Usability of the CP950 Sound Processor With Experienced Cochlear Implant Users
Phase: NA
Conditions: Hearing Loss
Sponsor: Cochlear

   
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Clinical Investigation Plan 
 
 Usability of the CP950 sound processor with experienced cochlear implant users.  
January 15, 2016 
_______________________ 
Study Sponsor: 
 
Cochlear Americas 
13059 E. Peakview Avenue 
Centennial, CO 80111 
 
 
CONFIDENTIAL – DO NOT COPY 
This document contains information that is confidential and proprietary to Cochlear. 
This information is being provided to you solely for the purpose of evaluating or 
conducting a clinical study for Cochlear. You may disclose the contents of this 
document only to study personnel under your supervision who need to know the 
contents for this purpose and to your Institutional Review Board (IRB); the contents 
of this document may not be disclosed without the prior authorization from Cochlear. 
The foregoing shall not apply to disclosure required by governmental regulations or 
laws. Any supplemental information that may be added to this document also is 
confidential and proprietary to Cochlear and must be kept in confidence in the same 
manner as the contents of this document. 

   
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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, “Usability of the CP950 sound processor with experienced cochlear implant users.  
 
Clinical Investigational Site 
 
 
Primary Investigator’s Name (print) 
 
 
Title 
 
 
Signature 
 
 
Sponsor Representative 
 
 
Title 
 
 
Signature 
 

   
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Table of Contents 
Table of Contents ............................................................................................................................. 3 
1. 
Clinical Investigation Synopsis ............................................................................................ 5 
2. 
Abbreviations ...................................................................................................................... 8 
3. 
Introduction ......................................................................................................................... 9 
4. 
Study Objective ................................................................................................................. 10 
4.1 
Primary Objective: ............................................................................................................... 10 
5. 
Study Design ..................................................................................................................... 10 
6. 
Study Length ..................................................................................................................... 10 
7. 
Device Description ............................................................................................................ 10 
7.1 
Sound Processor Description .............................................................................................. 11 
7.2 
Programming Software Description ..................................................................................... 11 
8. 
Subject Population ............................................................................................................ 11 
8.1 
Inclusion Criteria .................................................................................................................. 11 
8.2 
Exclusion Criteria ................................................................................................................. 11 
8.3 
Release of Medical Information ........................................................................................... 11 
9. 
Investigational Procedures ................................................................................................ 11 
9.1 
Design Overview .................................................................................................................. 11 
9.2 
Visit Schedule & Procedures ............................................................................................... 12 
9.2.1 
Visit 1: ............................................................................................................................... 12 
9.2.2 
Visit 2: ............................................................................................................................... 12 
9.3 
Summary of Data Collection Visits ...................................................................................... 12 
10. 
Adverse Events ................................................................................................................. 13 
10.1 Assessment and Reporting of Adverse Events ................................................................... 13 
10.2 Unanticipated Adverse Device Effects ................................................................................ 13 
11. 
Study Completion .............................................................................................................. 14 
11.1 Completed Subjects ............................................................................................................. 14 
11.2 Discontinued Subjects ......................................................................................................... 14 
11.3 Premature Study Termination .............................................................................................. 14 
12. 
Data Analysis .................................................................................................................... 14 

   
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12.1 Statistical Analysis ............................................................................................................... 14 
12.2 Sample Size ......................................................................................................................... 15 
13. 
Risk Benefit Statement ..................................................................................................... 15 
13.1 Benefits ................................................................................................................................ 15 
13.2 Risks .................................................................................................................................... 15 
14. 
Good Clinical Practices Statement ................................................................................... 15 
15. 
Access to Study Documents and Study Monitoring .......................................................... 15 
16. 
Quality Control and Assurance ......................................................................................... 15 
17. 
Institutional Review Board ................................................................................................ 16 
18. 
Informed Consent Process ............................................................................................... 16 
19. 
Confidentiality .................................................................................................................... 16 
20. 
Protocol Deviations and Amendments .............................................................................. 16 
21. 
Data Management............................................................................................................. 16 
22. 
Record Keeping and Retention ......................................................................................... 17 
23. 
Study Report and Publication ........................................................................................... 17 
 
 
 
 

   
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1. Clinical Investigation Synopsis 
Investigation title 
Usability of the CP950 sound processor with experienced 
cochlear implant users. 
Name of investigational device 
CP950 Sound processor 
 
