PI: Gifford, Rene H Title: Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, 

and Literacy 

Received: 08/16/2018 FOA: PA18-334 

Clinical Trial:Required 

Council: 01/2019 

Competition ID: FORMS-E FOA Title: NIDCD Clinical Trials in Communication Disorders (R01-Clinical Trial 

Required) 

1 R01 DC017683-01A1 Dual: Accession Number: 4206008 

IPF: 10040927 Organization: VANDERBILT UNIVERSITY MEDICAL CENTER 

Former Number: Department: Hearing And Speech Sciences 

IRG/SRG: LCOM AIDS: N Expedited: N 

Subtotal Direct Costs 

(excludes consortium F&A) 

Year 1: 

Year 2: 

Year 3: 

Year 4: 

Year 5: 

Animals: N 

Humans: Y 

Clinical Trial: Y 

Current HS Code: 30 

HESC: N 

New Investigator: N 

Early Stage Investigator: N 

Senior/Key Personnel: Organization: Role Category: 

Rene Gifford Vanderbilt University Medical Center PD/PI 

Stephen Camarata Vanderbilt University Medical Center MPI 

Robert Labadie Vanderbilt University Medical Center Other (Specify)-Co-Investigator 

Jack Noble Vanderbilt University Other (Specify)-Co-Investigator 

Benoit Dawant Vanderbilt University Other (Specify)-Co-Investigator 

Mary Dietrich Vanderbilt University Other (Specify)-Co-Investigator 

Susan Nittrouer University of Florida Other (Specify)-Consultant 

Ferenc Bunta The University of Houston Other (Specify)-Consultant 
OMB Number 4040-0001 

Expiration Date 10/31/2019 

Funding Opportunity Number: PA-18-334 . Received Date: 

2018-08-16T11:14:30.000-04:00 

3. DATE RECEIVED BY STATE State Application Identifier 

4.a. Federal Identifier 

DC017683

b. Agency Routing Number 

c. Previous Grants.gov Tracking Number 

Organizational DUNS*: 

Last Name*: Brown Suffix: 

Email 

M: Nonprofit with 501C3 IRS Status (Other than Institution of Higher

Education)

 Women Owned ❍ Socially and Economically Disadvantaged 

If Revision, mark appropriate box(es). 

 A. Increase Award ❍ B. Decrease Award ❍ C. Increase Duration 

 D. Decrease Duration ❍ E. Other (specify) :

No What other Agencies? 

10. CATALOG OF FEDERAL DOMESTIC ASSISTANCE NUMBER 

TITLE: NIDCD Clinical Trials in Communication Disorders (R01-Clinical 

Trial Required) 

Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and Literacy

13. CONGRESSIONAL DISTRICTS OF APPLICANT 

 Page 1

 

 

APPLICATION FOR FEDERAL ASSISTANCE 

SF 424 (R&R) 

1. TYPE OF SUBMISSION* 

❍ Pre-application ● Application ❍ Changed/Corrected 

Application 

2. DATE SUBMITTED Application Identifier 

2018-08-16 M0050027

5. APPLICANT INFORMATION 

Legal Name*: Vanderbilt University Medical Center

Department: Hearing And Speech Sciences

Division: School of Medicine

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province: 

Country*: USA: UNITED STATES

ZIP / Postal Code*: 

Person to be contacted on matters involving this application 

Prefix: First Name*: Donald Middle Name: Clinton

Position/Title: Director, Office of Sponsored Programs

Street1*: 

Street2: 

City*: 

County: 

State*: 

Province: 

Country*: USA: UNITED STATES

ZIP / Postal Code*: 

Phone Number*: Fax Number: 

6. EMPLOYER IDENTIFICATION NUMBER (EIN) or (TIN)* 

7. TYPE OF APPLICANT* 

Other (Specify): 

Small Business Organization Type ❍ 

8. TYPE OF APPLICATION* 

❍ New ● Resubmission 

❍ Renewal ❍ Continuation ❍ Revision 

❍ 

❍ 

Is this application being submitted to other agencies?* ❍Yes 

9. NAME OF FEDERAL AGENCY* 

National Institute on Deafness and Other Communication Disor

11. DESCRIPTIVE TITLE OF APPLICANT'S PROJECT* 

12. PROPOSED PROJECT 

Start Date* Ending Date* 

04/01/2019 03/31/2024

● 

Tracking Number: GRANT12696653 
Contact PD/Pl: Gifford, Rene H 

SF 424 (R&R) APPLICATION FOR FEDERAL ASSISTANCE Page 2 

14. PROJECT DIRECTOR/PRINCIPAL INVESTIGATOR CONTACT INFORMATION 

Prefix: First Name·: Rene Middle Name: H Last Name·: Gifford Suffix: 

Position/Title: Professor 

Organization Name•: Vanderbilt University Medical Center 

Department: Hearing And Speech Sciences 

Division: School of Medicine 

Street1•: 

Street2: 

City•: 

County: 

State•: 

Province: 

Country•: USA: UNITED STATES 

ZIP / Postal Code·: -

Phone Number·:- Fax Number:- Email•: 

15. ESTIMATED PROJECT FUNDING 16.IS APPLICATION SUBJECT TO REVIEW BY STATE 

EXECUTIVE ORDER 12372 PROCESS?* 

a. YES Q THIS PREAPPLICATION/APPLICATION WAS MADE 

a. Total Federal Funds Requested· AVAILABLE TO THE STATE EXECUTIVE ORDER 12372 

b. Total Non-Federal Funds· PROCESS FOR REVIEW ON: 

c. Total Federal & Non-Federal Funds· DATE: 

d. Estimated Program Income· b. NO e PROGRAM IS NOT COVERED BY E.O. 12372; OR 

Q PROGRAM HAS NOT BEEN SELECTED BY STATE FOR 

REVIEW 

17. By signing this application, I certify (1) to the statements contained in the list of certifications* and (2) that the statements herein 

are true, complete and accurate to the best of my knowledge. I also provide the required assurances * and agree to comply with 

any resulting terms if I accept an award. I am aware that any false, fictitious, or fraudulent statements or claims may subject me to 

criminal, civil, or administrative penalties. (U.S. Code, Title 18, Section 1001) 

e I agree• 

• The list of certifications and assurances, or an Internet site where you may obtain this list, is contained in the announcement or agency specific instructions. 

18. SFLLL or OTHER EXPLANATORY DOCUMENTATION File Name: 

19. AUTHORIZED REPRESENTATIVE 

Prefix: First Name·: Donald Middle Name: Clinton Last Name·: Brown Suffix: 

Position/Title•: Director, Office of Sponsored Programs 

Organization Name•: Vanderbilt University Medical Center 

Department: Office of Sponsored Programs 

Division: 

Street1•: 

Street2: 

City•: 

Co

State•

unty

: 

: 

-

Province: 

Country•: USA: UNITED STATES 

ZIP / Postal Code·: -

Phone Number·:- Fax Number:- Email•: 

Signature of Authorized Representative* Date Signed* 

Brown.Donald Clinton 08/16/2018 

20. PRE-APPLICATION File Name: 

21. COVER LETTER ATTACHMENT File Name:M-13_RRSF424_Cover_Letter.pdf 

Funding Opportunity Number: PA-18-334 . Received Date: Tracking Number: GRANT12696653 

Page2 2018-08-16T11:1430.000-04:00
Contact PD/PI: Gifford, Rene H Table of Contents 

424 R&R and PHS-398 Specific 

Table Of Contents 

SF 424 R&R Cover Page............................................................................................................1 

Table of Contents...................................................................................................................3 

Performance Sites.....................................................................................................................4 

Research & Related Other Project Information......................................................................5 

Project Summary/Abstract(Description)..............................................................................6 

Project Narrative....................................................................................................................7 

Facilities & Other Resources................................................................................................8 

Equipment.............................................................................................................................10 

Research & Related Senior/Key Person................................................................................12 

Research & Related Budget Year - 1......................................................................................56 

Research & Related Budget Year - 2......................................................................................59 

Research & Related Budget Year - 3......................................................................................62 

Research & Related Budget Year - 4......................................................................................65 

Research & Related Budget Year - 5......................................................................................68 

Budget Justification................................................................................................................71 

Research & Related Cumulative Budget...............................................................................74 

Research & Related Budget - Consortium Budget (Subaward 1).......................................75 

Total Direct Costs Less Consortium F&A.............................................................................92 

PHS398 Cover Page Supplement...........................................................................................93 

PHS 398 Research Plan...........................................................................................................95 

Introduction to Application.................................................................................................96 

Specific Aims........................................................................................................................97 

Research Strategy................................................................................................................98 

PHS Human Subjects and Clinical Trials Information....................................................110 

Study 1: Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, 

Literacy............................................................................................................................112 

Inclusion Enrollment Reports....................................................................................119 

Multiple PD/PI Leadership Plan........................................................................................134 

Bibliography & References Cited.....................................................................................135 

Consortium/Contractual Arrangements...........................................................................143 

Letters of Support..............................................................................................................145 

Resource Sharing Plan(s).................................................................................................147 

 Page 3
Contact PD/Pl: Gifford, Rene H 0MB Number: 4040-0010 

Expiration Date: 10/31/2019 

Project/Performance Site Location(s) 

Project/Performance Site Primary Location O I am submitting an application as an individual, and not on behalf of 

a company, state, local or tribal government, academia, or other type of 

organization. 

Organization Name: Vanderbilt University Medical Center 

Duns Number: 

Street1•: 

Street2: 

City•: 

County: 

State•: 

Province: 

Country•: USA: UNITED STATES 

Zip / Postal Code•: 

Project/Performance Site Co

-

ngressional District-: -

Project/Performance Site Location 1 O I am submitting an application as an individual, and not on behalf of 

a company, state, local or tribal government, academia, or other type of 

organization. 

Organization Name: 

DUNS Number: 

Vanderbilt University

St

St

r

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eet

eet2: 

1•: 

-

City•: 

County: 

State•: 

Province: 

Country•: USA: UNITED STATES 

Zip / Postal Code•: 

Project/Performance Site Co

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ngressional District-: -

Additional Location(s) File Name: 

Page 4 

Tracking Numbe Funding Opportunity Number: PA-18-334. Received Date: r: GRANT12696653 

2018-08-16T11 :14 :30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334. Received Date: 

OMB Number: 4040-0001

Expiration Date: 10/31/2019

RESEARCH & RELATED Other Project Information

Are Human Subjects Involved?* ● Yes ❍ No 

1.a. If YES to Human Subjects 

Is the Project Exempt from Federal regulations? ❍ Yes ● No 

If YES, check appropriate exemption number: 1 2 3 4 5 6 7 8 

If NO, is the IRB review Pending? ● Yes ❍ No 

IRB Approval Date: 

Human Subject Assurance Number 00005756

Are Vertebrate Animals Used?* ❍ Yes ● No 

2.a. If YES to Vertebrate Animals 

Is the IACUC review Pending? ❍ Yes ❍ No 

IACUC Approval Date: 

Animal Welfare Assurance Number 

Is proprietary/privileged information included in the application?* ❍ Yes ● No 

4.a. Does this project have an actual or potential impact - positive or negative - on the environment?* ❍ Yes ● No 

4.b. If yes, please explain: 

4.c. If this project has an actual or potential impact on the environment, has an exemption been authorized or an 

environmental assessment (EA) or environmental impact statement (EIS) been performed? 

❍ Yes ❍ No 

4.d. If yes, please explain: 

Is the research performance site designated, or eligible to be designated, as a historic place?* ❍ Yes ● No 

5.a. If yes, please explain: 

Does this project involve activities outside the United States or partnership with international 

collaborators?* 

❍ Yes ● No 

6.a. If yes, identify countries: 

6.b. Optional Explanation: 

Filename 

Project Summary/Abstract* M-5_Project_Summary.pdf

Project Narrative* M-1_Narrative.pdf

Bibliography & References Cited M-4_Bibliography.pdf

10.Facilities & Other Resources M-2_Facilities.pdf

11.Equipment M-3_Equipment.pdf

Contact PD/PI: Gifford, Rene H 

1. 

2. 

3. 

5. 

6. 

7. 

8. 

9. 

 Page 5 2018-08-16T11:14:30.000-04:00 
PROJECT SUMMARY 

Although the recent literature has indicated that children receiving cochlear implants (CIs) often have 

dramatically improved speech and language ability relative to previous generations of children with hearing 

loss, many pediatric CI recipients display persistent speech and language disorders despite early implantation 

and associated speech/language intervention. There is a striking paucity and ongoing need for studies that 

systematically examine the relationship between intracochlear electrode location, audiological profile, and 

subsequent phonological awareness, speech, language, and literacy in pediatric CI recipients. This project 

provides a unique opportunity to examine whether individualized, image guided CI programming (IGCIP) 

significantly improves outcomes in pediatric CI patients. The proposed research activities will examine the 

impact of personalized IGCIP in pediatric CI recipients on measures of basic auditory function (spectral, 

temporal, and spectrotemporal resolution), word and non word recognition, speech production, language, 

phonological awareness, and reading comprehension using a double blind, waitlist control randomized clinical 

trial (RCT) design. A total sample of 72 children with CIs aged six to twelve years old will be enrolled in the 

project: half (n 36) will be randomized to an immediate IGCIP condition and half to a waitlist control condition. 

The waitlisted participants (n 36) will undergo IGCIP after 12 months of monitoring and then followed for an 

additional 12 months after intervention (total time in the study for both groups: 24 months). Those immediately 

provided with IGCIP will also be followed for a total of 24 months. All participants will undergo extensive 

audiological assessment as well as tests of phonological awareness, speech, language, and literacy at 

baseline as well as at regular intervals: 2, 6, 12, 14, 18, and 24 months. We will use predictor analyses to 

determine the impact of immediate and deferred IGCIP on subsequent auditory, speech, language, and literacy 

outcomes. 

Contact PD/PI: Gifford, Rene H Project Summary/Abstract Page 6

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PROJECT NARRATIVE 

Despite significant advancements in technology and outcomes, pediatric cochlear implant (CI) recipients 

display persistent delay on measures of speech, language, and literacy despite early implantation and 

extensive speech/language intervention. Most CI recipients are programmed using a one size fits all approach 

to setting upper and lower stimulation levels, maximum number of active electrical contacts, and selection of 

various signal processing parameters for electrical stimulation of the auditory system. Our interdisciplinary 

research team will examine the impact of a personalized, image guided approach to CI programming and its 

effect on auditory processing, speech recognition, speech production, phonological processing, language, and 

literacy. 

Contact PD/PI: Gifford, Rene H Project Narrative Page 7

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Contact PD/Pl: Gifford, Rene H 

FACILITIES AND RESOURCES 

Vanderbilt University Medical Center and Vanderbilt University are both ideally suited for the proposed 

project. The Vanderbilt Bill Wilkerson Center located on the Vanderbilt University Medical Center campus has a 

large cochlear implant program which has recently been estimated to be the third largest implant program in the 

United States. Over the past three years, Vanderbilt has been implanting approximately 250 patients each year 

and has implanted over 3000 patients since the inception of the program. Given that Vanderbilt University is 

located within a large metropolitan area, there are many implant recipients who live either within the immediately 

surrounding communities or within a driving distance. The Cochlear Implant program, research laboratories 

(described below), engineering building, and medical facilities are collocated on a single campus are all within 

walking distance. Secure and reliable data exchange is already in place between these building for other existing 

collaborations using high speed encrypted network tunnels. The two Pl's (Ors. Gifford and Camarata) and the 

Co-l's (Ors. Dawant, Labadie, and Noble) have long a history of ..,.. ...... i:!:a.~ ""7-=;1 ;ercollaboration. \'5/ 

Cochlear Implant Research Laboratory 

The Vanderbilt Cochlear Implant (Cl) Research Laboratory, directed by 

Pl Dr. Gifford, is a 475-ft2 space equipped with two, single-walled sound 

booths. -

All audiological and auditory psychophysical assessments 

will take place in The Cochlear Implant 

Research Laboratory has all equipment needed to carry out the 

proposed research activities (see Equipment). 

Developmental Disabilities Laboratory 

The Developmental Disabilities Speech and Language Lab, directed 

by Pl Dr. Camarata, - The Lab consists of two 

Assessment/TreatmenURecording rooms, one observation room, 

three computer workstations, and one storage room that includes 

speech-language and achievement tests (and test records). The assessment rooms are equipped 

with built-in digital audio and video recording equipment (see Equipment for additional detail). 

The lab has open 

office space for multiple research assistants. Equipment is detailed on the equipment page. 

Medical-image Processing Laboratory 

The Medical Image Processing laboratory (MIPLAB), directed by Co-I, Dr. Dawant, is 600-ft2 equipped with state 

of the art computers. Thanks to existing multi-institutional projects, all the IT infrastructure required to transfer 

and store patient data in an HIPAA compliant way is in place. 

The MIPLAB has high speed connections to the Vanderbilt 

University Advanced Computing Center for Research and Education (see below) that will be used for tasks that 

require massive parallel computing and to the Vanderbilt Medical Center where images will be acquired -

Computer Assisted Otologic Surgery Lab {CAOS} 

The CAOS Laboratory, directed by Co-I Dr. Labadie, consists of over 2000-ft2 in three inter-connected rooms ■ 

--

Most relevant to the current proposal is the portable 

flat-panel volumetric computers tomography (fpVCT) Xoran scanner which is used to patients on site and/or 

in the operating room at the time of cochlear implant surgery. 

General Facilities Description: The Department of Hearing and Speech Sciences comprises one part of the 

Vanderbilt Bill Wilkerson Center for Otolaryngology and Communication Sciences, which is housed within five 

Page8 

Facilities & Other Resources 
floors of a 10 story building on the campus of the Vanderbilt University Medical Center. is 

dedicated to research and houses over 20 separate laboratories that conduct both clinical and basic 

investigations in the areas of hearing, speech, and language science. Emphasis is on both behavioral and 

electrophysiological measurements associated with communication science and communication disorders. The 

many ongoing research projects are tied closely to the academic program and to the 

speech, language, and audiology clinics that serve the Middle Tennessee region 

. Research activity is also coordinated with the Department of Otolaryngology and the 

Vanderbilt Voice and Balance Disorders clinics . In addition, animal research facilities 

associated with communication science are located in other buildings on the Vanderbilt University Medical 

Center campus. 

Office: The PI’s each have a private office in which participant counseling can be completed including 

consenting and counseling regarding study performance. Each office has a 5 drawer, lateral file cabinet in which 

hard copies of participant data will be locked when not in use. 

Other: The Department of Hearing and Speech Sciences at Vanderbilt University has a dedicated grants 

manager who assists with grant submissions, progress reports, and basic accounting. In addition to personnel, 

the budget has allocated funds for a project manager to assist with all aspects of the research project including 

IRB submission and management, subject recruitment, data collection, data entry, subject payment, analysis, 

presentation, and travel management for out of town participants. 

Resources available to Vanderbilt investigators: 

Vanderbilt University, with collaboration from a consortium of institutional partners, has developed a software 

toolset and workflow methodology for electronic collection and management of research and clinical trial data. 

REDCap (Research Electronic Data Capture) is a secure, web based application that is flexible enough to be 

used for a variety of types of research. REDCap provides an intuitive user interface that streamlines project 

development and improves data entry through real time validation rules (with automated data type and range 

checks). REDCap also provides easy data manipulation (with audit trails for reporting, monitoring and querying 

patient records) and an automated export mechanism to common statistical packages (SPSS, SAS, STATA, 

R/S Plus). All data for this project will be stored in a REDCap electronic database. 

REDCap servers are housed in a local data center at Vanderbilt, and all web based information transmission is 

encrypted. REDCap was developed specifically around HIPAA Security guidelines and is recommended to 

Vanderbilt researchers by both our Privacy Office and Institutional Review Board. REDCap has been 

disseminated for local use at more than 420 other academic/non profit consortium partners in 48 countries. 

Vanderbilt leads the REDCap Consortium, which currently supports more than 40,900 studies and 54,900 

research end users. More information about the consortium and system security can be found at 

http://www.project redcap.org/. 

anderbilt University has also developed ROCKET (Research Organization, Collaboration, and Knowledge 

Exchange Toolkit) which is a web based tool for sharing information and documents, allowing members of a 

workspace to collaborate more effectively and efficiently by building and sharing web pages. Starting with a blank 

slate, members can add and organize files, blocks of text, headers, dividers, lists (bulleted, numbered and 

checklists), images, and tables, as well as additional pages. By default, everything in the workspace is private 

and only accessible to its members. If information needs to be shared with a larger audience, one or more pages 

can be made public for a read only view. 

Animal N/A 

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EQUIPMENT 

Cochlear Implant Research Laboratory: The laboratory director and PI, Dr. Gifford, has all of the major 

equipment needed to perform the necessary experimentation in the proposal. The PI has been provided with 

dedicated lab space at Vanderbilt University Medical Center which houses two, single walled sound booths. 

Both booths have calibrated audiometers with insert earphones, bone oscillators and sound field speakers 

allowing for standard audiometric and speech perception testing. Both sound booths are also equipped with 

the REVITRONIX R SPACETM 8 loudspeaker sound system and a rack of equipment controlling the system 

including a CX168 8 channel amplifier, MOTU 8 channel audio interface enabled with firewire, high speed USB 

ports, spectrum analyzer, oscilloscope, and power conditioner. Additionally in each booth there is a Sound 

Track LXT sound level meter with mic and preamp suspended from the ceiling that can be used for real time 

calibration prior to and during experimentation. We have an additional sound level meter dedicated for 

earphone calibration in the lab. Both booths also have an affiliated iMac and PC from which digitized speech 

stimuli can be presented for standard clinical assessment of speech recognition performance [e.g., the 

minimum speech test battery (MSTB) for pre and post operative assessment of speech recognition]. The CI 

Research Laboratory also has an Audioscan Verifit system in her lab for real ear verification of hearing aid 

ettings as well as a GSI Tympstar Pro allowing for electrically evoked stapedial reflex threshold (ESRT) 

verification of CI upper stimulation levels and assessment of middle ear function. Finally the CI Research Lab 

has a dedicated Intelligent Hearing Systems (IHS) auditory evoked potential (AEP) system used for assessing 

acoustic evoked AEPs for adults and pediatric CI recipients with residual acoustic hearing. 

Developmental Disabilities Laboratory: The Developmental Disabilities Laboratory director and PI, Dr. 

Camarata, includes 4 video and speech coding stations, two therapy/diagnostic rooms with state of the art 

video recording equipment, and four camcorders. The Lab equipment includes five PC desktop computers with 

Video Analysis and SALT suites, a Mac server, and networked printers. Computers are outfitted with Microsoft 

Office, EndNote, SPSS, SALT, WavPedal, Start/Stop, and video storage (on the Mac server). 

Biomedical Image Analysis for Image Guided Interventions Laboratory (BAGL): The BAGL laboratory is 

equipped with state of the art computers. This includes 1 rack mounted processing server, a 20 TB file server, 

2 cloned oracle database servers, and high end personal computers for all lab personnel. All of these 

machines are on a private sub network behind a secure firewalled gateway server. The lab also has access to 

cluster computing resources at ACCRE with 620 compute nodes. 

Medical Image Processing Laboratory: The medical image processing laboratory is equipped with a state of 

the art computer lab. This includes 5 rack mounted computer servers, a 5TB file server, 2 cloned Oracle data 

base servers, and 15 high end personal computers. All these machines are networked and data servers are in 

a secure location behind a firewall. All of these machines are on a private sub network behind a secure 

firewalled gateway server. 

Computer Assisted Otologic Surgery Lab (CAOS) & CT Scanners: The main CAOS lab contains two Polaris 

infrared position trackers (Northern Digital, Waterloo, Ontario, CA), a MicronTracker visible light position tracker 

(Claron Technology Inc, Toronto, Ontario, CA), a XarTrax steerable laser system (Traxtal, Inc, Toronto, Canada), 

two robots a Mitsubishi RV 3S (Mitsubishi Electric & Electronics USA, Inc., Cyprus, CA) and a Motoman YR 

SV035 (Motoman, Inc., West Carrollton, OH), an Acu Rite III, xyz positioning system (Acu Rite Companies Inc., 

Jamestown, NY), two surgical stations with electric and pneumatic drills, surgical microscopes, and associated 

instrumentation, and three cubicle stations. The separate machine shop contains an Ameritech CNC Jr. Milling 

Machine (Brousard Enterprises Inc., Sante Fe Springs, CA), FARO Gage Plus measuring system (FARO 

Technologies, INC., Atlanta, GA), Delta tabletop band saw (Delta Tools, Jackson, TN), Delta belt sander (Delta 

Tools, Jackson, TN), Wilton tabletop drill press (WMH Tool Group, Inc., Elgin, IL), tool cabinet, metal stock shelf, 

and workbenches. Within the third CAOS room is a portable flat panel volumetric computers tomography 

(fpVCT) scanner which is used to scan patients onsite and/or in the operating room at the time of CI surgery. 

Additionally Vanderbilt imaging has three 64 slice multi detector CT scanners, three 16 slice multi detector 

scanners, and one flat panel, volumetric computerized tomography (fpVCT) scanner. 

Computers/Software: The PIs both have an iMac and PC computer in their offices. In her laboratory, Dr. 

Gifford has 2 iMac and 2 PC computers each of which is equipped with Windows 7 (via Parallels for Mac), 

Contact PD/PI: Gifford, Rene H Equipment Page 10

 

 

 

 

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Microsoft Office, MATLAB, Adobe Audition, SPSS, Sigma Plot 10.0, GraphPad Prism, R, and a number of 

additional software packages required for electronic data storage, analysis, and plotting. In his laboratory, Dr. 

Camarata has 6 computers for coding and analyses purposes. 

In addition, all project assistants will be granted password access to the research server. All Vanderbilt faculty 

and staff have free access to REDCap (Research Electronic Data Capture). REDCap is a secure, web based 

application for building and managing online databases (see Protection of Human Subjects for additional 

detail). Each of the study personnel will be provided with a secure ID that will grant access the password 

protected database that will be created for this project and used for data transmission to the centralized data 

repository developed and managed by Drs. Gifford, Camarata, and Dawant. 

Contact PD/PI: Gifford, Rene H Equipment Page 11

 

 

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OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED Senior/Key Person Profile (Expanded)

PROFILE - Project Director/Principal Investigator

Prefix:  First Name*: Rene Middle Name H Last Name*: Gifford Suffix: 

Position/Title*: Professor

Organization Name*: Vanderbilt University Medical Center

Department: Hearing And Speech Sciences

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Phone Number*:  Fax Number: 

E-Mail*: 

Credential, e.g., agency login: 

Project Role*:  PD/PI Other Project Role Category: 

Degree Type:  Doctor of Philosophy Degree Year:  2003

Attach Biographical Sketch*:   File Name: ID-0015550_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support:   File Name:

Contact PD/PI: Gifford, Rene H Page 12 2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

PROFILE - Senior/Key Person

Prefix:  First Name*: Stephen Middle Name M Last Name*: Camarata Suffix: 

Position/Title*: Professor

Organization Name*: Vanderbilt University Medical Center

Department: Hearing And Speech Sciences

Division:

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Phone Number*:  Fax Number: 

E-Mail*: 

Credential, e.g., agency login: 

Project Role*:  PD/PI Other Project Role Category: 

Degree Type:  Doctor of Philosophy Degree Year:  1984

Attach Biographical Sketch*:   File Name: ID-0004983_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support:   File Name:

PROFILE - Senior/Key Person

Prefix:  First Name*: Robert Middle Name F Last Name*: Labadie Suffix: 

Position/Title*: Professor

Organization Name*: Vanderbilt University Medical Center

Department: Otolaryngology

Division: School of Medicine

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Phone Number*:  Fax Number: 

E-Mail*: 

Credential, e.g., agency login: 

Project Role*:  Other (Specify) Other Project Role Category: Co-Investigator

Degree Type:  Medical Doctor Degree Year:  1996

Attach Biographical Sketch*:   File Name: ID-0039546_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support:   File Name:

Contact PD/PI: Gifford, Rene H Page 13 2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

PROFILE - Senior/Key Person

Prefix:  First Name*: Jack Middle Name H Last Name*: Noble Suffix: 

Position/Title*: Research Asst Professor

Organization Name*: Vanderbilt University

Department:

Division: Unknown

Street1*:

Street2:

City*:

County:

State*:

Province:

Country*: USA: UNITED STATES

Zip / Postal Code*:

Phone Number*:  Fax Number: 

E-Mail*: 

Credential, e.g., agency login: 

Project Role*:  Other (Specify) Other Project Role Category: Co-Investigator

Degree Type:  Doctor of Philosophy Degree Year:  2011

Attach Biographical Sketch*:   File Name: ID-38062_BN-1_BIOSKETCH.pdf

Attach Current & Pending Support:   File Name:

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Prefix:  First Name*: Benoit Middle Name  Last Name*: Dawant Suffix: 

Position/Title*: Professor

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Degree Type:  Doctor of Philosophy Degree Year:  1987

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Contact PD/PI: Gifford, Rene H Page 14 2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

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Position/Title*: Professor

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Degree Type:  Doctor of Philosophy Degree Year:  1985

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Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

PROFILE - Senior/Key Person

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Degree Type:  Doctor of Philosophy Degree Year:  2005

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BIOGRAPHICAL SKETCH 

Provide the following information for the Senior/key personnel and other significant contr butors. 

