CROS and Quality of Life of Elderly Cochlear Implant Recipients and Their Care Givers
Phase: NA
Conditions: Hearing Impairment
Sponsor: University of Utah

Protocol Summary (ERICA) 
 
IRB_00110953 
Page 1 of 7 
 
IRB Approval 5/29/2019 
 
 
CROS and Quality of Life of Elderly Cochlear Implant 
Recipients and Their Care Givers 
 
Protocol Summary 
 
 
 
IRB Approval 
Date of 
Current 
Version: 
5/29/2019 
University of 
Utah IRB #: 
IRB_00110953 
Sponsor: ADVANCED BIONICS 
  
Principal 
Investigator: 
Richard Gurgel 
Internal Staff 
and  Sub-
Investigators: 
Site Name 
Staff Names 
University of Utah Richard Gurgel 
 
Martin Carricaburu 
 
Austin Stevens 
 
Lisa Dahlstrom 
 
Diane Tyler 
 
Eun Kyung Jeon 
 
Kathryn Johnson 
 
This document was created using the ERICA Online System at the University of Utah. The document is created 
from study information approved by the IRB on the date listed above.  Any alteration to the original content of this 
document may not be considered to represent the study as approved by the IRB.  
 
 

Protocol Summary (ERICA) 
 
IRB_00110953 
Page 2 of 7 
 
IRB Approval 5/29/2019 
 
Background and Introduction 
 
Study Background and Information: 
Cochlear Implants are now a well-accepted treatment for severe to profound hearing 
impairment. Bilateral cochlear implants 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. 
About the Nadia Link CROS: 
The Naida Link CROS device extends the Naida family of hearing solutions from AB and 
Phonak for severe-to-profound individuals. Utilizing the proprietary Binaural VoiceStream 
Technology, an automatic wireless network is established between the Naida CI sound 
processor and a Naida Link CROS transmitter, Naida Link hearing aid, or second Naida CI 
sound processor. This wireless network enables the sharing of control signals, and full-
bandwidth audio streaming so that all cochlear implant recipients can benefit from hearing 
from both ears. The Naida Link CROS allows unilateral cochlear implant recipients to hear 
from wherever they want and walk into any listening situation with more confidence. 
Phonak Naída Link CROS device + AB Naída CI sound processor = Naída Link CROS 
solution 
 
 
 
Purpose and Objectives 
 
Purpose and Objectives: 
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: 
(a)  Unilateral CI recipients will obtain higher speech understanding scores with the 
CROS device in challenging listening conditions 

Protocol Summary (ERICA) 
 
IRB_00110953 
Page 3 of 7 
 
IRB Approval 5/29/2019 
 
          (b) 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. 
 
 
 
Study Population 
 
Age of Participants: 18+ 
 
Sample Size: 
At Utah: 
15  
All Centers: 
up to 35 
 
Inclusion Criteria: 
Study participants’ inclusion criteria: 
i. Unilateral recipients of Advanced Bionics CII/90K/Ultra implants 
ii. Ages 18 years and above 
iii. At least 6 months of CI use experience 
iv. Current users of a Naida CI Q70 or Q90 processor 
v. Do not currently use a Naida Link CROS device 
vi. Limited usable/aidable hearing in the contralateral ear 
vii. Fluent in spoken English 
viii. Willingness to use the CROS device regularly for the study duration 
ix. Willingness to follow-up on a biweekly/monthly basis 
FCP's participants’ inclusion criteria: 
i. A FCP of a recipient of a unilateral Advanced Bionics CII/90K/Ultra implants 
ii. Ages 18 years and above 
iii. Fluent in spoken English 
iv. Willingness to participate in the study 
 
 
Exclusion Criteria: 
Exclusion criteria: 
i. < 6 months of CI use experience 
ii. < 30% sentence recognition scores in quiet with unilateral CI 
iii. Inability to participate in speech testing 
iv. Inability to follow and complete questionnaires 
v. Inability to designate an FCP 

Protocol Summary (ERICA) 
 
IRB_00110953 
Page 4 of 7 
 
IRB Approval 5/29/2019 
 
FCP's Exclusion criteria: 
i. Not a FCP of a recipient of a unilateral Advanced Bionics CII/90K/Ultra implants 
ii. Under the age of 18 years 
iii. Not fluent in spoken English 
 
 
Design  
 
Survey/Questionnaire Research 
Prospective Clinical Research 
 
 
 
 
Study Procedures 
 
Recruitment/Participant Identification Process: 
Participants will be identified by Dr. Gurgel, Lisa Dahlstrom, Katie Johnson. 
They will be able to identify current patients that have received the Advanced Bionics implant 
and have had it for at least 6 months. 
Potential participants will be approached in clinic to provide informed consent. 
 
 
Informed Consent: 
Description of location(s) where consent will be obtained:  
Consents will be obtained in the ENT clinic at the University of Utah. 
 
Description of the consent process(es), including the timing of consent:  
For the Cochlear Implant Patient: A study team member will provide the patient with an 
information form on the study design that should be read to and/or discussed with the patient 
in an understandable way. In this document, patients willing to consent to participate in this 
study will be informed of the nature, extent, design and conduct of the study and their consent 
will be obtained in writing prior to inclusion to the study schedule. Patients will be given the 
opportunity to ask questions and will be informed of their right to withdraw from the study at 
any time, for any reason. For the Communication Partner: A study team member will provide 
the communication partner with an information form on the study design that should be read to 
and/or discussed with the partner in an understandable way. In this document, communication 
partners are informed about the nature and extent of their participation in the study. Their 
consent will be obtained in writing prior to inclusion to the study schedule. Communication 
partners will be given the opportunity to ask questions and will be informed of their right to 
withdraw from the study at any time, for any reason. Communication partners will be 
informed that they are not required to participate even if the Cochlear implant patient wishes 
to enroll. The study team will ensure that the participants know that enrollment in the study is 
voluntary.  
 

