Trial Outcomes & Findings for CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers (NCT NCT04794179)

Results Overview

AZBio speech testing was performed in a sound booth with two speakers. Sentences at 60 dB were presented in the following conditions: (1) CI-only, speech presented from the front in quiet; (2) CI-only, speech in the non-CI ear in quiet; (3) CI-only, speech in the non-CI ear in noise; (4) CI+CROS device, speech in the non-CI ear in noise. A higher average percentage of words repeated correctly corresponds to greater understanding. The goal was to assess the impact of the CROS device on speech and speech understanding. The test was planned at enrollment and after 6 months of CROS use to evaluate long-term effects, but due to COVID-19, only the enrollment test was completed.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

16 participants

Primary outcome timeframe

At baseline (enrollment visit), with a duration of 50 minutes

Results posted on

2024-11-19

Participant Flow

Participant milestones

Participant milestones
Measure	Naida Link CROS Device Individuals 18+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link Contralateral routing of signal (CROS) device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.	Frequent Communication Partners (FCPs) Individuals 18+ who spend at least two hours in-person with Naida Link CROS device users. One FCP will be selected by each CROS device recipient. In this study, A total of seven FCPs were enrolled: six spouses and one mother of the CROS device recipients. FCPs will complete a questionnaire to evaluate: 1. Improvements in communication between themselves and the CROS recipients 2. Whether these communication improvements affect the FCPs' quality of life. No additional data, such as demographics or baseline characteristics, will be collected regarding FCPs as this study focuses on cochlear implant/CROS users.
Overall Study STARTED	8	7
Overall Study COMPLETED	7	7
Overall Study NOT COMPLETED	1	0

Reasons for withdrawal

Reasons for withdrawal
Measure	Naida Link CROS Device Individuals 18+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link Contralateral routing of signal (CROS) device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.	Frequent Communication Partners (FCPs) Individuals 18+ who spend at least two hours in-person with Naida Link CROS device users. One FCP will be selected by each CROS device recipient. In this study, A total of seven FCPs were enrolled: six spouses and one mother of the CROS device recipients. FCPs will complete a questionnaire to evaluate: 1. Improvements in communication between themselves and the CROS recipients 2. Whether these communication improvements affect the FCPs' quality of life. No additional data, such as demographics or baseline characteristics, will be collected regarding FCPs as this study focuses on cochlear implant/CROS users.
Overall Study This participant didn't meet criteria after screening	1	0

Baseline Characteristics

CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Naida Link CROS Device n=7 Participants Individuals 18+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link CROS device to assess the effect the device has on speech understanding in challenging listening situations and on the quality of life in unilateral cochlear implant recipients and their frequent communication partners.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Age, Continuous	68.25 years STANDARD_DEVIATION 18.995 • n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	7 participants n=5 Participants

PRIMARY outcome

Timeframe: At baseline (enrollment visit), with a duration of 50 minutes

Population: 7 participants with unilateral Advanced Bionics CII/90K/Ultra cochlear implant cochlear implant and CROS device

AZBio speech testing was performed in a sound booth with two speakers. Sentences at 60 dB were presented in the following conditions: (1) CI-only, speech presented from the front in quiet; (2) CI-only, speech in the non-CI ear in quiet; (3) CI-only, speech in the non-CI ear in noise; (4) CI+CROS device, speech in the non-CI ear in noise. A higher average percentage of words repeated correctly corresponds to greater understanding. The goal was to assess the impact of the CROS device on speech and speech understanding. The test was planned at enrollment and after 6 months of CROS use to evaluate long-term effects, but due to COVID-19, only the enrollment test was completed.

Outcome measures

Outcome measures
Measure	Cochlear Implant Users n=7 Participants This group comprised of seven Advanced Bionics CII/90K/Ultra cochlear implant recipients who were tested with and without Naida Link contralateral routing of signal (CROS) \*(within-subjects comparison).
Speech Recognition CI only, with speech presented from front (Quiet environment)	70.03 percentage of words repeated correctly Interval 56.83 to 78.52
Speech Recognition CI only, with speech presented in the non-CI ear (Quiet environment)	67.92 percentage of words repeated correctly Interval 50.0 to 90.31
Speech Recognition CI only, with speech presented in the non-CI ear (Noisy environment)	30.43 percentage of words repeated correctly Interval 18.12 to 47.49
Speech Recognition CI+CROS, with speech presented in the non-CI ear (Noisy environment)	62.71 percentage of words repeated correctly Interval 46.08 to 91.74

SECONDARY outcome

Timeframe: At baseline (enrollment visit) and 6 months after using the CROS device.

Population: Data table is based on the responses of 7 participants with unilateral Advanced Bionics CII/90K/Ultra cochlear implant cochlear implant and CROS device. These participants were assessed for improvements in auditory satisfaction by comparing their responses at baseline and again at the 6-month follow-up. Each row corresponds to a different category/aspect of the participants' auditory experience. The column shows number of participants who reported a positive change for each statement.

