Trial Outcomes & Findings for Auditory Brainstem Implantation in Young Children (NCT NCT01904448)
NCT ID: NCT01904448
Last Updated: 2018-07-05
Results Overview
Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid (CSF) leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
5 participants
Primary outcome timeframe
Year 3
Results posted on
2018-07-05
Participant Flow
Participant milestones
| Measure |
Pediatric Auditory Brainstem Implantation (ABI)
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Overall Study
STARTED
|
5
|
|
Overall Study
COMPLETED
|
5
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Auditory Brainstem Implantation in Young Children
Baseline characteristics by cohort
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Region of Enrollment
United States
|
5 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
5 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
|
Age, Continuous
|
3.4 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
3 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Year 3Complications and related outcomes will be tracked and recorded. These include bleeding, infection, neural injury, cerebrospinal fluid (CSF) leakage, brain bleeding or bruising, stroke, death. Also, complications and sequelae related to the device such as non-auditory stimulation and device failure will be tracked.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Number of ABI Complications
|
2 Events
|
SECONDARY outcome
Timeframe: Year 3OWLS-II: Listening Comprehension measures oral language reception, which is the understanding of spoken language. The examiner orally presents increasingly difficult words, phrases, and sentences to the participant and he/she responds by pointing to or stating which of four pictures is correct. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better listening comprehension. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
The Oral and Written Language Scales (OWLS) Listening Comprehension Score
Subject 1
|
77 units on a scale
|
|
The Oral and Written Language Scales (OWLS) Listening Comprehension Score
Subject 2
|
46 units on a scale
|
|
The Oral and Written Language Scales (OWLS) Listening Comprehension Score
Subject 3
|
40 units on a scale
|
|
The Oral and Written Language Scales (OWLS) Listening Comprehension Score
Subject 4
|
40 units on a scale
|
|
The Oral and Written Language Scales (OWLS) Listening Comprehension Score
Subject 5
|
62 units on a scale
|
SECONDARY outcome
Timeframe: Year 3OWLS-II: Oral Expression measures oral language expression, which is the use of spoken language. The examiner presents a verbal prompt along with a picture and the participant must respond orally to the prompt with increasingly difficult language. The derived mean standard score for this test is 100 with a standard deviation of 15. Higher scores indicate better oral expression. Scores of 85 to 115 are within normal limits. Scores that fall 2 standard deviations below the mean are considered to be severely delayed.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
The Oral and Written Language Scales (OWLS) Oral Expression Score
Subject 1
|
48 units on a scale
|
|
The Oral and Written Language Scales (OWLS) Oral Expression Score
Subject 2
|
50 units on a scale
|
|
The Oral and Written Language Scales (OWLS) Oral Expression Score
Subject 3
|
40 units on a scale
|
|
The Oral and Written Language Scales (OWLS) Oral Expression Score
Subject 4
|
40 units on a scale
|
|
The Oral and Written Language Scales (OWLS) Oral Expression Score
Subject 5
|
58 units on a scale
|
SECONDARY outcome
Timeframe: Year 3Population: Due to limited progress in spoken language development and test difficulty, this measure was replaced by Identifying Early Phonological Needs in children with hearing loss (IEPN). No data were collected for this measure.
The GFTA-2 is a standardized, norm-based articulation measure that samples spontaneous sound production. Children are asked to respond to picture plates and verbal cues from the examiner with single words that test consonant accuracy in initial, medial, and final positions. This measure has norms based on the performance of normal-hearing children from age 2 years to 21 years.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 3Population: Since spoken language skills did not progress as expected, this measure was inappropriate for use in the study and was unobtainable.
