The iotaSOFT Insertion System Safety Study
Phase: NA
Conditions: Cochlear Implant
Sponsor: iotaMotion, Inc.

The iotaSOFT™ Insertion System Safety Study 
iotaSOFT000001v1 
 
For internal use only 
 
 
 
 
 
 
 
Clinical Safety Investigation Plan/Protocol 
 
Protocol Title:  
 
 
The iotaSOFT™ Insertion System Safety Study 
 
Investigational Product:   
iotaSOFT™ Insertion System 
 
Sponsor:  
 
 
 
iotaMotion, Inc. 
14 ½ S Clinton St 
Iowa City, IA 52240 
United States 
Phone: 
Fax: 
 
Document Number: 
 
iotaSOFT000001 
 
Version Number:   
 
1.0 
 
Date:   
 
 
 
February 19, 2020 
 
Authors:  
 
 
 
Camille Dunn, Bruce Gantz 
 
 
 
Good Clinical Practices 
This study will be conducted under Good Clinical Practices in accordance with US FDA, 21 
CFR requirements for investigations of medical devices; in accordance with the Declaration of 
Helsinki; and in compliance with applicable Local and Federal Regulations. 
 
Confidentiality Statement 
This document contains confidential information of the Sponsor. This information is to be 
disclosed only to the recipient study staff and the Institutional Review Board or Institutional 
Ethics Committee reviewing this protocol. This information can be used for no other purpose 
than evaluation or conduct of this study without prior written consent from the Sponsor. 

The iotaSOFT™ Insertion System Safety Study 
iotaSOFT000001v1 
 
For internal use only 
 
Investigator Signature 
 
 
 
Protocol Title:  
 
 
The iotaSOFT™ Insertion System Safety Study 
 
Investigational Product:  
 
iotaSOFT™ Insertion System 
 
Protocol Number:   
 
iotaSOFT000001v1 
 
 
I confirm that I have read this protocol. I will comply with the protocol and the principles of 
Good Clinical Practice (GCP), as described in the United States Code of Federal Regulation 
(CFR) 21 Parts 50, 54, 56, and 812. 
 
 
 
Investigator Printed Name 
 
 
 
Investigator Signature 
 
 
 
 
 
Date 
 
 

The iotaSOFT™ Insertion System Safety Study 
iotaSOFT000001v1 
 
For internal use only 
 
1.  
SYSTEM OVERVIEW 
1.1  
The iotaSOFT™ Insertion System is an electrode array insertion tool that assists 
cochlear implant (CI) surgeons to insert CI electrode arrays with consistent insertion speed 
and force. The system consists of a single-use, sterile drive unit connected to a reusable, non-
sterile touch screen control console and footpedal interface (Figures 1, 2, & 3. See also 
Overview Video 1 and Attachment 1 Device Description). After standard mastoidectomy and 
facial recess approach for cochlear implantation, the surgeon secures the stage base to the 
skull at superior edge of mastoidectomy with two pre-loaded self-drilling bone screws (Figure 
3). The drive unit is placed into the stage base and the adjustable drive head is coupled to a 
compatible CI electrode. Using manual manipulation, the drive unit head is positioned outside 
the facial recess and aligned to the surgeon-desired electrode array insertion trajectory. Before 
insertion begins, the surgeon selects the desired speed from 0.1mm/sec to 1.0mm/sec in 
0.1mm/sec intervals. With direct access and view of the surgical site, the surgeon controls the 
electrode insertion forward and reverse motion via footpedal while guiding the electrode array 
into the cochlea with standard CI instrumentation as necessary. Upon the completion of 
electrode array insertion and securing the array at the cochlea, the drive head and unit are 
uncoupled from the electrode lead and removed from the patient for disposal. The surgical site 
is closed and CI procedure is completed in the standard fashion.
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
Figure 1. Photos of (Left) iotaSOFT™ Insertion System – Controller and Accessories with 
computer console, power supply, rolling stand, footpedal, and extension cables coiled on stand 
basket. (Right) iotaSOFT™ Drive Unit and screwdriver in sterile packaging tray after Tyvek 
cover and sterile tray cover removed. 

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Figure 2. Representative rendering of iotaSOFT™ Drive Unit with parts labelled. 
Figure 3. iotaSOFT™ Drive Unit at edge of mastoidectomy during insertion into cadaveric cephalus 
(bottom) and computer render (top). (Left) iotaSOFT™ Drive Unit secured at edge of mastoidectomy 
and electrode engaged in drive head outside the facial recess as intended during use. (Right) Closer 
view of surgical site showing view of round window is not inhibited by device when in position.  

