Who is sponsoring NCT02189798?

NCT02189798 is sponsored by Advanced Bionics.

What condition does NCT02189798 study?

NCT02189798 studies Hearing Loss, Partial Deafness, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases.

Is NCT02189798 still recruiting?

NCT02189798 is currently terminated. Last updated 8 May 2025.

Are results published for NCT02189798?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2025-05-08 · How we verify

NCT02189798

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Implantation of the HiRes90K™ Advantage Cochlear Implant With HiFocus™ Mid-Scala and Development of a Combined Electric and Acoustic Stimulation Technology in Adults With Partial Deafness

Terminated NA Results posted Last updated 8 May 2025

What this trial tests

NA trial testing HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode in Hearing Loss in 67 participants. Terminated before completion.

Timeline

21 October 2014

Primary endpoint
29 March 2022

29 March 2022

Quick facts

Lead sponsor	Advanced Bionics
Phase	NA
Status	Terminated
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	67
Start date	21 October 2014
Primary completion	29 March 2022
Estimated completion	29 March 2022
Sites	11 locations across United States

Drugs / interventions tested

HiRes 90K™ Advantage implant with HiFocus™ Mid-Scala electrode
EAS sound processor

Conditions studied

Hearing Loss — all drugs for Hearing Loss →
Partial Deafness — all drugs for Partial Deafness →
Hearing Disorders — all drugs for Hearing Disorders →
Ear Diseases — all drugs for Ear Diseases →

Sponsor

Advanced Bionics — full company profile →

Who can join

18 and older, any sex, with Hearing Loss or Partial Deafness. 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.

Unaided Pure-tone Average (PTA) Hearing Threshold Measurements Primary · Twelve months post device activation

Unaided pure tone hearing threshold measurement in the implanted ear at months 3, 6 and 12 months after surgery compared to pre-implant audiometric thresholds (using pure-tone average of 125 - 1000 Hz for comparison)

Baseline PTA

Group	Value	95% CI
Newly Implanted Subjects	46.7	± 8.7
Existing Implanted	72.0	± 19.5

3 Month PTA

Group	Value	95% CI
Newly Implanted Subjects	69.4	± 12.1
Existing Implanted	71.6	± 20.5

6 Month PTA

Group	Value	95% CI
Newly Implanted Subjects	67.5	± 12.2
Existing Implanted	72.6	± 18.9

12 Month PTA

Group	Value	95% CI
Newly Implanted Subjects	71.6	± 15.6
Existing Implanted	74.5	± 17.1

Consonant-Nucleus-Consonant (CNC) Word Recognition Test in Quiet Primary · Up to 12 months post device activation

Consonant-Nucleus-Consonant (CNC) Word Recognition Test in quiet in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.

Baseline

Group	Value	95% CI
Newly Enrolled	19.3	± 13.5
Existing Implanted	61.5	± 19.5

Month 1 Post Device /EAS Activation

Group	Value	95% CI
Newly Enrolled	31.3	± 25.8
Existing Implanted	67.1	± 17.8

Month 3 Post Device /EAS Activation

Group	Value	95% CI
Newly Enrolled	50.4	± 28.0
Existing Implanted	70.5	± 15.9

Month 6 Post Device /EAS Activation

Group	Value	95% CI
Newly Enrolled	50.5	± 25.6
Existing Implanted	72.7	± 18.3

Month 12 Post Device /EAS Activation

Group	Value	95% CI
Newly Enrolled	51.1	± 25.0
Existing Implanted	73.3	± 19.2

Speech Perception Testing (AzBio) in Noise. Primary · up to 12 months post device activation

Speech perception testing (AzBio) in noise in the treated ear measured at Month 1, 3, 6 and 12 post device activation compared to pre-implant speech perception testing in quiet. Scores are determined on scale of 0% to 100% words correct with higher scores indicating a better outcome.

Baseline

Group	Value	95% CI
Newly Enrolled	11.9	± 8.5
Existing Implanted	46.2	± 22.6

1 Month Post Device/ EAS Activation

Group	Value	95% CI
Newly Enrolled	19	± 19.7
Existing Implanted	55.0	± 27.1

3 Month Post Device/ EAS Activation

Group	Value	95% CI
Newly Enrolled	42.1	± 28.3
Existing Implanted	57.7	± 25.8

6 Month Post Device/ EAS Activation

Group	Value	95% CI
Newly Enrolled	44.4	± 28
Existing Implanted	62.6	± 27.1

12 Month Post Device/ EAS Activation

Group	Value	95% CI
Newly Enrolled	46.2	± 26.3
Existing Implanted	64.1	± 23.2

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse Events (AEs) were documented from the signing of the informed consent form through two weeks after the final study visit, up to 12 months post-activation in the main phase. In the extended use phase, participants were assessed annually, with AEs tracked as reported until exit. The first subject exited at 24 months, while the last exited at 84 months post-device activation.. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Newly Implanted Group

Serious: 16/49 (33%)

Deaths: 1/49

Existing Implanted Group

Serious: 0/18 (0%)

Deaths: 0/18

Extended Use Phase - Newly Implanted Group

Serious: 1/15 (7%)

Deaths: 0/15

Extended Use Phase - Existing Implanted Group

Serious: 0/9 (0%)

Deaths: 0/9

Serious adverse events (10 terms)

