Implantation With the Cochlear Nucleus® CI532 Implant - Early Experience Study
Phase: NA
Conditions: Sensorineural Hearing Loss, Bilateral
Sponsor: Cochlear

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CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 2 of 21 
Rev. 1 
 
 
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, “Implantation with the Cochlear Nucleus® CI532 
Implant - Early Experience Study.  
 
 
Clinical Investigational Site 
 
 
Primary Investigator’s Name (print) 
 
 
Title 
 
 
Signature 
 
 
Sponsor Representative 
 
 
Title 
 
 
Signature 
 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 3 of 21 
Rev. 1 
 
 
Table of Contents 
Table of Contents ................................................................................................. 3 
 
Introduction ................................................................................................ 7 
1.
 
Study Objectives ........................................................................................ 8 
2.
 Primary Objectives: ...................................................................................... 8 
2.1
 Primary Endpoints: ....................................................................................... 8 
2.2
 
Study Design ............................................................................................. 8 
3.
 
Study Length .............................................................................................. 8 
4.
 
Device Description ..................................................................................... 8 
5.
 Implant Description ...................................................................................... 8 
5.1
 Sound Processor Description ....................................................................... 9 
5.2
 Programming Software Description ........................................................... 10 
5.3
 
Subject Population ................................................................................... 10 
6.
 Inclusion Criteria ........................................................................................ 10 
6.1
 Exclusion Criteria ....................................................................................... 10 
6.2
 Release of Medical Information .................................................................. 10 
6.3
 
Investigational Procedures ....................................................................... 11 
7.
 Design Overview ........................................................................................ 11 
7.1
 Description of Test Measures .................................................................... 11 
7.2
 Clinical Audiological Testing .................................................................... 11 
7.2.1
 Device Fitting ........................................................................................... 12 
7.2.2
 Preoperative Procedures ........................................................................... 12 
7.3
 Visit 1 ....................................................................................................... 12 
7.3.1
 Intraoperative Procedures .......................................................................... 12 
7.4
 Visit 2 ....................................................................................................... 12 
7.4.1
 Postoperative Procedures .......................................................................... 12 
7.5

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 4 of 21 
Rev. 1 
 
 
 Visit 3 ....................................................................................................... 12 
7.5.1
 Visit 4 ....................................................................................................... 13 
7.5.2
 Summary of Data Collection Visits ............................................................. 14 
7.6
 
Adverse Events ........................................................................................ 14 
8.
 Assessment and Reporting of Adverse Events .......................................... 15 
8.1
 Unanticipated Adverse Device Effects ....................................................... 15 
8.2
 
Study Completion .................................................................................... 16 
9.
 Completed Subjects ................................................................................... 16 
9.1
 Discontinued Subjects ............................................................................... 16 
9.2
 Premature Study Termination .................................................................... 16 
9.3
 
Data Analysis ........................................................................................... 17 
10.
 Statistical Analysis ..................................................................................... 17 
10.1
 Sample Size ............................................................................................... 17 
10.2
 
Risk Benefit Statement ............................................................................ 18 
11.
 Benefits ...................................................................................................... 18 
11.1
 Risks .......................................................................................................... 19 
11.2
 
Good Clinical Practices Statement .......................................................... 19 
12.
 
Access to Study Documents and Study Monitoring ................................. 19 
13.
 
Quality Control and Assurance ................................................................ 19 
14.
 
Institutional Review Board ....................................................................... 19 
15.
 
Informed Consent Process ...................................................................... 19 
16.
 
Confidentiality .......................................................................................... 20 
17.
 
Protocol Deviations and Amendments ..................................................... 20 
18.
 
Data Management ................................................................................... 20 
19.
 
Record Keeping and Retention ................................................................ 21 
20.
 
Study Report and Publication .................................................................. 21 
21.
 
References .............................................................................................. 21 
22.
 
