Mapping Strategies for Cochlear Implant Recipients

Recruiting in Palo Alto (17 mi)

Overseen by Kevin D Brown, MD, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: University of North Carolina, Chapel Hill

No Placebo Group

Trial Summary

What is the purpose of this trial?

Purpose: Investigate monaural and binaural hearing in electric-acoustic stimulation (EAS) users with place-based versus default maps. Participants: Cochlear implant recipients and normal-hearing listeners Procedures (methods): This is a prospective, longitudinal investigation of the monaural and binaural outcomes (such as speech perception, spatial hearing, and/or subjective benefit) of cochlear implant recipients listening with different programs. The programs will incorporate different patient and device variables to determine the effect on cochlear implant recipient outcomes.

Research Team

Margaret T Dillon, AuD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Kevin D Brown, MD, PhD

Principal Investigator

University of North Carolina, Chapel Hill

Eligibility Criteria

This trial is for cochlear implant recipients aged 18-80 who consider English their native language, have a MED-EL array, and can detect sounds at or below 65 dB HL at 125 Hz without aid. It's not specified who cannot join the trial.

Inclusion Criteria

I am between 18-80 years old, speak English natively, have a MED-EL implant, and can hear sounds below 65 dB at 125 Hz.

You have a cochlear implant.

Treatment Details

Interventions

• default mapping (Behavioural Intervention)
• place-based mapping (Behavioural Intervention)

Trial Overview The study is examining how different programming of cochlear implants affects hearing. Participants will try out 'place-based mapping' versus the standard settings to see which offers better speech perception, spatial hearing, and overall satisfaction.

Participant Groups

Group I: Place-based Experimental Treatment 1 Intervention

Frequency filters adjusted to align with the cochlear place frequency

Group II: Default Experimental Treatment 1 Intervention

The default frequency filters assigned by the clinical software

Who Is Running the Clinical Trial?

University of North Carolina, Chapel Hill

Lead Sponsor

Trials

1,588

Recruited

4,364,000+

Dr. Peggy P. McNaull

University of North Carolina, Chapel Hill

Chief Medical Officer

MD from Louisiana State University School of Medicine

Dr. Lynne Fiscus

University of North Carolina, Chapel Hill

Chief Executive Officer since 2020

MD from Georgetown University, MPH from UNC

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborator

Trials

377

Recruited

190,000+

Joshua M. Levy

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Medical Officer

MD, MPH, MS

Debara L. Tucci

National Institute on Deafness and Other Communication Disorders (NIDCD)

Chief Executive Officer since 2019

MD, MS, MBA