state)
SAFI tests:Microphone functionality
Functional Test
Transducer Impedance
CAUTION!
For the surgical tests, the TLA programming coil
must be wrapped in a sterile bag to be placed
over the implant coil.
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Step 5: Enlarging the Bone Bed for the Electronics Capsule,
Pendant Microphone, and Closing
The size of the bone bed is increased and a new bed
is created to accommodate the fully-implantable
electronics capsule and microphone. The capsuleshould be placed in a relatively flat location, and the
bone bed should be drilled under the entire capsule.
The bone bed should be enlarged to accommodatethe implant with the silicone bands installed. (Figure
57, 58, 59). The microphone should not be placed
under or adjacent to muscle tissue, such as thetemporalis muscle, as the localized tension created
by the muscle will affect the performance of the
microphone.
When inserting the capsule in to the bone bed, ensure
that the coil is not severely bent. Secure the fully-implantable capsule, microphone, and close the
wound in the normal manner.
Figure 57 MET Semi-Implantable Ossicular
Stimulator bone bed
Figure 58 Bone bed enlarged and microphone
bed created for MET Fully-Implantable OssicularStimulator
Figure 59 MET Fully-Implantable Ossicular
Stimulator in situ
Important Information!
Integrated straps are provided for securing theelectronics capsule and the microphone pendant to
the bone bed. Additional bending and fitting may be
required. The straps should constrain the implant or
the microphone pendant in a fixed location followingthe installation of the bone screws. For this reason,
two screws must be used in each strap. The
devices should be tested for movement following the
installation of the bone screws. If movement is
present additional adjustment to the straps must beperformed. Additional bending and shaping of the
straps may be performed using the surgical pliers
used to form the bone-mounting bracket.Precautions for bending are described in detail in the
Instructions for Use included with the straps.
Important Information!
The bone bed for the microphone may be done one
of two (2) ways (Figure 34). (1) At a minimum, a
circular depression may be made to accommodatethe raised portion on the under or back-side of the
microphone, or (2) A larger area to fit the shape forthe entire device may be drilled. A lead channel
should be drilled for the microphone lead in
either case. Also, a lead channel should be drilled
to accommodate the transducer lead.
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Step 6: Post Surgical Care and Activation
Post surgery care:
Follow up patient care is performed in the usual manner for otologic surgery. The patient is given the same
postoperative instructions provided after standard otologic surgery. If the patient was wearing amplification priorto surgery, he or she may wear amplification in the non-implant ear, but should not wear amplification in theimplant ear until after the eight week healing period is complete and medical clearance is given.
Activation:
Following a 8-week healing period and medical clearance, the MET Fully-Implantable Ossicular Stimulator will
be programmed according to the hearing needs of the individual patient. Detailed procedures for fitting the MET
Fully-Implantable Ossicular Stimulator are provided in the MET Fully-Implantable Ossicular Stimulator Fitting
Guide.
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Otologics Confidential
SURGICAL STEPS FOR REPLACING THE FULLY-
IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS)
WITH THE FULLY-IMPLANTABLE MET OSSICULAR
STIMULATOR (FIMOS)
Step 1: