Safety and Efficacy of Remote Programming of Nucleus Cochlear Implants
Phase: NA
Conditions: Telemedicine
Sponsor: Cochlear

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INVESTIGATIONAL PLAN 
Safety and efficacy of remote programming of Nucleus® 
cochlear implants 
▬▬▬▬▬▬▬▬▬▬▬ 
Version 1.0 
Dec. 4, 2015  
 IDE # 
     G150238 
▬▬▬▬▬▬▬▬▬ 
Study Sponsor:  
Cochlear Americas 
13059 East Peakview Avenue 
Centennial, CO 80111 
 
CONFIDENTIAL - DO NOT COPY 
 
This protocol contains confidential proprietary information with respect to Cochlear products and 
clinical trials. I agree to hold this information in confidence and not to disclose it to any third 
parties for the shortest of the following periods of time: three years from the date of this 
agreement, the time at which this information becomes a matter of public knowledge, or the time 
at which a formal agreement for that purpose has been entered into by the parties

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INVESTIGATOR RESPONSIBILITIES 
 
I, the undersigned, am responsible for the conduct of the study at the site below 
and by my signature below, I confirm that I have read, understand and will strictly 
adhere to the study protocol, “Safety and efficacy of remote programming of 
Nucleus® cochlear implants.” 
 
 
 
Clinical Investigational Site 
 
 
Primary Investigator’s Name (print) 
 
 
Title 
 
 
Signature 
 
 
Sponsor Representative 
 
 
Title 
 
 
Signature

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Contents 
INVESTIGATOR RESPONSIBILITIES .......................................................................... 2 
TERMS, DEFINITIONS, AND ABBREVIATIONS .......................................................... 5 
STUDY SUMMARY ........................................................................................................ 6 
INTRODUCTION ............................................................................................................ 7 
STUDY OBJECTIVES ................................................................................................... 8 
Primary Objectives ................................................................................................ 8 
INVESTIGATIONAL PROTOCOL ................................................................................. 8 
Subject Selection ...................................................................................................... 8 
Inclusion Criteria .................................................................................................... 8 
Criteria for Exclusion ............................................................................................. 8 
Investigational Procedures ........................................................................................ 9 
Design Overview ................................................................................................... 9 
MAP Programming Methods ............................................................................... 10 
System Requirements ......................................................................................... 10 
Speech Perception Testing ................................................................................. 10 
Evaluation Materials and Test Conditions ........................................................... 10 
Methods .................................................................................................................. 12 
VISIT 1 ................................................................................................................ 12 
VISIT 2 ................................................................................................................ 12 
VISIT 3 ................................................................................................................ 12 
VISIT 4 ................................................................................................................ 12 
VISIT 5 ................................................................................................................ 13 

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Endpoint Testing ................................................................................................. 14 
ADVERSE DEVICE EFFECTS .................................................................................... 15 
UNANTICIPATED ADVERSE DEVICE EFFECTS ...................................................... 16 
DATA ANALYSES ....................................................................................................... 16 
Sample Size ............................................................................................................ 16 
Additional Statistical Analyses ................................................................................ 17 
STUDY REPORT AND PUBLICATION ....................................................................... 17 
REFERENCES ............................................................................................................. 18 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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TERMS, DEFINITIONS, AND ABBREVIATIONS 
 
Terms/Abbreviations 
Definition 
AE 
Adverse Event 
CI 
Cochlear Implant 
Charge 
Unit of electrical stimulation 
Custom Sound™ 
Clinical programming software for Nucleus cochlear 
implant systems 
Facilitated MAP 
A MAP programmed remotely with the assistance of a 
facilitator 
Facilitator  
A trained staff member at the programming site  
 IDE 
Investigational Device Exemption 
Live Programming 
Traditional face to face programming interaction between a 
recipient and an audiologist at the same physical location 
 MAP 
A program that defines the individualized parameters of 
recipients for a specific speech coding strategy 
Nucleus® 5       
Sound Processor 
   BTE sound processor to be used in the evaluation 
Nucleus® 6 Sound 
Processor (CP910 
or CP920) 
   BTE sound processor to be used in the evaluation 
Primary Audiologist 
The audiologist who regularly provides programming services to 
the subject  
Remote Programming 
A programming interaction between a recipient and an 
audiologist that occurs via telecommunication technology when 
the two parties are at different physical locations 
Self MAP 
A MAP programmed remotely without the assistance of a 
facilitator 

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STUDY SUMMARY 
 
Title 
Investigation of consistencies and performance of cochlear 
implant MAPs programmed via telecommunication 
Study Sites 
Up to 5 North American centers 
Study Duration 
Up to 12 months 
Study Time 
3-4 months for each subject  
Study Population 
Up to 40 subjects aged 12 years or greater  
Design Overview 
The study will be conducted in a repeated measures design  
Primary 
Objective 
To demonstrate the safety and efficacy of CI programming via 
telecommunication.    
Study Intervals 
Visit 1 (at least 1 month but no more than 12 months after a regular 
programming session) 
Visit 2 (within one month after Visit 1) 
Visit 3 (2-4 weeks after Visit 2) 
Visit 4 (2-4 weeks after Visit 3)  
Visit 5 (2-4 weeks after Visit 4) 
Primary Safety 
Endpoint 
Characterize the safety profile of device and/or procedure 
related adverse events associated with facilitated remote 
MAP programming, unassisted MAP programming and 
audiologist live MAP programming  
Co-Primary 
Efficacy 
Endpoints 
1. Demonstrate that performance on CNC words using a 
remotely programmed facilitated MAP is no worse than 
when using a live programmed MAP  
2. Demonstrate that performance on CNC words using an 
unassisted remotely programmed MAP is no worse than 
when using a live programmed MAP 
Secondary 
Efficacy 
Endpoint 
Demonstrate non-inferiority of unassisted remote MAP 
programming compared to facilitated MAP programming via 
performance on CNC words.   

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INTRODUCTION 
 
Telemedicine is the practice of using technology to provide remote clinical services over the 
internet.  In that cochlear implantation requires regular programming visits with an 
audiologist, the use of telemedicine can prove valuable and efficacious for recipients, 
particularly those who live far from clinics, have limited transportation options, or are 
medically fragile.  Telemedicine can also be utilized for direct high level trouble shooting 
between recipients, clinicians, specialists, and manufacturers.  
Primary medicine and some of its auxiliary services have already entered into the arena of 
telepractice with successful outcomes (Uscher-Pines, et al., 2014; Darkins, et al., 2013; 
Mashima & Doarn, 2008).  Staying on track with this technological advent, resourceful 
clinicians and researchers have begun exploring the validity of remote audiological 
intervention. Documented outcomes suggest comparable results between traditional live 
programming and remote programming measures (Eikelboom, 2014; McElveen, 2010; 
Ramos, 2009; Rodriguez, 2014; Samuel, 2014; Wesarg, 2010).  Performance validation of 
remotely programmed maps as examined by Hughes (2012) and Goehring (2012) denotes 
that any changes in speech perception scores may be a result of sub-optimal testing 
environments as opposed to programming delivery method.  Furthermore, when probed, 
most study participants reported satisfaction with the remote programming sessions, and 
indicated they would be interested in utilizing the technology for future appointments.  
Some points of interest that have arisen include the capacity to assess physical integrity of 
devices, detection of adverse events over a telecommunication medium, remote 
programming in the pediatric population, duration of CI use prior to remote sessions, 
professional state licensure requirements, and reimbursement. These topics should be 
considered for future investigation. 
Given that telemedicine is being widely utilized, and studies show minimal to no change in 
aided thresholds and MAP Threshold (T) and Comfort (C) levels, this investigation aims to 
validate the safety and efficacy of remote cochlear implant programming in an effort to 
establish clinical support for this practice and subsequently increase access to recipients.  
Specifically, this study will show that speech recognition scores obtained using remotely 
programmed MAPs are no worse than those obtained using live programmed MAPs.  
Additionally, it will demonstrate that live MAPping adverse events are consistent with and not 
inferior to remote MAPping adverse events.  Finally, this study will capture overall electrical 
charge of remotely programmed MAPs, and explore any inconsistencies between the 
audiologist-to-facilitator model and the audiologist-to-recipient model of remote service 
delivery.  
 
 

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STUDY OBJECTIVES 
 
Primary Objectives 
 
The primary objective of this multi-site study is to investigate the safety and efficacy of 
programming cochlear implants through telecommunication. 
 
Safety will be determined by characterizing the safety profile of device and/or 
procedure related adverse events associated with facilitated remote MAP programming, 
unassisted MAP programming and audiologist live MAP programming.  An adverse event (AE) 
is the development of an untoward medical occurrence or the deterioration of a pre-existing 
medical condition following or during exposure to an investigational product, whether or not 
considered causally related to the product. 
Efficacy will be determined by showing that performance on the CNC word recognition 
test using a remotely programmed MAP is no worse than when using a live programmed MAP.
 
  
INVESTIGATIONAL PROTOCOL 
 
Subject Selection 
The proposed investigation will take place in the United States.  Up to 5 clinical sites and up to 
40 subjects will be enrolled.  Due to time needed for site training and subject recruitment, the 
total duration of this multi-site study will be 12 months.  
Inclusion Criteria 
• 
Individuals aged greater than 12 years that are native English speakers and are 
capable of completing the study evaluation as deemed by their primary 
audiologist 
• 
Unilateral  or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 
series implant who are in possession of a backup sound processor  
• 
A minimum of 12 months’ experience with a CP800 or CP900 series sound 
processor, and current MAP programmed within 12 months prior to Visit 1  
• 
Willingness to participate in and to comply with all requirements of the protocol 
• 
Able to demonstrate protocol competence as confirmed by primary audiologist 
Criteria for Exclusion 
• 
Unrealistic expectations on the part of the subject, regarding the possible 
benefits, risks, and limitations of remote service delivery 
• 
Unwillingness or inability of the candidate to comply with all investigational 
requirements 
• 
Additional handicaps that would prevent or restrict participation in the 
audiological evaluations 

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• 
Inability to demonstrate basic technological skills for simple computer-based 
tasks and device connecting after training by primary audiologist 
Investigational Procedures 
 
Design Overview 
Cochlear implant recipients aged greater than 12 years of age will be asked to 
participate in this clinical study. A single-subject research design (in which each 
subject serves as his or her own control) is appropriate since it accommodates the 
heterogeneity that characterizes hearing-impaired populations.  Subjects will be tested 
at three intervals: the first, third, and last of five total visits.  
At Visit One, the subjects will be screened and consented by their primary 
audiologist. They will complete speech testing in the unilateral condition, using their 
current MAP which they must have been using for no more than 12 months. Subjects 
will schedule Visit 2 to fall within one month after Visit 1.  
Visit Two will take place at a pre-determined site, different than the subject’s primary 
programming center.  The subjects will participate in a remote location programming 
session conducted by their primary audiologist via telecommunication, with on-site 
assistance provided by a trained facilitator. This MAP will be referred to as the 
Facilitated MAP. 
Subjects will return home and use this new program for 2-4 weeks, after which time 
they will return to their primary programming center for Visit 3.  
For Visit Three (2-4 weeks after Visit 2), subjects will return to their primary 
programming center for speech testing using their remotely programmed MAP 
(Facilitated MAP), and to complete a comparative survey.  
Visit Four will occur 2-4 weeks after Visit 3 at the same pre-determined site as Visit 2.  
The subjects will participate in a second remote programming session conducted by 
their primary audiologist via telecommunication, but the subject will serve as his or her 
own facilitator.  This MAP will be referred to as the Self MAP.  
Subjects will return home and use this new program for 2-4 weeks, after which time 
they will return to their primary programming center for Visit 5.  
At Visit Five, subjects will complete speech testing using their second remotely 
programmed MAP (Self MAP).  Subjects will also complete a comparative survey and 
a questionnaire regarding their experience with remote programming.  
The following study procedures will be completed:  
 

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MAP Programming Methods 
Subjects will be programmed at a remote clinic location by their primary audiologist 
programming via telecommunication.  The subjects’ existing “familiar” MAP will remain 
in slot #1. Audiologists will save each remotely programmed MAP into slot #2, 
overwriting any previous program in that slot (subjects will be able to have their choice 
of program re-entered into slot #2 after they have completed participation in this study). 
Audiologists will anonymize and export the MAP to the sponsor after each 
programming session.  
 
