d104096 rev m surgical training manual pdf

7/27/2019 D104096 Rev M Surgical Training Manual PDF

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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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____________________________________________________________________________________MET Fully-Implantable Ossicular Stimulator D104096 M


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 Fully-Implantable Ossicular Stimulator D104096 MSurgical Training Manual Page 5 of 69

Otologics Confidential

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.


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


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


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.


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


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


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.


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.


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


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


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


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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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


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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Surgical Training Manual Page 26 of 69


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).


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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Surgical Training Manual Page 27 of 69


Step 10: Attaching the Electronics Capsule to the Transducer


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.


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


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


31/69



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


The MET Fully-Implantable Ossicular Stimulator must be charged prior to surgery using the Charger and

instructions for use for the Charger.


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.


36/69



Step 3: Connector Disassembly


Disposable Torque Wrench Used to tighten or loosen septum screw securing transducer lead to electronics capsule


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


Disposable Torque Wrench Used to tighten or loosen septum screw securing transducer lead to electronics capsule


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.


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


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.


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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SURGICAL STEPS FOR REPLACING THE FULLY-

IMPLANTABLE MET OSSICULAR STIMULATOR (FIMOS)

WITH THE FULLY-IMPLANTABLE MET OSSICULAR

STIMULATOR (FIMOS)

Step 1:

d104096 rev m surgical training manual pdf

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