Outcomes in Children With Cochlear Implants and Pre-Operative Residual Hearing: Electric Only and Electric-Acoustic Stimulation
Phase: NA
Conditions: High Frequency Sensorineural Hearing Impairment, Hearing Disorders in Children
Sponsor: University of North Carolina, Chapel Hill

 
 
 
Outcomes in Children with Cochlear Implants and Pre-
Operative Residual Hearing: Electric Only and Electric-
Acoustic Stimulation 
IRB: 17-2360 
NCT03379870 
Protocol Number: 1.7 
Principal Investigator: Lisa Park, AuD 
Funded by: MED-EL 
Version Number:  v.1.7 
18 May 2020 
 
Summary of Changes from Previous Version: 
Affected 
Section(s) 
Summary of Revisions Made 
Rationale 
All 
Incorporated UNC Team Edits 
 
All 
Incorporated suggestions from Scientific 
Review Committee 
 
1, 3, 6, 8, 9, 
11, 12 
Substituting the children’s SSQ for the 
Peds- QL 
The Peds-QL is proving to be an 
inconsistent QOL measure in another 
ongoing study. The pediatric version of 
the SSQ is proving to provide much 
more data. 
1, 3, 6 
Testing in hearing aid (HA) condition 
rather than CI alone in Arm 1 participants 
This will allow us to compare to pre-
operative scores and account for 
developmental aspects. In addition, the 
CI alone condition would be novel and 
unfamiliar in this group, likely making 
for an invalid measurement. We can 
instead use the Arm 2 participants for 
comparison as they will have been used 
to a full CI program. 

NIH-FDA Phase 2 and 3 IND/IDE Clinical Trial Protocol Template   
 
 
ii 
5 
Changing inclusion criteria to include 5-
year-olds and children with a composite 
language score down to 60. 
Effort to ease recruitment. Five-year-
olds with residual hearing are capable 
of completing the test protocol. Many 
potential candidates have language 
skills that are poorer than we expected, 
and we want to be able to include 
these children and measure changes in 
language abilities as well. A standard 
score of 60 would avoid floor effects 
and still include children who are able 
to complete the test protocol. 
5 
Specifying that a neurotologist will read 
scans of potential candidates under a 
waiver of HIPAA to confirm a lack of 
cochlear nerve deficiency. 
This change is in response to the 
withdrawal of a subject who was noted 
to have CND after enrolment. 
1, 2, 6 
Adding SONNET 2 EAS as a device. 
Removing Maestro 7 as a device and 
simply including the Maestro System. 
SONNET 2 EAS has been FDA approved 
and will be arriving in patient kits. It is 
an updated version of the SONNET EAS 
device. Maestro 7 is no longer 
considered experimental and we will be 
using the FDA approved versions of the 
software from this point on as they 
now provide what we need to fit the 
EAS devices. 
1, 5, 6 
Removing Leiter-R from protocol and 
changing exclusion criteria to read 
“known or suspected cognitive 
impairment.”  
The Leiter-R has proven to be an 
unnecessary and cumbersome 
measure. For safety measures in light of 
COVID-19 it is being removed as a 
screening tool.  
5 
Changing screening procedures 
To ease scheduling difficulties in light of 
COVID-19, investigators may reach out 
to potential candidates prior to initial 
stimulation to discuss the study and 
schedule initial stimulation visits 
appropriately. 

  
 
 
ii 
Table of Contents 
STATEMENT OF COMPLIANCE ............................................................................................................ 1 
1 
PROTOCOL SUMMARY ............................................................................................................... 1 
1.1 
Synopsis ................................................................................................................................. 1 
1.2 
Schema ................................................................................................................................... 3 
1.3 
Schedule of Activities (SoA) ................................................................................................ 4 
2 
INTRODUCTION ............................................................................................................................ 4 
2.1 
Study Rationale ..................................................................................................................... 5 
2.2 
Background ............................................................................................................................ 5 
2.3 
Risk/Benefit Assessment ..................................................................................................... 7 
2.3.1 
Known Potential Risks ........................................................................................ 7 
2.3.2 
Known Potential Benefits ................................................................................... 7 
2.3.3 
Assessment of Potential Risks .......................................................................... 8 
3 
OBJECTIVES AND ENDPOINTS ................................................................................................ 9 
4 
STUDY DESIGN ........................................................................................................................... 10 
4.1 
Overall Design ..................................................................................................................... 10 
4.2 
Scientific Rationale for Study Design ............................................................................... 11 
4.3 
End of Study Definition ....................................................................................................... 11 
5 
STUDY POPULATION ................................................................................................................. 11 
5.1 
Inclusion Criteria.................................................................................................................. 11 
5.2 
Exclusion Criteria ................................................................................................................ 12 
5.3 
Lifestyle Considerations ..................................................................................................... 12 
5.4 
Screen Failures ................................................................................................................... 12 
5.5 
Strategies for Recruitment and Retention ....................................................................... 12 
6 
STUDY INTERVENTION ............................................................................................................. 13 
6.1 
Study Intervention Description .......................................................................................... 13 
6.1.1 
SONNET EAS Audio Processor (P000025/S084) ....................................... 13 
6.1.2 
Current labeling ................................................................................................. 14 
6.1.3 
SONNET 2 EAS Audio Processor .................................................................. 15 
6.1.4 
Current labeling ................................................................................................. 16 
6.2 
Intervention Schedule ......................................................................................................... 17 
6.2.1 
screening ............................................................................................................ 17 
6.2.2 
Initial Stimulation (completed on the same day as screening) ................... 17 
6.2.3 
2-Week 18 
6.2.4 
5-week 18 
6.2.5 
3-month 19 
6.2.6 
6-month 20 
6.2.7 
9-month 20 
6.2.8 
12-month ............................................................................................................ 21 
6.3 
Accountability ....................................................................................................................... 22 
7 
PARTICIPANT DISCONTINUATION/WITHDRAWAL ............................................................ 22 
7.1 
Participant Discontinuation/Withdrawal from the Study ................................................ 22 
7.2 
Lost to Follow-Up ................................................................................................................ 23 
8 
STUDY ASSESSMENTS AND PROCEDURES ...................................................................... 23 
8.1 
Efficacy Assessments ........................................................................................................ 23 
8.2 
Adverse Events and Serious Adverse Events ................................................................ 24 
8.2.1 
Definition of Adverse Events (AE) .................................................................. 24 
8.2.2 
Definition of Serious Adverse Events (SAE) ................................................. 24 

  
 
 
iii 
8.2.3 
Adverse Event Reporting ................................................................................. 24 
8.2.4 
Serious Adverse Event Reporting .................................................................. 25 
9 
STATISTICAL CONSIDERATIONS ........................................................................................... 25 
9.1 
Sample Size Determination ............................................................................................... 25 
9.2 
Statistical plan...................................................................................................................... 25 
10 
SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS .............. 26 
10.1 
Regulatory, Ethical, and Study Oversight Considerations ............................................ 26 
10.1.1 
Informed Consent Process .............................................................................. 26 
10.1.2 
Confidentiality and Privacy .............................................................................. 27 
10.1.3 
Quality Control ................................................................................................... 27 
10.1.4 
Data Handling and Record Keeping ............................................................... 28 
10.1.5 
Protocol Deviations ........................................................................................... 28 
10.2 
Protocol Amendment History ............................................................................................ 29 
11 
REFERENCES .............................................................................................................................. 30 
12 
ABBREVIATIONS ......................................................................................................................... 33 
 

Outcomes in Children with Cochlear Implants and Pre-Operative Residual Hearing 
V.1.6 
3 Dec 2019 
 
 
 
1 
STATEMENT OF COMPLIANCE 
 
The trial will be conducted in accordance with International Conference on Harmonisation Good Clinical 
Practice (ICH GCP) and applicable United States (US) Code of Federal Regulations (CFR). The Principal 
Investigator will assure that no deviation from, or changes to the protocol will take place without prior 
agreement from the Investigational Device Exemption (IDE) sponsor (if applicable), funding agency, and 
documented approval from the Institutional Review Board (IRB), except where necessary to eliminate an 
immediate hazard(s) to the trial participants. All personnel involved in the conduct of this study have 
completed Human Subjects Protection and ICH GCP Training. 
 
The protocol, informed consent form(s), recruitment materials, and all participant materials will be 
submitted to the IRB for review and approval.  Approval of both the protocol and the consent form must 
be obtained before any participant is enrolled.  Any amendment to the protocol will require review and 
approval by the IRB before the changes are implemented to the study.  All changes to the consent form 
will be IRB approved; a determination will be made regarding whether a new consent needs to be 
obtained from participants who provided consent, using a previously approved consent form. 
 
1 
 
PROTOCOL SUMMARY 
1.1 
SYNOPSIS  
 
 
Title: 
Outcomes in Children with Cochlear Implants and Pre-Operative Residual 
Hearing: Electric Only and Electric-Acoustic Stimulation. 
Study Description: 
The Children’s Cochlear Implant Center at UNC has seen evidence of 
postoperative hearing preservation in pediatric cochlear implant (CI) 
recipients during routine clinical care and data from pilot studies. The 
primary aim of this study is to investigate speech perception performance 
in pediatric CI recipients with functional pre-operative hearing. 
Objectives: 
 
Primary Objective:  To determine if listening with electric-acoustic 
stimulation (EAS) provides improved speech understanding over listening 
with the CI alone (CI-alone) in pediatric CI recipients. 
 
