Cochlear Implant Innovation, Research and Advancement (CIRCA) Workshop

Cochlear Implant Innovation, Research and Advancement (CIRCA) Workshop

Meeting Poster:

Poster

Meeting Agenda and Speaker Bios:

Agenda and Bios

Meeting Link: https://weillcornell.zoom.us/webinar/register/WN_hsoZDiKuR6uXDKsXgKznbw

Workshop Planning Organizations: 

American Academy of Otolaryngology - Head and Neck Surgery (AAO-HNS)

American Cochlear Implant Alliance (ACIA)

Boston Medical Center

FDA, Center for Devices and Radiological Health

Medical Device Epidemiology Network (MDEpiNet) Coordinating Center at Weill Cornell Medicine

National Evaluation System for health Technologies (NEST) 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.

Meeting Recordings / Additional Materials:

Day 1:

Opening Remarks Day 1

Session I: Cochlear Implants Technology and Regulation

Cochlear Implants Regulatory History and Challenges, FDA Perspective

Cochlear Implants Technological Developments, Industry Perspective Part 1

Cochlear Implants Technological Developments, Industry Perspective Part 2

Cochlear Implants Technological Developments, Industry Perspective Part 3

Cochlear Implants Technological Developments, Industry Perspective Part 4

Hearing Loss and Cochlear Implants Patients’ Perspective: Adults & Pediatrics Part 1

Hearing Loss and Cochlear Implants Patients’ Perspective: Adults & Pediatrics Part 2

Clinical Perspectives on Cochlear Implants, Academia/Clinical Perspective

Payer’s Perspective: Blue Cross Blue Shield

Discussion Section Day 1 Session I

Session II: Evaluation of Cochlear Implants Throughout the Total Product Life Cycle

Evidence Needs for Patients Candidacy Criteria Part 1

Evidence Needs for Patients Candidacy Criteria Part 2

Considerations for Preservation of Residual Hearing and Electroacoustic Stimulation Part 1

Considerations for Preservation of Residual Hearing and Electroacoustic Stimulation Part 2

Evidence Needs and Considerations for Individual Ear Indications

Evidence Needs and Considerations for Pediatric Patients

Evidence Needs for Post-Approval Studies Required as Condition of Approval for Cochlear Implants

Disparities in Access to Cochlear Implants Part 1

Disparities in Access to Cochlear Implants Part 2

Discussion Section Day 1 Session II

Session III: Evidence Needs to Support Cochlear Implants Innovation

Emerging Cochlear Implant Technologies and Associated Evidence Needs

Alignment of the Regulatory and Reimbursement Systems: Impact on the Cochlear Implants Community

Real‐World Evidence for Regulatory Purposes: Needs and Opportunities

Digital Health Opportunities for Innovation Part 1

Digital Health Opportunities for Innovation Part 2

Capabilities Patient Reported Outcome Measures Part 1

Capabilities Patient Reported Outcome Measures Part 2

Discussion Section Day 1 Session III and Closing Remarks

Day 2:

Session IV: Working on Data Infrastructure

NESTcc Overview

Coordinated Registries Networks (CRN) as Foundation for Device Evaluation

Overview of Cochlear Implant Registries Part 1

Overview of Cochlear Implant Registries Part 2

The Delphi Process: Stakeholders Effort to Identify Minimum Core Data Elements (MCDE) for Cochlear Implants

Discussion Section Day 2 Session IV and Opening Remarks

Session V: Tailoring Methods to Data Infrastructure

Lessons Learned from the Implementation of MCDE

International Registries - Blueprint for Success

Implementation of MCDE across the Coordinated Registry Network (CRN) ecosystem

Future Application of RWE/RWD for Hearing Devices

Discussion Section Day 2 Session V