Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
![]() |
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT02811549 |
Recruitment Status :
Active, not recruiting
First Posted : June 23, 2016
Last Update Posted : July 22, 2019
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Hearing Loss Ear Diseases Hearing Disorders Otorhinolaryngologic Diseases Asymmetrical Hearing Loss Single-Sided Deafness | Device: HiResolution Bionic Cochlear Implant | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 15 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss |
Actual Study Start Date : | November 28, 2016 |
Estimated Primary Completion Date : | April 2020 |
Estimated Study Completion Date : | December 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: HiResolution Bionic Cochlear Implant
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted 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).
|
Device: HiResolution Bionic Cochlear Implant
HiRes 90K™ Advantage implant with HiFocus™ 1J electrode, HiRes 90K™ Advantage implant with the HiFocus Helix™ electrode, HiRes 90K™ Advantage implant with the HiFocus™ Mid-Scala electrode or the HiRes™ Ultra Implant with the HiFocus™ Mid-Scala electrode will be implanted in adults with eligible hearing profile. |
- Change in Speech Perception (Implanted Ear only) [ Time Frame: Baseline and Twelve months ]CNC word scores compared to preimplant word scores
- Change in Unaided Hearing Thresholds (Contralateral, Non-Implanted Ear, only) [ Time Frame: Baseline and Twelve months ]Unaided audiometric thresholds compared to preimplant
- Change in Speech Perception (Bilateral Listening Condition) [ Time Frame: Baseline and Twelve months ]AzBio sentence scores in noise twelve months post implantation compared to preimplant bilateral sentence scores
- Change in Lateralization Ability Testing (Bilateral Listening Condition) [ Time Frame: Baseline and Twelve months ]Lateralization ability compared to preimplantation

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
General Requirements:
- Ability to provide Informed Consent
- 18 years of age or older
- English language proficiency
- Willingness to participate in all scheduled procedures outlined in the study investigational plan
- Willingness to use an approved cochlear implant signal processing strategy in an everyday listening program during study
Ear to be Implanted:
- Severe-to-profound sensorineural hearing loss (> 70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
- CNC word recognition score ≤30% (tested in subject's everyday listening condition for that ear)
- Duration of severe-to-profound sensorineural hearing loss (≥ 70 dB HL) >3 months and ≤10 years in the ear to be implanted only
Contralateral (non-implanted) ear:
- Up to a moderate sensorineural hearing loss (<70 dB HL) as defined by the pure tone average for 500, 1000, 2000 and 4000 Hz
- CNC word recognition score >30% (tested in subject's everyday listening condition for that ear)
Exclusion Criteria:
- Previous experience with a cochlear implant
- Cochlear malformation or obstruction (i.e. ossification) that would preclude full insertion of electrode array in the ear to be implanted
- Medical or psychological conditions that contraindicate surgery or impact the ability to manage an implanted device or the study related procedures as determined by the investigator
- Diagnosis of auditory neuropathy/dys-synchrony in either the ear to be implanted or the contralateral ear
- Active middle-ear disease/infection in the ear to be implanted
- Unrealistic expectations regarding potential benefits, risks and limitations inherent to implant surgical procedures as determined by the investigator
- Unwillingness or inability of subject to comply with all investigational requirements as determined by the investigator

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02811549
United States, Florida | |
The Silverstein Institute | |
Sarasota, Florida, United States, 34239 | |
United States, Washington | |
Virginia Mason Medical Center | |
Seattle, Washington, United States, 98101 |
Study Director: | Silke Thode, PhD | Advanced Bionics |
Responsible Party: | Advanced Bionics |
ClinicalTrials.gov Identifier: | NCT02811549 |
Other Study ID Numbers: |
CR0314 |
First Posted: | June 23, 2016 Key Record Dates |
Last Update Posted: | July 22, 2019 |
Last Verified: | July 2019 |
Cochlear Implant HiRes™ 90K Advantage Implant HiFocus™ Mid-Scala electrode HiFocus™ 1J electrode HiFocus Helix™ electrode Cochlear Implantation |
Listening Benefits Adults Cochlear Implant Benefit Electrical Stimulation HiRes™ Ultra Implant with HiFocus™ Mid-Scala electrode |
Hearing Loss Deafness Ear Diseases Hearing Disorders |
Otorhinolaryngologic Diseases Sensation Disorders Neurologic Manifestations Nervous System Diseases |