Follow this format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: René H. Gifford 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Professor 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

Arizona State University, Tempe, AZ B.S. 1995 Speech and Hearing 

Vanderbilt University, Nashville, TN M.S. 1997 Hearing and Speech 

Arizona State University, Tempe, AZ Ph.D. 2003 Psychoacoustics 

Arizona State University, Tempe, AZ Postdoc 2006 Speech perception, 

cochlear implant signal 

processing 

Personal Statement 

am a hearing scientist; however, I began my professional career 20 years ago as a clinical audiologist and 

have maintained an active clinical practice as I see complex and difficult to manage patients in the Cochlear 

Implant (CI) Audiology clinic at the Vanderbilt Bill Wilkerson Center. My line of research focuses on the study of 

basic auditory processing, spatial hearing, and speech recognition for individuals utilizing electric and acoustic 

stimulation with cochlear implants and hearing aids. Ultimately my goal is to improve outcomes for adults and 

children with cochlear implants affording each recipient the opportunity to achieve his/her maximum potential 

communication and auditory perception. As a clinician/scientist in an academic medical environment with 

on site OPTION school for children with hearing loss, I have first hand knowledge of the clinical problems 

associated with hearing loss, cochlear implants, speech and/or language delay, and the need for evidence 

based recommendations for intervention. The research activities outlined in this proposal have the potential to 

revolutionize clinical intervention using a precision medicine approach to aural (re)habilitation for children with 

CIs including CI programming, prescriptive speech/language intervention, and ultimately optimization of 

outcomes. As PI, co PI, and co I on current and past NIH funded grants, I have had nearly two decades of 

experience working with CI recipients on studies of speech perception and psychophysical estimates of 

auditory processing. Furthermore, I have administered all proposed auditory experimental protocols to pediatric 

recipients in our preliminary studies documenting the feasibility of the proposed research activities. These 

clinical, academic, and research experiences afford me the opportunity to significantly contribute to the 

proposed research activities as PI. It is an honor to be an active part of this interdisciplinary research team and 

I look forward to helping achieve significant improvements in outcomes for all cochlear implant recipients. 

Positions and Honors 

Positions and Employment 

2002 2003 NIH Pre doctoral Fellow (F31), Psychoacoustics Laboratory, Arizona State University 

2004 2006 NIH Post doctoral Fellow (F32), Cochlear Implant Research Laboratory, Arizona State 

University 

2006 2010 Director, Cochlear Implant Program, Mayo Clinic Rochester 

2008 2010 Assistant Professor, Mayo Clinic College of Medicine 

2011 Director, Cochlear Implant Program, Vanderbilt Bill Wilkerson Center 

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2011 2014 Assistant Professor, Vanderbilt University, Department of Hearing and Speech Sciences, 

Department of Otolaryngology 

2012 Member, Vanderbilt Kennedy Center for Research on Education and Human Development 

2014 2017 Associate Professor, Vanderbilt University, Department of Hearing and Speech Sciences, 

Department of Otolaryngology 

2014 Tier I Training Faculty, Vanderbilt Brain Institute 

2017 Professor, Vanderbilt University, Department of Hearing and Speech Sciences, Department of 

Otolaryngology 

Honors 

1995 Summa Cum Laude, undergraduate graduation Arizona State University 

1991 1995 Arizona State Regents Scholarship, all four years of undergraduate study 

1997 Jay W. Sanders “Honors in Audiology” Award, Vanderbilt University

2003 Mentored Student Poster Award. American Auditory Society. The effect of age on nonlinear 

cochlear processing. 

2004 Mentored Student Poster Award. American Auditory Society. Speech recognition in a modulated 

background and the relation to recovery from forward masking: comparison of younger and 

older threshold matched listeners 

2005 2007 NIH Loan Repayment Program Grant: Combined electric and acoustic hearing 

2007 The Best of 2007 “Most thought provoking” research article awarded for “Gifford et al., (2007).

Auditory function and speech understanding in listeners who qualify for EAS surgery. Ear Hear, 

28(2), 114S 118S,” The Hearing Journal, 2007. 

2008 The Best of 2008 “Great for the Clinician” research article awarded for “Gifford et al. (2008).

Speech Recognition Materials and Ceiling Effects: Considerations for Cochlear Implant 

Programs, Audiol Neurotol, 13, 193 205,” The Hearing Journal, 2008. 

2008 The Best of 2008 “Most thought provoking” research article awarded for “Gifford et al. (2008). 

Hearing preservation surgery: Psychophysical estimates of cochlear damage in recipients of a 

short electrode array, J Acoust Soc Am, 124, 2164 2173.” The Hearing Journal, 2008. 

2009 The Best of 2009 “Most thought provoking” research article (Co author) awarded for “Dorman et

al. (2009). Word recognition following implantation of conventional and 10 mm Hybrid 

electrodes. Audiol Neurotol, 14:181 189. The Hearing Journal, 2009. 

2015 Louis M. DiCarlo Award for Recent Clinical Achievement, American Speech Language Hearing 

Association (ASHA) 

2015 Selected as 1 of 18 VUMC featured StoryCorps interviews with Ally Sisler Dinwiddie, AuD for 

Voices of the NIH community. Interview recording archived at the American Folklife Center at 

the Library of Congress. 

2016 Featured scientist, National Public Radio, Science Friday: Breakthrough: Portraits of Women in 

Science Hearing a Whole New World, aired live September 9, 2016. Video documentary and 

recorded live broadcast available at http://www.sciencefriday.com/segments/breakthrough 

hearing a whole new world/ 

2017 Vanderbilt University Chancellor’s Award for Research; The Chancellor’s Award recognizes 

excellence on the part of faculty for published research, scholarship, or creative expression. 

Grant Review 

2011 2016 NIH NIDCD, Ad Hoc Reviewer, Communication Disorders Review Committee (CDRC) 

2012 NIH NIDCD, Ad Hoc Reviewer, Special Emphasis Panel, ZDC1 SRB R (35) 

2013 NIH NIDCD, Ad Hoc Reviewer, Special Emphasis Panel, ZDC1 SRB K (12) 

2016 2020 NIH NIDCD, Permanent member, Communication Disorders Review Committee (CDRC) 

2018 Department of Defense, Congressionally Directed Medical Research Programs, Hearing 

Restoration Research Program 

Contribution to Science 

We have developed a novel way to program cochlear implants using pre and post operative CT scans to 

specify the relationship between the cochlear implant (CI) electrode array and the locations of the primary 

auditory neurons located within the modiolus. To date, we have applied this technique to 226 adult CI recipients 

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and 36 pediatric CI recipients. After using the new program for at least 1 month, 156 of the 226 adults (69.0%) 

and 28 of the 36 pediatric patients (77.8%) have chosen to keep the new map either due to statistically significant 

improvement in speech understanding and/or subjective improvement in sound quality that was deemed 

significant enough for them to abandon the maps they had been using for, on average, 41⁄2 years. Select related 

publications and patent (a e) are shown below. I have worked as a co investigator and co PI on these projects. 

a. Noble JH, Gifford RH, Labadie RF, Dawant BM. (2012). Statistical shape model segmentation and 

frequency mapping of cochlear implant stimulation targets in CT. Med Imag Comput Assist Interv. 15 

(Pt 2): 421 8. PMID: 23286076 

b. Noble JH, Gifford RH*, Hedley Williams A, Sunderhaus L, Labadie RF, Dawant BM. (2014). Clinical 

evaluation of an image guided cochlear implant programming strategy. Audiol Neurotol. 19(6):400 11. 

PMID: 25402603. *co first author 

c. Noble JH, Labadie RF, Gifford RH, Dawant BM. (2013). Image guidance enables new methods for 

customizing cochlear implant stimulation strategies. IEEE Trans Neural Syst Rehabil Eng. 21(5):820 9. 

PMID: 23529109 

d. Noble JH, Hedley Williams A, Sunderhaus L, Dawant B, Labadie RF, Camarata S, Gifford RH. (2016). 

Image guided cochlear implant (CI) programming can improve hearing outcomes for pediatric CI 

recipients. Otol Neurotol. 37(2):e63 9. PMID: 26756157 

(2) I have worked as the PI on nearly 15 years of NIH funded research evaluating psychophysical processing 

related to combined electric and acoustic stimulation (EAS) with cochlear implantation. During my F32 funded 

postdoctoral fellowship, I defined basic auditory properties of low frequency acoustic hearing in EAS patients 

which led to additional prospective studies examining i) the efficacy of hearing preservation (e g), ii) the 

underlying mechanisms driving EAS benefit (e g), and iii) the best practices for optimizing EAS outcomes in a 

clinical environment (h). Work that my lab has completed over the past decade has documented significant 

speech understanding benefit for listening in complex environments including diffuse noise, reverberation, and 

informational masking, significant improvements in auditory localization abilities, retention of binaural hearing 

cues helpful for spatial hearing and speech understanding in noise, as well as optimization of EAS parameters 

clinical applicability. 

e. Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CLW, Roland P, Buchman CA. 

(2013). Cochlear implantation with hearing preservation yields significant benefit for speech recognition 

in complex listening environments. Ear Hear, 34(4):413 25. PMID: 23446225 

f. Gifford RH, Grantham DW, Sheffield SW, Davis TD, Dwyer R, Dorman MF. (2014). Localization and 

interaural time difference (ITD) thresholds for cochlear implant recipients with preserved acoustic 

hearing in the implanted ear. Hear Res, 312:28 37. PMID: 24607490 

g. Loiselle LH, Dorman MF, Yost WA, Cook SJ, Gifford RH. (2016). Using ILD or ITD cues for sound 

source localization and speech understanding in a complex listening environment by bilateral and 

hearing preservation cochlear implant listeners. J Speech Lang Hear Res. 59(4):810 8. PMID: 

27411035 

h. Gifford RH, Davis TJ, Sunderhaus LW, Menapace C, Buck B, Crosson J, O’Neill L, Beiter A, Segel P. 

(2017). Combined electric and acoustic stimulation (EAS) with hearing preservation: effect of cochlear 

implant low frequency cutoff on speech understanding and perceived listening difficulty. Ear Hear, 

38(5): 539 553. PMID: 28301392 

As co I or co PI on various projects related to test design for assessing speech understanding and non 

linguistic assessment of CI outcomes, we have provided clinicians and researchers with a direct translation of 

research proven tasks into validated clinical tests. These clinical tests have the potential to guide clinical decision 

making regarding cochlear implant candidacy, ear selection, and postoperative programming of CI processors. 

Our validated speech perception measures are now included in the adult minimum speech test battery (MSTB) 

and pediatric MSTB (PMSTB), both of which outline best practices protocols for clinical assessment of CI 

recipients in Audiology practice. Our work with assessment of speech perception in adults and children with 

cochlear implants as well as our clinical translation of a psychoacoustic measure of spectral resolution has 

resulted in the development of the AzBio sentence materials (i), BabyBio sentence materials (j), the Quick 

Spectral Modulation Detection (QSMD) test (k), and the Pediatric Minimum Speech Test Battery (PMSTB) (l). 

i. Spahr AJ, Dorman MF, Litvak LL, Van Wie S, Gifford RH, Loizou PC, Loiselle LM, Oakes T, Cook S. 

(2012). Development and Validation of the AzBio Sentence Lists. Ear Hear. 33:112 7. PMID: 21829134 

Contact PD/PI: Gifford, Rene H Biosketches Page 19

 

 

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j. Spahr AJ, Dorman MF, Cook SJ, Loiselle L, Hayes C, Hedley Williams A, Sunderhaus LW, DeJong 

MD, Gifford RH. (2014). Development and validation of the pediatric AzBio sentence test. Ear Hear 

35(4):418 22. PMID: 24658601 

k. Gifford RH, Hedley Williams A, Spahr AJ. (2014). Clinical assessment of spectral modulation detection 

for adult cochlear implant recipients: a non language based measure of performance outcomes. Int J 

Audiol. 53(3):159 64. PMID: 24456178 

l. Uhler K, Warner Czyz A, Gifford RH. (2017). Pediatric Minimum Speech Test Battery (PMSTB). J Am 

Acad Audiol. 28(3): 232 247. PMID: 28277214 

I have worked as PI along with a number of collaborating clinician/scientists in the scientific evaluation of 

current cochlear implant (CI) candidacy indications. Based on both retrospective and prospective, longitudinal 

studies, we have concluded that both adult and pediatric labeled indications for implantation are overly restrictive 

not allowing for potentially hundreds of thousands of individuals who are significantly affected by moderate to 

profound sensory hearing loss to take advantage of the communicative benefits afforded by cochlear 

implantation. This work has led to 1) two of the three FDA approved CI manufacturers to commence multi center 

FDA approved clinical trials to define revised indications for adult CI candidacy and 2) the FDA to convene an 

Ear, Nose, and Throat Devices Panel Meeting to review current labeled indications for pediatric CI candidacy. 

Related publications (o r) are as follows: 

o. Gifford RH, Shallop JK, Peterson AM. (2008). Speech Recognition Materials and Ceiling Effects: 

Considerations for Cochlear Implant Programs. Audiol Neurotol, 13:193 205. PMID: 18212519 

p. Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CLW, Roland P, Buchman CA. 

(2013). Cochlear implantation with hearing preservation yields significant benefit for speech recognition 

in complex listening environments. Ear Hear. 34(4):413 25. PMID: 23446225 

q. Carlson MC, Sladen DP, Haynes DS, Driscoll CLW, DeJong MD, Sunderhaus LW, Hedley Williams A, 

Rosenzweig EA, Davis TJ, Gifford RH. (2015). Evidence for the expansion of pediatric cochlear implant 

candidacy. Otol Neurotol. 36(1): 43 50. PMID: 25275867 

r. Sladen DS, Gifford RH, Haynes DS, Kelsall D, Benson A, Lewis K, Zwolan T, Fu, QJ, Gantz B, Gilden 

J, Westerberg B, Gustin C, White L, Driscoll CL. (2017). Evaluation of a revised indication for 

determining adult cochlear implant candidacy. Laryngoscope. 127(10):2368 2374. PMID: 28233910 

Complete List of Published Work in MyBibliography (from over 85 peer reviewed publications): 

http://www.ncbi.nlm.nih.gov/sites/myncbi/rene.gifford.1/bibliography/40425043/public/?sort=date&direction=asc 

ending 

Research Support 

Ongoing Support 

R01 DC009404 Gifford (PI) 2009 2020 

Title: Cochlear implants: combined electric and binaural acoustic stimulation 

Goal: The goal of this study is to determine the efficacy of binaural hearing preservation for speech recognition 

in complex listening environments, the spatial resolution in adult cochlear implant recipients, and describe the 

underlying auditory mechanisms driving this benefit associated with electric and acoustic stimulation (EAS). 

Role: Principal Investigator 

Overlap: There is no overlap with this grant and the current proposal. This grant focuses on underlying binaural 

hearing mechanisms driving auditory perceptual benefit for adults combining electric and acoustic stimulation 

(EAS). 

R01 DC13117 Gifford (PI) 2013 2018 

Title: Clinical application of spectral envelope perception: cochlear implant evaluation 

Goal: The goal of this project is to conduct a prospective, longitudinal study of acoustic and electric spectral 

resolution and speech recognition performance in adult cochlear implant (CI) recipients. 

Role: Principal Investigator 

Note: This grant is currently in a no cost extension year. At the completion of the no cost extension year, we 

will have met the objectives of this R01 clinical tool grant; thus, we will not be seeking renewal. 

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R01 DC014037 Noble (PI) 2014 2019 

Title: Image guided cochlear implant programming techniques 

Goal: The goal of this project is to develop and evaluate new image guided cochlear implant programming 

strategies that use objective information acquired from clinical images to determine patient customized 

frequency, current steering, and current focusing settings that lead to better hearing outcomes. 

Role: Co Investigator 

Overlap: There is no scientific overlap with this grant and the current proposal. Dr. Noble’s project is specific to

adult CI recipients and more specifically the investigation of objective auditory electrophysiologic correlates for 

image guided programming techniques. 

R01 DC014462 Dawant (PI) 2015 2020 

Title: Computer assisted, image guided programming of cochlear implants 

Goal: The goal of this project is to investigate the relationship between electrophysiologic and psychophysical 

responses to electric stimulation and objective estimates of the electrode to neuron interface obtained via pre 

and post operative imaging and to automate our image guided approach to cochlear implant programming. 

Role: Co Investigator 

Overlap: There is no scientific overlap with this grant and the current proposal. Dr. Dawant’s project is focused

adult CI recipients, comparison between auditory psychophysical and objective measures, and automation 

the IGCIP process. 

Completed Support 

R01 DC010821 Gifford (Co PI) 2010 2015 

Title: Cochlear Implant performance in Realistic Listening Environments 

Goal: The goal of this study is to assess speech recognition performance for unilateral and bilateral implant 

recipients in both standard and simulated realistic test environments, with the goal of creating a decision matrix 

that links data that can be easily collected in the clinic, e.g., CNC scores in quiet and the amount of residual 

hearing, with data that cannot be collected in the clinic, i.e., performance data collected with multiple, spatially 

separated loudspeakers 

Role: Co Principal Investigator (MPI) 

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NAME: Camarata, Stephen M. 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Professor of Hearing & Speech Sciences, Professor of Psychiatry, Associate Professor of 

Special Education, Peabody College 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, include postdoctoral training and residency 

training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if applicable) 

Completion Date 

MM/YYYY FIELD OF STUDY 

San Diego State University, San Diego, CA B.A. 1979 Communication 

Disorders 

San Diego State University, San Diego, CA M.A. 1981 Communication 

Disorders 

Purdue University, West Lafayette, IN 

University of Arizona, Tucson, AZ 

Ph.D. 

Post Doc 

1984 

1984 85 

Audiology & Speech 

Science 

Speech Science 

Personal Statement 

My expertise is in clinical research addressing the assessment and treatment of speech and language 

disorders in children with disabilities, including children with Hearing Loss, children with Down Syndrome, 

hildren with Autism Spectrum Disorders (ASD) and children with SLI. The work on children with hearing loss 

and on those with language disorders is of particular importance to the proposed research. This includes 

assessment and treatment of speech and language disorders in these children and Dr. Gifford and the other 

members of the research team and I have published a number of studies relating the measurement of speech 

and language skills in these children. This collaborative work includes a preliminary investigation of speech 

and language abilities in children with cochlear implants that serves as the basis for the pilot data supporting 

this application. In addition, the past five years, I’ve been collaborating with 

projects examining fatigue in children with 

hearing loss. This research includes assessment of language and literacy in these children. Finally, my own 

research has been focused on primary and tertiary outcomes in children with speech and language disorders 

arising from diverse etiology that provides specific expertise on: A) assessing children with disabilities who 

may be difficult to test (e.g., Down Syndrome, ASD) and B) exploring the relationships between speech, 

language, and related abilities (such as literacy) in these groups. It is perhaps noteworthy that this work 

includes successful (and productive) interdisciplinary collaboration both within Vanderbilt 

and across sites 

Positions and Honors 

Positions and Employment 

1979 1981 Teaching Assistant, Dept of Speech Pathology and Audiology, San Diego State University 

1981 1982 Clinical Fellow, Purdue University Speech and Hearing Clinic 

1982 1984 Teaching and Research Assistant, Dept of Audiology and Speech Sciences, Purdue University 

1984 1985 Postdoctoral Fellow, Early Childhood Language Laboratory, Dept of Speech and Hearing 

Sciences, University of Arizona 

1985 1988 Assistant Professor, Dept of Special Education & Communication Disorders, Pennsylvania State 

University 

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1988 1990 Assistant Professor, Dept of Speech and Hearing Sciences, University of California, Santa 

Barbara 

1990 1994 Assistant Professor, Dept of Speech and Hearing Sciences, Vanderbilt University School of 

Medicine 

1994 2002 Associate Professor, Dept of Speech and Hearing Sciences, Vanderbilt University School of 

Medicine 

1996 2017 Associate Professor, Dept of Special Education, Peabody College, Vanderbilt University 

1999 2002 Acting Director, John F. Kennedy Center for Research on Human Development, Vanderbilt 

University 

2002 2004 Deputy Director, John F. Kennedy Center for Research on Human Development, Vanderbilt 

University 

2004 2009 Director, Research Program in Communication & Learning, John F. Kennedy Center for 

Research on Human Development, Vanderbilt University 

2002 pres Professor, Dept of Speech and Hearing Sciences and Dept of Psychiatry, Vanderbilt University 

School of Medicine 

2018 pres Professor, Dept of Special Education, Peabody College, Vanderbilt University 

Honors and Awards 

1979 Graduated with high honors and distinction, San Diego State University 

1979 Phi Kappa Phi 

1986 Member of the Outstanding Young Men of America 

1987 "Who's Who in American Universities and Colleges" 

1988 “Who's Who Among Health Science Professionals"

1991 Appointed Research Investigator, John F. Kennedy Center for Research in Human 

Development 

1997 2001 Chair of the Special Interest Division on Treatment Efficacy of the American Speech Language 

Hearing Association 

2001 Distinguished Faculty Honoree, Vanderbilt University 

2007 2011 Chartered member, NIH Study Section on Child Psychopathology/Developmental Disabilities 

(CPDD) 

2009 2011 Chair, NIH Study Section on Child Psychopathology/Developmental Disabilities (CPDD) 

2017 Chair, NIH Review Panel, Autism Centers for Excellence (ACE) 

2015 2019 Chartered Member, NIH Study Section on Communication Disorders Research (CDRC) 

2010 Fellow, American Speech Language Hearing Association 

2012 Glenwood Endowed Lecture, University of Alabama, Birmingham 

2014 Distinguished Service Award, Autism Speaks 

2015 2016 Member, Institute of Medicine (National Academy of Sciences) Panel on Speech and Language 

Disorders in Children. 

2016 2018 Member, Institute of Medicine (National Academy of Sciences) Panel on Health Outcomes in 

Children with Disabilities 

2017 Art Wheeler Studio Award for Outstanding Service to Vanderbilt Translational and Clinical 

Science Award (CTSA). Vanderbilt University School of Medicine. 

Contributions to Science 

My research is focused on assessment and treatment of speech and language disorders in children with 

various disability typologies including Down Syndrome, specific language impairment, phonological disorder, 

d autism spectrum disorder. Contributions in these areas include foundational intervention studies testing 

the effectiveness of treatments designed to parallel enhance naturally occurring language input within the 

theoretical framework of the transactional model of development (e.g., Nelson, 1989; Sameroff, 1978). 

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A significant contribution especially relevant to the proposed research has been assessing speech and 

language disorders in children with hearing loss. This relatively recent addition to my research portfolio has 

indicated that recent advances in hearing technology (e.g., cochlear implants), has dramatically improved 

outcomes in these children from the severe range, to patterning more like children without hearing loss who 

have language disorders. The research also includes measuring subjective fatigue in these children 

Example publications from this contribution include: 

a. Camarata, S., Werfel, K., Davis, T., Hornsby, B. W., & Bess, F. H. (2018). Language Abilities, 

Phonological Awareness, Reading Skills, and Subjective Fatigue in School Age Children With Mild to 

Moderate Hearing Loss. Exceptional Children, 0014402918773316. 

b. Hornsby, B. W., Werfel, K., Camarata, S., & Bess, F. H. (2014). Subjective Fatigue in Children With 

Hearing Loss: Some Preliminary Findings. American Journal of Audiology, 23(1), 129 134. 

c. Bess, F. H., Gustafson, S. J., Corbett, B. A., Lambert, E. W., Camarata, S. M., & Hornsby, B. W. 

(2015). Salivary Cortisol Profiles of Children with Hearing Loss. Ear and Hearing. 

d. Noble JH1 

, Hedley Williams AJ, Sunderhaus L, Dawant BM, Labadie RF, Camarata SM, Gifford RH. 

(2016) Initial Results With Image guided Cochlear Implant Programming in Children. Otology and 

Neurotology, Feb;37(2):e63 e69. 

A significant contribution has been improving speech disorders in children with Down syndrome. Unlike 

other children with severe speech disorders, these children have significant lifelong challenges with not 

only articulation accuracy but also limitations in producing intelligible and comprehensible speech. Example 

publications from this contribution include: 

a. Camarata, S., Yoder, P., & Camarata, M. (2006). Simultaneous treatment of grammatical and speech 

comprehensibility deficits in children with Down syndrome. Down Syndrome: Research and Practice, 

11(1), 9 17. PMID: 17048805 

b. Yoder, P. J., Woynaroski, T., & Camarata, S. (2016). Measuring Speech Comprehensibility in Students 

with Down Syndrome. Journal of Speech, Language, and Hearing Research, 59(3), 460 467. 

c. Camarata, S. (1993). The application of naturalistic conversation training to speech production in 

children with speech disabilities. Journal of Applied Behavior Analysis, 26(2), 173 182. 

d. Yoder, P. J., Camarata, S., & Woynaroski, T. (2016). Treating speech comprehensibility in students 

with Down syndrome. Journal of Speech, Language, and Hearing Research, 59(3), 446 459. 

There have been a series of papers examining assessment and treatment of language disorders 

(especially grammatical morphology) in SLI. This work has been a primary contributor to a recent meta 

analysis showing that this approach has a large intervention effect size. We believe that the approach will 

be effective in CI as well if the Image Guided Mapping procedures are beneficial to children with hearing 

loss. 

a. Camarata, S., Nelson, K. E., & Camarata, M. (1994). A comparison of conversation based to imitation 

based procedures for training grammatical structures in specifically language impaired children. Journal 

of Speech and Hearing Research, 37, 1414 1423. 

b. Leonard, L., Camarata, S., Brown, B. & Camarata, M. (2008). The acquisition of tense and agreement 

in the speech of children with specific language impairment: Patterns of generalization through 

intervention. Journal of Speech Language Hearing Research, 51, 120 125. PMID: 18230859 

c. Davis, T. N., Lancaster, H. S., & Camarata, S. (2016). Expressive and receptive vocabulary learning in 

children with diverse disability typologies. International Journal of Developmental Disabilities, 62(2), 77 

88. 

d. McDaniel, J., Camarata, S., & Yoder, P. (2018). Comparing Auditory Only and Audiovisual Word 

Learning for Children with Hearing Loss. The Journal of Deaf Studies and Deaf Education. 

In addition, there have been a number of assessment and intervention studies on speech and language 

intervention and on multisensory processing in children with autism. These include: 

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a. Camarata, S. (2014). Early identification and early intervention in autism spectrum disorders: Accurate 

and effective? International Journal of Speech Language Pathology, 2014; 16(1): 1 10. 

b. Stevenson, R. A., Siemann, J. K., Schneider, B. C., Eberly, H. E., Woynaroski, T. G., Camarata, S. M., 

& Wallace, M. T. (2014). Multisensory Temporal Integration in Autism Spectrum Disorders. Journal of 

Neuroscience, 34(3), 691 697. 

c. Raghavan, R., Camarata, S., White, K., Barbaresi, W., Parish, S., & Krahn, G. (2018). Population 

Health in Pediatric Speech and Language Disorders: Available Data Sources and a Research Agenda 

for the Field. Journal of Speech, Language, and Hearing Research, 61(5), 1279 1291. 

d. Koegel, R. L., Koegel, L. K., & Camarata, S. M. (2010). Definitions of empirically supported 

treatment. Journal of autism and developmental disorders, 40(4), 516 517. 

Publication Metrics 

Google Scholar Publications: 92 Google Scholar Citation Index: 2,236. 

Research Gate Profile https://www.researchgate.net/profile/Stephen Camarata 

Impact Score: 29.92, Cumulative Impact: 78.77 

CV available on Lab Website: https://medschool.vanderbilt.edu/developmental disabilities lab/ 

Other Support 

Ongoing Research Support 

H325D140087 (Schuele) 04/30/2016 08/31/2019 1.20 calendar months 

U.S. Department of Education 

TRILL: Training Exemplary Pre Doctoral Researchers in Language Literacy 

The goal of this project is to prepare 6 pre doctoral students to conduct language and literacy intervention 

research and prepare the next generation of speech language pathologists. 

Role: Co Director 

R324A160300 (Bess) 09/28/2016 06/30/2019 1.80 calendar months 

IES 

Measurement of Listening Fatigue in School Age Children with Disabilities 

Goal: We plan to construct and validate a child centered measure of listening fatigue for children with hearing 

loss (CHL) and other communication based disabilities (CHLCD). 

Role: Co PI/PD 

5UL1T$002243 02 (Bernard) 06/01/2017 02/28/2022 0.30 calendar months 

NIH/NCATS 

Vanderbilt Institute for Clinical and Translational Research (VICTR) 

The major goal is to assist institutions to create a “novel, and integrative academic home for clinical and 

translational science.”

Role: Team Science Lead 

N/A (Camarata, PI) 01/01/2014 12/31/2018 0.60 calendar months 

Role: PI 

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R324A100225 (Yoder, PI) 09/01/2010 08/31/2015 1.20 Calendar Months 

IES 

Efficacy of Broad Target Speech Recasts on Students with Down Syndrome 

The major goals of this project are to conduct an efficacy trial to determine whether broad target speech 

recasts significantly improves generalized speech comprehensibility in the connected speech of elementary 

school students with Down syndrome. 

