N/A
Completed N=15
CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
Source: ClinicalTrials.gov NCT04794179 ↗Enrolled (actual)
15
Serious AEs
—
Results posted
Nov 2024
Primary outcomePrimary: Speech Recognition — 70.03; 67.92; 30.43; 62.71 percentage of words repeated correctly
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 in unilateral CI recipients and their frequent communication partners. We hypothesize that:
1. Unilateral CI recipients will obtain higher speech understanding scores with the CROS device in challenging listening conditions
2. Use of the CROS device will lead to positive changes in ratings on Quality of Life measures for (i) unilateral CI recipients, and (ii) their frequent communication partners
A frequent communication partner (FCP) is an individual (a family member, or a friend, or a care taker, or a significant other, or a colleague, etc.) who has at least two hours of in-person interactions with the CI recipient every week.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Speech Recognition |
70.03; 67.92; 30.43; 62.71 | — |
| SECONDARY Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients |
3; 2; 5; 6; 2; 2 | — |
| SECONDARY Frequent Communication Partners' (FCPs) Quality of Life |
5; 1; 1 | — |
| SECONDARY Cochlear Implant/CROS Device Recipients' Quality of Life |
3; 2; 2 | — |
Eligibility Criteria
Inclusion Criteria
- 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 Criteria
- < 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
Data sourced from ClinicalTrials.gov (NCT04794179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.