System Requirements 
Each remote site will require a programming computer, a programming pod, and a 
programming cable.  Computers will be outfitted with a password locked Custom 
Sound application to allow software access to the remote audiologist meanwhile 
preventing any accidental programming by the recipient.  Each site will also need 
microphone/speaker/camera capabilities on the computer for communication between 
the audiologist and the subject during the remote sessions. A wired or wireless internet 
broadcasting system is acceptable with a minimum connection speed of 1 megabit/sec 
in both directions.  
The programmer site will require the same computer, software, and connection 
specifications as outlined above.  
Speech Perception Testing 
Speech perception testing will be completed at Visit One, Visit Three, and Visit Five.  
Speech perception testing to evaluate the program settings will be assessed in the 
unilateral condition (cochlear implant ear only) and the contralateral ear will be plugged 
(or the contralateral CI will be removed if applicable).   
Speech perception testing will be completed at the subject’s primary clinic site, and 
evaluation lists will be randomized.  
Evaluation Materials and Test Conditions 
• 
At Visit One, Visit Three, and Visit Five, participants will have their speech 
perception tested using CNC words (Peterson & Lehiste, 1962) in quiet 
presented at 60 dBA as indicated in Figure 1. 
• 
Each participant will complete 2 full lists (50 words per list) per test condition 
 
For the purpose of evaluating the remotely programmed MAPs, test condition refers 
to a program slot number: 
1. Test condition: Familiar program – Program 1: Participant’s current program 
that he/she was utilizing prior to the remote MAPping (Tested at Visit 1) 

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2. Test condition: Remote program – Program 2: the Facilitated MAP programmed 
remotely at Visit 2 (tested at Visit 3) and the Self MAP programmed remotely at 
Visit 4 (tested at Visit 5).  
 
Figure 1:  Test Setup for Speech Recognition Testing 
Self-Assessment/Subjective Questionnaires 
 
The following subjective questionnaire will be completed at Visit 2 and Visit 4 after the 
remote programming session.   
Remote Programming Satisfaction Survey  
This in-house survey uses a satisfaction rating scale to gather subjects’ opinions 
regarding the ease, quality, and comfort of the remote programming sessions. 
 
The following self-assessment/subjective questionnaires will be completed at Visit 3 
and Visit 5, following home use of the remotely programmed MAPs. 
The Speech, Spatial and Qualities of Hearing Questionnaire – C (SSQ – C) 
The SSQ-C (Gatehouse & Noble, 2004) will be used as a subject self-assessment in 
three categories (speech hearing rating scale, spatial hearing rating scale, and sound 
qualities rating scale). The SSQ-C is the "comparative" version of the SSQ. It can be 
used for comparing two different hearing technologies. In this study, the SSQ-C will 
compare the subject’s familiar map (Program #1) and a remote MAP located in 
Program slot #2.  
 
The following subjective questionnaire will be completed at the final visit (Visit 5). 
Telemedicine Experience Questionnaire 
This in-house survey was specifically designed to examine subjects’ evaluations of the 
telemedicine experience. It includes a response rating scale, as well as the opportunity 
for open ended feedback.   
 

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Methods 
 
VISIT 1 
Step 1: Subject will arrive at his/her primary programming center. No programming will 
be completed at this visit.  
Step 2: The subject will read and sign the informed consent form.   
Step 3: The subject’s primary audiologist will orient him/her to the programming 
equipment, detailing how to hook up the speech processor to the computer, how to 
launch the necessary applications, and how to utilize the chat function.  The subject 
will demonstrate competency in these steps as deemed appropriate by the audiologist.   
Step 4: Speech perception testing will be completed using Program 1 (subject’s 
familiar program). 
Step 5: The cdx file for the subject’s current MAP will be anonymized and exported to 
the sponsor.  
VISIT 2 (occurring within 1 month after Visit 1) 
 
