Osseous--ENT_Product_Details---NOBLE_PHARMA

PREPARED BY:
EON MEDITECH PVT. LTD.
R&D DIVISION

THE HUMAN EAR
INTRODUCTION
The ear is divided, semi-artificially, into three regions:
Figure 1: THE HUMAN EAR
The Outer Ear consists of
1. The Pinna or external ear.
2. The Meatus or ear canal.
3. The Tympanic membrane or the eardrum.
The eardrum separates outer and middle ears, so it counts as being in both.
The Middle Ear consists of
4. The Tympanic membrane, or eardrum.
5. The Malleus or hammer.
6. The Incus or anvil.
7. The Stapes or stirrup.
The Inner Ear consists of
8. The Cochlea.

THE MIDDLE EAR
The middle ear is a cavity within the temporal bone of the skull.
Ossicles
There are three ossicles: the malleus, the Incus, and the stapes (Figure 2).
Figure 2: OSSICLES
Malleus
The malleus has two main parts: the manubrium and the head. The manubrium also
has two processes: one anterior and one lateral. The region between the manubrium
and the head is called the neck of the malleus.
Incus
The Incus is divided into 3 principal parts: a body and two processes (named short and
long, respectively). The head of the incus articulates with the head of the malleus. At
the end of the long process of the incus is a small region called the lenticular process?
The lenticular process articulates with the head of the stapes. The short process of the
incus is attached to the cavity wall by the posterior incudal ligament.
Stapes
It has four components: a footplate, two crura (posterior and anterior), and a head.
The head of the stapes articulates with the lenticular process of the Incus. The
footplate of the stapes covers the oval window (an opening into the inner ear cavity).

MIDDLE EAR DISEASES
Otosclerosis
It is defined as abnormal bone growth in the ear, eventually resulting in hearing
loss. It can be an inherited disorder, resulting in abnormal hardening of bone in the
middle ear and sometimes inner ear.
Cholesteatoma
Cholesteatoma is a disease of the ear in which a skin cyst grows into the middle ear
and mastoid.
Otitis Media
Otitis media means inflammation of the middle ear. The inflammation occurs as a
result of a middle ear infection. It can occur in one or both ears. Otitis media is the
most frequent diagnosis recorded for children who visit physicians for illness.
Tinnitus
Tinnitus may be a buzzing, ringing, roaring, whistling, or hissing, or it may involve
more complex sounds that vary over time.

1. TITANIUM MATERIALS :
Two of the greatest benefits of titanium are its high strength-to-weight ratio and its
corrosion resistance. Couple this with its non-toxic state and its ability to fight all
corrosion from bodily fluids.
Titanium is also incredibly durable and long-lasting. When titanium cages, rods,
plates and pins are inserted into the body, they can last for upwards of 20 years.
Due to its non-ferromagnetic property, which allows patients with titanium implants
to be safely examined with MRIs and NMRIs.
Osseo-integration is a unique phenomenon where body’s natural bone and
tissue actually bond to the artificial implant. This firmly anchors the titanium
medical implant into place. Titanium is one of the only metals that allows for this
integration.
Fig : Properties of Titanium as a Medical Material

ADVANTAGES OF TITANIUM MATERIALS :
• Excellent biocompatibility (non-toxic AND not rejected by the body).
• High affinity towards bone (Osseo-integrated behavior).
• No inflammation.
• Good acceptance at chronic inflammation site.
• Light weight and delicate structure facilitate excellent intra operative handling.
• High Corrosion stability.
• High rate of success in revision surgery.
• Secure placement.
• High Stiffness of the titanium relates to the optimal adjustment of the implants to
the elastic properties of the bone.
• Low input impedance for good sound reception.
• Balance between Stiffness and Flexibility.
• Faster surgical procedure and enhanced patient safety.
• MRI compatible (Due to Non-ferromagnetic).
• Flexibility and elasticity rivals that of human bone.
2. PTFE MATERIALS :
Polytetrafluoroethylene (PTFE) is a versatile polymer used in a broad range of
medical, industrial, and high technology applications. PTFE is inert, making it
unreactive to most chemicals, and, it can work in high processing and operating
temperature environments (500°F / 260°C continuous).
PTFE offers excellent thermal, electrical, mechanical, and chemical properties as
well as superior control over pore size, permeability, water entry pressure, and
thickness. PTFE is an ideal choice for a wide variety of demanding applications
requiring one or a combination of these exceptional properties.

ADVANTAGES OF PTFE MATERIALS:
• Chemically inert.
• Thermally resistant (500°F / 260°C continuous use).
• Compatible with ultrasonic/thermal welding and inset molding.
• Hydrophobic and oleo phobic.
• Omni-directional flow.
• High tensile strength.
• Steam and ETO (ethylene oxide) sterilizable.
• Natural white or black colour.
3. SILICONE MATERIALS:
Medical grade silicone is silicone with properties that allow it to be safely used in
contact with living tissue, a characteristic called biocompatibility. Silicones are a
group of synthetic polymers used in many medical devices due to their flexibility,
heat resistance, and low toxicity and chemical reactivity. Medical grade silicone is
used in medical devices such as bandages and medical implants.
ADVANTAGES OF SILICONE MATERIALS:
• Much Biocompatible.
• Thermally resistant.
• High flexibility.
• Hydrophobic and oleo phobic.
• Chemically inert.
• Steam and ETO (ethylene oxide) sterilizable.

