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Clinical Evaluation of a Cochlear Implant Sound Processor
NCT04237207 · View on ClinicalTrials.gov ↗
Study Summary
This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit
Conditions Studied
Interventions
- DEVICE Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software
- DEVICE 301-M062 sound processor & software
Study Locations (6)
Missouri
- Midwest Ear Institute/St. Luke's Health System — Kansas City
- Washington University Medical Center — St Louis
Colorado
- University of Colorado Anschutz Medical Campus — Aurora
Florida
- Tampa Bay Hearing and Balance Center — Tampa
Tennessee
- Vanderbilt University Medical Center — Nashville
Texas
- Austin Ear, Nose & Throat Clinic — Austin
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 22 participants |
| Start Date | 2019-12-17 |
| Est. Completion | 2020-10-15 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04237207
The ClinicalTrials.gov registry entry for NCT04237207 describes a study currently listed as completed. It is categorized as NA, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Advanced Bionics, which has 4 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 4 conditions, with Hearing Loss appearing as the primary indexed condition, and to 2 interventions — of which Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04237207 reports 6 study locations spanning 5 distinct geographic areas — top geographies include Missouri, Colorado, Florida. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04237207 about?
NCT04237207 is a clinical study titled "Clinical Evaluation of a Cochlear Implant Sound Processor". This is a prospective within-subjects repeated-measures study that will enroll 24 adult users implanted with a HiResolution Bionic Ear System (HiRes 90K or newer). Subjects will be assigned to one of two cohorts based on audiometric results at the Baseline visit
What is the current status of trial NCT04237207?
This trial is currently completed. It is a NA study. The enrollment target is 22 participants. The study started on 2019-12-17. Estimated completion is 2020-10-15.
What conditions does trial NCT04237207 study?
This clinical trial studies the following conditions: Hearing Loss, Hearing Disorders, Ear Diseases, Otorhinolaryngologic Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04237207?
The interventions under investigation include: Naída Cochlear Implant Q90 sound processor (Naida CI Q90) & software (DEVICE), 301-M062 sound processor & software (DEVICE). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04237207?
This trial is sponsored by Advanced Bionics, which has 4 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04237207 being conducted?
This trial has 6 study locations across Colorado, Florida, Missouri, Tennessee, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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