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Completed

NCT Number: NCT04722042

Place-based Mapping in EAS 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.

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Key information

Conditions

Cochlear Implant

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UNC ENT at Carolina Crossing

Chapel Hill, North Carolina, 27517, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

place-based mapping

Other

Adjusting the electric frequency filters to align with the cochlear place frequency

default mapping

Other

Default frequency filter assignments

Primary outcomes

  1. Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time

    Time frame: 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.

    This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

  2. Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)

    Time frame: 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.

    This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

  3. Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front)

    Time frame: 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.

    This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

Secondary outcomes

  1. Perceived Abilities Over Time

    Time frame: 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.

    This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps).

Other outcomes

  1. Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing

    Time frame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

    Participants with normal hearing (Arm 3) listening to simulations of default versus place-based maps.

    All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no follow-up visits.

  2. Vowel Recognition for Participants With Normal Hearing

    Time frame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

    Vowel recognition for participants with normal hearing controls listening to simulations of default versus place-based maps.

    All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no additional visits.

  3. Sentence Understanding in Noise for Participants With Normal Hearing

    Time frame: All procedures completed at baseline (one visit that was ~ 20 minutes in duration).

    Sentence understanding in noise for participants with normal hearing controls listening to simulations of default versus place-based maps

    All procedures completed at baseline (one visit that was ~ 20 minutes in duration). There were no additional visits.

Sponsors and collaborators

Lead sponsor

University of North Carolina, Chapel Hill

Other

Collaborators

  • National Institute on Deafness and Other Communication Disorders (NIDCD)

Registry information

Official study title

Place-based Mapping in Electric-acoustic Stimulation Listeners

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2021
Registry last updated
May 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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