TITANIUM MIDDLE EAR PROSTHESES
INTRODUCTION
Due to diseases trauma, or congenital malformation, the ossicles of the middle ear are
sometimes damaged. If this damage results in a discontinuity of bone between the
tympanic membrane and oval window, no sound conduction and hearing loss results.
Some or all of these ossicles can be replaced with a small prosthesis. Titanium based
Middle Ear Prosthesis is applied for ossicular replacement or reconstruction of the middle
Ear. Ossicular chain reconstruction is the rebuilding of the middle ear ossicular chain which
has been disrupted or destroyed through the use of some interpositioned device. This is to
regain the original mechanics of the ossicular chain and convert this mechanical energy
into the electrical impulse produced by the cochlea.
These types of Titanium Middle Ear Prosthesis consist of a flat coupling body designed to
rest against the Ear Drum, an oblong shank connected to the body for bridging the
tympanic cavity and a base which is joined to the shank and the rest against the base of
the prosthesis in the tympanic cavity. (Figure 3 & 4)
Figure 3 Figure 4
Figure 3: PORP (Partial Ossicular Replacement Prosthesis)
Figure 4: TORP (Total Ossicular Replacement Prosthesis)

APPLICATION OF MIDDLE EAR PROSTHESES (TORP, PORP) :
Ossiculoplasty :
The ossicles are the bones of hearing in the middle ear. They are very effective at
transmitting sound, so damage to them results in quite a large hearing loss. The bones
can be damaged by repeated infections or by head injury, or eaten away by a
cholesteatoma.
Ossicuplasty is an operation to
reconnect the bones of hearing. a cut is
made inside the ear canal so the
eardrum can be lifted for access. The
gap between the damaged ossicles is
bridged by a graft. often, the original
incus bone can be reshaped and
reinserted as the graft, or the graft
may be made of plastic or titanium, or
other small pieces of bone cartilage
taken from ear. The reconstruction can
be done alone oras part of a more
complex operation such as
mastoidectomy.
It may be necessary to stay in hospital overnight, but patient will usually be able to go
home the next day. A lightdressing of gauze or pieces of dissolvable dressing is placed in
the ear canal and is removed in the outpatients department after 1-2 weeks.
The graft does not always stick properly. However, 80% of patients find that their hearing
improves, even if it does not return completely to normal.
There is a small risk that the graft may be rejected if artificial materials such as plastic or
titanium are used. They are slowly expelled from the middle ear and eventually fall out,
even after several years. Same way, there is risk f bone or cartilage being resorbed over
several years, if this happens, hearing gets much worse again, and revision surgery is
required.

APPLICATION OF MIDDLE EAR PROSTHESES (STAPES PISTON) :
Stapedectomy :
Stapedectomy is an operation to treat hearing loss caused by otosclerosis, a hereditary
condition which causes the stapes bone in the middle ear to fuse in place. the operation is
performed under local anaesthesia and takes about 1-2 hours. patient usually have to stay
in hospital overnight.
A cut is made inside the ear canal so the
eardrum can be lifted and the fused stapes
bone removed. a tiny hole (about 0.5 mm
wide) is drilled into the wall of the inner ear
to hold the end of a replacement 'bone' of
plastic or metal. the hole is sealed with a clot
of blood, a piece of fat from the earlobe, or a
patch of dissolvable dressing. The ear drum
is replaced and finally pieces of dissolvable
dressing is placed in the canal for 1-2 weeks
while the cut heals.
After the operation, there is little discomfort,
though it is common to feel slightly dizzy for
1-2 days. patient may return to work after
about a week, but should avoid heavy lifting, diving and flying for 4-6 weeks.
The operation results in a big improvement in hearing in 85% of cases. Approximately
10% of people get very little benefit from the operation, and in up 5% of people it can
cause a permanent loss of hearing in the operated ear. For this reason, some people
choose to use a hearing aid instead of having the operation. The improvement in hearing
is usually noticed as soon as the dressing is removed from the ear canal. In some cases, it
may take a few days longer.

TITANIUM MIDDLE EAR PROSTHESES
E1101 - Tita-prosthesis type Partial Vario Campana
Tita-prosthesis type Partial Vario Campana is used for
partial ossicular chain reconstruction. It is just Malleus and
Incus replacement to connect Tympanic Membrane and Head
of the Stapes. It consists Head Plate (Disk), Shaft, and
Campana type cup.
Design Benefits:
• Partially roughened surface on upper part of disk and
inside cup stabilizes prosthesis placement.
• Low risk of dislocation because of campana shaped
cup.
• Stable design provides maximum sound output.
• Offers best possible length selection.
• Enhanced view capability during implantation because
of four symmetrical bore holes on disk.
• Due to trimmeble shaft it can be use as per patient’s
Anatomical Requirement.
• Radial outer facing of disk minimizes risk of tympanic
membrane injury.
• MRI Compatible.
REF Shaft Disk Functional Total Length Units per
Number Diameter Diameter Length (L) package
E1101 0.30 3.00 1.75-5.00 5.00
1 pc, Gamma
Sterile

E1102 - Tita-prosthesis type Total Vario Cask
Tita-prosthesis type Total Vario Cask is used for
total ossicular chain reconstruction. Total Ossicular chain
replacement to connect Tympanic Membrane and
Footplate of the stapes (At Oval Window). It consists Head
Plate (Disk), Shaft, and Cask type cup.
Design Benefits:
• Partially roughened surface on upper part of disk and
inside cup stabilizes prosthesis placement.
• Enhanced view capability during implantation because
of four symmetrical bore holes on disk.
• Radial outer facing of disk minimizes risk of tympanic
membrane injury.
• MRI Compatible.
E1102 0.30 3.00 3.00-7.00 7.00
1 pc, Gamma
Sterile