Secondary Objectives:  
1. To compare the pre-operative speech perception and quality of life 
scores with traditional hearing aids to post-operative scores listening with 
a CI alone in children with pre-operative low frequency hearing. 
 
2. To determine if listening with EAS achieves better performance and/or 
subjective benefit as compared to pre-operative findings with 
conventional amplification. 
 
3. To evaluate the differences in identification of questions vs answers in 
children listening to EAS vs CI-alone programs. 
Endpoints: 
Primary Endpoints:  
1. Mean CNC word scores, comparing EAS and CI-alone conditions at 12 
months post stimulation. 
 
2. Mean BKB-SIN scores, comparing EAS and CI-alone conditions at 12 
months post stimulation. 

Outcomes in Children with Cochlear Implants and Pre-Operative Residual Hearing 
V.1.6 
3 Dec 2019 
 
 
 
2 
 
Secondary Endpoints: 
1.  Mean Pediatric SSQ scores, comparing Pre-operative and 12 month 
post stimulation scores in both groups. 
 
2. Mean CNC word scores, comparing Pre-operative and best listening 
conditions at 12 months post stimulation in both groups. 
 
3. Mean articulation, expressive, and receptive language scores, 
comparing pre-operative scores to the 12 month test point for both 
groups using the Goldman Fristoe Test of Articulation 3 (GFTA 3) and the 
Oral and Written Language Scales II (OWLS II). 
 
4. Mean Question/Answer Task scores, comparing EAS to CI-Alone 
conditions at the 12 month test point. 
Study Population: 
Two cohorts of CI recipients aged 6 through 17 years who had pre-
operative low frequency residual hearing. Subjects in Arm 1 will present 
with a post-operative low frequency pure tone average (125, 250, and 500 
Hz) of < 75 dB HL, and those in Arm 2 will present with a post-operative 
low frequency pure tone average (LFPTA) that exceeds 75 dB HL. 
Phase: 
NA 
Description of 
Sites/Facilities Enrolling 
Participants: 
Subjects will be seen and enrolled at The University of North Carolina at 
Chapel Hill. Physical locations include The Children’s Cochlear Implant 
Center at UNC and the Carolina Crossing satellite clinic.  
Description of Study 
Intervention: 
The MED-EL EAS System is capable of providing electric stimulation to the 
mid- to high-frequency region of the cochlea and acoustic amplification to 
the low frequency regions for candidates with residual low frequency 
hearing sensitivity. The combination of acoustic (hearing aid) and electrical 
stimulation to the same ear is made possible through the external 
SONNET/SONNET 2 EAS Processor working in conjunction with the internal 
CI.  Patients without residual acoustic hearing can use the 
SONNET/SONNET 2 EAS Processor to provide electric stimulation; in these 
cases the patient does not wear the hearing aid component. 
 
The SONNET/SONNET 2 EAS Audio Processor is programmed with the 
MED-EL MAESTRO System Software used as part of typical clinical care.  
Study Duration: 
48 months 
Participant Duration: 
12 months 
 
 
 
 
 

Outcomes in Children with Cochlear Implants and Pre-Operative Residual Hearing 
V.1.6 
3 Dec 2019 
 
 
 
3 
 
1.2 
SCHEMA 
 
Prior to Enrollment
Total N:  Obtain informed consent. Screen potential participants by inclusion and exclusion criteria; obtain history, document.
Arm 1
With functional 
hearing
N=20
Arm 2
Without functional 
hearing
N=20
Arm Assignment
Visit 1
Initial Stim
•Fit and program the SONNET EAS device. 
•See Section 1.3, Schedule of Activities and Section 6.2, Intervention Schedule for more detail
Visit 2
2-Weeks
•Unaided testing and aided soundfield thresholds.
•Fit and program the SONNET/SONNET 2 EAS device
•See Section 1.3, Schedule of Activities and Section 6.2, Intervention Schedule for more detail
Visit 3
5-Weeks
•Unaided testing and aided soundfield thresholds.
•Fit and program the SONNET/SONNET 2 EAS device
•See Section 1.3, Schedule of Activities and Section 6.2, Intervention Schedule for more detail
Visit 4
3-Months
•Unaided testing and aided soundfield thresholds.
•CNC, Question/Statement Test, Pediatric SSQ
•Fit and program the SONNET/SONNET 2 EAS device
•See Section 1.3, Schedule of Activities and Section 6.2, Intervention Schedule for more detail
Visit 5
6-Months
•Unaided testing and aided soundfield thresholds.
•CNC, BKB-SIN, Pediatric SSQ
•Fit and program the SONNET/SONNET 2 EAS device
•See Section 1.3, Schedule of Activities and Section 6.2, Intervention Schedule for more detail
Visit 6
9-Months
•Unaided testing and aided soundfield thresholds.
•CNC, Question/Statement Test, Pediatric SSQ
•Fit and program the SONNET/SONNET 2 EAS device
•See Section 1.3, Schedule of Activities and Section 6.2, Intervention Schedule for more detail
Visit 7
12-Months
•Unaided testing and aided soundfield thresholds.
•FINAL ASSESSMENTS: CNC, BKB-SIN, Question/Statement Test, Pediatric SSQ, OWLS II, GFTA 3
•Fit and program the SONNET/SONNET 2 EAS device
•See Section 1.3, Schedule of Activities and Section 6.2, Intervention Schedule for more detail

Outcomes in Children with Cochlear Implants and Pre-Operative Residual Hearing 
V.1.6 
3 Dec 2019 
 
 
 
4 
 
 
 
1.3 
SCHEDULE OF ACTIVITIES (SOA) 
 
Procedures 
Screening/ Enrollment 
& Initial Stim: Day 1 
Study Visit 2  
Day 14  +/-5 days 
Study Visit 3 
Day 35 +/- 8 days 
Study Visit 4 
Day 90 +/-14 days 
Study Visit 5 
Day 180 +/-14 days 
Study Visit 6 
Day  270 +/-14 days 
Final Study Visit 7 
Day 365 +/-14 day  
Informed consent 
X 
 
 
 
 
 
 
Review of Demographics 
X 
 
 
 
 
 
 
Review of Hearing History 
X 
 
 
 
 
 
 
Review of Pre-Op Speech and 
Language Testing 
X 
 
 
 
 
 
 
Unaided Testing 
X 
X 
X 
X 
X 
X 
X 
Pediatric SSQ 
X 
 
 
X 
X 
X 
X 
Arm Assignment 
X 
 
 
 
 
 
 
Speech Processor 
Programming 
 
X 
X 
X 
X 
X 
X 
Soundfield Thresholds 
 
X 
X 
X 
X 
X 
X 
CNC Word List 
 
 
 
X 
X 
X 
X 
Question/Answer Test 
 
 
 
X 
 
X 
X 
BKB-SIN 
 
 
 
 
X 
 
X 
OWLS II 
 
 
 
 
 
 
X 
GFTA 3 
 
 
 
 
 
 
X 
Complete Case Report Forms 
(CRFs) 
X 
X 
X 
X 
X 
X 
X 
 
2 
 
INTRODUCTION 
 

Outcomes in Children with Cochlear Implants and Pre-Operative Residual Hearing 
V.1.6 
3 Dec 2019 
 
 
 
5 
2.1 
STUDY RATIONALE  
 
As CI candidacy continues to expand, The Children’s Cochlear Implant Center at UNC has seen evidence 
of postoperative hearing preservation in pediatric CI recipients during routine clinical care and data from 
pilot studies. Currently, only one manufacturer, Cochlear Americas, offers an FDA approved speech 
processor that allows us to take advantage of this functional hearing and use it to provide additional 
temporal cues. This external speech processor only works with internal devices from Cochlear Americas. 
MED-EL also has an approved speech processor, but it is currently only labeled for adult use, despite its 
more pediatric friendly design.  The Cochlear Americas external speech processor requires use of a 
Receiver in the Canal (RIC) which is easy for children to damage and does not fit in smaller ears. The 
MED-EL SONNET/SONNET 2 EAS speech processor uses a standard tone-hook and earmold just like a 
behind-the-ear hearing aid. An earmold can be made to fit many shapes and sizes of ear canals, and it is 
made from vinyl or silicone so it is comfortable.  
 
The primary aim of this study is to investigate speech perception performance with EAS in pediatric CI 
recipients with postoperative hearing preservation. While hearing preservation rates are good in our 
clinic, they are not guaranteed. Children with progressive hearing loss may continue to lose hearing, 
even if they maintain some residual hearing immediately after surgery. As a secondary aim, we intend to 
investigate outcomes in children who do not maintain residual hearing and are fit with traditional CI 
programming methods. Children with more residual hearing are being implanted, and this study design 
allows us to validate outcomes in both populations. 
 
2.2 
BACKGROUND  
 
Low-frequency acoustic hearing provides better temporal and spectral cues than low-frequency 
electrical stimulation (Dunn et al, 2010; Gifford et al, 2010; Incerti et al, 2013). These are cues that allow 
for localization, music appreciation, hearing in noise, and prosodic recognition.  Preservation of residual 
hearing is of continuing clinical interest in cochlear implantation (Adunka et al, 2013; Adunka, Pillsbury, 
& Buchman, 2010; Carlson et al, 2011; Havenith et al, 2014; Santa Maria, Gluth, Yuan, Atlas, & Blevins, 
2014; Van Avel et al, 2015). Modified electrode arrays and surgical techniques have resulted in 
postoperative hearing preservation (Adunka et al, 2014; Adunka, Pillsbury, & Buchman, 2010; Anagiotos 
et al 2015; Carlson et al, 2011; Frixon, Kobler, & Rask-Anderson, 2012; Havenith et al, 2013; Kisser et al, 
2016; Santa Maria et al, 2013; Santa Maria et al, 2014; Skarzynski et al, 2014; Sweeney et al, 2016; Tamir 
et al, 2012; Yao, Turner & Gantz, 2006). When low-frequency hearing is preserved, there is an 
opportunity to provide high frequency hearing through electric stimulation and low-frequency cues 
through acoustic hearing.  
 
Research with adult CI recipients has shown improved listening skills in quiet and noise when combining 
acoustic and CI technology, known as electric-acoustic stimulation (EAS), over fully acoustic or electric 
stimulation (Adunka, et al, 2013; Dillon, et al, 2014; Gfeller, et al, 2007; Gifford, et al, 2013; Gifford, 
Dorman, & Brown, 2010; Helbig & Baumann, 2010; Incerti, Ching, & Cowan, 2014; Roland, et al, 2015; 
Sheffield, Jahn, & Gifford, 2015). In EAS modes of hearing, frequencies with residual hearing in the 
implant ear are amplified using acoustic technology, and frequencies that cannot be sufficiently 
amplified are stimulated through traditional CI technology.  There are now commercially available 
external speech processors that combine these two technologies in one device.   
 

Outcomes in Children with Cochlear Implants and Pre-Operative Residual Hearing 
V.1.6 
3 Dec 2019 
 
 
 
6 
CI users are known to have poor spectral resolution due to limited neural survival rates and limitations 
of electrical stimulation.  The addition of acoustic stimulation is thought to increase spectral resolution, 
thereby improving speech understanding, particularly in noise (Gifford & Dorman, 2012).  
 
As of yet, there are few peer reviewed studies that investigate EAS in the pediatric population and all 
reports are on small groups of children. Wolfe, et al (2017) report on a cohort of 7 children aged 6-16 
who were fit with EAS speech processors and evaluated in quiet and in noise. In this small study, 
subjects were found to benefit from EAS in noise and in quiet when compared to electric or acoustic 
only conditions. The children in this study had been wearing electric stimulation only for at least 6 
months before being fit with the EAS speech processor.  In the second study, Scholz et al (2017) also 
report on a small group of 6 children (9 ears) aged 6-10 years who had worn full electric programs for an 
average of 5.9 years before being fit with EAS processors.  Contrary to Wolfe et al, no significant 
difference was found between the EAS and electric conditions. Skarzynski et al (2007) present on 6 
children, some of whom had CI-alone experience and some who did not. An improvement in speech 
perception was noted over preoperative scores.  Skarzynski and Lorens (2010) again show benefit of EAS 
in children over traditional hearing aids, but neither of these papers compare EAS outcomes to CI-alone 
listening. No peer reviewed studies exist that investigate the use of EAS in children when they are fit 
with the device from initial stimulation.  
 
In reviewing our patient database, 81% of children who had stable hearing thresholds pre-operatively 
and a LFPTA of 65 dB or better maintained functional hearing for more than a year after surgery 
(n=17/21). Of those patients, 100% of patients implanted with the MED-EL SYNCHRONY Cochlear 
Implant with FLEX24 electrode array had residual hearing at 12 months post-op. Across all patients 
included in this review, the mean change in LFPTA  was 14 dB HL. For children with progressive hearing 
loss pre-operatively, only 36% had functional hearing more than a year after surgery (n=18/50). The 
mean change in this group was 36 dB HL; not surprising given the already progressive nature of the loss.   
 
A pilot study completed with 16 children using the Cochlear Americas device indicated that EAS was 
superior to traditional CI programs for children with residual hearing.  CNC word scores were 
significantly better (p<0.001) for EAS programs (Mean=63.50%) than CI alone (Mean=44.63%). This held 
true for sentences in noise as well (P<0.001) with a mean EAS score of 70.74% and a mean CI alone score 
of 53.94%. For children who were recently implanted, we were able to compare outcomes to pre-
operative scores.  CNC word scores with a hearing aid (M=26.25%) were poorer than those in a CI-alone 
condition (Mean=38.00%), but this did not reach statistical significance. The EAS Condition 
(Mean=63.00%) was significantly higher than both the pre-operative hearing aid condition (p<0.01) and 
the CI alone condition (p<0.01). There may have been learning effects as the subjects were typically 
tested acutely in the CI-alone condition. We did not look at outcomes in children who lost residual 
hearing in this pilot group, but according to our database, children who had preoperative residual 
hearing and do not have enough hearing to be fit with EAS technology have an average CNC word score 
of 61.76%. The pre-operative CNC scores in this group are similar to the pilot group (M=25.21%) This 
leads us to believe that our pilot data may have been impacted by learning effects and we feel it is 
prudent to include the loss of hearing group that would be adapted to the CI-alone condition before 
testing. 
The Children’s Cochlear Implant Center at UNC offers three different device manufacturers for children 
who are receiving a cochlear implant and have sufficient acoustic hearing to confer a functional benefit. 
The decision on which device to implant is left up to the family, unless the surgeon has a preference 
based on anatomy. Families choosing MED-EL will receive the same internal and external device 

Outcomes in Children with Cochlear Implants and Pre-Operative Residual Hearing 
V.1.6 
3 Dec 2019 
 
 
 
7 
regardless of whether or not they choose to participate in the study. The SYNCHRONY Implant is not 
experimental. The SONNET/SONNET 2 EAS processor (external hardware) is considered experimental in 
children. Following implantation, we will approach families of children implanted with the MED-EL 
device for inclusion in the current study. 
All potential subjects in this study will have residual hearing prior to implantation. Participants will be 
enrolled following surgery in two Arms. The first Arm will be for those subjects who have enough 
residual hearing to fit with an EAS method. For the purposes of this study, we are defining functional 
hearing as a LFPTA of 75 dB HL or lower. Arm 2 will be for those who do not have enough residual 
hearing to amplify following implantation. These patients will be fitted with the same hardware as those 
in Arm 1, with the exception that they will not wear the hearing aid (HA) component. Having two arms 
will allow us to compare groups with similar pre-operative hearing and investigate differences in 
listening in full electric and EAS conditions. Subjects in Arm 1 will be tested in HA-alone and EAS 
conditions as we anticipate good hearing preservation in this study. Subjects in Arm 2 will be tested in 
the CI-alone condition.  Although unanticipated, it is possible that a subject with residual hearing would 
be enrolled in Arm 1 and subsequently lose hearing; in these cases they would be removed from Arm 1 
and reassigned to Arm 2. 
 
 
2.3 
RISK/BENEFIT ASSESSMENT   
 
2.3.1 KNOWN POTENTIAL RISKS  
Potential risks include (but are not limited to): 
• 
Poor sound quality from the device 
• 
Poorer speech perception and/or quality of life with the CI-alone and/or EAS 
• 
Embarrassment with device use due to device visibility to others 
• 
Loss of residual hearing in the implanted ear 
• 
Pain and/or discomfort from the fit of the earmold and/or the placement of the audio 
processor and/or coil/magnet 
• 
Facial stimulation from device use 
• 
Dizziness from CI use 
• 
Tinnitus  
• 
External equipment malfunction due to intermittencies in the device (i.e. cable needing to be 
replaced) 
2.3.2 KNOWN POTENTIAL BENEFITS  
Potential benefits include (but are not limited to): 
• 
Improved speech perception in quiet  
• 
Improved speech perception in noise  
• 
Improved quality of life 

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V.1.6 
3 Dec 2019 
 
 
 
8 
 
2.3.3 ASSESSMENT OF POTENTIAL RISKS  
• 
Poor sound quality from the device 
o All of the co-investigators are licensed audiologists with significant experience fitting 
EAS devices on children. Best practices will be followed to optimize sound quality. 
Subject feedback will be taken into account during programming. 
• 
Poorer speech perception and/or quality of life with the CI-alone and/or EAS 
o Should a subject find that their speech understanding or quality of life is poorer with 
the device, they are welcome to withdraw from the study at any time. 
o The SONNET/SONNET 2 EAS processor can be programmed in a traditional manner with 
no acoustic stimulation. 
o Poorer speech perception or quality of life was not noted during the pilot study for any 
subject. 
• 
Embarrassment with device use due to device visibility to others 
o Every effort will be made to mitigate cosmetic concerns. 
o There are a variety of earmold possibilities that are less conspicuous and will be 
presented to subjects. 
o This risk is highly unlikely as potential subjects will have been wearing hearing aids up 
until the time of cochlear implantation. 
• 
Loss of residual hearing in the implanted ear 
o This is a known risk to cochlear implantation and not increased with the EAS device. 
o Those with progressive hearing loss may have a continuation of that course and lose 
hearing over the course of the study. 
• 
Pain and/or discomfort from the fit of the earmold and/or the placement of the audio 
processor and/or coil/magnet 
o There are a variety of earmolds and magnet strengths that can be used to reduce or 
eliminate pain/discomfort. 
o Every effort will be made to reduce discomfort through alternate fitting methods 
(headbands, moleskin, etc). 
• 
Facial stimulation from device use 
o This is a known risk to cochlear implantation and not related to the EAS device itself. 
o Facial stimulation can typically be eliminated with proper programming. 
• 
Dizziness from CI use 
o This is a known risk to cochlear implantation and not related to the EAS device itself. 
o Dizziness can typically be eliminated with programming. 
• 
External equipment malfunction due to intermittencies in the device (i.e. cable needing to be 
replaced) 
o Subjects will be counseled extensively on how to troubleshoot equipment. 
o All subjects receive two speech processors at the time of implantation, ensuring that 
they have backup equipment and can have access to sound at all times. 

