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NCT05318417 · ClinicalTrials.gov registry record · NA
Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness
A NA study of Hearing Loss, Unilateral and Deafness, Unilateral, sponsored by Cochlear.
- Recruiting
- Registry status
- NA
- Development phase
- 60
- Enrollment target
- 8
- Study locations
NCT05318417: Recruiting NA study of Hearing Loss, Unilateral and Deafness, Unilateral, sponsored by Cochlear.
NCT05318417 is a NA study of Hearing Loss, Unilateral and Deafness, Unilateral that is actively recruiting participants, run by Cochlear. The registered enrollment target is 60 participants, below the 3,477-participant average among 4 other Hearing Loss, Unilateral trials with a reported enrollment target (98% lower). The trial reports 8 study locations across 8 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05318417, a NA study of Hearing Loss, Unilateral and Deafness, Unilateral, is actively recruiting participants, sponsored by Cochlear.
- RECRUITING
- Registry status
- NA
- Development phase
- 60 participants
- Enrollment target
- 8
- Study locations
Study Summary
The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
Primary Outcome
Measured with the Bamford-Kowal-Bench Sentence in Noise test (BKB-SIN). List of sentences are presented at 65 dBA with the level of noise varied stepwise at fixed signal to noise ratio to obtain a Speech Reception Threshold (SRT) where participants are able to repeat key words 50% of the time. Score range is not specified as metric is adaptive; lower scores indicate better performance. The 3 speaker configurations are: speech front/noise front; speech front/noise to NH ear; speech front/noise to
Conditions Studied
Interventions
- DEVICE The Cochlear™ Nucleus® Cochlear Implant (CI) System
Study Locations (8)
California
- Stanford University - Palo Alto
Colorado
- Rocky Mountain Ear Center - Englewood
Iowa
- University of Iowa - Iowa City
New York
- New York Eye and Ear Infirmary - New York
North Carolina
- University of North Carolina - Chapel Hill
Ohio
- Nationwide Children's Hospital - Columbus
Texas
- University of Texas Southwestern Medical Center- Department of Otolaryngology Head and Neck Surgery - Dallas
Washington
- Virginia Mason Medical Center - Seattle
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2022-08-19 |
| Est. Completion | 2027-06 |
| Phase | NA |
What NCT05318417 shows while recruiting
NCT05318417 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 60 participants, a relatively small participant target, below the 3,477-participant average among 4 other Hearing Loss, Unilateral trials with a reported enrollment target (98% lower).
The record links to 2 conditions, with Hearing Loss, Unilateral appearing as the primary indexed condition, and to 1 intervention - of which The Cochlear™ Nucleus® Cochlear Implant (CI) System is the first listed.
NCT05318417 lists 8 locations in 8 states (California, Colorado, Iowa).
Frequently Asked Questions
What is clinical trial NCT05318417 about?
NCT05318417 is a clinical study titled "Investigation to Evaluate the Safety and Effectiveness of Cochlear Implantation in Children and Adults With Unilateral Hearing Loss/Single-sided Deafness". The aim of the study is to assess the continued efficacy and safety of cochlear implantation in participants aged 5 years and above with Unilateral Hearing Loss (UHL)/Single Sided Deafness (SSD) supporting a change indication for use.
What is the current status of trial NCT05318417?
This trial is currently recruiting. It is a NA study. The enrollment target is 60 participants. The study started on 2022-08-19. Estimated completion is 2027-06.
What conditions does trial NCT05318417 study?
This clinical trial studies the following conditions: Hearing Loss, Unilateral, Deafness, Unilateral.
What interventions are being tested in trial NCT05318417?
The interventions under investigation include: The Cochlear™ Nucleus® Cochlear Implant (CI) System (DEVICE).
Who is sponsoring clinical trial NCT05318417?
This trial is sponsored by Cochlear, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05318417 being conducted?
This trial has 8 study locations across California, Colorado, Iowa, New York, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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