CIPUHL: Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss

• Sponsor: University of North Carolina, Chapel Hill (Other)
• Overall Status: Completed
• CT.gov ID: NCT02963974
• Collaborator: Med-El Corporation (Industry)
• Enrollment: 20
• Location: 1
• Arm: 1
• Actual Duration (Months): 48.6
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

This feasibility study evaluates whether children with unilateral, moderate to profound sensorineural hearing loss experience an improvement in speech perception, hearing in noise, localization, and quality of life with a cochlear implant as compared to an unaided listening condition.

Condition or Disease	Intervention/Treatment	Phase
Hearing Loss, Unilateral	Device: Cochlear implant	N/A

Detailed Description

Unilateral hearing loss (UHL) is a term used to describe a substantial hearing loss in one ear and normal hearing in the contralateral ear. Despite normal hearing in one ear, these individuals experience reduced speech perception in noise, variable abilities on localization tasks, increased reports of hearing handicap, reduced quality of life, and often, they obtain limited or no benefit from conventional amplification. In the United States, the prevalence of UHL in children ranges from 0.03% to 3%, depending on the age of the child.

Cochlear implantation performed for children with bilateral, severe to profound deafness has significant impacts on several aspects of child development.

The practice of providing cochlear implants to children who have significant hearing loss in one ear is of great interest and is occurring with greater frequency as reported in case studies and small set clinical reports. The primary purpose of this feasibility study is to demonstrate the effectiveness of cochlear implantation in children, age 3 years 6 months to 6 years, 6 months, with moderate to profound UHL. Postoperative results will be evaluated with speech perception measures, localization tasks, hearing in noise tasks, and subjective reports.

Study Design

• Study Type: Interventional
• Actual Enrollment: 20 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cochlear Implantation in Pediatric Cases of Unilateral Hearing Loss
• Actual Study Start Date: Apr 20, 2017
• Actual Primary Completion Date: May 7, 2021
• Actual Study Completion Date: May 7, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cochlear Implant Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss	Device: Cochlear implant; Implantation; Other Names: MED-EL Cochlear Implant MED-EL Synchrony with FLEX 28 array MED-EL Synchrony with FLEX 24 array

Outcome Measures

Primary Outcome Measures

1. Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing [up to 24 months post-activation]

   Recorded, open set word recognition presented pre-operatively in the soundfield when using a traditional hearing aid (contralateral ear masked) and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words. Scores are reported as percent words correct and a higher score is better. Change is measured from the pre-operative to the 3-month post-activation interval, and from the 3-month post-activation interval to each subsequent interval.

2. Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation [6 months post-activation]

   Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 6-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.

3. Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation [12 months post-activation]

   Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 12-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.

4. Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use [24 months post-activation]

   Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 24-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.

5. Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation [3 months post-activation]

   Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 3 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.

6. Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation [9 months post-activation]

   Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 9 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.

7. Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation [18 months post-activation]

   Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 18 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.

8. Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation [24 months post-activation]

   Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 24 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.

9. Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire [Pre-operatively through 24 months post-activation]

   The Speech Spatial Qualities Questionnaire requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. The SSQ questionnaire assesses performance in 3 domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items). Domain scores represent an average of item ratings, therefore each domain score ranges from 0 to 10 with a higher score indicating a better outcome. The pediatric version of this test was used and parents reported as proxy pre-operatively and at at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and between the 3-month interval to all subsequent intervals.

10. Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire [Pre-operatively through 24 months post-activation]

    Bern SSD Questionnaire is a 10-item questionnaire used for rating perceived benefit of a hearing technology designed to be used for persons with Unilateral Hearing Loss (UHL). A positive score indicates greater perceived ability with the device and a negative score indicates greater perceived ability without the device. Scores range from -5 meaning much easier listening without the hearing device to +5 indicating much easier listening with the device. Scores across all 10 items are averaged for a single score. A modified version of this test that can be completed by a parent was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and from the 3-month interval to each subsequent interval.

11. Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale [Pre-operatively through 24 months post-activation]

    PedsQL Multidimensional fatigue scale is a validated scale for determining fatigue in young children, including general fatigue, sleep/rest fatigue and cognitive fatigue. Scores from this test have been previously demonstrated to be substantially affected by hearing loss in children. A parent report version was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Items are scored on a 5-point Likert scale and are then reversed scored and linearly transformed to a 0-100 scale where 100 would indicate no fatigue and 0 would indicate near constant fatigue.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 42 Months to 78 Months
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

1. Inclusion Criteria

1. Unilateral moderate-to-profound sensorineural hearing loss.

2. Unaided residual hearing thresholds that yield a pure tone average (PTA) at frequencies 500 Hz, 1 kHz and 2 kHz of ≥70 dB HL in the ear to be implanted. It is possible that subjects may have hearing at other frequencies not included in this average.

3. Hearing thresholds in the contralateral ear of ≤25 dB HL

4. Between 3 years, 6 mos and 6 years, 6 mos of age at implantation.

5. Anatomically normal cochlear nerve

6. Cochlear anatomy that is amenable to cochlear implantation as evaluated by imaging (modality at the physician's discretion) including:

7. Normal cochlear anatomy or

8. Incomplete Partition Type II (IP2) with or without Enlarged Vestibular Aqueduct (EVA) or

9. EVA with normal partitioning

10. No evidence of progressive hearing loss.

11. Willing to undergo 4 week hearing aid trial as warranted based on achieving desired audibility when fitted via real ear desired sensation level (DSL) method.

12. Aided word recognition in the ear to be implanted of 30% or less as measured with Consonant Nucleus Consonant (CNC) words (50-word list)

13. When listening with an appropriately fit hearing aid and masking applied to the contralateral ear (Turner, 2004).

14. Aided testing will be conducted in a sound-proof booth with the participant seated 1 meter from the sound source, facing 0° azimuth. Recorded materials will be presented at 60 dB SPL.

15. The hearing aid output will be measured using DSL targets.

16. Realistic parental expectations: a verbal acknowledgement of the potential benefits and risks, and postoperative variation in performance. For instance, cochlear implantation will not restore normal hearing.

17. Willing to obtain recommended meningitis vaccinations per CDC recommendations.

(9) Development and cognition within the normal range as measured by the Leiter-R test of nonverbal intelligence and cognitive abilities and the Bracken Basic Concept Scale -Revised.

(10) Parental commitment to study parameters including being able and willing to participate in evaluation schedule, involvement in prescribed therapy, and travel to investigational site and study-related activities.

1. Exclusion Criteria

1. English is not primary language of the home

2. Speech perception materials are presented in English

3. Parental questionnaires are administered in English

4. Conductive hearing loss in either ear

5. Compromised auditory nerve

6. Ossification of the cochlea

7. Inability to participate in follow-up procedures (i.e., unwillingness, geographic location)

8. History of condition that contraindicates middle or inner ear surgery or anesthesia (i.e. otitis media refractory to treatment)

9. Case of sudden sensorineural hearing loss that has not been first evaluated by a physician

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina	United States	27599-7600

Sponsors and Collaborators

• University of North Carolina, Chapel Hill
• Med-El Corporation

Investigators

• Principal Investigator: Kevin D Brown, MD, PhD, University of North Carolina, Chapel Hill

