Implantation With the Nucleus CI532 Cochlear Implant in Adults
Phase: NA
Conditions: Hearing Loss
Sponsor: Cochlear

 
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CLINICAL INVESTIGATION PLAN (CIP) 
 
 
Implantation with the Nucleus® CI532 cochlear implant in Adults 
Feasibility Study 
 
 
Date:  Version 3, April 2016 
 
 

 
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Sponsor 
Cochlear Americas 
13059 East Peakview Ave 
Centennial, CO   80111 
Manufacturer 
Cochlear Limited 
1 University Avenue, 
Macquarie University, 
NSW 2109 
Principal Investigator  
 
J. Thomas Roland, Jr., MD, FACS 
Mendik Foundation Chairman Department of 
Otolaryngology 
Professor of Otolaryngology and 
Neurosurgery 
NYU Langone Medical Center and NYU 
School of Medicine 
Co-Director NYU Cochlear Implant Program 
Co-Director NYU NF2 Center 
550 First Ave, Suite 7Q 
New York, NY 10016 
Clinical Research Organisation (or other 
institution involved) 
Not applicable 
 
 

 
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Sponsor and Investigator Responsibilities 
Investigation Title 
Implantation with the Nucleus® CI532 cochlear implant in Adults. 
 
Signature on behalf of Sponsor 
I agree with the content in this clinical investigation plan, including all appendices. 
Name 
Title 
Christine Menapace, M.A. 
 
Vice President, Clinical, Quality, and Regulatory 
Signature 
Date 
(dd-mmm-yyyy) 
 
 
 
Signature of Principal Investigator 
I agree to the content of this clinical investigation plan, including all appendices. 
Name 
Title 
J Thomas Roland Jr, MD 
 
Principal Investigator 
Signature 
Date 
(dd-mmm-yyyy) 
 
 
 
 
 

 
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Table of Contents 
1 
Clinical Investigation Synopsis ................................................................................................... 7 
2 
Objectives and hypotheses ...................................................................................................... 11 
2.1 
Objectives ...................................................................................................................... 11 
2.2 
Hypotheses .................................................................................................................... 11 
3 
Identification and description of the study device ...................................................................... 11 
4 
Design of the clinical investigation ............................................................................................ 14 
4.1 
General .......................................................................................................................... 14 
4.2 
Study device and comparator ......................................................................................... 14 
4.3 
Endpoints ....................................................................................................................... 15 
4.3.1 
Primary endpoints ............................................................................................. 15 
4.3.2 
Secondary endpoints ........................................................................................ 15 
4.4 
Additional clinical measures ........................................................................................... 15 
4.4.1 
Audiometric assessment ................................................................................... 15 
4.4.2 
Speech perception ............................................................................................ 15 
4.4.3 
Electrode placement ......................................................................................... 16 
4.4.4 
Device characteristics ....................................................................................... 16 
4.5 
Equipment ...................................................................................................................... 16 
4.6 
Investigation schedule .................................................................................................... 17 
4.7 
Subjects ......................................................................................................................... 17 
4.7.1 
Inclusion Criteria ............................................................................................... 17 
4.7.2 
Exclusion Criteria .............................................................................................. 18 
4.7.3 
Number of subjects required ............................................................................. 19 
4.7.4 
Criteria and procedures for subject’s withdrawal or discontinuation .................... 19 
4.7.5 
Subject replacement ......................................................................................... 20 
4.7.6 
Point of enrollment ............................................................................................ 20 
4.7.7 
Total expected duration of the clinical investigation ........................................... 20 
5 
Justification for the design of the clinical investigation ............................................................... 20 
6 
Claims and intended performance ............................................................................................ 22 
7 
Procedures .............................................................................................................................. 22 
7.1 
Medical history and Counseling ...................................................................................... 22 
7.2 
Audiogram (Candidacy, Activation, 3, 6 and 12 months post-activation) .......................... 22 
7.3 
Speech recognition (Candidacy, 3, 6 and 12 months post-activation) .............................. 23 

 
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7.4 
Speech, Spatial, Qualities of Hearing Scale – SSQ (Candidacy & 6 months post-activation)23 
7.5 
Glasgow Benefit Inventory – GBI (6 months post-activation) ........................................... 24 
7.6 
Surgical Questionnaire – Intraoperatively........................................................................ 24 
7.7 
Video (Surgery) .............................................................................................................. 24 
7.8 
Imaging:  X-ray (Surgery) ............................................................................................... 24 
7.9 
Activation (approximately 1 month post-surgery) ............................................................. 24 
7.10 Device characteristics (Activation and 6 months post-activation) ..................................... 24 
7.11 Safety ............................................................................................................................ 24 
7.12 Medical care post-investigation ....................................................................................... 25 
7.13 Monitoring Plan .............................................................................................................. 25 
8 
Reporting process for adverse events, adverse device effects and device deficiencies ............. 26 
8.1 
Definitions ...................................................................................................................... 26 
8.1.1 
Adverse event (AE) ........................................................................................... 26 
8.1.2 
Adverse device effect (ADE) ............................................................................. 26 
8.1.3 
Device deficiency (DD) ...................................................................................... 26 
8.1.4 
Serious adverse event (SAE) ............................................................................ 27 
8.1.5 
Unanticipated adverse device effect (UADE) ..................................................... 27 
8.2 
Reporting process for adverse events ............................................................................. 27 
8.2.1 
Unanticipated Adverse Device Effects ............................................................... 27 
8.2.2 
Adverse Event Follow-up .................................................................................. 27 
8.2.3 
Sponsor’s Responsibilities ................................................................................ 28 
8.3 
Data Monitoring Committee ............................................................................................ 28 
9 
Study Completion ..................................................................................................................... 28 
9.1 
Completed Subjects ....................................................................................................... 28 
9.2 
Discontinued Subjects .................................................................................................... 28 
9.3 
Premature Study Termination ......................................................................................... 29 
10 Statistical Considerations ......................................................................................................... 29 
10.1 Efficacy Measurements .................................................................................................. 29 
10.2 Safety Measurements..................................................................................................... 30 
10.3 Baseline Characteristics ................................................................................................. 30 
10.4 Missing Data .................................................................................................................. 30 
11 Risks and benefits of the study device and clinical investigation ............................................... 31 
11.1 Anticipated clinical benefits ............................................................................................. 31 
11.2 Anticipated adverse device effects .................................................................................. 31 

 
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11.3 Risks associated with participation in the clinical investigation ........................................ 32 
11.4 Risk mitigation ................................................................................................................ 32 
11.5 Risk-to-benefit rationale .................................................................................................. 32 
12 Good Clinical Practice .............................................................................................................. 33 
12.1 Declaration of Helsinki and compliance with standards ................................................... 33 
12.2 Institutional Review Board (IRB) ..................................................................................... 33 
13 Quality Control and Assurance ................................................................................................. 33 
14 Informed consent process ........................................................................................................ 33 
14.1 Obtaining informed consent ............................................................................................ 34 
14.2 Confidentiality ................................................................................................................ 34 
15 Protocol Amendments and Deviations ...................................................................................... 35 
16 Data Management.................................................................................................................... 35 
17 Device accountability................................................................................................................ 36 
18 Vulnerable population............................................................................................................... 36 
19 Record Keeping and Retention ................................................................................................. 36 
20 Publication Policy ..................................................................................................................... 37 
21 Change History ........................................................................................................................ 38 
22 Definitions ................................................................................................................................ 38 
22.1 Definitions from ISO 14155:2011 .................................................................................... 38 
22.2 Other definitions ............................................................................................................. 39 
23 References .............................................................................................................................. 40 
23.1 Internal References ........................................................................................................ 40 
 
Table of Figures 
Figure 1: Left: The CI532 device (not to scale).  Right:  The EA32 electrode array loaded in the sheath 
(upper), advanced through the sheath, and with the sheath removed as in final situation (lower). ........ 12 
Figure 2: Speaker orientation for speech perception assessment ........................................................... 16 
 
Table of Tables 
Table 1: Investigation schedule .............................................................................................................. 17 
 

 
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1 CLINICAL INVESTIGATION SYNOPSIS 

 
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Investigation title 
Implantation with the Nucleus® CI532 cochlear implant in Adults 
Investigation number 
CAM5631 
Name of study device 
Nucleus® CI532 cochlear implant 
Investigators 
J Thomas Roland, Jr.  
New York University  
Investigation start  
November 2015 
Total expected duration of 
the clinical investigation 
18 months 
Enrolment period 
3 months 
Expected duration per 
subject 
Up to 15 months/subject  
Investigational design 
Prospective, single-center, single arm with sequential enrollment. 
Number of subjects 
Up to 10 Adults 

 
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Inclusion criteria 
1. Meet current cochlear implant indications at the implanting 
center. Current Nucleus cochlear implant indications 
include:  
a. Individuals 18 years of age or older who have 
bilateral, pre, peri or postlinguistic sensorineural 
hearing impairment 
b. Limited benefit from appropriate binaural hearing 
aids (verified by standard clinical practice), as 
defined by aided test scores of 50% correct or less 
in the ear to be implanted (60% or less in the best-
aided listening condition) on tests of open set 
sentence recognition 
i. Consistent with the Minimum Speech Test 
Battery (2011), it is required that all 
subjects be evaluated at 60 dBA 
presentation level.  
c. Moderate to profound hearing loss in the low 
frequencies and profound (90 dB HL) hearing loss 
in the mid to high speech frequencies 
2. In addition to meeting current cochlear implant indications, 
subjects must also possess preoperative unaided hearing 
thresholds between 40 and 65 dB HL, inclusively, at 250 & 
500Hz in the ear to be implanted. 
a. Typical subjects will have the following audiometric 
configuration:  
i. Low frequency (250 – 500 Hz): Thresholds 
between 40 and 65 dB HL, inclusively 
ii. Mid to High frequency (above 1500 Hz): 
Thresholds greater than or equal to 90 dB 
HL 
3. Fluent speaker in the local language used to assess clinical 
performance. 

