Cochlear Implant Innovation, Research and Advancement (CIRCA) Workshop  Click here for full agenda.

Served on the Planning Committee and participated as expert speakers for the FDA organized workshop “Cochlear Implants, Innovation, Research and Advancement (CIRCA) Virtual Workshop” held live February 1-2, 2022. Worked collaboratively with the FDA to determine topics and speakers for the virtual workshop with attendees from government, industry, academia, professional societies, and the clinical field (patients, physicians, and medical professionals). The recorded talks are an important resource for medical professionals, government, and the general public. https://www.acialliance.org/page/CIRCAWorkshop

The Cochlear Implants, Innovation, Research and Advancement (CIRCA) Virtual Workshop was held on February 1-2, 2022. The workshop reached an international audience of over 300 attendees from government, industry, academia, professional societies, and the clinical field (patients, physicians, and medical professionals). The recordings from the workshop are now online for your access. 

recordings available here

Speakers:

Donna Sorkin, Executive Director, American Cochlear Implant Alliance
Barbara Mellert, Patient Parent Representative
Hearing Loss and Cochlear Implants Patients’ Perspective: Adults & Pediatrics

Dr. Marlan Hansen, Otolaryngologist, University of Iowa Hospitals and Clinics
Clinical Perspectives on Cochlear Implants, Academia/Clinical Perspective

Dr. Terry Zwolan, Director of Audiology, Hearing First
Dr. Meredith Holcomb, Director of Hearing Implants, University of Miami (FL)
Evidence Needs for Patients Candidacy Criteria

Dr. Bruce Gantz, Head and Neck Surgery and Professor of Neurosurgery at the University of Iowa Carver College of Medicine
Dr. Craig Buchman, Lindburg Professor and Head Otolaryngology—Head & Neck Surgery, Washington School of Medicine, St. Louis
Considerations for Preservation of Residual Hearing and Electroacoustic Stimulation

Dr. Oliver Adunka, Professor & Director of Otology, Neurotology and Cranial Base Surgery, Ohio State University
Evidence Needs and Considerations for Individual Ear Indications

Dr. Nancy Young, Medical Director, Audiology & Cochlear Implant Programs, Lurie Children's Hospital
Evidence Needs and Considerations for Pediatric Patients

Dr. Matthew Bush, Professor & Endowed Chair in Rural Health Policy, University of KY College of Medicine
Disparities in Access to Cochlear Implants

René Gifford, Professor in the Department of Hearing and Speech Sciences, Vanderbilt University
Dr. Matthew Carlson, Professor of Otolaryngology and Neurologic Surgery, Mayo Clinic
Emerging Cochlear Implant Technologies and Associated Evidence Needs

Dr. Terry Zwolan, Director of Audiology, Hearing First
Alignment of the Regulatory and Reimbursement Systems: Impact on the Cochlear Implants Community

Dr. Theodore McRackan, Medical Director, Cochlear Implant Program, Medical University of South Carolina
Capabilities Patient Reported Outcome Measures

Dr. Jed Grisel, Texoma ENT & Allergy, ENT Specialty Partners
Overview of Cochlear Implant Registries

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.