E1103 - Tita-prosthesis Piston Type Loop
Tita-prosthesis Piston Type Loop is used for
Stapedioplasty. It is connected between Long process of Incus
and Oval window. It consists Loop (Flat Band) and Piston.
Design Benefits:
• Easy loop introduction.
• Reduced risk of osteonecrosis.
• Atraumatic design (Not produces any Injuries or
Damage).
• MRI Compatible.
E1102 0.30 3.00 3.00-7.00 7.00
1 pc, Gamma
Sterile

E1207 – TitaHAp-prosthesis type Vario Partial (PORP)
A thin layer of Hydroxyapatite (HAP) is coated onto
the top surface of Disk-cylinder for better fixation of
Disk to
Tympanic Membrane (TM).
The HAP coating gives a firmer grip of the
prostheses with the TM. It acts as an intermediate layer
between TM and the titanium disc. The prostheses has
the conducting capabilities of Titanium and the excellent
biocompatibility of HAP which provides excellent
flexibility and comfort for the surgeon.
It consists two units 1) Disk – Cylinder (Coated with Hydroxyapatite)
2) Campana Cup with radial shaft.
Function :
It is a replacement for the malleus & Incus as it connects the TM and the Head of the
Stapes.
Design Benefits :
• Better fixation of Disk with TM (Fibroblast cell fixation within HAP pores).
• Light Weight compare to conventional HAP prostheses.
• Excellent biocompatibility due to bioactive material.
• Hap Coating on Titanium promote Osseo-integration (the direct structural and functional
Connection between living bone and the surface of an artificial implant).
• Least extrusion due to HAP coating (Dislocation of prosthesis).
• Provides good flexibility.
• Good visibility during implantation of prostheses due to four holes on disk.
• Provides benefits of both: Titanium and Hydroxyapetite (Titanium provides
better conduction and Hap provides better fixation with biological tissues).
• Both Titanium and HAp are biocompatible materials.
• Shaft of PORP is Trimmeable hence it use as per patient anatomical requirement.
• Radial outer facing Disk minimizes risk of tympanic membrane injury.
• Atraumatic Design.
• MRI Compatible.

E1208 – TitaHAp-prosthesis type Vario Total (TORP)
It consists two units 1) Disk – Cylinder (Coated with Hydroxyapatite) .
2) Cask shaped Head with radial shaft.
Function :
It is a replacement for the complete ossicular chain as it connects the TM and the
footplate of the stapes (at the oval window).
Design Benefits:
• The Length of the shaft can be cut as per patient’s anatomical requirement and then
shaft inserted into the cylinder on the disk. Hence only one TORP is required for
particular total ossicular reconstruction.
• Better fixation of Disk with TM (Fibroblast cell fixation within HAP pores).
• Light Weight compare to conventional HAP prostheses.
• Excellent biocompatibility due to bioactive material.
• Hap Coating on Titanium promote Osseo-integration (the direct structural and functional
Connection between living bone and the surface of an artificial implant).
• Least extrusion due to HAP coating (Dislocation of prosthesis).
• Provides good flexibility.
• Good visibility during implantation of prostheses due to four holes on disk.
• Provides benefits of both: Titanium and Hydroxyapetite (Titanium provides better
conduction and Hap provides better fixation with biological tissues).
• Both Titanium and HAp are biocompatible materials.
• Radial outer facing Disk minimizes risk of tympanic membrane injury.
• MRI Compatible.
REF Shaft Disk Functional Total Units per
Number Diameter Diameter Length Length (L) package
E1207 0.30
3.00 HAp
Coated
1.75-5.00 5.00
1 pc, Gamma
Sterile
E1208 0.30
3.00 HAp
Coated
3.00-7.00 7.00
1 pc, Gamma
Sterile

E4119 – Tita-PTFE Vario Piston type Loop
Function :
Tita-PTFE Vario Piston type Loop replace stapes and
then connect long process of Incus and Oval window.
(Stapes surgery)
Consists : Loop or Flat Band (Titanium) and Shaft (PTFE).
Design Benefits:
• Only one OSSEOUS: Tita-PTFE Piston is required due to
best possible length selection.
• Made up of excellent biocompatible Titanium and PTFE
material.
• Easy loop introduction.
• Faster surgical procedure and enhanced patient safety.
• Reduced risk of osteonecrosis (bone death due to poor
blood Supply) because of flat band(loop).
• Reduce Surgery cost.
• Facilitate length selection as per requirement of patient
because shaft is of PTFE material hence it can be easily
trimmed as per required length during surgery using
simple blade or scissor.
• Atraumatic Design (Not produces any kind of Injuries).
• MRI Compatible.
REF Shaft Loop Shaft Functional Length Units per
E4119 0.40 0.20 4.00-6.00 6.00
1 pc, Gamma
Sterile

