Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

• Sponsor: Washington University School of Medicine (Other)
• Overall Status: Completed
• CT.gov ID: NCT03052920
• Collaborator: Midwest Ear Institute (Other), House Clinic, Inc. (Industry), NYU Langone Health (Other)
• Enrollment: 40
• Locations: 4
• Arm: 1
• Actual Duration (Months): 43.4
• Patients Per Site: 10
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

This longitudinal study evaluates the possible benefit of cochlear implantation in the poor ear of adults with asymmetric hearing loss who continue to use a hearing aid in the better hearing ear.

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

Detailed Description

The study will be conducted as a multicenter, prospective, single-arm clinical trial, evaluating the efficacy and safety of cochlear implantation in patients with asymmetric hearing loss. A repeated-measures analysis will be employed whereby patients will act as their own controls. Participants will be recruited from surgeons and audiologists in Otolaryngology departments at the participating sites.

Participants will be evaluated at multiple intervals using a variety of test measures (addressing sound localization, understanding speech in noise, understanding speech in quiet, and quality of life).

Prior to receiving a cochlear implant (CI) in the poor hearing ear, participants will be evaluated as follows:

• Hearing aid (HA) in the better ear alone

• HA in the poor ear alone

• Bilateral HAs

Participants who have not previously used a poor-ear hearing aid or BiCROS hearing aid will complete a 1-2 week trial and be evaluated at the end of the trial. If performance is better with the alternate therapy (bilateral hearing aids or BiCROS hearing aid) than the better ear alone performance and the participant prefers the alternate therapy, the participant will not continue in the study.

Participants who do continue in the study will be evaluated at several post-implant intervals. Post-implant evaluations will occur at 3, 6, 9, and 12 months after initial stimulation of the CI. Participants will be evaluated as follows:

• HA in the better ear alone

• CI in the poor ear alone

• HA and CI together

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
• Actual Study Start Date: Jul 28, 2017
• Actual Primary Completion Date: Nov 17, 2020
• Actual Study Completion Date: Mar 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Cochlear Implantation Cochlear implantation of the poor hearing ear	Device: Cochlear implant; Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.; Other Names: Cochlear America Advanced Bionics MED-EL

Outcome Measures

Primary Outcome Measures

1. Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet [Pre-implant and 6 months post-implant]

   Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.)

2. Change in Poor Ear Alone Soundfield Thresholds [Pre-implant and 6 months post-implant]

   Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.)

Secondary Outcome Measures

1. Change in Sound Localization [Pre-implant and 6 months post-implant]

   Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.)

2. Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) [Pre-implant and 6 months post-implant]

   Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.)

3. Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) [Pre-implant and 6 months post-implant]

   Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.)

4. Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear [Pre-implant and 6 months post-implant]

   Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)

5. Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone [Pre-implant and 6 months post-implant]

   Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.)

6. Change in Hearing Handicap Inventory (HHIE) [Pre-implant and 6 months post-implant]

   Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.)

7. Change in Health Utility Index (HUI3) Ratings [Pre-implant and 6 months post-implant]

   Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.)

8. Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant [Pre-implant and 6 months post-implant]

   Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)

9. Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant [Pre-implant and 12 months post-implant]

   Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)

10. Change in Satisfaction With Amplification in Daily Use (SADL) [Pre-implant and 6 months post-implant]

    Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.)

11. Change in Scores on the Communication Profile for the Hearing Impaired (CPHI) [Pre-implant and 6 months post-implant]

    The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.)

12. Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant [Pre-implant and 6 months post-implant]

    Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.)

13. Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear [Pre-implant and 6 months post-implant]

    Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

• 18 years of age or older

• English as the native language

• Have a desire for functional binaural hearing

• Have failed a previous hearing aid (HA) treatment for asymmetric hearing loss (BiCROS or poor ear HA) or willing to complete a trial if necessary

• Willingness to comply with all study requirements

• Ability to provide informed consent

• Poor ear (ear to be implanted):

• Pure-tone average (PTA) at .5, 1 and 2 kilohertz (kHz) > 70 dB HL (hereafter referred to as severe to profound hearing loss - SPHL)

• Aided word recognition score (CNC Word Test) at 60 dB SPL ≤ 30%

• Duration of SPHL ≥ 6 months

• Onset of hearing loss ≥ 6 years of age

• Better ear:

• PTA at .5, 1, 2, 4 kHz of 40 to 70 dB HL

• Currently using a HA

• Aided word recognition score (CNC Word Test) at 60 dB SPL > 40%

• Stable hearing for the previous 1-year period. "Stable" is defined as thresholds that have not changed by more than 10 dB at 2 or more octave interval audiometric frequencies