 
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Exclusion criteria 
1. Evidence of hearing loss prior to 5 years of age. 
2. Sensorineural severe-to-profound hearing loss greater than 
20 years at ≥ 2 kHz and above.  
3. Simultaneous bilateral cochlear implantation or prior 
cochlear implantation in the ear to be implanted.  
4. Medical or psychological conditions that contraindicate 
undergoing general anaesthesia or surgery. 
5. Ossification, malformation or any other cochlear anomaly, 
such as common cavity, that might prevent complete 
insertion of the electrode array, as confirmed by medical 
examination. 
6. Hearing impairment due to lesion or neuropathy of the 
acoustic nerve, VIII nerve or central auditory pathway. 
7. Active middle-ear infection.  
8. Tympanic membrane perforation.  
9. Unrealistic expectations on the part of the subject, 
regarding the possible benefits, risks, and limitations that 
are inherent to the surgical procedure(s) and prosthetic 
devices. 
10. Unwillingness or inability of the candidate to comply with all 
investigational requirements. 
11. Patients with existing CSF shunts or drains, existing 
perilymph fistula, skull fracture or CSF leak. 
12. Patients with recurrent episodes of bacterial meningitis. 
Primary objectives 
To obtain additional safety and efficacy data associated with CI532 
cochlear implantation and postoperative fitting of the acoustic 
component in adults.   
Secondary objectives 
Patient reported outcome measures  
i) 
SSQ preoperatively and 6 months post-activation 
ii) GBI at 6 months post-activation 
Primary endpoints 
1. To evaluate preoperative to 6 months post-activation 
performance outcomes in the best unilateral listening condition 
using AzBio Sentences in noise.  
2. Report of medical/surgical and device related adverse events 
compared to the current approved labelling with regard to type, 
frequency and seriousness at 6 months post-activation. 
Secondary endpoints 
1. To evaluate Patient Reported Outcomes (PRO) preoperatively 
to 6 months post-activation for the Speech Spatial and Quality of 
Hearing scale (SSQ) and the Glasgow Benefit Inventory (GBI) at 
6 months post-activation. 
 
 

 
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2 OBJECTIVES AND HYPOTHESES 
2.1 
Objectives 
The primary objective for the clinical investigation is to obtain additional safety and efficacy data 
associated with CI532 cochlear implantation in individuals who meet current indications for 
cochlear implantation but also have pre-operative hearing thresholds between 40 and 65 dB HL 
at 250 and 500 Hz in the ear to be implanted. 
2.2 
Hypotheses 
As this is a feasibility study, there is no formal hypothesis to be accepted or rejected on the 
basis of statistical analysis in the current clinical investigation. Individual outcomes will be 
compared, along with group effects, across pre- and postoperative test conditions for the 
speech perception outcomes. Adverse events will be summarized by event type, severity, 
seriousness, as well as relatedness to the device and implant procedure will be reported and 
tabulated.  
3 IDENTIFICATION AND DESCRIPTION OF THE STUDY DEVICE 
Peri-modiolar electrodes such as the Contour Advance™ (CA) are designed to bring electrode 
contacts closer to the medial wall of the cochlea and so therefore closer to the spiral ganglion. 
Up until now these “pre-curved” electrodes have required a flexible metallic “stylet” to hold the 
electrode straight at the point of first introduction into the cochlea to avoid premature curling of 
the electrode.  It is recommended that the electrode is advanced off the stylet™ (AOS) so that it 
follows the trajectory of the basal turn of the cochlea due to its curved shape.  In this way 
contact with the lateral wall, which may produce trauma, may be avoided.  Necessarily the 
cross-sectional area of the CA is somewhat larger than what may be required for a non-stylet 
“straight” array and there is always some chance that the stiffer array-stylet combination could 
still result in trauma such that the electrode array could dislocate between scala tympani and 
scala-media or scala-vestibuli, thus producing trauma to the interstitial membranes.  In addition 
an electrode array in scala vestibuli is at a greater distance from the stimulation target (spiral 
ganglion cells) compared to one in scala tympani – thus current paths to these cells may be 
irregular and stimulation will be less selective, potentially reducing performance (1). 
The device under investigation is the Nucleus® CI532 cochlear implant (Figure 1, left) which 
consists of a CI500 Series receiver/stimulator and a pre-curved, perimodiolar electrode array 
(EA32), which does not incorporate a lumen and stylet. Instead it has a thin electrode carrier 
which is introduced into the cochlea through a straightening sheath (Figure 1, right).  The CI532 
cochlear implant is manufactured by Cochlear Ltd, Macquarie University, Australia.  Cochlear 
has been manufacturing cochlear implants for over 30 years. The Nucleus® CI532 cochlear 
implant was approved by the U.S. Food & Drug Administration for commercial use in March 
2016. 

 
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Figure 1: Left: The CI532 device (not to scale).  Right:  The EA32 electrode array loaded in the 
sheath (upper), advanced through the sheath, and with the sheath removed as in final situation 
(lower). 
 
As for the CA, the EA32 array must be orientated correctly so that its curvature is in the plane of 
the basal turn, with electrodes towards the modiolus, and the sheath must be immobile during 
this process.  The cross-sectional area of the EA32 is approximately 40% of that of the CA and 
thus it is overall less stiff than the CA; these two factors may allow the EA32 array to take up a 
position within scala tympani closer to the modiolus.  The sheath is removed and discarded 
once the electrode is fully inserted. 
The CI532 cochlear implant is a single use device intended for long term implantation under the 
skin in the mastoid region of either side of the head. Cochlear implantation can only be 
undertaken by an experienced surgical team, or under supervision of such a team.   
The CI532 cochlear implant will be used in the current clinical investigation in adults who meet 
current indications for cochlear implantation in Australia and America. As the clinical 
investigation aims to assess the degree of hearing preservation with the CI532 device, 
candidates who are at the upper range of pre-operative residual hearing (40-65 dB HL at 500 
Hz) will be recruited to participate. 
 
The surgical approach will be cochlear implantation via posterior tympanotomy as described in 
the The Nucleus® CI532 cochlear implant with Slim Modiolar electrode Physician’s Guide (2) on 
page 34.  The bed for the CI500-series receiver-stimulator will be prepared before opening the 
cochlea, along with placement of the receiver-stimulator and extra-cochlea electrode.  Since the 
CI532 implant electrode is compatible with both of the round window and cochleostomy 
approaches, the appearance of the RW and niche will be need to be visualized in order 
determine the choice of surgical approach (see page 64 in the Physician’s Guide).   
 
To utilize a round window approach:  

 
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1. Visualize the stapes to confirm the site of the round window, and visualize the round window 
membrane. 
2. Remove the false membrane.  
Please note: Do not open the round window membrane until immediately before insertion of the 
electrode. 
 
To utilize a cochleostomy approach:  
1. Visualize the stapes to confirm the site of the round window, and visualize the round window 
membrane.  
2. Perform a cochleostomy into the scala tympani using a diamond burr at low speed. Position 
the cochleostomy inferior and slightly anterior to the round window membrane. It should be 
close to, or incorporating, the round window niche (RWN). A slight blue line of endosteum 
should become visible as the bone is being thinned for the cochleostomy. This indicates the 
location of the scala tympani. 
3. Drill sufficient bone to expose at least 0.8–1.0 mm of endosteum.  
Please note: To avoid risk of contamination, do not open the endosteum until immediately 
before insertion of the electrode. 
4. Remove the final layer of bone. 
 
Insertion of the array will be achieved using the advance-through-the-sheath technique 
described in the detailed step by step with imagery in the Physician’s guide on pages 71-78.  
 
Please note: the recommended cochlea opening is between 0.8 mm and 1.0 mm wide. With 
each CI532 an additional sterile silicon dummy implant and cochleostomy sizing tool is 
provided.  The dummy implant allows checking of the size of the drilled-out implant bed.  The 
sizing tool allows verification of the size of the cochleostomy hole such that the guide tube 
(yellow/orange figure 1 right) may easily enter the cochleostomy hole but that the stopper 
cannot (2). If the opening is larger than 1.4 mm, use the forceps holding the sheath handle to 
stabilize the sheath and ensure the stopper stays at the round window or cochleostomy 
opening.This ensures that intra-cochlear trauma is minimized and offers the potential for hearing 
preservation in as many cases as possible.   
 