Role: Co Investigator 

R324A090181 (Kaiser, PI) 07/01/2009 06/30/2015 1.20 calendar months 

IES 

NCSER EIECE G3: An Efficacy Trial of Enhanced Milieu Teaching Language Intervention with Language 

Delayed Toddlers 

The specific aim of this proposed project is to determine whether language deficits can be prevented through 

early intervention in preschool children at high risk for persistent language delays. 

Role: Co Investigator 

R324A110266 (Bess) 07/01/2011 06/30/2016 0.60 calendar months 

IES 

Fatigue and Listening Effort in School Age Children with Hearing Loss 

The major goals of this project are to examine whether school age children with mild to moderate hearing loss 

expend greater listening effort and subsequently experience more fatigue under noise conditions (similar to a 

classroom) than a group of normal hearing children. 

Role: Co PD/PI 

N/A (Camarata) 12/01/2011 12/31/2015 0.36 calendar months 

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BIOGRAPHICAL SKETCH 

Provide the following information for the key personnel and other significant contr butors in the order listed on Form Page 2. 

Follow this format for each person. DO NOT EXCEED FIVE PAGES. 

NAME 

Labadie, Robert F. 

POSITION TITLE 

Professor (with tenure) of Otolaryngology 

Professor of Biomedical Engineering 

Vanderbilt University, Nashville, TN 

eRA COMMONS USER NAME 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, and include postdoctoral training.) 

INSTITUTION AND LOCATION DEGREE 

(if applicable) YEAR(s) FIELD OF STUDY 

University of Notre Dame, Notre Dame, IN B.S. 1988 Mechanical Engineering 

University of Pittsburgh, Pittsburgh, PA Ph.D. 1995 Bioengineering 

University of Pittsburgh, Pittsburgh, PA M.D. 1996 Medicine 

University of NC at Chapel Hill, Chapel Hill, NC Residency 1996 01 Otolaryngology 

Vanderbilt University Owen School of Management M.S. 2012 13 Management 

 Personal Statement 

Over the past 16 years, I have been the clinical director of a multi-disciplinary research team composed of 

engineers, surgeons, audiologists, and biostatisticians which has focused on the use of image guidance 

techniques in the field of otology. This has included multiple NIH-funded endeavors in which I have served as 

including development of robotic techniques for surgically approaching the lateral skull base 

(R21EB006044–02) as well as development, clinical testing, and implementation of novel minimally-invasive 

surgical approaches for cochlear implantation (R01DC008408, R01DC010184). More recently our work has 

included use of imaging to improve cochlear implant programming and currently supported by two grants for 

which I am a co-I (R01DC014037, R01DC014462). Our compendium of work has expanded to include 

neuroscientists and speech language pathologists, and we now find ourselves in the unique situation to 

propose investigation of personalized algorithms for pediatric cochlear implant recipients. Given my experience 

leading multi-disciplinary teams and expertise in both surgery and engineering, I am happy to serve as Co-I 

lending my surgical and engineering expertise to this project investigating auditory, speech, language, and 

literacy outcomes following individualized programming for pediatric cochlear implant users. As an active 

clinician/scientist, I am acutely aware of the clinical problems associated with patient counseling and 

prognostic indecision due to highly variable outcomes for cochlear implant recipients—particularly pediatric 

cochlear implant recipients given the critical period for speech, language, and literacy. There are few 

interventions that are using a one-size-fits-all approach to rehabilitation. We have demonstrated in both adult 

and pediatric cochlear implant recipients that an individualized approach to otologic and audiologic 

rehabilitation results in statistical significant improvement in auditory-based outcomes. We have much to learn 

from this project with the ultimate goal of maximizing the potential of all implant recipients and I look forward to 

this collaborative project. 

Positions and Honors. 

1996-1997 General Surgery Intern; University of North Carolina Hospitals 

1997-2001 Otolaryngology Resident; University of North Carolina Hospitals 

7/1/2001-6/30/2007 Assistant Professor; Vanderbilt University 

Department of Otolaryngology-Head and Neck Surgery 

Joint Appointment Department of Biomedical Engineering 

7/1/2007-12/31/2012 Tenured Associate Professor, Vanderbilt University 

2011 present Vanderbilt Institute in Surgery and Engineering (VISE), Steering Committee 

09/2012-05/2014 Director of Research, Department of Otolaryngology-Head and Neck Surgery 

06/2014-present Vice Chair, Chief Research Officer, Dept. Otolaryngology-Head and Neck Surgery 

1/1/13 present Tenured Professor, Vanderbilt University 

2/1/15 5/1/16 Faculty Appointment and Promotions Committee, Vanderbilt University Medical Center 

Other Experience and Professional Memberships 

1996-present American Academy of Otolaryngology-Head and Neck Surgery 

2002-2008 Vanderbilt University Medical Center Institutional Review Board (IRB) 

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Member 2002-2012; Vice Chair 2003-2004; Chair 2004-2007 

2008-present Fellow, Triological Society 

2009-present American Otological Society 

2009-present American Neurotologyl Society 

2009-present Fellow of the American College of Surgeons 

2011-present Vanderbilt Initiative in Surgery and Engineering (VISE) 

Honors: 

Summa Cum Laude, University of Notre Dame 1988. 

National Institute of Health Medical Scientist Training Fellow 1988-1990, 1992-1996. 

American Heart Association Pre-Doctoral Fellow 1990-1991. 

First Place Doctoral Student Paper Competition, American Society of Mech Eng Bioeng Division, 1992 

Third Place Cardiothoracic Fellow’s Research Paper Competition, AHA (West PA Region), 1994. 

US Patent #5,537,335, Fluid Delivery Apparatus and Associated Method 

US Patent #7,794,469, Adjustable Universal Surgical Platform 

US Patent #7,899,512, System and Method for Surgical Instrument Disablement via Image-Guided Position 

Feedback 

US Patent #7,981,122, Adjustable Surgical Platform and Surgical Instrument Using Same 

US Patent #8,321,636, Anchor Driver with Assured Seating 

US Patentt #8,380,288, System and methods of using image-guidance for providing an access to a cochlear of 

a living subject 

US Patent #8,886,331, Apparatus and Methods for Percutaneous Cochlear Implantation. 

US Patent pending (claims allowed October 2016) Methods and Systems for Customizing Cochlear Implant 

Stimulation and Applications of Same. 

First Place Resident’s Research Award, University of North Carolina Womack Surgical Society, 1997. 

Second Place Basic Science Research Award, Amer. Acad. of Otolaryngology-Head and Neck Surgery, 1998. 

Sam Sanders Award for Basic Science Research, American Academy of Otolaryngic Allergy, 1999. 

MED-EL Corporation Clinical Research Award, 2000. 

Newton D. Fischer Temporal Bone Dissection Award, 6/2000, 6/2001 

American Academy of Otolaryngology-Head and Neck Surgery Honor Award, 10/2009 

Grant W. Liddle Award for Outstanding Contributions in Clinical Research, Vanderbilt University Medical 

Center, 5/2010. 

Distinguished Alumni Award, University of Pittsburgh, Department of Bioengineering, March 2012. 

Songs for Sound Cochlear Implant Awareness, Success Award, May 2013 

Award for Excellence in Resident Education, Vanderbilt University Department of Otolaryngology, June 2013 

Web Summit 2015. Is deafness curable? Dublin, Ireland. November 4, 2015. 

Magna Lecture: Use of imaging to improve cochlear implantation: from flat plate radiography to image-guided 

surgery with robots, Department of Otolaryngology-Head and Neck Surgery, University of San Paulo. 

December 9, 2015. San Paulo, Brazil. 

Creative Minds US State Department Series. Wired for Sound: Treating Deafness with Cochlear Implants. 

Residence of the United States Ambassador to Ireland. Dublin, Ireland. July 15, 2016 

(https://vimeo.com/189220973) 

Labadie RF, Fitzapatrick JM. Image-guided surgery: Fundamentals and Clinical Applications in 

Otolaryngology. Plural Publishing, Inc. San Diego, CA. 2016. 

Contribution to Science 

(1) We have developed a novel way to program cochlear implants using post-operative CT scans to specify the 

relationship between the neural interface of the cochlear implant electrode array and the endings of the 

auditory nerve (8th cranial nerve). This work built on prior work (see (a)-(d) below as well as significant 

publication (5) below) which was discovered during work on significant publication (3). To date, we have 

applied this technique to over 200 cochlear implant recipients and have long-term data on 101 adult recipients 

and 11 pediatric recipients. These populations consist of long-term recipients implying that they have achieved 

maximal benefit from their standard of care cochlear implant mapping. After using the new program for 1 

month, 79 of the 101 (79%) and 9 of the 11 pediatric patients (82%) chose to keep the new map either 

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because of statistically significant improvement in speech understanding or subjective improvement that was 

deemed significant enough for them to abandon the maps they had been using for, on average, 3 1⁄2 years. 

This is even more impressive given prior reports that show that cochlear implant recipients are likely to favor 

existing maps over new experimental maps. We have had cochlear recipients from 25 states travel—at their 

own expense—to Vanderbilt for such programming. More details of this work can be accessed at 

http://www.vanderbilt.edu/CAOS/research-projects/slideshow-that-describes-some-recent-research-atvanderbilt-in-image-guided-cochlear-implant-programming/. For this work, I have served as senior clinical 

advisor as well as co-inventor of the technology with patents pending. 

(a) Reda FA, McRackan TR, Labadie RF, Dawant BM, Noble JH. Automatic segmentation of intra-cochlear 

anatomy in post-implantation CT of unilateral cochlear implant recipients. Med Image Anal 2014 

Apr;18(3):605-15. PMID: 24650801. 

(b) Noble JH, Labadie RF, Gifford RH, Dawant BM. Image-guidance enables new methods for customizing 

cochlear implant simulation strategies. IEEE Trans Neural Syst Rehabil Eng 2013; 21(5): 820-9. PMID: 

23529109. 

(c) Noble JH, Labadie RF, Majdani O, Dawant BM. Automatic Segmentation of Intra-cochlear Anatomy in 

Convention CT. IEEE Trans Biomed Eng 2011;58(9):2625-2632. PMID:21708495. 

(d) Noble JH, Hedley-William AJ, Sunderhaus L, Dawant BM, Labadie RF, Camarata SM, Gifford RH. Initial 

results with image-guided cochlear implant programming in children. Otol Neurotol 2016 Feb;37(2):e63-9. 

PMID: 26756157. 

When we initially segmented inner ear anatomy as part of significant publication (3), there was a 

hypothesis in the field that final intracochlear position of cochlear implant electrode arrays had an impact upon 

audiological performance. Having developed technology that, with few tweaks, could be used to assess this 

question, we began a clinical study and have established ourselves as leaders in the field developing 

automatic algorithms to identify most commercially-available cochlear implant electrodes ((a) below) and 

assessing the relationship between final post-operative position ((b) and (c) below), especially regarding 

whether electrodes cross the basilar membrane, and audiological performance. This work, for which I have 

served as senior author and investigator, has resulted in the Harris P. Mosher, MD Award Given in recognition 

 excellence of a thesis in Clinical Research from the Triological Society for co-author Wanna (c below) for 

whom I have served as mentor both during his fellowship training as well as his early academic career. Our 

most recent work reporting on 220 cochlear implant recipients is included as (d). 

(a) Zhao Y, Dawant BM, Labadie RF, Noble JH. Automatic localization of cochlear implant electrodes in 

CT. Med Image Comput Comput Assist Interv, 2014;17(Pt 1):331-8. PMID: 25333135. 

(b) Schuman TA, Noble JH, Wright CG, Wanna GB, Dawant B, Labadie, RF. Anatomic Verification of a 

Novel, Non-rigid Registration Method for Precise Intrascalar Localization of Cochlear Implant Electrodes in 

Adult Human Temporal Bones Using Clinically-available Computerized Tomography. Laryngoscope, 2010; 

120(11):2277-2283. PMID: 20939074. 

(c) Wanna GB, Noble JH, McRackan TR, Dawant BM, Dietrich MS, Watkins LA, Rivas A, Schuman TA, 

Labadie RF. Assessment of Electrode Placement and Audiological Outcomes in Bilateral Cochlear 

Implantation. Otol Neurotol, 2011 Jan 28. PMID: 21283037. 

(d) O'Connell BP, Cakir A, Hunter JB, Francis DO, Noble JH, Labadie RF, Zuniga G, Dawant BM, Rivas A, 

Wanna GB. Electrode Location and Angular Insertion Depth Are Predictors of Audiologic Outcomes in 

Cochlear Implantation. Otol Neurotol. 2016 Sep;37(8):1016-23. PMID: 27348391 

Capitalizing on the underutilization of image-guided surgical technology in otolaryngology, especially at the 

lateral skull base where anatomy is encased in rigid bone which does not distort during surgical interventions, 

we began an investigation of the feasibility of replacing a wide-field surgical dissection (mastoidectomy) with a 

minimally-invasive, image-guide approach in targeting the cochlea for cochlear implantation. This technique 

progressed from concept ((b) below) to clinical validation ((a) and (c) below) to clinical implementation 

(significant publication (3)) as well as utility for other applications including implantation of the ossified cochlea 

((d) below) and drainage of petrous apex lesioss ((e) below). For this work I have served as PI. A video 

summarizing our validation studies can be viewed at http://www.vanderbilt.edu/CAOS/videos/. In October of 

2016, I received an Investigational Device Exemption from the FDA to continue this investigation. 

(a) Labadie RF, Noble JH, Dawant BM, Majdani O, Balachandran R, Fitzpatrick JM. Clinical validation of 

percutaneous cochlear implant surgery: initial report. Laryngoscope 2008;118:1031-39. PMID:18401279. 

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(b) Labadie RF, Mitchell J, Balachandran R, Fitzpatrick JM. Customized, Rapid-Production Microstereotactic Table for Surgical Targeting: Description of Concept and In-vitro Validation. Int J Comput

Assist Radiol Surg 2009;4(3):273-280. PMID:20033593. 

(c) Labadie RF, Balachandran R, Mitchell J, Noble JH, Majdani O, Dawant BM, Bennett M, Haynes DS,

Fitzpatrick JM. Clinical Validation Study of Percutaneous Cochlear Access Using Patient Customized 

Micro-Stereotactic Frames. Otol Neurotol 2010;31(1):94-99. PMID:20019561.

(d) Balachandran R, Tsai BS, Ramachandra T, Noble JH, Dawant BM, Labadie RF, Bennett ML. MinimallyInvasive Image-Guided Access for Drainage of Petrous Apex Lesions. Otol Neurotol 2014 Apr;35(4):649-

55. PMID: 24622019.

(4) Mechatronic surgical interventions involve using automated tools to perform portions of surgical

interventions. While in theory this is widely accepted, in practice limited demonstrations have occurred. We

undertook the above experiment to show that this concept was empirically reducible (significant work (4)) and

further explored in publications (a) (c) below. Furthermore, we have explored the limits of force needed to

cause damage to intracochlear structures (d below) and have shown that this force is approximately at the

threshold of human perception (e below) motivating continued development of mechatronic devices.

(a) Kratchman LB, Blachon GS, Withrow TJ, Balachandran R, Labadie RF, Webster RJ. Design of a BoneAttached Parallel Robot for Percutaneous Cochlear Implantation. IEEE Trans Biomed Eng

2011;58(10):2904-10. PMID:21788181. 

(b) Dillon NP, Balachandran R, Fitzpatrick JM, Siebold MA, Labadie RF, Wanna GB, Withrow TJ, Webster

RJ 3rd. A Compact, Bone-Attached Robot for Mastoidectomy. J Med Device. 2015 Sep;9(3):0310031-

310037. PMID: 26336572. 

(c) Danilchenko A, Balachandran R, Toennies JL, Baron S, Munske B, Fitzpatrick JM, Withrow TJ, Webster

RJ, Labadie RF. Robotic Mastoidectomy. Otol Neurotol, 2011;32(1):11-16. PMID:21042227.

(d) Schuster D, Kratchman LB, Labadie RF. Characterization of intracochlear rupture forces in fresh human

cadaveric cochleae. Otol Neurotol. 2015 Apr;36(4):657-6. PMID: 25233332.

(5) Early on in our work with image-guided surgical techniques we recognized the need for automatic

segmentation of temporal bone anatomy to improve upon time intensive manual segmentations. Our work built

upon prior work at Vanderbilt led by PI Benoit Dawant using statistical atlases to predict location of anatomical

structures coupled with image processing of clinical scans containing yet to be identified anatomy. Initially this

work involved rigid and non-rigid registration of anatomy encased in bone but subsequently involved more

elaborate techniques including development of a novel method to segment tubular structures ((c) below).

Statistical shape models were also created to allow advances in the area of significant paper (1). This allowed

use of these techniques to assess clinically-relevant anatomy ((a) and (b) below). Most recently, we have

shown that rigid + non-rigid registration is significantly better that rigid registration alone when assessing

cochlear anatomy. My involvement in the work has been as clinical PI directing the clinical relevance of the

work and supervising clinical validation.

(a) Noble JH, Dawant BM, Warren RM, Majdani O, Labadie RF. Automatic Identification and 3-D

Rendering of Temporal Bone Anatomy. Otol Neurotol 2009;30:436-442. PMID:19339909.

(b) McRackan TR, Reda FA, Rivas A, Noble JH, Dietrich MS, Dawant BM, Labadie RF. Comparison of

cochlear implant relevant anatomy in children versus adults. Otol Neurotol. 2012 Apr;33(3):328-34.

PMID:22377644.

(c) Noble JH, Warren FM, Labadie RF, Dawant BM. Automatic segmentation of the facial nerve and

chorda tympani in CT images using spatially dependent feature values. Medical Physics 2008;35(12):

5375-84. PMID:19175097. 

(d) Cakir A, Labadie RF, Zuniga MG, Dawant BM, Noble JH. Evaluation of Rigid Cochlear Models for

Measuring Cochlear Implant Electrode Position. Otol Neurotol. 2016 Dec;37(10):1560-1564. PMID:

27755453.

Complete List of Published Work in MyBibliography: 

https://www.ncbi.nlm.nih.gov/sites/myncbi/1Pksp2DTx5vkN/bibliography/47354331/public/?sort=date&directi 

on=descending 

Research Support 

Ongoing Research Support: 

NIDCD 2R01DC008408-11 7/1/12 3/31/23 

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Clinical Validation and Testing of Percutaneous Cochlear Implantation 

The major goal of this study is to validate a new technique for cochlear implantation. This technique utilizes 

image–guided surgery to reduce a wide–field, time intensive procedure to a minimally–invasive procedure. 

NIDCD 1R01DC012593-01A1 (PI: Webster, co-I: Labadie) 12/1/17 11/30/19 

Non-Invasive Transnasal Diagnosis of Inner Ear Disease 

The goal of this project is to provide guidance during the device design phase of the proposed work (Aim 1). 

NIDCD 1 R01 DC014037-01 (PI: Noble, co-I: Labadie) 6/1/2014 5/31/2019 

Image-Guided Cochlear Implant Programming Techniques 

The goal of this project is to develop and evaluate new image-guided cochlear implant programming strategies 

that use objective information acquired from clinical images to determine patient customized frequency, current 

steering, and current focusing settings that lead to better hearing outcomes. 

NIDCD 1 R01 DC014462-01A1 (PI: Dawant, Co-I: Labadie) 11/01/15-10/31/20 

Computer-Assisted, Image-Guided Programming of Cochlear Implant Evaluation 

The goals of this project are to develop on-line deployable tools to efficiently implement Image-Guided 

Cochlear Implant Programming (IGCIP) both within and outside of our home institution on a large scale. 

Additionally, we will construct and analyze the resultant large data base to identify factors that affect 

performance with IGCIP to facilitate further improvement in its efficacy. 

Completed research support: 

None 

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BIOGRAPHICAL SKETCH 

Provide the following information for the Senior/key personnel and other significant contributors. 

Follow this format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Jack H. Noble 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Assistant Professor of Electrical Engineering and Computer Science 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

Vanderbilt University 

B.E. 

M.S. 

Ph.D. 

05/2007 

12/2008 

05/2011 

Electrical Engineering 

Personal Statement 

In ongoing collaborative studies with Vanderbilt colleagues for which I am the principal investigator, I have 

developed algorithms and software systems that permit determining the position of small scale intra-cochlear 

anatomy and the precise intra-cochlear locations of cochlear implant (CI) electrodes in patient CT scans. We 

have demonstrated our methods to have a high degree of accuracy. We have used them to show that suboptimal intra-cochlear positioning of the electrodes is associated with poorer outcomes, and we have shown 

these techniques can be used to implement Image-Guided Cochlear Implant Programming (IGCIP) techniques, 

where CI processor settings are determined based on intra-cochlear electrode position to improve hearing 

outcomes. The main goal of the current project is to evaluate the effects of IGCIP techniques on basic auditory 

function, speech understanding, language abilities, speech production, and literacy outcomes in pediatric CI 

recipients. This project is of significant clinical interest as natural hearing quality and fidelity are rare among 

pediatric CI recipients, and any strategies that improve outcomes can have high impact on sound-quality-oflife. I have over 10 years of experience in the area of medical image processing and analysis. I will be site PI at 

Vanderbilt University and will oversee development, maintenance, and analysis of the imaging data repository 

and for the creation of IGCIP plans for the 60 cochlear implant recipients that will participate in this study. I will 

supervise with Dr. Dawant a staff engineer who will maintain the database, assist in the creation of plans, and 

perform any modification of the planning software necessary to support this project. As the primary investigator 

responsible for developing the image analysis tools that will be used, and as a successful PI on other previous 

and ongoing projects, I have the expertise necessary to fulfill my responsibilities for this project. 

Positions and Honors 

Positions and Employment 

2018-Present Assistant Professor of Electrical Engineering & Computer Science, Vanderbilt University 

2015-Present Research Assistant Professor of Hearing & Speech Sciences, Vanderbilt University 

2014-Present Research Assistant Professor of Otolaryngology Head & Neck Surgery, Vanderbilt University 

2011-2017 Research Assistant Professor of Electrical Engineering, Vanderbilt University 

Honors 

2017 Guest Associate Editor for SPIE Journal of Medical Imaging Special Issue on Image-Guided 

Procedures, Robotic Interventions, and Modeling 

2016 Communication Services Award from the Dept. of Hearing and Speech Sciences at the 

Vanderbilt Bill Wilkerson Center 

2015-2017 Awarded NIH Clinical Research Loan Repayment Program Grant (L30) 

2014 US Patent pending, An artifact-robust, shape library-based algorithm for automatic 

segmentation of inner ear anatomy in post-cochlear-implantation CT 

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B. 

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2013 US Patent pending, Method for Automatic Segmentation of Intra-Cochlear Anatomy in PostUnilateral-Implantation CT 

2013 Awarded $1000 first prize for best poster at the Vanderbilt Bill Wilkerson Center for 

Otolaryngology and Communication Sciences Combined Poster Session 

2012-2014 Awarded NIH Clinical Research Loan Repayment Program Grant, L30DC012689 

2012 US Patent pending #61/619,824, System and methods of cochlear implant mapping based on 

intracochlear position of electrode arrays and applications of same 

2011 US Patent #8,073,216, System and methods for automatic segmentation of one or more critical 

structures of the ear 

2010 Top ten finalist in the best student paper competition at the SPIE Conference on Medical 

Imaging 

2008-2011 NIH/NIDCD Pre-doctoral Fellowship 

2007-2011 Awarded IBM Engineering Graduate Scholarship 

2007 Magna Cum Laude with Honors, Vanderbilt University 

2006 Awarded stipend from the Vanderbilt Undergraduate Summer Research Program to conduct the 

research project “Automatic identification of the facial nerve in CT for percutaneous cochlear 

implant surgery” 

Student Honors (Mentor) 

2017 Runner up in the best student paper competition (from over 50 submissions) at the SPIE 

Conference on Medical Imaging 2017 (Ahmet Cakir) 

2014-2015 Awarded Vanderbilt Initiative in Surgery and Engineering (ViSE) Fellowship (Yiyuan Zhao) 

2013 Awarded Vanderbilt University School of Engineering Summer Undergraduate Research 

Program Fellowship (Rebecca Turok) 

2012 Top ten finalist in the best student paper competition at the SPIE Conference on Medical 

Imaging 2012 (Fitsum Reda) 

Grant Reviewing 

2018 Served on the NIH/NIDCD Translational R01 review study section. 

2017 Served on the NIH/NIDCD Hearing and Balance Fellowships Review study section. 

2016 Served on the NIH/NIDCD Translational R01 review study section. 

2016 Served as reviewer for Action on Hearing Loss research grant program. 

Journal Editorial Board Service and Reviewing 

Associate Editor: 2018 SPIE Jour. of Med. Imag. Spec. Iss. on Image-Guided Proc., Robotic Interv., and Modeling 

Journal of Medical Imaging 

International Journal of Computer Aided Radiology and Surgery 

Medical Image Analysis 

International Journal of Medical Robotics and Computer Assisted Surgery 

I.E.E.E. Transactions on Biomedical Engineering 

Physics in Medicine and Biology 

Medical Physics 

Medical Engineering & Physics 

Otology & Neurotology 

Audiology & Neurotology 

European Archives of Oto-Rhino-Laryngology 

Other Experience and Professional Memberships 

2008- Member, International Society for Optics and Photonics (SPIE) 

2008- Member, Institute of Electrical and Electronic Engineers (IEEE) 

2008- Member, Medical Image Computing and Computer Assisted Intervention Society (MICCAI) 

Contribution to Science 

In my earlier work I developed algorithms and techniques that can automatically and accurately identify 

many of the important anatomical structures of the ear in CT scans. Prior to these publications, no methods 

for automatically localizing ear anatomy had been developed and few studies existed that quantified 3D ear 

Contact PD/PI: Gifford, Rene H Biosketches Page 33

 

 

 

 

 

 

 

 

C. 

1. 
anatomy due to the difficulty in manual image analysis. The published methods have been transformative 

in the Otology community as they in many ways have lowered the barrier for use of patient-specific image 

information in Otology applications. These techniques have enabled for the first time large scale analysis of 

anatomical shape variations, development of computer assisted surgery planning methods, and 

development of post-operative assessment systems. I served as the primary or senior investigator in all 

these studies. 

a. Noble, J.H., Labadie, R.F., Majdani, O., Dawant, B.M., “Automatic segmentation of intra-cochlear 

anatomy in conventional CT”, IEEE Trans. on Biomedical. Eng., Vol. 58, No. 9, pp. 2625-32, 2011. 

PMC3804019 

b. Noble, J.H., Warren, F.M., Labadie, R.F., Dawant, B.M., "Automatic segmentation of the facial 

nerve and chorda tympani in CT images using spatially dependent feature values," Med. Phys., 

35:5375-5384, 2008. PMC2673604 

c. Noble, J.H., Dawant, B.M., Warren, F.M., Labadie, R.F., "Automatic Identification and 3D Rendering 

of Temporal Bone Anatomy," Otol & Neurotol., 30(4):436-42, 2009. PMC4437534 

d. Reda, F.A., McRackan T.R., Labadie, R.F., Dawant, B.M., Noble JH, “Automatic segmentation of 

intra-cochlear anatomy in post-implantation CT of unilateral cochlear implant recipients,” Medical 

Image Analysis, vol. 18(3), pp. 605-15, 2014. PMC4410997 

Other early and ongoing work has aimed at developing image processing fundamentals that permit 

localizing tubular structures in medical images. Tubular structures, such as nerves and vessels, are found 

throughout the body and their localization is crucial for a variety of application specific analyses. My work in 

this area has led to several novel algorithms that permit localization of a variety of structures. I served as 

the primary or co-investigator in these studies. 

a. Noble, J.H., Dawant, B.M., “An atlas-navigated optimal medial axis and deformable model algorithm 

(NOMAD) for the segmentation of the optic nerves and chiasm in MR and CT images,” Medical 

Image Analysis, Vol. 15, No. 6, pp. 877-884, 2011. PMC3191306 

b. Noble, J.H. and Dawant, B.M., 2011, “A New Approach for Tubular Structure Modeling and 

Segmentation Using Graph-Based Techniques,” Lecture Notes in Computer Science Proceedings 

of MICCAI, 6893, pp. 297-304. PMC4184473 

c. Ding, S., Miga, M.I., Noble, J.H., Cao, A., Dumpuri, P., Thompson, R.C., Dawant, B.M., "Semiautomatic registration of pre- and post- brain tumor resection laser range data: method and 

validation," IEEE Trans Biomed Eng., 56(3):770-80, 2008. PMC2791533 

d. Reda, F.A., Noble, J.H., Rivas, A., McRackan, T.R., Labadie, R.F., Dawant, B.M., “Automatic 

segmentation of the facial nerve and chorda tympani in pediatric CT scans,” Medical Physics 38, 

pp. 5590-5600, 2011. PMC3208411 

Our group has worked to develop novel systems for stereotactic framed-guided cochlear implantation 

procedures and deep brain stimulator placement procedures. Stereotactic frame guided surgery offers 

significant benefits over standard of care in terms of precision and invasiveness. I developed automated 

surgical path planning techniques that find probabilistically safe and effective surgical paths. These 

techniques were the first of their kind in that they permit estimating the probability of success or failure. 