Reaction	System	Newly Implanted Group	Existing Implanted Group	Extended Use Phase - Newly…	Extended Use Phase - Exist…
Postoperative decrease/loss of residual hearing	Ear and labyrinth disorders	—	—	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Severe inflammation from extensive radiation damage	General disorders	—	—	—	—
Death	General disorders	—	—	—	—
Fractured left femoral head secondary to fall	Musculoskeletal and connective tissue disorders	—	—	—	—
Fractured rib secondary to fall	Musculoskeletal and connective tissue disorders	—	—	—	—
Crushed legs secondary to Motor Vehicle Accident	Musculoskeletal and connective tissue disorders	—	—	—	—
Hospitalization due to Health Setback	General disorders	—	—	—	—
Complication at Implant Site	Ear and labyrinth disorders	—	—	—	—
Torn Shoulder Tendon	Musculoskeletal and connective tissue disorders	—	—	—	—

Other adverse events (48 terms — click to expand)

Reaction	System	Newly Implanted Group	Existing Implanted Group	Extended Use Phase - Newly…	Extended Use Phase - Exist…
Vertigo or Dizziness	Ear and labyrinth disorders	—	—	—	—
Post-operative Pain - Implanted ear	Surgical and medical procedures	—	—	—	—
Musculoskeletal injury, sprain or fracture	Musculoskeletal and connective tissue disorders	—	—	—	—
Device related/ Programming Problems	Product Issues	—	—	—	—
Upper Respiratory Tract Infection	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Complication at Implant site	Skin and subcutaneous tissue disorders	—	—	—	—
Ear Irritation/Pain	Ear and labyrinth disorders	—	—	—	—
Headaches	General disorders	—	—	—	—
Oral/Dental Disturbance	General disorders	—	—	—	—
Renal illness (injury, stones or failure)	Renal and urinary disorders	—	—	—	—
Skin Irritation (General)	Skin and subcutaneous tissue disorders	—	—	—	—
Tinnitus - Implanted Ear	Ear and labyrinth disorders	—	—	—	—
Oral/Taste disturbance	General disorders	—	—	—	—
Constipation	Gastrointestinal disorders	—	—	—	—
Epistaxis	General disorders	—	—	—	—
External/Middle Ear Postoperative Symptom	Ear and labyrinth disorders	—	—	—	—
Anemia	Blood and lymphatic system disorders	—	—	—	—
Numbness (Implanted Ear)	Ear and labyrinth disorders	—	—	—	—
Postoperative decrease/loss of residual hearing	Ear and labyrinth disorders	—	—	—	—
Postoperative Sensation of clogged ear (Implanted Ear)	Ear and labyrinth disorders	—	—	—	—
Prostate Dysfunction	Reproductive system and breast disorders	—	—	—	—
Sleep Deprivation	Gastrointestinal disorders	—	—	—	—
Condition of the Contralateral ear	Ear and labyrinth disorders	—	—	—	—
Anxiety	Psychiatric disorders	—	—	—	—
Decreased Concentration	General disorders	—	—	—	—
Depression	Psychiatric disorders	—	—	—	—
Parkinson's Disease	Nervous system disorders	—	—	—	—
Eye Fluttering - Right eye	Eye disorders	—	—	—	—
Facial Edema	General disorders	—	—	—	—
Fever	General disorders	—	—	—	—
Leaky Heart Valve	Cardiac disorders	—	—	—	—
Lockjaw with pain	General disorders	—	—	—	—
Macular Degeneration	Eye disorders	—	—	—	—
Pain due to bone fracture from a fall	Musculoskeletal and connective tissue disorders	—	—	—	—
Fatigue	General disorders	—	—	—	—
Pneumonia	Respiratory, thoracic and mediastinal disorders	—	—	—	—
Nausea after implant surgery in contralateral ear	Gastrointestinal disorders	—	—	—	—
Postoperative popping noise (Implanted Ear)	Ear and labyrinth disorders	—	—	—	—
Postoperative Sensitivity during testing (Implanted Ear)	Ear and labyrinth disorders	—	—	—	—
Prediabetes	Endocrine disorders	—	—	—	—

Most-reported serious reactions: Postoperative decrease/loss of residual hearing, Pneumonia, Severe inflammation from extensive radiation damage, Death, Fractured left femoral head secondary to fall, Fractured rib secondary to fall, Crushed legs secondary to Motor Vehicle Accident, Hospitalization due to Health Setback.

Data from ClinicalTrials.gov NCT02189798 adverse events section.

Sponsor's own description

The purpose of this feasibility study is to evaluate whether low-frequency acoustic hearing sensitivity can be preserved in newly implanted adults with partial deafness (considerable low frequency acoustic hearing profiles with severe-to-profound high frequency sensorineural hearing loss) using the HiResolution™ 90K™ Advantage cochlear implant with the HiFocus™ Mid-Scala electrode to support the development of electro-acoustic stimulation technology (EAS).

Publications & conference data

1 peer-reviewed publication reference this trial (live from Europe PMC):

Neurosensory Prosthetics: An Integral Neuromodulation Part of Bioelectronic Device.
Ezeokafor I, Upadhya A, Shetty S. · · 2021 · cited 6× · PMID 34867141 · DOI 10.3389/fnins.2021.671767

Verify or expand the search:

Other recruiting trials for Hearing Loss

Currently open trials in the same condition.

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.

NCT05859568 — Baseline Performance and Fitting Parameters for Sonova Products · 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
NCT02811549 — Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss · NA · completed

Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT02189798 (US National Library of Medicine, public domain)
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: 8 May 2025

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/NCT02189798.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing