Expanded Cochlear Implant Candidacy Guidelines and Technology Advances

Transcription

1 Expanded Cochlear Implant Candidacy Guidelines and Technology Advances University of Michigan Cochlear Implant Program Caroline Arnedt, AuD, CCC-A Financial- Employed by University of Michigan and receives a salary Nonfinancial-No relevant nonfinancial relationships exist Brandi Griffin, AuD, CCC-A Financial- Employed by University of Michigan and receives a salary Nonfinancial-No relevant nonfinancial relationships exist

2 University of Michigan Cochlear Terry Zwolan, Ph.D., CCC-A Cochlear Implant Program Director Caroline Arnedt AuD., CCC-A Heidi Slager, AuD, CCC-A Brandi Griffin, AuD, CCC-A Casey Stach, M.A. Amy Paoletti, Au.D Anita Vereb, PhD, CCC-A Kelly Starr, M.S, CCC-SLP, LSLS Cert. AVT Jennifer Still, MHS, CCC-SLP, LSLS Cert. AVT Ellen Thomas, M.A, CCC-SLP, LSLS Cert. AVT H. Alexander Arts, M.D. G. Basura, M.D. Hussam El-Kashlan, M.D. Steve Telian, M.D Marc Thorne, M.D. Implant Team..

3 Storm dumps 3 ft. of snow in U.P. USA Today Network Robert Allen, Detroit Free Press 11:54 a.m. EST November 12, 2014 Hazardous wind driven snow on the way; Part of Michigan expecting over a foot of snow November 16, 2014

4 Cochlear Implants Today Expansion of adult criteria to include adults with greater residual hearing will likely result in consideration of expansion of pediatric CI criteria as well. With significant advances in research and technology, cochlear implant candidacy continues to expand.

5 FDA Pediatric CI Guidelines Age: 12 months to 24 months - profound sensorineural hearing loss in both ears Age: 25 months to 17 years- severe to profound sensorineural hearing loss bilaterally (< 30% MLNT or LNT) Minimal benefit from appropriate hearing aids

6 "Off-Label" and Investigational Use Of Marketed Drugs, Biologics, and Medical Devices Guidance for Institutional Review Boards and Clinical Investigators Good medical practice and the best interests of the patient require that physicians use legally available drugs, biologics and devices according to their best knowledge and judgement. If physicians use a product for an indication not in the approved labeling, they have the responsibility to be well informed about the product, to base its use on firm scientific rationale and on sound medical evidence, and to maintain records of the product's use and effects. Use of a marketed product in this manner when the intent is the "practice of medicine" does not require the submission of an Investigational New Drug Application (IND), Investigational Device Exemption (IDE) or review by an Institutional Review Board (IRB). However, the institution at which the product will be used may, under its own authority, require IRB review or other institutional oversight.

7 CI Candidacy: Case by Case Basis Implant outside FDA guidelines when clinically indicated: Failure to make appropriate progress With appropriately fit hearing aids With regular speech and language therapy

8 Not your Typical CI Candidate Patients with: Auditory Neuropathy Spectrum Disorder Sloping High Frequency Hearing losses (Post- Chemotherapy) Enlarged Vestibular Aqueducts (EVA), Narrow IAC, Common Cavity Patients with multiple disabilities Meeting HA Targets but not making progress Single Sided Deafness (SSD)/Unilateral Hearing Loss

9 18 years and older Moderate-profound SNHL < 60% open sentence recognition tests in best aided condition Adult FDA criteria

10 Hybrid Hearing Implant Hybrid Hearing System from Cochlear Americas FDA approval date: March 20, 2014 Cochlear Americas

11 Hybrid Goal: Provide an advantage that the 2 parts in isolation could not achieve Hearing Aid A Amplification of low frequency sounds improves: Prosody Melody Music Appreciation Speech in noise Cochlear Implant E Stimulation of high frequency sounds improves: Clarity of speech Fuller, richer sound

12 Other Hybrid Hearing Devices Current Devices Under Investigation: Med-El: Electric-Acoustic Systems (EAS) Advanced Bionics: Implantation of the HiRes90K Advantage Cochlear Implant with HiFocus Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults with Partial Deafness

