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NCT04506853 · ClinicalTrials.gov registry record · NA
Single-Sided Deafness and Asymmetric Hearing Loss
A NA study of Hearing Loss, Sensorineural and Hearing Loss, Unilateral, sponsored by Med-El Corporation.
- Recruiting
- Registry status
- NA
- Development phase
- 65
- Enrollment target
- 6
- Study locations
NCT04506853: Recruiting NA study of Hearing Loss, Sensorineural and Hearing Loss, Unilateral, sponsored by Med-El Corporation.
NCT04506853 is a NA study of Hearing Loss, Sensorineural and Hearing Loss, Unilateral that is actively recruiting participants, run by Med-El Corporation. The registered enrollment target is 65 participants, below the 783-participant average among 20 other Hearing Loss, Sensorineural trials with a reported enrollment target (92% lower). The trial reports 6 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04506853, a NA study of Hearing Loss, Sensorineural and Hearing Loss, Unilateral, is actively recruiting participants, sponsored by Med-El Corporation.
- RECRUITING
- Registry status
- NA
- Development phase
- 65 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
Primary Outcome
The primary effectiveness endpoint will be change on speech in noise when speech is presented to the front and noise is presented to the acoustic hearing (contralateral) ear. The pre-operative, best-aided score will be compared to the 12-month and 36-month CI score for AzBio sentences in noise(range of score 0-100, higher score is better). Improvement is defined as greater than or equal to 10 percentage points.
Conditions Studied
Interventions
- DEVICE MED-EL Cochlear Implant System
Study Locations (6)
Illinois
- Ann & Robert H. Lurie Children's Hospital of Chicago - Chicago
Iowa
- University of Iowa - Iowa City
New York
- New York Eye and Ear Infirmary - New York
North Carolina
- University of North Carolina - Chapel Hill
Washington
- Virginia Mason Medical Center - Seattle
Ontario
- Sunnybrook Health Sciences Center - Toronto
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 65 participants |
| Start Date | 2021-02-22 |
| Est. Completion | 2026-12 |
| Phase | NA |
What NCT04506853 shows while recruiting
NCT04506853 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 65 participants, a relatively small participant target, below the 783-participant average among 20 other Hearing Loss, Sensorineural trials with a reported enrollment target (92% lower).
The record links to 2 conditions, with Hearing Loss, Sensorineural appearing as the primary indexed condition, and to 1 intervention - of which MED-EL Cochlear Implant System is the first listed.
NCT04506853 lists 6 locations in 6 states (Illinois, Iowa, New York).
Frequently Asked Questions
What is clinical trial NCT04506853 about?
NCT04506853 is a clinical study titled "Single-Sided Deafness and Asymmetric Hearing Loss". The purpose of the study is to evaluate the long-term safety and effectiveness of cochlear implantation of the approved population in adults and children with single-sided deafness and asymmetric hearing loss.
What is the current status of trial NCT04506853?
This trial is currently recruiting. It is a NA study. The enrollment target is 65 participants. The study started on 2021-02-22. Estimated completion is 2026-12.
What conditions does trial NCT04506853 study?
This clinical trial studies the following conditions: Hearing Loss, Sensorineural, Hearing Loss, Unilateral.
What interventions are being tested in trial NCT04506853?
The interventions under investigation include: MED-EL Cochlear Implant System (DEVICE).
Who is sponsoring clinical trial NCT04506853?
This trial is sponsored by Med-El Corporation, which has 14 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04506853 being conducted?
This trial has 6 study locations across Illinois, Iowa, New York, North Carolina, Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Hearing Loss, Sensorineural
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 NCT04506853's enrollment target sits among peer trials
65 8th of 20 higher than 13 of 20 other Hearing Loss, Sensorineural trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Hearing Loss, Sensorineural 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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