Step 1: The subject will arrive at the remote location site. 
Step 2: This session will be assisted by a trained facilitator.  The subject will be 
programmed by the remotely located primary audiologist.  This program will be saved 
in Program slot #2, and the cdx file will be anonymized and exported to the sponsor. 
Step 3: The subject will complete the Remote Programming Satisfaction Survey. 
Step 4: The subject will use this Facilitated MAP at home for 2-4 weeks.   
VISIT 3 (2-4 weeks after Visit 2)  
 
 Step 1: The subject will return to his/her primary programming center. 
Step 2:  Speech perception testing will be completed using the Facilitated MAP    
(Program 2). 
Step 3: The Subject will complete the SSQ-C comparing the familiar MAP and the 
Facilitated MAP. 
VISIT 4 (2-4 weeks after Visit 3)  
Step 1: The subject will arrive at the remote location site. 
Step 2: This session will be conducted with the subject acting and his/her own 
facilitator. The subject will be programmed by the remotely located audiologist.  This 

13 
 
program will be saved in Program slot #2 (taking the place of the previous MAP in that 
slot), and the cdx file will be anonymized and exported to the sponsor.   
Step 3: The subject will complete the Remote Programming Satisfaction Survey. 
Step 4: The subject will use this Self MAP at home for 2-4 weeks.   
VISIT 5 (2-4 weeks after Visit 4) 
Step 1: The subject will return to his/her primary programming center. 
 
Step 2:  Speech perception testing will be completed using the Self MAP (Program 2). 
Step 3: The subject will complete the SSQ-C (comparing the familiar MAP and the Self 
MAP), and the Telemedicine Experience Questionnaire.  
 
 
Figure 2:  Study visit flow chart  
 
 
 
 
 

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Endpoint Testing 
 
Primary Safety Endpoint: Characterize the safety profile of device and/or procedure 
related adverse events associated with facilitated remote MAP programming, 
unassisted MAP programming and audiologist live MAP programming  
 Safety Endpoint testing will occur at Visit 2 and Visit 4.  
• 
Recipients will be MAPped via telecommunication by a remotely located audiologist.   
• 
Any adverse events associated with the MAPping will be recorded on the New Adverse 
Event Reporting Form. Any AEs identified at Visit 2 or Visit 4 will be re-evaluated at 
subsequent visits and updated on the Follow Up Adverse Event Reporting Form.  
 
Co-Primary Efficacy Endpoint 1: Demonstrate that performance on CNC words using a 
remotely programmed facilitated MAP is no worse than when using a live programmed 
MAP  
Efficacy Endpoint 1 testing will occur at Visit 1 and Visit 3. 
• 
Visit 1: Speech perception scores will be obtained in Program 1 (familiar/Live)  
• 
Visit 3: Speech perception scores will be obtained in Program 2 (Facilitated MAP) 
 
Co-Primary Efficacy Endpoint 2: Demonstrate that performance on CNC words using an 
unassisted remotely programmed MAP is no worse than when using a live programmed 
MAP  
Efficacy Endpoint 2 testing will occur at Visit 1 and Visit 5. 
• 
Visit 1: Speech perception scores will be obtained in Program 1 (familiar/Live)  
• 
Visit 5: Speech perception scores will be obtained in Program 2 (Self MAP) 
 
Secondary Efficacy Endpoint: Demonstrate non-inferiority of unassisted remote MAP 
programming compared to facilitated MAP programming via performance on CNC 
words.   
Efficacy Endpoint 2 testing will occur at Visit 3 and Visit 5. 
• 
Visit 3: Speech perception scores will be obtained in Program 2 (Facilitated MAP)  
• 
Visit 5: Speech perception scores will be obtained in Program 2 (Self MAP) 
 
 
 

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Test Materials: 
• 
CNC word list presented at 60 dBA (subject facing speaker) with contralateral ear 
plugged. Two lists (of 50 words each) will be completed for each condition.  Score 
each test condition for % of words correct. 
 
Note: The test material lists will be randomized.   
 