MacArthur-Bates Communicative Development Inventories (CDIs)
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3This is a measure of the child's ability to vocalize on demand elicited by pictures of objects. Scores are derived from the percentage of time the child vocalized for 25 words.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 1 Year 1
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 1 Year 2
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 1 Year 3
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 2 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 2 Year 2
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 2 Year 3
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 3 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 3 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 3 Year 3
|
44 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 4 Year 1
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 4 Year 2
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 4 Year 3
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 5 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 5 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vocalize on Demand
Subject 5 Year 3
|
0 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Measure of percent correct for use of syllables elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct number of syllables on 25 items.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 1 Year 1
|
40 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 1 Year 2
|
80 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 1 Year 3
|
92 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 2 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 2 Year 2
|
40 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 2 Year 3
|
80 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 3 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 3 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 3 Year 3
|
40 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 4 Year 1
|
60 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 4 Year 2
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 4 Year 3
|
60 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 5 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 5 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Syllables
Subject 5 Year 3
|
0 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Measure of percent correct on initial consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced an initial consonant on 25 items.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 1 Year 1
|
63 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 1 Year 2
|
95 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 1 Year 3
|
100 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 2 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 2 Year 2
|
66 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 2 Year 3
|
75 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 3 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 3 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 3 Year 3
|
16 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 4 Year 1
|
71 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 4 Year 2
|
38 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 4 Year 3
|
60 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 5 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 5 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Initial Consonants
Subject 5 Year 3
|
0 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Measure of percent correct on vowel production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct vowel on 25 items.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 1 Year 1
|
12 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 1 Year 2
|
31 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 1 Year 3
|
53 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 2 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 2 Year 2
|
12 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 2 Year 3
|
26 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 3 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 3 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 3 Year 3
|
20 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 4 Year 1
|
28 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 4 Year 2
|
17 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 4 Year 3
|
45 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 5 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 5 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Vowels
Subject 5 Year 3
|
0 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Measure of percent correct on consonant manner cues production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct manner of consonant production on 25 items.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 1 Year 1
|
18 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 1 Year 2
|
54 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 1 Year 3
|
56 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 2 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 2 Year 2
|
24 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 2 Year 3
|
24 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 3 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 3 Year 2
|
4 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 3 Year 3
|
4 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 4 Year 1
|
35 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 4 Year 2
|
25 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 4 Year 3
|
37 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 5 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 5 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Manner Cues
Subject 5 Year 3
|
0 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Measure of percent correct on final consonant production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced a final consonant on 25 items.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 1 Year 1
|
29 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 1 Year 2
|
64 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 1 Year 3
|
94 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 2 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 2 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 2 Year 3
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 3 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 3 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 3 Year 3
|
11 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 4 Year 1
|
11 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 4 Year 2
|
41 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 4 Year 3
|
41 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 5 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 5 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Final Consonants
Subject 5 Year 3
|
0 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Measure of percent correct on consonant place cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct place of consonant production on 25 items.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 1 Year 1
|
20 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 1 Year 2
|
58 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 1 Year 3
|
58 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 2 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 2 Year 2
|
27 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 2 Year 3
|
27 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 3 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 3 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 3 Year 3
|
5 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 4 Year 1
|