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2.  
BACKGROUND 
2.1   360 million people worldwide, or 5% of the global population, have disabling 
hearing loss (>40 dB). Moderate to severe hearing loss affects 6.3 million patients in the 
US, yet only 5-6% of people who meet CI candidacy criteria receive a CI.1 The number of 
patients that could benefit from a CI is expected to dramatically rise which makes 
improving patient access to CI interventions of the utmost importance. 
2.2.   Since the first description of “atraumatic” insertion techniques in 1993,2 numerous 
studies have shown that trauma to the cochlea during electrode insertion results in 
damage to delicate inner ear structures, reduced implant performance, and the potential 
loss of residual hearing.3–7 While electrode array insertion technique has been shown to 
play a critical role in implant performance, the current standard of practice remains the 
use of manual forceps in which the inherent limitations of human kinematics makes slow 
and steady insertions difficult to achieve in a consistent manner.8 Alternatively, there are 
dedicated implant-specific manual insertion tools which have limited to no ability to 
precisely control the insertion speed or insertion force variability. Therefore, there is a 
clear need for an insertion tool that performs slow and steady insertions for a more 
standardized and controlled technique. 
2.3.   Studies evaluating the effect of electrode array insertion speed on insertion forces have 
shown that greater speeds directly correlate with greater intracochlear forces.9,10 Further, 
multiple studies demonstrate that high insertion forces damage the delicate structures of the 
cochlea, limiting CI performance and increasing the likelihood of the loss of residual hearing.11–
13 High insertion speeds have also been shown to increase the prevalence of intracochlear 
pressure spikes which can cause damage to the inner ear similar to loud noise exposure.14–16 
 
2.4  
Lastly, a clinical retrospective study evaluating CI recipients has shown that electrodes 
implanted at a “slow” manual speed (Average: 0.25mm/sec) experienced improved hearing 
preservation, decreased vestibular symptoms, and more complete electrode insertions 
compared to the “fast” speed (Average: 0.87 mm/sec).viii 
 
3.  
INTENDED/INDICATIONS FOR USE 
3.1   The iotaSOFT™ Cochlear Implant Electrode Insertion System is intended to aid the 
surgeon in placement of cochlear implant electrode arrays into a radiographically normal 
cochlea by controlling the speed of implant insertion.  
 
4.  
BENEFIT 
4.1 
The benefit of the iotaSOFTTM Insertion System is to provide the surgeon a 
standardized, more controlled, and consistent method of inserting the electrode array 
compared to manual insertion techniques. The system enables the surgeon to perform CI 
electrode array insertions more consistently and slowly than the capabilities of human motion. 
Literature shows consistent and slow insertions decrease the risk of additional hearing loss or 
vestibular symptoms from inherently uncontrolled, variable, and excessively forceful manual 
insertions.12 The iotaSOFTTM Insertion System also provides consistency of electrode array 
insertions among different ENT surgeons, helping to ensure that each patient receives an 

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equally slow and consistent insertion regardless of the surgeon performing the procedure or 
the electrode array used.  
4.2. Known risks associated with manual cochlear implantation (the current gold standard) 
include electrode translocation, electrode tip fold-over, incorrect placement of electrode array, 
loss of residual hearing, and/or vestibular symptoms. Currently, experienced CI surgeons 
mitigate these risks by performing slow and steady atraumatic CI insertion techniques by hand. 
The iotaSOFTTM insertion system enhances the surgeon’s ability beyond the capability of 
human motion during the electrode insertion and therefore has the potential to reduce the 
current risk profile inherent in the standard CI surgical procedure.  
4.3. Similarly, by giving each ENT surgeon more confidence in their ability to insert electrode 
arrays with less variability during CI surgery, the system has the potential to expand patient 
access for those with severe hearing loss in which less than 5% of eligible patients receive a 
CI.  
5.0 
RISK 
5.1.  The risk profile of the iotaSOFTTM Insertion System is predicated on the fact that the 
vast majority of the CI implantation procedure remains unchanged from manual CI insertion 
techniques. Likewise, the critical risks associated with use of the iotaSOFTTM Insertion System 
are also associated with manual insertion, meaning the iotaSOFTTM Insertion System does not 
add critical risk to the surgical procedure. Use of the device also does not prevent a surgeon 
from stopping at any time and immediately reverting to manual insertion techniques, and 
therefore the risk to the patient does not exceed the current gold standard of care. 
Nonetheless, all risks related specifically to the iotaSOFTTM Insertion System have been 
reduced to the lowest probabilities (<10-5) and have been mitigated by device design 
verification and validation by iotaMotion. A list of all potential patient risks, their severity, and 
the mitigation steps taken is outlined in Table 1.   
 
