Trial Outcomes & Findings for Place-based Mapping in EAS Listeners (NCT NCT04722042)

NCT ID: NCT04722042

Last Updated: 2025-05-18

Results Overview

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).

Recruitment status

COMPLETED

Study phase

Target enrollment

39 participants

Primary outcome timeframe

Up to 12 months post-activation

Results posted on

2025-05-18

Participant Flow

Three study arms: 1) Participants with a cochlear implant randomized to listen with a default map (Arm 1), 2) Participants with a cochlear implant randomized to listen with a place-based map, and 3) Participants with normal hearing who listened to simulations of both maps (control group).

Participants with cochlear implants were randomized to one of two groups (arms): Arm 1 (default maps) or Arm 2 (place-based maps) Participants with normal hearing (Arm 3; control group) listened to simulations of default and place-based maps.

Participant milestones

Participant milestones
Measure	Default The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency	Normal Hearing Control age-matched listeners with normal hearing in both ears
Overall Study STARTED	13	11	15
Overall Study COMPLETED	11	10	15
Overall Study NOT COMPLETED	2	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Default The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency	Normal Hearing Control age-matched listeners with normal hearing in both ears
Overall Study Withdrawal by Subject	2	1	0

Baseline Characteristics

Place-based Mapping in EAS Listeners

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Default n=13 Participants The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based n=11 Participants Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency	Normal Hearing Control Group n=15 Participants age-matched listeners with normal hearing in both ears	Total n=39 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Age, Categorical Between 18 and 65 years	7 Participants n=93 Participants	5 Participants n=4 Participants	11 Participants n=27 Participants	23 Participants n=483 Participants
Age, Categorical >=65 years	6 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	15 Participants n=483 Participants
Age, Continuous	61 years STANDARD_DEVIATION 14 • n=93 Participants	58 years STANDARD_DEVIATION 17 • n=4 Participants	54 years STANDARD_DEVIATION 16 • n=27 Participants	60 years STANDARD_DEVIATION 15 • n=483 Participants
Sex: Female, Male Female	8 Participants n=93 Participants	6 Participants n=4 Participants	11 Participants n=27 Participants	25 Participants n=483 Participants
Sex: Female, Male Male	5 Participants n=93 Participants	5 Participants n=4 Participants	4 Participants n=27 Participants	14 Participants n=483 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	13 Participants n=93 Participants	11 Participants n=4 Participants	15 Participants n=27 Participants	39 Participants n=483 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Asian	0 Participants n=93 Participants	1 Participants n=4 Participants	0 Participants n=27 Participants	1 Participants n=483 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Black or African American	0 Participants n=93 Participants	3 Participants n=4 Participants	2 Participants n=27 Participants	5 Participants n=483 Participants
Race (NIH/OMB) White	13 Participants n=93 Participants	7 Participants n=4 Participants	13 Participants n=27 Participants	33 Participants n=483 Participants
Race (NIH/OMB) More than one race	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=93 Participants	0 Participants n=4 Participants	0 Participants n=27 Participants	0 Participants n=483 Participants
Region of Enrollment United States	13 Participants n=93 Participants	11 Participants n=4 Participants	15 Participants n=27 Participants	39 Participants n=483 Participants
Unaided Threshold at 125 Hz	38 decibels STANDARD_DEVIATION 12 • n=93 Participants	30 decibels STANDARD_DEVIATION 13 • n=4 Participants	15 decibels STANDARD_DEVIATION 7 • n=27 Participants	34 decibels STANDARD_DEVIATION 13 • n=483 Participants

PRIMARY outcome

Timeframe: Up to 12 months post-activation

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

Outcome measures

Outcome measures
Measure	Default n=11 Participants The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based n=10 Participants Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time 1 month	40 percent of words correctly repeated Standard Deviation 23	34 percent of words correctly repeated Standard Deviation 22
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time activation	18 percent of words correctly repeated Standard Deviation 16	10 percent of words correctly repeated Standard Deviation 14
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time 3 months	49 percent of words correctly repeated Standard Deviation 20	45 percent of words correctly repeated Standard Deviation 16
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time 6 months	53 percent of words correctly repeated Standard Deviation 22	50 percent of words correctly repeated Standard Deviation 19
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time 12 months	56 percent of words correctly repeated Standard Deviation 26	54 percent of words correctly repeated Standard Deviation 15

PRIMARY outcome

Timeframe: Up to 12 months post-activation

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

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).