28 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 4 Year 2
|
21 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 4 Year 3
|
38 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 5 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 5 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Place Cues
Subject 5 Year 3
|
0 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Measure of percent correct on consonant voicing cue production elicited from pictures of single word items. Scores are derived from the percentage of time the child produced the correct voicing of consonant production on 25 items.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 1 Year 1
|
16 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 1 Year 2
|
67 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 1 Year 3
|
90 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 2 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 2 Year 2
|
41 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 2 Year 3
|
25 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 3 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 3 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 3 Year 3
|
3 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 4 Year 1
|
41 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 4 Year 2
|
20 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 4 Year 3
|
51 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 5 Year 1
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 5 Year 2
|
0 percentage of correct answers
|
|
Percentage of Correctly Produced Items From the Identifying Early Phonological Needs in Children With Hearing Loss (IEPN) Test-Voice Cues
Subject 5 Year 3
|
0 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Sound detection for octave frequencies of 250 Hz through 8k Hz were collected and a 4 frequency average was calculated for each annual test interval
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 5 Year 2
|
33 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 5 Year 3
|
32 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
Pure Tone Average (PTA) Subject 1 Year 1
|
30 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 1 Year 2
|
42 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 1 Year 3
|
30 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 2 Year 1
|
120 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 2 Year 2
|
47 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 2 Year 3
|
35 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 3 Year 1
|
33 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 3 Year 2
|
32 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 3 Year 3
|
30 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 4 Year 1
|
32 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 4 Year 2
|
30 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 4 Year 3
|
33 averaged decibel level
|
|
Change in Speech Perception Test Battery Scores-Detection Audiogram
PTA Subject 5 Year 1
|
35 averaged decibel level
|
SECONDARY outcome
Timeframe: Pre-ABI, Year 1, Year 2, Year 3A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until demonstrating a minimum performance on the previous measure. The Infant-Toddler Meaningful Auditory Integration Scale (IT-MAIS) is a parent questionnaire consisting of ten questions regarding a young infant or toddler's auditory behavior, e.g., "Does the child spontaneously respond to his/her name in quiet with auditory cues?" Each question is scored on a five point scale: 0 = never, 1 = rarely, 2 = occasionally, 3 = frequently, and 4 = always. The aim of this tool is to assess the benefit of the child's personal amplification device(s) and is used to assess hearing aid benefit. Higher scores reflect more consistent auditory response. Scores reported are the percentage of correctly answered questions of the total asked.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 1 Pre-ABI
|
3 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 1 Year 1
|
43 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 1 Year 2
|
32 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 1 Year 3
|
42 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 2 Pre-ABI
|
0 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 2 Year 1
|
28 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 2 Year 2
|
12 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 2 Year 3
|
72 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 3 Pre-ABI
|
0 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 3 Year 1
|
52 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 3 Year 2
|
70 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 3 Year 3
|
33 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 4 Pre-ABI
|
75 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 4 Year 1
|
50 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 4 Year 2
|
55 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 4 Year 3
|
52 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 5 Pre-ABI
|
0 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 5 Year 1
|
2 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 5 Year 2
|
5 percent correct
|
|
Speech Perception Test Battery Scores-IT-MAIS or MAIS
Subject 5 Year 3
|
0 percent correct
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Population: Single-arm study of Auditory Brainstem Implantation (ABI) in children
A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure. The Ling- 6 sounds test is a speech sound detection measurement of detection thresholds performed by an audiologist. Six sound files of "ah", "ee", "oo", "sh", "s", and "m" are presented one at a time in varying order for measurement of hearing threshold groups, per sound. The selected sounds tested validate hearing device fitting across the frequency range important for understanding speech. If the child can detect the stimuli a point is given and if they can not detect, no point is given. A total of 3 trials per sound were presented for a total of 18 presentations. The score reflects a percent of the total sounds that were detected.
Outcome measures
| Measure |
Pediatric ABI
n=5 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 1 Year 1
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 1 Year 2
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 1 Year 3
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 2 Year 1
|
0 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 2 Year 2
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 2 Year 3
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 3 Year 1
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 3 Year 2
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 3 Year 3
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 4 Year 1
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 4 Year 2
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 4 Year 3
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 5 Year 1
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 5 Year 2
|
100 percent correct
|
|
Change in Speech Perception Test Battery Scores-Ling Sound Test
Ling 6 Subject 5 Year 3
|
100 percent correct
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Population: Missing values indicate test was not administered at that interval and ESP-Standard was administered.
A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure. The Early Speech Perception (ESP) low verbal version estimates speech perception abilities in very young children who have limited verbal abilities. Stimuli consist of words varying in pattern as well as spondees and monosyllabic words presented in sets of four. The format is four item closed-set. Test materials consist of objects (toys) instead of pictures. It is scored by the percent of correctly identified items from the set of 4; 3 repetitions of each item are given for a total of 12 trials.