Table 1. Potential patient risks and mitigation actions 
Potential Risk (Harm) 
Severity 
Mitigation Completed 
Device fragments in patient  
Serious 
Device Functional Testing  
Electric shock not resulting in death  
Critical 
Electrical Safety Testing  
Environment Harm (Limited) - simple 
contamination, localized effects of short 
duration  
Minor 
Labeling  
Inconvenience or temporary discomfort.  
Customer dissatisfaction where there is no 
injury.  
Negligible 
Electrical Safety Testing  
Labeling  
Irritation / inflammation of surgical site 
(permanent)  
Critical 
Biocompatibility Testing  
Patient or user infection or cross infection 
(biosafety)  
Critical 
Sterilization Testing  
Packaging Validation  
Device Functional Testing  
Usability Study  

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Prolonged operative/ anesthesia time due 
to delay during surgery  
Minor 
Device Functional Testing  
Labeling  
Usability Study  
Electrical Safety Testing  
Prolonged operative/ anesthesia time due 
to delay during set up  
Negligible 
Electrical Safety Testing  
Electromagnetic 
Compatibility Testing  
Labeling  
Temporary discomfort  
Negligible 
Device Functional Testing  
Unintended thermal tissue damage; no 
intervention required  
Minor 
Electrical Safety Testing  
Device Functional Testing  
Severity Rating 
Catastrophic 
Results in patient death 
Critical 
Results in permanent impairment or life-threatening injury 
Serious 
Results in injury or impairment requiring professional medical intervention 
Minor 
Results in temporary injury or impairment not requiring professional 
medical intervention 
Negligible 
Inconvenience or temporary discomfort 
 
5.2.  In addition to the testing listed as device-specific mitigations above, the device was 
evaluated against the current techniques to ensure no new risks (not listed above) were added 
by the use of the iotaSOFTTM Insertion System. The current known risks associated with 
manual cochlear implantation, including electrode translocation, electrode tip fold-over, 
incorrect placement of electrode array, loss of residual hearing, or vestibular symptoms, are 
currently attempted to be reduced by experienced CI surgeons performing slow and steady 
atraumatic CI insertion techniques by hand. The iotaSOFTTM insertion system enhances the 
surgeon’s ability beyond the limits of human motion capabilities during CI insertions and 
therefore has the potential to reduce the current risk profile inherent in the standard CI surgical 
procedure. In summary, the risks associated with the iotaSOFTTM Insertion System have been 
successfully mitigated and are no worse than manual insertion. This conclusion was also 
supported by the results of the Cadaveric Comparative Analysis (see 6.1.3 Summary below 
and Attachment 4 for full report). 
6 
RISK MITIGATION – SUPPORTING DATA SUMMARY 
6.1.  As part of the overall risk mitigation, the iotaSOFTTM Insertion System was tested for 
functionality and safety in four categorical testing protocols and reports.  Results are included 
in Attachments 2-5 and summarized briefly here.  
6.1.1.  Bench Performance Testing Report (Attachment 2 – Doc #720-036-0031) 
This report verified the functionality of the system according to design inputs following 
simulated transportation and distribution and accelerated aging. The specific device 
requirements that were tested include: 
6.1.1.1. The device performs to the desired speed (selected between 0.1mm/s and 
1.0mm/s) within 20%.  

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6.1.1.2. The device can overcome electrode slip forces of at least 80mN.  
6.1.1.3. The device has maximum insertion forces and insertion force variation 
significantly less than the literature derived manual insertion forces and force 
variation, <300mN and ≤400mN/sec respectively.  
6.1.1.4.  Forces imparted by the device during sheath removal following electrode 
insertion measured <100mN to ensure the device does not cause the electrode 
to dislodge during device removal.  
6.1.1.5.  Forces imparted by the device on the electrode measured significantly less 
than the maximum pinch force a surgeon could impart on the electrode using a 
pad pinch and forceps.  
6.1.2.  Benchtop Comparative Analysis Report (Attachment 3 – Doc #722-036-0021) 
This engineering study compared the insertional force profiles obtained when inserting 
cochlear implant electrodes into synthetic cochleae using either manual technique or the 
iotaSOFTTM insertion system.  Results showed that: 
6.1.2.1.  The average insertion force variation for iotaSOFTTM driven electrode arrays 
was 78% lower than the average insertion force for manually inserted 
electrodes at 0.1mm/sec and 70% lower at 1.0mm.sec. These comparisons 
were both significantly different (p≤0.007).  
6.1.2.2.  The average of maximum insertion force for iotaSOFTTM driven electrode 
arrays was significantly lower than average of maximum insertion force for 
manually driven electrodes (p<0.05); for both insertion rates, a 51% and 32% 
reduction at 0.1mm/sec and 1.0mm/sec, respectively, was observed.  
6.1.2.3.  The iotaSOFTTM insertion system performed electrode array insertions with a 
lower variance of insertion force and force variation compared to manual 
surgeon insertions across surgeon skill levels. The total variance (cluster + 
residual) for the insertion force variation using the iotaSOFTTM assisted 
insertion was 186% and 190% lower than manual insertions for 0.1 and 
1mm/sec respectively. Similarly, the maximum insertion force total variance for 
iotaSOFTTM assisted insertion was 190% and 188% lower compared to manual 
insertions across varying surgeon experience levels at both 0.1 and 1 mm/sec 
insertion rates, respectively.  
 