Outcomes in Children with Cochlear Implants and Pre-Operative Residual Hearing 
V.1.6 
3 Dec 2019 
 
 
 
9 
o Subjects can always contact the manufacturer or clinicians for assistance with 
troubleshooting. 
3 
OBJECTIVES AND ENDPOINTS 
 
OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
Primary 
 
 
1. To determine if listening with 
electric-acoustic stimulation 
(EAS) provides improved speech 
understanding over listening 
with the CI alone (CI-alone) in 
pediatric CI recipients. 
1. Mean CNC word scores, 
comparing EAS and CI-alone 
conditions at 12 months post 
stimulation (Arm 1 to Arm 2). 
2. Mean BKB-SIN scores, comparing 
EAS and CI-alone conditions at 12 
months post stimulation (Arm 1 to 
Arm 2). 
The CNC word list is 
established as a 
standard test of speech 
perception outcomes. 
The BKB-SIN evaluates 
speech perception in 
multi-talker babble. 
Testing in multi-talker 
babble is an effective 
way to evaluate 
differences in listening 
conditions with and 
without acoustic 
stimulation. Both of 
these tests are 
routinely given pre-
operatively as part of 
candidacy 
determination. We will 
obtain and use these 
pre-operative scores in 
our analysis. 
Secondary 
 
 
1. To compare the pre-operative 
speech perception and quality of 
life scores with traditional 
hearing aids to post-operative 
scores listening with a CI alone 
in children with pre-operative 
low frequency hearing. 
2. To determine if listening with 
EAS achieves better 
performance and/or subjective 
benefit as compared to pre-
operative findings with 
conventional amplification 
1. Mean 
Pediatric 
SSQ 
scores, 
comparing Pre-operative and 12 
month post stimulation scores in 
both groups.  
2. Mean CNC word scores, comparing 
Pre-operative and best listening 
conditions at 12 months post 
stimulation in both groups. 
3. Mean articulation, expressive, and 
receptive 
language 
scores, 
comparing pre-operative scores to 
the 12 month test point for both 
groups using the Goldman Fristoe 
Test of Articulation 3 (GFTA 3) and 
the Oral and Written Language 
Scales II (OWLS II). 
The Pediatric SSQ 
measures perception 
of speech, spatial, and 
sound quality 
outcomes. The 
language is simple for 
children with hearing 
loss to understand.  
The OWLS II is a test of 
receptive and 
expressive language. 
The GFTA 3 is a test of 
articulation. Both are 
given routinely pre-and 
post-operatively in the 
clinic for all children 

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OBJECTIVES 
ENDPOINTS 
JUSTIFICATION FOR 
ENDPOINTS 
who receive CIs. We 
will obtain and use 
these pre-operative 
scores in our analysis. 
3. To evaluate the differences in 
identification of questions vs 
answers in children listening to 
EAS vs CI-alone programs. 
1. Mean Question/Answer Task 
scores, comparing EAS to CI-Alone 
conditions at the 12 month test 
point (Arm 1 to Arm 2). 
The Question/Answer 
Task (Peng et al, 2012) 
evaluates a listener’s 
ability to identify 
statements vs 
questions using 
listening alone. We 
expect that the 
prosodic differences in 
these sentences would 
be more available to 
those using EAS 
programs. This would 
have implications for 
language development. 
 
4 
STUDY DESIGN  
 
4.1 
OVERALL DESIGN 
 
Randomization: 
This is a non-randomized trial. Participants will fall into one of two arms: 
• 
Arm1. Subjects who receive a CI and present with a post-operative LFPTA of < 75 dB HL. 
• 
Arm 2. Subjects with pre-operative low frequency hearing who receive a CI and present with a 
post-operative LFPTA of > 75 dB HL. 
Hypotheses:  
 
1. Subjects will experience an improvement in speech perception in quiet, speech understanding in 
noise, and identification of prosodic features when listening with EAS as compared to listening 
to the CI-alone. 
2. Subjects will experience an improvement in speech perception in quiet, speech understanding in 
noise, articulation, language, and quality of life after 12 months of implant use as compared to 
pre-operative findings with conventional amplification. 
 

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4.2 
SCIENTIFIC RATIONALE FOR STUDY DESIGN 
 
Randomization for this study would be inappropriate.  Using two arms allows us to examine two groups 
of subjects with comparable pre-operative characteristics and post-operative characteristics that 
necessitate different treatment options. For each group, we are able to use a within-subjects design to 
compare interventions.  
 
4.3 
END OF STUDY DEFINITION 
 
A participant is considered to have completed the study if he or she has completed all phases of the 
study, including the last visit or the last scheduled procedure shown in the Schedule of Activities (SoA), 
Section 1.3. 
 
The end of the study is defined as completion of the last visit or procedure shown in the SoA in the trial 
globally. 
 
5 
STUDY POPULATION 
 
5.1 
INCLUSION CRITERIA 
 
ARM 1 
• 
Children between the ages of 5 and 17 years of age. 
• 
Spoken English as the primary language (speech perception testing conducted in English). 
• 
Recipient of a MED-EL SYNCHRONY Cochlear Implant device. 
• 
Pre-operative LFPTA of < 75 dB HL.    
• 
Post-operative LFPTA of < 75 dB HL.    
• 
Willing and able to participate in study procedures. 
• 
Realistic parental/patient expectations. 
• 
Composite language standard score of >60 per the OWLS II as measured within the 6 months 
prior to enrollment. 
ARM 2 
• 
Children between the ages of 5 and 17 years of age. 
• 
Spoken English as the primary language. 
• 
Recipient of a MED-EL SYNCHRONY Cochlear Implant device. 
• 
Pre-operative LFPTA of < 75 dB HL.    
• 
Post-operative LFPTA of > 75 dB HL.    
• 
Willing and able to participate in study procedures. 
• 
Realistic parental/patient expectations. 
• 
Composite language standard score of >60 per the OWLS II as measured within the 6 months 
prior to enrollment. 

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5.2 
EXCLUSION CRITERIA 
• 
Inability to perform open set speech perception due to oral motor delays. 
• 
Inability to perform test battery due to behavior. 
• 
Suspected or known cognitive impairment. 
• 
Unwilling or unable to participate in study procedures. 
• 
Cochlear nerve deficiency based on a neurotologist’s read of imaging. 
• 
Anatomical considerations that necessitated surgical modifications such as ossification, 
incomplete insertion, or placement in scala vestibuli. 
 
Potential subjects will not be excluded based on race, gender, or ethnicity, although subjects will be 
excluded if English is not the child's primary language.  The test materials in this study are presented in 
English.  
5.3 
LIFESTYLE CONSIDERATIONS 
 
There will be no lifestyle restrictions during the course of this study. 
 
5.4 
SCREEN FAILURES 
 
Screen failures are defined as participants who consent to participate in the clinical trial but are not 
subsequently assigned to the study intervention or entered in the study. A minimal set of screen failure 
information is required to ensure transparent reporting of screen failure participants, to meet the 
Consolidated Standards of Reporting Trials (CONSORT) publishing requirements and to respond to 
queries from regulatory authorities. Minimal information includes demography, screen failure details, 
eligibility criteria, and any serious adverse event (SAE). 
 
Individuals who do not meet the criteria for participation in this trial (screen failure) because of oral 
motor delays or behavioral concerns may be rescreened. Rescreened participants should be assigned 
the same participant number as for the initial screening. 
 
5.5 
STRATEGIES FOR RECRUITMENT AND RETENTION 
Potential subjects will be identified during the evaluation process for cochlear implantation at the 
Children's Cochlear Implant Center at UNC. Potential candidates may be recruited by research and/or 
clinical audiologists on the CI team and/or their implanting physician. Only those who have chosen a 
MED-EL device will be approached for inclusion. 
To offset the time and travel commitment for participation, MED-EL Corporation will provide earmolds 
and subject compensation cards during the course of the study. The SONNET/SONNET 2 EAS devices 
themselves are provided as part of the internal device package prior to enrollment.  
We anticipate enrollment of 20 subjects in Arm 1 and 20 subjects in Arm 2 (total: 40 subjects). 

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6 
STUDY INTERVENTION 
 
6.1 
STUDY INTERVENTION DESCRIPTION 
 
The MED-EL EAS System is intended to provide electric stimulation to the mid- to high-frequency region 
of the cochlea and acoustic amplification to the low frequency regions for candidates with residual low 
frequency hearing sensitivity. The combination of acoustic (hearing aid) and electrical stimulation to the 
same ear is made possible through the external SONNET/SONNET 2 EAS Processor working in 
conjunction with the internal CI.  
 
