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

Not Applicable

Completed

Conditions: Hearing Impairment

Interventions: Device: Naida Link CROS

Registration Number: NCT04794179

Lead Sponsor: University of Utah

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

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 16

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

Study & Design

Study Type: INTERVENTIONAL

Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Naida Link CROS device	Naida Link CROS	Individuals 65+ 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.

Primary Outcome Measures

Name	Time	Method
Speech Recognition	At baseline (enrollment visit), with a duration of 50 minutes	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.

Secondary Outcome Measures

Name	Time	Method
Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients	At 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 Life	At baseline(enrollment visit), and after 6 months after CROS device use	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
Cochlear Implant/CROS Device Recipients' Quality of Life	At baseline, and after 6 months of CROS use	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.