Place-based Mapping in EAS Listeners

Place-based Mapping in Electric-acoustic Stimulation Listeners

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Cochlear Implant
• Intervention / Treatment: Other: default mapping; Other: place-based mapping

• Study Type: Interventional
• Enrollment (Estimated): 80
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Margaret Dillon, AuD, PhD; Phone Number: 919-966-5251; Email: mdillon@med.unc.edu

Study Locations

• United States
  • North Carolina
    • Chapel Hill, North Carolina, United States, 27517
      • UNC ENT at Carolina Crossing

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

Description

Cochlear implant participants

Inclusion Criteria:

• 18-80 years of age at implantation, identify English as native language, Medical Electronics (MED-EL) array recipient, and a postoperative unaided detection threshold of less than or equal to 65 decibel (dB) hearing level (HL) at 125 Hz

Exclusion Criteria:

• Report or present with a cognitive delay or impairment

Normal-hearing controls

Inclusion Criteria:

• 18-80 years of age at time of testing, unaided detection thresholds of 35 dB HL or better from 500-4000 Hz, identify English as native language

Exclusion Criteria:

• Report or present with a cognitive delay or impairment

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Default; The default frequency filters assigned by the clinical software	Other: default mapping; Default frequency filter assignments
Experimental: Place-based; Frequency filters adjusted to align with the cochlear place frequency	Other: place-based mapping; Adjusting the electric frequency filters to align with the cochlear place frequency

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Monaural perception over time	Monaural perception (e.g., word recognition in quiet) will be assessed at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals.	Up to 12 months post-activation
Binaural hearing abilities over time	Binaural hearing abilities (e.g., spatial release from masking) will be assessed at defined intervals (e.g., 1, 3, 6, and 12 months post-activation). Performance (e.g., percent correct) will be compared within-subject and between group over the study intervals.	Up to 12 months post-activation

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Perceived abilities over time	Perceived abilities will be assessed with questionnaires (e.g., Speech, Spatial, and Qualities of hearing scale; SSQ) at defined intervals (e.g., activation, and 1, 3, 6, and 12 months post-activation). A subject indicates his/her perceived abilities for each question on the SSQ using a Likert scale, with a range of 0-10 (with 10 indicating better perceived abilities). Responses will be compared between group over the study intervals.	Up to 12 months post-activation

Collaborators and Investigators

• Sponsor: University of North Carolina, Chapel Hill
• Collaborators: National Institute on Deafness and Other Communication Disorders (NIDCD)
• Investigators: Principal Investigator: Margaret T Dillon, AuD, PhD, University of North Carolina, Chapel Hill; Principal Investigator: Kevin D Brown, MD, PhD, University of North Carolina, Chapel Hill

Study record dates

Study Major Dates

• Study Start (Actual): February 23, 2021
• Primary Completion (Estimated): June 30, 2024
• Study Completion (Estimated): June 30, 2024

Study Registration Dates

• First Submitted: January 19, 2021
• First Submitted That Met QC Criteria: January 19, 2021
• First Posted (Actual): January 25, 2021

Study Record Updates

• Last Update Posted (Actual): April 18, 2024
• Last Update Submitted That Met QC Criteria: April 16, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Other Study ID Numbers: 20-3022; R21DC018389 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
• IPD Sharing Time Frame: beginning 9 to 36 months following publication
• IPD Sharing Access Criteria: Investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No