Status:
COMPLETED
CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
Lead Sponsor:
University of Utah
Collaborating Sponsors:
Advanced Bionics
Conditions:
Hearing Impairment
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The purpose of this study is to assess the effect of the Naida Link contralateral routing of signal (CROS) device on speech understanding in challenging listening situations and on the quality of life...
Detailed Description
Cochlear Implants (CI) are now a well-accepted treatment for individuals with severe to profound hearing impairment. Compared to using one CI, bilateral CIs are known to provide access to some of the ...
Eligibility Criteria
Inclusion
- Unilateral recipients of Advanced Bionics CII/90K/Ultra implants
- Ages 18 years and above
- At least 6 months of CI use experience
- Current users of a Naida CI Q70 or Q90 processor
- Do not currently use a Naida Link CROS device
- Limited usable/aidable hearing in the contralateral ear
- Fluent in spoken English
- Willingness to use the CROS device regularly for the study duration
- Willingness to follow-up on a biweekly/monthly basis
Exclusion
- \< 6 months of CI use experience
- \< 30% sentence recognition scores in quiet with unilateral CI
- Inability to participate in speech testing
- Inability to follow and complete questionnaires
- Inability to designate an FC
- not a unilateral recipient of Advanced Bionics CII/90K/Ultra implants
- Frequent communication partner (FCP) participants' inclusion criteria:
- Ages 18 years and above
- Fluent in spoken English
- Willingness to participate in the study
- Spends at least two hours of in-person interactions with the recipient of Advanced Bionics CII/90K/Ultra implants every week.
- FCP's Exclusion criteria:
- Under the age of 18 years
- Not fluent in spoken English
- Spends less than two hours of in-person interactions with the recipient of Advanced Bionics CII/90K/Ultra implants per week
Key Trial Info
Start Date :
November 6 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 23 2021
Estimated Enrollment :
16 Patients enrolled
Trial Details
Trial ID
NCT04794179
Start Date
November 6 2019
End Date
June 23 2021
Last Update
November 19 2024
Active Locations (1)
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1
University of Utah Heath
Salt Lake City, Utah, United States, 84112