6.1.3.  Cadaveric Comparative Analysis Report (Attachment 4 – Doc #722-036-0020) 
This report evaluated the effect of the iotaSOFT insertion system on the final intracochlear 
electrode array position and electrode functionality compared to manual insertion of cochlear 
implant electrode arrays in cadaveric cochleae during simulated operative use. Results 
showed that: 
6.1.3.1.  When compared directly to manual insertions, the iotaSOFT™ insertion system 
electrode insertions exhibited a lower percentage of intracochlear scala 
translocations, though the result was not statistically significant. 
6.1.3.2.  A lower percentage of tip fold-overs was also observed with the iotaSOFT™ 
insertion system electrode insertions when compared to manual electrode 
insertions, though this result was also not statistically significant. 

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6.1.3.3 A lower percentage of tip fold-overs was also observed with the iotaSOFT™ 
insertion system electrode insertions when compared to manual electrode 
insertions, though this result was also not statistically significant. 
 
6.1.4.  Usability Validation Report (Attachment 5 – Doc #712-036-0010) 
The Usability Study assessed the occurrence of use errors related to the device. 16 ENT 
Surgeon/Nurse teams (in which the surgeons had completed a training session and training 
decay time) performed an CI implantation into a cadaveric cephalus in a simulated use 
environment. Test engineers observed insertions and noted any use errors, and user 
comments including a questionnaire and scoring table were collected. Results showed that: 
6.1.4.1.  Harms associated with the use errors found in the study were minor: prolonged 
operative/anesthesia time due to delay during surgery and prolonged 
operative/anesthesia time due to delay during set up. These minor potential 
harms were associated with use errors witnessed in a small percentage of 
users and tasks and were mitigated with a design change (eliminating the 
difficulties experienced with the device screwdriver) and updates to items 
emphasized in training. The residual use-related risk was minor and could not 
be further reduced with additional mitigations. 
6.1.4.2.  For all tasks, the use errors found could not lead to serious patient harm and no 
risk mitigations would lead to the reduction of overall or individual risks. The 
Usability results support that the iotaSOFTTM Insertion System is safe and 
effective for use by the intended users in a hospital setting. Surgeons can 
successfully use the iotaSOFTTM Insertion system to aid in placement of the 
electrode into the cochlea with nurse staff support.  
 
7. CONCLUSION  
The benefits of the device outweigh the minimal risks associated with the device. The 
iotaSOFTTM Insertion System provides the benefit of a 70% reduction in insertion force, 30% 
reduction in force variation (jerk), 180% reduction in variation between insertions with different 
surgeons or with different electrodes, and reduction in occurrence of electrode scala 
translocations and tip fold-over when compared to manual insertion. Furthermore, the 
iotaSOFTTM Insertion System is not statistically different than standard manual insertion 
techniques related to insertion angle, intracochlear scala position, and electrode electrical 
functionality. The risks associated with the device are not a significant clinical risk and are 
further mitigated by device completed design verification and validation testing as well as 
training provided to surgeons before the device can be used on patients.  
  
8.  
STUDY PURPOSE AND ASSESSMENT  
8.1  
Study Purpose. The purpose of the proposed study is to evaluate safety of the 
iotaSOFTTM Insertion System when used by a surgeon to assist with inserting a cochlear 
implant electrode array. We will evaluate for successful device use during electrode array 
insertion via a surgeon questionnaire regarding device usability, monitor electrode array 
insertion time, assess CI electrode positioning or tip-fold-over by post-insertion X-ray, and 
measure electrode impedances and neural response telemetry at post-operative activation. A 