++
E9131 - Super Titanium Vario Piston type Loop
(OSSEOUS: Super Titanium Piston)+
Material: Titanium (Elastic Properties) Medical Grade
E9132 - Super Tita-PTFE Vario Piston type Loop
(OSSEOUS: Super Tita-PTFE Piston)++
Material: Titanium (Elastic Properties) & PTFE Medical Grade
Flat band loop of Self Crimping Super Titanium material
Material Information:
Super titanium Piston made up of CP Titanium Medical Grade 2 (ASTM F67) material. A
“Super Titanium” property is because of specialized manufacturing technique at EON
Meditech Pvt. Ltd. After several quality & expertise manufacturing process, we have
achieved special properties of Titanium having elastic properties for self crimping
attachment.
Features:
Insertion of Super Titanium Piston to the long process of Incus is as similar to Self
crimping NITINOL. Unique flat loop design of Super Titanium material provides self
crimping (elastic properties) attachment to Incus and also provides uniform attachment of
loop around total periphery of Incus which reduces the risk of compressive necrosis. A
Superelastic property of loop reduces the surgical process time and crimping difficulties.
• More Elastic Titanium material for self crimping effect.
• Simplified loop introduction to Incus by easy downward movement.
• Elastic self crimping loop shortens the time of surgery.
• Reduced risk of osteonecrosis.
• MRI Compatible.
+

Loop attachment procedure to Incus:
1. The loop attaches to Incus by applying an easy Vertical little force which opens
loop. (Figure 1)
2. The loop will be opened (Figure 2) and again it returns to its original shape due to
its Superelastic properties. (Figure 3)
Figure 1 Figure 2 Figure 3
(Super Titanium Piston – Loop attachment procedure to Incus)
REF
Number
Item
Shaft
Diameter
Loop
Shaft
Diameter
Functional
Length
Length
(L)
Units per
package
E9131
Super Titanium Vario
Piston type Loop
0.40 0.20 3.50-5.50 5.50
1 pc,
Gamma
Sterile
E9132
Super Tita-PTFE Vario
Piston type Loop
0.40 0.20 4.00-6.00 6.00
1 pc,
Gamma
Sterile

E8130 - Superelastic NITINOL-PTFE Vario Piston type Loop
(OSSEOUS: NITINOL-PTFE Piston)
Flat band loop with Super Elastic NITINOL material
Material: Super Elastic NITINOL & PTFE Medical Grade
Figure 1 Figure 2 Figure 3
(Superelastic NITINOL Piston – Loop attachment procedure to Incus)
Features:
Unique flat loop design of Superelastic NITINOL material provides self crimping attachment
to Incus and also provides uniform attachment of loop around total periphery of Incus
which reduces the risk of compressive necrosis. A Superelastic property of loop reduces
the surgical process time and crimping difficulties.
Loop attachment procedure to Incus:
3. The loop attaches to Incus by applying an easy Vertical little force which opens
loop. (Figure 1)
4. The loop will be opened (Figure 2) and again it returns to its original shape due to
its Superelastic properties. (Figure 3)
REF
Number
Shaft
Diameter
Loop Shaft
Diameter
Functional
Length
Length
(L)
Units per
package
E8130 0.40 0.20 4.00-5.50 5.50
1 pc, Gamma
Sterile

PTFE MIDDLE EAR PROSTHESES
E3133 - PTFE Partial Prostheses (PORP)
Design Benefits:
• Much Biocompatible with biological tissues.
• Easily Trimmeble from 5.00 mm to 2.00 mm in length.
• Reduce surgery cost.
• Conventional design.
REF
Number
Shaft
Diameter
OD/ID
Disk Diameter
Functional
Length
Total
Length (L)
Units per
package
E2133
2.00/1.20
hollow, partially
4.00 5.00 – 2.00 5.00
1 pc, ETO
Sterile
E3134 - PTFE Total Prostheses (TORP)
Design Benefits:
• Easily Trimmeble from 7.00 mm to 3.00 mm in length.
• Reduce surgery cost.
• Conventional design.
REF Shaft Flange Functional
Total
Length
Units per
E2134 1.00 3.00 7.00 - 3.00 7.00
1 pc, ETO
Sterile

PTFE Stapes Piston
Using smooth jaw alligator forceps, the piston loop can be expanded with a pick to slip
over the Incus.
Design Benefits:
• "Plastic memory" provides secure closure.
• Conventional design for easy attachment with Long
process of Incus.
• Can be easily trimmed with scissor or cutting tool from
6.00 mm to 3.50 mm.
REF Piston Loop Inner Functional Length Units per
E2127 0.50 0.60 3.50-6.00 6.00 1 pc, ETO Sterile
E2128 0.40 0.60 3.50-6.00 6.00 1 pc, ETO Sterile
E2129 0.60 0.60 3.50-6.00 6.00 1 pc, ETO Sterile

MIDDLE EAR RELATED INSTRUMENTS (OSSEOUS INSTRUMENTS)
OSSOUES CUTTER
Osseous cutter is used to trim the Osseous Surgical
implants to optimal length in accordance with the
patient's anatomical condition and surgical
requirement. The following prostheses can be trimmed
using this cutter:
• Tita-prostheses type Partial Vario Campana
• Tita-prostheses type Total Vario Cask
• Tita-Prostheses Piston Type Loop
INSTRUCTIONS FOR OSSOUES CUTTER
The purpose of these instructions is to make
the handling of the OSSEOUS Cutter and
implants as easy and simple as possible for
all operating room staff using EON’s
OSSEOUS surgical implants.
Osseous Cutter is having 3 parts:
A) Cutting Block
B) Lever
C) Shortening Blade
A) Cutting Block consists: (1) Station
for Disk (For Partial Cup or Total Cup
Assembly with Disk) (2) Station for
Stapes Piston for easy handling.
B) Lever is having sharp edge for
cutting the prostheses.
C) Shortening Blade consists: (1)
various length steps from 1.50 mm
to 5.00 mm (Hole Length - H.L.)
(2) Two holes on each steps (0.4
mm dia for Stapes Piston & 0.3 mm
dia for Partial Cup and Total Cup)
(Figure 1: OSSEOUS CUTTER)
A
B
C
A
B
C