Outcome measures
| Measure |
Pediatric ABI
n=4 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 1 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 1 Year 1
|
58 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 1 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 1 Year 2
|
100 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 1 Year 2
|
75 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 1 Year 2
|
67 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 2 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 2 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 2 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 2 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 2 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 2 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 2 Year 3
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 2 Year 3
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 2 Year 3
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 3 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 3 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 3 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 3 Year 2
|
83 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 3 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 3 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 5 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 5 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 5 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 5 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 5 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 5 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Pattern Subject 5 Year 3
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Monosyllable Subject 5 Year 3
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Low Verbal
Spondee Subject 5 Year 3
|
25 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Population: Missing values indicate test was not administered at that interval and ESP-LV (Low Verbal) was administered.
A hierarchy of tests were chosen that capture auditory skills from sound awareness to open set word and sentence understanding. Participants did not advance to the next level of difficulty until they demonstrated a minimum performance on the previous measure. This may have been due to child's age or inability to complete task. The Early Speech Perception (ESP) Standard measures the progression of speech discrimination skills in children (age 5+) with profound hearing loss as they develop. The stimuli consist of 3 subtests \[1) patterns and words, 2) monosyllable, 3) spondees\] of 12 pictured words each presented in an auditory-only condition. The format is a closed-set. Two repetitions of each item are given for a total of 24 items for each subtest. Each subtest is scored by the percent of correctly identified items from the set of pictured words.
Outcome measures
| Measure |
Pediatric ABI
n=3 Participants
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Pattern Subject 1 Year 3
|
70 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Word Subject 1 Year 3
|
62 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Monosyllable Subject 1 Year 3
|
50 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Spondee Subject 1 Year 3
|
41 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Pattern Subject 3 Year 2
|
66 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Word Subject 3 Year 2
|
41 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Monosyllable Subject 3 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Spondee Subject 3 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Pattern Subject 3 Year 3
|
46 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Word Subject 3 Year 3
|
29 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Monosyllable Subject 3 Year 3
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Spondee Subject 3 Year 3
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Pattern Subject 4 Year 1
|
50 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Word Subject 4 Year 1
|
45 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Monosyllable Subject 4 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Spondee Subject 4 Year 1
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Pattern Subject 4 Year 2
|
45 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Word Subject 4 Year 2
|
41 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Monosyllable Subject 4 Year 2
|
16 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Spondee Subject 4 Year 2
|
25 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Pattern Subject 4 Year 3
|
53 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Word Subject 4 Year 3
|
42 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Monosyllable Subject 4 Year 3
|
8 percentage of correct answers
|
|
Change in Speech Perception Test Battery Scores-ESP Standard
Spondee Subject 4 Year 3
|
42 percentage of correct answers
|
SECONDARY outcome
Timeframe: Year 1, Year 2, Year 3Population: Since spoken language skills did not progress as expected, this measure was inappropriate for use in the study and was unobtainable.
The PLS-5 is a standardized language test designed for infants and young children. The Auditory Comprehension subscale targets skills known to precede language development, including: attention to speakers, appropriate object play, basic vocabulary, concepts, grammatical markers, and complex sentences. The Expressive Communication subscale assesses vocal development, social communication, naming of common objects, phonological awareness, sequencing skills, as well as use of concepts, prepositions, grammatical markers, and varying sentence structures.
Outcome measures
Outcome data not reported
Adverse Events
Pediatric ABI
Serious events: 2 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Pediatric ABI
n=5 participants at risk
Single-arm study of Auditory Brainstem Implantation (ABI) in children
|
|---|---|
|
Surgical and medical procedures
Cerebral Spinal Fluid (CSF) Leak
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected during the three year study course following enrollment for each participant.
|
|
Surgical and medical procedures
Aseptic Meningitis
|
20.0%
1/5 • Number of events 1 • Adverse event data were collected during the three year study course following enrollment for each participant.
|
Other adverse events
Adverse event data not reported
Additional Information
Craig A. Buchman, MD, FACS
University of North Carolina at Chapel Hill
Phone: 314-362-7395
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place