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set of relevant safety and effective use measures will be collected, and adverse events will be 
tracked and reported per applicable regulations.   
 8.2 
Study Assessments  
8.2.1  Surgeon Questionnaire 
Surgeon questionnaires will be administered to solicit information about device utility, ease of 
device use during the procedure, and clinical workflow in the surgical setting. The surgeon 
questionnaire shall not contain any subject data and therefore, does not impact subject safety, 
welfare or confidentiality. The questionnaire will be completed by the implanting surgeon 
following completion of the surgical procedure. The information will be gathered and tabulated 
for qualitative analysis. For more details, see the surgical questionnaire (FRM00002). 
8.2.2 Surgical Electrode Array Insertion Timing 
iotaSOFTTM CI insertion system utilizes the same surgical approach and procedure as current 
manual CI insertion techniques without alteration to the approach workflow. The current 
standard CI surgical procedure includes a cortical mastoidectomy, facial recess approach to 
the cochlea, and placement of the CI receiver/stimulator under skin flap in bone recess. This is 
followed by preparation of the round window or cochleostomy and appropriate cochlea 
opening. Subsequent manual insertion of the electrode array is performed into the cochlea by 
grasping the electrode utilizing one or a combination of instruments or forceps. The surgeon 
then gently inserts the array by hand under direct microscope visualization for any buckling 
while avoiding excessive forces per universal insertion principles and specific CI manufacturer 
guidelines.17–20 Following CI electrode array insertion, a small fascia graft or muscle plug is 
placed to seal the cochlea opening to secure the array and the excess electrode lead is 
additionally secured in the mastoid cavity.20 The CI ground is then placed in soft tissues at the 
zygomatic root. 
Using the iotaSOFTTM insertion system to assist with electrode array insertion, the surgeon will 
perform the above described standard surgical approach but will have more speed control of 
the electrode array insertion and stable trajectory as well as improved consistency of insertion. 
Should the surgeon need to quickly revert to alternative standard manual insertion techniques 
at any point during a CI procedure which utilizes the iotaSOFTTM insertion system, this can be 
accomplished immediately without the need to modify the surgical approach or perform 
additional surgical steps aside from uncoupling of the iotaSOFT drive head from the CI lead in 
seconds.   
Surgical insertion timing using the iotaSOFTTM insertion system will be evaluated via operative 
microscope video record analysis. Time stamp mark will start when the electrode begins 
insertion through appropriate cochlea opening (e.g. through round window or cochleostomy) 
and end when surgeon determines insertion is complete without further advancement as 
reviewed on operative microscope recording. The end time will be defined by when the 
electrode has been inserted fully or the surgeon stops electrode advancement. Should the 
insertion end due to unanticipated anatomical reasons or significant resistance in insertion, 
proper adverse event documentation will be completed.  
8.2.4 Post-Insertion Electrode Position X-ray Assessment  

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As per standard of care, following CI electrode array insertion, an intraoperative or post-
operative “cochlea view” x-ray via c-arm will be performed to determine radiographically the 
insertion position of the electrode array and presence of tip-fold. 
8.2.3 Post-Activation Impedance and Neural Telemetry 
Per current standard of care, post-activation impedance and neural telemetry measurements 
will be collected at the initial in-clinic activation of the CI (approximately 2 weeks to 1 month 
following surgery), and at 1-month, 3-months, and 6 months post-activation using the standard 
non-invasive measurement techniques per CI manufacturer guidelines. Measurement values 
will be reported via case report form. 
8.2.6  Safety Assessments 
8.2.6.1 Adverse Events will be reported and documented throughout the duration of 
the study. All reported events will be recorded on case report forms and 
determinations will be made as to the whether the events are Adverse Events, 
Serious Adverse Events, Unanticipated Adverse Device Effects, and/or related 
to the investigational device or the procedure.  
9.  
STUDY DESIGN  
The study is a prospective, single arm, open-label study. Baseline medical data questionnaire 
will be collected for each subject prior to CI surgery. This will aid in determining adverse events 
as a result of the study. Aside from the insertion timing, data for evaluation of device safety will 
be collected after the device has been placed. 
9.1 
Number of Sites and Subjects 
Up to 30 subjects will be enrolled at up to 3 investigational sites. Each site will have adequate 
facilities for all medical procedures, and sites selected will represent private and larger medical 
center practice settings. All sites will be required to receive Institutional Review Board (IRB) 
approval prior to study initiation. Should clearance of the marketing application be received 
during the study, the Sponsor will determine whether to continue enrolling new subjects. 
Subjects already enrolled in the study who have not been implanted will be allowed to continue 
in the study. 
9.2 
Cochlear Implant Electrodes 
Only FDA approved cochlear implant electrode arrays and those validated for compatible use 
by the iotaSOFT manufacturer will be used for this study, specifically those without a sheath or 
stylet required for use including MedEl Flex, Cochlear 622/624, and AB Slim J electrode 
arrays.  
9.3 
Subject Selection and Withdrawal 
Subjects will be screened to verify that they meet all inclusion and exclusion criteria prior to 
being enrolled in the study. Informed consent will be obtained from every subject as described 
in Section 13.2 before they are considered enrolled in the study. 
9.4 
Inclusion criteria 
1) Candidate for cochlear implantation according to FDA indications for only the following 