CUTTING ACTION
Partial Cup/Total Cup/Stapes Piston can be easily trimmed
using OSSEOUS Cutter by just pressing the lever down as
shown in figure 2.
Cutting PORP
The required length is exact the length of Hole (H.L.).
Means if 3.5 mm length of Partial Cup required,
Surgeons can easily insert Partial Cup into 3.5 mm
Hole and cut excess length by just pressing down the
lever. (Figure 3)
Cutting TORP
The required length is Hole Length (H.L.) + 1.00 mm.
Means if 4.5 mm length of Total Cup required,
Surgeons can easily insert Total Cup into 3.5 mm Hole
and cut excess length by just pressing down the lever.
So the length will be 3.5 mm + 1.0 mm i.e. 4.5 mm.
(Figure 4)
Cutting Stapes Piston
The required length is exact the length of Hole (H.L.).
Means if 4.25 mm length of Piston required, Surgeons
can easily insert Piston into 4.25 mm Hole and cut
excess length by just pressing down the lever. (Figure 5)
(Figure 3: Inserting PORP & Excessive length comes out from shortening Blade)
(Figure 4: Inserting TORP & Excessive length comes out from shortening Blade)
(Figure 2: Cutting action using lever)

(Figure 4: Inserting Piston & Excessive length comes out from shortening Blade)
(Figure 5: Stations for Disk & Stapes Piston for easy handling)
IMPORTANT NOTE: One or two drops of sterile NaCl 0.9% should be placed on the shaft
of Partial Cup / Total Cup / Stapes Piston & nearby shortening blade, all stations.

OSSEOUS SIZER
Osseous Sizer is used to measure the distance between
any two points in the middle ear cavity which is to be
connected using prosthesis. For instance, In a
Stapedioplasty surgery the exact distance between the
long process of the Incus and the footplate can be
measured using the Osseous Sizer and accordingly the
Osseous surgical implants can be trimmed using
Osseous cutter (REF: EI01).
INSTRUCTIONS FOR OSSOUES SIZER
OSSEOUS Sizer is equipped with a pointer for the precise
measurement of prostheses for middle ear reconstruction and
tympanoplasty. In order to measure the distance between two
points during surgery, hold the instrument like as a pen and
position the tab at the end of the needle at the level of the first
point. With your index finger push the button until the mandrel
coming out of the needle reaches the second point. Distances
are indicated in millimeters on the instrument's handle. This
instrument is made completely of stainless steel which can be
sterilized or autoclaved.
PARTIAL/ TOTAL OSSICULAR CHAIN RECONSTRUCTION
First Point: Near By Tympanic Membrane
Second Point: Stapes Head (Partial Prosthesis) or Footplate of
the Stapes (Total Prosthesis)
1) Hold the Osseous Sizer like as pen and Put the needle
of the measuring device in a position perpendicular to
the footplate with the tab at the same level as
Tympanic Membrane.
2) With your index finger push the button until the
mandrel coming out of the needle reaches the second
point.
(Figure 6: OSSEOUS SIZER)
3) Pull the measuring device out and, read the measured distance on the graduated
section on the handle.
4) Required prosthesis length:
• Partial Prosthesis – Distance between Tympanic Membrane and Stapes Head.
• Total Prosthesis – Distance between Tympanic Membrane and Footplate of
Stapes plus the depth into the fenestration.
5) Distances are indicated in millimeters on the instrument's handle.
6) Appropriately cut the prostheses in “Osseous Cutter” as per measurement.

STAPES SURGERY
First point: Under the long process of the Incus (Medial Side)
Second point: Footplate of the Stapes
1. Hold the Osseous Sizer like as pen and Put the needle of the measuring device in a
position perpendicular to the footplate with the tab at the same level as under the
long process of the incus (Medial Side).
2. With your index finger push the button until the mandrel coming out of the needle
reaches the second point.
3. Pull the measuring device out and, read the measured distance on the graduated
section on the handle.
4. Required prosthesis length:
• PISTON – Distance between long process of the Incus (Medial Side) and
Footplate of the Stapes plus the depth into the fenestration.
5. Distances are indicated in millimeters on the instrument's handle.
6. Appropriately cut the Piston in “Osseous Cutter” as per measurement.
(Figure 7: OSSEOUS SIZER How to measure)
REF Point

VENTILATION TUBES (TITANIUM, PTFE & SILICONE) :
What are Ear Ventilation Tubes?
Vent tubes for the ear are generally only a few millimeters wide.
Fluid trapped behind the eardrum is a breeding ground for
bacteria and infection. An ear ventilation tube (or vent tube) is
a very small tube that’s placed in the eardrum. It’s also called
a myringotomy tube, tympanostomy tube, or pressure
equalization (PE) tube. Vent tubes let fluid trapped behind the
eardrum drain, which helps prevent ear infections (otitis
media).
The operation to insert a vent tube is very safe, simple, and quick. The ENT (ear, nose,
and throat) specialist or ear specialist makes a very small cut in the eardrum and puts a
vent tube in one or both ears. The vent tubes cause no pain or hearing loss.
Why is ventilation tube needed?
A child’s Eustachian tubes sometimes can't drain fluid away from the middle ear into the
throat very well. If fluid builds up behind the eardrum, bacteria can grow. This is how ear
infections begin. After an ear
infection is gone, fluid often
remains behind the eardrum.
A very small ear ventilation
tube (vent tube) is put into
the eardrum to allow fluid
drainage and help prevent
further infections.
Detail - Normal ear Detail - Infected middle ear
What is the Eustachian tube?
The Eustachian tube is a canal that runs from the middle part of each ear to the back of
the throat. It does two things. First, it keeps the air pressure inside the middle ear the
same as the air pressure outside the ear. This helps you hear better. Second, it helps fluid
from the middle ear drain into the throat.
In young children, the Eustachian tube is smaller, narrower, and more horizontal. This
makes it easier for germs to move from the throat to the ear and for the tube to become