CP950 Programming Cable Adaptor 
Cochlear Wireless Programming Pod 
Total expected duration of the 
clinical investigation 
6 months 
Enrollment period 
3 months 
Expected duration per subject 
1 Month post CP950 Fitting 
Investigational design 
Single-subject usability study 
Number of subjects 
Up to 30 subjects 
Number of investigational 
sites 
Up to 3 sites 
Inclusion criteria 
1. 
At least 6 months experience with a Nucleus 24 
series or later implant in at least one implanted 
ear 
2. 
Subjects age 12 and older who are cognitively 
and developmentally able to complete all study 
related questionnaires as deemed by the 
principal investigator or delegated staff 
3. 
At least 3 months experience with the 
CP810,CP920 or CP910 sound processor  
4. 
Ability to use 2 zinc air batteries with their current 
MAP 
5. 
Willingness to participate in and to comply with 
all requirements of the protocol for the duration of 
the trial 
Exclusion criteria 
1. 
Unrealistic expectations on the part of the 
subject, regarding the possible benefits, risks 
and limitations that are inherent to the 
procedure and prosthetic device 
2. 
Additional disabilities that would prevent 
participation in evaluations 
3. 
Implant types not currently supported by the 

   
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CP950 sound processor (i.e.,N22) 
Primary objectives 
To evaluate usability of the CP950 sound processor using 
the CP950 Take Home Questionnaire for existing cochlear 
implant users.  
Specifically:   
1) Patient Reported Hearing Performance  
2) Retention & Comfort 
3) Ease of use  
4) Use of remote controls  
5) Look & feel  
6) Reliability 
7) Maintenance & use 
Additional Information 
To characterize CP950 sound processor field use data 
collected via Datalogging 
To evaluate the success of wireless pairing to both the 
wireless programming pod and wireless accessories 
Investigation schedule 
 
 
Visit 1 
Visit 2 
Subject Enrollment & 
Informed Consent 
X 
 
CP950 Fitting & 
Programming  
X 
X 
(Datalogs) 
Fit Wireless 
Accessories  
X 
 
CP950 Take Home 
Questionnaire - 
Subject 
 
X 
 
Return of the CP950 
Sound Processor 
 
X 
Primary endpoints 
Patient reported satisfaction of the CP950 sound processor 
as measured by the CP950 Take Home Questionnaire for 
existing cochlear implant users.  
Areas of assessment:    

   
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1) Patient Reported Hearing Performance  
2) Retention & Comfort 
3) Ease of use  
4) Use of remote controls  
5) Look & feel  
6) Reliability 
7) Maintenance & use 
Additional Information  
Field use data including time on air, listening environment 
type, and accessory use will be described.  
The success/failure rate of wireless pairing to both the 
wireless programming pod and the remote microphone 
accessory will be quantified.  

   
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2. Abbreviations 
Term 
Definition 
AE 
Adverse Event 
CRF 
Case Report Form 
IA 
Initial Activation 
IRB 
Institutional Review Board 
SAE 
Serious Adverse Event 

   
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3. Introduction 
Cochlear Limited’s current commercial system is the Nucleus 6 (N6). This is comprised of 
external behind the ear (BTE) sound processors (CP910 and CP920) offering new input 
processing algorithms designed to improve recipients’ hearing in specific situations, including 
background noise. The sound processors are controlled by either the remote assistant (CR230) 
or remote control (CR210) which avoids the user having to physically touch the sound processor. 
Clinicians are able to program the Nucleus 6 devices with Custom Sound 4 clinical software 
through either the Wireless Programming Pod or the traditional programming cable.   
The CP950 Sound Processor functionality is comparable to the commercially approved Nucleus 
CP920 Sound Processor but in an off the ear (OTE) configuration. The processing unit, coil and 
magnet are integrated into one unit which is positioned directly over the magnet of the cochlear 
implant rather than behind the ear. The CP950 sound processor is designed to provide the same 
access to N6 technology including the CR210 Remote Control, the CR230 Remote Assistant as 
well as being compatible with the Cochlear Wireless Accessories. 
 
Figure 1. CP950 Sound Processor 
 
While the CP950 Sound Processor maintains the functionality of the CP920 Sound Processor, 
there have been a few modifications to support the OTE configuration:  
 
The CP950 Sound Processor only has one button while the CP920 Sound Processor has 
two.  The ability to change volume and sensitivity for the CP950 Sound Processor will be 
available via either the CR230 remote assistant or CR210 remote control. 
 
Depending upon whether the CP950 Sound Processor is worn on the left (L) or right (R) 
sides of the recipients head the front and back microphones associated with wearing 
condition (R vs L) will need to be defined.   
 
