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| Name | Class |
|---|---|
| Advanced Bionics | INDUSTRY |
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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:
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.
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:
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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Frequent communication partner (FCP) participants' inclusion criteria:
FCP's Exclusion criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Richard Gurgel, MD | University of Utah | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Utah Heath | Salt Lake City | Utah | 84112 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Agrawal S. (2008) Spatial hearing abilities in adults with bilateral cochlear implants. PhD diss., University of Wisconsin-Madison. | ||
| 17063004 | 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. | |
| 25285624 |
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| ID | Title | Description |
|---|---|---|
| FG000 | Naida Link CROS Device | Individuals 18+ who already have Advanced Bionics CII/90K/Ultra cochlear implants will be given Naida Link Contralateral routing of signal (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. |
| FG001 | Frequent Communication Partners (FCPs) | Individuals 18+ who spend at least two hours in-person with Naida Link CROS device users. One FCP will be selected by each CROS device recipient. In this study, A total of seven FCPs were enrolled: six spouses and one mother of the CROS device recipients. FCPs will complete a questionnaire to evaluate:
No additional data, such as demographics or baseline characteristics, will be collected regarding FCPs as this study focuses on cochlear implant/CROS users. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
7 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.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | 7 participants with unilateral Advanced Bionics CII/90K/Ultra cochlear implant cochlear implant and CROS device | Posted | Mean | Full Range | percentage of words repeated correctly | At baseline (enrollment visit), with a duration of 50 minutes |
|
All-cause mortality, serious and other adverse events were not monitored/assessed.
All-cause mortality, serious and other adverse events were not monitored/assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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: 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Richard Gurgel MD, PI | University of Utah Healthcare | 801-585-1626 | Richard.Gurgel@hsc.utah.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 29, 2019 | Jun 16, 2022 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
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|
| At baseline (enrollment visit) and 6 months after using the CROS device. |
| 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 | At baseline(enrollment visit), and after 6 months after CROS device use |
| 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. | At baseline, and after 6 months of CROS use |
| 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. |
| 20874053 | 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. |
| 16197280 | 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). |
| 22846635 | 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. |
| 25373837 | 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. |
| 22441359 | 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. |
| 25677966 | 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. |
| 25058838 | 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. |
| 22668767 | 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. |
| 24686778 | 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. |
| 21829134 | 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. |
| Participants |
|
| Age, Continuous | Mean | Standard Deviation | years |
|
| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
This group comprised of seven Advanced Bionics CII/90K/Ultra cochlear implant recipients who were tested with and without Naida Link contralateral routing of signal (CROS) *(within-subjects comparison). |
|
|
| Secondary | 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. | Data table is based on the responses of 7 participants with unilateral Advanced Bionics CII/90K/Ultra cochlear implant cochlear implant and CROS device. These participants were assessed for improvements in auditory satisfaction by comparing their responses at baseline and again at the 6-month follow-up. Each row corresponds to a different category/aspect of the participants' auditory experience. The column shows number of participants who reported a positive change for each statement. | Posted | Count of Participants | Participants | At baseline (enrollment visit) and 6 months after using the CROS device. |
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| Secondary | 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 | The table shows communication outcomes reported by 7 Frequent Communication Partners (FCPs) who had at least two hours per week of in-person interactions with the recipient of Advanced Bionics CII/90K/Ultra implants/CROS device | Posted | Count of Participants | Participants | At baseline(enrollment visit), and after 6 months after CROS device use |
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| Secondary | 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. | 7 Advanced Bionics CII/90K/Ultra cochlear implant and CROS device users | Posted | Count of Participants | Participants | At baseline, and after 6 months of CROS use |
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| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
| 0 |
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| D009461 |
| Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Music Sounds better |
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| Speech sounds more natural |
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| overall quality of speech is better |
|