blocked. Most children stop having ear infections around age 6 because their Eustachian
tubes are more fully developed.
What are the benefits of a ventilation tube?
A vent tube lets fluid drain out of the middle ear, which reduces the chance of ear
infections coming back. It is a very common and standard procedure with little risk.
When should a ventilation tube be used?
A vent tube is usually recommended if your child has several of the following conditions:
• There's been fluid in the middle ear continuously for over 4 months
• There's fluid in both ears
• Recurrent ear infections haven’t responded to continuous antibiotic treatment for
several months
Benefits and Risks – Ventilation Tubes
The risks and benefits of an ear ventilation tube (vent tube) are different for each child.
It’s important to get the answers you need from your pediatrician and ENT or ear
specialist.
Benefits:
• Reduced risk of future ear infections.
• Restored hearing in some children who’ve had hearing problems.
• Allows time for the child’s Eustachian tube to mature and work more effectively. As
a child grows, the Eustachian tube gets longer and wider so it can provide better
drainage of fluid from the ears.
• It’s a very common and quick procedure.
Risks
Some of the risks include:
• Some children may continue to get ear infections, in spite of a vent tube.
• The tube may come out. A vent tube usually falls out in about a year. If it falls out
sooner, it may need to be replaced. Occasionally, the vent tube becomes stuck in
the middle ear. When this happens, it has to be removed by your doctor.
• If the vent tube doesn’t fall out on its own, a surgeon may have to remove it.
• It may leave a small scar on the eardrum, which could cause some hearing loss.
• After the vent tube falls out, a small hole may remain in the eardrum, which might
have to be repaired by your doctor.

Application of Ventilation Tube:
Tympanoplasty
Tympanoplasty is an operation to repair holes (perforations) in the eardrum. It is
usually performed under local anaesthesia, but in uncooperative or very anxious
patients should be performed under general anaesthesia. It usually takes 1-3 hours
depending on other a procedure like ossiculoplasty is required.
A cut is normally made in the
skin crease just behind or just in
front of the ear. Often a small
amount of hair is shaved off
immediately beside the ear. a
piece of tissue called a graft is
used to patch the eardrum. This
graft is normally taken from
tissue called fascia that lies just
under the skin behind the ear.
The ear drum with some canal
skin is lifted up, and the graft is
placed on underside of the hole
(inlay) and held in position with
small pieces of dissolvable
packing. Graft can be placed
over the ramnent of ear drum
(onlay) or in between the layers
of ear drum (interlay). A gauze
wick or the same dissolvable
material fills the ear canal
forwards to protect the ear drum
and is removed 1-2 weeks later
in outpatient department.
After the operation, there is little discomfort. Any pain is easily controlled with
painkillers. It is quite common to feel slight dizzy for 1-2 days. Most patients go
home the same day or the day after surgery. it is best to take about 7 days off
work. Patient should not get any water in the ear and should avoid swimming and
flying for at least 4 weeks.
The graft fails to take in about 10-20 % of cases. the operation can be repeated if
this happens. If the eardrum heals successfully hearing should improve, though it
may not return completely to normal.

Titanium Ventilation Tubes
Tita-prosthesis Vent Tube Type Collar Button
Tita-prosthesis Vent Tube Type Collar Button is used for
implantation in the tympanic membrane to drain and
temporarily aerate the tympanic cavity.
Design Benefits:
• Excellent tissue biocompatibility.
• Antibacterial effect.
• Long-term durability.
• Smooth surfaces that facilitate secretion drainage.
• Simple implantation.
• MRI Compatible.
REF Inner Inner Flange Outer Flange Units per
Number Diameter Diameter Diameter package
E1104 1.40 2.55 2.55
1 pc, Gamma Sterile
E1105 1.30 2.55 2.55
1 pc, Gamma Sterile
E1106 1.50 2.75 2.75
1 pc, Gamma Sterile

PTFE Ventilation Tubes
E2124 – Donaldson
Features:
• Short term ventilation tube
• Dual Flange provides good migration and
extrusion resistance.
• Its easy-to-use design has made this one of
the most popular types of ventilation tubes.
REF Inner Inner Flange Outer Flange Total Units per
Number Diameter Diameter Diameter Length package
E2124 1.14 2.30 2.30 2.20
1 pc, ETO
Sterile
E2123 & E2125 – Collar Button
Features:
• Classic Design.
• Midterm ventilation tube.
• A larger inner diameter reduces the risk of
occlusion.
E2123 1.27 3.00 3.00 2.15
1 pc, ETO
Sterile
E2125 1.14 2.30 2.30 2.15
1 pc, ETO
Sterile

