Cochlear Implant
Conditions
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.
Interventions
OTHERplace-based mapping
Adjusting the electric frequency filters to align with the cochlear place frequency
OTHERdefault mapping
Default frequency filter assignments
Sponsors
National Institute on Deafness and Other Communication Disorders (NIDCD)
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Masking description
Participant and testing audiologist were blinded to the randomized map for Arm 1 (cochlear implant users with default maps) and Arm 2 (cochlear implant users with place-based maps). Arm 3 is normal hearing participants listening to simulations of default and place-based maps.
Intervention model description
Subjects will be randomized to one of two groups.
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) 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. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). |
| Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) | 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). |
| Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) | 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
| Measure | Time frame | Description |
|---|---|---|
| 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. This procedure is specific to Arm 1 (participants with default maps) and Arm 2 (participants with place-based maps). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing | 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. |
| Sentence Understanding in Noise for Participants With Normal Hearing | 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. |
| Vowel Recognition for Participants With Normal Hearing | 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. |
Countries
United States
Participant flow
Recruitment details
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).
Pre-assignment details
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.
Participants by arm
| Arm | Count |
|---|---|
| Default The default frequency filters assigned by the clinical software
default mapping: Default frequency filter assignments | 13 |
| 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 | 11 |
| Normal Hearing Control Group age-matched listeners with normal hearing in both ears | 15 |
| Total | 39 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Withdrawal by Subject | 2 | 1 | 0 |
Baseline characteristics
| Characteristic | Default | Place-based | Normal Hearing Control Group | Total |
|---|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Age, Categorical >=65 years | 6 Participants | 5 Participants | 4 Participants | 15 Participants |
| Age, Categorical Between 18 and 65 years | 7 Participants | 5 Participants | 11 Participants | 23 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 14 | 58 years STANDARD_DEVIATION 17 | 54 years STANDARD_DEVIATION 16 | 60 years STANDARD_DEVIATION 15 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 13 Participants | 11 Participants | 15 Participants | 39 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 3 Participants | 2 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 13 Participants | 7 Participants | 13 Participants | 33 Participants |
| Region of Enrollment United States | 13 Participants | 11 Participants | 15 Participants | 39 Participants |
| Sex: Female, Male Female | 8 Participants | 6 Participants | 11 Participants | 25 Participants |
| Sex: Female, Male Male | 5 Participants | 5 Participants | 4 Participants | 14 Participants |
| Unaided Threshold at 125 Hz | 38 decibels STANDARD_DEVIATION 12 | 30 decibels STANDARD_DEVIATION 13 | 15 decibels STANDARD_DEVIATION 7 | 34 decibels STANDARD_DEVIATION 13 |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 13 | 0 / 11 | 0 / 15 |
| other Total, other adverse events | 0 / 13 | 0 / 11 | 0 / 15 |
| serious Total, serious adverse events | 0 / 13 | 0 / 11 | 0 / 15 |
Outcome results
Primary
Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front)
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Default | 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 |
| Default | 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 |
| Default | 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 |
| Default | 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 |
| Place-based | Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) | 12 month | 17 percent of words correctly repeated | Standard Deviation 18 |
| Place-based | Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) | 1 month | 0 percent of words correctly repeated | Standard Deviation 11 |
| Place-based | Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) | 6 month | 5 percent of words correctly repeated | Standard Deviation 14 |
| Place-based | Binaural Hearing Abilities Over Time (Noise to the Non-study Ear Minus Noise From the Front) | 3 month | 10 percent of words correctly repeated | Standard Deviation 14 |
Comparison: comparison of spatial release from masking between the groups over timep-value: 0.126ANOVA
Primary
Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front)
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Default | 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 |
| Default | 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 |
| Default | 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 |
| Default | 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 |
| Place-based | Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) | 12 month | 28 percent of words correctly repeated | Standard Deviation 14 |
| Place-based | Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) | 1 month | 19 percent of words correctly repeated | Standard Deviation 23 |
| Place-based | Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) | 6 month | 20 percent of words correctly repeated | Standard Deviation 24 |
| Place-based | Binaural Hearing Abilities Over Time (Noise to the Study Ear Minus Noise From the Front) | 3 month | 24 percent of words correctly repeated | Standard Deviation 17 |
Comparison: comparison of spatial release from masking over time (1, 3, 6, and 12 months post-activation) between the groups (default versus place-based)p-value: 0.208ANOVA
Primary
Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time
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).