These publications report the novel path planning methods and how they are used in these image-guided 

surgery systems. I was primary or co-investigator in these studies. 

a. Noble, J.H., Majdani, O., Labadie, R.F., Dawant, B.M., Fitzpatrick, J.M., "Automatic Determination 

of Optimal Linear Drilling Trajectories for Cochlear Access Accounting for Drill-Positioning Error," 

Intl. J. of Med. Robotics and Comp. Assist. Surg., 6(3):281-290, 2010. PMC2933923 

b. Liu, Y., Konrad, P., Neimat, J., Tatter, S., Yu, H., Datteri, R., Landman, B., Noble, J.H., Pallavaram, 

S., Dawant, B.M., and D’Haese, P., “Multi-Surgeon, Multi-Site Validation of a Trajectory Planning 

Algorithm for Deep Brain Stimulation Procedures,” IEEE Trans. on Biomedical Engineering, vol. 

61(9), pp. 2479-87, 2014. PMC4142093 

c. Labadie, R.F., Noble, J.H., Dawant, B.M., Balachandran, R., Majdani, O., Fitzpatrick, J.M., “Clinical 

validation of percutaneous cochlear implant surgery: initial report,” Laryngoscope, 118:1031-9, 

2008. PMC4453765 

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2. 

– 

3. 
d. Labadie, R.F., Balachandran, R., Mitchell, J., Noble, J.H., Majdani, O., Haynes, D.S., Bennett, M., 

Dawant, B.M., Fitzpatrick, J.M., “Clinical Validation Study of Percutaneous Cochlear Access Using 

Patient Customized Micro-Stereotactic Frames,” Otology & Neurotology, 31(1):94-99, 2010. 

PMC2845321 

Cochlear implants are neural prosthetic devices used to treat profound hearing loss. Outcomes with cochlear 

implants are highly variable. Placement of the device is one factor linked to outcomes but has not been well 

understood. I developed automated image processing techniques to analyze placement of the electrodes, 

permitting large scale investigation of how hearing outcomes relate not only to device placement, but also to 

device design and programming. The following publications detail the methodology and how it was validated as 

well as some of the large scale investigations we have performed. I was senior, principal, or co-investigator in 

these studies. 

a. Zhao, Y., Dawant, B.M., Labadie, R.F., and Noble, J.H., “Automatic Localization of Cochlear 

Implant Electrodes in CT,” Lecture Notes in Computer Science Proceedings of MICCAI, vol. 8673, 

pp. 331-8, 2014. PMC4426961 

b. Cakir A., Labadie R.F., Dawant B.M., Noble J.H., “Evaluation of cochlear anatomy models for 

determining intra-cochlear electrode position,” Otology & Neurotology, 37(10):1560-1564. 2016. 

PMC5240585 

c. Noble, J.H. and Dawant, B.M., “Automatic graph-based localization of cochlear implant electrodes 

in CT,” Lecture Notes in Computer Science Proceedings of MICCAI, vol. 9350, pp. 152-9, 2015. 

PMC4854292 

d. Wanna, G.B., Noble J.H., Carlson, M.L., Gifford, R.H., Dietrich, M.S., Haynes, D.S. Dawant, B.M., 

and Labadie, R.F., “Impact of Electrode Design and Surgical Approach on Scalar Location and 

Cochlear Implant Outcomes,” Laryngoscope, vol. 124(S6), pp. S1-7, 2014. PMC4209201 

Much of my recent work has focused on developing techniques for image-guided cochlear implant 

programming (IGCIP), where information from patients’ CT images is used to customize the settings that 

control how the implant operates. Leveraging much of the ear anatomy and cochlear implant image 

analysis techniques developed above, I was able to propose, develop, and clinically test the first method 

for IGCIP. IGCIP is exciting because the reward is high--our studies have shown IGCIP significantly 

improves hearing outcomes for cochlear implant recipients--while risks are low—IGCIP requires only 

making a simple and reversible change of settings without any additional surgical procedures. The 

following publications report the development of IGCIP and the results of recent clinical tests. This is an 

emerging research area, and we are in progress with publications reporting new clinical studies and IGCIP 

strategies. I was the principal investigator in these studies. 

a. Noble, J.H., Gifford, R.H., Labadie, R.F., Dawant, B.M., 2012, “Statistical Shape Model 

Segmentation and Frequency Mapping of Cochlear Implant Stimulation Targets in CT,” N. Ayache 

et al. (Eds.): MICCAI 2012, Part II, LNCS 7511, pp. 421-428. 2012. PMC3559125 

b. Noble JH, Labadie RF, Gifford RH, Dawant BM, “Image-guidance enables new methods for 

customizing cochlear implant stimulation strategies,” IEEE Trans Neural Syst Rehabil Eng. vol. 

21(5):820-9, 2013. PMC3769452 

c. Noble JH, Gifford RH, Hedley-Williams AJ, Dawant BM, and , Labadie RF, “Clinical evaluation of an 

image-guided cochlear implant programming strategy,” Audiology & Neurotology, vol. 19, pp. 400-

11, 2014. PMC4305276 

d. Noble JH, Hedley-Williams AJ, Sunderhaus LW, Dawant BM, Labadie RF, Gifford RH, “Initial 

results with image-guided cochlear implant programming in children,” Otology & Neurotology 37(2), 

pp. 69-9, 2016. PMC4849538 

Complete List of Published Work in MyBibliography (Over 50 peer-reviewed publications): 

http://www.ncbi.nlm.nih.gov/sites/myncbi/jack.noble.1/bibliography/41146802/public/?sort=date&direction=asce 

nding 

Contact PD/PI: Gifford, Rene H Biosketches Page 35

4. 

– 

– 

5. 
Research Support 

Ongoing Research Support 

5R01DC014037 (Noble) 6/01/14-05/31/19 

NIH/NIDCD 

Image-guided cochlear implant programming techniques 

The goals of this project are to develop and evaluate new patient-customized, Image-Guided Cochlear Implant 

Programming (IGCIP) strategies that could provide objective information to the programming process and lead 

to programs that better approximate natural hearing performance. 

Role: Principal Investigator 

5R01DC014462 (Dawant) 12/01/15-11/30/20 

NIH/NIDCD 

Computer-assisted, image-guided programming of Cochlear Implants 

 mature the system we have developed for patient-customized, image-guided cochlear implant programming 

to produce a system that will be clinically deployable, thus increasing the number of cochlear implant recipients 

who can benefit from this technology. 

Role: Co-investigator, responsible for overseeing and conducting some software development tasks 

1R01 DC15798 (Noble) 09/01/16-08/31/19 

NIH/NIDCD (Subcontract from U of MD) 

Single-Sided Deafness Cochlear Implants for Functioning in Complex Auditory Environments 

The subcontract of this award is to Jack Noble (co-I, Vanderbilt) is the world’s leading expert in reading x-rays 

(CT scans) to determine cochlear implant location in the head, a critical piece to this work. 

1R21DC16153 (Webster) 09/01/17-08/31/19 

NIH/NIDCD 

Transnasal Diagnosis of Middle Ear Disease 

The objective of this proposal is to replace exploratory surgery with a novel natural-orifice approach to 

diagnose and surveil middle ear disease. 

Previous Research Support 

5R01 DC008408 (Labadie) 07/13/12-06/30/17 

NIH/NIDCD 

Clinical Validation and Testing of Percutaneous Cochlear Implantation 

This application is to propose a multi-center study looking at the use of patient-specific drill guides built via 

rapid-prototyping based on pre-operative CT scans. 

Role: Co-Investigator, responsible for some of the segmentation and planning software tasks of the project 

1R21 EY024036 Landman (PI) 12/01/13-11/30/16 

NIH/NEI 

Quantitative Image Analysis Techniques for Optic Nerve Disease 

 translate medical imaging computing procedures from the neuroimaging community to provide robust, 

quantitative tools for assessing the optic nerve (ON) on clinical and research imaging sequences. 

Role: Co-Investigator, responsible for overseeing some segmentation development tasks 

5R21 DC012620 Noble (PI) 07/01/12-06/30/15 

NIH/NIDCD 

Image-based Frequency Reallocation for Optimizing Cochlear Implant Programming 

 develop and assess the clinical utility of an approach for determining the position of implanted cochlear 

implant electrodes relative to the nerves of the Spiral Ganglion for CI tuning assistance. 

Role: Principal Investigator 

Contact PD/PI: Gifford, Rene H Biosketches

 

 

 

 

 

 

 

 

 

 

 

D. 

To 

To 

 Page 36

To 
BIOGRAPHICAL SKETCH 

Provide the following information for the Senior/key personnel and other significant contributors. 

Follow this format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Benoit Dawant 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Cornelius Vanderbilt Professor of Engineering, Professor of Electrical Engineering, 

Professor of Biomedical Engineering, Professor of Radiology and Radiological Sciences, Vanderbilt 

University 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as 

nursing, include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

Catholic University of Louvain, Belgium 

University of Houston, TX 

MSEE 

Ph.D. 

1982 

1987 

Electrical Engineering 

Systems Engineering 

PERSONAL STATEMENT 

am the founding director of the Vanderbilt Initiative in Surgery and Engineering that is an interdisciplinary, 

trans-institutional center whose mission is the creation, development, implementation, clinical evaluation 

and commercialization of methods, devices, algorithms, and systems designed to facilitate interventional 

processes and their outcome. I am also the director of the Medical Image Processing laboratory at 

Vanderbilt where the image processing algorithms supporting the IGIP technique have been developed. I 

have more than 20 years of experience in the area of medical image processing and analysis. I have also 

more than 10 years of experience with large data repositories and associated processing pipelines, and 

with the clinical deployment of software designed for assisting surgical and post-surgical processes. I will 

supervise the software engineer/database specialist who has developed the current IGCIP database and associated webbased portals that permit uploading images, storing plans, setting calendars, and communication between study personnel. 

She will be responsible for maintaining the database and for the transfer of images and plans. She will also assist in the 

creation of plans and on the modification of the planning tools and the database necessary to support new IGCIP 

techniques. 

POSITIONS AND HONORS 

Positions and Employment 

1988-1994 Assistant Professor of Electrical Engineering, Vanderbilt University 

1994-2002 Associate Professor of Electrical and Computer Engineering, Vanderbilt 

University 2002-Present Professor of Electrical and Computer Engineering 

2002-Present Professor of Radiology and Radiological Sciences 

2009-Present Professor of Biomedical Engineering 

2011-Present Cornelius Vanderbilt Professor of Engineering 

2011-Present Director, Vanderbilt Initiative in Surgery and Engineering 

Honors 

1994: Recipient of the Japanese Government Research Award for foreign specialist in the area of 

medical imaging. 

1996-2004: Associate Editor, IEEE Transactions on Biomedical Engineering 

1996 (Fall): Senior visiting fellow, Katholieke Universiteit Leuven, Depts. of Electrical Engineering and 

Radiology, Leuven, Belgium 

1999: Co-Guest Editor, Special Section on Data Fusion, IEEE Transactions on Biomedical Engineering 

1999:Invited Guest Editor, IEEE Transactions on Information Technology in Biomedicine 

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I 

A. 

B. 
2000: Recipient of the most often cited paper award, IEEE Transactions on Medical Imaging (award 

received for paper published in 1993) 

2001-2008: Member of the steering Committee, IEEE Transactions on Medical Imaging, Chair of this committee 

from 2005-2008 

2002 (Summer) Visiting Professor, Université Catholique de Louvain (UCL) 2010 Fellow, IEEE 

CONTRIBUTION TO SCIENCE 

For the last twenty years, I have worked in the area of medical image processing and analysis. I have worked 

the interface between engineering and medicine. My laboratory has developed both basic image processing 

algorithms and systems that have been clinically translated, integrated into the clinical flow, and 

commercialized. 

Segmentation: Early in my career I worked on the problem of tissue classification in MR images of the head. 

While working on this problem I identified image intensity inhomogeneity in MR images as an important 

problem to be addressed. Together with graduate student I developed a method for the 

correction of this artifact, which was reported in the IEEE Transactions on Medical Imaging (TMI) paper entitled 

“Correction of intensity variations in MR images for computer-aided tissue classification” [Daw93]. This paper 

has drawn interest from the community and I later received an IEEE TMI award for authorship of the journal’s 

most frequently cited paper published in 1993. This award recognizes this paper as “a classic paper in the field 

medical imaging, with exceptional originality and enduring impact”. Using this technique to correct for 

intensity inhomogeneity, an automatic MR method for the segmentation of multi-modal MR images into white 

matter, gray matter, cerebrospinal fluid, and white matter lesions (these are abnormalities thought to be 

correlated with Alzheimer’s disease) was developed and reported in the IEEE TMI paper entitled 

“Morphometric analysis of white matter lesions in MR images: method and validation” [Zij94]. This paper was 

published in 1994 and is still being cited (505 Web of Science citations in total and 42 in 2013). My laboratory 

has also developed methods for the automatic segmentation of the liver [Her05] that have been patented (US 

patent 7,519,209 “System and methods of organ segmentation and applications of same”) and included in a 

commercial system for image-guided liver surgery developed by a spinoff called Pathfinder, Inc. that has now 

been acquired by Analogic Corporation as well as techniques for the segmentation of radiation sensitive 

structures in the head and neck for radiotherapy planning [Dee11]. 

• [Daw93] Dawant BM, Zijdenbos, AP., and Margolin R, "Correction of Intensity Variations in MR Images 

for Automatic Tissue Characterization", IEEE Transactions on Medical Imaging. 12(4), 1993, pp. 770-

781; PMID: 18218473, No PMC, published prior to 2007 

• [Zij94] Zijdenbos AP., Dawant BM., and Margolin R. "Morphometric Analysis of White Matter Lesions in 

MR Images: Method and Validation" IEEE Transactions on Medical Imaging, 13(4), pp.716-724, 1994; 

PMID: 18218550, No PMC, published prior to 2007. 

• [Her05] Hermoye L., Laamari I., Cao Z., Annet L., Lerut J., Dawant BM., and Van Beers BE., “Semiautomatic liver volumetry: validation in living donors for liver transplantatikon”, Radiology 234 (1), pp. 

171-178, 2005, PMID: 15564393, No PMC, published prior to 2007 

• [Dee11] Deeley, MA, Chen A, Datteri R, Noble JH, Cmelak AJ, Donnelly EF, Malcolm AW, Moretti L, 

Jaboin J, Niermann JK, Yang ES, Yu DS, Yei F, Koyama T , Ding GX, Dawant BM. "Comparison of 

Manual and Automatic Segmentation Methods for Brain Structures in the Presence of SpaceOccupying Lesions: A Multi-Expert Study." Phys Med Biol 56, no. 14 (Jul 21 2011): 4557-77, 

PMC3153124 

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C. 

at 

of 
Registration: Although early in my career, I focused on segmentation, my research interest subsequently 

evolved to include image registration as I identified this as a way to incorporate a-priori information into the 

segmentation process. I initiated a collaboration with who 

had proposed a method for the non-rigid registration of images. I demonstrated that automatic segmentation of 

internal brain structures using a combination of rigid and non-rigid registration techniques was indeed 

achievable. This was reported in the TMI paper entitled “Automatic 3-D segmentation of internal structures of 

the head in MR images using a combination of similarity and free-form transformations: Part I, methodology 

and validation on normal subjects” [Daw99].This paper also had a lasting effect on the field and is still being 

cited. Although results obtained in this study were satisfactory, the approach suffers from one major drawback: 

it is only applicable to images with comparable intensity characteristics. With mathematician colleague 

and graduate student I began working on the development of a multi-modal non-rigid 

registration method. This led to a novel spline-based method for non-rigid registration reported in the paper 

entitled “The adaptive bases algorithm for intensity-based nonrigid image registration” [Roh03]. This approach 

is different from the ones that had been proposed in the literature at that point in one key aspect. The algorithm 

operates on an irregular grid. It permits the spatial adaptation of the compliance of the transformation and local 

optimization, which has been shown to improve convergence properties and execution speed. This paper has 

been published in 2004, it has been cited 226 times with 19 citations in 2014. Registration techniques my 

laboratory developed have been used to integrate 3D mass spectrometry images and in vivo magnetic 

resonance imaging [Sin08] as well as for longitudinal studies of breast images [Li09]. 

• [Daw99] Dawant BM., Hartmann SL, Thirion J-P., Maes F., Vandermeulen D., and Demaerel P. 

“Automatic 3D segmentation of internal structures of the head in MR images using a combination of 

similarity and free form transformations: Part I, methods and validation on normal subjects”, IEEE 

Transactions on Medical Imaging , 18(10), 897-908, 1999, No PMC, published prior to 2007 

• [Roh03] Rohde G.K., Aldroubi A., Dawant B.M., “The adaptive bases algorithm for intensity-based 

nonrigid image registration.” IEEE Trans Med Imaging, 2003 Nov; 22(11): 1470-9; No PMC, published 

prior to 2007 

• [Sin08] Sinha TK., Khatib-Shahidi S., Yankeelov TE., Mapara K., Ehtesham M., Cornett DS., Dawant 

BM., Caprioli RM., Gore J.C., “Integrating spatially resolved three-dimensional MALDI IMS with in vivo 

magnetic resonance imaging”, Nature Methods, 5(1), pp. 57-59, 2008; PMC2649801 

• [Li09] Li X, Dawant BM, Welch EB, Chakravarthy AB, Freehardt D, Mayer I, Kelley M, Meszoely I, Gore 

JC, Yankeelov TE. “A Nonrigid Registration Algorithm for Longitudinal Breast MR Images and the 

Analysis of Breast Tumor Response”. Magn Reson Imaging. 2009 Nov;27(9):1258-70; PMC2763059 

Assistance for the planning, placement, and programming of Deep Brain Stimulators (DBS). Over the 

last ten years my laboratory has developed a system designed to assist clinical teams that perform DBS 

procedures that are used to treat movement disorders such as Parkinson’s disease. In the paper entitled 

“Computer-aided Placement of deep brain stimulators: From planning to intra-operative guidance” published in 

2005 [Dha05] we demonstrated that automated selection of the implantation target was feasible and at least as 

good as a trained neurosurgeon. We also obtained a patent for this work (US patent 7,167,760, “Apparatus 

and methods for optimal placement of deep brain stimulator”). More recently we showed that automating the 

complete trajectory, i.e., both the entry and target points, planning was also achievable [Liu14] and that 

computer-assistance is of value for programming the implant [Phi14]. Supported by three NIH R01s we 

developed a complete system to assist in all phases of the procedure, which is now integrated into the clinical 

flow at Vanderbilt. This system has been described in the paper entitled “Cranial Vault and its Crave tools: A 

clinical computer assistance system for deep brain stimulation (DBS) therapy” [Dha12]. In parallel, together 

with my colleagues , I create a spinoff company to commercialize and distribute the 

research system developed at Vanderbilt. Supported by one NIH STTR Phase I and one STTR Phase II, this 

small concern obtained FDA clearance for the pre-operative and intra-operative components of the system, 

which are currently distributed by FHC, Inc. under the name WayPoint Navigator (http://www.fhco.com/products/clinical-systems/waypoint-navigator ). It also obtained CE clearance for the post-operative 

component that is currently distributed by Medtronic, Inc. We are currently collaborating with the major DBS 

centers in the US to field our research system at these sites and to create what we envision will become a 

central resource for DBS procedures. 

Contact PD/PI: Gifford, Rene H Biosketches Page 39

 

 

 

 

 
• [Dha05] D’Haese P-F., Cetinkaya E., Konrad PE., Kao Ch., and Dawant BM., “Computer-aided 

placement of deep brain stimulators: from planning to intra-operative guidance”, IEEE Transactions on 

Medical Imaging, 24(11), pp. 1469-1478, 2005; No PMCID; published before 2007 

• [Liu14] Liu Y, Konrad PE, Neimat JS, Tatter SB, Yu H, Datteri RD, Landman BA, Noble JH, Pallavaram 

S, Dawant BM, DHaese PF. “Multisurgeon, multisite validation of a trajectory planning algorithm for 

deep brain stimulation procedures”. IEEE Trans Biomed Eng. 2014 Sep;61(9):2479-87; PMC4142093 

• [Dha12] D'Haese PF, Pallavaram S, Li R, Remple MS, Kao C, Neimat JS, Konrad PE, Dawant BM. 

“Cranialvault and Its Crave Tools: A Clinical Computer Assistance System for Deep Brain Stimulation 

(DBS) Therapy”. Med Image Anal. 2012 Apr;16(3):744-53; PMC3021628 

• [Phi14] Phibbs FT, Pallavaram S, Tolleson C, D'Haese PF, and Dawant BM, “Use of efficacy 

probability maps for the post-operative programming of deep brain stimulation in essential tremor”, 

Parkisonism and Related disorders, 2014, 20(12), 1341-1344; PMC4039015 

Image-guided programming of cochlear implants. Cochlear implants are used to treat patients who suffer 

from profound hearing loss. Current technology yields very good results for the vast majority but a significant 

number of users receive marginal benefit, and even the best performers complain that the fidelity of natural 

hearing is not reproduced. One of the issues is the difficulty to come up with optimal parameter settings. In 

current clinical practice, this is done based on subjective feedback provided by the patient to the audiologist. 

Together with former graduate student and now colleague Dr. Noble and clinical colleague Dr. Labadie I have 

developed a series of unique image processing algorithms that permit the automatic segmentation off all 

internal structures in the inner ear as well the localization of the electrode [Nob08, Nob09]. Thanks to these 

algorithms, which have been patented (US patent 8,073,216, “System and methods for automatic 

segmentation of one or more critical structures of the ear”), programming of the electrodes can now be 

accomplished based on objective information, e.g., relative position of each contact and the nerves they 

stimulate. We have developed a new programming strategy that makes use of this information, which has been 

described in the paper entitled “Image-guidance enables new methods for customizing cochlear implant 

stimulation strategies” [Nob13]. We have conducted a large scale evaluation study of this strategy. Long-term 

recipients (some have been implanted several years ago) who had been programmed using the current clinical 

protocol and for whom programming parameter settings were considered to be optimal were enrolled. These 

recipients were re-programmed using the image-guided protocol we have developed and outcomes prior to 

and after re-programming were compared. In the paper entitled “Clinical evaluation of an image-guided 

cochlear implant programming strategy” [Nob14] we report results that show in 68 adult CI recipients that our 

image-guided approach yields significant improvement in speech understanding in both quiet and noise as well 

improved spectral resolution. These results indicate that image guidance can improve hearing outcomes for 

many existing CI recipients without requiring additional surgery or the use of 'experimental' stimulation 

strategies, hardware or software. At the time of writing, we have used IGCIP to re-program well over 200 adult 

ears. We have seen 178 adult study participants (197 ears) for both the baseline and post-IGCIP visits and 135 

68.5% of the re-programmed patients chose to keep the IGCIP settings. 

• [Nob08] Noble JH, Warren FM, Labadie RF, Dawant BM. “Automatic Segmentation of the Facial Nerve 

and Chorda Tympani in Ct Images Using Spatially Dependent Feature Values”. Med Phys. 2008 

Dec;35(12):5375-84, PMC2673604 

• [Nob09] Noble JH, Dawant BM, Warren FM, Labadie RF. Automatic Identification and 3D Rendering of 

Temporal Bone Anatomy. Otol Neurotol. 2009 Jun;30(4):436-42; NIHMSID 685248, PMCID in process 

• [Nob13]Noble JH, Labadie RF, Gifford RH, and Dawant BM, “Image-Guidance Enables New Methods 

for Customizing Cochlear Implant Stimulation Strategies” IEEE Transactions on Neural Systems and 

Rehabilitation Engineering, 2013, 21(5), pp. 820-829, PMC3769452 

• [Nob14] Noble JH, Gifford RH, Hedley-Williams AJ; Dawant BM, and Labadie RF, “Clinical Evaluation 

of an Image-Guided Cochlear Implant Programming Strategy”, Audiology and Neuro-Otology, 2014, 

19(6), pp. 400-411, PMC4305276 

LINK TO BIBLIOGRAPHY 

http://www.ncbi.nlm.nih.gov/sites/myncbi/benoit.dawant.1/bibliography/40737322/public/?sort=date&direction= 

ascending 

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as 

or 

 Page 40
 RESEARCH SUPPORT 

Ongoing Research Support 

5R01NS095291-10 (Dawant/D’Haese) 09/30/15-07/31/19 

NINDS 

Computer-Assisted Functional Neurosurgery 

The goal of this project is to continue the clinical evaluation of our system, expand its functionality, and deploy 

at collaborating sites. Our long term goals are to develop and field (1) the first integrated DBS solution that 

will permit seamless exchange of information between all phases of the procedure and (2) a shared and global 

resource that will allow rapid dissemination of discovery and outcomes related to specific brain targets. It will 

thus be a catalyst that can both speed up discoveries in neurological sciences and improve clinical processes 

5R01DC014462-02 (Dawant) 12/01/15-11/30/20 

NIDCD 

Computer-assisted, image-guided programming of Cochlear Implants 

The goals of this project are to develop an Image-Guided Cochlear Implant Programming (IGCIP) strategy that 

can substantially and sometime dramatically improve hearing in long term CI users without requiring an 

additional surgical procedure and to conduct a large scale clinical validation both at Vanderbilt and at 

collaborating sites to discover factors that affect the performance of the method and further improve it. 

5R01DC014037-03 (Noble) 06/01/14-05/31/19 

NIH/NIDCD 

Image-guided cochlear implant programming techniques 

The goal of this project is to develop and evaluate new image-guided cochlear implant programming strategies 

that use objective information acquired from clinical images to determine patient customized frequency, current 

steering, and current focusing settings that lead to better hearing outcomes. 

COMPLETED 

5R01NS049251-10 (Miga) 08/01/04-4/30/16 

NINDS 

Multimodal Registration of the Brain's Cortical Surface.3 

Development of methods and techniques to compensate for brain shift during tumor resection surgery. 

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BIOGRAPHICAL SKETCH 

Provide the following information for the Senior/key personnel and other significant contributors. 

Follow this format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Dietrich, Mary S. 

eRA COMMONS USER NAME (agency login): 

POSITION TITLE: Professor, Statistics & Measurement 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable.) 

INSTITUTION AND LOCATION DEGREE 

(if applicable) 

Completion Date 

MM/YYYY 

FIELD OF STUDY 

Bethel College, North Newton, Kansas BS 05/1979 Psychology 

Fort Hays State University, Hays, Kansas MS 12/1986 Experimental Psychology 

Vanderbilt University, Nashville, Tennessee PHD 05/1996 Statistics/Measurement 

PERSONAL STATEMENT 

a Professor in the School of Medicine (Department of Biostatistics, Vanderbilt Ingram Cancer Center, 

Department of Psychiatry) and in the School of Nursing at Vanderbilt University, I have broad-ranging and 

extensive experience in biostatistical collaborations and applications including collaborations with Dr.Gifford 

and other researchers developing and evaluating image-guided cochlear implant programming (IGCIP) as 

noted below. 

Gifford RH, Loiselle L, Natale S, Sheffield SW, Sunderhaus LW, Dietrich MS, Dorman MF. Speech 

understanding in noise for adults with cochlear implants: effects of hearing configuration, source location 

uncertainty, and head movement. Journal of Speech Language and Hearing Research. [In press]. 

Gifford RH, Noble JH, Camarata SM, Sunderhaus LW, Dwyer RT, Dawant BM, Dietrich MS, Labadie RF. (in 

press). The relationship between spectral modulation detection and speech recognition: adult versus 

pediatric cochlear implant recipients. Trends in Hearing. [In press]. 

McRackan TR, Noble JH, Wilkinson EP, Mills D, Dietrich MS, Dawant BM, Gifford RH, Labadie RF. 

Implementation of image-guided cochlear implant programming at a distant site. Otolaryngology Head 

and Neck Surgery; 2017 May; 156(5); 933-937. PMID: 28374640. 

Wanna GB, Noble JH, Gifford RH, Dietrich MS, Sweeney AD, Zhang D, Dawant BM, Rivas A, Labadie RF. 

Impact of intrascalar electrode location, electrode type, and angular insertion depth on residual hearing in 

cochlear implant patients: Preliminary results. Otology & Neurotology; 2015 Sep; 36(8); 1343-1348. PMID: 

26176556. 

Wanna GB, Noble JH, Carlson ML, Gifford RH, Dietrich MS, Haynes DS, Dawant BM, Labadie RF. Impact of 

electrode design and surgical approach on scalar location and cochlear implant outcomes. The 

Laryngoscope; 2014 Nov; 124(S6); S1-S7. PMCID: PMC4209201. 

The goal of this proposed research is to expand the evaluation of IGCIP in the pediatric population to 

effects on auditory function, speech understanding, language abilities, speech production, and literacy 

outcomes. My role in this research will be to advise and collaborate on all data management and statistical 

considerations, conduct statistical analyses as necessary, and to substantially participate in activities related to 

the dissemination of the findings from this research, as well as the development of research proposals based 

these findings. I am currently Co-I on multiple NIH-funded studies. As is evident in my contributions to 

science and in my on-going/completed research support, these collaborations have been successful and 

productive. 

