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

NCT04794179 | Completed Results FDA Device

• 1 other identifier: IRB_00110953
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

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. 1.Unilateral CI recipients will obtain higher speech understanding scores with the CROS device in challenging listening conditions
2. 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

Conditions

Hearing Impairment

Outcome Measures

Primary Outcomes (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.

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

Secondary Outcomes (3)

• 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

Study Arms (1)

Naida Link CROS device

EXPERIMENTAL

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.

Device: Naida Link CROS

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.

Naida Link CROS device

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \< 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 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.
• 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

Sponsors & Collaborators

• University of Utah: lead
• Advanced Bionics: collaborator

Study Sites (1)

University of Utah Heath

Salt Lake City, Utah, 84112, United States

Location

Related Publications (13)

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

  BACKGROUND

• 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.

  PMID: 17063004 BACKGROUND

• 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.

  PMID: 25285624 BACKGROUND

• 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.

  PMID: 20874053 BACKGROUND

• 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).

  PMID: 16197280 BACKGROUND

• 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.

  PMID: 22846635 BACKGROUND

• 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.

  PMID: 25373837 BACKGROUND

• 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.

  PMID: 22441359 BACKGROUND

• 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.

  PMID: 25677966 BACKGROUND

• 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.

  PMID: 25058838 BACKGROUND

• 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.

  PMID: 22668767 BACKGROUND

• 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.

  PMID: 24686778 BACKGROUND

• 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.

  PMID: 21829134 BACKGROUND

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

Questionaries and speech recognition were intended to be measured pre and post-CROS device use. Questionnaires for Cochlear Implant recipients: Modified APS-SSD \& Nijmegen, and SOS-HEAR for Frequent Communication Partners were completed after 6 months of CROS device use to assess quality of life. However, due to the COVID-19 pandemic, the speech recognition test was not conducted after 6 months, thereby restricting the evaluation of speech outcomes following prolonged CROS use.

Results Point of Contact

• Title: Richard Gurgel MD, PI
• Organization: University of Utah Healthcare

Richard.Gurgel@hsc.utah.edu

801-585-1626

Study Officials

• Richard Gurgel, MD

  University of Utah

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 1, 2019
• First Posted: March 11, 2021
• Study Start: November 6, 2019
• Primary Completion: April 8, 2021
• Study Completion: June 23, 2021
• Last Updated: April 17, 2026
• Results First Posted: November 19, 2024

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)