Time frame: 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).
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Default | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | 6 months | 53 percent of words correctly repeated | Standard Deviation 22 |
| Default | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | activation | 18 percent of words correctly repeated | Standard Deviation 16 |
| Default | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | 12 months | 56 percent of words correctly repeated | Standard Deviation 26 |
| Default | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | 1 month | 40 percent of words correctly repeated | Standard Deviation 23 |
| Default | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | 3 months | 49 percent of words correctly repeated | Standard Deviation 20 |
| Place-based | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | 1 month | 34 percent of words correctly repeated | Standard Deviation 22 |
| Place-based | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | 3 months | 45 percent of words correctly repeated | Standard Deviation 16 |
| Place-based | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | 6 months | 50 percent of words correctly repeated | Standard Deviation 19 |
| Place-based | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | 12 months | 54 percent of words correctly repeated | Standard Deviation 15 |
| Place-based | Monaural Perception for Participants With Cochlear Implants (Arms 1 and 2) Over Time | activation | 10 percent of words correctly repeated | Standard Deviation 14 |
Comparison: comparison of word recognition over time (activation, and 1, 3, 6, and 12 months post-activation) between groups (default versus place-based)p-value: 0.557ANOVA
Secondary
Perceived Abilities Over Time
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).
Time frame: 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.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Default | Perceived Abilities Over Time | 1 month | 5 score on scale of 1 (worst) to 10 (best) | Standard Deviation 2 |
| Default | Perceived Abilities Over Time | 6 months | 5 score on scale of 1 (worst) to 10 (best) | Standard Deviation 2 |
| Default | Perceived Abilities Over Time | 3 months | 5 score on scale of 1 (worst) to 10 (best) | Standard Deviation 2 |
| Default | Perceived Abilities Over Time | 12 months | 6 score on scale of 1 (worst) to 10 (best) | Standard Deviation 2 |
| Default | Perceived Abilities Over Time | preop | 4 score on scale of 1 (worst) to 10 (best) | Standard Deviation 1 |
| Place-based | Perceived Abilities Over Time | 12 months | 7 score on scale of 1 (worst) to 10 (best) | Standard Deviation 1 |
| Place-based | Perceived Abilities Over Time | preop | 4 score on scale of 1 (worst) to 10 (best) | Standard Deviation 1 |
| Place-based | Perceived Abilities Over Time | 1 month | 5 score on scale of 1 (worst) to 10 (best) | Standard Deviation 2 |
| Place-based | Perceived Abilities Over Time | 3 months | 6 score on scale of 1 (worst) to 10 (best) | Standard Deviation 2 |
| Place-based | Perceived Abilities Over Time | 6 months | 6 score on scale of 1 (worst) to 10 (best) | Standard Deviation 2 |
Comparison: comparison of perceived benefit between the groups over timep-value: 0.369ANOVA
Other Pre-specified
Sentence Understanding in Noise for Participants With Normal Hearing
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Default | Sentence Understanding in Noise for Participants With Normal Hearing | default map | 52 percent of words correctly repeated | Standard Deviation 24 |
| Default | Sentence Understanding in Noise for Participants With Normal Hearing | place-based map | 63 percent of words correctly repeated | Standard Deviation 18 |
p-value: 0.02t-test, 2 sided
Other Pre-specified
Vowel Recognition for Participants With Normal Hearing
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Default | Vowel Recognition for Participants With Normal Hearing | default map | 49 percent of vowels correctly repeated | Standard Deviation 17 |
| Default | Vowel Recognition for Participants With Normal Hearing | place-based map | 60 percent of vowels correctly repeated | Standard Deviation 13 |
p-value: <0.001t-test, 2 sided
Other Pre-specified
Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing
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.
Time frame: 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
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Default | Word Recognition With Default Versus Place-based Maps for Participants With Normal Hearing | default map | 64 percent of words correctly repeated | Standard Error 28 |
| Default | 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 |
p-value: 0.006t-test, 2 sided