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

Hearing Impairment Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04794179
• Other study ID #: IRB_00110953
• Status: Completed
• Phase: N/A
• Start date: November 6, 2019
• Est. completion date: June 23, 2021

Study information

• Verified date: September 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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:

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.

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:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: June 23, 2021
• Est. primary completion date: April 8, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 65 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Deafness
• Hearing Impairment
• Hearing Loss

Intervention

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.

Locations

Country	Name	City	State
United States	University of Utah Heath	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Advanced Bionics

Country where clinical trial is conducted

United States, 

References & Publications (13)

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. Epub 2006 Oct 6. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Härkönen K, Kivekäs 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. — View Citation

Illg A, Bojanowicz M, Lesinski-Schiedat A, Lenarz T, Büchner 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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

* Note: There are 13 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Higher Speech Understanding	Unilateral CI recipients will change tohigher speech understanding scores with the CROS device in challenging listening conditions	6 months
Secondary	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