 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 5 of 21 
Rev. 1 
 
 
Clinical Investigational Synopsis 
Title 
Implantation with the Cochlear Nucleus® CI532 Implant  
Early Experience Study 
Study Sites 
Up to 15 study sites 
Study Duration 
3 months post-activation (per subject) 
Study Population 
Up to 50 newly implanted cochlear-implant recipients 
Design Overview 
The design is a within-subject, repeated-measures study. 
The period of participation will be 3 months postactivation.  
Study procedures will include mapping, speech perception, 
and questionnaires. 
Primary 
Objectives 
1. To determine if unilateral listening performance at 3 
months post activation with the CI532 will be superior to 
the best aided unilateral preoperative condition for 
sentence perception in quiet. 
2. To determine if unilateral listening performance at 3 
months post activation with the CI532 will be superior to 
the best aided unilateral preoperative condition for 
sentence perception in noise. 
Primary 
Endpoints 
1. Sentence perception in quiet will be superior for subjects 
implanted with the CI532 when compared to their 
preoperative best aided unilateral listening condition.  
2. Sentence perception in noise will be superior for subjects 
implanted with the CI532 when compared to their 
preoperative best aided unilateral listening condition.  
Additional 
Information 
1. To quantify the change in audiometric threshold (125 – 
750 Hz) at 3 months postactivation when compared to 
the preoperative period 
Study Intervals 
Primary data points are at 3 months post-activation. 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 6 of 21 
Rev. 1 
 
 
Abbreviations 
Term 
Definition 
AE 
Adverse Event 
CRF 
Case Report Form 
IA 
Initial Activation 
IRB 
Institutional Review Board 
SAE 
Serious Adverse Event 
SNR 
Signal to noise ratio 
S0N90 
Speech  presented at 0 degrees azimuth and background 
noise presented from the side of the implant 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 7 of 21 
Rev. 1 
 
 
 Introduction 
1.
Cochlear implantation is an FDA and Health Canada approved treatment for 
sensorineural hearing loss.  Nucleus cochlear implants are indicated for 
individuals who demonstrate minimal benefit from appropriately fit hearing aids.  
Audiometrically, adults must possess a bilateral moderate to profound 
sensorineural hearing loss and children must possess a severe to profound 
sensorineural hearing loss.  A common hypothesis in peer reviewed literature is 
that performance outcomes with cochlear implants depend critically on the 
placement of the electrode array within the cochlea. 
A cochlear implant is composed of two main components: a receiver stimulator 
and an electrode array.  Electrode array designs are typically either lateral wall or 
peri-modiolar hugging.  A lateral wall electrode is a straight electrode design that, 
when inserted into the cochlea, hugs the outer wall of the cochlea, with final 
position lateral to the modiolus. A perimodiolar electrode is a pre-curved 
electrode design, held straight for insertion purposes, but as inserted into the 
cochlea curves to mimic the curvature of the modiolus, with final position medial 
to the modiolus.  Electrode placement closer to the modiolus has been 
documented to improve performance outcomes in traditional cochlear implant 
candidates (Holden et al. 2013; van der Beek et al. 2005). 
In addition to medial and lateral placement, there are also scala considerations 
within the cochlea.  The cochlea is divided into three scala: scala media, scala 
tympani and scala vestibuli.  Holden et al (2013), Finley et al. (2008), 
Aschendorff et al. (2007), Skinner et al. (2007) as well as other peer reviewed 
publications have demonstrated that electrode arrays located within scala 
tympani, as opposed to scala vestibuli, are often correlated with higher speech 
perception scores. Due to the location of ganglion cells within the modiolus, it has 
been suggested that there is a higher potential for electrodes in scala vestibuli to 
stimulate more than one turn of the cochlea, potentially causing cross-turn 
stimulation, pitch confusions and therefore diminished speech recognition (Finley 
et al. 2008). 
The device proposed for study is the Nucleus® CI532 cochlear implant which 
consists of a CI500 Series receiver/stimulator and a pre-curved, modiolar 
electrode array (EA32).  Individuals who will be recruited for participation in this 
study will be required to meet commercial cochlear implant indications. The study 
will compare the performance outcomes at 3 months postactivation with the best 
aided preoperative performance outcomes using a within subject study design. 
Up to 15 clinical study sites will be asked to participate with up to 50 subjects 
implanted.     