The MED-EL EAS System is not currently approved or cleared by the FDA for use in the pediatric 
population. It is limited to investigational use for the purposes of this study. All subjects will be fit with 
the SONNET/SONNET 2 EAS external audio processor. It is provided as part of the overall device kit prior 
to enrollment. There is an option to fit with or without the acoustic output. Subjects in Arm 1 with be fit 
with the acoustic output and a traditional earmold. Those in Arm 2 will be fit without the acoustic 
output.   
 
 
6.1.1 SONNET EAS AUDIO PROCESSOR 
 
6.1.1.1 WEIGHT 
 
11.3 g (including batteries) 
6.1.1.2 POWER SUPPLY 
 
2 hearing aid batteries type 675 zinc air (1.4 V), high power batteries recommended 
6.1.1.3 HARDWARE 
 
• 
Fully digital signal processing 
• 
4 Programs 
• 
Up to 12 band pass filters; filter characteristics programmable 
• 
Non-linear amplification programmable 
• 
2 omnidirectional microphones 
• 
Integrated telecoil 
• 
Audio processor self-test: checksum on programs, continuous parity check 
• 
Automatic Gain Control (AGC) configurable 
• 
FineTuner commands can selectively be disabled 
• 
Acoustic stimulation up to 2000 Hz 
• 
Fully digital hearing aid signal processing 
• 
Independent compressors in up to 7 frequency bands 
6.1.1.4 AUDIO INPUT 

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• 
Via FM Battery Pack Cover 
• 
Hearing aid type three pin connection (Euro Audio) acc. to IEC 60118–12 
• 
Sensitivity: –57.5 dBV 
• 
Impedance: 4.5 kΩ 
6.1.1.5 CONTROLS/INDICATORS 
 
• 
ON/OFF switch 
• 
Indicator light: 1 multi-color LED 
6.1.1.6 MATERIALS 
 
• 
Mixture of polycarbonate and acrylonitrile-butadiene-styrol polymer (PC/ABS): audio processor 
• 
Polyamide (PA): earhook 
6.1.1.7 TEMPERATURE AND HUMIDITY RANGE 
 
• 
Operating temperature range: 0 °C to 50 °C 
• 
Storage temperature range: –20 °C to 60 °C 
• 
Relative humidity range: 10 % to 93 % 
6.1.1.8 RADIO FREQUENCY (RF) LINK (FINETUNER) 
 
Frequency band of reception: 9.07 kHz (±3 %) 
 
6.1.2 CURRENT LABELING 
6.1.2.1 INTENDED USE AND INDICATIONS 
 
The user of a SONNET does not need any special skills or elevated level of education, however, the user 
(or custodian if the user is a child or a handicapped person not able to perform the actions listed below) 
shall at minimum be able to perform the following actions: 
 
• 
Switching ON/OFF 
• 
Changing batteries 
• 
Placing/removing SONNET on/from the ear 
• 
Placing/removing coil over/from the implant site 
 
As the SONNET is a component of the MED-EL Cochlear Implant System, all indications stated for the 
MED-EL Cochlear Implant System are applicable. 
 
To obtain optimal benefit from the CI, candidates and their families shall be sufficiently motivated and 
shall understand the importance of returning to the CI center for regular processor programming, 
assessment sessions and training. 

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6.1.2.2 CONTRA-INDICATIONS 
 
A patient must not receive a SONNET if the individual is known to be intolerant of the materials used in 
the SONNET. Combined EAS is contra-indicated for patients unable to use acoustic amplification.  
 
The SONNET and any external wireless device (e.g. FineTuner) are not intended to be used in 
environments where RF transmissions are prohibited (e.g. operating theatre). 
 
As the SONNET is a component of the MED-EL Cochlear Implant System, all contra-indications stated for 
the MED-EL Cochlear Implant System are applicable. 
 
 
6.1.3 SONNET 2 EAS AUDIO PROCESSOR 
 
6.1.3.1 WEIGHT 
 
11.0 g (including batteries) 
6.1.3.2 POWER SUPPLY 
 
2 hearing aid batteries type 675 zinc air (1.4 V), high power batteries recommended 
6.1.3.3 HARDWARE 
 
• 
Fully digital signal processing 
• 
Various parameters programmable 
• 
4 Programs selectable 
• 
Up to 12 band pass filters; filter characteristics programmable 
• 
Non-linear amplification programmable 
• 
2 omnidirectional microphones 
• 
Integrated telecoil 
• 
Audio processor self-test: checksum on programs, continuous parity check 
• 
Automatic Gain Control (AGC) configurable 
• 
FineTuner commands can selectively be disabled 
• 
Acoustic stimulation up to 2000 Hz 
• 
Fully digital hearing aid signal processing 
• 
Independent compressors in up to 7 frequency bands 
6.1.3.4 AUDIO INPUT 
 
• 
Via FM Battery Pack Cover 
• 
Hearing aid type three pin connection (Euro Audio) acc. to IEC 60118–12 
• 
Sensitivity: –57.5 dBV 
• 
Impedance: 4.5 kΩ 

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6.1.3.5 CONTROLS/INDICATORS 
 
• 
ON/OFF switch 
• 
Indicator light: 1 multi-color LED 
6.1.3.6 MATERIALS 
 
• 
Mixture of polycarbonate and acrylonitrile-butadiene-styrol polymer (PC/ABS): audio processor 
• 
Polyamide (PA): earhook 
6.1.3.7 TEMPERATURE AND HUMIDITY RANGE 
 
• 
Operating temperature range: 0 °C to 50 °C 
• 
Storage temperature range: –25 °C to 60 °C 
• 
Relative humidity range: 10 % to 93 % 
• 
Atmospheric pressure range: 700hPa (mbar) to 1060 hPa (mbar) 
6.1.3.8 RADIO FREQUENCY (RF) LINK (FINETUNER) 
 
Frequency band of reception: 9.07 kHz (±3 %) 
6.1.3.9 RADIO FREQUENCY (2.4 GHZ WIRELESS TECHNOLOGY) 
 
• 
Frequency band of reception/transmission: 2400 MHz – 2483.5 MHz 
• 
Short Range Device (SRD) according to ERC/REC 70-03 Annex 1 (band 1) and Annex 3 (band B) 
• 
Type of Modulation: Gaussian frequency shift keying (GFSK) 
• 
Maximum effective radiated power (ERP): 610μW (-2.15 dBm) 
• 
Channel band width: 2MHz (MED-EL proprietary protocol) 
• 
Channel bandwidth: 1MHz (Bluetooth) 
6.1.4 CURRENT LABELING 
6.1.4.1 INTENDED USE AND INDICATIONS 
 
The user of a SONNET 2 does not need any special skills or elevated level of education, however, the 
user (or custodian if the user is a child or a handicapped person not able to perform the actions listed 
below) shall at minimum be able to perform the following actions: 
 
• 
Switching ON/OFF 
• 
Changing batteries 
• 
Placing/removing SONNET 2 on/from the ear 
• 
Placing/removing coil over/from the implant site 
 
As the SONNET 2 is a component of the MED-EL Cochlear Implant System, all indications stated for the 
MED-EL Cochlear Implant System are applicable. 

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6.1.4.2 CONTRA-INDICATIONS 
 
A patient must not receive a SONNET 2 if the individual is known to be intolerant of the materials used 
in the SONNET 2. Combined EAS is contra-indicated for patients unable to use acoustic amplification.  
 
The SONNET 2 and any external wireless device (e.g. FineTuner) are not intended to be used in 
environments where RF transmissions are prohibited (e.g. operating room). 
 
As the SONNET 2 is a component of the MED-EL Cochlear Implant System, all contra-indications stated 
for the MED-EL Cochlear Implant System are applicable. 
 
 
6.2 
INTERVENTION SCHEDULE 
6.2.1 SCREENING  
Recipients of the MED-EL SYNCHRONY Cochlear Implant with a pre-operative LFPTA of < 75 dB HL will be 
screened for possible candidacy at initial activation of the external audio processor.  
• 
Complete the consenting process  
• 
Review of preoperative speech and language results for eligibility 
• 
Review of inclusion/exclusion criteria 
• 
Pure tone unaided thresholds in both ears, including 125 Hz 
o Assignment to Arm 1 versus Arm 2 based on hearing levels 
6.2.2 INITIAL STIMULATION (COMPLETED ON THE SAME DAY AS SCREENING) 
6.2.2.1 TESTING 
• 
Screening for eligibility (see above) 
• 
Complete the Pediatric SSQ Scale 
6.2.2.2 FITTING 
• 
Arm 1 
o Obtain RECD values and use them to fit to DSL targets through 70 dB HL audiometric 
threshold (crossover frequency). 
o Set the most apical electrode frequency boundary for 100 Hz lower than the crossover 
frequency.  
▪ 
Deviations to frequency boundaries may be allowed based on clinical 
experience and subject performance. 
o Programming using our standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4). 
o Obtain earmold impression.  