As the batteries are integrated into the body of the CP950 Sound Processor they remain 
connected to the device when the programming cable is attached.  During programming 
using the traditional wired Programming Pod, both the CP920 and CP950 Sound 
Processors are powered by the programming computer.  Alternatively, due to the 
integrated batteries of the CP950 design, the sound processor may also be programmed 
via a Cochlear Wireless Programming Pod.                                          

   
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The primary objective of this study is to evaluate usability of the CP950 sound processor using 
the CP950 Take Home Questionnaire for existing cochlear implant users, specifically with regards 
to patient reported hearing performance, retention & comfort, ease of use, remote control use, 
look & feel, reliability and maintenance & use.  The CP950 sound processor may provide added 
comfort and ease of use for recipients due to its off-the-ear configuration, smaller footprint on the 
head and ear, as well as its simplistic design and wireless compatibility, however; retention and 
patient reported hearing performance must remain acceptable.  
The investigation is intended to provide the Sponsor with regional clinical experience in fitting this 
product on existing cochlear implant recipients prior to commercial release.  The current study will 
evaluate the usability of the CP950 device using the CP950 Take Home Questionnaire distributed 
to each subject after approximately 4 weeks of take home use with the CP950 Sound Processor.  
Additional information such as subject datalogging and wireless pairing will also be captured.  
Each subject will be required to return the CP950 Sound Processor upon trial completion.   
4. Study Objective 
4.1 
Primary Objective: 
To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire 
for existing cochlear implant users. Specifically:   
1) Patient Reported Hearing Performance  
2) Retention & Comfort 
3) Ease of use  
4) Use of remote controls  
5) Look & feel  
6) Reliability 
7) Maintenance & use 
5. Study Design 
The design is a within-subject usability study. 
6. Study Length 
The approximate length of the study for each subject is 1 month post CP950 sound processor 
fitting.  
7. Device Description 
The cochlear implant system that will be used in this study comprises: 
 
CP950 Sound processor 
 
 
CP950 Programming Cable Adaptor 
 
Cochlear Wireless Programming Pod. 

   
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7.1 
Sound Processor Description 
The CP950 Sound Processor is functionally comparable to the CP920 Sound Processor.  Sharing 
the same ASIC chipset, the CP950 Sound Processor introduces a new form factor which 
integrates the processing unit, coil, coil cable and magnet into a single unit.  As a result the 
CP950 Sound Processor will be worn in an OTE configuration positioned directly over the magnet 
of the cochlear implant on the recipients head rather than behind the ear.   
7.2 
Programming Software Description 
Custom Sound version 4 will be used in this study.   
8. Subject Population 
8.1 
Inclusion Criteria 
 
At least 6 months experience with a Nucleus 24 series or later implant in at least one 
implanted ear 
 
At least 3 months experience with the CP810,CP920 or CP910 sound processor  
 
Ability to complete study related questionnaires 
 
Willingness to participate in and to comply with all requirements of the protocol for the 
duration of the trial 
8.2 
Exclusion Criteria 
 
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and 
limitations that are inherent to the procedure and prosthetic device 
 
Additional disabilities that would prevent participation in evaluations 
 
Implant types not currently supported by the CP950 sound processor (i.e., N22) 
8.3 
Release of Medical Information 
Subjects will be required to release the exchange of medical information between the 
Investigator(s) and the Sponsor. This requirement will be clearly identified in the Informed 
Consent form.  
9. Investigational Procedures 
9.1 
Design Overview 
Usability of the CP950 Sound Processor with Experienced Cochlear Implant Users will be 
conducted as a multi-center, prospective, single-subject usability study, evaluating the usability of 
the CP950 Sound Processor in existing cochlear implant recipients.  A single-subject research 
design is appropriate since it accommodates the heterogeneity that characterizes hearing-
impaired populations. Blinding procedures are not appropriate for this trial design, as it is not 
possible to conceal the presence, or absence, of a cochlear implant from device recipients and/or 
clinical investigators. 
 

