What Is A Cochlear Implant Cochlear Implant Devices Currently by jizhen1947


									                                                     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

   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

                  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
                                                  • 3 dB SNR improvement
• Normal hearing -
             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
                                                          – 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
•   Cochlear Implant in High Frequencies            candidates
    –   Speech discrimination                     • Expand the
                                                    criteria of current
                                                                          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

                                                                   *NOT FDA APPROVED, CLINICAL TRIALS

        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

                  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

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