18 and older, any sex, with Hearing Loss or Ear Diseases. 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 Consonant Nucleus-Consonant (CNC) Word Recognition Test (Implanted Ear Only)Primary· Baseline and Twelve months
The post-implant CNC word scores were compared to preimplant word scores. The CNC monosyllabic word test is a validated test of open-set word recognition ability. The test was administered in quiet at 60 target 0° azimuth) and scored as total number of words correct which is expressed for results/reporting as percentage correct. The CNC word test was the primary speech perception metric used for study inclusion determination and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words. Th
Baseline CNC Score
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
2.13
± 7.453
12 Month Post Implant CNC score
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
61.14
± 20.240
Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, Only)Primary· Baseline and Twelve months
Unaided audiometric thresholds compared to preimplant. Standard audiometric procedures were used for the testing of inter-octave frequencies as necessary.
• Unaided air conduction thresholds using insert earphones at octave frequencies were measured for the contralateral, non-implanted ear at 250, 500, 1000, 2000, 4000 and 8000 Hz. Clinical masking was completed as appropriate.
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 250 HZ
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
17.14
± 7.774
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 250 HZ
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
17.14
± 8.254
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 500 HZ
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
17.86
± 14.769
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 500 HZ
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
20.00
± 14.005
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 1000 HZ
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
23.21
± 17.277
Pooled Air Conduction Threshold Data for the Contralateral Ear at 12 Month 1000 HZ
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
25.71
± 18.172
Pooled Air Conduction Threshold Data for the Contralateral Ear at Baseline 2000 HZ
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
28.57
± 21.342
Pooled Air Conduction Threshold Data for the Contralateral Ear at the 12 Month 2000 HZ
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
28.93
± 20.679
Change in Speech Perception (Bilateral Listening Condition) - Speech Front, Noise FrontPrimary· Baseline and Twelve months
AzBio speech scores in speech front, noise front twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was the primary speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Baseline Pooled AzBio in Noise Data - Speech Front / Noise Front
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
87.39
± 15.382
Month 12 Pooled AzBio in Noise Data - Speech Front / Noise Front
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
91.20
± 13.08
Change in Lateralization Ability Testing (Bilateral Listening Condition)Primary· Baseline and Twelve months
Lateralization is ability to recognize the location of sound origin compared to preimplantation. The subject was asked to identify if the sentence was heard from the right or left loudspeaker. Scoring was based on the number of sentence locations correctly identified and expressed as a percent average. A higher percent average indicates a better ability to identify sound location.
Baseline Pooled Lateralization Ability Data
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
72
± 21.634
Month 12 Pooled Lateralization Ability Data
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
89.10
± 19.522
Change in Speech Perception (Bilateral Listening Condition) - Speech Front/Noise to Implanted EarPrimary· Baseline to Twelve Months
AzBio word scores in speech front, noise to implanted ear twelve months post implantation compared to preimplant bilateral sentence scores. The AzBio speech testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Baseline Pooled AzBio in Noise Data - Speech Front / Noise to Implanted Ear
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
92.15
± 15.689
Month 12 Pooled AzBio in Noise Data - Speech Front / Noise to Implanted Ear
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
93.01
± 10.165
Bilateral Listening Condition (Both Ears - Everyday Listening Condition for Each Ear) - Speech Front /Noise to Non-Implanted Ear.Primary· Baseline to Twelve Months
AzBio speech scores in speech front, noise to the contralateral ear at 12 months post implantation compared to preimplant bilateral sentence scores. The baseline speech perception testing was a speech perception metric used for baseline and postoperative outcome comparison at defined intervals for this feasibility study. A higher percentage of recognized words represents better hearing of spoken words.
Baseline Pooled AzBio in Noise Data - Speech Front / Noise to Contralateral Ear
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
82.24
± 19.318
Month 12 Pooled AzBio in Noise Data - Speech Front / Noise to Contralateral Ear
Group
Value
95% CI
HiResolution Bionic Cochlear Implant
89.10
± 19.522
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse Events (AEs) were recorded and tracked between completion of the informed consent form (signed and dated) and two weeks after the participant's last study visit (approximately 13 months)..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
HiResolution Bionic Cochlear Implant
Serious: 0/15 (0%)
Deaths: 0/15
Other adverse events (29 terms — click to expand)
Reaction
System
HiResolution Bionic Cochle…
Residual hearing loss with a PTA greater than 30dB
Ear and labyrinth disorders
—
Vertigo or Dizziness
General disorders
—
Numbness, discomfort, or pain at or around the pinna
Ear and labyrinth disorders
—
Soreness, Tenderness, or Pain at or around the incision site
General disorders
—
Taste Disturbance
General disorders
—
Moderate Tinnitus, continuous - Right Ear
Ear and labyrinth disorders
—
Severe Tinnitus - Left Ear
Ear and labyrinth disorders
—
Severe Tinnitus - Right ear
Ear and labyrinth disorders
—
Complication at implant site
Surgical and medical procedures
—
Mild Tinnitus, intermittent - Left Ear
Ear and labyrinth disorders
—
Allergy induced asthma
Respiratory, thoracic and mediastinal disorders
—
Anxiety
General disorders
—
Cerumen Impaction
Ear and labyrinth disorders
—
Granuloma
General disorders
—
Headache
General disorders
—
Imbalance
General disorders
—
Itching in implanted ear
Ear and labyrinth disorders
—
Lightheadedness
General disorders
—
Mild ear pressure
Ear and labyrinth disorders
—
mild head & neck pain post-surgery
General disorders
—
Pain and Anxiety when wearing external device
General disorders
—
Sinus Infection
Infections and infestations
—
Small scab superior pole of incision line related to the patient's haircut
The purpose of this feasibility study is to evaluate the benefit of unilateral implantation in adults who have severe to profound sensorineural hearing loss in one ear, and up to moderate sensorineural hearing loss in the other ear (asymmetric hearing loss).
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
NCT07176936 — Improving Speech in Noise Using Noninvasive Stimulation
· NA
· recruiting
NCT07506408 — Randomised Study of Web-Based Auditory Training With Varying Perceptual and Cognitive Demands on Training Gains and Gene
· NA
· recruiting
NCT07218913 — Testing the Addition of Pedmark to Cisplatin Chemotherapy for Reducing Drug-Induced Ear Damage in Men With Stage II-III
· Phase 1
· recruiting
NCT07414329 — Efficacy and Effectiveness of an Investigational Behind-the-Ear Hearing Device Kit
· NA
· recruiting
NCT06930560 — HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
· NA
· recruiting
Other Advanced Bionics trials
Trials by the same sponsor.
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· NA
· enrolling by invitation
NCT05034731 — Evaluation of Remote Fitting in Adult and Pediatric Users of the HiResolution Bionic Ear System
· completed
NCT04237207 — Clinical Evaluation of a Cochlear Implant Sound Processor
· NA
· completed
NCT05488535 — Non-significant Risk Study of a Cochlear Implant Headpiece
· completed
NCT02189798 — Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric
· NA
· terminated
Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Advanced Bionics
Last refreshed: 21 August 2023
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT02811549.