Exclusion Criteria:

• Medical condition that contraindicates surgery

• Actively using an implantable device in the ear to be implanted

• Known cochlear malformation or obstruction that would preclude full insertion of the electrode array in the ear to be implanted

• Hearing loss of neural or central origin

• Unrealistic expectations related to the benefits and limitations of cochlear implantation

• Unwillingness or inability to comply with all investigational requirements

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	House Clinic	Los Angeles	California	United States	90057
2	Saint Luke's Midwest Ear Institute	Kansas City	Missouri	United States	64111
3	Washington University School of Medicine	Saint Louis	Missouri	United States	63110
4	New York University School of Medicine	New York	New York	United States	10016

Sponsors and Collaborators

• Washington University School of Medicine
• Midwest Ear Institute
• House Clinic, Inc.
• NYU Langone Health

Investigators

• Principal Investigator: Jill B Firszt, PhD, Washington University School of Medicine

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Apr 27, 2018

More Information

Publications

None provided.

• Responsible Party: Washington University School of Medicine
• ClinicalTrials.gov Identifier: NCT03052920
• Other Study ID Numbers: 201612147
• First Posted: Feb 14, 2017
• Last Update Posted: Jan 12, 2022
• Last Verified: Dec 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 Washington University School of Medicine: cochlear implant; asymmetric hearing loss
• Additional relevant MeSH terms: Hearing Loss; Deafness

Study Results

Participant Flow

Recruitment Details	Recruitment occurred from Summer 2017 through 2019.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Period Title: Overall Study
STARTED	40
COMPLETED	39
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Overall Participants	40
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	10 25%
>=65 years	30 75%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	68.96 (10.27)
Sex: Female, Male (Count of Participants)
Female	17 42.5%
Male	23 57.5%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	1 2.5%
Not Hispanic or Latino	35 87.5%
Unknown or Not Reported	4 10%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	2 5%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	1 2.5%
White	33 82.5%
More than one race	0 0%
Unknown or Not Reported	4 10%
Region of Enrollment (Count of Participants)
United States	40 100%
Length of Deafness - Poor Ear (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	10.18 (12.06)

Outcome Measures

1. Primary Outcome

Title	Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet
Description	Group mean difference in CNC monosyllabic word understanding score in quiet with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (CNC scored on a scale from 0% to 100%; Higher scores are better.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

36 participants had both pre-implant and 6-month post-implant CNC scores for the poor ear alone.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	36
Pre-Implant Mean	0.09 (0.016)
6 Month Post-Implant Mean	0.53 (0.422)
Group mean difference	0.44 (0.039)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in percent correct for CNC words at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments	t(35) = 11.29

2. Primary Outcome

Title	Change in Poor Ear Alone Soundfield Thresholds
Description	Group mean difference in soundfield thresholds (dB HL average across frequency range) with the CI alone at 6 months post-implant compared to pre-implant with a hearing aid. (Measurable decibels in hearing level (dB HL) generally range from -10 dB to 120 dB; Lower levels are better.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

36 participants had both pre-implant and 6-month post-implant Soundfield thresholds for the poor ear alone.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	36
Pre-Implant Mean	54.95 (1.72)
6 Month Post-Implant Mean	26.54 (1.03)
Group mean difference	28.41 (1.68)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in Soundfield thresholds (averaged across the frequency range in dB HL) at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <=0.05
	Method	t-test, 2 sided
	Comments	t(35) = 16.947

3. Secondary Outcome

Title	Change in Sound Localization
Description	Sound localization in RMS error at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Root Mean Error Scores in degrees of error can range from 0 to approximately 80 degrees. Chance level performance is 64 degrees. Lower scores indicate better performance.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

36 participants had both pre-implant and 6-month localization scores in the bilateral/bimodal condition

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	36
Pre-Implant Mean	45.05 (2.79)
6 Month Post-Implant Mean	39.07 (1.57)
Group Mean Difference	5.99 (2.80)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in degrees RMS error at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for statistical significance was <= 0.05
	Method	t-test, 2 sided
	Comments	t(35) = 2.14

4. Secondary Outcome

Title	Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL)
Description	Understanding of sentences at a soft presentation level at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct ranging from 0 to 100%; Higher scores indicate better performance.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

Both pre-implant and 6-month post-implant data were available for 36 participants.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	36
Pre-Implant Mean	66.81 (4.56)
6-month Post-implant Mean	83.06 (3.14)
Group mean difference	16.25 (4.04)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in percentage of understanding (words correct) at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(35) = 4.02