The EA32 electrode (Figure 1, right) is placed into the cochlea and carries twenty-two electrode 
contacts.  In addition there are two extra-cochlear return electrode contacts; one is connected to 
the CI500 body via a lead wire and placed under the temporalis muscle and the other is an 
exposed area of the case of the CI500 (Figure 1, left).  
The CI532 is a device which is commercially available for implantation based on FDA approval 
in March 2016.  Orders for devices will be placed in the Oracle system, with shipment to be 
approved by the Clinical Project Manager, Cochlear Americas.  Devices are identified by unique 
serial numbers. 
This device when combined with the approved external Nucleus 6 Sound Processor (SP) 
(CP900 Series) provides electrical stimulation to the auditory nerve which can be interpreted as 
sound by the hearing impaired recipient. Biphasic current pulses at the electrode contacts are 
generated by the CI500-series receiver/stimulator which is controlled by the external Sound 
Processor via a transcutaneous radio link. 

 
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Standard activation of the CI532 will be achieved using Custom Sound software running on a 
PC equipped with a Nucleus Pod programming interface.  Electrically-evoked Compound Action 
Potentials (ECAPs) may be measured using either Custom Sound or Custom Sound EP 
software during surgery or at the device activation appointment. 
The external envelope materials of the CI532, and sterile accessories, and the Nucleus 6 
CP900 Sound Processors are biocompatible according to applicable standards (i.e. ISO 10993: 
2009/AC:2010).       
 
4 DESIGN OF THE CLINICAL INVESTIGATION 
4.1 
General 
The Implantation of the Cochlear™ Nucleus® CI532 in Adults feasibility study will be conducted 
as a single-site, prospective, single-arm clinical study, evaluating the safety and functionality of 
the Cochlear Nucleus CI532 cochlear implant in up to 10 subjects who meet current cochlear 
implant indications with low frequency unaided thresholds at 250 and 500 Hz between 40 and 
65 dB HL. 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. 
4.2 
Study device and comparator 
Subjects will be implanted with the study device, the Nucleus CI532 cochlear implant.  The 
device will be activated at approximately 1 month post-operatively according to the 
investigational site’s standard clinical procedures.  Activation generally consists of determination 
of active electrodes via impedance measurements followed by the determination of subjective 
threshold (T) and comfortable (C) levels of stimulation (current amplitude) for each electrode.  
The Nucleus CP900 Series Sound Processor, is programmed such that input sound frequencies 
are allocated across the electrode array with input sound intensities being converted to 
stimulation levels between Ts and Cs.  According to the postoperative audiogram, a subject 
may also receive the acoustic component. The acoustic component will be determined and fit 
according to commercial clinical recommendations and training.  T and C-levels as well as use 
of the acoustic component may be re-evaluated at intervals after activation to take into account 
acclimatization of the subject as well as postoperative residual hearing status.  
This is a single-arm, single center investigation. The comparator device is one of the sponsor’s 
other current commercially available pre-formed or peri-modiolar Contour Advance electrode 
which may be connected to the CI24RE “Freedom” receiver-stimulator electronics module or the 
later CI500 module.  There is no difference in electronic capability between the CI24RE and 
CI500; the difference lies in the form factor.  There is no proposed concurrent medical device or 
medication.  The investigational site may use systemic application of corticosteroids and/or 

 
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antibiotics at time of surgery possibly followed by oral application according to clinical standard 
of care. 
4.3 
Endpoints 
4.3.1 Primary endpoints 
The six month post-activation visit serves as the primary endpoint for data collection related to: 
1. Efficacy – To evaluate preoperative to 6 months post-activation performance outcomes in 
the best unilateral listening condition using AzBio Sentences in speech weighted noise 
(SWN). 
2. Safety – Report of medical/surgical and device related adverse events compared to the 
current approved labelling with regard to type, frequency and seriousness at 6 months post-
activation. 
4.3.2 Secondary endpoints 
To evaluate Patient Reported Outcomes (PRO) preoperatively to 6 months post-activation for 
the Speech Spatial and Quality of Hearing scale (SSQ) and the Glasgow Benefit Inventory (GBI) 
at 6 months post-activation. 
4.3.2.1 Speech, Spatial and Qualities of Hearing scale (SSQ) 
The six month post-activation visit serves as the secondary endpoint for data collection related 
to self-reported auditory disability and quality assessment with the SSQ for the CI532 cochlear 
implant. 
4.3.2.2 Glasgow Benefit Inventory 
The six month post-activation visit serves as the secondary endpoint related to health utility data 
collection with the GBI for the CI532 cochlear implant. 
4.4 
Additional clinical measures 
4.4.1 Audiometric assessment 
Unaided audiometric thresholds obtained for each ear1, with insert earphones, using the 
standard audiometric technique for pure-tone air and bone conduction testing.   Aided 
thresholds will be obtained for each ear. 
4.4.2 Speech perception 
For individuals who utilize the acoustic component, the electric alone condition will also be 
assessed.  Subjects will also be assessed using the CNC monosyllabic word test in quiet in the 
best unilateral listening condition.  
                                                             
1 As these subjects may have measureable low-frequency hearing, it is important that appropriate consideration be 
made for masking or plugging the contralateral ear during unilateral testing in the sound field. 

 
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4.4.3 Electrode placement 
An X-ray will be obtained intraoperatively (preferably a lateral or modified Stenver’s view) to 
confirm proper electrode placement.   
4.4.4 Device characteristics 
Device characteristics such as impedance measurements, programming map parameters, 
psychophysical threshold and comfort levels, and neural response telemetry (NRT) will be 
exported into an anonymous .cdx file.   
4.5 
Equipment  
Speech perception performance in quiet will be assessed using a loud speaker configuration 
with the signal from the front (S0). Speech perception performance in noise will be assessed 
using a loud speaker configuration with signal from the front and noise from the implanted side 
(S0N90 or S0N270) as shown in Figure 2. 
 
Figure 2: Speaker orientation for speech perception assessment 
The loudspeakers are located at head height for a seated subject (reference point). The 
distance from the loudspeaker from the reference point is approximately one meter. There will 
be defined locations for the loudspeakers and subject within the test environment. Sound field 
calibration of the Average Sound Level (Leq) is performed prior to each visit using a sound level 
meter (SLM) using a dB A-weighting (dBA), slow time weighting.  
 
 
or 
or 

 
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4.6 
Investigation schedule 
Table 1: Investigation schedule 
Procedure 
Pre-op 
Surgery 
Activation 
3 months 
post-
activation 
6 months 
post-
activation 
12 
months 
post-
activation 
Medical history 
x 
 
 
 
 
 
X-ray                   
 
x 
 
 
 
 
Impedances 
 
 
x 
x 
x 
x 
T/C Levels 
 
 
x 
x 
x 
x 
Speech Perception 
Testing 
x 
 
 
x 
x 
x 
Unaided Audiogram 
x 
 
x 
x 
x 
x 
SSQ 
x 
 
 
 
x 
 
GBI 
 
 
 
 
x 
 
Surgical 
Questionnaire 
 
x 
 
 
 
 
Adverse Events 
 
x 
x 
x 
x 
x 
4.7 
Subjects  
4.7.1 Inclusion Criteria 
1. Meet current cochlear implant indications at the implanting center.  Current Nucleus 
cochlear implant indications include:  
a. Individuals 18 years of age or older who have bilateral, pre, peri or postlinguistic 
sensorineural hearing impairment 
b. Limited benefit from appropriate binaural hearing aids (verified by standard 
clinical practice), as defined by aided test scores of 50% correct or less in the ear 
to be implanted (60% or less in the best-aided listening condition) on tests of 
open set sentence recognition 
i. Consistent with the Minimum Speech Test Battery (2011), it is required 
that all subjects be evaluated at 60 dBA presentation level.  
c. Moderate to profound hearing loss in the low frequencies and profound (90 dB 
HL) hearing loss in the mid to high speech frequencies 

 
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2. In addition to meeting current cochlear implant indications, subjects must also possess 
preoperative unaided hearing thresholds between 40 and 65 dB HL at 250 & 500Hz in 
the ear to be implanted2  
a. Typical subjects will have the following audiometric configuration:  
i. Low frequency (250 – 500 Hz): Thresholds between 40 and 65 dB HL, 
inclusively 
ii. Mid to High frequency (above 1500 Hz): Thresholds greater than or equal 
to 90 dB HL 
3. Fluent speaker in the local language used to assess clinical performance3 
4.7.2 Exclusion Criteria 
1. Evidence of hearing loss prior to 5 years of age 
2. Sensorineural severe-to-profound hearing loss greater than 20 years at ≥ 2 kHz and 
above 
3. Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to 
be implanted  
4. Medical or psychological conditions that contraindicate undergoing general anaesthesia 
or surgery 
5. Ossification, malformation or any other cochlear anomaly, such as common cavity, that 
might prevent complete insertion of the electrode array, as confirmed by medical 
examination 
6. Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or 
central auditory pathway 
7. Active middle-ear infection  
8. Tympanic membrane perforation  
9. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, 
and limitations that are inherent to the surgical procedure(s) and prosthetic devices as 
determined by the Investigator 
10. Unwillingness or inability of the candidate to comply with all investigational requirements 
as determined by the Investigator 
11. Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or 
CSF leak 
12. Patients with recurrent episodes of bacterial meningitis 
                                                             
2 If it is more than 90 days past the date of the Candidacy Evaluation, candidacy needs to be reconfirmed by 
repeating hearing threshold test measures at 250 and 500Hz. Any changes observed will need to be reviewed in 
consultation with the Sponsor prior to surgery occurring. If candidate is not currently aided in the ear to be 
implanted, documentation of previous hearing aid trial is required. 
3 As judged by the investigator i.e. able to complete the speech perception assessments tasks and questionnaires. 

 
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4.7.3 Number of subjects required 
The proposed study is designed to collect safety and efficacy data associated with CI532 
cochlear implantation and the feasibility of fitting of the acoustic component postoperatively in 
adults. The protocol describes a feasibility study within a single site and a limited number of 
subjects (up to 10 subjects). Based on the data collected in IDE G120234, assuming the 
observed mean and standard deviation for each 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 
25 subjects to be recruited into the study and implanted.   The planned sample size of up to 10 
subjects will not provide adequate power for the primary efficacy endpoints hence the proposal 
for a feasibility study design.   
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 three months to recruit up to 10 subjects at a single 
investigational site. The enrollment period may be extended if required.  
4.7.4 Criteria and procedures for subject’s withdrawal or discontinuation 
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 

 
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 
Voluntary decision to withdraw consent made by the subject4 
 
Investigator decision5 
 
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, IRB and FDA. 
During surgery, an alternative device (e.g., CI522 or CI512) may be implanted in subjects where 
there are substantial difficulties with the CI532.  These subjects will continue the clinical 
investigation and their outcomes will be compared to those subjects who received the CI532 
device. 
4.7.5 Subject replacement 
The total number of subjects proposed for this clinical investigation is up to 10.  If a subject 
withdraws pre-operatively, they will be replaced by a newly recruited subject who meets the 
selection criteria for participation. 
4.7.6 Point of enrollment 
Subjects are recruited to the study by the investigators usually during the course of medical 
consultation. Subjects will be sequentially enrolled once Cochlear Americas receives a properly 
executed Informed Consent form and has approved the preoperative candidacy evaluation. 
4.7.7 Total expected duration of the clinical investigation 
The total expected duration of the clinical investigation is 18 months. The total duration will be 
dependent on the ability to recruit the required number of subjects within the enrollment period.   
5 JUSTIFICATION FOR THE DESIGN OF THE CLINICAL INVESTIGATION 
A multi-center clinical early feasibility trial was performed with 17 cases being implanted with 
version 1 of the electrode array/sheath assembly (3). Electrode tip fold-over was identified in 
32% of cases and due to this complication, 23% of cases received a commercial back-up device 
(CI24RE(CA) or CI512). Complications were related to device deficiencies and surgical protocol 
deviations. Hearing preservation was generally poor and most subjects lost their residual 
                                                             
4 Withdrawal of consent is defined as the subject’s voluntary decision to revoke consent to continue 
participation in the study. 
5 Subject withdrawal from the study is defined as an Investigator decision. The Investigator may elect to 
withdraw a subject from the study at any time if he/she considers that remaining in the study 
compromises the patient’s health or if the Investigator considers the subject lost to follow-up. 
 

 
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hearing in the implanted ear. The participants recruited for the early feasibility trial met current 
local indications for a conventional implant. The inclusion criteria specified an unaided hearing 
threshold in the ear to be implanted of equal to or better than 80 dB HL at 500Hz. Speech 
perception in quiet and noise significantly improved pre-operatively-to-post-operatively. Follow-
up of these cases is now more than 5 years with no device related adverse events reported – all 
devices remain functional and in place.  
Rotation of the electrode in the sheath may have contributed to the adverse device effects seen 
in the early feasibility trial and lead to further sheath design by Cochlear Limited. Most of the 
development focussed on the sheath until version 4 where the sheath to guide-tube assembly 
was reconfigured to further improve handling and visibility. In the intermediate designs tip 
folding occurrence was reduced by removing rotation and finally by modification of the slit in the 
sheath.  The slit allows the sheath to be removed after the electrode is fully deployed.  The final 
version improved the stability of the sheath especially when some bending of the array and 
sheath occurs.   
Pre-clinical testing with the CI532 was performed with four versions of the electrode-sheath 
assembly over four rounds of formal temporal bone trials. The temporal bone data on the EA32 
(using the latest sheath design) shows perimodiolar positioning in a large majority of cases with 
a relatively low potential for intra-cochlear trauma shown by a dislocation rate of 3.3%.  Once 
use errors were taken into account the tip fold-over rate was 3/110 or <3%.   
Currently, an outside the United States (OUS) multicenter clinical investigation is being 
undertaken to determine if a low rate of dislocation can be achieved in clinical cases.  Fourteen 
adult candidates have been successfully implanted with the CI532 device (Melbourne, Australia 
and Las Palmas, Spain) at the time of this submission with no scala dislocation or electrode tip 
fold-over.  Due to early success in the positioning of the CI532 device, further clinical evaluation 
is warranted to assess the feasibility of accessing acoustic hearing postoperatively in a clinical 
population with greater potential to preserve residual hearing.  
The primary objectives of the clinical investigation is to 1) evaluate preoperative to 6 months 
post-activation performance outcomes in the best unilateral listening condition using AzBio 
Sentences in speech-weighted noise (SWN) and 2) report the medical/surgical and device 
related adverse events compared to the current approved labelling with regard to type, 
frequency and seriousness at 6 months post-activation. In order to demonstrate the atraumatic 
nature of the CI532 electrode design and insertion technique, as well as the possibility of fitting 
of the acoustic component postoperatively, the inclusion criteria has been structured to capture 
subjects who currently meet the clinical criteria for cochlear implantation but who also possess 
unaided audiometric thresholds between 40 and 65 dB HL in the low frequencies.  The 
secondary objectives of this clinical investigation are to evaluate Patient Reported Outcomes 
(PRO) preoperatively to 6 months postactivation for the Speech Spatial and Quality of Hearing 
scale (SSQ) and the Glasgow Benefit Inventory (GBI) at 6 months postactivation. The outcomes 
from this feasibility study may be used to support the development of a randomized multicenter 

 
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clinical investigation evaluating the functional hearing preservation with the CI532 cochlear 
implant. 
6 CLAIMS AND INTENDED PERFORMANCE 
The claims and intended performance of the study device that are to be verified are: 
1. The number and percentage of subjects who were able to be fit with the acoustic 
component postoperatively. 
2. Pre-to-post performance benefits with the CI532 cochlear implant for speech 
recognition in the best unilateral listening condition. 
7 PROCEDURES 
7.1 
Medical history and Counseling  
Information regarding subject hearing-history (e.g., etiology, onset of hearing loss, duration of 
severe-to-profound hearing loss, amplification use) will be obtained and reported on the 
respective case-report form.  In addition, patients will be carefully and extensively counseled to 
ensure that their expectations from cochlear implantation are reasonable and appropriate (as 
determined by the Investigator). 
7.2 
Audiogram (Candidacy, Activation, 3, 6 and 12 months post-
activation) 
An unaided audiogram will be performed for both ears at Candidacy6, Initial Activation, 3, 6 and 
12 months post-activation at the following pure-tone frequencies: 
 
Air Conduction:  125, 250, 500, 750, 1000, 2000, 3000, 4000, 6000 & 8000 Hz  
Air conduction thresholds >80 dB HL at 125 Hz, >90 dB HL at 250 Hz, >100 dB at 80000Hz and 
>120 dB for other test frequencies will be marked NR (no response). Thresholds that exceed 
the air conduction limits of the audiometer, where the recipient reports feeling the acoustic 
stimuli, shall be recorded as vibrotactile (VT). 
 
Bone conduction: 1257, 250, 500, 750, 1000, 2000, 3000, 4000 Hz 
Bone conduction thresholds >20 dB HL at 125 Hz, >30 dB HL at 250 Hz, >60 dB HL at 500 Hz 
and >70 dB HL for other test frequencies will be marked NR (no response).  
                                                             
6 If it is more than 90 days past the date of the Candidacy Evaluation, candidacy needs to be reconfirmed 
by repeating audiometric threshold test measures. Any changes observed will need to be reviewed in 
consultation with the Sponsor prior to surgery occurring. 
7 Bone conduction measures at 125 Hz are optional based on potential audiometric equipment limitations. 