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 8 of 21 
Rev. 1 
 
 
 Study Objectives 
2.
 Primary Objectives: 
2.1
1) To determine if performance at 3 months post activation with the CI532 is 
superior to the best aided unilateral preoperative condition for sentence 
perception in quiet. 
2) To determine if performance at 3 months post activation with the CI532 is 
superior to the best aided unilateral preoperative condition for sentence 
perception in noise. 
 Primary Endpoints: 
2.2
1) Sentence perception in quiet will be superior for subjects implanted with the 
CI532 when compared to their preoperative best aided unilateral listening 
condition. 
2) Sentence perception in noise will be superior for subjects implanted with the 
CI532 when compared to their preoperative best aided unilateral listening 
condition. 
 Study Design 
3.
The design is a within-subject, repeated-measures clinical investigation. 
 Study Length 
4.
The duration of the study for each subject is 3 months post-activation.  
 Device Description 
5.
The cochlear implant system that will be used in this study comprises: 
 Nucleus® CI532 Cochlear Implant 
 Nucleus 6 (CP900 series) Sound Processor, and 
 Nucleus Custom Sound™ programming software. 
 Implant Description 
5.1
The commercially available Cochlear Nucleus CI532 cochlear implant will be 
used in this study. 

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CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 10 of 21 
Rev. 1 
 
 
 Programming Software Description 
5.3
The commercially available programming software, Custom Sound, will be used 
in this study.   
 Subject Population 
6.
 Inclusion Criteria 
6.1
 Medical and audiological candidate for a CI532 cochlear implant per 
commercially approved, age appropriate, FDA indications 
 Post-linguistically deafened  
 Ability to complete age appropriate testing  
 Exclusion Criteria 
6.2
 
Previous cochlear implantation in the ear to be implanted 
 
Pre-linguistically deafened (onset of hearing loss at less than two years of 
age) 
 
Women who may be pregnant at the time of cochlear implant surgery 
 
Ossification or any other cochlear anomaly that might prevent complete 
insertion of the electrode array  
 
Diagnosis of retro-cochlear pathology 
 
Diagnosis of auditory neuropathy 
 
Unrealistic expectations on the part of the subject regarding the possible 
benefits, risks, and limitations that are inherent to the surgical procedure and 
use of the prosthetic device 
 
Unwillingness or inability to comply with all investigational requirements 
 
Additional cognitive handicaps that would prevent participation on all study  
requirements 
 Release of Medical Information 
6.3
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.  

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 11 of 21 
Rev. 1 
 
 
 Investigational Procedures 
7.
 Design Overview 
7.1
The Implantation with the Cochlear Nucleus® CI532 Implant - Early Experience 
Study will be conducted as a multi-center, prospective, single-arm clinical study, 
evaluating the safety and functionality of the Cochlear Nucleus CI532 cochlear 
implant in up to 50 subjects who meet current cochlear implant indications. A 
single-subject repeated-measures analysis will be employed whereby subjects 
will act as their own control. 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. 
 Description of Test Measures 
7.2
 Clinical Audiological Testing 
7.2.1
Subjects will undergo a standard battery of audiological tests. Audiological data 
will be gathered pre-operatively, at Initial Activation (IA) and at 3-months post IA.  
The clinical data gathered for this study will include:  
1) Tympanometry, both ears. 
2) Frequency-specific thresholds at standard audiometric frequencies for both 
ears.  
a) Air conduction: 125, 250, 500, 750, 1000, 2000, 3000, 4000, and 8000 Hz 
b) Bone conduction: 250, 500, 1000, 2000, 3000 and 4000 Hz 
3) Aided speech recognition in quiet: AzBio sentences (Spahr et al., 2012) 
presented at 60 dBA in the sound field for the unilateral listening ear.  
a) Sentence testing in quiet will only be conducted in subjects aged 12 years 
and older 
4) Aided speech recognition in noise: AzBio sentences (Spahr et al., 2012) using 
speech weighted noise presented at 65 dBA with a +5 dB signal to noise ratio 
spatially separated, speech 0 degrees azimuth and noise 90 degrees towards 
the implanted ear.  
a) Sentence testing in noise will only be conducted in subjects aged 12 years 
and older.  
Note: The contralateral ear will be plugged/muffed for all audiological testing.   

