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NCT04237207 · ClinicalTrials.gov registry record · NA

Clinical Evaluation of a Cochlear Implant Sound Processor

A NA study of Hearing Loss and Hearing Disorders, sponsored by Advanced Bionics.

Completed
Registry status
NA
Development phase
22
Enrollment target
6
Study locations

NCT04237207 is a NA study of Hearing Loss and Hearing Disorders that has completed, run by Advanced Bionics. The registered enrollment target is 22 participants, below the 6,121-participant average among 58 other Hearing Loss trials with a reported enrollment target (100% lower). The trial reports 6 study locations across 5 states.

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The verdict

NCT04237207, a NA study of Hearing Loss and Hearing Disorders, has completed, sponsored by Advanced Bionics.

COMPLETED
Registry status
NA
Development phase
22 participants
Enrollment target
6
Study locations

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

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

FieldValue
Enrollment Target 22 participants
Start Date 2019-12-17
Est. Completion 2020-10-15
Phase NA

Sponsor

Advanced Bionics

8 total trials

What the Registry Record Tells You About NCT04237207

The ClinicalTrials.gov registry entry for NCT04237207 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 22 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 6,121-participant average among 58 other Hearing Loss trials with a reported enrollment target (100% lower). The listed sponsor is Advanced Bionics, which has 8 total studies on file at ClinicalTrials.gov.

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.

NCT04237207 reports 6 study locations spanning 5 distinct geographic areas - top geographies include Missouri, Colorado, Florida.

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.

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).

Who is sponsoring clinical trial NCT04237207?

This trial is sponsored by Advanced Bionics, which has 8 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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