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Hearing ImpairmentNCT04794179

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

A study testing Naida Link CROS in people with Hearing Impairment, run by University of Utah at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Hearing Impairment
What is being tested?
Naida Link CROS
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
1 siteUnited States
Study dates
6 Nov 2019to 23 Jun 2021
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
Show all 9Show fewer
  • Fluent in spoken English
  • Willingness to use the CROS device regularly for the study duration
  • Willingness to follow-up on a biweekly/monthly basis

Who cannot join

  • < 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country.

United States1 site

  • University of Utah Heath

    Salt Lake City, Utah, 84112

Other trials in United States

About this study

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.

Read the 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

Being tested
Naida Link CROS
Medical subject headings
Hearing Loss

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naida Link CROSDevice

    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.

Study groups in NCT04794179
Study groupRoleWhat they receive
Naida Link CROS deviceExperimentalIndividuals 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.
Receives: Device: Naida Link CROS

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

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

Secondary outcomes (3)

  1. 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.

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

  2. 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

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

  3. 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.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted11 Mar 2021
  2. Study start6 Nov 2019
  3. Primary completion8 Apr 2021
  4. Study completion23 Jun 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04794179
Sponsor's protocol ID
IRB_00110953
Status last verified
Apr 2026
First submitted
1 Feb 2019
Last updated
17 Apr 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
Yes
Individual data sharing
No

Publications

  • Agrawal S. (2008) Spatial hearing abilities in adults with bilateral cochlear implants. PhD diss., University of Wisconsin-Madison.

  • Ching TY, Incerti P, Hill M, van Wanrooy E. An overview of binaural advantages for children and adults who use binaural/bimodal hearing devices. Audiol Neurootol. 2006;11 Suppl 1:6-11. doi: 10.1159/000095607. Epub 2006 Oct 6.

    PubMed 17063004

  • Dorman MF, Cook S, Spahr A, Zhang T, Loiselle L, Schramm D, Whittingham J, Gifford R. Factors constraining the benefit to speech understanding of combining information from low-frequency hearing and a cochlear implant. Hear Res. 2015 Apr;322:107-11. doi: 10.1016/j.heares.2014.09.010. Epub 2014 Oct 5.

    PubMed 25285624

  • Dorman MF, Gifford RH. Combining acoustic and electric stimulation in the service of speech recognition. Int J Audiol. 2010 Dec;49(12):912-9. doi: 10.3109/14992027.2010.509113. Epub 2010 Sep 27.

    PubMed 20874053

  • Dunn CC, Tyler RS, Witt SA. Benefit of wearing a hearing aid on the unimplanted ear in adult users of a cochlear implant. J Speech Lang Hear Res. 2005 Jun;48(3):668-80. doi: 10.1044/1092-4388(2005/046).

    PubMed 16197280

  • Dunn CC, Tyler RS, Witt S, Ji H, Gantz BJ. Sequential bilateral cochlear implantation: speech perception and localization pre- and post-second cochlear implantation. Am J Audiol. 2012 Dec;21(2):181-9. doi: 10.1044/1059-0889(2012/12-0004). Epub 2012 Jul 30.

    PubMed 22846635

  • Farinetti A, Roman S, Mancini J, Baumstarck-Barrau K, Meller R, Lavieille JP, Triglia JM. Quality of life in bimodal hearing users (unilateral cochlear implants and contralateral hearing aids). Eur Arch Otorhinolaryngol. 2015 Nov;272(11):3209-15. doi: 10.1007/s00405-014-3377-8. Epub 2014 Nov 6.

    PubMed 25373837

  • Firszt JB, Holden LK, Reeder RM, Cowdrey L, King S. Cochlear implantation in adults with asymmetric hearing loss. Ear Hear. 2012 Jul-Aug;33(4):521-33. doi: 10.1097/AUD.0b013e31824b9dfc.

    PubMed 22441359

  • Harkonen K, Kivekas I, Rautiainen M, Kotti V, Sivonen V, Vasama JP. Sequential bilateral cochlear implantation improves working performance, quality of life, and quality of hearing. Acta Otolaryngol. 2015 May;135(5):440-6. doi: 10.3109/00016489.2014.990056. Epub 2015 Feb 13.

    PubMed 25677966

  • Illg A, Bojanowicz M, Lesinski-Schiedat A, Lenarz T, Buchner A. Evaluation of the bimodal benefit in a large cohort of cochlear implant subjects using a contralateral hearing aid. Otol Neurotol. 2014 Oct;35(9):e240-4. doi: 10.1097/MAO.0000000000000529.

    PubMed 25058838

  • Litovsky RY, Goupell MJ, Godar S, Grieco-Calub T, Jones GL, Garadat SN, Agrawal S, Kan A, Todd A, Hess C, Misurelli S. Studies on bilateral cochlear implants at the University of Wisconsin's Binaural Hearing and Speech Laboratory. J Am Acad Audiol. 2012 Jun;23(6):476-94. doi: 10.3766/jaaa.23.6.9.

    PubMed 22668767

  • Reeder RM, Firszt JB, Holden LK, Strube MJ. A longitudinal study in adults with sequential bilateral cochlear implants: time course for individual ear and bilateral performance. J Speech Lang Hear Res. 2014 Jun 1;57(3):1108-26. doi: 10.1044/2014_JSLHR-H-13-0087.

    PubMed 24686778

  • Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. Development and validation of the AzBio sentence lists. Ear Hear. 2012 Jan-Feb;33(1):112-7. doi: 10.1097/AUD.0b013e31822c2549.

    PubMed 21829134

Questions about this trial

What is this clinical trial studying?

A study testing Naida Link CROS in people with Hearing Impairment, run by University of Utah at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 17 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Nov 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Speech Recognition (time frame: At baseline (enrollment visit), with a duration of 50 minutes). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04794179, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2026.

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