5. Secondary Outcome

Title	Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR)
Description	Group mean difference in understanding of sentences in noise at 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. (Percent correct scoring ranging from 0 - 100%; Higher scores indicate better performance.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

36 participants had both pre-implant and 6-mongh post-implant AzBio scores in noise.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	36
Pre-Implant Mean	64.39 (4.16)
6-Month Post-Implant Mean	71.42 (3.87)
Group Mean Difference	7.03 (2.72)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in AzBio sentence scores in noise at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(35) = 2.58

6. Secondary Outcome

Title	Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear
Description	Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the better ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

36 participants had BKB-SIN scores for noise to the better ear at both the pre-implant and 6-month test intervals

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	36
Pre-implant mean	6.61 (0.83)
6-month post-implant mean	4.06 (0.83)
Group mean difference	2.56 (0.81)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in dB SNR for BKB-SIN sentences with noise to the better ear at 6-months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.01
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(35) = 3.16

7. Secondary Outcome

Title	Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone
Description	Group mean difference in AzBio sentence scores in quiet for the poor ear alone with the CI at 6-months post-implant compared to pre-implant with a hearing aid. (Scores are percent of words correct and can range from 0 to 100%; higher scores indicate better performance.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

36 participants had poor ear alone AzBio sentence scores at both the pre-implant and 6-month test intervals.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	36
Pre-implant mean	13.97 (2.75)
6-month post-implant mean	64.86 (4.96)
Group mean difference	50.89 (4.89)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in AzBio sentence scores at 60 dB SPL for the poor ear alone at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(35) = 10.42

8. Secondary Outcome

Title	Change in Hearing Handicap Inventory (HHIE)
Description	Inventory completed by participant regarding emotional and social consequences of hearing loss. Group mean difference in the total HHIE ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 100; Lower scores indicate less perceived hearing handicap - lower scores are better.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

39 participants had completed the HHIE at both the pre-implant and 6-month post-implant test intervals.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	39
Pre-implant mean	0.67 (0.03)
6-months post-implant mean	0.46 (0.04)
Group mean difference	0.21 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in HHIE reported scores at 6-months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(38) = 7.15

9. Secondary Outcome

Title	Change in Health Utility Index (HUI3) Ratings
Description	Questionnaire completed by participant regarding ability/disability across several health dimensions. Group mean difference in HUI3 ratings (total score) at 6 months post-implant compared to pre-implant. (Scores can range from 0.0 to 1.0; Higher scores indicate greater perceived health/ability.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

39 participants completed the HUI3 at both the pre-implant and 6-month post-implant test intervals.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	39
Pre-implant mean	0.51 (0.04)
6-month post-implant mean	0.66 (0.03)
Group mean difference	0.15 (0.03)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in HUI3 ratings at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(38) = 4.34

10. Secondary Outcome

Title	Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant
Description	Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 6-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

39 participants had SSQ ratings at both the pre-implant and 6-month test intervals.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	39
Pre-implant mean	3.42 (0.23)
6-month post-implant mean	5.46 (0.22)
Group mean difference	2.03 (0.26)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in ratings for the SSQ total score at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(38) = 7.71

11. Secondary Outcome

Title	Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant
Description	Questionnaire completed by participant regarding impact of hearing loss on various listening situations. Group mean difference in SSQ ratings at 12-months post-implant compared to pre-implant. (Ratings can range from 0 to 10; Higher scores indicate greater perceived abilities.)
Time Frame	Pre-implant and 12 months post-implant

Outcome Measure Data

Analysis Population Description

39 participants had SSQ ratings for both the pre-implant and 12-month post-implant test intervals. (These were not the same 39 who had SSQ ratings at both the 6-month and pre-implant test intervals.)

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	39
Pre-implant mean	3.37 (0.23)
12-month post-implant mean	5.37 (0.25)
Group mean difference	2.00 (0.25)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in SSQ ratings at 12 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(38) = 7.90

12. Secondary Outcome

Title	Change in Satisfaction With Amplification in Daily Use (SADL)
Description	Questionnaire completed by participant regarding satisfaction of HA use (pre-implant) and bimodal (HA+CI) device use at 6 months post-implant. (Ratings can range from 1 to 7; Higher scores indicate greater satisifaction.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

39 participants completed the HA version of the SADL pre-implant and also the bimodal version at 6 months post-implant (a modification of the original SADL).