E2112 & E2113 – Shah & Mini Shah
Features:
•Mid term ventilation tube.
•Good extrusion resistance.
E2112 1.14 3.40 2.30 2.40
1 pc, ETO
Sterile
E2113 0.76 2.20 1.50 1.50
1 pc, ETO
Sterile
E2114 – Shepard
Features:
• Classic popular grommet design for easy
insertion, adequate ventilation and short
term duration. Available in Fluoroplastic.
• A popular short-term ventilation tube.
• Available with and without tail.
• The average extrusion time was 8.5 ± 4.6
months for Shepard tubes.
E2114 1.14 2.40 2.40 2.20
1 pc, ETO
Sterile

E2116 – Straight Tube
Features:
• Smaller inner flange (Smaller inner flange
facilitates insertion in a smaller incision).
• Longer shaft lengths may help resist water
migration into the middle ear.
• Can be trimmed to length.
• Available both for short-term and long- term use, with different flange diameters.
• The tube for long-term use has a larger outer flange diameter,
preventing the tube from an early extrusion.
REF Inner Inner Flange Outer Flange Total No. of Pcs/
Number Diameter Diameter Diameter Length Package
E2116 1.14 2.70 - 7.25
1 pc, ETO
Sterile
E2117 – Bevel Bobbin
Features:
• The bell-shaped outer flange improves
ventilation and helps viewing through
the lumen.
• Designed to enhance retention and aeration.
• The tapered lumen assists the surgeon in
cleaning if necessary.
• Combining the best features of the Baxter
Bevel Button and the Reuter Bobbin, the
beveled shape resists occlusion and clears easily.
• Excellent secretion drainage
REF Inner Inner Flange Outer Flange Total No. of Pcs/
E2117 1.14 2.80 2.80 1.70
1 pc, ETO
Sterile

E2136 – Baxter Beveled Bobbin
Features:
• Combine features of Bevel Bobbin and the
Reuter Bobbin.
E2136 1.27 2.80 2.80 2.20
1 pc, ETO
Sterile
E2137 – Reuter Bobbin
Features:
• Classic Design.
• It has an excellent history of providing a
somewhat longer duration for middle ear
ventilation.
E2137 1.14 2.30 2.30 1.60
1 pc, ETO
Sterile

E2109 – Armstrong
Features:
• Mid-term ventilation tube.
• Beveled inner flange (The beveled inner
flange is angled to the shank, which allows
easier insertion and keeps the tube parallel to
the auditory canal.
• Better visibility through tube & Good
extrusion resistance.
E2109 1.14 2.5 2.5 3.8
1 pc, ETO
Sterile
E2110 – Modified Armstrong
Features:
• Mid-tern ventilation tube.
• Beveled Inner Flange.
• Good extrusion resistance and easier
insertion.
E2110 1.14 2.5 2.5 2.3
1 pc, ETO
Sterile

Silicone Ventilation Tubes
E3111 – Donaldson
Its easy-to-use design has made this one of the most popular types of ventilation tubes.
The silicone version can be compressed for easy insertion.
Features:
• The large lumen offers good ventilation
and the dual flange design resists
migration and extrusion.
• Short term ventilation tube.
E3111 1.10 2.30 2.30 2.20
1 pc, ETO
Sterile
E3126 – Paparella
Unique design of notched inner flange facilitates insertion through simple "twist-in"
movement. Very stable for short-term implantation. Integral tab for removal with forceps.
This tube is conveniently rotated into position by introducing the lead corner of the flange
into the myringotomy.
Features:
• Notched inner flange is designed for easier
insertion in a smaller incision.
• Short-term ventilation tube.
E3126 1.14 2.40 2.10 2.20
1 pc, ETO
Sterile

E3115 – T-Tube
The soft large flanges prevent the tube from extrusion. The tube is easily inserted with the
T-tube inserter. The 12 mm tube can be cut to desired length. A T-tube has two flanges
and is composed of medical grade
silicone. T-tubes are inserted
when long-term ventilation is
required. T-tubes usually remain
in the eardrum for 24 months or
longer. If T-tubes are retained
and are not spontaneously
ejected, they may be removed
and the eardrum may be repaired
with a fat graft or other tissue
(fascia or cartilage).
Features:
• Long-term ventilation tube.
• Shafts and flanges can be partly shortened.
• Proven and popular design.
• Soft flanges open out after insertion into ear drum.
• Opened flanges prevent premature loss.
REF Inner Outer Flange Flange Total No. of Pcs/
Number Diameter Diameter Width Length Package
E3115S 1.14 1.70 8.00 6.00
1 pc, ETO
Sterile
E3115M 1.14 1.70 8.00 9.00
1 pc, ETO
Sterile
E3115L 1.14 1.70 8.00 12.00
1 pc, ETO
Sterile

EAR PVA DRESSINGS
Ear Wick: Soft and resilient, Osseous ear wicks are designed to aid the treatment of otitis
externa. They deliver medication, such as an antibiotics solution, to the ear canal and the
ear canal membrane.
Osseous ear wicks are designed to deliver antibiotics during the treament of otitis externa.
• Perfect Design to use in treatments for otitis externa
• Deliver medication to ear canal
• Fenestrated variety available
Ear Pack: Designed for use in otic surgery, Osseous ear packs help absorb fluids during
surgery. The soft and porous PVA foam material expands evenly to support the ear canal
after surgery. Osseous ear packs are sterile and come with rounded edges for quick and
easy insertion.
Osseous ear packs are designed for use in otic surgery. They absorb fluids and support
canals after surgery.
• Helps prevent stenosis of the ear canal
• Porous foam for rapid absorption
REF
Number
Product
Name
Specification Product Description
Units per
package
E7161 Ear wick Ø 9.0mm x 15.0mm No string
10 pcs,
Gamma Sterile
10 pcs,
Gamma Sterile
10 pcs,
Gamma Sterile
10 pcs,
Gamma Sterile
E7165 Ear Pack Ø 9.0mm x 15.0mm With String
10 pcs,
Gamma Sterile
10 pcs,
Gamma Sterile
10 pcs,
Gamma Sterile
10 pcs,
Gamma Sterile
E7169 Ear wick Ø 9.0mm x 15.0mm Fenestrated
10 pcs,
Gamma Sterile
E7170 Ear wick Ø 9.0mm x 24.0mm Fenestrated
10 pcs,
Gamma Sterile