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Aug 13, 2018

More Information

Publications

• Arndt S, Aschendorff A, Laszig R, Beck R, Schild C, Kroeger S, Ihorst G, Wesarg T. Comparison of pseudobinaural hearing to real binaural hearing rehabilitation after cochlear implantation in patients with unilateral deafness and tinnitus. Otol Neurotol. 2011 Jan;32(1):39-47. doi: 10.1097/MAO.0b013e3181fcf271.
• Arndt S, Prosse S, Laszig R, Wesarg T, Aschendorff A, Hassepass F. Cochlear implantation in children with single-sided deafness: does aetiology and duration of deafness matter? Audiol Neurootol. 2015;20 Suppl 1:21-30. doi: 10.1159/000380744. Epub 2015 May 19.
• Bess FH, Tharpe AM, Gibler AM. Auditory performance of children with unilateral sensorineural hearing loss. Ear Hear. 1986 Feb;7(1):20-6.
• Firszt JB, Holden LK, Reeder RM, Waltzman SB, Arndt S. Auditory abilities after cochlear implantation in adults with unilateral deafness: a pilot study. Otol Neurotol. 2012 Oct;33(8):1339-46. doi: 10.1097/MAO.0b013e318268d52d.
• Galvin KL, Noble W. Adaptation of the speech, spatial, and qualities of hearing scale for use with children, parents, and teachers. Cochlear Implants Int. 2013 Jun;14(3):135-41. doi: 10.1179/1754762812Y.0000000014.
• Kompis M, Pfiffner F, Krebs M, Caversaccio MD. Factors influencing the decision for Baha in unilateral deafness: the Bern benefit in single-sided deafness questionnaire. Adv Otorhinolaryngol. 2011;71:103-111. doi: 10.1159/000323591. Epub 2011 Mar 8.
• PETERSON GE, LEHISTE I. Revised CNC lists for auditory tests. J Speech Hear Disord. 1962 Feb;27:62-70.
• Varni JW, Limbers CA, Burwinkle TM. Impaired health-related quality of life in children and adolescents with chronic conditions: a comparative analysis of 10 disease clusters and 33 disease categories/severities utilizing the PedsQL 4.0 Generic Core Scales. Health Qual Life Outcomes. 2007 Jul 16;5:43.

• Responsible Party: University of North Carolina, Chapel Hill
• ClinicalTrials.gov Identifier: NCT02963974
• Other Study ID Numbers: 15-3350
• First Posted: Nov 15, 2016
• Last Update Posted: Aug 6, 2021
• Last Verified: Jun 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Keywords provided by University of North Carolina, Chapel Hill: cochlear implant
• Additional relevant MeSH terms: Hearing Loss; Deafness; Hearing Loss, Unilateral

Study Results

Participant Flow

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Period Title: Overall Study
STARTED	20
COMPLETED	19
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Overall Participants	20
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	5.5 (2.0)
Sex: Female, Male (Count of Participants)
Female	8 40%
Male	12 60%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	2 10%
White	14 70%
More than one race	3 15%
Unknown or Not Reported	0 0%
Region of Enrollment (participants) [Number]
United States	20 100%
Ear Affected (Count of Participants)
Left Ear	10 50%
Right Ear	10 50%
Etiology of Hearing Loss (Count of Participants)
Unknown	12 60%
Congenital Cytomegalovirus	3 15%
Mondini Malformation	2 10%
Infection	1 5%
Trauma	1 5%
Waardenburg Syndrome	1 5%
Suspected Length of Deafness (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	3.3 (1.7)

Outcome Measures

1. Primary Outcome

Title	Change Over Time in the Ability to Perceive Single Words as Assessed by Consonant-Nucleus-Consonant (CNC) Word Recognition Testing
Description	Recorded, open set word recognition presented pre-operatively in the soundfield when using a traditional hearing aid (contralateral ear masked) and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals by direct input to the speech processor using the Consonant-Nucleus-Consonant (CNC) words. Scores are reported as percent words correct and a higher score is better. Change is measured from the pre-operative to the 3-month post-activation interval, and from the 3-month post-activation interval to each subsequent interval.
Time Frame	up to 24 months post-activation

Outcome Measure Data

Analysis Population Description

One participant was lost to follow-up after Month 12

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	20
Pre-operatively	1.4 (6.3)
Month 3	14.4 (14.5)
Month 6	28.2 (18.0)
Month 9	45.0 (15.2)
Month 12	50.3 (33.1)
Month 18	51.8 (11.3)
Month 24	58.6 (15.4)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Analyzed CNC Word scores from 3 months through 24 months to evaluate change over time with device use. Scores were converted to Rau prior to analysis.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	The a priori threshold for statistical significance was < 0.05.
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Analyzed pre-op to 3 month post activation CNC Word scores to test superiority of cochlear implant use to pre-operative hearing aid use.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	The a priori threshold for statistical significance was p < 0.05.
	Method	Wilcoxon (Mann-Whitney)
	Comments

