N/A
N=39
Place-based Mapping in EAS Listeners
Cochlear Implant
Bottom Line
View on ClinicalTrials.gov: NCT04722042 ↗Enrolled (actual)
39
Serious AEs
0.0%
Results posted
May 2025
Primary outcome: Primary: Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time — 18; 10; 40; 34 percent of words correctly repeated — p=0.557
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- place-based mapping (Other); default mapping (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- University of North Carolina, Chapel Hill
- Primary completion
- Jul 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time |
18; 10; 40; 34; 49; 45 | 0.557 |
| PRIMARY Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) |
10; 19; 20; 24; 10; 20 | 0.208 |
| PRIMARY Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) |
6; 0; 15; 10; 14; 5 | 0.126 |
| SECONDARY Perceived Abilities Over Time |
4; 4; 5; 5; 5; 6 | 0.369 |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT04722042). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.