Adults 18 to 80, any sex, with Cochlear Implant. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over TimePrimary· 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).
activation
Group
Value
95% CI
Default
18
± 16
Place-based
10
± 14
1 month
Group
Value
95% CI
Default
40
± 23
Place-based
34
± 22
3 months
Group
Value
95% CI
Default
49
± 20
Place-based
45
± 16
6 months
Group
Value
95% CI
Default
53
± 22
Place-based
50
± 19
12 months
Group
Value
95% CI
Default
56
± 26
Place-based
54
± 15
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)Primary· 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).
1 month
Group
Value
95% CI
Default
10
± 21
Place-based
19
± 23
3 month
Group
Value
95% CI
Default
20
± 19
Place-based
24
± 17
6 month
Group
Value
95% CI
Default
10
± 19
Place-based
20
± 24
12 month
Group
Value
95% CI
Default
18
± 21
Place-based
28
± 14
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front)Primary· 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).
1 month
Group
Value
95% CI
Default
6
± 14
Place-based
0
± 11
3 month
Group
Value
95% CI
Default
15
± 11
Place-based
10
± 14
6 month
Group
Value
95% CI
Default
14
± 14
Place-based
5
± 14
12 month
Group
Value
95% CI
Default
16
± 16
Place-based
17
± 18
Perceived Abilities Over TimeSecondary· 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).
preop
Group
Value
95% CI
Default
4
± 1
Place-based
4
± 1
1 month
Group
Value
95% CI
Default
5
± 2
Place-based
5
± 2
3 months
Group
Value
95% CI
Default
5
± 2
Place-based
6
± 2
6 months
Group
Value
95% CI
Default
5
± 2
Place-based
6
± 2
12 months
Group
Value
95% CI
Default
6
± 2
Place-based
7
± 1
Word Recognition With Default Versus Place-based Maps for Participants With Normal HearingSecondary· 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.
default map
Group
Value
95% CI
Normal Hearing Control
64
± 28
place-based map
Group
Value
95% CI
Normal Hearing Control
78
± 23
Vowel Recognition for Participants With Normal HearingSecondary· 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.
default map
Group
Value
95% CI
Normal Hearing Control
49
± 17
place-based map
Group
Value
95% CI
Normal Hearing Control
60
± 13
Sentence Understanding in Noise for Participants With Normal HearingSecondary· 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.
default map
Group
Value
95% CI
Normal Hearing Control
52
± 24
place-based map
Group
Value
95% CI
Normal Hearing Control
63
± 18
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by University of North Carolina, Chapel Hill
Last refreshed: 18 May 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04722042.