   
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9.2 
Visit Schedule & Procedures 
9.2.1 
Visit 1: 
The following activities will occur during Visit 1:  
1) Subjects will be converted from their current behind the ear sound processor (CP810 or 
CP900 series) to the CP950 sound processor using the recommended clinical 
conversation parameters. An anonymous .cdx file will be sent to the Sponsor.  
2) The Sound Processor MAP conversion will be completed using the Wireless Pod and 
Custom Sound version 4.  
3) If applicable, the subjects’ wireless accessories will be paired to the CP950 Sound 
Processor.  
4) The subject will be instructed to utilize the CP950 Sound Processor, Remote Assistant or 
Control and wireless accessories for a minimum of 30 days +/-1 week. 
5) The subject will complete a weekly diary documenting the CP950 Sound Processor user 
experience.  
9.2.2 
Visit 2:  
The following activities will occur during Visit 2:  
1) Datalogging for the CP950 Sound Processor will be extracted. An Anonymous .cdx file 
will be sent to the Sponsor.  
2) The CP950 Take Home Use Questionnaire will be completed by the subject.  
3) The CP950 Sound Processor will be collected from each subject.  
9.3 
Summary of Data Collection Visits 
 
Visit 1 
Visit 2 
Subject Enrollment & 
Informed Consent 
X 
 
CP950 Fitting & 
Programming  
X 
X 
(Datalogs) 
Fit Wireless 
Accessories  
X 
 
Collect Subject 
Weekly Diary 
X 
X 
CP950 Take Home 
Questionnaire - 
Subject 
 
X 
Return of the CP950 
Sound Processor 
 
X 

   
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10. Adverse Events 
An adverse event (AE) is any undesirable clinical or medical occurrence associated with the use 
of the device, procedure, or participation in the study, which does not result in serious injury or 
illness related to the surgical procedure or the device.  
A serious adverse event (SAE) is any untoward medical occurrence that  
 
results in death 
 
is life-threatening 
 
requires inpatient hospitalization or prolongation of existing hospitalization 
 
results in persistent or significant disability/incapacity 
 
requires medical or surgical intervention to prevent life-threatening illness or injury or 
permanent impairment to a body structure or a body function 
 
leads to fetal distress, death, or congenital abnormality or birth defect 
 
is a medically important event or reaction 
10.1 Assessment and Reporting of Adverse Events 
To monitor subject safety throughout this 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 study, even if the event was acknowledged as a risk factor 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. 
10.2 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 all reviewing IRBs and investigators within 10 working days after first 
receiving notice of the event. 

   
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11. Study Completion 
11.1 Completed Subjects 
Once the 1 month post-fitting visit is completed, the subject will be deemed complete.  Each 
subject will be required to return the CP950 Sound Processor to the providing clinic.  Subjects will 
continue to receive standard clinical follow-up care at their cochlear implant facility after the study.  
11.2 Discontinued Subjects 
Any subject may voluntarily discontinue the study at any time without prejudice. The Investigator 
may discontinue a subject from the study at any time if (s)he considers that remaining in the study 
compromises the subject’s health or the subject is not sufficiently cooperative. In either event, 
reason(s) for discontinuation should be recorded on a study withdrawal form, provided as part of 
the CRFs for the study.  Possible reasons for study discontinuation include the following: 
• 
AE necessitating discontinuation from the study 
• 
The subject is lost to follow-up 
• 
Voluntary decision to withdraw consent made by the subject  
• 
Investigator decision  
• 
Other reason 
In case of a subject lost-to-follow-up, the Investigator must attempt to contact the subject (or 
relative/family contact) by phone, email or letter at least three times. If attempts are unsuccessful, 
the ‘subject withdrawal’ form is to be completed in the study file and reported, as appropriate, in 
required reports to the Sponsor and IRB. 
11.3 Premature Study Termination 
The Sponsor may terminate the study early in the case of major non-adherence to the protocol, or 
if it is anticipated that recruitment will not be met for the required number of subjects to complete 
the study objectives. In the event of premature study termination, the subjects who are already 
enrolled will be sponsored through study completion.  
12. Data Analysis 
12.1 Statistical Analysis 
All subjects who are consented into the clinical study will constitute the intention-to-treat (ITT) 
population for the purposes of safety evaluation.  Only subjects fit with the CP950 Sound 
Processor and completed per the protocol will be considered as the completed cases (CC) 
population and per protocol (PP).  
Demographic and outcomes data will be tabulated individually along with group summary 
descriptive statistics.  
Descriptive statistics will be summarized for the following assessments:  
 
CP950 Take Home Questionnaire for existing cochlear implant users 
 
The number of connections as well as the success or failure of those connections to both 
the Wireless Pod and Wireless Accessories will be captured  