POSITIONS AND HONORS 

Positions and Employment 

1984 1989 Statistical Consultant/Data Analyst, Center of Excellence, TN State University, Nashville, TN 

1986 2004 Statistician, Instructional & Research Support, Vanderbilt University Information Technology 

Services, Nashville, TN 

1998 Adjunct Faculty, College of Health Sciences, Belmont University, Nashville, TN 

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2002 Professor, Statistics & Measurement (Secondary Appt), Department of Psychiatry, School of 

Medicine, Vanderbilt University, Nashville, TN 

2004 2006 Director, Education and Outreach, Vanderbilt Advanced Computing Center for Research and 

Education, Nashville, TN 

2006 Professor, Biostatistics & Vanderbilt Ingram Cancer Center, School of Medicine, Vanderbilt 

University, Nashville, TN 

2006 Professor, Statistics & Measurement, School of Nursing, Vanderbilt University, Nashville, TN 

2008 2014 Senior Biostatistical Consultant/Co Education Director, The Eunice Kennedy Shriver 

Intellectual, and Human Development Disability Research Ctr., Nashville, TN 

Other Experience and Professional Memberships 

1993 Member, American Statistical Association 

2008 Member, Eastern North American Region / International Biometric Society 

Honors 

1996 Hardy C. Wilcoxon Award, Most Distinguished Doctoral Dissertation in any area of 

psychological inquiry, Dept. of Psychology & Human Development, Vanderbilt University 

2008 Dean's Award, Recognition of Faculty Achievement in Scholarly Endeavors, School of Nursing, 

Vanderbilt University 

2014 Dean's Award, Recognition of Faculty Achievement in Research Endeavors, School of Nursing, 

Vanderbilt University 

2015 Dean Colleen Conway Welch Award for contributions to student learning, mentoring, modeling 

of professional behaviors, and encouragement of scholarship (Vanderbilt U. School of Nursing) 

2016 Professional Research Recognition Award, 

Child Life Council 

2017 Dean Colleen Conway Welch Award for contributions to student learning, mentoring, modeling 

of professional behaviors, and encouragement of scholarship (Vanderbilt U. School of Nursing) 

C. Contribution to Science 

a co-investigator with expertise in both statistics and measurement, my contributions to science could be 

organized a number of different ways. As demonstrated by my other support documentation, I am currently 

CO-I on multiple NIH-funded studies. My contributions to science listed below, as well as my complete 

bibliography online, demonstrate that my collaborations have been productive. 

I have collaborated with researchers in psycho-neuroimaging (primarily fMRI) for more than 10 years. As 

those imaging methods have matured, I have facilitated the incorporation of cognitive and other self-report 

measures into the analyses of signal change measures (e.g., BOLD percent signal change). 

a. Monroe TB, Gibson SJ, Bruehl SP, Gore JC, Dietrich MS, Newhouse P, Atalla S, Cowan RL. Contact 

heat sensitivity and reports of unpleasantness in communicative people with mild to moderate cognitive 

impairment in Alzheimer’s disease: a cross-sectional study. BMC Medicine, 2016 May; 14:74 

b. Monroe TB Beach PA, Bruehl SP, Dietrich MS, Rogers BP, Gore JC, Atalla SW, Cowan RL. The 

impact of Alzheimer’s disease on the resting state functional connectivity of brain regions modulating 

pain: A cross sectional study. Journal of Alzheimer’s Disease; 2017 Mar; 57(1); 71-83. PMID: 28222526. 

c. Atalia S, Gore J, Bruelh S, Rogers B, Dietrich MS, Benningfield M, Cowan R, Monroe T. BMI 

associated sex differences in pain reports and resting state functional connectivity in older adults. 

Journal of Pain; 2016 April; 17(4S); S59. PMID: 28162571. 

d. Monroe TB, Fillingim RB, Bruehl SP, Rogers BP, Dietrich MS, Gore JC, Atalla SW, Cowan RL. Sex 

Differences in Brain Regions Modulating Pain: A Cross Sectional Resting State Functional Connectivity 

Study. Pain Medicine; 2017 May 13; [Epub ahead of print]. PMID: 28505337. 

Evidence of successful management and integration of data collected from large multi-site, multi-PI 

collaborative projects as well as statistical expertise related to appropriately conducting and analyzing data 

collected from clinical trials: 

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a. Sohl SJ, Dietrich MS, Wallston KA, Ridner SH. A randomized controlled trial of expressive writing in 

breast cancer survivors with lymphedema. Psychology and Health; 2017 Jul; 32(7); 826-842. PMID: 

28355890 

b. Lutenbacher M, Gabbe PT, Karp SM, Dietrich MS, Narrigan D, Carpenter L, Walsh W. Does additional 

prenatal care in the home improve birth outcomes for women with a prior preterm delivery? A 

randomized clinical trial. Matern Child Health J. 2014 Jul;18(5):1142-54. PubMed PMID: 23922160. 

c. FitzHenry F, Wells N, Slater V, Dietrich MS, Wisawatapnimit P, Chakravarthy AB. A randomized 

placebo-controlled pilot study of the impact of healing touch on fatigue in breast cancer patients 

undergoing radiation therapy. Integr Cancer Ther. 2014 Mar;13(2):105-13. PubMed PMID: 24105358. 

d. Ridner SH, Poage-Hooper E, Kanar C, Doersam JK, Bond SM, Dietrich MS. A pilot randomized trial 

evaluating low-level laser therapy as an alternative treatment to manual lymphatic drainage for breast 

cancer-related lymphedema. Oncol Nurs Forum. 2013 Jul;40(4):383-93. PubMed PMID: 23803270; 

PubMed Central PMCID: PMC3887507. 

The application of my expertise in multiple domains of measurement methods (e.g., development and 

validation of self-report measures, assessment of possible screening measures, use and validation of 

physiological measures) is evidenced by the subset of manuscripts below. 

a. Dillon NP, Kratchman LB, Dietrich MS, Labadie RF, Webster RJ 3rd, Withrow TJ. An experimental 

evaluation of the force requirements for robotic mastoidectomy. Otol Neurotol. 2013 Sep;34(7):e93-

102. PubMed PMID: 23787968; PubMed Central PMCID: PMC3761064. 

b. Ridner SH, Bonner CM, Doersam JK, Rhoten BA, Schultze B, Dietrich MS. Bioelectrical impedance 

self-measurement protocol development and daily variation between healthy volunteers and breast 

cancer survivors with lymphedema. Lymphat Res Biol. 2014 Mar;12(1):2-9. PubMed PMID: 24502422; 

PubMed Central PMCID: PMC3961792. 

c. Young CC, Dietrich MS. Screening for rumination and brooding may be a feasible method of 

identifying adolescents at high risk for depression. J Pediatr Nurs. 2014 Nov-Dec;29(6):688-95. 

PubMed PMID: 24950241. 

d. Ridner SH, Dietrich MS. Development and validation of the Lymphedema Symptom and Intensity 

Survey-Arm. Support Care Cancer. 2015 Oct; 23(10), 3103-3112. PMID: 25752884; PMCID: 

PMC4554806. 

Novel application of statistical methods commonly used in disciplines outside of medicine and nursing to 

biomedical research. The work referenced below primarily focused on the application of group-based 

trajectory modeling from psychosocial research to biomedical research 

a. Anderson CB, Kaufman MR, Dietrich MS, Barocas DA, Chang SS, Cookson MS, Smith JA Jr, Clark 

PE, Herrell SD. Recovery of urinary function after radical prostatectomy: identification of trajectory 

cluster groups. J Urol. 2012 Apr;187(4):1346-51. PubMed PMID: 22341278. 

b. Ridner SH, Dietrich MS, Niermann K, Cmelak A, Mannion K, Murphy BA. A prospective study of the 

lymphedema and fibrosis continuum in patients with head and neck cancer. Lymphatic Research and 

Biology, 2016 Dec; 14(4), 198-205. PMID: 27305456. 

c. Role: Co-I 1R01DE024982-01 (Deng) NIH/NIDCR 03/01/2015-02/28/2019 

Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients 

Determining reliability and validity of a patient-reported outcome measure, clinician-reported outcome 

measures, and imaging techniques (CT scan and ultrasonography) for assessing lymphedema and 

fibrosis in oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, 

and survival 

d. Neal JL, Lowe NK, Phillippi JC, Ryan SL, Knupp AM, Dietrich MS, Thung SF. Likelihood of cesarean 

delivery after applying leading active labor diagnostic guidelines. Birth; 2017 Jun; 44(2); 128-136. 

PMID: 28198038. 

Complete List of Published Work in My Bibliography: 

http://www.ncbi.nlm.nih.gov/myncbi/1BCXkivlxwqQc/bibliography/47517739/public/?sort=date&direction=d 

escending 

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Research Support (Ongoing Research Support) 

R01DC008408 (Dawant) NIH/NIDCD / sub: VUMC: (Labadie) 07/01/2016-06/30/2018 

Clinical Validation and Testing of Percutaneous Cochlear Implantation 

Continues to build on our successful development of PCI and explore potential benefits by (i) extending our 

Phase I study by one year in order to produce a robust clinical protocol and (ii) carrying out a Phase II study 

consisting of a randomized clinical trial comparing PCI to traditional CI surgery. 

1R01DE024982-01 (Deng) NIH/NIDCR 04/01/2015-03/31/2019 

Establishing Lymphedema and Fibrosis Measures in Oral Cancer Patients 

Determining reliability and validity of a patient-reported outcome measure, clinician-reported outcome 

measures, and imaging techniques (CT scan and ultrasonography) for assessing lymphedema and fibrosis in 

oral cavity and oropharyngeal cancer patients across the trajectory of treatment, recovery, and survival 

1R01NR015353-02 (Akard) NIH/NINR 09/26/2014-06/30/2018 

Impact of a PCRC-Supported Legacy Intervention in Pediatric Palliative Care 

Leveraging resources from the PCRC and contribute back to the greater body of palliative care and end of 

life knowledge promoted by the PCRC. 

2P30 CA068485-19 (Pietenpol) NIH/NCI 09/05/1995-08/31/2020 

Cancer Center Support Grant 

Conduct, coordinate, and integrate the cancer-related activities of Vanderbilt University. 

Completed Research Support (Completed in past 3 years from 32 completed) 

1R21AG050483-A01A (Sarkar) NIH/NIA 08/15/2016-04/30/2018 

Socially Assistive Robotic Architecture for Elder Care 

Continues the development of an innovative socially assistive robotic framework in addressing the needs of 

older adults examining the feasibility for use in the community, assisted living and nursing home, and 

examine older adults’ acceptance and tolerance. 

1R21EB015623-01A1 (Simaan) NIBIB 07/01/2013-06/30/2017 

Dexterous Robot-Assisted Trans-Urethral Bladder Resection 

Enabling higher precision, safer, and more dexterous resection and surveillance of bladder tumors. 

1DP3DK097706-01 (Mulvaney) NIH/NIDCD 0 9/21/2012-12/31/2016 

Using Social Learning to Improve Adolescent Diabetes Adherence Problem Solving 

Integrating social interactions with peers with skill building activities to improve diabetes control adherence in 

the adolescent population. 

5R01 DC008408-05A1 (Labadie) NIH/NIDCD 07/13/2012-06/30/2016 

Clinical Validation and Testing of Percutaneous Cochlear Implantation 

Investigation of less invasive cochlear access by using image guided surgical (IGS) techniques (adults). 

Contact PD/PI: Gifford, Rene H Biosketches Page 45

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

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1R21AG045735-01A1 (Monroe) NIH/NIA 04/01/2014-06/30/2016 

Age-related Differences in Psychophysical and Neurobiological Response to Pain 

Compare pain processing in a broad range of adults (ages 30-89)with the goal of providing a foundation for 

developing improved pain treatment methods for older adults. 

5 R21 DA033341 (Cowan) NIDA 01/15/2013-1/14/2016 

Neural Mechanisms of Increased Cortical Excitability in Human MDMA/Ecstasy Users 

Use of several neuroimaging methods to further understand how MDMA use damages the brain and how we 

might eventually develop treatments for people with MDMA-induced brain damage. 

1R21MH101321-01A1 (Cascio) NIMH 03/07/2014-10/31/2015 

Mapping Thalamocortical Networks across Development in ASD 

Contribute to our understanding of the brain-basis of ASD and provide useful biomarkers that will further our 

understanding of the etiology of ASD and contribute to the development of new treatments. 

R21CA173202-1A1 (Ridner) NIH/NCI 07/01/2013-07/31/2015 

Feasibility and Preliminary Efficacy of Yoga in Head and Neck Cancer Survivors 

Tailoring Yoga techniques to address musculoskeletal impairment (MSI) of the neck, shoulder, and jaw, as 

well as postural abnormalities in head and neck cancer survivors. 

Contact PD/PI: Gifford, Rene H Biosketches Page 46

 

 

 

 

 

 
BIOGRAPHICAL SKETCH 

Provide the following information for the Senior/key personnel and other significant contributors. 

Follow this format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Nittrouer, Susan 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Professor and Chair 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

West Chester State College, West Chester, PA B.S. 06/1974 Education, Speech 

Pathology 

Smith College, Northampton, MA M.E.D. 06/1975 Education of the Deaf 

City University of New York, New York, NY Ph.D. 07/1985 Speech and Hearing 

Sciences 

Haskins Laboratories, New Haven, CT Postdoctoral 

Fellowship 02/1987 Speech Science 

Personal Statement 

Work in my laboratory focuses on how listeners manage to recover linguistically significant and stable 

representations from the acoustic speech signal, which is highly variable. My interests have largely involved the 

development of speech perception abilities, and investigations in my laboratory have included typically 

developing children, in order to extend our understanding of how this process normally unfolds. Nonetheless, 

two additional populations in which I have been especially interested are children with hearing loss and children 

with phonologically based dyslexia. The goal is to explore why these children face particular challenges in this 

process of discovering phonological structure in the acoustic speech signal; syntactic competencies remain 

relatively intact. 

The work proposed on this grant titled Image Guided Cochlear Implant Programming: Pediatric Speech, 

Language, and Literacy is commensurate with my interests because proposed procedures could improve the 

quality of the signal available to children with cochlear implants. Presumably, these children suffer language 

deficits especially in the phonological domain because of degraded auditory signals. Improving the signal 

should improve their acquisition of sensitivity to phonological structure, which should have cascading effects on 

the learning of other language skills. 

Nittrouer, S. (2006) Children hear the forest. J. Acoust. Soc. Am. 120, 1799 1802. PMCID: PMC1994091 

Nittrouer, S. & Pennington, B.F. (2010). New approaches to the study of childhood language disorders. Current 

Directions in Psychological Science 19, 308 313. PMCID: PMC3374334 

Nittrouer, S. (2012). A new perspective on developmental language problems: Perceptual organization deficits. 

Perspective on Language Learning & Education, 19, 87 97. PMCID: PMC3749876 

Nittrouer, S. & Lowenstein, J.H. (2014). Separating the effects of acoustic and phonetic factors in linguistic 

processing by adults and children. Appl. Psycholinguist. 35, 333 370. PMCID: PMC3981461 

Positions and Honors. 

Positions and Employment 

1975 1976 Middle School Teacher, Clarke School for the Deaf, Northampton, MA 

1976 1978 Preschool Teacher, Montreal Oral School for the Deaf, Montreal, Quebec 

1978 1979 Speech Coordinator, Beverly School for the Deaf, Beverly, MA 

1979 1980 Speech Coordinator, The Learning Center for Deaf Children, Framingham, MA 

1980 1982 Graduate Student, Psychology, Utah State University, Logan, UT 

1981 1982 Teaching Assistant for Graduate Statistics Classes, Utah State University, Logan, UT 

1982 1985 Graduate Student, Speech and Hearing Sciences, City University of New York Graduate 

School, New York, NY (Advisor: M Studdert Kennedy) 

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1982 1983 Coordinator, Inservice Training Project on Teaching Speech to the Hearing Impaired, City 

University of New York Graduate School, New York, NY (PI: I Hochberg) 

1983 1985 Research Assistant on a project examining the contributions to speech perception of “top

down” phonotactic and sentential context, CUNY Graduate School, New York, NY (PI: A Boothroyd) 

1985 1987 NIH Postdoctoral Fellow, Haskins Laboratories, New Haven, CT (Mentors: S Kelso, T Baer, 

K Harris) 

1987 1990 Staff Scientist, Boys Town National Research Hospital (BTNRH), Omaha, NE 

1987 1990 Assistant Professor, Dept. of Otolaryngology and Human Communication, Creighton 

University School of Medicine, Omaha, NE 

1990 1993 Associate Professor, University of Nebraska at Omaha, Omaha, NE 

1993 2002 Staff Scientist, Boys Town National Research Hospital (BTNRH), Omaha, NE 

1993 1999 Associate Professor, Dept. of Otolaryngology & Human Communication, Creighton 

University School of Medicine, Omaha, NE 

1999 2002 Professor, Dept. of Otolaryngology and Human Communication, Creighton University School 

of Medicine, Omaha, NE 

2002 2005 Director, Division of Exemplary Services, Center for Persons with Disabilities, Utah State 

University, Logan, UT 

2002 2005 Professor, Dept. of Communicative Disorders, Utah State University, Logan, UT 

2005 2015 Professor, Speech and Hearing Science, Ohio State University, Columbus, OH 

2007 2015 Professor and Director of Research, Otolaryngology, Ohio State University, Columbus, OH 

2015 present Professor and Chair, Speech, Language, and Hearing Sciences, University of Florida, 

Gainesville, FL 

Other Experience and Professional Memberships 

1991 1992 Member, NIDCD ad hoc committee for the review of small grant proposals 

1992 2000 Member, Acoustical Society Technical Committee on Speech Communication 

1994 1996 Ad hoc member, Sensory Disorders and Language Study Section 

1997 1998 Associate Editor, speech, Journal of Speech, Language, and Hearing Research 

2002 2005 Associate Editor, Volta Review 

2003 2005 Associate Editor, language, Journal of Speech, Language, and Hearing Research 

2005 Member of organizing committee, Hearing Loss in Children: Rehabilitation and Education 

Issues, American Speech Language Hearing Convention 

2010 Chair of organizing committee for early intervention for deaf children special session, 

American Speech Language Hearing Convention 

Ongoing Reviewer for various NIDCD and LCOM study sections 

2011 present Associate Editor, International Journal of Audiology 

2012 2015 Member, Academic Affairs Board, American Speech, Language, Hearing Association 

Honors 

1989 Editors' Award for best paper in speech, Journal of Speech and Hearing Research 

1996 Editors' Award for best paper in hearing, Journal of Speech and Hearing Research 

2009 Fellow, Acoustical Society of America 

2013 Editor’s Award for best paper in hearing. Journal of Speech, Language, and Hearing Research 

Contribution to Science 

C.1. Developmental Weighting Shift 

The prevailing wisdom among speech perception researchers in the latter half of the 20th century was that human 

listeners collect discrete pieces of the spectrotemporal structure from the speech signal, termed acoustic cues, 

and directly map the values of those cues to phonemic categories. The major experimental paradigm utilized in 

that work involved categorical perception experiments, in which all structure of simple (usually CV) syllables 

remained constant across a set, except one. That one cue would be manipulated to span values from one 

appropriate for one phonemic category to one appropriate for another. Results revealed a range of cue settings 

that signaled the phoneme represented at each end of the continuum. In 1980, Mann and Repp demonstrated a 

phenomenon they termed “trading relations” in which they showed that if two cues were manipulated in an 

experiment, the value of one cue required to signal a specific phonemic category varied depending on the setting 

another cue. In particular, the value of a relatively stationary cue such as the spectral shape of a fricative 

noise signaling a specific sibilant varied depending on the structure of formant transitions at voicing onset. But 

that dynamic cue the formant transitions was viewed as “secondary,” meaning it was thought that adults had

learned over childhood how formant transitions covary with the “primary” cue, which was thought to be the

fricative noise spectrum. My dissertation research was designed to track the developmental course of learning 

about the presumed secondary cue, so the emergence of trading relations. But things did not go as expected. 

matter how I constructed my stimuli, children always showed a stronger effect of the supposed secondary 

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cue, the formant transitions, than adults. And the attention or weight given to that cue diminished with 

increasing age, while the weight given to the noise spectrum increased. Thus the notion of a developmental 

weighting shift was born, and future studies supported the idea. At the same time, other investigators were 

reporting that the perceptual weights given to various cues were language specific, meaning they varied across 

languages. Thus the developmental weighting shift was determined to depend on experience with a first 

language, rather than simply to unfold across childhood, irrespective of input. 

Nittrouer, S. (1992). Age related differences in perceptual effects of formant transitions within syllables and 

across syllable boundaries. J. Phonet. 20, 351 382. 

Nittrouer, S., Manning, C. & Meyer, G. (1993). The perceptual weighting of acoustic cues changes with linguistic 

experience. J. Acoust. Soc. Am. 94, S1865. 

Nittrouer, S. & Miller, M.E. (1997). Predicting developmental shifts in perceptual weighting schemes. J. Acoust. 

Soc. Am. 101, 2253 2266. PMID: 9104027 

Nittrouer, S. (2004). The role of temporal and dynamic signal components in the perception of syllable final stop 

voicing by children and adults. J. Acoust. Soc. Am. 115, 1777 1790. PMCID: PMC1994085 

C.2. Perceptual organization and speech perception 

The work described above helped move theoretical models of speech perception (so of how listeners recover 

phonemic structure from the acoustic speech signal) away from passive ones suggesting acoustic cues are 

simply harvested, and values compared against a menu of cue to phoneme translations. It was becoming clear 

at perceptual/cognitive processes were involved; although the point where perceptual gives way to cognitive 

hard to assign. At the same time it was being demonstrated by other investigators that listeners are able to 

recognize speech, especially when presented at sentence length, when acoustic cues are almost completely 

eliminated. This was accomplished with the use of sine wave analogs and noise vocoded stimuli. Thus more 

evidence was accumulating to support the idea that listening to speech entails active mechanisms that guide 

what sensory inputs are attended to and how they are organized. Although this phenomenon of perceptual 

organization is best assessed when sensory inputs are degraded (think of the simple line drawings of the Ruben 

vase that can be organized as two profiles or one vase), we actively organize sensory inputs in all of perception. 

Work in our laboratory helped to establish a few effects related to perceptual organization for speech signals. (1) 

The way these signals are organized is apparently language specific, just like perceptual weighting strategies. 

This was demonstrated when it was observed that even highly proficient second language learners (adults) of 

English are poorer than native speakers at recognizing signals such as noise vocoded and sine wave speech. 

Children acquire the perceptual organization strategies that are optimal for their native language through 

language experience. This was demonstrated when it was observed that recognition of noise vocoded and sine 

wave speech improves as children get older, and so gain language experience. (3) Children learn to organize 

dynamic spectral structure associated with speech production sooner than they learn to organize signals lacking 

that kind of structure. This was demonstrated when it was observed that by age 7 years children recognize 

sine wave speech as well as adults, but continue to perform more poorly with noise vocoded signals, at least up 

eight channels. (Some studies on perception of noise vocoded signals by adults and children have interpreted 

the age related difference observed in these studies as indicating that children need more channels of 

information. While strictly accurate, we interpret the poorer recognition of children than of adults for equivalent 

numbers of noise vocoded channels as evidence of their immature perceptual organization.) (4) Development 

perceptual organization for speech is delayed for children with normal hearing who have language learning 

deficits, such as dyslexia: Children with dyslexia are poorer at recognition of noise vocoded speech than their 

peers with normal reading development. 

Nittrouer, S., Lowenstein, J.H., & Packer, R. (2009). Children discover the spectral skeletons in their native 

language before the amplitude envelopes. J. Exp. Psych.: Human Percep. and Perf. 35, 1245 1253. 

PMCID: PMC3307092 

Nittrouer, S. & Lowenstein, J. H. (2010). Learning to perceptually organize speech signals in native fashion. J. 

Acoust. Soc. Am. 127, 1624 1635. PMCID: PMC2856515 

Nittrouer, S. & Lowenstein, J.H. (2013). Perceptual organization of speech signals by children with and without 

dyslexia. Res. Dev. Disabil. 34, 2304 2325. PMCID: PMC3674161 

Nittrouer, S., Lowenstein, J. H., Wucinich, T. & Tarr, E. (2014). Benefits of preserving stationary and time 

varying formant structure in alternative representations of speech: Implications for cochlear implants. J. 

Acoust. Soc. Am. 136, 1845 1856. PMCID: PMC4223981 

3. Combining electric stimulation with even a little acoustic stimulation enhances language learning 

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Work in my laboratory has investigated ways to enhance the acoustic speech signal to permit better recognition, 

within the limits imposed by hearing loss. One earlier and unexpected outcome of our work was that we found 

that children with cochlear implants (CIs) who had continued using a hearing aid after receiving a first CI were 

performing better on language measures than the children who discontinued using a hearing aid. This was the 

case, in spite of other relevant factors such as socioeconomic status, age of receiving that first CI, and amount 

residual hearing prior to implantation. This finding led us to explore the phenomenon in more depth, asking if 

very low frequency signal is beneficial to speech perception with degraded signals in the spectral range 

typically provided by auditory prostheses. 

Nittrouer, S. & Chapman, C. (2009). The effects of bilateral electric and bimodal electric acoustic stimulation on 

language development. Trends in Amplification, 13, 190 205. PMCID: PMC3271432 

Nittrouer, S., Caldwell, A. Lowenstein, J. H., Tarr, E., & Holloman, C. (2012). Emergent literacy skills in 

kindergartners with cochlear implants. Ear & Hearing, 33, 683 697. PMCID: PMC3419773 

Nittrouer, S., Tarr, E., Bolster, V., Caldwell Tarr, A., Moberly, A.C., & Lowenstein, J.H. (2014). Very low 

frequency signals support perceptual organization of implant simulated speech for adults and children. 

International Journal of Audiology. 53, 270 284. PMCID: PMC3954900 

Moberly, A.C., Lowenstein, J.H., & Nittrouer, S. (2016) Early bimodal stimulation benefits language acquisition 

for children with cochlear implants. Otology & Neurotology, 37, 24 30. PMCID: PMC4675676 

C.4. The development of mature speech perception strategies depends on more than just auditory sensitivity to 

acoustic cues 

Research in this laboratory has shown that the acquisition of sensitivity to phonological (especially phonemic) 

structure by children is an event that unfolds over a protracted period of time; infants are not born being able to 

recognize phonemic segments, and they do not learn to do so early in life. That conclusion makes sense, in light 

the fact that recovering phonemic structure in one’s native language does not rest solely on having sensitivity 

the acoustic cues underlying phonemic categories. Although it is critically important to have access to as much 

signal detail as possible (making bimodal stimulation advantageous), there is more to speech recognition. 

Appropriate attentional and organizational strategies are required. Evidence for that assertion comes from 

studies showing that listeners are able to recognize speech when acoustic cues are almost completely 

eliminated. This finding has been demonstrated with sine wave analogs and noise vocoded stimuli. Thus 

listening to speech entails active mechanisms that guide what sensory inputs are attended to, and how they are 

organized. It takes time for children to develop these skills. We know these mechanisms are critical to language 

acquisition because the development of language specific attentional and organizational strategies for speech 

delayed for children with normal hearing who have language learning deficits, such as dyslexia: For example, 

hildren with dyslexia are poorer at recognition of noise vocoded speech than their peers with normal reading 

development. It is precisely the fact that these kinds of organizational strategies are involved in speech 

perception that makes recognition with a CI possible; if speech recognition depended exclusively on having 

access to specific acoustic cues, it likely would be much poorer for listeners with CIs than what we observe. 

Consequently understanding how children acquire the appropriate attentional and organizational strategies for 

speech is important to understanding spoken language development in deaf children, especially those who use 

CIs. 

Nittrouer, S. (1996). Discriminability and perceptual weighting of some acoustic cues to speech perception by 

three year olds. J. Speech Hear. Res. 39, 278 297. 

Nittrouer, S. & Crowther, C.S. (1998). Examining the role of auditory sensitivity in the developmental weighting 

shift. J. Speech Lang. Hear. Res. 41, 809 818. PMID: 9712128 

Nittrouer, S. (1999). Do temporal processing deficits cause phonological processing problems? J. Speech 

Lang. Hear. Res. 42, 925 942. PMID:10450912 

Nittrouer, S., & Lowenstein, J.H. (2007). Children’s weighting strategies for word final stop voicing are not 

explained by auditory capacities. J. Speech Lang. Hear. Res. 50, 58 73. PMCID: PMC1994088 

Full bibliographic resource can be found at: http://www.ncbi.nlm.nih.gov/pubmed/?term=nittrouer+s 

Current Research Support. 

R01 DC015992 Nittrouer (PI) 03/01/2017 02/28/2020 

NIH NIDCD 

Spoken Language in Adolescents with Hearing Loss 

This is part of a longitudinal project designed to examine outcomes in children born with moderate to profound 

hearing loss. 

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Research Support within the past 3 years. 

R01 DC000633 Nittrouer (PI) 12/01/88 06/30/17 

NIH NIDCD 

Ontogeny of Segmental Speech Organization 

The long term goal of this project is to develop a theoretical account of how children acquire access to the 

segmental structure of speech. 

R01 DC006237 Nittrouer (PI) 09/01/03 08/31/16 

NIH NIDCD 

Early Development of Children with Hearing Loss 

The long term goal of this project was to understand the factors that contribute to the development of spoken 

language, cognition, and psychosocial wellbeing in children with hearing loss. 

Contact PD/PI: Gifford, Rene H Biosketches

 

 

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BIOGRAPHICAL SKETCH 

Provide the following information for the Senior/key personnel and other significant contributors. 

