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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04794179
Enrollment
16
Registered
2021-03-11
Start date
2019-11-06
Completion date
2021-06-23
Last updated
2026-04-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hearing Impairment

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 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.

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 benefits of binaural hearing like improved speech understanding in noise (primarily due to headshadow), improved localization, reduced stress and fatigue, and improved quality of life (e.g., Dunn et al. 2012, Litovsky et al. 2012, Härkönen et al. 2016, Reeder et al. 2014, Agrawal 2008). However, a number of CI recipients are unable to or choose not to be implanted bilaterally for many reasons. Those with acoustic hearing in the contralateral ear can benefit significantly by using a hearing aid in that ear (bimodal hearing) (Ching et el. 2006, Dorman and Gifford 2010, Dorman et al. 2015, Dunn et al. 2005, Firszt et al. 2012, Illg et al. 2014, Farinetti et al. 2015). Unilateral CI recipients do not have access to advantages of bilateral and bimodal hearing. In addition to reduced speech understanding in noise, especially when the speech source is located towards the non-CI, they can also experience increased stress and fatigue. Studies have shown that a CROS device, when worn on the contralateral, non-implanted ear, can help overcome speech understanding deficits due to head-shadow. The effect of such technology on quality of life of the CI recipient and their frequent communication partners has not been evaluated over an extended duration of use. Study methodology: Fourteen unilateral CI recipients will participate in this study. Testing will be conducted at the University of Utah Hospital ENT clinic. The study will comprise of 2 clinic visits separated by a take-home phase of 6 months. A designated FCP will be a part of each study visit, preferably. Following are the test measures for CI recipients: * Questionnaires * Data logs * Pure-tone audiometry * Speech intelligibility Following are the test measures for FCPs: • Questionnaires Speech testing will be conducted in a sound booth with a two speaker set-up (± 90°). AZBio sentences (Spahr et al., 2012) presented at 65 dB A will be the target stimuli. The interferer will be a multi-talker babble. The babble will be presented at an individualized level for each participant where their performance in noise in SCROS(Off)NCI configuration is half of their performance in quiet in SCROS(Off) configuration. Study devices: For speech testing in the sound booth, a study Naida CI Q90 sound processor will be used. For the take-home phase, recipients will use their own Naida CI processor (Q70 or Q90). A Naida Link CROS will also be used for sound-booth testing as well as the take-home phase. Workflow: After recruiting, following will be mailed to the participants to be completed prior to the study visit and hand carried to visit 1: For each CI subject: (i) Informed consent form (ii) APS-SSD (Schafer et al, 2013, modified by H. Snapp, 2017) (iii) Nijmegen questionnaire (adapted from Hinderink et al, 2000) For each CI subject's frequent communication partner: (i) Informed consent form (ii) SOS-HEAR

Interventions

DEVICENaida Link CROS

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.

Sponsors

University of Utah
Lead SponsorOTHER
Advanced Bionics
CollaboratorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Speech RecognitionAt baseline (enrollment visit), with a duration of 50 minutesAZBio 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.

Secondary

MeasureTime frameDescription
Auditory Performance and Satisfaction of Cochlear Implant/CROS Device RecipientsAt baseline (enrollment visit) and 6 months after using the CROS device.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.
Frequent Communication Partners' (FCPs) Quality of LifeAt baseline(enrollment visit), and after 6 months after CROS device useTo 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
Cochlear Implant/CROS Device Recipients' Quality of LifeAt baseline, and after 6 months of CROS useTo 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.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORRichard Gurgel, MD

University of Utah

Participant flow

Participants by arm

ArmCount
Naida Link CROS Device
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.
7
Total7

Baseline characteristics

CharacteristicNaida Link CROS Device
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
5 Participants
Age, Categorical
Between 18 and 65 years
2 Participants
Age, Continuous68.25 years
STANDARD_DEVIATION 18.995
Ethnicity (NIH/OMB)
Hispanic or Latino
0 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
7 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
Region of Enrollment
United States
7 participants
Sex: Female, Male
Female
3 Participants
Sex: Female, Male
Male
4 Participants

Adverse events

Event typeEG000
affected / at risk
deaths
Total, all-cause mortality
0 / 0
other
Total, other adverse events
0 / 0
serious
Total, serious adverse events
0 / 0

Outcome results

Primary

Speech Recognition

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.

Time frame: 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

ArmMeasureGroupValue (MEAN)
Cochlear Implant UsersSpeech RecognitionCI only, with speech presented from front (Quiet environment)70.03 percentage of words repeated correctly
Cochlear Implant UsersSpeech RecognitionCI only, with speech presented in the non-CI ear (Quiet environment)67.92 percentage of words repeated correctly
Cochlear Implant UsersSpeech RecognitionCI only, with speech presented in the non-CI ear (Noisy environment)30.43 percentage of words repeated correctly
Cochlear Implant UsersSpeech RecognitionCI+CROS, with speech presented in the non-CI ear (Noisy environment)62.71 percentage of words repeated correctly
Secondary

Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients

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.

Time frame: 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.

ArmMeasureGroupValue (COUNT_OF_PARTICIPANTS)
Cochlear Implant UsersAuditory Performance and Satisfaction of Cochlear Implant/CROS Device RecipientsSpeech sounds more natural2 Participants
Cochlear Implant UsersAuditory Performance and Satisfaction of Cochlear Implant/CROS Device RecipientsSpeech is clearer and easier to understand in a noisy situation3 Participants
Cochlear Implant UsersAuditory Performance and Satisfaction of Cochlear Implant/CROS Device RecipientsSpeech is clearer and easier to understand in a small group of people2 Participants
Cochlear Implant UsersAuditory Performance and Satisfaction of Cochlear Implant/CROS Device RecipientsSpeech is clearer and easier to understand when speaking to 1 person in quiet5 Participants
Cochlear Implant UsersAuditory Performance and Satisfaction of Cochlear Implant/CROS Device RecipientsMusic Sounds better6 Participants
Cochlear Implant UsersAuditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipientsoverall quality of speech is better2 Participants
Secondary

Cochlear Implant/CROS Device Recipients' Quality of Life

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.

Time frame: At baseline, and after 6 months of CROS use

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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Cochlear Implant UsersCochlear Implant/CROS Device Recipients' Quality of LifeOverall Positive Quality of Life Change3 Participants
Cochlear Implant UsersCochlear Implant/CROS Device Recipients' Quality of LifeOverall Negative Quality of Life Change2 Participants
Cochlear Implant UsersCochlear Implant/CROS Device Recipients' Quality of LifeOverall No Quality of Life Change2 Participants
Secondary

Frequent Communication Partners' (FCPs) Quality of Life

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

Time frame: 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

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Cochlear Implant UsersFrequent Communication Partners' (FCPs) Quality of LifeImproved Communication5 Participants
Cochlear Implant UsersFrequent Communication Partners' (FCPs) Quality of LifeNo Change in Communication1 Participants
Cochlear Implant UsersFrequent Communication Partners' (FCPs) Quality of LifeWorse Communication1 Participants

Source: ClinicalTrials.gov · Data processed: Apr 18, 2026