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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 is a NA study that has completed, run by University of Miami. The registered enrollment target is 9 participants.

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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.

Interventions

  • DEVICE Phase I - Standard Microphone Cros Input
  • DEVICE Phase II - Automatic directional microphone Cros Input
  • DEVICE Phase III - No Cros Input

Trial Details

FieldValue
Enrollment Target 9 participants
Start Date 2017-08-24
Est. Completion 2021-03-26
Phase NA

Sponsor

University of Miami

721 total trials

What the Registry Record Tells You About NCT03243097

The ClinicalTrials.gov registry entry for NCT03243097 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 9 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Miami, which has 721 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which Phase I - Standard Microphone Cros Input is the first listed.

NCT03243097 reports 0 study locations.

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.

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

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.