 
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An aided audiogram will be performed for both ears at candidacy, and the implanted ear at initial 
activation8, three, six and 12 months post-activation at the following frequencies using warble 
tones: 
 
Aided thresholds: 125, 250, 500, 750, 1000, 2000, 3000, 4000 Hz 
7.3 
Speech recognition (Candidacy, 3, 6 and 12 months post-
activation) 
Speech recognition will be measured pre-operatively, and at 3, 6, and 12 months post 
activation.  Pre-operatively, speech recognition will be evaluated in the unilateral aided condition 
with the contralateral ear masked or plugged. Post-activation, the best unilateral listening 
condition will be evaluated; “Implant ear” using the acoustic component and/or the CI SP alone 
on one ear with the contra-lateral ear plugged or masked.  If the subject uses the acoustic 
component, speech perception will also be completed as electric alone. Post-activation speech 
recognition will be evaluated with default input processing options. 
Assessment of speech perception in quiet will be measured using two lists of CNC monosyllabic 
word test (7) at 60 dBA in the S0 speaker orientation (Figure 2).  
Assessment of speech understanding in noise will be measured using a list of 20 sentences 
drawn from the AzBio sentences lists (8) at 60 dBA at a fixed +5 dB signal-to-noise ratio (SNR) 
in the S0N90 or S0N270 speaker orientation (Figure 2). The competing noise will be speech 
weighted noise (SWN).  
Test lists will be randomized throughout the clinical investigation in order to avoid learning 
effects. 
Performance benefits are change in scores pre- to post-operatively: 
1. Gain in speech recognition in quiet (% correct) 
2. Gain in speech recognition in noise (% correct) 
7.4 
Speech, Spatial, Qualities of Hearing Scale – SSQ (Candidacy & 
6 months post-activation) 
Subjective quality assessment will be measured using the SSQ preoperatively and again at 6 
months post-activation.  
Performance benefits are a change in scores pre- to post-operatively: 
1. Gain in SSQ score (-10 to +10) 
                                                             
8 Assessing aided thresholds after the initial activation will only be conducted if there is a shift in unaided hearing 
of more than 10 dB HL (for the better or worse) at two or more aidable frequencies. 

 
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7.5 
Glasgow Benefit Inventory – GBI (6 months post-activation) 
Health Utility assessment will measured using the GBI at six months post-operatively.  
Performance benefits are a change in scores pre- to post-operatively: 
1. GBI score (-100 to +100) 
7.6 
Surgical Questionnaire – Intraoperatively 
Surgical questionnaire will be completed by the implanting surgeon for each subject implanted.   
7.7 
Video (Surgery) 
Surgery may be recorded via a video camera connected to the surgeon’s microscope.   
7.8 
Imaging:  X-ray (Surgery) 
The presence of tip fold-over may be detected intra-operatively via planar X-ray, so that it may 
be corrected in-situ.  Consistent with the Nucleus® CI532 cochlear implant with Slim Modiolar 
electrode Physician’s Guide on page 81, an X-ray will be obtained prior to closure (preferably a 
lateral or modified Stenvers view) to confirm proper electrode placement.  
7.9 
Activation (approximately 1 month post-surgery) 
The CI532 cochlear implant will be activated with a commercially available Nucleus CP910 or 
CP920 Sound Processor and Custom Sound programming software.  This will take place 
approximately 1 month after surgery (plus/minus 2 weeks). 
Impedances and T/C levels will be collected during the visit.  These data will be extracted from 
anonymized computer record files (“CDX”) produced by the Custom Sound software. 
Initially the default ACE sound coding strategy will be used with the parameters pulse rate 900 
pps per channel, 25 µs / phase, mode MP1+2, and 8 maxima.  These parameters may be 
adjusted afterward according to local procedures to improve subjective sound quality, if deemed 
necessary by the clinician.  The sound processor should be loaded with the currently available, 
default input processing options. 
7.10 Device characteristics (Activation and 6 months post-activation) 
Device characteristics will be recorded at every post-activation visit and maintained within the 
subjects anonymous .cdx file.  
7.11  Safety 
The investigator will complete an Adverse Event (AE) and or Adverse Device Effect Case 
Report Form (AE and ADE CRF) if any AE or ADE is reported or observed for a subject during 
the investigation, even if they were acknowledged as risk factors in the Informed Consent Form. 

 
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7.12  Medical care post-investigation 
Routine medical care from the implanting center will be provided for the subjects during, as well 
as, after the clinical investigation has been completed. Subjects will be followed-up as per the 
centers standard clinical procedures. 
7.13  Monitoring Plan 
The sponsor will appoint appropriately trained monitors to review the progress of the study and 
assure the quality and integrity of data accumulated. Clinical monitors, as representatives of the 
Sponsor, have the obligation to provide site qualification and initiation visits as well as regular 
site visits.  The study monitors will be employees of the sponsor, Cochlear Americas, or any 
contracted vendors qualified by experience and training to conduct study site monitoring for this 
investigation. 
Study monitors, employed by Cochlear Americas, for this study will be: 
Ginger Grant, AuD 
13059 E Peakview Avenue 
Centennial, Colorado 80111 
Kimberly Nix, AuD 
13059 E Peakview Avenue 
Centennial, Colorado 80111 
Lori O’Neill, AuD 
13059 E Peakview Avenue 
Centennial, Colorado 80111 
Megan Mears, AuD 
13059 E Peakview Avenue 
Centennial, Colorado 80111 
Samantha Albawab, CRA 
13059 E Peakview Avenue 
Centennial, Colorado 80111 
Shanell Laner 
13059 E Peakview Avenue 
Centennial, Colorado 80111 
 
All data generated during this study and the source documents from which they originated are 
open to inspection by the Sponsor or its representative, the FDA, and other regulatory agencies. 
The Study Monitor will ensure study conduct is within compliance with regional requirements 
and ISO14155, where applicable.  
Source documents are defined as any printed, optical or electronic document containing source 
data (hospital records, audiograms, speech test results, laboratory notes, device accountability 
records, radiographs, records kept at the investigational site) containing data necessary for the 
reconstruction and evaluation of the clinical investigation. The extent of source data verification 
is defined in the Monitoring Plan. The investigator shall provide all requested documentation in a 
timely and organized manner. 
The investigator has to inform the Sponsor about any additional local requirements that may 
impact the work of a monitor especially if access to source data may be limited by local 
regulations. This is to ensure any necessary action to be taken before the study start to allow 
proper monitoring according to regional requirements and the ISO Guidance, where applicable. 

 
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The Study Monitor shall inform the Sponsor about any problems relating to facilities, technical 
equipment or medical staff at the study site. The Study Monitor shall provide the CPM with 
written reports, after each visit or contact with the investigational site. 
Upon completion of the study, the clinical monitor will conduct a study close-out of the 
investigational site.  The objectives of this visit are to ascertain that all subjects are accounted 
for, that the regulatory records and reports are complete, verify that study device and other 
supplies have been accounted for and ensure that the Investigator is aware of his/her 
responsibilities post-study. 
8 REPORTING PROCESS FOR ADVERSE EVENTS, ADVERSE DEVICE 
EFFECTS AND DEVICE DEFICIENCIES 
8.1 
Definitions 
All definitions are according to the EN ISO 14155:2011 standard. 
8.1.1 Adverse event (AE) 
Any untoward medical occurrence, unintended disease or injury, or untoward clinical signs 
(including abnormal laboratory findings) in subjects, users or other persons whether or not 
related to the investigational medical device.  
NOTE 1 This definition includes events related to the investigational medical device or the 
comparator. 
NOTE 2 This definition includes events related to the procedures involved.   
NOTE 3 For users and other persons, this definition is restricted to events related to 
investigational medical devices. 
8.1.2 Adverse device effect (ADE) 
Adverse device effect is an adverse event related to the use of an investigational medical 
device. 
NOTE 1 This includes any adverse event resulting from insufficiencies or inadequacies in the 
instructions for use, the deployment, the implantation, the installation, the operation, or any 
malfunction of the investigational medical device. 
NOTE 2 This definition includes any event resulting from use error or from intentional misuse of 
the investigational medical device. 
8.1.3 Device deficiency (DD) 
A device deficiency is an inadequacy of a medical device with respect to its identity, quality, 
durability, reliability, safety or performance. 
NOTE Device deficiencies include malfunctions, use errors, and inadequate labelling. 

 
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8.1.4 Serious adverse event (SAE) 
A serious adverse event is any adverse event that: 
1) led to a death, 
2) led to a serious deterioration in the health of the subject that either resulted in 
a) a life-threatening illness or injury, or 
b) a permanent impairment of a body structure or a body function, or 
c) in-patient hospitalization or prolonged hospitalization, or 
d) medical or surgical intervention to prevent life-threatening illness or injury or permanent 
impairment to a body structure or a body function, 
3) led to fetal distress, fetal death or a congenital abnormality or birth defect 
NOTE Planned hospitalization for a pre-existing condition, or a procedure required by the CIP, 
without serious deterioration in health, is not considered a serious adverse event. 
8.1.5 Unanticipated adverse device effect (UADE) 
An unanticipated serious adverse device effect is a serious adverse device effect which by its 
nature, incidence, severity or outcome has not been identified in the risk analysis report (for the 
investigational device or its comparator). 
8.2 
Reporting process for adverse events  
8.2.1 Unanticipated Adverse Device Effects 
Unanticipated adverse device effects (UADEs) must be reported directly to the clinical center’s 
reviewing IRB and the Sponsor, Cochlear Americas, within 10 working days of knowledge of the 
event, or as dictated by the specific IRB policy, whichever is sooner. Information regarding the 
UADE will be recorded on the Unanticipated Adverse Device Effect Report, provided with the 
CRFs for the study. 
8.2.2 Adverse Event Follow-up 
All AEs must be followed until resolution, or the condition stabilizes. The Investigator is 
responsible to ensure that follow-up includes any supplemental investigations as may be 
indicated to elucidate as completely as possible the nature and/or causality of the AE. This may 
include additional laboratory tests or investigations, or consultation with other health care 
professionals. Cochlear or its designee may request that the Investigator perform or arrange for 
the conduct of supplemental measurements and/or evaluations. AE follow up information will be 
recorded using a Follow Up to a Previously Reported Adverse Event Questionnaire, provided 
with the CRFs for the study. 