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▪ 
We will use the earmold from the hearing aids worn preoperatively for fitting at 
initial stimulation. 
• 
Arm 2 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4, default frequency boundaries). 
6.2.3 2-WEEK 
6.2.3.1 TESTING 
• 
Unaided pure tone thresholds in the implanted ear, including 125 Hz. 
• 
Soundfield thresholds, measured using warble tones, with the SONNET/SONNET 2 EAS  
o Contralateral ear plugged and masked if necessary 
6.2.3.2 FITTING 
• 
Arm 1 
o Fit to DSL targets through 70 dB HL audiometric threshold (crossover frequency) using 
measured RECDs. 
o Set the most apical electrode frequency boundary for 100 Hz lower than the crossover 
frequency. 
▪ 
Deviations to frequency boundaries may be allowed based on clinical 
experience and subject performance. 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4) 
• 
Arm 2 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4, default frequency boundaries) 
6.2.4 5-WEEK 
6.2.4.1 TESTING 
• 
Unaided pure tone thresholds in both ears, including 125 Hz. 
• 
Soundfield thresholds, measured using warble tones, with the SONNET/SONNET 2 EAS  
o Contralateral ear plugged and masked if necessary 
6.2.4.2 FITTING 
• 
Arm 1 
o Fit to DSL targets through 70 dB HL audiometric threshold (crossover frequency) using 
measured RECDs. 

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o Set the most apical electrode frequency boundary for 100 Hz lower than the crossover 
frequency. 
▪ 
Deviations to frequency boundaries may be allowed based on clinical 
experience and subject performance. 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4) 
• 
Arm 2 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4, default frequency boundaries) 
6.2.5 3-MONTH 
6.2.5.1 TESTING – TEST ORDER AND WORD LISTS RANDOMIZED 
• 
Unaided pure tone thresholds in both ears, including 125 Hz. 
• 
Soundfield thresholds, measured using warble tones, with the SONNET/SONNET 2 EAS alone 
(contralateral ear plugged and masked if necessary).  
o Arm 1 participants will be tested in their EAS Map 
o Arm 2 participants will be tested in their familiar, CI-alone map. 
• 
Soundfield testing, SONNET/SONNET 2 EAS alone (contralateral ear plugged and masked if 
necessary), 60 dB SPL, 0 degrees, EAS Map (Arm 1) or familiar, CI-alone map (Arm 2) 
o CNC Words 
o Question/Statement Test (Peng et al, 2012) 
• 
Arm 1 only: Soundfield testing, SONNET/SONNET 2 EAS alone (contralateral ear plugged and 
masked if necessary), 60 dB SPL, 0 degrees, HA portion only. 
o CNC Words 
o Question/Statement Test  
• 
Pediatric SSQ 
6.2.5.2 FITTING 
• 
Arm 1 
o Fit to DSL targets through 70 dB HL audiometric threshold (crossover frequency) using 
measured RECDs. 
o Set the most apical electrode frequency boundary for 100 Hz lower than the crossover 
frequency. 
▪ 
Deviations to frequency boundaries may be allowed based on clinical 
experience and subject performance. 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4) 
• 
Arm 2 

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o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4, default frequency boundaries) 
6.2.6 6-MONTH 
6.2.6.1 TESTING – TEST ORDER AND WORD LISTS RANDOMIZED 
• 
Unaided pure tone thresholds in both ears, including 125 Hz. 
• 
Soundfield thresholds, measured using warble tones, with the SONNET/SONNET 2 EAS alone 
(contralateral ear plugged and masked if necessary).  
o Arm 1 participants will be tested in their EAS Map 
o Arm 2 participants will be tested in a familiar, CI-alone map. 
• 
Soundfield testing, SONNET/SONNET 2 EAS alone (contralateral ear plugged and masked if 
necessary), 60 dB SPL, 0 degrees, EAS Map (Arm 1) or familiar, CI-alone map (Arm 2) 
o CNC Words 
o BKB-SIN 
• 
Arm 1 only: Soundfield testing, SONNET/SONNET 2 EAS alone (contralateral ear plugged and 
masked if necessary), 60 dB SPL, 0 degrees, HA portion only. 
o CNC Words 
o BKB-SIN 
• 
Pediatric SSQ 
6.2.6.2 FITTING 
• 
Arm 1 
o Fit to DSL targets through 70 dB HL audiometric threshold (crossover frequency) using 
measured RECDs. 
o Set the most apical electrode frequency boundary for 100 Hz lower than the crossover 
frequency. 
▪ 
Deviations to frequency boundaries may be allowed based on clinical 
experience and subject performance. 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4) 
• 
Arm 2 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4, default frequency boundaries) 
6.2.7 9-MONTH 
6.2.7.1 TESTING – TEST ORDER AND WORD LISTS RANDOMIZED 
• 
Unaided pure tone thresholds in both ears, including 125 Hz. 

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• 
Soundfield thresholds, measured using warble tones, with the SONNET/SONNET 2 EAS alone 
(contralateral ear plugged and masked if necessary).  
o Arm 1 participants will be tested in their EAS Map. 
o Arm 2 participants will be tested in a familiar, CI-alone map. 
• 
Soundfield testing, SONNET/SONNET 2 EAS alone (contralateral ear plugged and masked if 
necessary), 60 dB SPL, 0 degrees, EAS Map (Arm 1) or familiar, CI-alone map (Arm 2) 
o CNC Words 
o Question/Statement Test  
• 
Arm 1 only: Soundfield testing, SONNET/SONNET 2 EAS alone (contralateral ear plugged and 
masked if necessary), 60 dB SPL, 0 degrees, HA portion only. 
o CNC Words 
o Question/Statement Test  
• 
Pediatric SSQ 
6.2.7.2 FITTING 
• 
Arm 1 
o Fit to DSL targets through 70 dB HL audiometric threshold (crossover frequency) using 
measured RECDs. 
o Set the most apical electrode frequency boundary for 100 Hz lower than the crossover 
frequency. 
▪ 
Deviations to frequency boundaries may be allowed based on clinical 
experience and subject performance. 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4) 
• 
Arm 2 
o Programming using standard clinic procedures and software defaults (natural 
directionality, mild wind noise reduction, FS4, default frequency boundaries) 
6.2.8 12-MONTH 
6.2.8.1 TESTING – TEST ORDER AND WORD LISTS RANDOMIZED 
• 
Unaided pure tone thresholds in both ears, including 125 Hz. 
• 
Soundfield thresholds, measured using warble tones, with the SONNET/SONNET 2 EAS alone 
(contralateral ear plugged and masked if necessary).  
o Arm 1 participants will be tested in their EAS Map. 
o Arm 2 participants will be tested in a familiar, CI-alone map.  
• 
Soundfield testing, SONNET/SONNET 2 EAS alone (Arm 1) or SONNET/SONNET 2 (Arm 2) 
(contralateral ear plugged and masked if necessary), 60 dB SPL, 0 degrees, EAS Map (Arm 1) or 
familiar, CI-alone map (Arm 2) 
o CNC Words 

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o BKB-SIN 
o Question/Statement Test  
• 
Arm 1 only: Soundfield testing, SONNET/SONNET 2 EAS alone (contralateral ear plugged and 
masked if necessary), 60 dB SPL, 0 degrees, HA portion alone. 
o CNC Words 
o BKB-SIN 
o Question/Statement Test  
• 
Pediatric SSQ 
• 
OWLS II 
• 
GFTA III 
6.2.8.2 FITTING 
• 
Program based on best practices and standard clinical procedures based on the results of 
today’s testing. 
6.3 
ACCOUNTABILITY 
 
The MED-EL SONNET/SONNET 2 EAS is routinely fit off-label in our practice and can be ordered as part 
of the initial stimulation kit. These kits are ordered at the time of surgery, prior to enrollment. 
Registration of these devices is kept as part of the medical file. The specific device serial numbers will be 
kept in the regulatory binder as well. 
 
7 
PARTICIPANT DISCONTINUATION/WITHDRAWAL 
 
7.1 
PARTICIPANT DISCONTINUATION/WITHDRAWAL FROM THE STUDY 
Subjects in Arm 1 may be moved to Arm 2. If a subject loses residual hearing and no longer falls within 
the inclusion criteria, they will remain enrolled in the study, but will be shifted to Arm 2.  
An investigator may discontinue or withdraw a participant from the study for the following reasons: 
 
• 
Significant study intervention non-compliance  
• 
If any clinical adverse event (AE) or other medical condition or situation occurs such that 
continued participation in the study would not be in the best interest of the participant 
• 
If the participant meets an exclusion criterion (either newly developed or not previously 
recognized) that precludes further study participation 
The reason for participant discontinuation or withdrawal from the study will be recorded. Subjects who 
sign the informed consent form and are assigned but do not receive the study intervention may be 
replaced.  Subjects who sign the informed consent form, and are assigned and receive the study 
intervention, and subsequently withdraw, or are withdrawn or discontinued from the study, will be 
replaced. 

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Subjects will continue to be followed for regular CI programming by the clinical CI team if they are 
withdrawn.  Data collection for this study will stop following withdrawal. 
 
7.2 
LOST TO FOLLOW-UP 
 
A participant will be considered lost to follow-up if he or she fails to return for 5 months and is unable to 
be contacted by the study site staff.  
 
The following actions must be taken if a participant fails to return to the clinic for a required study visit: 
• 
The site will attempt to contact the participant and reschedule the missed visit within 3 working 
days and counsel the participant on the importance of maintaining the assigned visit schedule 
and ascertain if the participant wishes to and/or should continue in the study. 
• 
Before a participant is deemed lost to follow-up, the investigator or designee will make every 
effort to regain contact with the participant (where possible, 3 telephone calls and, if necessary, 
a letter to the participant’s last known mailing address or local equivalent methods). These 
contact attempts should be documented in the participant’s medical record or study file.  
• 
Should the participant continue to be unreachable, he or she will be considered to have 
withdrawn from the study with a primary reason of lost to follow-up. 
 