Follow this format for each person. DO NOT EXCEED FIVE PAGES. 

NAME: Ferenc Bunta 

eRA COMMONS USER NAME (credential, e.g., agency login): 

POSITION TITLE: Associate Professor of Communication Sciences and Disorders 

EDUCATION/TRAINING (Begin with baccalaureate or other initial professional education, such as nursing, 

include postdoctoral training and residency training if applicable. Add/delete rows as necessary.) 

INSTITUTION AND LOCATION 

DEGREE 

(if 

applicable) 

Completion 

Date 

MM/YYYY 

FIELD OF STUDY 

Lajos Kossuth University, Debrecen, Hungary B.Ed. 06/1994 TESL 

Arizona State University, Tempe, AZ M.A. 05/1999 Linguistics 

Arizona State University, Tempe, AZ Ph.D. 08/2005 Speech & Hearing 

Science 

Temple University, Philadelphia, PA Postdoctoral 05/2008 Communication 

Sciences & Disorders 

Personal Statement 

 have expertise directly relevant for the proposed project (specifically, Aims 2 and 3), and I am glad to assist 

Dr. Gifford to successfully complete the research project as her consultant. I have conducted research on 

bilingual and monolingual speech and language acquisition throughout my academic career with a recent focus 

on phonological development in children with hearing loss who use cochlear implants; work funded in part by 

the NIH/NIDCD. Aim 2 of the proposed project is on speech and language outcomes in pediatric cochlear 

implant (CI) users; an area on which my research directly focuses, evidenced by my publication record. I use 

techniques (such as acoustic analyses and other phonological measures) proposed by Dr. Gifford, so my 

expertise are directly relevant. Regarding Aim 3, I have also published in the area of language outcomes as 

well as phonological awareness in bilingual and monolingual children, so a combination with my expertise in 

phonological acquisition, speech and language outcomes, and how those are related to phonological 

awareness in CI users will benefit Dr. Gifford’s project. I have also had the privilege of collaborating with Dr. 

Gifford on a paper we published on Dual language versus English only support for bilingual children with 

hearing loss who use cochlear implants and hearing aids listed below that is not only relevant to this project, 

but it also provides evidence of our professional collaborative relationship. I am enthusiastic about supporting 

Dr. Gifford’s proposed project as a consultant, and I am looking forward to our collaboration on this research as 

well as providing my expertise to the project. 

My publications most relevant for the present project include: 

a) Li, F., Bunta, F., & Tomblin, J. B. (2017). Alveolar and postalveolar voiceless fricative and affricate 

productions of Spanish-English bilingual children with cochlear implants. Journal of Speech, Language, 

and Hearing Research, 60, 2427-2441. doi:10.1044/2017_JSLHR-S-16-0125 

b) Bunta, F., Goodin-Mayeda, C. E., Procter, A., & Hernandez, A. (2016). Initial stop voicing in bilingual 

children with cochlear implants and their peers with normal hearing. Journal of Speech, Language, and 

Hearing Research, 59, 686-698. doi:10.1044/2016_JSLHR-S-15-0212 

c) Bunta, F., Douglas, M., Dickson, H., Cantu, A., Wickesberg, J., & Gifford, R. H., (2016). Dual language 

versus English only support for bilingual children with hearing loss who use cochlear implants and 

hearing aids. International Journal of Language and Communication Disorders, 51(4), 460-472. doi: 

10.1111/1460-6984.12223 

Contact PD/PI: Gifford, Rene H Biosketches Page 52

 

I 

A. 
d) Bunta, F., & Douglas, M. (2013). The effects of dual language support on the English language skills of 

bilingual children with cochlear implants and hearing aids as compared to monolingual peers. 

Language, Speech and Hearing Services in Schools, 44, 281-290. doi: 10.1044/0161-1461(2013/12-

0073) 

Positions and Honors 

2005-2008 Postdoctoral Research Fellow, Department of Communication Sciences and Disorders, Temple 

University, Philadelphia, PA 

2008-2014 Assistant Professor, Department of Communication Sciences and Disorders, The University of 

Houston, Houston, TX 

2014-present Associate Professor, Department of Communication Sciences and Disorders, The University of 

Houston, Houston, TX 

Other Experience and Professional Memberships 

2017-present Editorial Board member for Journal of Speech, Language, and Hearing Research and 

Beszédkutatás 

2015 Peer Reviewer for American Speech-Language-Hearing Association (New Century Scholars 

grant panel) 

2014 Reviewer for American Speech-Language-Hearing Association (Advancing Academic Research 

Careers, Students Preparing for Academic & Research Careers Grant, ad-hoc) 

2012-present Member, International Expert Panel on Multilingual Children's Speech 

2010-present Member, International Clinical Phonetics and Linguistics Association 

2009-2010 Peer Reviewer for NSF (ad-hoc) 

2004-present Peer Reviewer for over 20 scholarly journals (e.g., Applied Psycholinguistics, American Journal 

of Speech-Language Pathology, etc.) 

Academic and Professional Honors 

1999-2002 University Graduate Fellows, Arizona State University (ASU) 

2003 Student Affairs’ Tribute to University Staff for excellence in teaching and student mentoring, 

ASU, 

2003-2004 Spencer Fellow, The Spencer Foundation 

2004 Fifteenth Annual Student Affairs’ Tribute to Faculty and Academic Professionals, ASU 

Contributions to Science 

1. One of my current lines of work is on phonological skills of bilingual and monolingual children with hearing 

loss who use CIs (funded by the NIDCD/NIH, R03DC012640 from 2013 through 2017). This innovative 

research provides novel insights into both theory and clinical practice, because it represents the intersection of 

speech and language acquisition in bilinguals who have a diminished auditory signal and the population is one 

that is in critical need of information for educators and practicing speech-language pathologists. This research 

 directly relevant for the proposed project (as detailed in the Personal Statement section above), because it 

includes speech analyses (including acoustic measures and phonological analyses), some of which are also 

used in the present proposal. Relevant peer-reviewed publications are listed in the Personal Statement 

section above. 

 As part of an interdisciplinary team of researchers across multiple sites (University of Houston and 

University of Texas at Dallas), I am currently also a co-investigator on a current grant by the US Department of 

Education (R324A160258). I provide my expertise in phonology and speech development as a co-investigator 

 a project whose goal is to develop guidelines for the identification and classification of Spanish-speaking 

English Learners (ELs) who are at-risk of developing significant learning disabilities in reading, language, or 

both. This project is also directly relevant to the current application, because they both include investigations of 

Contact PD/PI: Gifford, Rene H Biosketches

 

 

B. 

C. 

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the effects of phonological awareness on other language measures. A selection of my representative 

publications on this topic are: 

a) Rojas, R., Iglesias, A., Bunta, F., Goldstein, B., Goldenberg, C., & Reese, L. (2015). Interlocutor 

differential effects on the expressive language skills of Spanish-speaking English learners. International 

Journal of Speech-Language Pathology. doi: 10.3109/17549507.2015.1081290. 

b) Branum-Martin, L, Tao, S., Garnaat, S., Bunta, F., & Francis, D. J. (2012). Meta-analysis of bilingual 

phonological awareness: Language, age, and psycholinguistic grain size. Journal of Educational 

Psychology, 104(4), 932-944. doi: 10.1037/a0027755 

c) Major, R. C., Fitzmaurice, S., Bunta, F., & Balasubramanian (2002). The effects of nonnative accents 

on listening comprehension: Implications for ESL assessment. TESOL Quarterly, 36, 173-190. 

I transitioned from linguistics and second language phonology to speech and hearing sciences for my 

doctoral studies, and therefore, my work expanded to include bilingual and cross-linguistic phonological 

acquisition in children with typical speech and language development. My collaborators and I have made 

significant contributions to science in this area by conducting a series of studies using various techniques from 

acoustic analyses to traditional phonological and speech measures. Some of our work on phonological wholeword measures was novel and has since received recognition. The eclectic approach to analyzing speech 

allowed me to address complex phonological problems from various angles that will benefit Dr. Gifford’s 

project. A selection of my representative publications on the topic are: 

a) Bunta, F., Davidovich, I., & Ingram, D. (2006). The relationship between the phonological complexity of 

a bilingual child’s words and those of the target languages. International Journal of Bilingualism, 10 (1), 

71-88. 

b) Bunta, F., & Ingram, D. (2007). The acquisition of speech rhythm by bilingual Spanish- and Englishspeaking four- and five-year-old children. Journal of Speech, Language, and Hearing Research, 50 (4), 

999-1014. doi:10.1044/1092-4388(2007/070). 

c) Bunta, F., Fabiano, L., Ingram, D., & Goldstein, B. (2009). Phonological whole-word measures in threeyear-old bilingual children and their monolingual peers. Clinical Linguistics and Phonetics, 23(2), 156-

175. 

d) Goldstein, B., & Bunta, F. (2012). Positive and negative transfer in the phonological systems of bilingual 

speakers. The International Journal of Bilingualism, 16(4), 388-401. doi:10.1177/1367006911425817. 

 My early work focused on second language phonology and foreign accents from a linguistic perspective. 

This line of work provided contributions to both the effects of non-native accents on listening comprehension 

and regarding the acquisition of specific phonemes that pose challenges to English as a second language 

learners. Listening comprehension is related to speech perception, so I will be able to provide my relevant 

expertise to the proposed project. A selection of my representative publications on the topic are: 

a) Bunta, F., & Major, R. C. (2004). An Optimality Theoretic account of Hungarian ESL learners 

acquisition of /Ε/ and /Θ/. International Review of Applied Linguistics in Language Teaching, 42, 

277-298. doi:10.1515/iral.2004.014. 

b) Major, R. C., Fitzmaurice, S., Bunta, F., & Balasubramanian, C. (2005). Testing the effects of 

regional, ethnic, and international dialects of English on listening comprehension. Language 

Learning, 55 (1), 37-69. 

c) Major, R. C., Fitzmaurice, S., Bunta, F., & Balasubramanian (2002). The effects of nonnative 

accents on listening comprehension: Implications for ESL assessment. TESOL Quarterly, 36, 173-

190. 

d) Santos Oliveira, D., Casenhiser, D. M., Hedrick, M., Teixeira, A., & Bunta, F. (2016). Effects of 

language experience on the discrimination of the Portuguese palatal lateral by nonnative listeners. 

Clinical Linguistics and Phonetics. doi: 10.3109/02699206.2016.1152508. 

Partial List of Publications on PubMed 

http://www.ncbi.nlm.nih.gov/pubmed/?term=bunta%2C+ferenc 

Contact PD/PI: Gifford, Rene H Biosketches

3. 

4. 

 Page 54
Research Support 

Current Research Support 

US Department of Education 08/01/16-07/31/18 

(R324A160258) 

Identification of reading and language disabilities in Spanish-speaking English learners 

The goal of the project is to develop guidelines for the identification and classification of Spanish-speaking 

English Learners (ELs) who are at-risk of developing significant learning disabilities in reading, language, or 

both. 

Role: Co-Investigator 

Completed Research Support 

National Institute on Deafness and Other Communication Disorders/National Institutes of Health 

(R03DC012640) 08/01/13-07/31/17 

Phonological acquisition in bilingual children with cochlear implants 

The goal of this research is to discover how bilingual children who use cochlear implants acquire the 

phonological systems of their target languages. Specifically, I will (1) investigate the effects of the diminished 

auditory signal on the speech of bilingual children with cochlear implants via comparisons to bilingual peers 

with normal hearing. I will also (2) examine cross-language effects by comparing the phonological skills of 

bilingual children with cochlear implants to those of their monolingual English-speaking peers with cochlear 

implants. 

Role: PI 

Contact PD/PI: Gifford, Rene H Biosketches Page 55

 

 

 

D. 
-

0MB Number: 4040-0001 

Contact PD/Pl: Gifford, Rene H Expiration Date: 10/31/2019 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period 1 

ORGANIZATIONAL DUNS*: -

Budget Ty pe*: • Project O Subaward/Consortium 

Enter name of Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2019 End Date*: 03-31-2020 Budget Period: 1 

A. Senior/Key Person 

Prefix First Name* Middle Last Name* Suffix Project Role* Base Calendar Academic Summer Requested Fringe Funds Requested ($)* 

Name Salary ($) Months Months Months Salary ($)* Benefits ($)* 

1 . Rene H Gifford PD/Pl •••••••••••••-••••-•..••••-•••••••••-•••••••••-••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••--••• •o•-•••••-•o••-•••••••-••••••••-•••••••-•••••• ....... ................0 ................. 0.............J I.._..........I 1................- ............ 

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Additional Senior Key Persons : File Name: Total Senior/Key Person 

B. Other Personnel 

Number of Project Role* Calendar Months Academic Mo nths Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

Personnel* 

.............o.............Post.Doctoral.Associates...........................................o....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............1..............Graduate.Students.................................................... ...................................o.................................... 0...............................................- ..................................... ............................- . 

.............o.............Undergraduate.Students............................................o....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............o.............secretarial/Clerical.......................................................0 ....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............1..............0ther ............................................................................... ...................................0.................................... 0............................................... ......................... ............................ . 

.............o.............other Professionals .....................................................0 ....................................0.................................... 0.......................................................... ..................................... ........................................ . 

0 Allocated Admin Support O O O •-------.....•---- --- -----

2 Total Number Other Pers onnel Total Other Personnel

--------- Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-8} (Funds Requested) 

Page 56 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334. Received Date: 2018-08-16T11 :14:30 000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 1 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2019 End Date*: 03-31-2020 Budget Period: 1 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: Other 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 57

 

0 

2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 1 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2019 End Date*: 03-31-2020 Budget Period: 1 

F. Other Direct Costs Funds Requested ($)* 

1. Materials and Supplies 

2. Publication Costs 

3. Consultant Services 

4. ADP/Computer Services 

5. Subawards/Consortium/Contractual Costs 

6. Equipment or Facility Rental/User Fees 

7. Alterations and Renovations 

Other Direct Costs 

All Other Costs 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC, Research On/ Off campus-Remote 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: 

M-19_S2S_Budget_Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 58

 

 

8 . 

9 . 

1 . 

2018-08-16T11:14:30.000-04:00 
OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 2018-08-16T11:14:30.000-04:00 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period  2

ORGANIZATIONAL DUNS*:   

Budget Type*: ● Project ❍ Subaward/Consortium 

Enter name of Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2020 End Date*: 03-31-2021 Budget Period: 2 

A. Senior/Key Person 

Prefix First Name* Middle 

Name 

Last Name* Suffix Project Role* Base 

Salary ($) 

Calendar 

Months 

Academic 

Months 

Summer 

Months 

Requested 

Salary ($)* 

Fringe 

Benefits ($)* 

Funds Requested ($)* 

Rene H Gifford PD/PI 0 0 

Stephen M Camarata PD/PI 0 0 

Robert F Labadie Co-Investigator 0 0 

Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of 

Personnel* 

Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

0 Post Doctoral Associates 0 0 0 

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0 Secretarial/Clerical 0 0 0 

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2 Total Number Other Personnel Total Other Personnel 

Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-B} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 59

1 . 

2 . 

3 . 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 2 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2020 End Date*: 03-31-2021 Budget Period: 2 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: Other 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 60

 

0 

2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 2 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2020 End Date*: 03-31-2021 Budget Period: 2 

F. Other Direct Costs Funds Requested ($)* 

1. Materials and Supplies 

2. Publication Costs 

3. Consultant Services 

4. ADP/Computer Services 

5. Subawards/Consortium/Contractual Costs 

6. Equipment or Facility Rental/User Fees 

7. Alterations and Renovations 

Other Direct Costs 

All Other Costs 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC, Research On/ Off campus-Remote 58 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: 

M-19_S2S_Budget_Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 61

 

 

8 . 

9 . 

1 . 

2018-08-16T11:14:30.000-04:00 
-

0MB Number: 4040-0001 

Contact PD/Pl: Gifford, Rene H Expiration Date: 10/31/2019 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period 3 

ORGANIZATIONAL DUNS--

Budget Type*: • Project O Subaward/Consortium 

Enter name of Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2021 End Date*: 03-31-2022 Budget Period: 3 

A. Senior/Key Person 

Prefix First Name* Middle Last Name* Suffix Project Role* Base Calendar Academic Summer Requested Fringe Funds Requested ($)* 

Name Salary($) Months Months Months Salary ($)* Benefits ($)* 

1 . Rene H Gifford PD/Pl •••••••••••••-••••-•..••••-•••••••••-•••••••••-••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••--••• •o•-•••••-•o••-•••••••-••••••••-•••••••-•••••• ....... ................0 ................. 0.............J I.._..........I 1................- ............ 

..?..:......._...._..Stephen .........-...... ........................S:~~~ ~!~.......................-.....-...~_'?.!.~~........-.......-...... ....... ................0 ................. 0.............J I.._.......... ................-............ ..~.:......._...._..~9-~.~r.!.._.........-......E......................... ~~~~ ..........................-.....-...Co-Investigator...... ....... ................0 ................. 0................ .._............ -................-.............. Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

Personnel* 

.............o.............Post.Doctoral.Associates...........................................o....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............1..............Graduate.Students.................................................... ...................................o.................................... 0...............................................- ..................................... ............................- . 

.............o.............Undergraduate.Students............................................o....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............o.............secretarial/Clerical.......................................................0 ....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............1..............0 ther .............................................................................. ...................................0.................................... 0............................................... ......................... ............................ .

.............o.............o ther Professionals .....................................................0 ....................................0.................................... 0.......................................................... ..................................... ........................................ . 

0 Allocated Admin Support O O O •-------.....

2 Total Number Other Personnel Total Other Personnel

 - Total Salary, Wages and Fringe Benefits (A+B)

RESEARCH & RELATED Budget {A-8} (Funds Requested) 

Page 62 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334. Received Date: 2018-08-16T11:14:30 000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 3 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2021 End Date*: 03-31-2022 Budget Period: 3 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: Other 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 63

 

0 

2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 3 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2021 End Date*: 03-31-2022 Budget Period: 3 

F. Other Direct Costs Funds Requested ($)* 

1. Materials and Supplies 

2. Publication Costs 

3. Consultant Services 

4. ADP/Computer Services 

5. Subawards/Consortium/Contractual Costs 

6. Equipment or Facility Rental/User Fees 

7. Alterations and Renovations 

Other Direct Costs 

All Other Costs 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC, Research On/ Off campus-Remote 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: 

M-19_S2S_Budget_Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 64

 

 

8 . 

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1 . 

2018-08-16T11:14:30.000-04:00 
-

0MB Number: 4040-0001 

Contact PD/Pl: Gifford, Rene H Expiration Date: 10/31/2019 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period 4 

ORGANIZATIONAL DUNS*: -

Budget Type*: • Project O Subaward/Consortium 

Enter name of Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2022 End Date*: 03-31-2023 Budget Period: 4 

A. Senior/Key Person 

Prefix First Name* Middle Last Name* Suffix Project Role* Base Calendar Academic Summer Requested Fringe Funds Requested ($)* 

Name Salary ($) Months Months Months Salary ($)* Benefits ($)* 

1 . Rene H Gifford PD/Pl •••••••••••••-••••-•..••••-•••••••••-•••••••••-••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••••--••• •o•-•••••-•o••-•••••••-••••••••-•••••••-•••••• ....... ................0 ................. 0.............J I.._..........I 1................- ............ 

..?..:......._...._..Stephen .........-...... ........................S:~~~ ~! .......................-.....-...~_'?.!.~~........-.......-...... ....... ................0 ................. 0.............J I.._.......... ................-............ ..~.:......._...._..~9-~.~r.!.._.........-......E......................... ~~~~ ..........................-.....-...Co-Investigator...... ....... ................0 ................. 0................ .._............ -................-.............. Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

Personnel* 

.............o.............Post.Doctoral.Associates...........................................o....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............1..............Graduate.Students.................................................... ...................................o.................................... 0...............................................- ..................................... ............................- . 

.............o.............Undergraduate.Students............................................o....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............o.............secretarial/Clerical.......................................................0 ....................................0.................................... 0.......................................................... ..................................... ........................................ . 

.............1..............0ther ............................................................................... ...................................0.................................... 0............................................... ......................... ............................ . 

.............o.............other Professionals .....................................................0 ....................................0.................................... 0.......................................................... ..................................... ........................................ . 

0 Allocated Admin Support O O O •-------.....•---- --- -----

2 Total Number Other Personnel Total Other Personnel

--------- Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-8} (Funds Requested) 

Page 65 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334. Received Date: 2018-08-16T11 :14:30 000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 4 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2022 End Date*: 03-31-2023 Budget Period: 4 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: Other 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 66

 

0 

2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 4 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2022 End Date*: 03-31-2023 Budget Period: 4 

F. Other Direct Costs Funds Requested ($)* 

1. Materials and Supplies 

2. Publication Costs 

3. Consultant Services 

4. ADP/Computer Services 

5. Subawards/Consortium/Contractual Costs 

6. Equipment or Facility Rental/User Fees 

7. Alterations and Renovations 

Other Direct Costs 

All Other Costs 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC, Research On/ Off campus-Remote 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: 

M-19_S2S_Budget_Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 67

 

 

8 . 

9 . 

1 . 

2018-08-16T11:14:30.000-04:00 
OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 2018-08-16T11:14:30.000-04:00 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period  5

ORGANIZATIONAL DUNS*:   

Budget Type*: ● Project ❍ Subaward/Consortium 

Enter name of Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2023 End Date*: 03-31-2024 Budget Period: 5 

A. Senior/Key Person 

Prefix First Name* Middle 

Name 

Last Name* Suffix Project Role* Base 

Salary ($) 

Calendar 

Months 

Academic 

Months 

Summer 

Months 

Requested 

Salary ($)* 

Fringe 

Benefits ($)* 

Funds Requested ($)* 

Rene H Gifford PD/PI 0 0 

Stephen M Camarata PD/PI 0 0 

Robert F Labadie Co-Investigator 0 0 

Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of 

Personnel* 

Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

0 Post Doctoral Associates 0 0 0 

1 Graduate Students 0 0 

0 Undergraduate Students 0 0 0 

0 Secretarial/Clerical 0 0 0 

1 Other 0 0 

0 Other Professionals 0 0 0 

0 Allocated Admin Support 0 0 0 

2 Total Number Other Personnel Total Other Personnel 

Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-B} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 68

1 . 

2 . 

3 . 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 5 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2023 End Date*: 03-31-2024 Budget Period: 5 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: Other 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 69

 

0 

2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 5 

ORGANIZATIONAL DUNS*: 

Budget Type*: ● Project ❍ Subaward/Consortium 

Organization: Vanderbilt University Medical Center 

Start Date*: 04-01-2023 End Date*: 03-31-2024 Budget Period: 5 

F. Other Direct Costs Funds Requested ($)* 

1. Materials and Supplies 

2. Publication Costs 

3. Consultant Services 

4. ADP/Computer Services 

5. Subawards/Consortium/Contractual Costs 

6. Equipment or Facility Rental/User Fees 

7. Alterations and Renovations 

Other Direct Costs 

All Other Costs 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC, Research On/ Off campus-Remote 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , Steven Zuraf (301) 

492-4855 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: 

M-19_S2S_Budget_Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 70

 

 

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9 . 

1 . 

2018-08-16T11:14:30.000-04:00 
DETAILED BUDGET JUSTIFICATION 

PRINCIPAL INVESTIGATORS 

Multi PI: René H. Gifford, PhD, CCC A 

calendar months in Years 1 5 

the director of the Cochlear Implant Program at the Vanderbilt Bill Wilkerson Center, Dr. Gifford will be 

critical in the recruitment of study participants as well as CI programming as she is one of 3 study members 

who will be familiar with the randomization. She will prepare the data for analysis as well as for written and oral 

presentation and oversee study personnel including the project manager and PhD student. 

Multi PI: Stephen Camarata, PhD, CCC SLP 

calendar months in Years 1 5 

Dr. Camarata will train all experimenters involved in the developmental assessments, including language, 

literacy and achievement assessments. In addition, he will prepare these data (i.e., standard scores, raw 

scores and/or score transformations) and will participate in the dissemination of findings from this project. He 

will also oversee study personnel including the project manager and PhD student. 

CO INVESTIGATORS 

Jack Noble, PhD 

calendar months, Years 1 5 

Dr. Noble is an assistant professor and engineer at Vanderbilt University who is chiefly responsible for the 

development, implementation, and revision of the Image Guided Cochlear Implant Programming (IGCIP) 

model, database, and associated software. Dr. Noble will play a vital role in the execution of the proposed 

project in which he will guide our exploration of IGCIP for all enrolled participants. 

Benoit Dawant, PhD 

academic months, Years 1 5 

Dr. Dawant is a Professor and an engineer who has had over two decades of experience in image guided 

surgery and analysis. He is vital member of the IGCIP research team and has played an integral role in the 

development and refinement of the algorithms, associated database, and software implementation. Dr. 

Dawant’s expertise and insight will be of critical value to the successful execution of IGCIP for the proposed 

patient population. 

Robert Labadie, MD, PhD 

calendar months Years 1 5 

Dr. Labadie is both an otologic surgeon and an engineer with extensive experience in the development and 

implementation of our IGCIP research program. Because he is a surgeon who routinely implants pediatric 

patients, he intimately understands the research questions and will thus provide valuable insight into the 

execution of the experiments, recruitment of study participants, and data analysis particularly with respect to 

specific aim 1. 

Mary Dietrich, PhD 

calendar months Years 1 4, calendar months in Year 5 

Dr. Dietrich is a biostatistician who has a history of collaborative research and publication with the PIs on 

behavioral research projects examining speech, language, and hearing outcomes. 

CONSULTANTS 

Susan Nittrouer, PhD 

Dr. Nittrouer has been listed as a consultant as her input and experience with childhood language with our 

target study population (i.e. children with cochlear implants) will be of critical value to the project. 

annually has been budgeted for consulting with Dr. Nittrouer. This includes up to 5 full days consulting per year 

plus travel expenses (airfare, lodging and meals, per year) 

Ferenc Bunta, PhD 

Contact PD/PI: Gifford, Rene H Budget Justification Attachment Page 71

 

 

 

 

 

- -

- -

-

As 

-

-

-

-

-

-

-

—

-
Dr. Bunta has been listed as a consultant as his expertise in speech production and accompanying acoustic 

nalysis will be of great value to aim 2 of the proposed project. annually has been budgeted for 

consulting with Dr. Bunta which includes bi monthly videoconferences and 1 on site visit per year during which 

will provide guidance regarding acoustic analyses of the speech production wave files obtained for each 

study participant. 

PROGRAMMER, TBD 

A computer programmer with expertise in MATLAB® will be consulted on a PRN basis as shown here. 

Programming will be primarily used to refine the computer controlled administration of the psychoacoustic 

measures. We anticipate that the majority of the programming will be needed in years 1 & 2: 

Year 1: 

Year 2: 

Year 3 5: 

SPEECH PRODUCTION ANALYSIS: AURAL ANALYTICS 

Aural analytics has a specific set of acoustic tools to serve as a proxy for measuring articulation changes in 

speech production that may not be measurable via human factors. The speech analysis software will provide 

measures of 1) vocal quality i.e., harmonic to noise ratio, 2) pitch (F0, mean, SD, range), 3) articulatory control, 

and 4) nasality. Data will be collected on an iPad equipped with Aural Analytics software (see equipment 

budget). The costs include a combined fee of automated and backup human coded/verified analyses for 60 

study participants at baseline and two post intervention visits. We have budgeted for years 1 4 and 

for year 5 to complete these analyses. 

OTHER PERSONNEL 

Project Manager (TBD) 

calendar months Years 1 5 

Funding for 1.0 FTE project manager working on this project, is requested for all five years of the grant. The 

project manager will manage participant recruitment, the secure web based database “REDCap” (Research 

Electronic Data Capture), data collection, data entry, and all matters pertaining to the IRB. In addition to the 

PIs, the project manager will also interact directly with the clinical team at the Vanderbilt Bill Wilkerson Center 

Audiology Clinic to ensure that pediatric CI patients are provided with information regarding the study. Because 

much of the research activities involve audiologic and speech/language measurement and practice, this 

individual will ideally be a certified and licensed audiologist or speech/language pathologist with research 

interest. The project manager will be trained by the PIs in responsible conduct of research and ethics of 

research and will complete the CITI training course on the Protection of Human Subjects. Finally, the project 

manager will assist out of town participants with travel management including air/ground transportation and 

hotel accommodations. 

Staff engineer (TBD) 

calendar months Years 1 5 

staff engineer/database specialist will be required who maintains the current IGCIP database and associated 

web based portals that permit uploading CT images, storing plans, setting calendars, and communication 

between study personnel. She will be responsible for maintaining the database and for the transfer of images 

and plans. She will also assist in the creation of plans and on the modification of the planning tools and the 

database necessary to support new IGCIP techniques. 

STUDENTS 

GRA, 1 PhD student, TBD 

calendar months Years 1 5 

Funding for one PhD student is requested for all five years of the grant FTE working on this project). 

The PhD students will work up to 20 hours/week on the project and their compensation will not exceed 

limitations of NIH NRSA stipends. The student will assist with subject recruitment, data collection, data entry, 

and overall lab management with respect to the proposed research activities. 

