Cochlear Implant Innovation, Research and Advancement (CIRCA) Workshop
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Cochlear Implant Innovation, Research and Advancement (CIRCA)
Workshop
February 1-2, 2022
Workshop Planning Organizations:
American Academy of Otolaryngology – Head and Neck Surgery (AAO-HNS)
American Cochlear Implant Alliance (ACIA)
Boston Medical Center
US Food and Drug Administration, Center for Devices and Radiological Health
Medical Device Epidemiology Network (MDEpiNet) Coordinating Center at Weill Cornell Medicine
National Evaluation System for health Technologies (NESTcc) Coordinating Center
National Institute on Deafness and Other Communication Disorders
About the Workshop:
The Food and Drug Administration (FDA) and the Medical Device Epidemiology Network (MDEpiNet) are
cosponsoring a Cochlear Implants Innovation, Research and Advancement (CIRCA) Virtual Workshop, to be held
February 1-2, 2022. As cochlear implant technologies advance, new applications arise such as cochlear implants
with capabilities for remote and artificial intelligence/machine learning-assisted programming, expansion of
patients’ candidacy using real-world evidence (RWE), preservation of residual hearing, new speech coding
strategies, and the need for consensus on core data elements necessary for the clinical evaluation and research of
cochlear implants.
Goal:
The goal of this workshop is for stakeholders to gain a better understanding of the current landscape of cochlear
implants and their related regulatory processes, and to contribute best practices to strengthen the research and
clinical infrastructure to capture and assess patients’ experiences with cochlear implants. This workshop will give
stakeholders an opportunity to provide input on the challenges and opportunities for advancing cochlear implant
research and innovation.
Objectives:
(1) Explore current science and the clinical practice as it relates to the future directions of
cochlear implants technology development.
(2) Identify critical research areas and review various clinical data types (e.g., data collected
from pivotal studies, real world data, registry data, etc.) that could support assessment of
device performance, new device indications, and device innovation.
(3) Discuss minimum core data elements (MCDE) that would efficiently capture the
experience of patients undergoing cochlear implant procedures.
(4) Summarize workshop consensus in a future journal article.
1February
1
TIME TOPIC CONFIRMED SPEAKER
8:30 AM 8:45 AM Day 1: Welcome and Introductory Remarks Dr. Malvina Eydelman, Director of the Office
of Health Technology, FDA
Dr. Vasum Peiris, Chief Medical Officer and
Director of Pediatrics and Special
Populations, FDA
8:45 AM 10:55 Session I: Cochlear Implants Technology
AM and Regulation
8:45 AM 9:00 AM Cochlear Implants Regulatory History and Dr. Srinivas Nandkumar, Director, Division of
Challenges, FDA Perspective Dental and ENT Devices, FDA
9:00 AM 9:15 AM Cochlear Implants Technological
Developments, Industry Perspective
9:15 AM 9:30 AM Hearing Loss and Cochlear Implants Patients’ Donna Sorkin, Executive Director, American
Perspective: Adults & Pediatrics Cochlear Implant Alliance
Barbara Mellert, Patient Advocate
9:30 AM 9:45 AM Clinical Perspectives on Cochlear Implants,
Academia/Clinical Perspective
9:45 AM 10:00 Payer’s Perspective: CMS & Private
AM
10:00 10:45 Moderated Q&A for Session I co-moderators: Dr. Eric Mann, Chief Medical
AM AM Officer, Office of Ophthalmic, Anesthesia,
Respiratory, ENT & Dental Devices, FDA
10:45 10:55 Break
AM AM
10:55 1:10 PM Session IIa: Evaluation of Cochlear
AM Implants Throughout the Total Product
Life Cycle
10:55 11:10 Evidence Needs for Patients Candidacy
AM AM Criteria
11:10 11:25 Considerations for Preservation of Residual
AM AM Hearing and Electroacoustic Stimulation
11:25 11:40 Evidence Needs and Considerations for
AM AM Individual Ear Indications
11:40 11:55 Evidence Needs and Considerations for
AM AM Pediatric Patients
11:55 12:10 PM Needs and Consideration Postmarket Dr. Shu-Chen Peng, Audiology & Senior Lead
AM Surveillance Reviewer, FDA
12:10 PM 12:25 PM Disparities in Access to Cochlear Implants Dr. Anand Devaiah, Professor and