   
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 
Field use data such as Time on Air, Listening Environment, Program Usage, and 
Accessory Use  
12.2 Sample Size 
The proposed study is designed to collect usability data on up to 30 subjects across up to 3 
participating sites.  Since the study was designed with the intent to collect usability data, not for 
the purposes of demonstrating safety and efficacy, formal sample size and power analyses have 
not be completed.  The study is intended to provide clinical guidance and regional experience on 
the fitting and use associated with CP950 Sound Processor on existing cochlear implant 
recipients. Based on a sample size of 30 subjects, there is an approximately 80% probability of 
observing one or more major usability issues for issues that occur in the population at a rate of as 
low as 5.4%. 
Subject enrollment is estimated to take 3 months to recruit up to 30 subjects across 3 sites. The 
enrollment period may be extended if required. 
13. Risk Benefit Statement 
13.1 Benefits 
It is possible but not guaranteed that advances to cochlear implant technology will improve 
performance or increase usability of devices for future recipients. This investigation will help to 
inform the future development of potentially new sound processor designs as well as develop the 
associated clinical guidance when fitting existing cochlear implant patients. There are no direct 
benefits anticipated for subjects participating in this study.  
13.2 Risks 
With any cochlear implant mapping, there is a very small risk of unintentional over-stimulation. 
Subjects may experience sounds during mapping that are uncomfortably loud. Mitigation of this 
risk is similar to that used during clinical cochlear implant mapping wherein the sound processor 
is removed from the subjects head and/or the stimulation to the sound processor is ceased in 
Custom Sound.  
There is risk that the CP950 Sound Processor will not connect wirelessly to the Wireless Pod. If 
this occurs, CP950 Sound Processor programming will occur using the traditional programming 
cable.  
14. Good Clinical Practices Statement 
The study obligations for the Investigator(s) are outlined in guidelines for Good Clinical Practice 
(GCP), ISO14155:2011 (Clinical Investigation of Medical Devices for Human Subjects – Good 
Clinical Practice), and the Declaration of Helsinki. 
15. Access to Study Documents and Study Monitoring 
Investigator(s) will provide access to study documentation including source data for the purposes 
of monitoring, audits, IRB review, and regulatory inspections. 
16. Quality Control and Assurance 
Study sites may be subject to Quality audits at any point during the study. Regulatory agencies 
may conduct inspections during the course of the clinical investigation and after study completion. 

   
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17. Institutional Review Board 
Each site will obtain approval from its designated IRB prior to commencing any study-related 
activities. A copy of the IRB approval will be kept in the Investigator file(s). Any additional 
requirements imposed by the IRB and/or regulatory authority shall be followed. The 
Investigator(s) will submit the appropriate documentation if any necessary extension or renewal of 
the IRB approval must be obtained. 
18. Informed Consent Process 
Written informed consent shall be obtained from each subject after explaining the rationale for 
and the details, aims, and objectives of the study, the risks and benefits of the trial treatment (and 
alternative treatments), and the extent of the patient’s involvement. The Investigator is 
responsible for ensuring that all patients give written informed consent prior to any study-related 
examination or activity. All patients shall sign and date the Informed Consent Form, and a copy of 
the Informed Consent Form shall be given to the patient. 
The Sponsor and the Investigator(s) shall avoid improper influence on or inducement of the 
subject, monitor, the Investigator(s) or other parties participating in or contributing to the clinical 
investigation. 
19. Confidentiality 
A Case Report Form (CRF) will be completed for each study subject, summarizing all clinical and 
study data. The CRF contains confidential material. Subjects will only be referred to in the CRF 
by their subject numbers in order to retain subject confidentiality. Specific instructions to complete 
the CRF shall be provided to the clinical investigation team as appropriate. 
Copies of the completed CRFs are to be provided to the Sponsor as soon as practical after 
completion and review. The original CRFs are to be retained by the Investigator for a period of 
time as determined by local regulations. 
20. Protocol Deviations and Amendments 
The Investigator must receive prior approval from the Sponsor, and the IRB when necessary, to 
deviate from the protocol except in cases of emergency to protect the rights, safety, and well-
being of the subjects. Emergency protocol deviations must be documented and reported to the 
Sponsor and the IRB. 
Study procedures will not be changed without mutual agreement between the Sponsor and the 
Investigator(s). Changes will be implemented in a signed protocol amendment, and for significant 
changes, approval will be obtained from the IRB.  
21. Data Management 
Data will be recorded on electronic CRFs within the electronic data capture system DataLabsTM. 
DataLabs will produce a report of the summary data per subject. Source data for study 
evaluations may include paper worksheets or electronic spreadsheets. All source data will be 
stored in subject binders or on password-protected computers. The study monitor will compare 
the DataLabs CRFs with the source data. 

   
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22. Record Keeping and Retention 
All source documents, CRFs, and trial documentation will be kept by the Investigator(s) for the 
appropriate retention period as stipulated by local regulations and ICH-GCP. 
23. 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 study Investigators or their 
designee and reviewed by the Sponsor.