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

Study Overview
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Brief Summary
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The purpose of this study is to assess the effect of the Naida Link 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: Unilateral CI recipients will obtain higher speech understanding scores with the CROS device in challenging listening conditions 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
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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: Fifteen 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

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

Conditions
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Hearing Impairment

Intervention / Treatment
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* Device: Naida Link CROS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Unilateral recipients of Advanced Bionics CII/90K/Ultra implants Ages 65+ 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

Ages Eligible for Study
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Minimum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Naida Link CROS device<br>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. | Device: Naida Link CROS<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Higher Speech Understanding | Unilateral CI recipients will change tohigher speech understanding scores with the CROS device in challenging listening conditions | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Increased Quality of Life | Use of the CROS device will lead to positive changes in ratings on Quality of Life measures(using Auditory Performance and Satisfaction Scale for Single-Sided Deafness (APS-SSD) for unilateral CI recipients and their frequent communication partners. This scale asks participants to choose between a range of 0(Good Function) to 6(cannot function at all). | 6 months |