13 What does the hybrid mean for children? Soft surgery, less traumatic devices and hybrid technology make it more likely that hearing will be preserved AND utilized in conjunction with a CI FDA approval of the hybrid for adults makes insurance approval for off label use with children more likely Ototoxicity Some insurances will approve a hybrid for an older child Anticipate a hybrid clinical trial in children in the next 5 years

14 CLINICAL TRIALS Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults (PI: H. Alexander Arts, MD) Evaluation of Revised Indications (ERID) for Cochlear Implant Candidacy for the Adult CMS Population (PI: Teresa Zwolan, PhD)

15 Safety and Efficacy of the Cochlear Nucleus CI422 Cochlear Implant in Adults (PI: H. Alexander Arts, MD) Moderate sloping to severe SNHL PTA Hz = 40+ db PTA Hz = 70+ db Candidacy is based on individual ear CNC scores using recorded stimuli at 60 db SPL CNC 10%-50% in the ear to be implanted CNC up to 70% in the contralateral ear HEARING LEVEL (db HL)

16 Evaluation of Revised Indications (ERID) for Cochlear Implant Candidacy for the Adult CMS Population Bilateral Moderate to profound sensorineural hearing loss Open set, recorded sentence score of < 60% in the best aided condition Bilateral Moderate to profound sensorineural hearing loss Recorded HINT sentence score of < 40% in the best aided condition

17 CIs & Single Sided Deafness Clinical Trials Cochlear Implantation in Single Sided Deafness and Asymmetrical Hearing Loss: a Cost/Utility Study Sponsor: University Hospital, Toulouse ClinicalTrials.gov Identifier: NCT Single-sided Deafness and Cochlear Implants Sponsor: University of Zurich ClinicalTrials.gov Identifier: NCT Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss Sponsor: Mayo Clinic ClinicalTrials.gov Identifier: NCT Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss Sponsor: Washington University School of Medicine ClinicalTrials.gov Identifier: NCT

18 SSD We now know that SSDs can have a significant effect including: Spatial hearing or localization of sound Due to head/shadow effect interaural time difference squelch effect Loss of binaural summation *All of these cause difficulty hearing in noise

19 And from the perspective of crucial Auditory BRAIN development Optimal Auditory Input to Brain EARLY Optimal Auditory Neural Network Development Optimal Brain Development and Function throughout Life

20 From Where it Began 1986

21 to Today 2014

22 Advances in Technology Lifestyle Adaptations Signal Streaming Accessories Remote Control & Improved Access FM/Roger Compatibilities Telephone Use Data Logging

23 Lifestyle Adaptations: Size

24 Lifestyle Adaptations: Water Resistance *not approved for use in the US

25 Streaming: Cochlear Corp. & Resound N6 Resound Hearing aid TV Streamer Mini Microphone Phone Clip

26 Streaming: Phonak & Advanced Bionics Remote Mic ComPilot TV link

27 Streaming: Med-El Opus Quattro 4 Rondo

28 Remote Control Med-El Advanced Bionics Cochlear Americas

29 Roger Technology Roger Inspiro Transmitter Roger X Universal Receiver Roger Pen Roger Clip-On Mic

30 Roger & Dynamic FM Compatibility

31 Telephone use Streaming of phone calls to both ears Cell phone on dominant/designated ear T-Mic Natural phone placement Automatic Telecoil

32 Data Logging Good user Why are decreasing volume Lots of time in quiet

33 Bimodal HA (R) + CI (L) HA (L) + CI (R) Bilateral HA (R) + HA (L) CI (R) + CI (L) Bilateral-Bimodal Complex Management: Bilateral and Bimodal (HA + CI (R) ) + (HA + CI (L)) : 2 Hybrid Devices HA (R) + (HA + CI (L)): 1 HA + 1 Hybrid (HA + CI (R)) + HA (L): 1 HA + 1 Hybrid

34 Summary Pediatric CI Candidacy Guidelines: Continue to expand & will follow adult CI candidacy expansion Consider CI options: When non-traditional CI candidate fails to make appropriate progress with traditional amplification Technology: Many great advances are available, use them! Advances will continue at a rapid rate, stay tuned!!

35 Thank you for your attention!