STANDARD NASAL DRESSINGS
Osseous standard nasal packs are designed for use in a variety of nasal surgeries:
septoplasty, turbinectomy, rhinoplasty, and more. They fill and support nasal cavities
during surgery, allowing smooth septum ventilation to ensure patient comfort. Osseous
nasal packs also absorb post-operative bleeding effectively and efficiently. They are
available with or without String and airway tube.
Standard packs are used in a variety of nasal surgeries to support nasal cavities and
effectively stop nose bleeding.
• Designed for nasal surgeries
• Gentle compression to stop bleeding and absorb blood
• Excellent alternative to cumbersome gauze packing
REF
Number
Product
Name
Specification Product Description
Units per
package
E7176
Nasal
Dressing
4.5cm x1.5cm x2.0cm No string
10 pcs,
Gamma Sterile
E7177
Nasal
Dressing
4.5cm x1.5cm x2.0cm With String
10 pcs,
Gamma Sterile
E7178
Nasal
Dressing
4.5cm x1.5cm x2.0cm With String & Tube
10 pcs,
Gamma Sterile
E7179
Nasal
Dressing
4.5cm x1.0cm x2.0cm Thin
10 pcs,
Gamma Sterile
E7180
Nasal
Dressing
8.0cm x1.5cm x2.0cm No string
10 pcs,
Gamma Sterile
E7181
Nasal
Dressing
10 pcs,
Gamma Sterile
E7182
Nasal
Dressing
10 pcs,
Gamma Sterile
E7183
Nasal
Dressing
10 pcs,
Gamma Sterile
ANATOMICAL NASAL DRESSINGS
Designed to fill the nasal cavity, Osseous anatomical nasal packs are used during and after
nasal surgery. With optional airway tube, they enhance patient comfort by ensuring easy
breathing. Moderately-sized, and with soft yet supportive texture for easy placement and
removal, Osseous anatomical packs effectively reduce patient discomfort.

Anatomical packs are used during and after nasal surgery to support nasal cavities and
facilitate proper breathing.
• Support the nasal cavity after surgery
REF
Number
Product Name Specification Product Description
Units per
package
E7188
Anatomical Nasal
Dressing
10 pcs,
Gamma Sterile
E7189
Anatomical Nasal
Dressing
10 pcs,
Gamma Sterile
E7190
Anatomical Nasal
Dressing
10 pcs,
Gamma Sterile
EPISTAXIS NASAL DRESSINGS
Osseous epistaxis nasal packs are used in the treatment of anterior and posterior nose
bleeding. The soft round edges create less friction and reduce irritation during nasal
passage insertion. The epistaxis packs expand to gently compress and effectively stop
nose bleeding.
Epistaxis packs stop nosebleeds, safely and effectively.
• Designed to treat nosebleeds
• Softness reduces irritation
• Quick and uniform expansion
• Fluid absorption causes the packing to expand producing a tamponading effect
REF
Number
Units per
package
E7184
Epistaxis Nasal
Dressing
10.0cm x1.5cm x2.5cm No String
10 pcs,
Gamma Sterile
E7185
Epistaxis Nasal
Dressing
10 pcs,
Gamma Sterile
E7186
Epistaxis Nasal
Dressing
10 pcs,
Gamma Sterile
E7187
Epistaxis Nasal
Dressing
10 pcs,
Gamma Sterile

SINUS PACKS
Osseous sinus packs are made with soft, porous, resilient PVA foam. They are designed to
support the sinus cavity and the osteomeatal complex to ensure airflow through nose.
They also expand to stop bleeding through gentle compression, and facilitate faster
recovery. They have rounded edges to allow easy insertion during surgery, and provide
comfort even during removal.
Sinus packs are designed for use after sinus surgery, to ensure proper breathing.
• Ideal for FESS (Functional Endoscopic Sinus Surgery) sinus surgery
• Reduce bleeding and facilitate healing
• Allows the sinus cavity to remain open while absorbing post-operative fluids
• Fine pore construction reduces tissue adherence
REF
Number
Units per
package
E7191 Sinus Pack 3.5cm x1.2cm x0.6cm With String
10 pcs,
Gamma Sterile
E7192 Sinus Pack 3.5cm x1.2cm x0.9cm With String
10 pcs,
Gamma Sterile
Common Advantages for all kind of Osseous PVA dressings:
• Lint and fiber-free
• Sterilized by gamma radiation
• Packaged in clean-room facilities
• All products have good biocompatibility, low antigenicity, tissue reaction and
transmissibility.
403, B Tower, Diamond World, Mangadh Chowk,
Varachha Road, Surat-395006,
Gujarat, India.
Phone: +91 261 3072190.
E-mail ID: info@eonmeditech.com
sales@eonmeditech.com
www.eonmeditech.com

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