What Is A Cochlear Implant Cochlear Implant Devices Currently

					                                                     What Is A Cochlear Implant?
        Cochlear Implantation:                       • Very different from a hearing aid
Bilateral, Bimodal, Asymmetric, Hybrid                 – Whereas a hearing aid simply amplifies sound, a
                                                         cochlear implant bypasses the outer hair cells of
                                                         the cochlea and directly stimulates the auditory
     Presenter: Sarah King, Au.D., CCC-A                 nerve

            Midwest Ear Institute
           4200 Pennsylvania Ave.
           Kansas City, MO 64111
               816/932-1660
              www.mei-kc.org




   Cochlear Implant Devices                            Cochlear Implant Devices
 Currently Available in the U.S.                     Currently Available in the U.S.
   Advanced Bionics Corp. HiRes/90K                     Med-El Corp. Sonata
    “Bionic Ear”                                            - Opus 2 modular speech processor
      - Harmony “ear level” or Platinum “body               - Rechargeable and disposable batteries
        worn” speech processor                              - Remote control
      - Rechargeable batteries




   Cochlear Implant Devices                            Current Candidacy Guidelines -
 Currently Available in the U.S.                                  Adults

   Cochlear Americas Nucleus 5                   •   Moderate to profound SNHL
       - N5 “ear level” or “lite wear” speech
         processor                               •   <50% sentence scores in ear to be
       - Rechargeable and disposable batteries       implanted
       - Remote control
                                                 •   <60% sentence scores in opposite ear

                                                 •   Lack of benefit from hearing aids
     Current Candidacy Guidelines -
               Children                                   Candidacy Changes

                                             • Sentence test changes
•   >12 months of age
                                                 – HINT sentences vs. AZ Bio sentences
•   <30% speech scores
                                             • Monosyllabic Word Test
•   Lack of auditory progress




Other Candidacy Considerations                          Predicting Performance

• CT-scan or MRI showing no
  contraindications to electrode placement   •   Age at onset
  in the cochlea                                 –   Pre-lingual
                                                 –   Post-lingual
• Medical exam showing no
                                             • Duration of deafness
  contraindications to surgery               • Hearing Aid Use
• Appropriate expectations and high          • Age at Implantation
  motivation




                  Outcomes                               Outcomes in Children


• Open Set Sentences - HINTQ >80%            • Different expectations based on
                                               speech/language development
• Open Set Words - CNC >50%
                                             • Age at implantation makes a difference
• Ability to use telephone
                                             • Auditory rehabilitation/education critical
• Enhanced lip reading
What about bilateral candidacy?                            Binaural Advantages
•   Hearing with 2 ears is better than with 1

•   Handicap of unilateral hearing loss well      • Summation
    documented                                    • Head Shadow
                                                  • Sound Localization
•   Extensive support in hearing aid literature
                                                  • Hearing in Noise
•   Now unequivocal evidence of advantage in
    cochlear implant recipients




                  Summation                                 Head Shadow Effect
                                                  • Most robust
• Benefit of signal presentation to both            bilateral effect
  ears as opposed to either ear alone             • Reduction is
• Effect of central processing                      almost
• Perceived sound is louder than same               immediately
  signal perceived in one ear                       noted after
• 3dB gain
                                                    bilateral CI




            Sound Localization                                Hearing in Noise
• Up to 30 degree
  improvement in
  sound localization                              • Marked improvement with bilateral CI
• Best users can                                  • 22% advantage when listening to
  localize to                                       speech in noise
  <5degrees
                                                  • 3 dB SNR improvement
• Normal hearing -
  <2degrees
             Cost Effectiveness                         Current Clinical Trials for Non-
                                                         Traditional Cochlear Implant
•   Quality Adjusted Life Year [QALY]                             Candidates
    –   Dialysis = $61,294/QALY                    •    Cochlear Implants in Adults with
    –   Knee replacement = $59,000/QALY                 Asymmetric Hearing Loss

• Unilateral implant = $9,000-                     •    Nucleus Hybrid L24 (electro-acoustic
  11,000/QALY                                           stimulation)
• Bilateral implants = $24,859/QALY