2. Primary Outcome

Title	Mean Change in the Signal-to-noise Ratio 50 (SNR-50) From Device Off to Device on as Measured With the Bamford-Kowal-Bench Speech in Noise Test (BKB-SIN) at 6 Months Post-activation
Description	Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 6-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Time Frame	6 months post-activation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	20
Device off to device on with speech and noise in front	1.8
Device off to device on with speech in front and noise to the implanted side	0.4
Device off to device on with speech in front and noise to the normal side	1.9

3. Primary Outcome

Title	Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 12 Months Post-activation
Description	Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 12-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Time Frame	12 months post-activation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	20
Device on with speech and noise in front	1.6
Device off to device on with speech in front and noise to the implanted side	2.5
Device off to device on with speech in front and noise to the normal side	3.5

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Analyzed BKB-SIN SNR-50 scores at 12 months post activation to evaluate the impact of device use (CI off vs on) and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	The a priori threshold for statistical significance was < 0.05. This was a two-way repeated measures ANOVA.
	Method	ANOVA
	Comments

4. Primary Outcome

Title	Mean Change in the SNR-50 From Device Off to Device on as Measured With the BKB-SIN at 24 Months of Device Use
Description	Two ½ lists of the BKB-SIN were presented in each condition device off and device on after 24-months of device use: Speech and masker in front, speech in front and masker directed 90 degrees to the normal ear, speech in front and masker directed 90 degrees to the affected ear. The SNR-50 represents the signal-to-noise ratio required to perceive 50% of the sentence. A lower score is better.
Time Frame	24 months post-activation

Outcome Measure Data

Analysis Population Description

One participant was lost to follow-up after Month 12

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	19
Device off to device on with speech and noise in front	1.4
Device off to device on with speech in front and noise to the implanted side	1.7
Device off to device on with speech in front and noise to the normal side	4.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Analyzed BKB-SIN SNR-50 scores across all time points (6, 12, and 24 months post activation) to evaluate the impact of time, device use (CI off vs on), and masker location (front, to the affected ear, or to the normal hearing ear) on hearing in noise.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	The a priori threshold for statistical significance was < 0.05.
	Method	Mixed Models Analysis
	Comments

5. Primary Outcome

Title	Median Change in Localization Error From Device Off to Device on at 3 Months Post-activation
Description	Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 3 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.
Time Frame	3 months post-activation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	20
Overall RMS error from device off to device on	14.7
Random error from device off to device on	-0.8
Constant error from device off to device on	18.8
Adjusted constant error from device off to device on	19.1

6. Primary Outcome

Title	Median Change in Localization Error From Device Off to Device on at 9 Months Post-activation
Description	Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 9 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.
Time Frame	9 months post-activation

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	20
Overall RMS error from device off to device on	24.6
Random error from device off to device on	15.8
Constant error from device off to device on	27.9
Adjusted constant error from device off to device on	24.9

7. Primary Outcome

Title	Median Change in Localization RMS Error From Device Off to Device on at 18 Months Post-activation
Description	Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 18 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.
Time Frame	18 months post-activation

Outcome Measure Data

Analysis Population Description

One participant was lost to follow-up after Month 12

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	19
RMS error from device off to device on	37.7
Random error from device off to device on	20.2
Constant error from device off to device on	27.5
Adjusted constant error from device off to device on	24.9

8. Primary Outcome

Title	Median Change in Localization Error From Device Off to Device on at 24 Months Post-activation
Description	Soundfield localization of 200-ms speech-shaped noise, presented from 11 speakers at 70 decibel (dB) sound pressure level (SPL) in a sound treated room. Error measures are made device on and device off after 24 months of device use. Overall root-mean-square (RMS) error is the difference between the sound source azimuth and the response azimuth and a lower score indicates more accurate localization of the sound source. Random error is the average of the standard deviation of the responses for each source and a lower score reflects a more consistently accurate response. Constant error is a measure of side bias, and a lower score indicates less response bias to either side. Adjusted constant error is a measure of reliability in the response taking side bias into account, and a lower score indicates a more reliable response.
Time Frame	24 months post-activation

