Cochlear implant systems

1. Cochlear implant systems
Dr Rohit Udaya Prasad
Junior Consultant
ENT & cochlear Implant surgeon
Dr Hans Center For ENT, Hearing Care & Vertigo,New Delhi

2. Cochlear implant
• Implantable device
• Electrode array
• Sound processor

3. Implant
Coclear Nucleus
Medel
Advance Bionics
Digisonic
Neurotron

4. Surgeon
Knowledge on available implant devices
Design the bed for the implant based on the device used
Use of specific electrode for specific conditions

5. Cochlear Nucleus
Monopolar
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)

6. Inside the receiver-stimulator
CI24RE chip
Application Specific Integrated Circuit
Mounted directly on circuit board
Freedom significantly increases impact strength
Withstands 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

7. Performance
POWERFUL DIGITAL MICROCHIP
• AutoNRT™ – precise and convenient Neural Response
Telemetry system
• ‘Future Ready’ – capacity to support ongoing
advancements in sound processing technologies

8. Performance
MRI 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)

9. 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

11. 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 &
intra- operative repositioning

12. Contour Advance™ Perimodiolar Electrode
Straight with stylet in place
With stylet removed
Softip and white to enable Advance Off-Stylet™ (AOS™)
insertion technique.

13. Postoperative X-ray
Contour Advance™ electrodeStraight Electrode

14. Scala
Tympani
Scala Vestibuli
Scala Media
To auditory nerve
Basilar
Membrane
Lateral Wall
Modiolar Wall
Spiral Ganglion nerve
cells
1
Hair
Cells

15. Scala
Tympani
Scala Vestibuli
Scala Media
Lateral Wall
Modiolar Wall
1

16. Scala
Tympani
Scala Vestibuli
Scala Media
Lateral Wall
Modiolar Wall
Electrode
1
Electrode

17. Scala
Tympani
Scala Vestibuli
Scala Media
Lateral Wall
Modiolar Wall
1
Electrode

18. Scala
Tympani
Scala Vestibuli
Scala Media
Lateral Wall
Modiolar Wall
1
Electrode

19. Scala
Tympani
Scala Vestibuli
Scala Media
Lateral Wall
Modiolar Wall
Electrode
1

20. Precision
FOCUSED 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 length
for excellent hearing zone coverage1-3
• 17 mm length targets majority of
spiral ganglion cells4 for effective frequency
coverage
Nucleus CI24RE with Contour Advance electrode

21. Distribution of spiral ganglion
3-Dimension reconstruction
Ariyasu et al. (1989)
Organ of Corti
Spiral ganglion Osseous spiral lamina
Cochlear nerve

23. 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
LateralPerimodiolar
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.

24. Standard
insertion
technique
Precise
GENTLE 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

25. protect delicate cochlear structures1
AOS™ insertion technique:
• Flexible pre-curved electrode
• With Softip™
• AOS insertion technique
Nucleus 5 Cochlear Implant (CI512)
Precise
GENTLE INSERTION
protect delicate cochlear structures1
protect delicate cochlear structures1
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).

26. Cochlear Nucleus CI422
• Cochlear’s next generation straight electrode
• Suitable for round window or cochleostomy
• features

27. 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

28. 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

29. 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).

30. 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.

31. 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

32. 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

33. 12 SKARZYNSKI ET AL(2012)
29 SKARZYNSKI ET AL(2010
49 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

34. Cochlear™ electrode types
15mm
E1
20mmCochlear™ Nucleus® CI422 straight electrode
16mmCochlear™ Nucleus® Hybrid L24 electrode
17mm
Cochlear™ 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°

35. Considerations for electrode choice
Handling Approach Outcomes
Implant
Appropriate Insertion
Depth (400-450
degrees)
Atraumatic (half-
band, basal stiffener,
smooth lateral
surface)
Cochleostomy Round Window Periomodiolar
Preservation of
residual hearing
Contour
Advance
?
CI422

36. It’s a Challenging World
More people with
hearing needs
They have different
levels of hearing loss
They need different
treatment solutions

37. Different Clinical Indications

38. 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

39. It’s a Challenging World
More people with
hearing needs
They have different
levels of hearing loss
They need different
treatment solutions
A perfect fit
For every ear

40. You can focus on
what matters!

41. Electrode Selection
WHICH
ELECTRODE
TO USE?

42. 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, 2013
Susan et al, The American Journal of Otology, 1999

43. Post Operative X-rays
(Source: courtesy the Hearing CRC)
Nucleus Contour Advance Electrodes

44. COCHLEAR ELECTRODE SOLUTION
Slim Straight
Indication Group 2:
PATIENT NEEDS
Optimise Hybrid hearing
ELECTRODE FEATURE
Hearing
preservation electrode
Moderately Severe to Profound High Frequency Hearing Loss
PROVEN CLINICAL DATA
Skarzynski et al, Ear and Hearing, 2014
Jurawitz et al, Audiology & Neurotology, 2014

45. Proven Clinical Data
CLINICAL 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)

46. 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)

47. Proven Clinical Data
CLINICAL 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)

48. 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

49. COCHLEAR ELECTRODE SOLUTION
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
PROVEN CLINICAL DATA
Various clinical papers report good outcomes with Nucleus electrodes
for the a variety of malformations.
* Product not available in all markets

50. PROVEN CLINICAL DATA
Special Medical Conditions Electrode Type Clinical Data
Otosclerosis & LVA
Straight
Contour 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
Straight
Contour 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, III
Straight
Contour 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

51. Cochlear Electrode Solution
Special 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

52. It’s a Challenging World
Dissatisfaction with hearing aids
More patients with presbycusis,
who are missing out on life

53. Cochlear Electrode Portfolio
Clinical Indications
Contour Advance® Slim
Straight
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

54. 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
Straight
For special anatomical conditions
1 Holden et al, Ear and Hearing, 2013
2 Skarzynski et al, Ear and Hearing, 2014
* Product not available in all markets
Contour Advance®
Perimodiolar placement for optimum performance1
Slim Straight
Hearing preservation electrode
for optimal Hybrid Hearing2

55. Medel
• Maestro
• Synchrony
• Synchrony EAS

56. Medel sonata

57. Stimulation Features
• Sequentail and parallel
• 50,704/sec
• Biphasic/triphasic

58. Sonata

59. Concerto

65. Electrode array

73. Advance bionics

74. • HR 90k advantage cochlear implant
Electrode array – HF 1J
Electrode array - HF midscala

75. • 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