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 12 of 21 
Rev. 1 
 
 
 Device Fitting 
7.2.2
Mapping will be conducted using standard clinical procedures using Custom 
Sound default program settings for the Nucleus 6 sound processor.  
 Preoperative Procedures  
7.3
 Visit 1 
7.3.1
A baseline evaluation will be conducted to measure the subject’s preoperative, 
best aided, unilateral listening performance pre-surgery. The following 
audiological testing will be completed:  
1) Tympanometry, both ears.  
2) Frequency-specific thresholds at standard audiometric frequencies for both 
ears.  
a) Air conduction: 125, 250, 500, 750, 1000, 2000, 3000, 4000, and 8000 Hz 
b) Bone conduction: 250, 500, 1000, 2000, 3000 and 4000 Hz 
3) Aided speech recognition in quiet: AzBio sentences (Spahr et al., 2012) 
presented at 60 dBA in the sound field for the unilateral listening ear.  
a) Only to be collected on subjects aged 12 years and older. 
4) Aided speech recognition in noise: AzBio sentences (Spahr et al., 2012) using 
speech weighted noise presented at 65 dBA with a +5 dB signal to noise ratio 
spatially separated, speech 0 degrees azimuth and noise 90 degrees towards 
the implanted ear for the unilateral listening ear. 
a) Only to be collected on subjects aged 12 years and older. 
 Intraoperative Procedures 
7.4
 Visit 2 
7.4.1
There are no modifications to the standard surgical procedure for this study.  
All surgeons will be required to complete a surgical questionnaire for each 
implanted subject.  Intraoperative measures (impedance and NRT) are optional. 
Additionally, intraoperative imaging (plain film x-ray) is recommended but not 
required, consistent with the Cochlear Nucleus CI532 Surgeons Guide.  
 Postoperative Procedures 
7.5
 Visit 3 
7.5.1
At the initial activation appointment, the following procedures will be completed:  

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 13 of 21 
Rev. 1 
 
 
1) Tympanometry, both ears. 
2) Frequency-specific thresholds at standard audiometric frequencies for both 
ears.  
a) Air conduction: 125, 250, 500, 750, 1000, 2000, 3000, 4000, and 8000 Hz 
b) Bone conduction: 250, 500, 1000, 2000, 3000 and 4000 Hz 
3) The initial activation will be performed according to standard clinical 
procedures using Custom Sound and the default programming settings for the 
Nucleus 6 sound processor.   
a) Impedances and NRT are to be measured.   
b) An anonymous .cdx file will be provided to the study sponsor.  
4) Audiologist Questionnaire will be completed for each subject.  
 Visit 4 
7.5.2
At 3 months postactivation, the following procedures will be completed:  
1) Tympanometry, both ears.  
2) Frequency-specific thresholds at standard audiometric frequencies for both 
ears.  
a) Air conduction: 125, 250, 500, 750, 1000, 2000, 3000, 4000, and 8000 Hz 
b) Bone conduction: 250, 500, 1000, 2000, 3000 and 4000 Hz 
3) Aided speech recognition in quiet: AzBio sentences (Spahr et al., 2012) 
presented at 60 dBA in the sound field for the unilateral listening ear.  
a) Only to be collected on subjects aged 12 years and older. 
4) Aided speech recognition in noise: AzBio sentences (Spahr et al., 2012) using 
speech weighted noise presented at 65 dBA with a +5 dB signal to noise ratio 
spatially separated, speech 0 degrees azimuth and noise 90 degrees towards 
the implanted ear for the unilateral listening ear.  
a) Only to be collected on subjects aged 12 years and older. 
5) Mapping will be performed according to standard clinical procedures using 
Custom Sound and the default programming settings for the Nucleus 6 sound 
processor.   
a) Impedances and NRT are to be measured.   
b) An anonymous .cdx file will be provided to the study sponsor. 
 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 14 of 21 
Rev. 1 
 