Otolaryngologist, Boston Medical Center
12:25 PM 1:10 PM Moderated Q&A for Session IIa
2TIME TOPIC CONFIRMED SPEAKER
1:10 PM 1:55 PM Lunch Break
1:55 PM 3:55 PM Session IIb: Evidence Needs to Support
Cochlear Implants Innovation
1:55 PM 2:10 PM Emerging Cochlear Implant Technologies and
Associated Evidence Needs
2:10 PM 2:25 PM Alignment of the Regulatory and
Reimbursement Systems: Impact on the
Cochlear Implants Community
2:25 PM 2:40 PM Real‐World Evidence for Regulatory Purposes: Dr. Veronica Sansing-Foster, Senior
Needs and Opportunities Epidemiologist, FDA
Dr. Nilsa Loyo-Berríos, Associate Director,
FDA
2:40 PM 2:55 PM Digital Health Opportunities for Innovation
2:55 PM 3:10 PM Capabilities Patient Reported Outcome
Measures
3:10 PM 3:55 PM Moderated Q&A for Session IIb
3:55 PM 4:05 PM Day 1 Concluding Remarks Dr. Art Sedrakyan, Professor, Weill Cornell
Medicine, Medical Device Epidemiology
Network (MDEpiNet)
3February
2
TIME TOPIC CONFIRMED SPEAKER
8:30 AM 8:45 AM DAY 2: Welcome
8:45 AM 10:45 AM Session IV: Working on Data
Infrastructure
8:45 AM 9:00 AM NESTcc Overview Sandra Siami, Senior Vice President, National
Evaluation System for health Technology
(NESTcc)
9:00 AM 9:15 AM Coordinated Registries Networks (CRN) as Dr. Art Sedrakyan, Professor, Weill Cornell
Foundation for Device Evaluation Medicine, Medical Device Epidemiology
Network (MDEpiNet)
9:15 AM 9:30 AM Overview of Cochlear Implant Registries
9:30 AM 9:45 AM The Delphi Process: Stakeholders Effort to Suvekshya Aryal, Senior Research Analyst,
Identify Minimum Core Data Elements Weill Cornell Medicine, MDEpiNet
(MCDE) for Cochlear Implants
9:45 AM 10:00 AM International Registries for Cochlear
Implants
10:00 AM 10:45 AM Moderated Q&A for Session IV Co-moderators: Dr. Shu-Chen Peng,
Audiology & Senior Lead Reviewer, FDA
Dr. James C. Denneny, Executive Vice
President/CEO, American Academy of
Otolaryngology - Head and Neck Surgery
(AAO – HNS)
10:45 AM 10:55 AM Break
10:55 AM 12:25 PM Session V: Tailoring Methods to Data
Infrastructure
10:55 AM 11:10 AM Implementation of MCDE – Lessons
Learned
11:10 AM 11:25 AM Implementation of MCDE – Future Martha Velezis, Data Standards and
Adoption and Opportunities: Industry, Interoperability Consultant (FDA),
Clinical, Regulatory Chair/CRN Architecture Task Force
(MDEpiNet)
11:25 AM 11:40 AM Future Application for Hearing Aids Dr. Eric Mann, Chief Medical Officer, FDA
11:40 AM 12:25 PM Moderated Q&A for Session V Dr. Danica Marinac-Dabic, Associate Director,
FDA
Dr. Art Sedrakyan, Professor, Weill Cornell
Medicine, Medical Device Epidemiology
Network (MDEpiNet)
12:25 PM 12:40 PM Concluding Remarks and Next Steps Dr. Danica Marinac-Dabic, Associate Director,
FDA
4CIRCA CONFIRMED PARTICIPANTS LANGUAGE
If someone says yes, send this out to all persons who have said yes to participating.
Thank you for agreeing to participate in the CIRCA Workshop. Your contribution to this effort is invaluable and we
are looking forward your involvement. Please see the information below regarding your role in this workshop. You
can register for the workshop and see the latest agenda at https://www.mdepinet.net/event-details/.
I. Moderators:
a. No slides
b. Ensure speakers adhere to the assigned time limit
c. 45 minutes total for your session
II. Speakers:
a. Opening and Closing Remarks Speakers: 7-8 minutes (slides optional)
b. Speaker: 15 minutes (15-20 slides)
c. Co-Speakers
- 2-part talk - 7 minutes for each speaker (7-8 slides)
- Mulit participant talk (>2 speakers) – 5-7 minutes for each speaker (5-7 slides)
III. Panel Discussants:
a. Total time for questions directed to you: ~2 minutes (NO slides)
b. Focus: spontaneous comments based on preceding presentations, to launch the open Discussion segments
Finally, we are also compiling a speaker bio listing to distribute online. Please provide your full name, degrees,
title, professional affiliation, and provide a color headshot with brief bio (1 paragraph) sketch please do so by COB
Friday, January 7, 2022. Do not forget to register online for the workshop at https://www.mdepinet.net/event-
details/. For questions, please do not hesitate to contact me.
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