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electrode arrays: MedEl Flex, Cochlear 622/624, AB Slim J 
2) Age 18 years or older at the time of enrolment 
3) Willingness to participate in and to comply with all requirements of the protocol 
4) Fluent speaker of American English due to language used in consent document. 
9.5 
Exclusion criteria   
The Subject must not have known or active medical issues that would preclude having a CI 
device, including:  
1) Prior cochlear implantation in the ear to be implanted  
2) Ossification or any other cochlear anomaly that might prevent complete insertion of the 
electrode array  
3) Craniofacial abnormality or Abnormal cochlear/nerve anatomy on pre-operative CT or 
MRI imaging (excluding a mild Mondini malformation or Large Vestibular Aqueduct 
Syndrome)  
4) Deafness due to lesions of the acoustic nerve or central auditory pathway  
5) Diagnosis of auditory neuropathy  
6) Active middle-ear infection  
7) Additional handicaps that would prevent participation in evaluations  
8) Unrealistic expectations on the part of the subject, regarding the possible benefits, risks 
and limitations that are inherent to the procedure and investigational device 
9) Must not fit the definition of a vulnerable subject, as per FDA regulations 21 CFR Parts 
50 and 56 21,22 
10 
DETAILED STUDY PROCEDURES 
10.1 Candidacy and Enrolment 
Once a subject has been determined a candidate for cochlear implantation according to FDA 
indications the patient will be invited to participate in this study. This will take place at the CI 
evaluation or the preoperative visit. The subject will be given the Informed Consent and given 
ample time to review and ask questions (see 13.2 for more information on the consent 
process). The subject will be given the medical health history questionnaire (FRM00001). 
Study enrolment will be accounted for on Attachment 6.   
10.2  Surgical Preparation  
Preparation for surgery will occur as per standard clinical procedures. Surgeons will be trained 
on iotaSOFT system use and operation with training certification by iotaSOFT manufacturer 
personnel prior to use, including at least a 1-hour period between training and use of the 
device. Training will be documented on Attachment 7.  Operating room setup and procedure 
preparation will be followed according to the iotaSOFTTM insertion system instructions for use 
to ensure the sterile field is not compromised and system is operational (Attachment 8). The 
operative microscope will be capable of video recording collection. If bilateral cochlear implant 

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procedure, the first iotaSOFT drive unit will be discarded and new, sterile unit will be used for 
the contralateral electrode array insertion.  
10.3  Surgeon Device Training 
Surgeons will be trained on iotaSOFT system use and operation with training certification by 
iotaSOFT manufacturer personnel prior to use, including at least a 1-hour period between 
training and use of the device. Training will be documented on Attachment 7. 
10.4  Device Surgical Use   
CI surgery will be conducted as per each surgeon’s standard clinical practice and surgical 
approach including cortical mastoidectomy and facial recess approach to the cochlea for 
cochlear implantation.  The surgeon then secures the stage base to the skull at superior edge 
of mastoidectomy with two pre-loaded self-drilling cortical bone screws and supplied sterile 
screwdriver. The drive unit is placed into the stage base and the adjustable drive head is 
coupled to a compatible CI silicon lead by clasping clip action onto the CI excess silicone lead 
away from the electrode array. With manual surgeon manipulation, the drive unit head is 
positioned outside the facial recess and aligned to the surgeon-desired electrode array 
insertion trajectory. Before insertion begins, the surgeon selects the desired speed from 
0.1mm/sec to 1.0mm/sec in 0.1mm/sec intervals using footpedal controller. With direct access 
and microscopic view of the surgical site, the surgeon advances or retracts the electrode array 
via footpedal while guiding the electrode array into the cochlea with standard manual CI 
instrumentation as necessary. Upon the completion of electrode array insertion and securing 
the array at the cochlea, the surgeon unclips the drive head and unit from the excess silicone 
lead then removes the device and screws from the patient for disposal. Per current standard of 
care, cochlea view X-rays will be performed, and the surgical site is then closed. For detailed 
device description and professional instructions for use see Attachment 1 & 8.   
10.5 Subject Withdrawal or Early Termination 
Subjects can choose to withdraw from the study at any time, for any reason, specified or 
unspecified, and without prejudice. Subjects will be withdrawn from the study for any of the 
following reasons: termination of study, request by the subject, development of an exclusion 
criterion prior to CI surgery (i.e., change in ability to meet protocol requirements). 
10.6 Medications 
No special medications are required for this study. Subjects will follow all standard clinical 
preparatory surgical procedures given to them by their doctor.     
10.7 Protocol Deviations 
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 such an event. 
If parts of the study 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. 

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10.8 Device Replacements 
There is the possibility of device failures (e.g. the iotaSOFT drive unit does not move the 
electrode as intended, etc), in that case, the surgeon may troubleshoot per instructions for use 
(Attachment 8), ask for replacement sterile iotaSOFT drive unit, or abandon the study and 
revert to the standard manual insertion techniques to complete the CI insertion procedure. 
Such events should be documented.  
10.9 Data Identification 
Designated study personnel at each site will assign each subject a unique Subject ID identifier. 
Each case report form will contain this identifier only. Other than the consent form, the names 
of the subjects will not be documented on any study forms. All consent forms and study-related 
forms will be archived in a secured area with limited access during the study and upon its 
completion.  
10.10 Accountability Procedures for the Investigational Product 
Device accountability will be controlled by documenting (Attachment 9) the dispensing and 
return of unused devices by designated study personnel.  
10.11 Maintenance of Study Randomization Codes 
The study will have no treatment randomization. All enrolled subjects will be implanted using 
the investigational device. 
10.12 Identification of Source Data 
All study data collected will be source data recorded directly on the CRFs or in the Electronic 
Database.  
11. 
ADVERSE EVENTS 
11.1 Definitions 
An Adverse Event (AE) is any untoward medical occurrence in a study subject. This may 
include illness, sign(s), symptom(s), or clinically significant laboratory test abnormality that has 
appeared or worsened during the course of the study, regardless of causal relationship to the 
study device(s) under study.  
A Serious Adverse Event (SAE) is any untoward medical occurrence that: results in death, is 
life-threatening (defined as an event in which the participant or patient was at risk of death at 
the time of the event; it does not refer to an event which hypothetically might have caused 
death if it were more severe), requires inpatient hospitalization or prolongation of existing 
hospitalization, results in persistent or significant disability/incapacity, is a congenital 
anomaly/birth defect, or is an important medical event (defined as a medical event(s) that may 
not be immediately life-threatening or result in death or hospitalization but, based upon 
appropriate medical and scientific judgment, may jeopardize the patient/participant or may 
require intervention (e.g., medical, surgical) to prevent one of the other serious outcomes listed 
in the definition above. Note: Planned hospitalization for a pre-existing condition without 
subsequent serious deterioration in health is not considered a serious adverse event. 
An Adverse Device Effect (ADE) is any untoward or unintended response to a medical device. 