        Cochlear Implants in Adults with               Candidacy Criteria for Asymmetric
           Asymmetric Hearing Loss                                   Study
•   Designed for patients with asymmetric
    hearing loss who are effectively functioning   •    18 years of age or older
    with one ear, but may be missing benefits of   •    Poorer ear (implant ear): severe to profound
    binaural hearing (localization, hearing in          sensorineural hearing loss, meets current CI
    noise, quality)                                     candidacy criteria
•   Does crossover from the “good” ear help        •    Better ear: sensorineural hearing loss with 4-
                                                        frequency PTA >= 40 dB HL, but not reaching
    keep the poorer ear functioning for an              severe to profound range
    implant?
                                                          – Does not meet current CI candidacy criteria
•   Subjects are a traditional implant candidate
                                                          – Documented stable hearing thresholds for at
    in one ear, but not in the “good” ear (i.e.
    speech recognition better than 60%)                     least one year
                                                          – Uses appropriately fit hearing aid




    Asymmetric Study Requirements                                 Patient Example
                                                   •   77 year old male
• Study evaluation testing (~4 hours each
                                                   •   Aided speech understanding left: CNC words 0%,
  visit) at pre-op, initial activation, 1              HINT sentences 0% with masking
  month, 3 month, 6 month, 9 month, and
  12 months
• Questionnaires at each study visit
• Travel to Washington University in St.
  Louis for 1 test session
                Patient Example                            Hybrid Cochlear Implants

•   Surgery – Complication
•   Post Op
    –   After only 2 weeks, patient reported he
        could localize sound source
    –   At 1 month, 85% on HINTs with CI only
    –   Bimodal improvements on all tests
•   3 months post




     Hybrid Cochlear Implantation                               The best of both?

                                                  • Help hearing aid
•   Acoustic Hearing in Low Frequencies             patients who are
                                                    not quite cochlear
    –   Music, melody, tone
                                                    implant
•   Cochlear Implant in High Frequencies            candidates
    –   Speech discrimination                     • Expand the
                                                    criteria of current
                                                    implant
                                                                          HEARING AID   CI




            Principles of Hybrid CI                           Cochlear Hybrid L24
                                                      • Current FDA Study
• Hearing preservation
                                                      • 16mm electrode
• Reduce surgical trauma
                                                      • 22 contacts
• Stimulation with combined modalities
                                                      • Same surgical approach
• Electrode Design
    –   Thinner, shorter, flexible
               Nucleus Hybrid L24                                         Hybrid™ Candidacy
                                                                                             •     Candidates typically present with stable
    •    Expansion of ongoing study beginning in 2003                                              mild to moderate hearing loss in the low
                                                                                                   frequencies (up to 500 Hz) threshold < 60
    •    Designed for ski-slope hearing losses, where                                              dB and severe to profound hearing loss in
                                                                                                   the mid and/or high frequencies (above
         traditional hearing aids provide no benefit to                                            1500 Hz).

         speech understanding
                                                                                             •     Audiometric thresholds for the ear to be
    •    Electrode only partially inserted for high                                                implanted should fall within the shaded
                                                                                                   area indicated.
         frequencies, patient hears lower pitches
         acoustically                                                                        •     Aided monosyllabic word scores between
    •    First Hybrid devices were 10 mm, 6                                                        10% and 60% in ear to be implanted

         electrodes, now 15 mm, 22 electrodes                                                •     Aided word scores equal to or better than
                                                                                                   ear to be implanted, but no more than
                                                                                                   80%

                                                                   *NOT FDA APPROVED, CLINICAL TRIALS
                                                                                   ONGOING




        Exclusion Criteria for Hybrid CI                  Hybrid L24 Study Requirements
    •    Duration of severe-to-profound hearing           • Study evaluation testing (4-6 hours each
         loss greater than 30 years                         visit) at pre-op, initial activation, 3
    •    Congenital hearing loss                            months, 6 months, and 12 months
    •    Conductive hearing loss                          • Questionnaires at each study visit
    •    Auditory neuropathy
    •    Ossification or any other cochlear
         anomaly that might prevent electrode
         insertion.




                  Patient Example                                            Patient Example
•   69 y/o male, stable                                   •   3 months post
    hearing loss                                              –   CNC’s:
•   Fit with Widex                                                 •   Ipsilateral Acoustic: 46%
    Audibility Extender                                            •   Implant Alone: 80%
•   CNC: 52% aided                                                 •   Hybrid Mode: 92%
    right, 44% aided left                                          •   Combined Mode: 94%
•   AzBio +5 SNR                                              –   AZ Bio +5 SNR:
                                                                   •   Combined: 75%
                                                          •   6 months post
    Cochlear Implant Summary
                                                    Thank you!
• Cochlear Implants provide safe, effective
  auditory (re)habilitation to adult and
  pediatric patients with severe-profound           Questions?
  SNHL                                              Comments?
• Bilateral Implantation provides greater
  benefit than unilateral implantation        Sarah King, Au.D., CCC-A
• Indications have increased along with
  performance

				
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posted:7/29/2011
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