 
 Summary of Data Collection Visits 
7.6
 
Visit 1 
Visit 2 
Visit 3 
Visit 4 
Test 
Baseline 
Surgery 
Initial 
Activation 
3 Mos Post 
Activation 
Informed Consent 
X 
 
 
 
Tympanometry 
X 
 
X 
X 
Audiometric 
X 
 
X 
X 
AzBio Quiet 
X* 
 
 
X* 
AzBio Noise 
X* 
 
 
X* 
Surgical 
Questionnaire 
 
X 
 
 
Intraoperative 
Testing  
 
X (optional) 
 
 
Imaging 
 
X (optional) 
 
 
Audiological 
Questionnaire  
 
 
X 
 
Device 
Programming 
(.cdx) 
 
 
X 
X 
*Note for subjects aged 12 years and older.  
 Adverse Events 
8.
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 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 15 of 21 
Rev. 1 
 
 
 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 
 Assessment and Reporting of Adverse Events 
8.1
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. 
 Unanticipated Adverse Device Effects 
8.2
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. 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 16 of 21 
Rev. 1 
 
 
 Study Completion 
9.
 Completed Subjects 
9.1
Once the 3 month postactivation visit is completed, the subject will be deemed 
complete.  Subjects will continue to receive standard clinical follow-up care at 
their cochlear implant facility after the study.  
 Discontinued Subjects 
9.2
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. 
During surgery, an alternative device (e.g., CI522 or CI512) may be implanted in 
subjects where there are difficulties with the CI532.  These subjects will be 
discontinued from the study.  
Subjects who withdraw or are discontinued prior to the completion of the 3 month 
visit will receive compensation of $12.50/ hour for the cumulative period of time 
spent on study procedures. 
 Premature Study Termination 
9.3
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 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 17 of 21 
Rev. 1 
 
 
premature study termination, the subjects who are already enrolled will be 
sponsored through study completion.  
 Data Analysis 
10.
 Statistical Analysis 
10.1
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 
implanted with the CI532 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. Speech perception scores will be presented for 
each study evaluation, pre- and postoperatively, so that postoperative progress 
can be evaluated over time.  
Performance with the Nucleus CI532 will be determined by a comparison of 
preoperative, best aided, ear to be implanted vs. 3 months postactivation 
outcome measures. The speech perception measures chosen for this purpose 
are the AzBio sentences in both quiet and noise in the unilateral listening 
condition.  
The primary study endpoints will be statistically significant differences between 
the mean, preoperative speech perception scores and postoperative scores for 
the activated, CI532 cochlear implant subjects who completed speech perception 
testing. Mean scores as measured by AzBio sentences in quiet and noise will be 
compared. The null hypothesis to be tested is that there is no difference for the 
subjects between their pre- vs. postoperative speech performance  
Individual scores obtained at 3 months will be compared with those obtained, on 
the same measures preoperatively, based on the binomial model where 
appropriate (see Thornton and Raffin, 1978; Boothroyd and Nittrouer, 1988). 
Although the binomial model is the more appropriate statistical model for analysis 
of single-subject experimental data, conventional group-based statistics will also 
be applied to the pooled results. For all of the speech perception measures, 
nonparametric procedures (e.g., a Signed-Ranks test) will be conducted in order 
to further confirm the results of the single-subject analyses. These tests will be 
two-tailed and applied using an alpha level of 0.05.  
 Sample Size 
10.2
The proposed study is designed to collect performance data associated with 
CI532 cochlear implantation. Based on the preliminary data collected in IDE 
G120234, assuming the observed mean and standard deviation for each 