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(This includes any event resulting from insufficiencies or inadequacies in the instructions for 
use or the procedures related to the device.) This includes any AE that is determined to be 
definitely or probably a result of device use. 
An Anticipated Adverse Device Effect (AADE) is an adverse device-related event that has 
been identified as to the nature, severity or incidence in the protocol. 
An Unanticipated Adverse Device Effect (UADE) is any serious adverse effect on health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that 
effect, problem, or death was not previously identified in nature, severity, or degree of 
incidence in the investigational plan or application (including a supplementary plan or 
application), or any other unanticipated serious problem associated with a device that relates 
to the rights, safety, or welfare of subjects. 
11.2 Assessment and Recording of Adverse Events  
AEs may be either spontaneously reported or elicited during questioning and examination of a 
participant or discovered during review of the clinical data. All AEs must be reported to the 
Sponsor by recording them on the Adverse Event form.  
The Investigator will decide whether the particular problem is investigational device-related or 
not and record his/her decision on the AE form. The relationship to the study product or 
procedure will be determined by the Investigator, as being: a) definitely related, b) probably 
related, c) possibly related, d) unlikely related or e) not related.  
If an event is deemed serious, such events will be reported to the Sponsor via the completion 
of the Serious Adverse Event CRF. 
11.3 Procedures for Reporting Adverse Events 
Adverse events classified as "serious" or “unanticipated” (SAEs or UADEs) will be reported 
promptly to the IRB and study Sponsor to comply with regulatory requirements.  All serious 
AEs, whether related or unrelated to the device, as well as all UADEs, will be immediately 
reported (but in no event later than 2 working days after the Investigator first learns of the 
event) to the Sponsor by telephone or confirmed facsimile or email transmission.  
The Sponsor will immediately conduct an evaluation of any unanticipated adverse device 
effect. If the Sponsor determines that an unanticipated adverse device effect presents an 
unreasonable risk to subjects, the Sponsor will terminate all investigations or parts of 
investigations presenting that risk as soon as possible. Termination will occur not later than 5 
working days after the sponsor makes this determination and not later than 15 working days 
after the sponsor first receives notice of the effect. 
As required, the Sponsor will summarize all reported AEs that are serious, unexpected, and 
certainly, probably, possibly, or of undetermined relationship to the device. This information will 
be provided to the FDA (by the sponsor) and to the IRB by the Investigator or designee, as 
appropriate.  
12. 
QUALITY CONTROL AND QUALITY ASSURANCE 
Accurate, consistent, and reliable data will be ensured through the use of standard practices 
and procedures. All of the Data Management, query resolution, Monitoring, etc. will be 