Protocol Summary (ERICA) 
 
IRB_00110953 
Page 5 of 7 
 
IRB Approval 5/29/2019 
 
Procedures: 
Screening: 
The PI will refer eligible patients to the study team. Someone from the team will present the 
study to the patient for recruitment. 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 
Following are the procedures for visit 1 (Estimated total duration of 2 hours): 
a. Review and sign consent forms and the pre-intervention questionnaires for CI subjects 
and their FCPs (15 minutes) 
b. Collect demographic information (15 minutes) 
c. Conduct unaided pure-tone audiometry using insert earphones for each ear (15 
minutes) 
d. Connect CI participant’s own Naida CI processor to SoundWave to obtain the 
following pre-intervention data-logged information (5 minutes):  
i. Duration of daily CI use 
ii. The proportion of time spent in noisy environments (by level) 
e. Program the study CI processor (5 minutes):  
i. Initialize the processor to communicate with CROS 
ii. Create a study program using recipients’ everyday program as a baseline:  
i. Use omnidirectional mic mode 
ii. 100% T-Mic 
iii. If ClearVoice is OFF in baseline program, activate it and set it to 
medium in the study program. Increase M-levels globally, based on 
recipient’s feedback. 
f. Measure benefit in speech understanding with CI only and with CI+CROS in the 
following listening configurations (50 minutes)  
i. SpeechFront 
ii. SpeechCROS(Off) 
iii. SpeechCROS(Off)NoiseCI 
iv. SpeechCROS(On)NoiseCI 
g. Program recipients’ own Naida CI processor for the take-home phase (5 minutes):  
i. Program 1 would be the same as the CI recipient’s preferred everyday program 
but with CROS activated 

Protocol Summary (ERICA) 
 
IRB_00110953 
Page 6 of 7 
 
IRB Approval 5/29/2019 
 
ii. Program 2: noise program with CROS enabled:  
i. UltraZoom (if own processor is a Naida CI Q70) 
ii. StereoZoom (if own Q90 
h. Provide instructions for chronic use of the new CI programs and CROS (10 minutes) 
Following are the procedures for visit 2 (Estimated total duration of 1 hour): 
a. Obtain post-intervention questionnaire ratings from CI recipients (complete on the 
same forms that were used for pre-intervention ratings) (30 minutes)  
i. APS-SSD (Schafer et al., 2013, modified by H. Snapp, 2017) 
ii. Nijmegen questionnaire (adapted from Hinderink et al., 2000) 
b. Obtain post-intervention questionnaire ratings from FCPs (complete on the same form 
that was used for pre-intervention ratings) (to be completed while the CI recipients are 
working on their questionnaires)  
i. SOS-HEAR 
c. Connect participant’s own Naida CI processor to SoundWave to obtain the following 
post-intervention data-logged information: (conducted while participants are 
completing questionnaires)  
i. Duration of daily CI use 
ii. The proportion of time spent in noisy environments (by level) 
d. Program the study Naida CI Q90 for sound booth testing: (conducted while 
participants are completing questionnaires)  
i. Program 1: Same as that used for speech testing in visit 1 
ii. Program 2: Same as P1 but with UltraZoom ON. 
e. Measure benefit in speech understanding with CROS device at the same SNR that was 
used in visit 1 (15 minutes)  
i. SCROS(On)NCI (with P1, to assess the effect of chronic experience) 
ii. SFrontNBack (with P1 and with P2, to assess the benefit of UltraZoom) 
f. Review study findings. The recipients can choose if they want to keep the CROS 
device for everyday use at this point. They would be advised that they would be 
responsible for any extended warranty needs. Program settings will be based on patient 
preference and clinical judgment. (15 minutes) 
Participants will also be contacted over the course of the take-home phase to ensure 
compliance and obtain additional insight into device use and effect. Contact will be over 
phone or email as per their preference. Frequency will be every 2 weeks for the first 3 months 
and monthly after that until visit 2. Following questions will be asked: 
-           How many days in the past two weeks/ one month did you use the CROS 
device? 
-           On an average, how many hours a day did you use the CROS device? 
-           In which situations(s) did you find the CROS device most helpful? 
-           Did you use the noise program? 

Protocol Summary (ERICA) 
 
IRB_00110953 
Page 7 of 7 
 
IRB Approval 5/29/2019 
 
-           Were there any situations where you only listened with the CI processor 
(with the CROS turned off or muted)? 
o          Why? 
-           How many days in the past two weeks did you communicate with your 
FCP in person? 
 
 
Procedures performed for research purposes only:  
The quality of life surveys and hearing tests are all for research. 
  
 
 
Statistical Methods, Data Analysis and Interpretation 
 
Statistical methods, data analysis, and interpretation:  
• Questionnaire ratings: Wilcoxon Signed Rank Test 
• Speech understanding scores: ANOVA, paired sample t-Tests 
• Correlation between changes measured via speech perception scores and questionnaires