NCT03052920

Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial

Completed NA Results posted Last updated 11 March 2026

What this trial tests

NA trial testing Cochlear implant in Hearing Loss in 40 participants. Completed in 10 March 2021.

Timeline

28 July 2017

Primary endpoint
17 November 2020

10 March 2021

Quick facts

Lead sponsor	Washington University School of Medicine
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	40
Start date	28 July 2017
Primary completion	17 November 2020
Estimated completion	10 March 2021
Sites	4 locations across United States

Drugs / interventions tested

• Cochlear implant

Conditions studied

• Hearing Loss — all drugs for Hearing Loss →

Sponsor

Washington University School of Medicine

Who can join

18 and older, any sex, with Hearing Loss. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Poor Ear Alone CNC Monosyllabic Word Understanding in Quiet Primary · 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.)

Pre-Implant Mean

Group	Value	95% CI
Cochlear Implantation	0.09	± 0.016

6 Month Post-Implant Mean

Group	Value	95% CI
Cochlear Implantation	0.53	± 0.422

Group mean difference

Group	Value	95% CI
Cochlear Implantation	0.44	± 0.039

Change in Poor Ear Alone Soundfield Thresholds Primary · 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.)

Pre-Implant Mean

Group	Value	95% CI
Cochlear Implantation	54.95	± 1.72

6 Month Post-Implant Mean

Group	Value	95% CI
Cochlear Implantation	26.54	± 1.03

Group mean difference

Group	Value	95% CI
Cochlear Implantation	28.41	± 1.68

Change in Sound Localization Secondary · 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.)

Pre-Implant Mean

Group	Value	95% CI
Cochlear Implantation	45.05	± 2.79

6 Month Post-Implant Mean

Group	Value	95% CI
Cochlear Implantation	39.07	± 1.57

Group Mean Difference

Group	Value	95% CI
Cochlear Implantation	5.99	± 2.80

Change in AzBio Sentences at 50 Decibels (dB) Sound Pressure Level (SPL) Secondary · 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.)

Pre-Implant Mean

Group	Value	95% CI
Cochlear Implantation	66.81	± 4.56

6-month Post-implant Mean

Group	Value	95% CI
Cochlear Implantation	83.06	± 3.14

Group mean difference

Group	Value	95% CI
Cochlear Implantation	16.25	± 4.04

Change in AzBio Sentence Scores at 60 dB SPL and 4-talker Babble at +8 dB Signal-to-noise Ratio (SNR) Secondary · 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.)

Pre-Implant Mean

Group	Value	95% CI
Cochlear Implantation	64.39	± 4.16

6-Month Post-Implant Mean

Group	Value	95% CI
Cochlear Implantation	71.42	± 3.87

Group Mean Difference

Group	Value	95% CI
Cochlear Implantation	7.03	± 2.72

Change in Bamford-Kowal-Bench Speech-in-Noise (BKB-SIN) Sentence Understanding With Noise to the Better Ear Secondary · 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.)

Pre-implant mean

Group	Value	95% CI
Cochlear Implantation	6.61	± 0.83

6-month post-implant mean

Group	Value	95% CI
Cochlear Implantation	4.06	± 0.83

Group mean difference

Group	Value	95% CI
Cochlear Implantation	2.56	± 0.81

Change in AzBio Sentence Scores at 60 dB SPL for the Poor Ear Alone Secondary · 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.)

Pre-implant mean

Group	Value	95% CI
Cochlear Implantation	13.97	± 2.75

6-month post-implant mean

Group	Value	95% CI
Cochlear Implantation	64.86	± 4.96

Group mean difference

Group	Value	95% CI
Cochlear Implantation	50.89	± 4.89

Change in Hearing Handicap Inventory (HHIE) Secondary · 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.)

Pre-implant mean

Group	Value	95% CI
Cochlear Implantation	0.67	± 0.03

6-months post-implant mean

Group	Value	95% CI
Cochlear Implantation	0.46	± 0.04

Group mean difference

Group	Value	95% CI
Cochlear Implantation	0.21	± 0.03

Change in Health Utility Index (HUI3) Ratings Secondary · 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.)

Pre-implant mean

Group	Value	95% CI
Cochlear Implantation	0.51	± 0.04

6-month post-implant mean

Group	Value	95% CI
Cochlear Implantation	0.66	± 0.03

Group mean difference

Group	Value	95% CI
Cochlear Implantation	0.15	± 0.03

Change in Speech, Spatial and Sound Qualities (SSQ) by 6-months Post-implant Secondary · 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.)

Pre-implant mean

Group	Value	95% CI
Cochlear Implantation	3.42	± 0.23

6-month post-implant mean

Group	Value	95% CI
Cochlear Implantation	5.46	± 0.22

Group mean difference

Group	Value	95% CI
Cochlear Implantation	2.03	± 0.26

Change in Speech, Spatial and Sound Qualities (SSQ) by 12-months Post-implant Secondary · 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.)

Pre-implant mean

Group	Value	95% CI
Cochlear Implantation	3.37	± 0.23

12-month post-implant mean

Group	Value	95% CI
Cochlear Implantation	5.37	± 0.25

Group mean difference

Group	Value	95% CI
Cochlear Implantation	2.00	± 0.25

Change in Satisfaction With Amplification in Daily Use (SADL) Secondary · 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.)

Pre-implant mean

Group	Value	95% CI
Cochlear Implantation	4.88	± 0.12

6-month post-implant mean

Group	Value	95% CI
Cochlear Implantation	5.36	± 0.15

Group mean difference

Group	Value	95% CI
Cochlear Implantation	0.48	± 0.20

Adverse events — posted to ClinicalTrials.gov

Time frame: Approximately 15 months, from enrollment until 12-month evaluation.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Cochlear Implantation

Serious: 8/40 (20%)

Deaths: 0/40

Serious adverse events (8 terms)

Reaction	System	Cochlear Implantation
Stroke	Vascular disorders	—
Infection	Infections and infestations	—
Coronary angioplasty and stint	Vascular disorders	—
Gall bladder removal	Gastrointestinal disorders	—
Nausea	General disorders	—
Kidney stone removal	Renal and urinary disorders	—
Tear of medial meniscus	Musculoskeletal and connective tissue disorders	—
Heart bypass surgery	Cardiac disorders	—

Other adverse events (3 terms — click to expand)

Reaction	System	Cochlear Implantation
Dizziness	Ear and labyrinth disorders	—
Tinnitus	Ear and labyrinth disorders	—
Swelling	Ear and labyrinth disorders	—

Most-reported serious reactions: Stroke, Infection, Coronary angioplasty and stint, Gall bladder removal, Nausea, Kidney stone removal, Tear of medial meniscus, Heart bypass surgery.

Data from ClinicalTrials.gov NCT03052920 adverse events section.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Current Profile of Adults Presenting for Preoperative Cochlear Implant Evaluation.
   Holder JT, Reynolds SM, Sunderhaus LW, Gifford RH. · · 2018 · cited 98× · PMID 29441835 · DOI 10.1177/2331216518755288
2. Systematic review of cochlear implantation in adults with asymmetrical hearing loss.
   Sampathkumar R, Kaehne A, Kumar N, Kameswaran M, et al · · 2021 · cited 9× · PMID 34126876 · DOI 10.1080/14670100.2021.1936363