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managed by iotaMotion, Inc. These are described in the following sections.  
12.1 Direct Access to Source Data/Documentation 
The investigators and accompanying institutions will agree in writing to allow study-related 
monitoring and audits by the Study Sponsor, or designee, and regulatory authorities. The IRB 
and FDA will have the authority for regulatory review and inspection(s) by being allowed direct 
access to the source data and related documentation. 
12.2 Data Collection, Monitoring, and Transfer 
The investigators and study personnel will perform data collection. The Sponsor will perform all 
monitoring and data transfer tasks. A Monitor designated by the Sponsor will be responsible 
for monitoring the clinical study in accordance with current federal and relevant foreign 
regulations. Monitoring dates will be documented on Attachment 10. A monitoring plan for the 
study will be developed by the Sponsor.  
12.3 Data Management 
The study Monitor will review all consent forms, CRFs, Electronic database entries, and related 
reports including adverse event reports consistent with the monitoring plan. These will form the 
basis for all data analysis related to this study.  All data will be scanned or keyed into a 
computer system or electronic database for direct access and for subsequent reports. A 
clinical review will be performed by the Sponsor to identify those minor issues that otherwise 
remain unresolved. 
13. 
ETHICS 
13.1 Compliance Statement 
The study will be conducted in accordance with the approved study protocol and applicable 
regulatory requirements as described in the United States Code of Federal Regulation (CFR) 
21 Parts 50, 54, 56, and 812.21–23 As required by 21 CFR Part 50 and Part 56 and the 
Declaration of Helsinki, the study protocol, amendments, and Informed Consent form will be 
reviewed and approved by each study center’s IRB or an appropriate independent IRB prior to 
study initiation at that site.  
13.2 Subject Information and Consent 
The written Informed Consent forms will meet requirements for subject information, as outlined 
in FDA regulations (21 CFR Part 50),21 and the Declaration of Helsinki. Informed consent will 
be obtained from every subject in a manner compliant with 21 CFR Part 50 before any testing 
is done. The information will be presented verbally as well as in a written document. The 
Informed Consent form will be signed by each subject. A copy of the signed consent form will 
be given to each subject.  
13.3 Compensation, Insurance and Indemnity 
Financing and insurance will be addressed in separate agreements with the 
investigator(s)/institution(s). The subject will not be compensated for participating in the study 
as detailed in the Informed Consent. In case of injury related to this research, the subject will 
be appropriately treated by the study doctors without cost to the subject. If the subject seeks 
alternative medical treatment, that treatment will be billed to the subject’s health insurance and 

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will not be paid by iotaMotion, Inc. The company will not pay for lost wages or other financial 
compensation for injury.  
14. 
STUDY REPORT AND PUBLICATION PLAN 
iotaMotion, Inc. will own the data generated from this prospective study and the study devices. 
The Principal Investigator will be responsible for publishing or presenting any findings in 
accordance with the Investigator Agreement. A description of this clinical trial will be available 
on http://www.ClinicalTrials.gov, as required by U.S. Law. 
15. ATTACHMENTS 
 
15.1 Attachment 1 – Detailed Device Description  
15.2 Attachment 2 – 720-036-0031 – Bench Performance Testing Report 
15.3 Attachment 3 – 722-036-0021 – Benchtop Comparative Analysis Report 
15.4 Attachment 4 – 722-036-0020 – Cadaveric Comparative Analysis Report 
15.5 Attachment 5 – 712-036-0010 – Usability Validation Report 
15.6 Attachment 6 – Study participant log  
15.7 Attachment 7– Investigator training log 
15.8 Attachment 8 – Professional instructions for use 
15.9 Attachment 9 – Device accountability log 
15.9 Attachment 10– Study monitoring plan 
15.10 FRM00001– Medical History form 
15.11 FRM00002 – Surgical Questionnaire 
16. 
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Lehnhardt E. Intracochlear placement of cochlear implant electrodes in soft surgery 
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3.  
Eshraghi AA, Van De Water TR. Cochlear implantation trauma and noise-induced 
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4.  
Ishai R, Herrmann BS, Nadol JB, Quesnel AM. The pattern and degree of capsular 
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Roland PS, Wright CG. Surgical Aspects of Cochlear Implantation: Mechanisms of 
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doi:10.1159/000094642 
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Scheperle RA, Tejani VD, Omtvedt JK, et al. Delayed changes in auditory status in 
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7.  
Mowry S, Woodson E, J Gantz B. New Frontiers in Cochlear Implantation: Acoustic Plus 
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Kesler K, Dillon NP, Fichera L, Labadie RF. Human Kinematics of Cochlear Implant 
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Kontorinis G, Lenarz T, Stöver T, Paasche G. Impact of the Insertion Speed of Cochlear 
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implant electrode arrays in-vitro: Comparison of surgeon to automated insertion tool. 
Acta Otolaryngol. 2010;130(1):31-36. doi:10.3109/00016480902998281 
11.  De Seta D, Torres R, Russo FY, et al. Damage to inner ear structure during cochlear 
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Function during Cochlear Implantation: A Comparison Study. Audiol Neurotol. 
2013;18(1):17-22. 
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temporal bone specimens implanted with a straight atraumatic electrode array. Eur Arch 
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14.  Todt I, Mittmann P, Ernst A. Intracochlear Fluid Pressure Changes Related to the 
Insertional Speed of a CI Electrode. Vol 2014.; 2014. doi:10.1155/2014/507241 
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doi:10.1159/000442041 
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aspx. 
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18.  Cochlear Nucleus CI522 Cochlear Implant with Slim Straight Electrode Physicians 
Guide. 
19.  Advanced Bionics Surgeon Manual for the HiRes Ultra Cochlear Implants with the 
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20.  MedEl Mi1250 Synchrony 2 Surgical Guide. 
21.  21 CFR Part 50: Protection of Human Subjects. 
22.  21 CFR Part 56: Institutional Review Boards. 
23.  21 CFR Part 812: Investigational Device Exemptions.