Cochlear implant systems

Cochlear implant systems

Dr Rohit Udaya Prasad

Junior Consultant

ENT & cochlear Implant surgeon

Dr Hans Center For ENT, Hearing Care & Vertigo,New Delhi

Cochlear implant

• Implantable device

• Electrode array

• Sound processor

Implant

Coclear Nucleus

Medel

Advance Bionics

Digisonic

Neurotron

Surgeon

Knowledge on available implant devices

Design the bed for the implant based on the device used

Use of specific electrode for specific conditions

Cochlear NucleusMonopolar

reference electrodes

(ball & plate)

Removable

Magnet for MRI

Receiver

Antenna

(platinum coil- 2.5 turns)

receiver-stimulator

titanium

Micro-coiled electrode Wires

(Helix)

Electrode array

(22 platinum electrodes)

Inside the receiver-stimulator

CI24RE chip Application Specific Integrated Circuit

Mounted directly on circuit board

Freedom significantly increases impact strengthWithstands 50% greater impact than CI24R

• More efficient- lower power consumption

• Cleaner sound reproduction

• New higher stimulation rates with

access to all existing

coding strategies (31.5KHZ )

• Future ready platform to deliver

further advances in

technology

PerformancePOWERFUL DIGITAL MICROCHIP

• AutoNRT™ – precise and convenient Neural Response Telemetry system

• ‘Future Ready’ – capacity to support ongoing advancements in sound processing technologies

PerformanceMRI SAFETY WITH REMOVABLE MAGNET

• Designed for minimal MRI image obstruction

• Easy removal of magnet Access to high power MRI scans

1 MRI field strength approval varies by country, check your warnings and precautions document. MRI field strength of 3 Tesla approved with magnet removed and 1.5 Tesla with magnet in place. Magnet must be removed before MRI procedure in Indonesia and Thailand.

With magnet Magnet removedNo implant

MRI scans at 1.5 Tesla

Image Courtesy MHH Department of Neuroradiology (Hannover, Germany)

Nucleus® Profile Series

3.9mm

Benefits1

– Easier and potentially faster surgery due to minimal drilling

– More discreet for patients

– 99.97% combined Cumulative Survival Percentage within two years

References:1: Cochlear Limited, Cochlear™ Nucleus® Reliability Report, Volume 14, February 2016 D828700 APRIL 16

22 Active Electrodes10 Inactive Stiffening Rings

Straight electrode option

22 active full band electrodes (17mm)

10 non stimulating support bands/ stiffening rings (25mm total length)

Surgeon preference for some abnormal anatomies &intraoperative repositioning

Contour Advance™ Perimodiolar Electrode

Straight with stylet in place

With stylet removed

Softip and white to enable Advance Off-Stylet™ (AOS™) insertion technique.

Postoperative X-ray

Contour Advance™ electrodeStraight Electrode

Scala

Tympani

Scala Vestibuli

Scala Media

To auditory nerve

Basilar

Membrane

Lateral WallModiolar Wall

Spiral Ganglion nerve

cells

1

Hair

Cells

Scala

Tympani

Scala Vestibuli

Scala Media


1

Scala

Tympani

Scala Vestibuli

Scala Media


Electrode

1

Electrode

Scala

Tympani

Scala Vestibuli

Scala Media


1

Electrode

Scala

Tympani

Scala Vestibuli

Scala Media


1

Electrode

Scala

Tympani

Scala Vestibuli

Scala Media


Electrode

1

PrecisionFOCUSED STIMULATION

1 Shepherd, R., et al. Electrical stimulation of the auditory nerve: The effect of electrode position on neural excitation. (1993).2 Ariyasu, L., et. al. Computer-generated three dimensional reconstruction of the cochlea. (1989).3 Blamey P, et al. Pitch Matching of Electric and Acoustic Stimuli. (1995).4 Stakhovskaya, O., et al. Frequency Map for the Human Cochlear Spiral Ganglion. (2007).

• Extensively researched electrode lengthfor excellent hearing zone coverage1-3

• 17 mm length targets majority of spiral ganglion cells4 for effective frequency coverage

Nucleus CI24RE with Contour Advance electrode

Distribution of spiral ganglion

3-Dimension reconstruction

Ariyasu et al. (1989)

Organ of Corti

Spiral ganglion Osseous spiral lamina

Cochlear nerve

Perimodiolar benefits

• Close proximity to the spiral ganglion cells

– Better frequency resolution through narrower spread of excitation1

• Reduced stimulation intensity

– Psychophysical levels2

– ECAP/EABR3

– Reduced risk of facial nerve stimulation4

Late

ral

Perim

odio

lar

Spread of excitation from lateral

placement reduces precision

1. Hughes ML, Abbas PJ. Electrophysiologic channel interaction, electrode pitch ranking, and behavioral threshold in straight versus

perimodiolar cochlear implant electrode arrays. J Acoust Soc Am. 2006 Mar;119(3):1538-47.

