Place-based Mapping in EAS Listeners

Not Applicable

Completed

• Conditions: Cochlear Implant
• Interventions: Other: default mapping; Other: place-based mapping

• Registration Number: NCT04722042
• Lead Sponsor: University of North Carolina, Chapel Hill

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-19
• Study First Submitted QC: 2021-01-19
• Study First Posted: 2021-01-25
• Study Start: 2021-02-23
• Status Verified: 2024-07
• Primary Completion: 2024-07-07
• Study Completion: 2024-07-07
• Last Update Submitted: 2024-07-23
• Last Update Posted: 2024-07-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 39

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Default	default mapping	The default frequency filters assigned by the clinical software
Place-based	place-based mapping	Frequency filters adjusted to align with the cochlear place frequency

Primary Outcome Measures

Name	Time	Method
Monaural perception over time	Up to 12 months post-activation	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.
Binaural hearing abilities over time	Up to 12 months post-activation	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.

Secondary Outcome Measures

Name	Time	Method
Perceived abilities over time	Up to 12 months post-activation	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.

Trial Locations

Locations (1)

UNC ENT at Carolina Crossing; 🇺🇸 Chapel Hill, North Carolina, United States