CROS Application in CI (CROS)
Primary Purpose
Hearing Loss
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Phase I - Standard Microphone Cros Input
Phase II - Automatic directional microphone Cros Input
Phase III - No Cros Input
Sponsored by
About this trial
This is an interventional device feasibility trial for Hearing Loss
Eligibility Criteria
Inclusion Criteria:
- Unilateral Advanced Bionics CI recipient
- ≥ 6 months CI-listening experience and/or better than 50%-word recognition on Consonant-Nucleus-Consonant (CNC) word testing
- English speaking
Exclusion Criteria:
- Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study
Sites / Locations
- University of Miami Department of Otolaryngology
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Study Subjects
Arm Description
All subjects enrolled in the study are required to complete Phase I before entering Phase II, and Phase II before entering Phase III.
Outcomes
Primary Outcome Measures
Speech perception in noise
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.
Secondary Outcome Measures
Subjective Benefit
Benefit of wireless CROS technology with the cochlear implant will be assessed using a customized questionnaire with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03243097
Brief Title
CROS Application in CI
Acronym
CROS
Official Title
Contralateral Routing of Signal in Unilateral Cochlear Implant Users
Study Type
Interventional
2. Study Status
Record Verification Date
April 2023
Overall Recruitment Status
Completed
Study Start Date
August 24, 2017 (Actual)
Primary Completion Date
March 12, 2021 (Actual)
Study Completion Date
March 26, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Miami
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hearing Loss
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
9 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Study Subjects
Arm Type
Experimental
Arm Description
All subjects enrolled in the study are required to complete Phase I before entering Phase II, and Phase II before entering Phase III.
Intervention Type
Device
Intervention Name(s)
Phase I - Standard Microphone Cros Input
Intervention Description
Subject will be fit with the research processor plus CROS microphone and wear for a 4 week period
Intervention Type
Device
Intervention Name(s)
Phase II - Automatic directional microphone Cros Input
Intervention Description
Automatic directional microphone technology will be activated in the research processor. Subjects will wear the CI+CROS configuration with directionality activated exclusively for 4-weeks.
Intervention Type
Device
Intervention Name(s)
Phase III - No Cros Input
Intervention Description
Subjects will return the research processor and CROS device and wear their own processor for a 2-week period
Primary Outcome Measure Information:
Title
Speech perception in noise
Description
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.
Time Frame
8 weeks
Secondary Outcome Measure Information:
Title
Subjective Benefit
Description
Benefit of wireless CROS technology with the cochlear implant will be assessed using a customized questionnaire with the subjects cochlear implant alone and then with the combined application of CROS technology to the cochlear implant.
Time Frame
8 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Unilateral Advanced Bionics CI recipient
≥ 6 months CI-listening experience and/or better than 50%-word recognition on Consonant-Nucleus-Consonant (CNC) word testing
English speaking
Exclusion Criteria:
Subjects who do not meet one or more of the above mentioned inclusion criteria are excluded from the study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hillary Snapp, AuD
Organizational Affiliation
University of Miami
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Miami Department of Otolaryngology
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
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CROS Application in CI
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