Outcome Measure Data

Analysis Population Description

One participant was lost to follow-up after Month 12

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	19
RMS error from device off to device on	35.1
Random error from device off to device on	17.9
Constant error from device off to device on	25.8
Adjusted constant error from device off to device on	21.1

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Analyzed overall RMS error at 3, 9, 18, and 24 months post activation to evaluate the impact of device use (CI off vs on) and time on localization.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.01911
	Comments	The a priori threshold for statistical significance was < 0.05.
	Method	Mixed Models Analysis
	Comments

9. Primary Outcome

Title	Change in Mean Response Scores on the Speech Spatial & Qualities (SSQ) Questionnaire
Description	The Speech Spatial Qualities Questionnaire requires participants to rate their perceived hearing ability for 49 scenarios using a 10-point scale, ranging from 0 (Not at all) to 10 (Perfectly). A score higher than 0 for each listening scenario shows some benefit of the device, while a score of 10 indicates the device was extremely beneficial. The SSQ questionnaire assesses performance in 3 domains, hearing speech in quiet and noise environments (9 items), spatial or directional hearing (5 items) and sound qualities (8 items). Domain scores represent an average of item ratings, therefore each domain score ranges from 0 to 10 with a higher score indicating a better outcome. The pediatric version of this test was used and parents reported as proxy pre-operatively and at at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and between the 3-month interval to all subsequent intervals.
Time Frame	Pre-operatively through 24 months post-activation

Outcome Measure Data

Analysis Population Description

One participant was lost to follow-up after Month 12

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	20
Speech: pre-operative to 3-month post-activation interval	1.4
Speech: 3-month to 6-month post-activation interval	0.7
Speech: 3-month to 9-month post-activation interval	0.6
Speech: 3-month to 12-month post-activation interval	0.7
Speech: 3-month to 18-month post-activation interval	0.8
Speech: 3-month to 24-month post-activation interval	0.9
Spatial: pre-operative to 3-month post-activation interval	2.6
Spatial: 3-month to 6-month post-activation interval	0.8
Spatial: 3-month to 9-month post-activation interval	1.0
Spatial: 3-month to 12-month post-activation interval	1.3
Spatial: 3-month to 18-month post-activation interval	1.7
Spatial: 3-month to 24-month post-activation interval	1.1
Qualities: pre-operative to 3-month post-activation interval	1.0
Qualities: 3-month to 6-month post-activation interval	0.6
Qualities: 3-month to 9-month post-activation interval	0.5
Qualities: 3-month to 12-month post-activation interval	0.5
Qualities: 3-month to 18-month post-activation interval	0.9
Qualities: 3-month to 24-month post-activation interval	0.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Comparison of scores across time to investigate change in scores over time: Speech subtest.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	The a priori threshold for statistical significance was p < 0.05
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Comparison of scores across time to investigate change in scores over time: Spatial subtest.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.001
	Comments	The a priori threshold for statistical significance was p < 0.05.
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Comparison of scores across time to investigate change in scores over time: Qualities subtest.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	The a priori threshold for statistical significance was p < 0.05.
	Method	Mixed Models Analysis
	Comments

10. Primary Outcome

Title	Change in Mean Response Scores as Measured by the Bern Single Sided Deafness (SSD) Questionnaire
Description	Bern SSD Questionnaire is a 10-item questionnaire used for rating perceived benefit of a hearing technology designed to be used for persons with Unilateral Hearing Loss (UHL). A positive score indicates greater perceived ability with the device and a negative score indicates greater perceived ability without the device. Scores range from -5 meaning much easier listening without the hearing device to +5 indicating much easier listening with the device. Scores across all 10 items are averaged for a single score. A modified version of this test that can be completed by a parent was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Change is measured from the pre-operative to the 3-month post-activation interval and from the 3-month interval to each subsequent interval.
Time Frame	Pre-operatively through 24 months post-activation