Contact PD/PI: Gifford, Rene H Budget Justification Attachment Page 72

 

 

 

 

 

 

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- -

- -

- -

a 

he 

-

-

-

-

-

A 

-

-
Student Health Insurance: Student health insurance is estimated at /year. 

Tuition: Tuition support is requested for the PhD graduate student for of Vanderbilt’s graduate tuition and

student health insurance. Tuition is excluded from the indirect cost calculations. 

Estimated annual tuition expense: 

LAB SUPPLIES 

Year 1 

Leiter International Performance Scale, 3rd edition 

Expressive One Word Picture Vocabulary Test 

Receptive One Word Picture Vocabulary Test 

Test of Auditory Comprehension of Language 

Comprehensive Test of Phonological Processes 

Woodcock Johnson Tests of Achievement 

Renfrew Bus Story North American (RSB NA) 

PedsQL 4.0 

iPad with Aural Analytics software 

General lab supplies 

General Lab Supplies 

Year 2 5: 

TRAVEL & CONFERENCE ATTENDANCE 

YEAR 1: ASHA, 2 attendees 

YEAR 2: ASHA, 2 attendees 

YEAR 3: ASHA, 2 attendees; AAS, 1 attendee, 

Conference on Implantable Auditory Prostheses 

(CIAP) 1 attendee 

YEAR 4: ASHA, 1 attendee; ACIA, 1 attendee, 

Hearing Across the Lifespan, 1 attendee 

YEAR 5: ASHA, 2 attendees, SRCD, 1 attendee 

STUDY PARTICIPANT FEES: 

Participant Remuneration 

Year 1: 

Year 2: 

Year 3: 

Year 4: 

Year 5: 

We anticipate having to recruit a proportion of our pediatric CI recipients from outside the greater Nashville 

metropolitan area. We are budgeting for ground travel and hotel accommodations for approximately 40% of our 

study population (pediatric study participant and a parent). Our patient population includes much of the 

southeastern U.S. with many of our pediatric patients residing in west or east Tennessee residences which 

can be over 300 miles from the Vanderbilt University Medical Center. Thus, we are budgeting for mileage 

reimbursement, plus 2 nights’ hotel , and meals for of our proposed study population over the 5 

year period, as follows: 

Participant Travel 

Year 1: 

Year 2: 

Year 3: 

Year 4: 

Year 5: 

Contact PD/PI: Gifford, Rene H Budget Justification Attachment Page 73

 

 

 

 

 

 

 

 

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— -

-

—

-
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - Cumulative Budget 

Totals ($)

Section A, Senior/Key Person

Section B, Other Personnel

Total Number Other Personnel 10

Total Salary, Wages and Fringe Benefits

(A+B)

Section C, Equipment

Section D, Travel

1. Domestic 

2. Foreign

Section E, Participant/Trainee Support

Costs

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other

6. Number of Participants/Trainees 0

Section F, Other Direct Costs

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual

Costs

6. Equipment or Facility Rental/User

7. Alterations and Renovations

8. Other 1

9. Other 2

10. Other 3

Section G, Direct Costs

(A thru F)

Section H, Indirect Costs

Section I, Total Direct and Indirect Costs

(G + H)

Section J, Fee

Section K, Total Costs and Fee (I + J)

Contact PD/PI: Gifford, Rene H 

Fees

 Page 74 2018-08-16T11:14:30.000-04:00 
OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 2018-08-16T11:14:30.000-04:00 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period  1

ORGANIZATIONAL DUNS*:   

Budget Type*: ❍ Project ● Subaward/Consortium 

Enter name of Organization: Vanderbilt University 

Start Date*: 04-01-2019 End Date*: 03-31-2020 Budget Period: 1 

A. Senior/Key Person 

Prefix First Name* Middle 

Name 

Last Name* Suffix Project Role* Base 

Salary ($) 

Calendar 

Months 

Academic 

Months 

Summer 

Months 

Requested 

Salary ($)* 

Fringe 

Benefits ($)* 

Funds Requested ($)* 

Jack H Noble PD/PI 

Benoit Dawant Co-Investigator 

Mary S. Dietrich Biostatistician 

Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of 

Personnel* 

Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

Post Doctoral Associates 

Graduate Students 

Undergraduate Students 

Secretarial/Clerical 

1 TBA Staff Engineer 

1 Total Number Other Personnel Total Other Personnel 

Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-B} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 75

1 . 

2 . 

3 . 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 1 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2019 End Date*: 03-31-2020 Budget Period: 1 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H 

 

 Page 76 2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 1 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2019 End Date*: 03-31-2020 Budget Period: 1 

F. Other Direct Costs Funds Requested ($)* 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: Budget Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 77

 

 

1 . 

2018-08-16T11:14:30.000-04:00 
OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 2018-08-16T11:14:30.000-04:00 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period  2

ORGANIZATIONAL DUNS*:   

Budget Type*: ❍ Project ● Subaward/Consortium 

Enter name of Organization: Vanderbilt University 

Start Date*: 04-01-2020 End Date*: 03-31-2021 Budget Period: 2 

A. Senior/Key Person 

Prefix First Name* Middle 

Name 

Last Name* Suffix Project Role* Base 

Salary ($) 

Calendar 

Months 

Academic 

Months 

Summer 

Months 

Requested 

Salary ($)* 

Fringe 

Benefits ($)* 

Funds Requested ($)* 

Jack H Noble PD/PI 

Benoit Dawant Co-Investigator 

Mary S. Dietrich Biostatistician 

Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of 

Personnel* 

Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

Post Doctoral Associates 

Graduate Students 

Undergraduate Students 

Secretarial/Clerical 

1 TBA Staff Engineer 

1 Total Number Other Personnel Total Other Personnel 

Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-B} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 78

1 . 

2 . 

3 . 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 2 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2020 End Date*: 03-31-2021 Budget Period: 2 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H 

 

 Page 79 2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 2 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2020 End Date*: 03-31-2021 Budget Period: 2 

F. Other Direct Costs Funds Requested ($)* 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC 57.00 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: Budget Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 80

 

 

1 . 

2018-08-16T11:14:30.000-04:00 
OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 2018-08-16T11:14:30.000-04:00 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period  3

ORGANIZATIONAL DUNS*:   

Budget Type*: ❍ Project ● Subaward/Consortium 

Enter name of Organization: Vanderbilt University 

Start Date*: 04-01-2021 End Date*: 03-31-2022 Budget Period: 3 

A. Senior/Key Person 

Prefix First Name* Middle 

Name 

Last Name* Suffix Project Role* Base 

Salary ($) 

Calendar 

Months 

Academic 

Months 

Summer 

Months 

Requested 

Salary ($)* 

Fringe 

Benefits ($)* 

Funds Requested ($)* 

Jack H Noble PD/PI 

Benoit Dawant Co-Investigator 

Mary S Dietrich Biostatistician 

Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of 

Personnel* 

Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

Post Doctoral Associates 

Graduate Students 

Undergraduate Students 

Secretarial/Clerical 

1 TBA Staff Engineer 

1 Total Number Other Personnel Total Other Personnel 

Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-B} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 81

1 . 

2 . 

3 . 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 3 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2021 End Date*: 03-31-2022 Budget Period: 3 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H 

 

 Page 82 2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 3 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2021 End Date*: 03-31-2022 Budget Period: 3 

F. Other Direct Costs Funds Requested ($)* 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , Steven Zuraf (301) 

492-4855 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: Budget Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 83

 

 

1 . 

2018-08-16T11:14:30.000-04:00 
OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 2018-08-16T11:14:30.000-04:00 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period  4

ORGANIZATIONAL DUNS*:   

Budget Type*: ❍ Project ● Subaward/Consortium 

Enter name of Organization: Vanderbilt University 

Start Date*: 04-01-2022 End Date*: 03-31-2023 Budget Period: 4 

A. Senior/Key Person 

Prefix First Name* Middle 

Name 

Last Name* Suffix Project Role* Base 

Salary ($) 

Calendar 

Months 

Academic 

Months 

Summer 

Months 

Requested 

Salary ($)* 

Fringe 

Benefits ($)* 

Funds Requested ($)* 

Jack H Noble PD/PI 

Benoit Dawant Co-Investigator 

Mary S Dietrich Biostatistician 

Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of 

Personnel* 

Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

Post Doctoral Associates 

Graduate Students 

Undergraduate Students 

Secretarial/Clerical 

1 TBA Staff Engineer 

1 Total Number Other Personnel Total Other Personnel 

Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-B} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 84

1 . 

2 . 

3 . 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 4 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2022 End Date*: 03-31-2023 Budget Period: 4 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H 

 

 Page 85 2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTIONS F-K, Budget Period 4 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2022 End Date*: 03-31-2023 Budget Period: 4 

F. Other Direct Costs Funds Requested ($)* 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

MTDC 

Total Indirect Costs 

Cognizant Federal Agency 

(Agency Name, POC Name, and POC Phone Number) 

Department of Health and Human Services , 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

J. Fee Funds Requested ($)* 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: Budget Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 86

 

 

1 . 

2018-08-16T11:14:30.000-04:00 
OMB Number: 4040-0001 

Expiration Date: 10/31/2019 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 2018-08-16T11:14:30.000-04:00 

RESEARCH & RELATED BUDGET - SECTION A & B, Budget Period  5

ORGANIZATIONAL DUNS*:   

Budget Type*: ❍ Project ● Subaward/Consortium 

Enter name of Organization: Vanderbilt University 

Start Date*: 04-01-2023 End Date*: 03-31-2024 Budget Period: 5 

A. Senior/Key Person 

Prefix First Name* Middle 

Name 

Last Name* Suffix Project Role* Base 

Salary ($) 

Calendar 

Months 

Academic 

Months 

Summer 

Months 

Requested 

Salary ($)* 

Fringe 

Benefits ($)* 

Funds Requested ($)* 

Jack H Noble PD/PI 

Benoit Dawant Co-Investigator 

Mary S Dietrich Biostatistician 

Total Funds Requested for all Senior Key Persons in the attached file 

Additional Senior Key Persons: File Name: Total Senior/Key Person 

B. Other Personnel 

Number of 

Personnel* 

Project Role* Calendar Months Academic Months Summer Months Requested Salary ($)* Fringe Benefits* Funds Requested ($)* 

Post Doctoral Associates 

Graduate Students 

Undergraduate Students 

Secretarial/Clerical 

1 TBA Staff Engineer 

1 Total Number Other Personnel Total Other Personnel 

Total Salary, Wages and Fringe Benefits (A+B) 

RESEARCH & RELATED Budget {A-B} (Funds Requested) 

Contact PD/PI: Gifford, Rene H Page 87

1 . 

2 . 

3 . 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - SECTION C, D, & E, Budget Period 5 

ORGANIZATIONAL DUNS*: 

Budget Type*: ❍ Project ● Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2023 End Date*: 03-31-2024 Budget Period: 5 

C. Equipment Description 

List items and dollar amount for each item exceeding $5,000 

Equipment Item Funds Requested ($)* 

Total funds requested for all equipment listed in the attached file 

Total Equipment 

Additional Equipment: File Name: 

D. Travel Funds Requested ($)* 

1. Domestic Travel Costs ( Incl. Canada, Mexico, and U.S. Possessions) 

2. Foreign Travel Costs 

Total Travel Cost 

E. Participant/Trainee Support Costs Funds Requested ($)* 

1. Tuition/Fees/Health Insurance 

2. Stipends 

3. Travel 

4. Subsistence 

5. Other: 

 Number of Participants/Trainees Total Participant Trainee Support Costs 

RESEARCH & RELATED Budget {C-E} (Funds Requested) 

Contact PD/PI: Gifford, Rene H 

 

 Page 88 2018-08-16T11:14:30.000-04:00 
Contact PD/Pl: Gifford, Rene H 

RESEARCH & RELATED BUDGET-SECTIONS F-K, Budget Period 5 

ORGANIZATIONAL DUNS*: 

Budget Type*: O Project • Subaward/Consortium 

Organization: Vanderbilt University 

Start Date*: 04-01-2023 End Date*: 03-31-2024 Budget Period: 5 

F. Other Direct Costs Funds Requested ($)* 

Total Other Direct Costs 

G. Direct Costs Funds Requested ($)* 

Total Direct Costs (A thru F) 

H. Indirect Costs 

Indirect Cost Type Indirect Cost Rate (%) Indirect Cost Base ($) Funds Requested ($)* 

1 . MTDC -

Total Indirect Costs 

Cognizant Federal Agency Department of Health and Human Services , 

(Agency Name, POC Name, and POC Phone Number) 

I. Total Direct and Indirect Costs Funds Requested ($)* 

Total Direct and Indirect Institutional Costs (G + H) 

Funds Requested ($1"1 

K. Total Costs and Fee Funds Requested ($)* 

L. Budget Justification* File Name: Budget Justification.pdf 

(Only attach one file.) 

RESEARCH & RELATED Budget {F-K} (Funds Requested) 

Page 89 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

2018-08-16T11 :14:30.000-04:00 
Vanderbilt Budget Justification

PERSONNEL

Jack Noble, PhD

academic months and summer months, Years 1-5

Dr. Noble is an assistant professor and engineer at Vanderbilt University who is chiefly

responsible for the development, implementation, and revision of the Image-Guided Cochlear

Implant Programming (IGCIP) model, database, and associated software. He will serve as site

PI at Vanderbilt University and will play a vital role in the execution of the proposed project. He 

will oversee software modifications and the creation of IGCIP plans for the 60 cochlear implant

recipients in this study.

Benoit Dawant, PhD

academic months and summer months, Years 1-5

Dr. Dawant is a Professor and an engineer who has had over two decades of experience in

image-guided surgery and analysis. He is vital member of the IGCIP research team and has

played an integral role in the development and refinement of the algorithms, associated 

database, and software implementation. Dr. Dawant will oversee modifications to the IGCIP

database for this project. His expertise and insight will be of critical value to the successful 

execution of IGCIP for the proposed patient population.

Mary Dietrich, PhD 

calendar months, Years 1-4, calendar months, Years 5

Dr. Dietrich is a biostatistician who has a history of collaborative research and 

publications with the PIs on behavioral research projects examining speech, language,

and hearing outcomes. She will be providing statistical consult and guidance in years 4

and 5.

Staff Engineer, TBD

calendar months Years 1-5

A staff engineer/database specialist will be identified to modify the existing IGCIP database and

associated web-based portals for use in this project. These systems permit uploading images,

storing plans, setting calendars, and communication between study personnel. The engineer will 

be responsible for maintaining the database and for the transfer of images and plans. The

engineer will also assist in the creation of plans and on any modification of the planning

software necessary to support this project.

Contact PD/PI: Gifford, Rene H Budget Justification Attachment 

 

 Page 90
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

RESEARCH & RELATED BUDGET - Cumulative Budget 

Totals ($)

Section A, Senior/Key Person

Section B, Other Personnel

Total Number Other Personnel 5

Total Salary, Wages and Fringe Benefits

(A+B)

Section C, Equipment

Section D, Travel

1. Domestic 

2. Foreign

Section E, Participant/Trainee Support

Costs

1. Tuition/Fees/Health Insurance

2. Stipends

3. Travel

4. Subsistence

5. Other

6. Number of Participants/Trainees

Section F, Other Direct Costs

1. Materials and Supplies

2. Publication Costs

3. Consultant Services

4. ADP/Computer Services

5. Subawards/Consortium/Contractual

Costs

6. Equipment or Facility Rental/User

7. Alterations and Renovations

8. Other 1

9. Other 2

10. Other 3

Section G, Direct Costs

(A thru F)

Section H, Indirect Costs

Section I, Total Direct and Indirect Costs

(G + H)

Section J, Fee

Section K, Total Costs and Fee (I + J)

Contact PD/PI: Gifford, Rene H 

Fees

 Page 91 2018-08-16T11:14:30.000-04:00 
Contact PD/Pl: Gifford, Rene H 

Total Direct Costs less Consortium F&A 

NIH policy (NOT-OD-05-004) allows applicants to exclude consortium/contractual F&A costs when determining if an application falls at or beneath any applicable direct cost limit. When a direct 

cost limit is s ecified in an FOA the followin table can be used to determine if our a lication falls within that limit. 

Category Budget Period 1 Budget Period 2 Budget Period 3 Budget Period 4 Budget Period 5 TOTALS 

Total Direct Costs less Consortium F&A - - - - -

Page 92 

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334. Received Date: 2018-08-16T11 :14:30 000-04:00 
PHS 398 Cover Page Supplement OMB Number: 0925-0001

Expiration Date: 03/31/2020

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

1. Vertebrate Animals Section

Are vertebrate animals euthanized? ❍ Yes ● No

If "Yes" to euthanasia

Is the method consistent with American Veterinary Medical Association (AVMA) guidelines?

❍ Yes ❍ No

If "No" to AVMA guidelines, describe method and provide scientific justification

2. *Program Income Section

*Is program income anticipated during the periods for which the grant support is requested?

❍ Yes ● No

If you checked "yes" above (indicating that program income is anticipated), then use the format below to reflect the amount and

source(s). Otherwise, leave this section blank.

*Budget Period *Anticipated Amount ($) *Source(s)

Contact PD/PI: Gifford, Rene H 

   

 Page 93 2018-08-16T11:14:30.000-04:00 
PHS 398 Cover Page Supplement

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 . Received Date: 

3. Human Embryonic Stem Cells Section

*Does the proposed project involve human embryonic stem cells? ❍ Yes ● No

If the proposed project involves human embryonic stem cells, list below the registration number of the specific cell line(s) from the

following list: http://grants.nih.gov/stem_cells/registry/current.htm. Or, if a specific stem cell line cannot be referenced at this time,

check the box indicating that one from the registry will be used:

Specific stem cell line cannot be referenced at this time. One from the registry will be used.

Cell Line(s) (Example: 0004):

4. Inventions and Patents Section (Renewal applications)

*Inventions and Patents: ❍ Yes ❍ No

If the answer is "Yes" then please answer the following:

*Previously Reported: ❍ Yes ❍ No

5. Change of Investigator/Change of Institution Section

❏ Change of Project Director/Principal Investigator

Name of former Project Director/Principal Investigator

Prefix:

*First Name:

Middle Name:

*Last Name:

Suffix:

❏ Change of Grantee Institution

*Name of former institution:

Contact PD/PI: Gifford, Rene H Page 94 2018-08-16T11:14:30.000-04:00 
PHS 398 Research Plan OMB Number: 0925-0001

Expiration Date: 03/31/2020

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334. Received Date: 

Introduction

1. Introduction to Application

(for Resubmission and Revision applications) M-18_PHS_ResearchPlan_IntroductionToApplication.pdf

Research Plan Section

2. Specific Aims M-6_PHS_ResearchPlan_SpecificAims.pdf

3. Research Strategy* M-11_PHS_ResearchPlan_ResearchStrategy.pdf

4. Progress Report Publication List

Other Research Plan Section

5. Vertebrate Animals

6. Select Agent Research

7. Multiple PD/PI Leadership Plan M-10_PHS_ResearchPlan_MultiplePILeadershipPlan.pdf

8. Consortium/Contractual Arrangements M-7_PHS_ResearchPlan_ConsortiumContractualArrangements.pdf

9. Letters of Support M-8_PHS_ResearchPlan_LettersOfSupport.pdf

10. Resource Sharing Plan(s) M-9_PHS_ResearchPlan_ResourceSharingPlans.pdf

11. Authentication of Key Biological and/or

Chemical Resources

Appendix

12. Appendix

Contact PD/PI: Gifford, Rene H 

 

 

 Page 95 2018-08-16T11:14:30.000-04:00 
INTRODUCTION 

This is a resubmission of 1 R01 DC017683-01 entitled Image-Guided Cochlear Implant Programming: 

Pediatric Speech, Language, and Literacy. The reviewers invested considerable time in the review of this 

application and their efforts to provide a thorough and objective review are genuinely appreciated. We have 

endeavored to address all critiques. As a result, we are confident that the reviewers’ valuable advice has 

greatly enhanced the quality of this application. In accord with NIH’s newest guidelines for A1 applications, we 

have not highlighted changes in the research strategy; however, all changes are summarized below. 

General comments: There was consensus among reviewers on the following weaknesses: 1) blinding, 2) 

timeline, 3) working memory, 4) ceiling effects, 5) greater detail regarding age range and analysis plan, and 6) 

reliability of standardized measures. Detail is provided below for each point. 

1) Blinding: This is an excellent suggestion and adds scientific rigor. The revised experimental plan now 

includes blinding of both experimenters and participants. Only the PIs and Co-I, Dr. Dietrich—who will generate 

the randomization scheme—will know whether the participant is in the immediate intervention or deferred 

waitlist group until the end of the study. Neither PI or Dr. Dietrich will be administering assessments nor scoring 

test for any of the participants. Additional blinding detail, including provisions for breaking the blind, are located 

in the application in Approach, Data Safety and Monitoring Plan, and Statistical Design and Power Analyses. 

2) Timeline: We have added much greater detail to the timeline in accord with clinical trial guidelines. 

3) Working memory: We recognize that working memory could confound the results and thus we have added 

working memory controls to the study. We will administer 3 assessments of working memory including the 

Numbers Reversed test from the 4th edition of the Woodcock Johnson Test of Cognitive Ability and two tasks 

developed by project consultant Dr. Nittrouer including a serial recall task and visual-spatial task. We will be 

using the "W" score from the WJ-4 Numbers Reversed test, which is a weighted raw score that, unlike 

standard scores, permits direct comparisons of ability levels across age ranges. The serial recall and visualspatial tasks yield criterion scores than can be standardized across participants. We will statistically control for 

working memory by partialling out individual pre-intervention working memory levels from the pre- to postintervention gain scores on the treatment outcome measures of interest (e.g., phonological awareness, 

language). Greater detail for all 3 tasks is included in the Approach. 

4) Ceiling effects: Ceiling effects—defined here as a baseline score > 80% correct—were an issue for many 

participants on measures of speech recognition in quiet. For speech recognition in noise as shown in Figure 5, 

only 30% of the subjects exhibited ceiling level performance for +5 dB signal-to-noise ratio (SNR). However, 

we do recognize that this could prove problematic in this randomized clinical trial (RCT) with a larger 

population. Thus, we have added an adaptive speech receptive threshold in semi-diffuse background noise 

providing a threshold, in dB SNR, required for 50% correct performance. We have administered this task to 

pediatric and adult CI recipients and have published normative data for children and adults (1,2). We have also 

added the quasi-adaptive BKB-SIN measure which also provides a score, in dB SNR, for 50% correct; further, 

the BKB-SIN is recommended for use in this population by the pediatric minimum speech test battery (PMSTB) 

working group (3) thereby strengthening clinical relevance of the auditory assessment battery. Due to the 

adaptive nature of the speech receptive threshold and BKB-SIN measures, ceiling effects are not encountered 

 individuals with hearing loss. Because we had originally included the BKB-SIN in our preliminary studies, 

we have baseline and post-intervention data for 19 participants [18 of whom are included in Noble et al. (4)]. 

Baseline and post-IGCIP data for the BKB-SIN test are now described in the application in Preliminary Studies. 

5) Details re: age range and analysis plan: We acknowledge that we did not provide sufficient detail 

regarding the age range of participants included in our preliminary studies. We have now included the age 

range for the 41 participants’ data included in the Preliminary Studies section as 4.4 to 17.9 years (mean 

9.8). The age range we will include in the proposed studies will be 6 to 12 years; thus 32 of the 41 participants 

(78%) were in the age range specified in the application and all in this age range were able to complete the 

auditory test battery as proposed. This provided us with feasibility data motivating the chosen age range as all 

should be capable of completing a comprehensive behavioral battery of auditory perception. All measures of 

speech, language, phonological awareness, working memory, and literacy are routinely completed in this age 

range and have age normative data. With respect to the analysis plan, we have provided greater detail 

regarding our plans for analysis of longitudinal data and how measures of working memory will be factored as 

covariate. Biostatistician and Co-I, Dr. Dietrich, has edited and clarified this section of the proposal. 

6) Reliability of standardized measures: We have examined the test-retest reliability for all standard 

measures in the battery for the age range we plan to include. Because 6- to 12-year olds are relatively 

consistent responders to the testing procedures herein, the reliability coefficients are all above 0.90 according 

to the test manuals. We have added this information to the approach. 

Contact PD/PI: Gifford, Rene H Introduction to Application Page 96

 

 

 

for 

= 

a 
SPECIFIC AIMS 

Although children with cochlear implants (CIs) have significantly improved speech, language, and 

reading outcomes relative to previous generation CI recipients, too many pediatric CI users still display 

persistent speech, language, and reading difficulties despite early implantation and early intervention [see (5– 

7)]. Children with CIs typically lag behind their peers with normal hearing (NH) by 1 or more years on measures 

speech, language and/or reading [e.g., (8–15)]. Though these persistent delays can be attributed in part to a 

period of auditory deprivation prior to implantation (12,16,17), increasing evidence suggests that a degraded CI 

signal is also implicated in poorer development of auditory, speech, language, and reading skills for pediatric 

recipients (6,18–22). A related developmental path to reading also disrupted from the degraded CI signal is 

phonological awareness (PA) because PA is predicated, in part, on speech recognition (23). 

A procedure developed by Noble and colleagues (4,24–26), image-guided CI programming (IGCIP), 

significantly improves auditory function, speech recognition, and distally, receptive language abilities for adult 

users. We have preliminary evidence that pediatric CI recipients also significantly benefit from IGCIP (4). 

But there is a need to systematically investigate IGCIP in children to determine whether this individualized 

intervention yields a) associated benefits in auditory function and b) related improvements in speech, 

language, PA and/or reading. Thus, our primary goal is to evaluate the effects of IGCIP on auditory 

function, speech recognition, PA and reading, as well as speech and language abilities in pediatric CI 

recipients within the context of a double blind, waitlist controlled randomized clinical trial (RCT). We 

will obtain psychophysical estimates of auditory function and speech recognition, PA, reading, speech, and 

language abilities for 60 pediatric CI users in a baseline assessment and repeated time points for 24 months to 

test the impact of IGCIP. We will examine the immediate (short-term) and longer-term effects over a 2-year 

period by comparing outcomes between groups for those randomly assigned to immediate (n 30) or deferred 

30) IGCIP using a waitlist control study design (deferred IGCIP). The initial comparison will be for 

immediate and deferred IGCIP groups at 2, 6, and 12 months. The deferred group will then receive the IGCIP 

intervention and both groups will be followed for an additional 12 months (total enrollment for 24 months). The 

proposed research includes the following aims and specific hypotheses: 

Aim 1: Auditory function. We will compare auditory function and speech recognition of the immediate 

and waitlist control participants. Hypothesis 1a: There will be significant positive short-term gains (2-6 months) 

spectral and/or temporal resolution as well as speech recognition—particularly in noise—for children 

immediately receiving IGCIP as compared to waitlist controls. This hypothesis will be tested by comparing the 

difference in the amount of change in scores within-subjects (pre- to post-IGCIP gain) between the groups 

(treated vs. untreated) controlling for initial scores. Hypothesis 1b: IGCIP gain in spectral and/or temporal 

resolution will significantly predict gain in speech recognition. This hypothesis will be tested via regression 

analyses of change in speech recognition scores on change in resolution, controlling for baseline values and 

also controlling for baseline levels of speech recognition and working memory. 

Aim 2: PA and reading. We will explore the complex relationships amongst auditory function, speech 

recognition, PA, and reading ability. Hypothesis 2a: Differential growth in spectral/temporal resolution and/or 

speech recognition will predict growth in PA, which in turn will predict mediated growth in reading. Hypothesis 

2b: Growth in PA will be associated with amount of IGCIP benefit (gain) and will mediate growth in reading, 

which will be tested via cross-legged panel and path analyses. Note that testing these hypotheses is not 

dependent on the outcomes of Aim 1 as only variable gain in the Aim 1 measures (e.g., speech recognition) 

are required for aim 2 analyses, not a significant between-group difference for IGCIP in Aim 1. 

Aim 3: Speech and language. We will compare pre- and post-IGCIP receptive and expressive 

language abilities and speech production of pediatric CI recipients to the waitlist control group. We will test 

these skills at various time points on standardized and clinical measures of 1) receptive language, 2) 

expressive language, and 3) speech production (articulation and acoustic analyses). Hypothesis 3a: There will 

significant differences between groups for positive growth in speech and language and this growth will be 

predicted by the relative improvement in auditory function (aim 1) from IGCIP while controlling for baseline 

levels of working memory. Hypothesis 3b: Spectral/temporal resolution and speech recognition and/or PA will 

serve as mediators of expressive and receptive language gains and speech production gains both within and 

between groups. 3a and 3b will also be tested using mixed effects modeling and regression analyses to 

examine these “downstream” effects. Even if no between group differences in Aim 1 and/or Aim 2 are seen, we 

will nonetheless be able to test whether spectral/temporal resolution, speech recognition, and/or PA predict 

growth in receptive and/or expressive language and/or changes in speech production (including subclinical 

acoustic analyses). 

Contact PD/PI: Gifford, Rene H Specific Aims Page 97

 

 

 

of 

CI 

CI 

(n = 

in 

be 

= 
Contact PD/Pl: Gifford, Rene H 

RESEARCH STRATEGY 

SIGNIFICANCE 

Cochlear implant (Cl) technology yields significant improvement in auditory function, speech 

recognition, speech production, language, reading, and overall quality of life for the majority of recipients. 