Table 1: Summary of data collection visits  
 
Test Material and Condition 
Visit 1 
 Visit 2 
 Visit 3 
Visit 4 
Visit 5 
CNC words in Program 1 (original/Live program) 
X 
 
 
 
 
CNC words in Program 2 (remote program) 
 
 
X 
 
X 
Remote Programming Satisfaction Survey 
 
X 
 
 
X 
 
SSQ-C 
 
 
X 
 
X 
Telemedicine Experience Questionnaire 
 
 
 
 
X 
 
MAP Analysis: 
 
Anonymized Live MAP, Remote Facilitated MAP, and Remote Self MAP cdx files will 
be submitted by the audiologist to the sponsor for analysis of electrical charge data.   
ADVERSE DEVICE EFFECTS 
 
To monitor subject safety throughout this IDE study, any procedure or device related adverse 
events will be recorded. Information on all adverse events will be maintained by event type. 
The investigator will complete an Adverse Event form if any adverse event is reported or 
observed for a subject during this IDE, even if they were acknowledged as risk factors in the 
Informed Consent form. 
Adverse device effects refer to any undesirable clinical or medical occurrence associated with 
use of the device or participation in the study. Any/all adverse device effects are to be 
recorded via the Adverse Event form. Adverse device effects will be reported if observed, even 
if they were acknowledged as risk factors in the Informed Consent form. 

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UNANTICIPATED ADVERSE DEVICE EFFECTS 
 
Unanticipated adverse device effects refer to any event not identified above that represents a 
“serious adverse effect on health or safety or any life-threatening problem or death caused by, 
or associated with, a device if that effect, problem or death was not previously identified in 
nature, severity, or degree of incidence in the investigational plan or application, or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, or 
welfare of subjects.” [FDA 21 CFR 812.3(s)] 
Investigators are to inform their respective Institutional Review Boards (IRBs) and Cochlear 
Americas immediately if an unanticipated adverse device effect is suspected (no more than 10 
working days after the investigator learns of the effect). If the case is determined to be an 
unanticipated adverse device effect, the investigator will fill out an “Unanticipated Adverse 
Device Effect Form.” Cochlear Americas will report the results of an evaluation of the 
unanticipated adverse device effect to the FDA and all other reviewing IRBs and investigators 
within 10 working days after first receiving notice of the event. 
DATA ANALYSES 
 
Sample Size 
 
Based on the variability observed in earlier studies, it was determined using PASS (NCSS 
Statistical Software) that a minimum of 26 subjects would provide at least 90% power for 
hypothesis testing of the two co-primary endpoints at the 0.025 alpha level. 
The planned sample size of 40 subjects will provide adequate power for hypothesis testing of 
the two coprimary endpoints at the 0.025 alpha level. The following general assumptions have 
been made: 
• 
T-tests of difference scores to test for non-inferiority with a non-inferiority margin of 
10% for CNC word recognition 
• 
One-sided 0.025 alpha level 
• 
Assumed distribution for population (standard deviation) 
• 
Desire for 90% power 
The power analyses for the primary test metrics are provided below. 
Table 2: Sample size calculation for CNC word recognition 
 
Scenario (Non-inferiority) 
Minimum Evaluable Sample Size 
Required 
One-sided 0.025 alpha, 90% power,  
SD = 15%, NIM = 10%, true difference = 0 
26 
 
 

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Additional Statistical Analyses 
 
Statistical Analysis for this study is addressed in detail in the document entitled “Statistical 
Analysis Plan: Use of telemedicine in the remote programming of Nucleus® cochlear 
implants.”   
STUDY REPORT AND PUBLICATION 
 
A description of this clinical trial will be available on http://www.ClinicalTrials.gov, as required 
by U.S. Law. 
The aggregate data resulting from this study will be the proprietary information of the Sponsor 
and may be made public after all data have been analyzed and the study results are available.  
None of the data resulting from this study will be allowed to be presented or published in any 
form, by the Investigator or any other person, without the prior written approval of the Sponsor.  
At the end of the study, a clinical study report will be written by the Investigators or their 
designee and reviewed by the Sponsor. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

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