    
CONFIDENTIAL 
March 31, 2016 
CAM-CL-027_PRT 
Page 18 of 21 
Rev. 1 
 
 
endpoint are representative of the corresponding values for the population, it was 
determined that a minimum of 23 evaluable subjects would provide at least 90% 
power for a hypothesis test of superiority at the one-sided 0.025 alpha level. 
Allowance of 10% to account for possible attrition brings the sample size to a 
minimum of 25 subjects to be recruited into the study and implanted. In effort to 
enroll subjects 12 years and under who are unable to complete speech 
perception for primary endpoint testing and have more than 3 subjects per site, 
the sample size has been increased to up to 50 subjects.      
The following general assumptions have been made: 
• 
Paired t-tests  
• 
One-sided 0.025 or 0.05 alpha levels  
• 
Assumed distribution for population (mean, SD) based on IDE G120234 
• 
Desire for 80% or 90% power 
Power for the primary test metric AzBio Sentences in SWN under a variety of 
assumptions is provided below. 
Scenario 
Minimum Evaluable Sample Size 
One-sided 0.025 alpha, 80% power 
18 
One-sided 0.025 alpha, 90% power 
23 
One-sided 0.05 alpha, 80% power 
16 
One-sided 0.05 alpha, 90% power 
20 
Subject enrollment is estimated to take six months to recruit up to 50 subjects. 
The enrollment period may be extended if required. 
 Risk Benefit Statement 
11.
 Benefits 
11.1
It is possible but not guaranteed that advances to cochlear implant technology 
will improve performance or usability of devices for future recipients. This 
investigation will help to inform the future development of potentially new 
electrode designs and the planning of future studies in the newly implanted 
population. There are no direct benefits anticipated for subjects participating in 
this study.  

    
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 Risks 
11.2
It is expected that the risks associated with the procedure to place the cochlear 
implant are no greater than those associated with cochlear implantation in 
general.  Cochlear implantation is an accepted treatment option for adults with 
bilateral moderate (for low frequencies) to profound sensorineural hearing loss. 
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.  
 Good Clinical Practices Statement 
12.
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. 
 Access to Study Documents and Study Monitoring 
13.
Investigator(s) will provide access to study documentation including source data 
for the purposes of monitoring, audits, IRB review, and regulatory inspections. 
 Quality Control and Assurance 
14.
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. 
 Institutional Review Board 
15.
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. 
 Informed Consent Process 
16.
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 

    
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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. 
 Confidentiality 
17.
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. 
 Protocol Deviations and Amendments 
18.
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.  
 Data Management 
19.
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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 Record Keeping and Retention 
20.
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. 
 Study Report and Publication 
21.
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. 
 References 
22.
Aschendorff, A., Kromeier, J., Klenzner, T., et al. (2007). Quality control after 
insertion of the nucleus contour and contour advance electrode in adults. Ear 
Hear, 28(2 Suppl), 75S–79S. 
Finley, C., Holden, T., Holden, L., et al. (2008). Role of electrode placement as a 
contributor to variability in cochlear implant outcomes. Otol Neurotol, 29(7), 920-
928. 
Holden, L., Finley, C., Fiszt, J., et al. (2014). Factors affecting open-set word 
recognition in adults with cochlear implants. Ear Hear, 34, 342-360. 
Skinner, M. W., Holden, T. A., Whiting, B. R., et al. (2007). In vivo estimates of 
the position of advanced bionics electrode arrays in the human cochlea. Ann Otol 
Rhinol Laryngol Suppl, 197, 2–24. 
van der Beek, F. B., Boermans, P. P., Verbist, B. M., et al. (2005). Clinical 
evaluation of the Clarion CII HiFocus 1 with and without positioner. Ear Hear, 26, 
577–592.