2. Tykocinski M, Roland T, Laszig R, Cowan R. Threshold, comfortable level and impedance changes as a function of electrode-modiolar

distance. Ear Hear. 2002 Feb;23(1 Suppl):28S-40S.

3. Runge-Samuelson C, Firszt JB, Gaggl W, Wackym PA. Electrically evoked auditory brainstem responses in adults and children: effects of

lateral to medial placement of the nucleus 24 contour electrode array. Otol Neurotol. 2009 Jun;30(4):464-70.

4. Battmer R, Pesch J, Stover T, Lesinski-Schiedat A, Lenarz M, Lenarz T. Elimination of facial nerve stimulation by reimplantation in

cochlear implant subjects. Otol Neurotol. 2006 Oct;27(7):918-22.

Standard insertion technique

PreciseGENTLE INSERTION

AOS™ insertion technique

• Flexible, pre-curved electrode

• SoftipTM

• Minimal lateral wall forces with AOS1

1 Roland, J.T. Jnr. A model for Cochlear Implant Electrode Insertion and Force Evaluation: Results with a New Electrode Design and Insertion Technique (2005).

• Standard insertion technique

• AOS insertion technique

protect delicate cochlear structures1

AOS™ insertion technique:

• Flexible pre-curved electrode

• With Softip™

• AOS insertion technique

Nucleus 5 Cochlear Implant (CI512)

PreciseGENTLE INSERTION



1 Roland, J.T. Jnr. A model for Cochlear Implant Electrode Insertion and Force Evaluation: Results with a New Electrode Design and Insertion Technique (2005).

Cochlear Nucleus CI422

• Cochlear’s next generation straight electrode

• Suitable for round window or cochleostomy

• features

CI422 Specifications

• White marker to indicate insertion depth at 20mm

• 0.3mm diameter: new thin electrode suitable for round window insertion

• 0.6mm diameter.

• White marker to indicate maximum depth insertion at 25mm

• Surgical wing /electrode handle for surgical handling.

0.35

0.3

0.6

0.5

• 22 half band rings spread over 20mm, with smooth lateral surface

• SoftipPermanent stiffener rather than using inactive stiffening rings

Softip for minimal insertion trauma.

Diameter at apical end 0.3 mm.

Half-band intracochlear electrode array with smooth lateral surface.

22 platinum electrode contacts spread over 20 mm active length, face medially on opposite side to handle.

Diameter at basal end: 0.6 mm.

White marker at 20 mm indicates active electrode array.

Patented basal stiffener enables smooth, single motion insertion and prevents buckling.

White marker at 25 mm indicates maximum insertion depth.

Handle assists with reliable electrode orientation and surgical handling.

CI422 detailed view

Performance with CI422

N=56, 6 month post operative data12,47. Audiometric findings before and after implantation with CI422 Straight.

12 Skarzynski et al 2012). 29 Skarzynski et al(2010).31 Stakhovskaya et al(2007). 32 Ariyasu et al(1989).49 Data on file. 256202.47 Lenarz et al(2011). 48 Briggs et al(2011).

Preservation with CI422

Image courtesy of Professor H. Skarzynaski

• Patented basal stiffener adds strength only

where it’s needed

- Minimise electrode buckling29,49

- Allow identification of point of first resistance29,49

• Handle

- Greater electrode control, assists with electrode

orientation49

• Softip, 0.3 mm apical diameter, flexibility,

smooth lateral surface.

- Facilitate an easy, atraumatic, single stroke

insertion49

- Smooth trajectory along lateral wall 49

29 Skarzynski et al(2010) 49 Data on file. 256202.

Cochlear Nucleus Contour Advance Electrode

Cochlear Nucleus CI422 with Straight Electrode

Cochlear Nucleus Hybrid L24 Electrode

Handle

Wing

Stylet

Basal Stiffener

Basal Stiffener

• BASAL STRENGTH FOR CONTROL AND

TACTILE FEEDBACK.

• APICAL FLEXIBILITY MINIMISES INSERTION

FORCES.

• ALL OUR ELECTRODES COME WITH BOTH,

BASAL STRENGTH AND APICAL FLEXIBILITY.

• Contour Advance: Stylet as basal stiffener.

• CI422 Straight, Hybrid L24: Patented, tapering basal

stiffener.

• Transfers insertion force to apical section.

• Limited to basal electrode section, where insertion trajectory

is straight.

Preservation

Basal Strength

CI422 straight array

Cochleostomy & RW

Contour Advance

“Insertion depth angles, relative to entry via the round-window, ranged from

300° to 500° (N=25, mean 403°, SD 51°)”- Skarzynski et al 2011

Placement

Insertion depth to stimulate remaining nerves

12 SKARZYNSKI ET AL(2012) 29 SKARZYNSKI ET AL(201049 DATA ON FILE. 256202.

• THIN DIAMETER PARTICULARLY SUITABLE FOR

ROUND WINDOW INSERTIONS12,29.

