Benefits of the HiResolution Bionic Ear System in Adults With Asymmetric Hearing Loss
NCT ID: NCT02811549
Last Updated: 2023-08-21
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
24 participants
INTERVENTIONAL
2016-11-07
2020-03-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Clinical Study of Cochlear Implants in Adults With Asymmetrical Hearing Loss
NCT02004535
Cochlear Implantation Among Adults and Older Children With Unilateral or Asymmetric Hearing Loss
NCT02105441
Cochlear Implantation in Adults With Asymmetric Hearing Loss Clinical Trial
NCT03052920
Single-Sided Deafness and Asymmetric Hearing Loss
NCT04506853
Safety and Effectiveness of Cochlear Implantation in an Expanded Adult Population
NCT06293482
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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).
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Advanced Bionics
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Silverstein Institute
Sarasota, Florida, United States
Virginia Mason Medical Center
Seattle, Washington, United States
Countries
Review the countries where the study has at least one active or historical site.
Provided Documents
Download supplemental materials such as informed consent forms, study protocols, or participant manuals.
Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
CR0314
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.