Outcome Measure Data

Analysis Population Description

One participant was lost to follow-up after Month 12

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	20
Pre-operative to 3-month post-activation interval	1.9
3-month to the 6-month post-activation interval	0.7
3-month to the 9-month post-activation interval	0.9
3-month to the 12-month post-activation interval	1.4
3-month to the 18-month post-activation interval	1.5
3-month to the 24-month post-activation interval	1.4

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Comparison of scores over time.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	< 0.001
	Comments	The a priori threshold for statistical significance was p < 0.05
	Method	Mixed Models Analysis
	Comments

11. Primary Outcome

Title	Change in Mean Fatigue Scores as Measured by the Pediatric Quality of Life (PedsQL) Multidimensional Fatigue Scale
Description	PedsQL Multidimensional fatigue scale is a validated scale for determining fatigue in young children, including general fatigue, sleep/rest fatigue and cognitive fatigue. Scores from this test have been previously demonstrated to be substantially affected by hearing loss in children. A parent report version was used pre-operatively and at 3-, 6-, 9-, 12-, 18-, and 24-month post-activation intervals. Items are scored on a 5-point Likert scale and are then reversed scored and linearly transformed to a 0-100 scale where 100 would indicate no fatigue and 0 would indicate near constant fatigue.
Time Frame	Pre-operatively through 24 months post-activation

Outcome Measure Data

Analysis Population Description

One participant was lost to follow-up after Month 12

Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
Measure Participants	20
General Fatigue: pre-operative to 3-month post-activation	5.4
General Fatigue: 3-month to 6-month post-activation	4.6
General Fatigue: 3-month to 9-month post-activation	1.9
General Fatigue: 3-month to 12-month post-activation	2.5
General Fatigue: 3-month to 18-month post-activation	-1.0
General Fatigue: 3-month to 24-month post-activation	4.0
Sleep Fatigue: Pre-operative to 3-month post-activation	3.5
Sleep Fatigue: 3-month to 6-month post-activation	6.5
Sleep Fatigue: 3-month to 9-month post-activation	2.7
Sleep Fatigue: 3-month to 12-month post-activation	2.7
Sleep Fatigue: 3-month to 18-month post-activation	4.2
Sleep Fatigue: 3-month to 24-month post-activation	3.5
Cognitive Fatigue: Pre-operative to 3-month post-activation	7.5
Cognitive Fatigue: 3-month to 6-month post-activation	3.3
Cognitive Fatigue: 3-month to 9-month post-activation	0.8
Cognitive Fatigue: 3-month to 12-month post-activation	-2.3
Cognitive Fatigue: 3-month to 18-month post-activation	1.7
Cognitive Fatigue: 3-month to 24-month post-activation	-2.2

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Comparison of scores to evaluation change over time: General Fatigue Subtest
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1009
	Comments	The a priori threshold for statistical significance was p < 0.05
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Comparison of scores to evaluation change over time: Sleep Fatigue Subtest
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.109
	Comments	The a priori threshold for statistical significance was p < 0.05.
	Method	Mixed Models Analysis
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implant
	Comments	Comparison of scores to evaluation change over time: Cognitive Fatigue Subtest
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.1733
	Comments	The a priori threshold for statistical significance was p < 0.05.
	Method	Mixed Models Analysis
	Comments

Adverse Events

Time Frame	From the time of surgery through the Month 24 visit, a total of up to 25 months
Arm/Group Title	Cochlear Implant
Arm/Group Description	Pediatric patients with single sided deafness will receive a cochlear implant in the ear of loss Cochlear implant: Implantation
All Cause Mortality
	Cochlear Implant
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Serious Adverse Events
	Cochlear Implant
	Affected / at Risk (%)	# Events
Total	0/20 (0%)
Other (Not Including Serious) Adverse Events
	Cochlear Implant
	Affected / at Risk (%)	# Events
Total	4/20 (20%)
Ear and labyrinth disorders
Facial stimulation	2/20 (10%)	2
Vertigo	1/20 (5%)	1
Hearing loss progression in contralateral ear	1/20 (5%)	1
General disorders
Fall	1/20 (5%)	1
Sensory processing disorder	1/20 (5%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.