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NCT03243097 · ClinicalTrials.gov registry record · NA
CROS Application in CI
A NA study, sponsored by University of Miami.
- Completed
- Registry status
- NA
- Development phase
- 9
- Enrollment target
NCT03243097: Completed NA study, sponsored by University of Miami.
NCT03243097 is a NA study that has completed, run by University of Miami. The registered enrollment target is 9 participants, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03243097, a NA study, has completed, sponsored by University of Miami.
- COMPLETED
- Registry status
- NA
- Development phase
- 9 participants
- Enrollment target
Study Summary
Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. For unilateral CI users, the deficits inherently associated with monaural listening remain despite the considerable benefits achieved through implantation. Providing bilateral input to monaural listeners (MLs) overcomes some of these disadvantages. Treatment by contralateral routing of signal (CROS) hearing aids, where the signal of interest is routed from the impaired (deaf) ear to the normal cochlea for processing is a promising alternative in unilateral CI recipients who cannot benefit from bilateral CIs. Utilizing CROS technology provides a less invasive alternative for patients who are unable or unwilling to undergo a second CI surgery and offers an innovative approach to resolving the auditory deficits associated with monaural listening. CROS technology has been used to treat traditional monaural listeners since 1965. When applied to unilateral CI users, this novel approach can overcome a key limitation of current treatment by restoring access to sound from the non-implanted ear and improving speech perception in noise.
Primary Outcome
Speech perception in noise will be evaluated with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.
Interventions
- DEVICE Phase I - Standard Microphone Cros Input
- DEVICE Phase II - Automatic directional microphone Cros Input
- DEVICE Phase III - No Cros Input
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 9 participants |
| Start Date | 2017-08-24 |
| Est. Completion | 2021-03-26 |
| Phase | NA |
What the finished NCT03243097 record still lists
NCT03243097 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 9 participants, a relatively small participant target, below the 1,404-participant average among 58,714 other NA trials with a reported enrollment target (99% lower).
The record links to 0 conditions, and to 3 interventions - of which Phase I - Standard Microphone Cros Input is the first listed.
NCT03243097 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT03243097 about?
NCT03243097 is a clinical study titled "CROS Application in CI". Bilateral profound sensorineural hearing loss (PSNHL) is often treated with Cochlear Implants. The majority of bilaterally deafened patients, however, often only receive a unilateral cochlear implant (CI), with resultant limitations related to monaural listening. For unilateral CI users, the deficit...
What is the current status of trial NCT03243097?
This trial is currently completed. It is a NA study. The enrollment target is 9 participants. The study started on 2017-08-24. Estimated completion is 2021-03-26.
What interventions are being tested in trial NCT03243097?
The interventions under investigation include: Phase I - Standard Microphone Cros Input (DEVICE), Phase II - Automatic directional microphone Cros Input (DEVICE), Phase III - No Cros Input (DEVICE).
Who is sponsoring clinical trial NCT03243097?
This trial is sponsored by University of Miami, which has 721 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT03243097's enrollment target sits among peer trials
9 1975th of 2000 higher than 25 of 2,000 other NA trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other NA 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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