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

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. According to ClinicalTrials.gov, the official US trial registry.

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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

Primary Outcome

The primary efficacy endpoints are AzBio sentence recognition scores in quiet at Baseline with the new sound processor as compared to AzBio sentence recognition scores in quiet at Baseline with currently approved software on a Q90 processor. Scores are determined on a scale of 0% to 100% words correct with higher scores indicating a better outcome.

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
Advanced Bionics

8 total trials

What the finished NCT04237207 record still lists

NCT04237207 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 22 participants, a relatively small participant target, below the 6,121-participant average among 58 other Hearing Loss trials with a reported enrollment target (100% lower).

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 lists 6 locations in 5 states (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.

Similar trials for Hearing Loss

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT04237207's enrollment target sits among peer trials

22 55th of 58 higher than 4 of 58 other Hearing Loss trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Hearing Loss trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT04237207, the US trial registry maintained by the National Library of Medicine. NCT04237207 (small enrollment · multi site footprint · completed) retrieved and formatted by PlainTrial, see methodology.