• Easy navigation through the hook region.

• Minimise friction forces during lateral wall transition.

• SUITABLE FOR COCHLEOSTOMY

APPROACHES49.

• VARIABLE INSERTION DEPTH.

• Markers at 20mm and 25mm to determine final insertion

depth.

Preference

Round window or cochleostomy insertion

Cochlear™ electrode types

15mm

E1

20mmCochlear™ Nucleus® CI422 straight electrode

16mmCochlear™ Nucleus® Hybrid L24 electrode

17mmCochlear™ Nucleus® CI24RE (ST) straight electrode

Cochlear™ Nucleus® CI24RE (CA) perimodiolar

electrode

Ø 0.6 - 0.4

Ø 0.8 - 0.5

Ø 0.5 - 0.25

Ø 0.6 - 0.3

Mean = 420º

Range is ~260-450°

Mean = 360º

Range is ~270-390°

Mean = 403º

Range is ~300-500°

Considerations for electrode choice

Handling Approach Outcomes

ImplantAppropriate Insertion

Depth (400-450 degrees)

Atraumatic (half-band, basal stiffener,

smooth lateral surface)

Cochleostomy Round Window PeriomodiolarPreservation of residual hearing

Contour Advance

?

CI422

It’s a Challenging World

More people with hearing needs

They have different levels of hearing loss

They need different treatment solutions

Different Clinical Indications

Clinical Indications

Traditional CI Candidates

Hybrid Hearing Candidates

Case-by-case

Severe to Profound Sensorineural Hearing Loss

1

Moderately Severe to Profound High Frequency Hearing Loss

2

Special Medical Conditions

3


More people with hearing needs

They have different levels of hearing loss

They need different treatment solutions

A perfect fitFor every ear

You can focus on what matters!

Electrode Selection

WHICH ELECTRODE TO USE?

COCHLEAR ELECTRODE SOLUTION

Contour Advance®

Slim Straight

Straight

Indication Group 1

PATIENT NEEDS

Optimal electrical stimulation

ELECTRODE FEATURE

Perimodiolar electrode

Lateral wall

Severe to Profound Sensorineural Hearing Loss

PROVEN CLINICAL DATA

Holden et al, Ear and Hearing, 2013Susan et al, The American Journal of Otology, 1999

Post Operative X-rays

(Source: courtesy the Hearing CRC)

Nucleus Contour Advance Electrodes


Slim Straight

Indication Group 2:

PATIENT NEEDS

Optimise Hybrid hearing

ELECTRODE FEATURE

Hearing preservation electrode

Moderately Severe to Profound High Frequency Hearing Loss


Skarzynski et al, Ear and Hearing, 2014Jurawitz et al, Audiology & Neurotology, 2014

Proven Clinical DataCLINICAL PAPER 1:

Skarzynski et al, Ear and Hearing, 2014

KEY FINDINGS:

• Hearing was substantially preserved with the electrode inserted to one full turn.

• All patients substantially improved their speech performance in noise.

PAPER OPTION 1 ( SLIM STRAIGHT)

Residual hearing preserved and speech performance improved with the Slim Straight Electrode

Skarzynski, Henryk, et al. "Cochlear Implantation With the Nucleus Slim Straight Electrode in Subjects With Residual Low-Frequency Hearing." Ear and hearing 35.2 (2014): e33-e43.

Sample size:

35 patients separated in 3 groups, age ranged from 15-84 years

Electrode used:

Nucleus Slim Straight Electrode

Results:32/35 patients retained residual hearing at 12 months (91.5%).

All patients substantially improved their speech performance in noise & in quiet post-operative using electro-acoustic stimulation.

(Skarzynski et al, Ear and Hearing, 2014)

Proven Clinical DataCLINICAL PAPER 2:

Jurawitz et al, Audiology & Neurotology, 2014

KEY FINDING:

Hearing preservation is possible for a substantial patient cohort with the (CI422) Slim Straight electrode.

PAPER OPTION 2 ( SLIM STRAIGHT)

Post Operative X-rays

(Source: Shakeel R Saeed, David Selvadurai, Tim Beale, Nigel Biggs, Brendan Murray, Peter Gibson, Frank Risi,Paul Boyd. The use of cone-beam computed tomography to determine cochlear implant electrode position in human temporal bones. Otol. Neurotol. 2014 Sep;35(8):1338-44)

Nucleus Slim Straight Electrodes


Contour Advance®

Straight

Hybrid L24*

Slim Straight

Auditory Brainstem (ABI)*

Indication Group 3:

PATIENT NEEDS

Coverage of full frequency range given their medical

condition

Special Medical Conditions

ELECTRODE FEATURE

Variety of electrode options


Various clinical papers report good outcomes with Nucleus electrodes for the a variety of malformations.

