CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Utah
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Speech Recognition
Study Overview
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:
- 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
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:
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts 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 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
Arms & Interventions
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.
Intervention: Naida Link CROS (Device)
Outcomes
Primary Outcomes
Speech Recognition
Time Frame: 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 Outcomes
- Auditory Performance and Satisfaction of Cochlear Implant/CROS Device Recipients(At baseline (enrollment visit) and 6 months after using the CROS device.)
- Frequent Communication Partners' (FCPs) Quality of Life(At baseline(enrollment visit), and after 6 months after CROS device use)
- Cochlear Implant/CROS Device Recipients' Quality of Life(At baseline, and after 6 months of CROS use)
Investigators
Richard Gurgel
Principle Investigator
University of Utah