8 
STUDY ASSESSMENTS AND PROCEDURES 
 
8.1 
EFFICACY ASSESSMENTS  
 
BKB-SIN: The BKB-SIN is a speech-in noise test that uses the BKB (Bamford-Kowal-Bench) sentences, 
recorded in four-talker babble.  The BKB-SIN is quick and easy to administer and score, contains age-
related norms for children, is suitable for CI users, and is less susceptible to ceiling effects. 
 
CNC: A standardized word list comprised of 50 words with consonant-vowel-consonant construction ie, 
Consonant-Nucleus-Consonant (CNC) words (Peterson & Lehiste, 1962).  The CNC test assesses 
perception of monosyllabic words. The test includes 10 lists of 50 words each. Each word is preceded by 
a carrier word “ready.”  
 
Desired Sensation Level (DSL): The DSL Method was originally developed to provide audiologists with a 
systematic, science-based approach to pediatric hearing instrument fitting that ensures audibility of 
amplified speech by accounting for factors that are uniquely associated with the provision of 
amplification to infants and young children who have hearing loss (Seewald, Ross and Spiro, 1985; Ross 
and Seewald, 1988; Seewald and Ross, 1988). 
 
Goldman-Fristoe Test of Articulation (3rd Ed) (GFTA 3): This test is administered to assess a child’s 
phoneme production in single words. Standard scores are based on a mean of 100 and standard 
deviation of 15. 
 
Leiter-R: The Leiter International Performance Scale-Revised (Roid & Miller, 1997) is a nonverbal 
measure of intellectual functioning normed for individuals between the ages of 2 years 0 months and 20 
years 11 months.  
 

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Oral and Written Language Scales (2nd Ed) (OWLS II): This test assesses receptive (understanding of 
language) and expressive (use of language) language for children and young adults aged 3 through 21 
years. Standard scores are based on a mean of 100 and standard deviation of 15.  
 
Speech, Spatial and Qualities of Hearing Scale (SSQ): (Gatehouse & Noble, 2004). The SSQ 
questionnaire assesses performance in three domains, hearing speech in quiet and noise environments 
(9 items), spatial or directional hearing (5 items) and sound qualities (8 items), which address sound 
segregation and listening effort. Each item is rated on a 10-point scale. Domain scores represent an 
average of item ratings. There is a version for children that will be used for this study.  
 
The Question/Answer Task (Peng et al, 2012): Evaluates a listener’s ability to identify statements vs 
questions using listening alone. 
   
8.2 
ADVERSE EVENTS AND SERIOUS ADVERSE EVENTS 
 
8.2.1 DEFINITION OF ADVERSE EVENTS (AE) 
 
Adverse event means any untoward medical occurrence associated with the use of an intervention in 
humans, whether or not considered intervention-related (21 CFR 312.32 (a)). 
 
Anticipated Events: those events described as potential risks in the protocol. 
 
Unanticipated Events: Events not reported as potential risks. 
 
8.2.2 DEFINITION OF SERIOUS ADVERSE EVENTS (SAE)  
 
Unanticipated serious adverse events are defined as any serious adverse event related to the health or 
safety or any life-threatening problem or death caused by, or associated with, a device, if that event, 
problem, or death that was not previously defined in nature, severity, or degree of incidence in the 
literature or investigational plan. It can also include any other unanticipated serious problem associated 
with a device that relates to the rights, safety or welfare of participants. 
 
Serious Adverse Event: Serious injury means an injury or illness that: 1) is life-threatening, 2) results in 
permanent impairment of a body function or permanent damage to a body structure, or 3) necessitates 
medical or surgical intervention to preclude permanent impairment to a body function or permanent 
damage to a body structure.  
 
Permanent means an irreversible impairment or damage to a body structure or function, excluding 
trivial impairment or damage.  
 
8.2.3 ADVERSE EVENT REPORTING  
 
All adverse events will be recorded and tracked using an Adverse Event Report Form.  These forms will 
be reviewed by the sponsor/PI and will be followed until satisfactory resolution. Frequent adverse 
events will be discussed with co-investigators. 
 
Anticipated events will be reported to the IRB in the annual report. 

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Unanticipated events will be reported to the IRB within 10 days of the investigator becoming aware of 
the event. 
 
8.2.4 SERIOUS ADVERSE EVENT REPORTING  
 
The study investigator shall complete a Serious Adverse Event Form and submit to the study sponsor/PI 
and to the reviewing Institutional Review Board (IRB) as soon as possible, but in no event later than 10 
working days after the investigator first learns of the effect.  The study sponsor/PI is responsible for 
conducting an evaluation of an SAE and shall report the results of such evaluation to the IRB and 
participating investigators within 10 working days after the sponsor/PI first receives notice of the effect. 
Thereafter, the sponsor shall submit such additional reports concerning the effect as the IRB requests. 
 
All SAEs will be followed until satisfactory resolution or until the site investigator deems the event to be 
chronic or the participant is stable. Other supporting documentation of the event may be requested by 
the study sponsor/PI and should be provided as soon as possible. 
 
9 
STATISTICAL CONSIDERATIONS  
 
9.1 
SAMPLE SIZE DETERMINATION 
• 
A power calculation utilizing CNC scores obtained from the pilot data determined that a 
minimum of 9 evaluable subjects would provide at least 90% power. A sample size of 20 
participants per arm was selected due to known variability in pediatric CI recipient outcomes 
and the possibility of those with progressive loss moving from Arm 1 to Arm 2. Sample size was 
calculated via G*Power 3.1.9.2 and the following assumptions were made: 
o Paired t-tests 
o One-sided 0.05 alpha levels 
o Desire for 90% power 
o Assumed distribution (mean, standard deviation) based on pilot data. 
9.2 
STATISTICAL PLAN 
 
• 
Descriptive summaries will be provided for the following:  
o Participant demographics 
o Frequency of major and minor complications/adverse events. 
• 
A single-subject design will be utilized, where each participant serves as his or her own control, 
for analysis of objective and subjective results. A single-subject design was chosen in order to 
accommodate the heterogeneity that is well known to characterize auditory prosthesis 
research.  
• 
Considering the possibility of subjects moving from Arm 1 to Arm 2, mixed-design ANOVA will be 
calculated with a p-value of ≤ 0.05 for statistical significance.  
• 
Effect sizes and confidence intervals of 95% will be calculated and reported for primary 
endpoints. 

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• 
Normality will be evaluated based on visual inspection of the data and using Kolmogorov-
Smirnov test.  These steps will be used prior to all statistical analyses at the 12-month endpoint.. 
• 
Bonferroni corrections for multiple tests (n=2) will be applied to analyses of the primary 
endpoints. 
• 
Statistical analysis will be conducted with SPSS software. 
• 
The following measures will be analyzed: 
o Comparison of CNC scores between conditions and groups. 
o The distributions of CNC word scores will be evaluated for assumptions of normality.  
Depending on the outcome, comparisons will be made with paired t-test or Mann-
Whitney test. Comparison of BKB-SIN scores between conditions and groups. 
▪ 
The SNR-50 score is computed based on an algorithm that is implemented in the 
test materials.  It is an estimate of the signal-to-noise ratio associated with 50% 
correct based on word-level scoring. 
▪ 
Distributions will be evaluated for assumptions of normality.  Depending on the 
outcome, comparisons will be made with paired t-test or Mann-Whitney test. 
o Comparison of Pediatric SSQ subjective report scores in the pre- and post-initial 
activation intervals.  
o The distributions Pediatric SSQ scores will be evaluated for assumptions of normality.  
Depending on the outcome, comparisons will be made with paired t-test or Wilcoxon 
Signed Rank test. Comparison of pre- and post-operative speech and language scores 
(OWLS II and GFTA) between groups. 
▪ 
The distributions of articulation and language scores will be evaluated for 
assumptions of normality.  Depending on the outcome, comparisons will be 
made with paired t-test or Mann-Whitney test. 
o Comparison of prosodic discrimination abilities between conditions and groups. 
• 
If needed, statistical consultation will be sought from the North Carolina Translational and 
Clinical Sciences Institute (TraCS) or UNC Odum Institute. 
10 SUPPORTING DOCUMENTATION AND OPERATIONAL CONSIDERATIONS 
 
10.1 REGULATORY, ETHICAL, AND STUDY OVERSIGHT CONSIDERATIONS 
 
10.1.1 INFORMED CONSENT PROCESS 
 
10.1.1.1 CONSENT/ASSENT AND OTHER INFORMATIONAL DOCUMENTS PROVIDED TO 
PARTICIPANTS 
 
 
Consent forms describing in detail the study intervention, study procedures, and risks are given to the 
participant’s parent(s)/guardian(s) and written documentation of informed consent is required prior to 
starting intervention.  Assent forms will be given to subjects over the age of 7.  Signed copies will be 
given to participants. 
 