* Product not available in all markets


Special Medical Conditions Electrode Type Clinical Data

Otosclerosis & LVAStraightContour Advance

• Aschendorff A, Jaekel K, Klenzner T, Laszig R, Impact of electrode design on facial nerve stimulation in otosclerosis, Proceedings of the 4th Asia Pacific Symposium on Cochlear Implant, Cochlear Implants Int, 5[Suppl 1], 63-65. 2004.(Otosclerosis)

• Miyamoto, CI w Large Vestibular Aquaduct Syndrome, Laryngoscope 2002

Common Cavity StraightContour Advance • Coelho D, Waltzman S, Roland J, et al, Implanting Common Cavity Malformations Using Intraoperative Fluoroscopy, O&N 2008

Neurofibromatosis Type II (NF2)

ABI • Colletti V, Shannon B, Carner, M, Colletti L, Outcomes in Nontumor Adults Fitted With the Auditory Brainstem Implant: 10 Years’ Experience, Otol & Neurotol 2009

Incomplete Partition I, II, IIIStraightContour Advance

• Sennaroglu L, Sarac S, Ergin T, Surgical Results of Cochlear Implantation in Malformed Cochlea, Otol & Neurotol, 27:615-623, 2006

Cochlear Aplasia enlarged vestibule Straight

• Dettman S, et al, Cochlear implants in 48 children with cochlear and/or vestibular abnormality, in press 2010

• Puram, Sidharth V.; Tward, Aaron D.; Jung, David H.; Dilger, Amanda E.; Herrmann, Barbara S.; Duhaime, Ann-Christine; Barker, Fred G. II; Lee, Daniel J. Auditory Brainstem Implantation in a 16-Month-Old Boy With Cochlear Hypoplasia. Otology & Neurotology, 2014.

Cochlear Hypoplasia I, II, III Straight • Papsin, BC., Cochlear Implantation in Children with Anomalous Cochleovestibular Anatomy, The Laryngoscope, 2005

Ossified Cochlea Straight• Rinia, Cochlear Implantation in obstructed cochleas: the effect of the degree of obstruction on the number of activated

electrodes and the amount of postoperative speech perception, Clinical Otolaryngology, 2006

• Smullen J, Balkany T, Implantation of the Ossified Cochlea, Operative Techniques in Otolaryngology, 2005, 16, 117-120

Proven Clinical Data

Cochlear Electrode SolutionSpecial Medical Conditions

Contour Advance®

Straight Slim Straight Hybrid L24* Auditory Brainstem (ABI)*

Otosclerosis & LVA ●Common Cavity ●

Neurofibromatosis Type II (NF2) ●

Incomplete Partition I, II, III ● ● ● ● ●

Cochlear Aplasia enlarged vestibule ●

Cochlear Hypoplasia I, II, III ●

● Electrode selections for different conditions* Product not available in all markets


Dissatisfaction with hearing aids

More patients with presbycusis, who are missing out on life

Cochlear Electrode Portfolio

Clinical Indications

Contour Advance® SlimStraight

Straight Auditory Brainstem (ABI)*

Severe to Profound Sensorineural Hearing Loss ● ● ●

Moderately Severe to Profound High Frequency Hearing Loss ●

Special Medical Conditions ● ● ● ●

● Electrode selections for different conditions* Product not available in all markets

Nucleus® Electrode Portfolio

Freedom Series

Most implanted& reliable

Profile™ Series

Thinnest & most advanced

Auditory Brainstem Implant*For stimulation of the auditory brainstem

Hybrid™ L24*For patients with high levels of

residual hearing

StraightFor special anatomical conditions

1 Holden et al, Ear and Hearing, 20132 Skarzynski et al, Ear and Hearing, 2014* Product not available in all markets

Contour Advance®

Perimodiolar placement for optimum performance1

Slim StraightHearing preservation electrode

for optimal Hybrid Hearing2

Medel

• Maestro

• Synchrony

• Synchrony EAS

Medel sonata

Stimulation Features

• Sequentail and parallel

• 50,704/sec

• Biphasic/triphasic

Sonata

Concerto

Electrode array

Advance bionics

• HR 90k advantage cochlear implant

Electrode array – HF 1J

Electrode array - HF midscala

• Atraumaticity-Designed to preserve delicate intra

cochlear structures with proven preservation of

hearing

• Consistent Mid Scala placement

• Surgical flexibility

– RW or Cochleostomy

– Free hand or insertion tool

– Reloadable

• Full spectrum electrical coverage

Electrode Innovations-HiFocus MidScala Electrode

Education

Cochlear implant systems