Outcome measures

Outcome measures
Measure	Default n=11 Participants The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based n=10 Participants Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) 1 month	10 percent of words correctly repeated Standard Deviation 21	19 percent of words correctly repeated Standard Deviation 23
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) 3 month	20 percent of words correctly repeated Standard Deviation 19	24 percent of words correctly repeated Standard Deviation 17
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) 6 month	10 percent of words correctly repeated Standard Deviation 19	20 percent of words correctly repeated Standard Deviation 24
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) 12 month	18 percent of words correctly repeated Standard Deviation 21	28 percent of words correctly repeated Standard Deviation 14

PRIMARY outcome

Timeframe: Up to 12 months post-activation

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

Outcome measures

Outcome measures
Measure	Default n=11 Participants The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based n=10 Participants Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) 1 month	6 percent of words correctly repeated Standard Deviation 14	0 percent of words correctly repeated Standard Deviation 11
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) 3 month	15 percent of words correctly repeated Standard Deviation 11	10 percent of words correctly repeated Standard Deviation 14
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) 6 month	14 percent of words correctly repeated Standard Deviation 14	5 percent of words correctly repeated Standard Deviation 14
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) 12 month	16 percent of words correctly repeated Standard Deviation 16	17 percent of words correctly repeated Standard Deviation 18

SECONDARY outcome

Timeframe: Up to 12 months post-activation

Population: This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). One participant in the place-based group did not complete the SSQ questionnaire at the 6 month post-activation visit.

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).

Outcome measures

Outcome measures
Measure	Default n=11 Participants The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based n=10 Participants Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency
Perceived Abilities Over Time preop	4 score on scale of 1 (worst) to 10 (best) Standard Deviation 1	4 score on scale of 1 (worst) to 10 (best) Standard Deviation 1
Perceived Abilities Over Time 1 month	5 score on scale of 1 (worst) to 10 (best) Standard Deviation 2	5 score on scale of 1 (worst) to 10 (best) Standard Deviation 2
Perceived Abilities Over Time 3 months	5 score on scale of 1 (worst) to 10 (best) Standard Deviation 2	6 score on scale of 1 (worst) to 10 (best) Standard Deviation 2
Perceived Abilities Over Time 6 months	5 score on scale of 1 (worst) to 10 (best) Standard Deviation 2	6 score on scale of 1 (worst) to 10 (best) Standard Deviation 2
Perceived Abilities Over Time 12 months	6 score on scale of 1 (worst) to 10 (best) Standard Deviation 2	7 score on scale of 1 (worst) to 10 (best) Standard Deviation 1

OTHER_PRE_SPECIFIED outcome

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

Population: Arm 3: Participants with normal hearing listening to simulations of default versus place-based maps One participant did not complete this task

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.

Outcome measures

Outcome measures
Measure	Default n=14 Participants The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency
Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing default map	64 percent of words correctly repeated Standard Error 28	—
Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing place-based map	78 percent of words correctly repeated Standard Error 23	—

OTHER_PRE_SPECIFIED outcome

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

Population: Arm 3: Participants with normal hearing listening to simulations of default versus place-based maps

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.

Outcome measures

Outcome measures
Measure	Default n=15 Participants The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency
Vowel Recognition for Participants With Normal Hearing default map	49 percent of vowels correctly repeated Standard Deviation 17	—
Vowel Recognition for Participants With Normal Hearing place-based map	60 percent of vowels correctly repeated Standard Deviation 13	—

OTHER_PRE_SPECIFIED outcome

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

Population: Arm 3: Participants with normal hearing listening to simulations of default versus place-based maps

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.

Outcome measures

Outcome measures
Measure	Default n=15 Participants The default frequency filters assigned by the clinical software default mapping: Default frequency filter assignments	Place-based Frequency filters adjusted to align with the cochlear place frequency place-based mapping: Adjusting the electric frequency filters to align with the cochlear place frequency
Sentence Understanding in Noise for Participants With Normal Hearing default map	52 percent of words correctly repeated Standard Deviation 24	—
Sentence Understanding in Noise for Participants With Normal Hearing place-based map	63 percent of words correctly repeated Standard Deviation 18	—

Adverse Events

Cochlear Implant Users With Default Maps

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Cochlear Implant Users With Place-based Maps

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Normal Hearing Controls

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Margaret Dillon, AuD, PhD

University of North Carolina at Chapel Hill

Phone: 919-966-5251

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place