 
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8.2.3 Sponsor’s Responsibilities 
All AE, DD and SAEs will be reported in the Annual Progress Report (APR) to FDA in 
accordance with the IDE regulation [FDA 21 CFR Part 812.150(b)(5)].  
All unanticipated adverse device effects (UADEs) will be reported to FDA within 10 calendar 
days of the event in accordance with FDA 21 CFR Part 812.46(b) and 812.150(b)(1).  
Cochlear Americas or its designee will notify all participating Investigators of any new 
information that alters the current risk-benefit assessment of the study device or that would be 
sufficient to consider changes in management of the Nucleus cochlear implant or in the overall 
conduct of the trial. 
8.3 
Data Monitoring Committee 
No DMC will be established. 
9 STUDY COMPLETION 
9.1 
Completed Subjects 
Each subject in the study will be considered completed when all assessments through 12 
months post-activation have been performed in accordance with the study protocol.  To be 
considered a primary endpoint success at 6 months postactivation, subjects must retain their 
originally implanted device. 
9.2 
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 subject9 
 
Investigator decision10 
                                                             
9 Withdrawal of consent is defined as the subject’s voluntary decision to revoke consent to continue participation 
in the study. 
10 Subject withdrawal from the study is defined as an Investigator decision. The Investigator may elect to withdraw 
a subject from the study at any time if he/she considers that remaining in the study compromises the patient’s 
health or if the Investigator considers the subject lost to follow-up. 

 
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 
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, IRB and FDA. 
9.3 
Premature Study Termination 
The Sponsor reserves the right to discontinue the study for any safety, ethical or administrative 
reason at any time. Subjects already implanted with the device being studied will continue to be 
supported, independent of any decision made about study continuation. 
10 STATISTICAL CONSIDERATIONS 
All subjects who are recruited to the clinical investigation 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).  
As this is a feasibility clinical investigation, there have been no formal power or sample size 
estimations performed for the primary objectives. The intent of the proposed investigation is to 
establish preliminary safety and effectiveness data. There are no pass/fail criteria to be applied 
to the results of the clinical investigation. 
10.1 Efficacy Measurements 
At a minimum, individual data will be tabulated and summarized for all measures to establish 
the proportions of those subjects showing improvement, no change, and decrement in 
performance.  
The efficacy objectives include: 
a) To understand if subjects implanted with the CI532 can retain low frequency thresholds and 
be fit with the acoustic component  
Audiometric data will be collected and acoustic fittings will be tracked at each follow up time 
point. For those fit with the acoustic component, outcomes will be assessed with and without the 
acoustic component.  
b) To understand if implantation with the CI532 results in improved postoperative speech 
perception outcomes in both quiet and noise when using the best unilateral listening 
condition 
                                                             
 

 
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Device efficacy will be evaluated by comparisons of group and individual performance pre- and 
postoperatively at 3, 6, and 12-months post-activation. Performance benefits are change in 
scores pre- to post-operatively: 
 
Gain in speech recognition in quiet on CNC words (% correct) 
 
Gain in speech recognition in noise on AzBio Sentences (% correct) 
c) To understand if implantation with the CI532 results in improved patient reported hearing 
performance and health utility 
Scores from the SSQ obtained postoperatively will be compared with those obtained 
preoperatively, prior to implantation. The SSQ will act to provide a measure of hearing 
performance as perceived by the subjects. The GBI will provide a measure of change in health 
status as a result of cochlear implantation. Since the GBI is structured as a post-intervention 
(change) metric, there will be no preoperative measures derived for comparison with 
postoperative scores. 
10.2 Safety Measurements 
No formal statistical hypothesis will be tested. The number and percent of patients with adverse 
events will be reported and tabulated, including the number and percentage of tip fold overs. 
Adverse events will be summarized by event type, severity, seriousness, as well as relatedness 
to the device and implant procedure. Since the proposed study involves a limited number of 
subjects, group analyses are not planned.  
10.3 Baseline Characteristics 
The characteristics of the study group will be presented descriptively. Quantitative variables 
such as age will be presented with mean, standard deviation, median, minimum and maximum 
and 95% CI. Qualitative variables such as age or gender will be presented as percentages and 
observed frequencies. If differences in outcome are found for subgroups defined by baseline 
age or gender, analyses will be performed to explore the possible role of other baseline 
characteristics to explain the results. 
10.4 Missing Data  
All efforts will be put forth to ensure near complete follow-up, with particular focus on the 
assessment of the primary outcomes and occurrence of adverse events. A reminder of subject 
follow-up due date will be provided to participating centres to facilitate scheduling of the follow-
up visit.  
In the event a subject is withdrawn prior to the six month post-activation assessment, the 
analysis of the primary endpoint will involve imputing the last data point captured (candidacy, 
activation or 3 months post-activation) for the six month post-activation assessment. The p-
value for the primary statistical hypothesis tests will be calculated using this imputation to 
understand the impact of missing data on the primary results. 

 
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11 RISKS AND BENEFITS OF THE STUDY DEVICE AND CLINICAL 
INVESTIGATION 
For this clinical investigation, safety will be defined as freedom from device or procedure-related 
adverse events compared to the commercially available Cochlear Nucleus CI24RE. Additionally, 
the number and percentage of tip fold overs as confirmed by intraoperative x-ray will be 
reported.  
11.1 Anticipated clinical benefits 
Analysis of the final positions of EA32 electrode in temporal bones, as reported above in 
Section 5, revealed a low incidence of intra-cochlear trauma shown by a dislocation rate of 
3.3%.  The absence of dislocation is correlated with higher speech recognition scores (1, 4).  In 
addition, close proximity of the electrode array to the medial wall is correlated with higher 
speech recognition scores (1).  In both temporal bones and in the previous early feasibility 
study, the thinness of the pre-formed EA32 array gave in most cases wrapping factors of ~0.5 
as estimated from images of temporal bones – this is at the best-performing end of the 
distribution presented by Holden et al. (1) Therefore due to low potential for trauma and close 
proximity of electrode contacts to the modiolus, we expect a high clinical benefit for patients 
from the CI532. 
11.2 Anticipated adverse device effects 
Subjects are exposed to the anticipated adverse device, and or procedure related effects 
associated with standard cochlear implant surgery and general anaesthesia. 
Adverse effects associated with any cochlear implant are: 
 
Individuals are exposed to the normal risks associated with surgery and general 
anaesthesia. 
 
 
The surgical procedure may result in infection or bleeding, numbness or stiffness about 
the ear, injury to or stimulation of the facial nerve, taste disturbance, dizziness, increased 
tinnitus, neck pain, or perilymph fluid leak. Inner ear fluid leak may result in meningitis. 
 
 
The cochlear implant results in a palpable lump under the skin just behind the ear. The 
presence of a foreign body under the skin may cause irritation, inflammation or breakdown 
of the skin and, in some cases, extrusion of the device. The electrode array may migrate 
partially or completely out of the cochlea, resulting in decreased hearing ability. The 
electrode lead may perforate structures of the external ear, such as the tympanic 
membrane or canal wall. Misplacement of the electrode array may result in the perception 
of non-auditory sensations. Such complications may require additional medical treatment, 
surgery and/or removal of the device. 
 
 
Electrical stimulation may result in increased tinnitus, facial nerve stimulation, dizziness or 
pain. 
 
 

 
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 
Individuals who have residual hearing in the ear selected for the cochlear implant have a 
slightly greater risk of short-term postoperative dizziness than individuals with no residual 
hearing in that ear. 
 
 
The long term effects of electrode insertion trauma or from chronic electrical stimulation 
are unknown. Such effects may include new bone growth in the cochlea or deterioration 
of the nerve cells. These effects may preclude replacement of the electrode array or may 
lead to eventual deterioration of cochlear response. 
 
 
Failure of component parts (both external and internal) could result in the perception of an 
uncomfortably loud sound sensation or no sound. Failure of various component parts of 
the implanted device could require removal or replacement of the implant, or a reduction 
in the number of electrodes used. 
 