10.1.1.2 CONSENT PROCEDURES AND DOCUMENTATION 
 
Informed consent is a process that is initiated prior to the individual’s agreeing to participate in the 
study and continues throughout the individual’s study participation. Consent and assent forms will be 

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Institutional Review Board (IRB)-approved, and the participant will be asked to read and review the 
document. The investigator will explain the research study to the participant and family and answer any 
questions that may arise. A verbal explanation will be provided in terms suited to the participant’s 
comprehension of the purposes, procedures, and potential risks of the study and of their rights as 
research participants.  Participants will have the opportunity to carefully review the written consent and 
assent forms and ask questions prior to signing. The participants should have the opportunity to discuss 
the study with their family or surrogates or think about it prior to agreeing to participate. The 
participant will sign the informed consent document prior to any procedures being done specifically for 
the study. Participants must be informed that participation is voluntary and that they may withdraw 
from the study at any time, without prejudice. A copy of the informed consent document and assent 
form will be given to the participants’ guardian for their records. The informed consent process will be 
conducted and documented in the source document (including the date), and the form signed, before 
the participant undergoes any study-specific procedures. The rights and welfare of the participants will 
be protected by emphasizing to them that the quality of their medical care will not be adversely affected 
if they decline to participate in this study. Communication will occur in a closed-door room at the 
Children’s Cochlear Implant Center and/or the Clinical Research Lab at the Children’s Cochlear Implant 
Center. 
 
10.1.2 CONFIDENTIALITY AND PRIVACY  
 
Participant confidentiality and privacy is strictly held in trust by the participating investigators. All 
research activities will be conducted in as private a setting as possible. 
 
Representatives of the Institutional Review Board (IRB), regulatory agencies, or the manufacturer may 
inspect all documents and records required to be maintained by the investigator. The clinical study site 
will permit access to such records. When data is pulled from the database for analysis, no identifying 
information will be kept with the data. 
 
Upon enrollment, all subjects will be assigned an anonymous subject ID.  The subject ID will be stored in 
a password protected FileMaker database housed on a UNC server. This will be linked to the subject’s 
name, but this information is only viewable by study personnel. The study coordinator will enter all of 
the subject’s demographic information and test results into this database. All personal identifiers will be 
kept separate from the study data. 
 
Subject specific binders will be maintained in a locked cabinet in the Children’s Cochlear Implant Center. 
Individual data collection sheets will be coded with the subject number, and placed in the subject 
specific binder at each interval.  
 
10.1.3 QUALITY CONTROL 
 
We will perform internal quality management of documentation and completion.  An individualized 
quality management plan will be developed. 
 
Quality control (QC) procedures will be implemented beginning with the data entry system and data QC 
checks that will be run on the database will be generated. Any missing data or data anomalies will be 
communicated with the investigator for clarification/resolution. 
 

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10.1.4 DATA HANDLING AND RECORD KEEPING  
 
10.1.4.1 DATA COLLECTION AND MANAGEMENT RESPONSIBILITIES  
 
Subjects will be assigned a specific alpha-numeric participation code upon enrollment. The linkage file 
for that code will be stored in a password protected, customized FileMaker database secured on UNC 
servers. Only co-investigators will have access to this file. 
 
Data collection is the responsibility of the clinical trial staff under the supervision of the PI. Each 
investigator is responsible for ensuring the accuracy, completeness, legibility, and timeliness of the data 
reported.  All source documents should be completed in a neat, legible manner to ensure accurate 
interpretation of data.   
 
The data will be recorded on Case Report Forms (CRFs) in patient-specific binders on a case-by case 
basis after each subject encounter. CRFs and source documents will not contain identifiable information. 
Hardcopies of the CRFs and source documents will be maintained in the study binders.  Data recorded 
on Case Report Forms should be consistent with the data recorded on the source documents. The study 
coordinator will verify consistency. Subject binders will be stored in a locked cabinet at The Children’s 
Cochlear Implant Center at UNC. 
 
Clinical data (including adverse events (AEs)) will be entered into the FileMaker database. Only co-
investigators will have access to this data. The data system includes password protection and internal 
quality checks, such as automatic range checks, to identify data that appear inconsistent, incomplete, or 
inaccurate. A customized database will be used for this study. Only subject IDs will be used when 
entering data. Clinical data will be entered directly from the CRFs. 
 
The co-investigators will be responsible for data entry and for cross checking data for accuracy.  At the 
time of data analysis the data will be exported by desired field to an Microsoft Excel spreadsheet for 
further analysis.   Any use of the data outside of the database will employ the subject ID and will not 
include personal identifiers 
 
10.1.4.2 STUDY RECORDS RETENTION  
 
After the closure of the study, subject data will be retained for seven years. At that time, paper data will 
be shredded and destroyed in a HIPAA compliant manner. Electronic data will be destroyed following 
UNC policy. 
 
10.1.5 PROTOCOL DEVIATIONS  
 
A protocol deviation is any noncompliance with the clinical trial protocol, International Conference on 
Harmonisation Good Clinical Practice (ICH GCP), or Manual of Procedures (MOP) requirements. The 
noncompliance may be either on the part of the participant, the investigator, or the study site staff. As a 
result of deviations, corrective actions are to be developed by the site and implemented promptly.  
 
These practices are consistent with ICH GCP:  
• 
4.5 Compliance with Protocol, sections 4.5.1, 4.5.2, and 4.5.3  
• 
5.1 Quality Assurance and Quality Control, section 5.1.1  

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• 
5.20 Noncompliance, sections 5.20.1, and 5.20.2.  
 
It is the responsibility of the site investigator to use continuous vigilance to identify and report 
deviations within 5 working days of identification of the protocol deviation, or within 10 working days of 
the scheduled protocol-required activity.  All deviations must be addressed in study documents.  
Protocol deviations will be reported to the IRB as part of the annual report. 
 
10.2 PROTOCOL AMENDMENT HISTORY 
 
Version 
Date 
Description of Change  
Brief Rationale 
V1.1 
11/21/17 
Incorporated Scientific Review 
Committee suggestions 
 
V1.2 
5/4/2018 
Will be doing the Pediatric SSQ 
rather than the Peds-QL 
Peds QL is not proving to be a 
good measure of fatigue in 
another ongoing study. The 
pediatric SSQ is providing much 
more valid data. 
V1.3 
9/22/2018 
Testing in HA condition rather than 
CI alone in Arm 1 participants 
This will allow us to compare to 
pre-operative scores and 
account for developmental 
aspects. In addition, the CI 
alone condition would be novel 
and unfamiliar in this group, 
likely making for an invalid 
measurement. We can instead 
use the Arm 2 participants for 
comparison as they will have 
adapted to a full CI program. 
V1.4 
11/1/2018 
Changing inclusion criteria to include 
5-year-olds and children with a 
composite language score down to 
60. 
Effort to ease recruitment. Five-
year-olds with residual hearing 
are capable of completing the 
test protocol. Many potential 
candidates have language skills 
that are poorer than we 
expected, and we want to be 
able to include these children 
and measure changes in 
language abilities as well. A 
standard score of 60 would 
avoid floor effects and still 
include children who are able to 
complete the test protocol. 
V1.5 
11/18/2019 
Changing exclusion criteria to specify 
that a neurotologist will read scans 
of potential candidates under a 
waiver of HIPAA to confirm a lack of 
cochlear nerve deficiency. 
This change is in response to 
the withdrawal of a subject who 
was noted to have CND after 
enrolment. 

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V1.6 
12/3/2019 
Added SONNET 2 EAS as a device. 
Removed Maestro 7 as a device and 
changed to simply include the 
Maestro System. 
SONNET 2 EAS has been FDA 
approved and will be arriving in 
patient kits. It is an updated 
version of the SONNET EAS 
device. Maestro 7 is no longer 
considered experimental and 
we will be using the FDA 
approved versions of the 
software from this point on as 
they now provide what we 
need to fit the EAS devices. 
V1.7 
5/18/2020 
Removing Leiter-R from protocol and 
changing exclusion criteria to read 
“known or suspected cognitive 
impairment.”  
 
Changing screening procedures. 
The Leiter-R has proven to be 
an unnecessary and 
cumbersome measure. For 
safety measures in light of 
COVID-19 it is being removed as 
a screening tool.  
 
To ease scheduling difficulties 
in light of COVID-19, 
investigators may reach out to 
potential candidates prior to 
initial stimulation to discuss the 
study and schedule initial 
stimulation visits appropriately. 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
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12 ABBREVIATIONS 
 
CI 
Cochlear Implant 
EAS 
Electric-Acoustic Stimulation 
CNC 
Consonant-Nucleus-Consonant  
BKB-SIN 
Bamford-Kowal-Bench - Speech in Noise Test 
Pediatric SSQ 
Pediatric Speech, Spatial, and Qualities 
Questionaire 
GFTA 3 
Goldman Fristoe Test of Articulation – 3rd edition 
OWLS II 
Oral and Written Language Scales – 2nd edition 
LFPTA 
Low Frequency Pure Tone Average (Average of 
thresholds at 125, 250, and 500 Hz) 
CRF 
Case Report Form 
RIC 
Receiver in the Canal 
SNR-50 
Signal to Noise Ratio required for 50% 
performance 
SoA 
Schedule of Activities 
CONSORT 
Consolidated Standards of Reporting Trials 
SAE 
Serious Adverse Event 
AGC 
Automatic Gain Control 
dB 
Decibel 
SPL 
Sound Pressure Level 
HL 
Hearing Level 
V 
Volts 
Hz 
Hertz 
Ω 
Ohms 
KHz 
KiloHertz 
G 
Grams 
RECD 
Real Ear to Coupler Difference 
DSL 
Desired Sensation Level 
RF 
Radio Frequency 
FS4 
Fine Structure 4 channel 
P1, P2, etc. 
Program 1, Program 2, etc. 
AE 
Adverse Event 
PI 
Primary Investigator 
IRB 
Institutional Review Board 
HA 
Hearing Aid