Tue, Feb 01 | Zoom Webinar

Cochlear Implant Innovation, Research and Advancement (CIRCA) Workshop

Time & Location

Feb 01, 8:30 AM – Feb 02, 5:00 PM
Zoom Webinar

About the Event

Cochlear Implant Innovation, Research and Advancement (CIRCA) Workshop

Meeting Poster:

Poster

Meeting Agenda:

Agenda (to be updated with confirmed speakers)

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.

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