 
Inserting the electrode into the cochlea may result in a partial or complete loss of residual 
hearing in the implanted ear. 
Residual risks for the study device compared to a similar device, such as the Nucleus CI512, 
relate to use errors which may increase the risk of tip fold-over.  It should be noted that tip 
folding is not unknown in similar pre-curved arrays or in straight arrays. The presence of a tip 
fold-over does not usually produce any untoward clinical symptoms however; it is likely that the 
distribution of current produced by the electrode array would be perturbed such that 
performance outcomes could be limited. 
All residual risks for the device will be described within the Informed Consent. 
11.3 Risks associated with participation in the clinical investigation 
There are no anticipated adverse reactions specific to the study device other than those usually 
associated with cochlear implantation (as listed above) and concomitant medical treatments (2). 
11.4 Risk mitigation 
Tip fold-over of the array may necessitate re-implantation.  Tip fold-over is typically detected via 
imaging.  In this case, the EA32 electrode may be removed from the cochlea, re-loaded and re-
inserted or alternatively, the CI532 device may be explanted and replaced with the back-up 
device. 
More detail on device specific risks and how they are mitigated may be found in the  Physician’s 
Guide (2). All surgeons will receive surgical training in the use and handling of the CI532 
cochlear implant as part of study initiation. In addition, Cochlear surgical support may be 
present during surgeries performed by the investigational site. 
11.5 Risk-to-benefit rationale 
The improved likelihood of correct scala tympani placement, increased proximity to the 
modiolus, and reduced potential for trauma for the CI532 may provide better access to residual 

 
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hearing postoperatively for patients with moderate levels of preoperative hearing compared to 
the existing CI512 or CI24RE(CA) implants equipped with CA electrode arrays. 
In conclusion, the risk benefit ratio of participating in this study is similar to the risk benefit ratio 
of receiving treatment with a commercially approved Nucleus cochlear implant. 
 
12 GOOD CLINICAL PRACTICE 
12.1 Declaration of Helsinki and compliance with standards 
The clinical investigation shall be conducted in accordance with the ethical principles that have 
their origin in the Declaration of Helsinki (2013), the ISO 14155:2011 Standard and any regional 
or national regulations, as appropriate. 
12.2 Institutional Review Board (IRB) 
Prior to the initiation of the study, the Protocol, the Informed Consent Form, and other 
supporting documentation must be submitted to the Institutional Review Board (IRB) for 
approval after FDA conditional or final approval. A copy of the IRB approval letter for the 
Protocol, the Informed Consent, and the Protocol Signature page must be submitted to the 
Sponsor prior to the consent of the first subject.  The study site must maintain an accurate and 
complete record of all reports, documents, and other submissions made to the IRB concerning 
this protocol.  
A list of the IRB members, their titles or occupations, and their institutional affiliation, or an IRB 
assurance number and their contact information must be provided to the Sponsor or its 
designee prior to release of study supplies. Additionally, the Chair of the IRB must be identified.  
FDA/relevant health authority regulations require that all advertisements for subject recruitment 
be approved by an IRB prior to implementation. The complete text and format must be 
submitted to the Sponsor or its designee for approval prior to IRB submission. 
13 QUALITY CONTROL AND ASSURANCE 
Sponsor employees and/or their contracted representatives utilize Standard Operating 
Procedures (SOP) designed to ensure that clinical study procedures and documentation are 
consistently conducted/prepared to the highest quality standards.  Safety data adjudication will 
be conducted by the Sponsor’s Chief Medical Officer, in accordance with these SOPs.  These 
SOPs require compliance with federal regulations and Good Clinical Practice guidance.   
14 INFORMED CONSENT PROCESS 
A sample informed consent form containing the required elements of informed consent is 
provided by the Sponsor once FDA approved. Any changes made to this sample must be 

 
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approved by the Sponsor, or its designee, prior to submission to an IRB. After approval by the 
Sponsor, the informed consent must be submitted to and approved by an IRB. 
14.1 Obtaining informed consent 
It is the responsibility of the investigator to inform each subject prior to the initial study 
evaluation, of the purpose of this clinical trial, including possible risks and benefits, and 
document the informed consent process in the subject’s chart. The investigator shall obtain 
written informed consent using an approved Informed Consent Form from the subject prior to 
any clinical investigation related examination or activity. Ample time shall be provided for the 
subject to inquire about details of the clinical investigation and to decide whether to participate. 
All questions about the clinical investigation shall be answered to the satisfaction of the subject 
or the subject’s legally acceptable representative. Subjects shall not be coerced or unduly 
influenced to participate or to continue to participate in a clinical investigation. 
Each subject and the person who conducted the informed consent discussion shall sign and 
date the informed consent. Where required, a witness shall sign and personally date the 
informed consent. 
A copy of the signed informed consent shall be given to the subject. The other original signed 
consent shall be archived in the Investigator’s File at the investigational site, according to the 
requirements of the country’s health regulations, but for at least 2 years after shipment and 
delivery of the last device for study use and FDA/health authorities or regulatory agencies have 
been notified of study closure. 
The subject or the subject’s legally authorized representative shall be informed in a timely 
manner if new information becomes available that may be relevant to the subject’s willingness 
to continue participation in the clinical investigation. The communication of this information shall 
be documented. 
In circumstances where the subject is unable to give informed consent (e.g. surgical 
complications requiring the use of a back-up CI422 device), the informed consent of the 
subject’s legally authorized representative, if present, shall be requested. 
14.2 Confidentiality 
In accordance with Good Clinical Practices (GCPs) and with the Health Insurance Portability 
and Accountability Act of 1996 (“HIPAA”) all information concerning the subjects in the study 
must be treated as strictly confidential by all persons involved in the study. The investigator 
acknowledges that any and all information acquired from the Sponsor or its designee or 
developed or acquired in connection with the study are strictly confidential. The investigator will 
not disclose any confidential information to any third party nor use confidential information for 
any purpose without first obtaining the consent of Sponsor in writing. Such consent shall be 
deemed to have been given for disclosure to any person for whom the investigator is 
responsible at his/her center, but only so far as required for the purposes of the study, and, in 
the case of disclosures to staff, only if such staff are bound by obligations of confidentiality no 
less strict than those set out herein. 

 
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15 PROTOCOL AMENDMENTS AND DEVIATIONS 
The Sponsor will document modifications to the protocol in the form of a written amendment. 
Protocol modifications that impact subject safety or the validity of the study must be approved 
by the FDA and IRB before implementation.  
A protocol deviation refers to a study-related activity that is not in compliance with the 
investigational protocol.  Deviations that are required to protect the life or well-being of a subject 
do not require prior approval from the Sponsor and should be implemented immediately.  The 
IRB and Sponsor must be notified within 5 (five) days of the event. 
If a subject is unable to return for follow-up before the closure of a study visit window (+/- 30 
days for post-activation study visits), or if protocol defined assessments or parts thereof are 
omitted or completed incorrectly, the event is to be noted on the Protocol Deviation Log 
provided to the Investigator in the study Regulatory Binder.  Depending on the type or severity 
of the deviation the Investigator may be required to notify the IRB and/or Sponsor if the 
deviation impacts safety or performance of the subject or data integrity. 
16 DATA MANAGEMENT 
Data collection is performed through electronic data capturing (EDC) on eCRFs. All study data 
will be entered into an Electronic Database Capture (EDC) system. Site personnel will be 
trained on the completion of the eCRFs prior to obtaining their own Login/Password. Access to 
clinical study information will be based on an individual’s role and responsibilities.  
The application provides hierarchical user permission for data entry, viewing, and reporting 
options. For optimum security, all communications between the users and the EDC operate on a 
secured socket layer (SSL) using 256-bit encryption. Sponsor’s web servers are protected by a 
managed firewall from potential web and network attacks and the network is guarded by an 
intrusion detection and protection surveillance system against malicious threats. This application 
is designed to be in full compliance with International Conference on Harmonization and Good 
Clinical Practices (ICH-GCP), FDA CFR 21 Part 11 Electronic Record and Electronic 
Signatures, the FDA's “Guidance: Computerized Systems Used in Clinical Trials (May 2007), 
and the Privacy Rule of the Health Insurance Portability and Accountability Act of 1996 
(HIPAA).”  
The data quality assurance tool has been designed as an automatic feature of the EDC system. 
When a form is submitted the system conducts instantaneous validation and cross-form 
validation checks. A query is generated and sent to the site coordinator so that data may be 
verified and corrected. All changes made to a form are stored in an audit trail. Upon request 
investigators will be provided with site specific data (e.g. on a CD-ROM) for national and site 
specific archiving requirements. After the final progress report has been approved by the 
agency, the data are maintained with the trial master file at the sponsor’s site. The data are 
stored for at least 2 years after shipment and delivery of the last device for study use and 
FDA/health authorities or regulatory agencies have been notified of study closure. 