The Auditory Performance and Satisfaction Scale for Single-Sided Deafness (APS-SSD) assesses hearing in various environments through 31 statements grouped by context (general, home, social, work/school). Hearing ability is rated from 0: Can function fine to 6: Cannot function at all, lower score indicates better performance.The second section has 2 parts: Part one: 13 statements about satisfaction with CROS device, rated from 0: very satisfied to 6: very dissatisfied, lower score indicates higher satisfaction. Part two: 10 miscellaneous questions regarding overall quality and satisfaction with the CROS device. The data table shows the number of subjects reporting improvements in auditory satisfaction, assessed by comparing baseline responses to the 6-month follow-up. A decrease in score indicates perceived improvement. Rows represent categories of participants' auditory experiences, while column shows the number of participants reporting positive changes in that category.

Outcome measures

Outcome measures
Measure	Cochlear Implant Users n=7 Participants This group comprised of seven Advanced Bionics CII/90K/Ultra cochlear implant recipients who were tested with and without Naida Link contralateral routing of signal (CROS) \*(within-subjects comparison).
Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients Speech is clearer and easier to understand in a noisy situation	3 Participants
Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients Speech is clearer and easier to understand in a small group of people	2 Participants
Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients Speech is clearer and easier to understand when speaking to 1 person in quiet	5 Participants
Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients Music Sounds better	6 Participants
Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients Speech sounds more natural	2 Participants
Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients overall quality of speech is better	2 Participants

SECONDARY outcome

Timeframe: At baseline(enrollment visit), and after 6 months after CROS device use

Population: The table shows communication outcomes reported by 7 Frequent Communication Partners (FCPs) who had at least two hours per week of in-person interactions with the recipient of Advanced Bionics CII/90K/Ultra implants/CROS device

To asses FCPs' quality of life, they completed the Significant Other Scale for Hearing Disability (SOS-HEAR) questionnaire at baseline and 6 months after the CI users whom they communicate with began using the CROS device. The SOS-HEAR evaluates the disability experienced by the FCP of individuals with hearing loss (i.e., CROS device users). This questionnaire has 26 Statements grouped into: concern for partner, emotional reactions, going out and socializing, relationship changes, communication burden, and communication changes. FCPs rated statements on a 4-point Likert scale ranging from 0-4 with 0=No Problem and 4=A Complete Problem. A lower score represents better outcome. Table shows communication outcomes reported by FCPs, assessed by comparing their baseline responses to their 6-month follow-up responses. A decrease in scores represents improvement in communication with CI users. Rows represent communication experience and column shows the count of FCPs within each category

Outcome measures

Outcome measures
Measure	Cochlear Implant Users n=7 Participants This group comprised of seven Advanced Bionics CII/90K/Ultra cochlear implant recipients who were tested with and without Naida Link contralateral routing of signal (CROS) \*(within-subjects comparison).
Frequent Communication Partners' (FCPs) Quality of Life Improved Communication	5 Participants
Frequent Communication Partners' (FCPs) Quality of Life No Change in Communication	1 Participants
Frequent Communication Partners' (FCPs) Quality of Life Worse Communication	1 Participants

SECONDARY outcome

Timeframe: At baseline, and after 6 months of CROS use

Population: 7 Advanced Bionics CII/90K/Ultra cochlear implant and CROS device users

To evaluate the effect of CROS device use on participant's quality of life, they completed the Nijmegen Cochlear Implant Questionnaire (NCIQ) Adapted from Hinderink et al., 2000, a subjective self-assessment of health-related assessment for cochlear implant (CI) users that includes 60 questions. The answers to the questionnaire range on a 5-point Likert scale never (0), rarely (1), sometimes(3), very often(4), and always (5). A higher score represents a better quality of life experience. The table summarizes perceived changes in life quality among participants after 6 months of using the CROS device, assessed by comparing responses at baseline questionnaire to those at the 6-month follow-up. An increase in scores on the questionnaires indicates a perceived improvement in quality of life. Rows represent the categories of life quality changes reported by participants, while the column shows the count of participants within each category.

Outcome measures

Outcome measures
Measure	Cochlear Implant Users n=7 Participants This group comprised of seven Advanced Bionics CII/90K/Ultra cochlear implant recipients who were tested with and without Naida Link contralateral routing of signal (CROS) \*(within-subjects comparison).
Cochlear Implant/CROS Device Recipients' Quality of Life Overall Positive Quality of Life Change	3 Participants
Cochlear Implant/CROS Device Recipients' Quality of Life Overall Negative Quality of Life Change	2 Participants
Cochlear Implant/CROS Device Recipients' Quality of Life Overall No Quality of Life Change	2 Participants

Adverse Events

Naida Link CROS Device

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Richard Gurgel MD, PI

University of Utah Healthcare

Phone: 801-585-1626

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place