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	39
Pre-implant mean	4.88 (0.12)
6-month post-implant mean	5.36 (0.15)
Group mean difference	0.48 (0.20)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in SADL scores at 6 months post-implant and pre-implant are reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(38) = 2.31

13. Secondary Outcome

Title	Change in Scores on the Communication Profile for the Hearing Impaired (CPHI)
Description	The CPHI was completed by participant's spouse/significant other indicating their perception of how well the participant communicates in various situations. Group mean difference in CPHI ratings at 6 months post-implant compared to pre-implant. (Ratings can range from 1 to 5; Higher scores indicate better communication abilities as perceived by the spouse/significant other.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

26 participants had a spouse or significant other who completed the CPHI at both the pre-implant and 6-month post-implant test intervals.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	26
Pre-implant mean	2.27 (0.10)
6-month post-implant mean	3.50 (0.15)
Group mean difference	1.22 (0.17)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in the CPHI scores at 6 months post-implant and pre-implant are reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(25) = 7.27

14. Secondary Outcome

Title	Change in Hearing Impaired Impact - Significant Other Profile (HII-SOP) by 6 Months Post-implant
Description	Questionnaire completed by participant's spouse/significant other indicating their perception of the impact of the participant's hearing loss on the spouse/significant other. Group mean difference in HII-SOP scores at 6 months post-implant compared to pre-implant. (Scores can range from 0 - 100; Lower scores are better - less impact of the hearing loss on the spouse/significant other.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

26 participants had a spouse or significant other who completed the HII-SOP at both the pre-implant and 6 month post-implant test intervals.

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	26
Pre-implant mean	55.96 (4.71)
6-month post-implant mean	22.98 (4.63)
Group mean difference	32.98 (4.31)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in HII-SOP scores at 6 months post-implant and pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.001
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(25) = 7.65

15. Secondary Outcome

Title	Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Poor Ear
Description	Group mean difference in BKB-SIN scores in noise (dB SNR) 6-months post-implant in the CI+HA (CI at poor ear; HA at better ear) condition compared to the pre-implant best aided condition. Speech is from the front and noise to the poor ear. (Scores are the signal to noise ration in decibels for approximately 50% understanding and can range from -7.5 dB to 23.5 dB; Lower scores indicate better performance.)
Time Frame	Pre-implant and 6 months post-implant

Outcome Measure Data

Analysis Population Description

36 participants had BKB-SIN scores for noise to the poor ear at both the pre-implant and 6-month test intervals

Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
Measure Participants	36
Pre-implant mean	1.82 (0.72)
6-month post-implant mean	0.42 (0.78)
Group mean difference	1.40 (0.60)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Cochlear Implantation
	Comments	Mean difference in the dB SNR scores for BKB-SIN sentences at 6 months post-implant minus pre-implant is reported.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	<0.05
	Comments	The threshold for statistical significance was <= 0.05.
	Method	t-test, 2 sided
	Comments	t(35) = 2.34

Adverse Events

Time Frame	Approximately 15 months, from enrollment until 12-month evaluation.
Arm/Group Title	Cochlear Implantation
Arm/Group Description	Cochlear implantation of the poor hearing ear Cochlear implant: Participants who have failed a BiCROS or bilateral hearing aid trial and otherwise meet inclusion criteria will receive a cochlear implant at the poor hearing ear. Post-implant, participants will continue use of a hearing aid at the better ear and the cochlear implant at the poor ear.
All Cause Mortality
	Cochlear Implantation
	Affected / at Risk (%)	# Events
Total	0/40 (0%)
Serious Adverse Events
	Cochlear Implantation
	Affected / at Risk (%)	# Events
Total	8/40 (20%)
Cardiac disorders
Heart bypass surgery	1/40 (2.5%)	1
Gastrointestinal disorders
Gall bladder removal	1/40 (2.5%)	1
General disorders
Nausea	1/40 (2.5%)	1
Infections and infestations
Infection	1/40 (2.5%)	1
Musculoskeletal and connective tissue disorders
Tear of medial meniscus	1/40 (2.5%)	1
Renal and urinary disorders
Kidney stone removal	1/40 (2.5%)	1
Vascular disorders
Stroke	1/40 (2.5%)	1
Coronary angioplasty and stint	1/40 (2.5%)	1
Other (Not Including Serious) Adverse Events
	Cochlear Implantation
	Affected / at Risk (%)	# Events
Total	11/40 (27.5%)
Ear and labyrinth disorders
Dizziness	7/40 (17.5%)	7
Tinnitus	2/40 (5%)	2
Swelling	2/40 (5%)	2

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.