 
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In addition to the data collected on the eCRF, data is also to be collected through the clinical 
fitting software.  The file records shall be anonymized and unique alphanumeric code will 
identify the subject throughout the course of the study. For example, US01-532-0000, where: 
 
US = United States 
 
01 = a sequential numeral corresponding the order in which a subject is enrolled into 
the study for a given study site, in this case this would correspond to the first subject 
recruited into the study for a particular site, 
 
532 = an abbreviation for the study, in this case 532 for the CI532 implant, 
 
0000 = a unique, numeric study site identification. 
17 DEVICE ACCOUNTABILITY 
Study devices will be shipped with individual registrations cards indicating the study number. 
Devices should be registered by the clinic according to usual practice.    
18 VULNERABLE POPULATION 
Not applicable for this clinical investigation. 
19 RECORD KEEPING AND RETENTION 
Data generated for the study should be stored in a limited-access file area and be accessible 
only to representatives of the study site, the Sponsor and its representatives, and FDA/relevant 
health authorities/regulatory agencies. All reports and communications relating to study subjects 
will identify subjects only by subject unique identification code. Complete subject identification 
will be kept by the Investigator. This information will be treated with strict adherence to 
professional standards of confidentiality. 
An Investigator must in reasonable time, upon request from any properly authorized officer or 
employee of FDA/relevant health authority or regulatory agency, permit such officer or 
employee to have access to requested records and reports, and copy and verify any records or 
reports made by the Investigator. Upon notification of a visit by the FDA, the Investigator will 
contact the Sponsor or its designee immediately. The Investigator will also grant Sponsor 
representatives the same privileges offered to FDA/relevant health authority or regulatory 
agents/officers/employees. 
The Investigator must provide the Sponsor or its designee with the following documents at the 
time of site qualification and prior to study initiation and retain a copy in the site study file: 
 
Signed and dated curriculum vitae for the Principal Investigator. 
 
A copy of the original approval for conducting the study by the IRB. Renewals, with 
continuance of the study, must be submitted at yearly intervals or as required by IRB 
policy and a copy of the approved and dated renewal provided to the Sponsor. 
 
A copy of the IRB approved informed consent form along with any modifications initiated 
by the Sponsor over the course of the study. 
 
An IRB member list and Federal Wide Assurance (FWA) Number. 

 
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 
A signed Financial Disclosure Form for each Investigator. 
 
An Investigator Agreement for this protocol signed and dated by each Investigator. 
In addition to the documents listed above, the study site will also retain the following items and 
make them available for Sponsor review upon request.   
 
Certifications, applicable study equipment (audiometers, etc.) calibration records and 
laboratory reference ranges for all local laboratories used for this study. The Sponsor will 
verify all equipment requirements at the study qualification and/or initiation. Sites with 
outdated and/or non-compliant equipment will either not be approved for study 
participation or will be advised to discontinue study-related activities should non-
compliance be noted during regular study monitoring visits. 
 
All original informed consent forms with required signatures. 
 
All IRB correspondence (i.e., informed consent [including any approved revisions], 
protocol, AEs, advertisements, newsletters). 
 
Copy of the Study Monitoring Log Sheet. 
 
Clinical and non-clinical supply shipment forms and device accountability logs. 
 
Copies of all correspondence pertaining to the study between Sponsor and the site. 
 
Copies of all AE reports submitted to the Sponsor. 
 
Copies of all FDA progress reports submitted to the site by the Sponsor. 
 
Site Delegation Signature Log. 
All study-related records must be maintained for at least 2 years after a marketing application 
(PMA) is approved for the study device; or if the application is not approved, until at least 2 
years after shipment and delivery of the last device for investigational use is discontinued and 
FDA/health authorities or regulatory agencies have been notified of study closure. The Sponsor 
will notify the principal Investigator when records are no longer needed. The Investigator will not 
discard any records without notifying the Sponsor. If the Principal Investigator moves from the 
current investigational site, the Sponsor should be notified of the name of the person who will 
assume responsibility for maintenance of the records at the investigational site or the new 
address at which the records will be stored. The Investigator will notify the Sponsor as soon as 
possible in the event of accidental loss or destruction of any study documentation. 
20 PUBLICATION POLICY 
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.  

 
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The responsibility for writing the publication lies with the Principal Investigator. The publication 
shall be reviewed by the sponsor at least 30 days in advance to any release of publication. If the 
publication contains information that the sponsor at his discretion finds worth protecting in the 
form of a patent or trademark etc., the sponsor has the right to delay the publication or 
presentation.  
21 CHANGE HISTORY 
Version 
Change 
Author 
Date 
 
 
 
 
 
 
 
 
22 DEFINITIONS 
22.1 Definitions from ISO 14155:2011 
Term 
Description 
Adverse event (AE) 
Any untoward medical occurrence, unintended disease or injury, or 
untoward clinical signs (including abnormal laboratory findings) in subjects, 
users or other persons whether or not related to the investigational medical 
device. 
NOTE 1 This definition includes events related to the investigational medical 
device or the comparator 
NOTE 2 This definition includes events related to the procedures involved.   
NOTE 3 For users and other persons, this definition is restricted to events 
related to investigational medical devices. 
Adverse device effect 
(ADE) 
Adverse device effect is an adverse event related to the use of an 
investigational medical device. 
Note to the author:  
NOTE 1 This includes any adverse event resulting from insufficiencies or 
inadequacies in the instructions for use, the deployment, the implantation, 
the installation, the operation, or any malfunction of the investigational 
medical device. 
NOTE 2 This definition includes any event resulting from use error or from 
intentional misuse of the investigational medical device. 
Device deficiency (DD) 
A device deficiency is an inadequacy of a medical device with respect to its 
identity, quality, durability, reliability, safety or performance. 
NOTE Device deficiencies include malfunctions, use errors, and inadequate 
labelling. 
Incident 
Any malfunction or deterioration in the characteristics and/or performance of 
a device, as well as any inadequacy in the labelling or the instructions for 
use which, directly or indirectly, might lead to or might have led to the death 
of a subject, or USER or of other persons or to a serious deterioration in 
their state of health. 

 
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Term 
Description 
Serious adverse event 
(SAE) 
A serious adverse event is any adverse event that: 
a) led to a death, 
b) led to a serious deterioration in the health of the subject that either 
resulted in 
1) a life-threatening illness or injury, or 
2) a permanent impairment of a body structure or a body function, or 
3) in-patient hospitalization or prolonged hospitalization, or 
4) medical or surgical intervention to prevent life-threatening illness or 
injury or permanent impairment to a body structure or a body function, 
c) led to foetal distress, foetal death or a congenital abnormality or birth 
defect 
NOTE Planned hospitalization for a pre-existing condition, or a procedure 
required by the CIP, without serious deterioration in health, is not 
considered a serious adverse event. 
Serious adverse device 
effect (SADE) 
A serious adverse device effect is an adverse device effect that has resulted 
in any of the consequences characteristic of a serious adverse event. 
Unanticipated serious 
adverse device effect 
(USADE) 
An unanticipated serious adverse device effect is a serious adverse device 
effect which by its nature, incidence, severity or outcome has not been 
identified in the risk analysis report (for the investigational device or its 
comparator). 
22.2 Other definitions 
Term 
Description 
CA 
Competent Authority 
CER 
Clinical Evaluation Report 
EC 
Ethics Committee 
IB 
Investigator’s brochure is a compilation of the current clinical and non-
clinical information on the investigational device(s) relevant to the clinical 
investigation. 
ITT analysis 
The comparison of the treatment groups for all subjects as originally 
allocated after randomisation to avoid bias. 
NCA 
National Competent Authority 
PASS 
Post-authorization safety studies mandated by medical device regulators  
PIC 
Patient Informed Consent form 
PIL 
Principal Investigator List 
PMS 
Post-market surveillance studies 

 
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Term 
Description 
PP analysis 
The comparison of treatment groups that includes only those subjects who 
completed the treatment originally allocated according to the protocol (i.e. a 
complete dataset). This form of analysis is open to bias is it does not 
include comparison of treatment groups for all subjects enrolled into the 
investigation.  
 
23 REFERENCES 
23.1 Internal References 
ID 
Document Title 
Number 
 
 
 
 
 
 
 
 
External Reference List 
 
1. 
Holden LK, Finley CC, Firszt JB, Holden TA, Brenner C, Potts LG, et al. Factors 
affecting open-set word recognition in adults with cochlear implants. Ear Hear. 2013;34(3):342-
60. 
2. 
Cochlear. CI532 Physician's Guide. 
3. 
Knight M, Killian M. Clinical evaluation of the Modiolar Research Array Cochlear Implant. 
2015  Contract No.: 343015. 
4. 
Aschendorff A, Kromeier J, Klenzner T, Laszig R. Quality control after insertion of the 
nucleus contour and contour advance electrode in adults. Ear Hear. 2007;28(2 Suppl):75S-9S. 
5. 
Gatehouse S, Noble W. The Speech, Spatial and Qualities of Hearing Scale (SSQ). Int J 
Audiol. 2004;43(2):85-99. 
6. 
Robinson K, Gatehouse S, Browning GG. Measuring patient benefit from 
otorhinolaryngological surgery and therapy. Ann Otol Rhinol Laryngol. 1996;105(6):415-22. 
7. 
Peterson GE, Lehiste I. Revised CNC lists for auditory tests. J Speech Hear Disord. 
1962;27:62-70. 
8. 
Spahr AJ, Dorman MF, Litvak LM, Van Wie S, Gifford RH, Loizou PC, et al. 
Development and validation of the AzBio sentence lists. Ear Hear. 2012;33(1):112-7. 
9.  
Minimum Speech Test Battery (MSTB) User Manual (2011). 
http://www.auditorypotential.com/MSTBfiles/MSTBManual2011-06-20%20.pdf