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Cochlear implant systems

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Cochlear implant systems

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Cochlear implant systems

  1. 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. 2. Cochlear implant • Implantable device • Electrode array • Sound processor
  3. 3. Implant Coclear Nucleus Medel Advance Bionics Digisonic Neurotron
  4. 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. 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. 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. 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. 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. 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
  10. 10. 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
  11. 11. Contour Advance™ Perimodiolar Electrode Straight with stylet in place With stylet removed Softip and white to enable Advance Off-Stylet™ (AOS™) insertion technique.
  12. 12. Postoperative X-ray Contour Advance™ electrodeStraight Electrode
  13. 13. Scala Tympani Scala Vestibuli Scala Media To auditory nerve Basilar Membrane Lateral Wall Modiolar Wall Spiral Ganglion nerve cells 1 Hair Cells
  14. 14. Scala Tympani Scala Vestibuli Scala Media Lateral Wall Modiolar Wall 1
  15. 15. Scala Tympani Scala Vestibuli Scala Media Lateral Wall Modiolar Wall Electrode 1 Electrode
  16. 16. Scala Tympani Scala Vestibuli Scala Media Lateral Wall Modiolar Wall 1 Electrode
  17. 17. Scala Tympani Scala Vestibuli Scala Media Lateral Wall Modiolar Wall 1 Electrode
  18. 18. Scala Tympani Scala Vestibuli Scala Media Lateral Wall Modiolar Wall Electrode 1
  19. 19. 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
  20. 20. Distribution of spiral ganglion 3-Dimension reconstruction Ariyasu et al. (1989) Organ of Corti Spiral ganglion Osseous spiral lamina Cochlear nerve
  21. 21. 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.
  22. 22. 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
  23. 23. 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).
  24. 24. Cochlear Nucleus CI422 • Cochlear’s next generation straight electrode • Suitable for round window or cochleostomy • features
  25. 25. 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
  26. 26. 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
  27. 27. 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).
  28. 28. 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.
  29. 29. 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
  30. 30. 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
  31. 31. 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
  32. 32. 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°
  33. 33. 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
  34. 34. It’s a Challenging World More people with hearing needs They have different levels of hearing loss They need different treatment solutions
  35. 35. Different Clinical Indications
  36. 36. 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
  37. 37. 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
  38. 38. You can focus on what matters!
  39. 39. Electrode Selection WHICH ELECTRODE TO USE?
  40. 40. 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
  41. 41. Post Operative X-rays (Source: courtesy the Hearing CRC) Nucleus Contour Advance Electrodes
  42. 42. 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
  43. 43. 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)
  44. 44. 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)
  45. 45. 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)
  46. 46. 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
  47. 47. 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
  48. 48. 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
  49. 49. 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
  50. 50. It’s a Challenging World Dissatisfaction with hearing aids More patients with presbycusis, who are missing out on life
  51. 51. 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
  52. 52. 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
  53. 53. Medel • Maestro • Synchrony • Synchrony EAS
  54. 54. Medel sonata
  55. 55. Stimulation Features • Sequentail and parallel • 50,704/sec • Biphasic/triphasic
  56. 56. Sonata
  57. 57. Concerto
  58. 58. Electrode array
  59. 59. Advance bionics
  60. 60. • HR 90k advantage cochlear implant Electrode array – HF 1J Electrode array - HF midscala
  61. 61. • 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

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