Despite such advances, pediatric Cl recipients continue to display significant variability in speech and 

language development with too many recipients continuing to display poor outcomes [e.g., (10, 14, 15, 17,27-

31 )]. A recent study of pediatric Cl users brought these issues into sharp focus: Dettman et al. (2016) 

investigated speech recognition and language outcomes for a large cohort of pediatric Cl recipients (n = 403) 

who were all educated in an inclusion classroom using listening and spoken language as the primary mode of 

communication (17). Figure 1 is a reproduction of data illustrating mean standard scores for language and 

vocabulary for all children upon entry into 1st grade (14). This figure displays the magnitude and pervasive 

nature of the deficits across language measures for even the group of children implanted under 24 months 

(green bars). Indeed, all means were at least 1 standard deviation below the age normative range. 

Clearly, there is an ongoing need to improve language outcomes in these children (7). The source of 

delay is partially attributed to a period of auditory deprivation prior to implantation [e.g., (12, 16)]. However, it is 

120 ---------------------------· also likely that an impoverished Cl signal is implicated in ongoing poorer-

~ 110,_____-+---1-- than-normal development on measures of auditory, speech, language, 

~ 100 and reading (8,22,32). Several researchers have documented extremely "O 90 

~ 80 ------- - ------- poor spectral resolution for pediatric Cl users- much poorer than that 

c: 10 I  exhibited by adult Cl recipients (20,33- 37). Such findings suggest that

~ so □ a1 c1c11ildren pediatric Cl users with prelingual deafness may not depend upon spectral so -~ ~~■ Ct <24mo PLs PPVT cELF resolution for speech recognition in the same manner as adults, 

language test particularly in noisy environments. Indeed Lowenstein & Nittrouer (19) 

recently demonstrated that children with hearing loss- using hearing aids and Cls- placed significantly less 

weight on spectral cues than children with NH . In contrast, the children with Cls placed greater weight on 

amplitude cues-related to temporal envelope perception- as compared to the children with NH (19). Thus, it 

is possible that young children with Cls are making use of different cues, such as those contained within the 

temporal envelope, or spectrotemporal contrasts, both of which have been shown to yield high levels of 

consonant recognition in NH adults (e.g., (38- 41 )]. Further investigation is warranted to investigate the 

relationship between spectral resolution, temporal resolution, and speech recognition so that we can identify 

the underlying mechanisms driving speech recognition in pediatric Cl users as well as links to PA, reading, 

speech, and language abilities. Understanding the underlying mechanisms driving speech recognition in 

pediatric Cl users is not only necessary for theoretical purposes. but this information is critical to maximize a 

child's auditory abilities in the context of both Cl programming and. ultimately, for speech/language/reading 

intervention. For example, if we learn that children are using different auditory cues to drive speech 

recognition- such as greater weight on temporal vs. spectral cues- we could select Cl stimulation parameters 

that best transmit a well-defined temporal envelope such as high channel stimulation rates [>1500 pulses per 

second (42-44)] and removal of current steering which can introduce fluctuations in the temporal envelope that 

are uncorrelated with the incoming signal (45). In contrast, should we find that children rely heavily on spectral 

resolution and/or spectrotemporal cues as adult Cl recipients do, we could choose image-guided programming 

strategies designed to transmit finer spectral detail- such as patient-specific electrode deactivation to improve 

spatial selectivity of intracochlear excitation patterns and its psychological correlate, spectral resolution. 

Image-guided Cl programming (IGCIP) 

Our team has pioneered the use of postoperative CT scanning of Cl users to delineate the Cl 

electrode-neural interface and use this information to create customized programming maps. We refer to this 

process as image-guided cochlear implant programming (IGCIP) and here describe how it is performed. We 

have constructed an atlas based on 10 μCT scans of human cadaveric cochleae in which scala tympani (ST), 

scala vestibuli (SV), and the modiolus have been manually delineated as these anatomical structures are not 

visually identifiable on clinical CT scans. Next, on a pre-operative clinical CT scan, this atlas is iteratively fit to 

the patient's own anatomy to minimize the sum of the squared distance between the bony outline of the 

cochlea, which is identifiable both on the clinical CT scan as well as via μCT. Next, a post-operative CT scan is 

obtained, the centerline of the electrode array extracted, and a 3D model of the electrode array fit to the scan. 

Finally, the pre- and post-op scans are superimposed upon each other as the bony anatomy is consistent. The 

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Research Strategy 
Contact PD/Pl: Gifford, Rene H 

output (top panel, Figure 2) includes 3D surfaces showing the position of individual electrodes relative to the 

neural endings they are intended to stimulate in the modiolus. 

Next, we define the electrode-to-neural interface by calculating the distance-versus-frequency curves 

from the frequency mapped neural endings within the modiolus to each individual electrode. This is shown in 

the bottom panel of Figure 2 where each of the colored curves represents a different electrode and shows the 

Euclidian distance from the electrode to the modiolus (ordinate) as well as the predicted frequency range of the 

modiolus (8) at that location (top abscissa). Electrodes are chosen for deactivation to minimize channel 

interaction- or spread of intracochlear electrical excitation. The premise is that such electrodes would be 

providing "redundant" electrical stimulation for a given segment 

of the cochlea. So, by deactivating these electrodes, we theorize 

that we are able to reduce channel interaction which should 

increase spatial selectivity of intracochlear electrical excitation. 

The heuristic we use to achieve this is to deactivate as few 

electrodes as possible while producing an overall curve with 

clearly defined local minima and with electrodes centered on the 

I""'...,,,,.., e...,,.., rr,,. ~ range of frequencies to which they are closest. Following this 

"' :!_i.1- .------.- .- .- . - . -.-.- .- .- .-- strategy for the example shown in Figure 2, we have 

~ C::: 3., 311 ,,. m : ! ! ~=: ~::W ~ ':f=';f=.,,. deactivated electrodes 2, 3, 4, 6, 8, 10, and 16. 30, 

Clinical significance: Cl programming 

Clinical Cl programming includes the mapping of 

incoming sound using a "one size fits all" approach of current 

limiting, frequency allocation, and stimulation of all electrodes. 

For some individuals, it is likely that these default programming 

methods provide a reasonable approximation to the patient's 

individualized anatomy and electrode location and that 

activation of all electrodes yields adequate outcomes. For other 

patients- particularly those who may exhibit poorer-thanaverage performance, have atypical cochlear anatomy, 

electrode dislocation, or extracochlear electrodes- a ''one size 

fits all" approach wil l not afford the restoration of hearing that 

could be achieved had the recipient's anatomy and intracochlear electrode positioning been considered. For 

example, a recent study of 262 Cl users showed that 13.4% of patients had at least 1 extracochlear electrode 

despite surgical reports of complete insertion (46). Active extracochlear electrodes will produce suboptimal 

high-frequency transmission as the acoustic information being transmitted to the extracochlear electrodes will 

not reach primary auditory neurons. Thus an additional goal of IGCIP is identification of extracochlear 

electrodes- critical information needed to ensure stimulus delivery of high frequency speech sounds (Figure 6 

preliminary studies). Such considerations are particularly critical for pediatric Cl users for whom audibility of 

high-frequency stimuli is central to the acquisition of auditory-based speech and language. 

Children are routinely implanted at ~12 months of age- the minimum age referenced by FDA labeled 

indications. Thus, it is the case that for the first 3 to 5 years of Cl use, we are relying on external factors for Cl 

programming and verification of Cl map appropriateness. Such factors include "aided" audiometric thresholds, 

auditory skill development gauged primarily via parental questionnaire, and progress on measures of language 

and speech production. Even if a child is making progress, it is possible that using an individualized approach 

to Cl parameter manipulation- capitalizing on the underlying hearing mechanisms driving performance as well 

as individualized anatomy and electrode location- would result in greater performance at a faster rate allowing 

for higher overall outcomes. Indeed, we have documented that pediatric Cl recipients can derive significant 

benefit from IGCIP on measures of speech recognition in quiet and noise (4). 

Underlying mechanisms driving auditory-based speech recognition 

For adults with NH, speech recognition is dependent upon a high degree of spectral resolution of the 

individual components of speech including resolution of individual and relative formant frequencies as well as 

rapid formant transitions. Speech recognition- as dependent upon spectral resolution- poses a major obstacle 

for Cl recipients and attempts to improve spatial selectivity of intracochlear electrical stimulation (i.e. reduction 

in channel interaction) have resulted in minimal improvements in speech recognition abilities [e.g., (47- 50)). 

Most attempts at improving intracochlear spatial selectively of electrical excitation patterns and subsequent 

improvements in spectral resolution, however, have investigated current focusing such as tripolar electrode 

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Research Strategy 
configuration [e.g., (51–58)] for adult CI users. Attempts at limiting channel interaction via current focusing 

have resulted in programming parameters and electrode configurations that significantly limit the dynamic 

range of electrical stimulation as well as significantly increase power demands for the sound processor. Such 

consequences render the applicability of these strategies clinically prohibitive. 

Spectral resolution for CI users is often characterized using tasks of spectral modulation detection 

(SMD) or spectral ripple discrimination (e.g., (59–62)]. Numerous studies have shown a significant correlation 

between spectral resolution with a CI and auditory speech recognition for adult CI users (e.g., (60,63–69)]. 

Furthermore, researchers (45,70) have demonstrated that psychophysical measures of spectral resolution are 

more sensitive to changes in CI processing strategies and central auditory reorganization following 

implantation than traditional clinical measures of speech recognition (62,70). Thus it is common for researchers 

 use SMD as a proxy for channel interaction to determine whether CI programming changes may impact this 

phenomenon. Indeed we have shown that IGCIP yields statistically significant improvements in spectral 

resolution, via SMD, in adult CI users (24,26,49,71). In contrast to these findings, pediatric CI users exhibit 

extremely poor spectral resolution and estimates of pediatric CI spectral resolution are not significantly 

correlated with speech recognition [e.g., (20,37,72,73)] or were modestly correlated with vowel recognition in 

quiet (74). Furthermore there are conflicting reports regarding the relationship between listener age, age at CI, 

and overall spectral resolution abilities (20,72,74). 

Description of underlying auditory mechanisms responsible for pediatric CI speech recognition is not 

only important for research purposes, but holds significant clinical relevance. To maximize outcomes for 

auditory function and related outcomes for speech, language, and literacy of our pediatric CI recipients, we 

must identify the auditory mechanisms driving speech recognition, whether those be spectral, temporal, or 

some combination thereof. The reason is that clinicians have access to a variety of CI signal coding strategies 

all focusing on different aspects of the incoming stimulus. For example, there are current-steering strategies 

designed to provide greater spectral representation of incoming stimuli (e.g., Fidelity-120, Optima), strategies 

designed to provide temporal fine structure in the apical channels via variable rate stimulation [e.g., fine 

structure processing], and high-rate strategies specifically designed to provide fine detail for temporal envelope 

representation at each stimulated electrode [e.g., HiRes, high-definition continuous interleaved sampling, and 

high-rate Advanced Combination Encoder]. Despite the known fact that adult and pediatric CI users 

demonstrate a significantly different relationship between spectral resolution and speech recognition 

(20,72,73), clinical audiologists are using the same default programming strategies (i.e. current steering and/or 

low-to-mid rate stimulation) with both adult and pediatric CI users within a one-size-fits-all philosophy. If we 

determine that pediatric CI users are more reliant on temporal coding for speech recognition, we can adapt a 

clinical approach to provide greater representation of temporal envelope with higher channel stimulation rates 

and removal of current steering. Ideally we would develop a data driven, personalized plan for CI programming 

capitalizing on the mechanisms driving auditory-based speech recognition combined with selective IGCIP 

channel activation to improve intracochlear spatial selectivity and resultant spectrotemporal resolution. Based 

our published and preliminary data (4,20), our hypotheses are that IGCIP will improve 1) auditory function 

(spectral and/or temporal resolution), 2) speech recognition, and 3) improvements noted for spectral and 

temporal resolution will mediate improvements on measures of PA, speech production, language, and reading 

while controlling for confounds [e.g., nonverbal cognition, working memory (75–81)]. 

Auditory Function, Speech Recognition, PA, and Reading 

Researchers and clinicians have been interested in the interrelationship between hearing, speech 

recognition, speech and language skills, PA, and reading outcomes for more than half a century (82–84). Until 

recently, speech recognition, speech production, language, PA and reading for children with CIs have been 

relatively poor and all domains have significantly lagged behind typically developing peers (6,8,21,30,85–88). 

Advances in CI technology have yielded dramatic improvements in all these domains. Indeed, recent reports 

have indicated that a number of CI recipients are trending into the typical range and in some cases, even into 

advanced range for language and reading outcomes [e.g., (10,14,15,17,21,89)]. Despite these encouraging 

findings, a significant number of CI users continue to demonstrate relatively poor outcomes for speech, 

language, PA and/or reading. A likely explanation is that spectral resolution is strongly correlated with PA (90– 

92). Given the generally poor, but variable, spectral resolution abilities exhibited by pediatric CI recipients 

(20,72–74), it is not surprising that both PA and reading skills are often poorer than typically developing 

children. Despite the fact that pediatric CI users have poor spectral resolution and below average PA, some CI 

recipients are able to approach typical levels of performance on speech, language and reading achievement. 

One must then ask how are some children with CIs capable of achieving such high levels of speech 

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on 

an 

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recognition and ultimately high levels of language and reading despite poor spectral and phonological 

processing? In other words, how are children with relatively poor spectral resolution able to bootstrap 

phonological decoding and subsequent reading? One explanation is grounded in lexical restructuring theory 

(93–96). Lexical restructuring theory posits that a child initially has a global representation of lexical 

information, and thus does not require fine spectral detail. As a child ages, she begins to learn phonotactic 

structure within her native language(s) and ultimately builds a more comprehensive lexicon (97). Nittrouer and 

colleagues reported that “Oral language skills explained more variance in emergent reading for children with 

CIs than for children with NH” suggesting that children who successfully build lexical and phonotactic 

representations despite incomplete spectral resolution will bootstrap PA and ultimately achieve higher 

vocabulary and reading levels (98,99). That is, converging syllable and lexical cues can be utilized to build 

partial phonotactic representations that are supported by non-spectral cues (i.e., temporal or spectrotemporal) 

(100). On the other hand, it is also plausible that some children cannot bootstrap the relative weaknesses in 

spectral resolution to PA (101) and thus continue to display poor vocabulary and reading skills. We 

hypothesize that improving intracochlear spatial selectivity via IGCIP will lead to improvements in auditory 

function and speech recognition, which will facilitate bootstrapping of PA. IGCIP could provide a direct unique 

path to benefit PA—a plausible hypothesis that can be tested in this experimental design. 

There is a reliable relationship between speech recognition in noise and spectral resolution [e.g., 

(20,73,102,103)] and emerging data supporting a relationship between PA and spectral resolution (19). 

However, in the presence of poor spectral resolution for children with CIs, we must examine the relative 

contributions of alternative paths taken from speech recognition to PA, speech, language, and reading. Figure 

displays theorized models of IGCIP-mediated benefits of speech recognition and the subsequent effects on 

PA and receptive language. For example, it is plausible that there is an indirect path to PA mediated by a direct 

path through IGCIP-improved speech recognition. This can also be 

statistically tested within the context of a longitudinal double-blind, 

waitlist controlled RCT design, especially with measurements of 

potential mediators. A similar direct and indirect path can also be 

tested for IGCIP-gain scores in speech recognition and receptive 

language. Again, it is possible that IGCIP benefit directly improves 

receptive language and that this relationship is mediated via 

improvement in speech recognition resulting from IGCIP gain. 

Within the context of the current proposal, we have a unique 

opportunity to gain a better understanding of factors that predict 

speech, language, and reading outcomes in pediatric CI recipients. 

Specifically, the research activities proposed here can compare the 

growth in spectral and temporal resolution, speech recognition, PA, 

speech, language, and reading following IGCIP within the context of a double blind, waitlist controlled RCT. 

That is, hypothesized distal “benefits” resulting from refinement of intracochlear spatial selectivity via IGCIP 

can be systematically studied with a waitlist control longitudinal RCT. Figure 3 includes examples of the basic 

design approach. A putative predictor, namely IGCIP gain scores for auditory function, can be tested as a 

direct and indirect predictor of speech recognition and PA. The direct path is from IGCIP gain to the outcome 

which may be PA and/or receptive language. The strength of the longitudinal RCT design is that the indirect 

path wherein speech recognition as a mediator of the relationship can also be tested. This design approach will 

also be employed to examine the direct and indirect relationships amongst speech recognition to receptive 

language, receptive language to expressive language, and receptive language to reading comprehension in 

addition to speech recognition to PA and PA to reading comprehension. 

IMPACT 

The impact of a personalized approach to CI programming on auditory function, speech recognition, 

PA, language, speech, and reading will be examined as a step in programmatic research designed to optimize 

auditory, speech, language, PA and reading outcomes in children with CIs. Having access to personalized data 

regarding individualized anatomy, electrode location, and electrode-to-modiolus distances will make this 

investigation the first of its kind in the space of outcomes-based research for pediatric CI recipients. The use of 

randomized wait-list control design will not only afford a prospective and longitudinal investigation into the 

effects of IGCIP, but this design will enable us to describe the expected growth trajectory for validated 

measures of speech recognition and psychophysical measures auditory perception for children with CIs over 

the course of a 2-year period. Such data have never before been described with these measures and thus this 

IGCIP path figure for Phonological Awareness (PA) 

IGCIP path figure for Receptive Language 

Figure 3. Direct and indirect (mediated) effects for GC P & 

speech recognition on PA and receptive language 

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a 
Contact PD/Pl: Gifford, Rene H 

project offers high clinical relevance for audiologic management, test interpretation, and subsequent 

recommendations for pediatric Cl recipients and their families. 

INNOVATION 

This proposal is innovative in a number of ways. Although subsets of all of the potential relationships 

illustrated in Figures 3 and 4 have been included piecemeal in cross-sectional and longitudinal studies of 

children with Cls, previous studies have not included these measures 

in an integrated correlational longitudinal design nor have they 

considered individualized anatomical variations, electrode location, nor 

electrode-to-modiolus distances, while attempting to define the 

mechanistic underpinnings of speech recognition in this 

population within the context of a double blind, waitlist controlled 

RCT. However, we have the benefit of these previous studies to power 

our analyses. We are also able to implement a newly developed 

refinement in Cl programming to produce baseline changes in auditory 

function using IGCIP and then use this variability to refine the predictor 

models. In addition, the proposed research includes an innovative 

effects of IGCIP on speech, anguage,and read ng. application of mediated analyses to test direct and indirect paths to the 

outcomes (i.e. PA and reading abilities) while controlling for confounds, including nonverbal intellectual skills 

and working memory. Our proposal challenges current clinical practices built on a "one size fits all" approach 

IGCIP path 

model 

· · 

Figure 4: conceptua mode of ct rect and nd rect 

assumin that all Cl users depend predominant( on spectral cues for auditor , speech, and Ian ua e skills. 

IGCIP. Our image-guided approach to Cl programming provides an automated electrode position 

analysis accounting for non-rigid variations in individualized cochlear anatomy. This requires a pre- and postimplant CT for all participants. Preoperative CT is considered standard of care for all Cl recipients in the 

majority of Cl programs and is thus available for all participants. Post-implant CT is also considered standard 

of care at Vanderbilt University Medical Center given the value-added information regarding electrode 

placement. Postoperative CT scans are obtained in the operating room immediately following implantation 

(preferred for pediatric Cl recipients) or at subsequent clinical visits. We use a low radiation CT scanner (Xoran 

XCAT) (104,105) with 1⁄4 of the radiation exposure of a typical head CT scan. Though we are using postimplant CT to identify extracochlear electrodes and overall electrode placement at Vanderbilt per standard of 

care, we are not yet applying IGCIP strategies in our clinical practice. 

Participants. The impact of IGCIP has been assessed in 41 pediatric Cl users for measures of spectral 

resolution, speech recognition, and quality of life. Children were 4.4 to 17.9 years (mean: 9.7 years) and all 

were provided with IGCI P and followed for 1 month up to 1 year. A subset of these 41 participants (n= 17) were 

assessed on measures of speech production and language both pre- and post-lGCIP. None had confounding 

diagnoses such as autism spectrum disorder, neurological disorder, or general cognitive impairment. 

RESULTS: Speech recognition and auditory function. 

Figure 5 displays speech recognition data in the experimental ear for 41 pediatric Cl users with the 

IGCIP score plotted as a function of the baseline score obtained with the clinical Cl program. The dashed lines 

represent the averaged 95% confidence intervals for monosyllabic words (106) and BabyBio sentences (107). 

Data points falling within the dashed lines represent no change in performance with IGCIP, points located 

above the top dashed line represent significantly better performance with IGCIP, and points located below the 

bottom dashed line represent significantly better performance with the standard clinical program. For speech 

recognition in quiet (monosyllables & sentences), 16% exhibited significantly better scores with IGCIP, 79% 

exhibited no change, and 5% demonstrated significantly poorer scores with IGCIP. For sentence recognition in 

noise, collapsed across signal-to-noise ratio (SNR), 28% exhibited significantly better performance with IGCIP, 

69% exhibited no change, and only 3% exhibited significantly poorer performance with IGCIP. Considering the 

bilateral aided condition (i.e. IGCIP ear plus contralateral ear using either hearing aid or 2nd Cl), no child 

exhibited a significant decrement in speech recognition following IGCIP and 24% of the sample exhibited a 

significant improvement for sentence recognition in noise. Auditory outcomes for an 18-participant subset of 

these 41 participants were published in Noble et al. (4). 31 of 41 children enrolled to date have elected to keep 

their IGCIP map for full-time use. In other words, though children are highly resistant to change, 76% of the 

sample opted to keep a novel program as compared to a program used for a range of 2 to 16 years prior to 

study enrollment-a testament to the perceptual benefits afforded by this intervention. 

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Research Strategy 
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As displayed in Figure 5, many scores approached ceiling values for speech recognition in quiet and 

some even for speech recognition in noise with fixed SNRs (+10 and +5 dB). Thus we also administered a 

quasi-adaptive measure of sentence recognition in noise, the Bamford-Kowal-Bench Speech-In-Noise [BKBSIN (108)] test. The BKB-SIN is a norm-referenced test [5 to 80 years (109)] yielding a score expressing the 

SNR required for 50% correct, and thus lower scores represent 

better performance. We obtained BKB-SIN data at baseline and    following IGCIP for 19 of the 41 pediatric Cl users [18 included          Nob   le et al. (4)]. For the IGCIP ear, 32% demonstrated 

IGCIP improvement, 63% exhibited no change, and just 1 (5%) 

exhibited significant IGCIP decrement. Mean BKB-SIN scores in 

the experimental ear were 13.0 and 11.8 dB at baseline and 

IGCIP, respectively. In the bilateral aided condition (IGCIP ear   

plus contralateral hearing aid or 2° Cl), no one exhibited IGCIP 

decrement and 37% of the sample exhibited a significant IGCIP 

benefit. Mean scores in the bilaterally aided condition were 8.2 

and 6.8 dB at baseline and IGCIP, respectively. 

We followed 23 of the 41 children longitudinally for 1 year following enrollment. Children who kept the 

IGCIP map (n=16 or 70%) continued to demonstrate significant improvement in speech recognition at the 

group level (p = 0.002) 1 year following enrollment, and no one exhibited decrement in performance relative to 

baseline. The children who did not keep the IGCIP map (n=7 or 30%) either returned to baseline and 

maintained that performance for 1 year or showed minimal, non-significant improvement over the course of the 

year following study enrollment (p > 0.05). In other words, even children who rejected IGCIP for lack of 

benefit- or even exhibited short-term decrement- returned to baseline and maintained baseline-level 

performance following intervention. Thus we can conclude that IGCIP did not produce long-term harm for 

children not deriving benefit as well as children who demonstrated short-term decrement. 

Spectral and temporal resolution. For 41 pediatric Cl recipients, we found no relationship between 

spectral modulation detection (SMD) and speech recognition nor was SMD correlated with listener age (r = -

0.07 to 0.11 ; p > 0.05) (20). This finding is contrary to multiple reports for adult Cl users as well as for our own 

data for which we found a significant correlation between SMD and various measures of speech recognition for 

542 adult Cl users (20). This suggests that pediatric Cl users- with 

prelingual onset of deafness- may not be dependent on spectral 

resolution for high levels of speech recognition. In fact, we have pilot 

data for 14 pediatric Cl users demonstrating a correlation between 

temporal modulation detection at 128 Hz and both monosyllabic word 

recognition (r = -0.51, p = 0.05) and sentence recognition in quiet (r = 

0.55, p = 0.04). Furthermore, we have baseline and post-lGCIP data 

for 5 pediatric Cl users showing a correlation between IGCIP benefit 

for monosyllabic word recognition and temporal modulation detection (r 

= 0.94, p = 0.059). These data are consistent with adult studies 

showing a significant correlation between temporal modulation detection and word recognition (59,11 0) and 

further motivate our hypothesis that pediatric Cl users place greater weight on temporal vs. spectral cues. 

Figure 6 displays data for a case study of a 4-year old Cl recipient who demonstrated significant IGCIP 

benefit. Figures 6A & B display two views of the 3D reconstruction of the participant's cochlea with the 

implanted electrode array in place (green=scala tympani; blue=scala vestibuli; yellow=modiolus). The 2 most 

basal electrodes were found to be extracochlear. With these electrodes active in the Cl map, the child was not 

receiving intracochlear stimulation for information above 4500-5000 Hz. Our IGCIP plan recommended 

deactivation of extracochlear electrodes (Fig. 6B), in addition to 1 electrode in the apical region based on 

calculation of intracochlear electrode-to-modiolus distance. By doing this, the incoming speech spectrum was 

reallocated to the remaining intracochlear electrodes transmitting information from 100 through 8500 Hz. 

Following IGCIP, this child exhibited a significant improvement in monosyllabic word recognition from 48% to 

72% with just 6 weeks of IGCIP use; he did not, however, exhibit change on norm-referenced assessments of 

articulation. However, Figures 6C and D display spectrograms of his baseline and post-lGCIP production of 

the word "yes." After 6 weeks with IGCIP, he produced significantly greater higher frequency speech (p < 

0.001) with greater amplitude in the Isl region. Acoustic analyses also revealed significantly greater vowel 

precision (t = 6.8, p < 0.0001- articulatory vowel precision improving by more than a factor of 2). Despite 

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Research Strategy 
Contact PD/Pl: Gifford, Rene H 

significantly greater speech energy> 3000 Hz following IGCIP (Figure 6D), there was no noted improvement 

in overall consonant precision nor consonant or vowel duration following IGCIP (p > 0.05). In contrast, we 

present a case study of a 6-year old Cl user who did not demonstrate significant IGCIP benefit and in fact, 

showed slight decrement in monosyllabic word recognition with IGCIP (80% to 72%). However, this child 

exhibited a significant improvement in consonant precision (most pronounced for /j/, /h/ and /g/; t =4.2, p = 

0.0001) with an accompanying 30% increase in consonant duration following IGCIP. This child did not show 

any change in vowel precision nor vowel length. This highlights the value of speech production and acoustic 

analyses in the context of this research proposal as we can track subclinical changes in speech production 

resulting from refinement of the Cl signal. 

PA. The proposed measures of PA have been studied extensively by consultant Nittrouer and she has 

provided access to the paradigms she has employed in multiple studies of children with Cls. These measures 

TABLE 1: Regr89Sion Models or Phonological Awareness Receptive 

Language Reeding Basic Skills• and Reeding Comprehension• (adapted 

rom able 5 in Camarata etal in rvessl

- R' 

adl measure B SE 

B ~ I p 

3' 543 

Age 

Nonvefbal ntelligence 

Phonoloalcal Awareness 

- 134 

467 

.544 

075 

150 

.107 

. 175 

325 

.509 

-1 793 

3 110 

5.073 

079 

003 

.000 

'J!' 645 

Age 

Nonvefbal ntelligence Readlna-8aslc Skllls 

- 007 

290 

.666 

065 

138 

.097 

- 010 

208 

.676 

- 114 

2 109 6.833 

910 

040 

.000 

4' 745 

Age 

Nonvefbal ntelligence 

Readlng-8aslc Skllls 

Readlnn-Receptlve Lana 

• 037 

125 .412 

.401 

056 

122 

.099 

.091 

. 049 

089 .099 

.091 

- 655 

1 021 4.152 

4.388 

515 

312 .000 

.000 

have repeatedly been shown to predict language and reading in 

pediatric Cl. In addition, Camarata has begun examining PA in 

children with hearing loss in the context of language, reading, 

and subjective fatigue and recently reported that standardized 

measures of PA predict language ability and reading skills 

(Table 1 ). Though consultant Nittrouer has more expertise in 

this area, Pl Camarata also has experience and preliminary data 

on assessing PA in children with hearing loss that are directly 

relevant for the proposed research. These data also illustrate the 

analytic approach to be employed for these parameters in the proposed research. 

Speech and language measures: Speech and language tests administered for 17 of the pediatric 

IGCIP study participants included receptive language and speech using the Test of Auditory Comprehension of 

Language [TACL-3 (1 11 )] and Goldman Fristoe Test of Articulation [GFTA-2 (112)], respectively. Correlations 

were computed for the raw gain scores on each test (note that "gain" could have been positive, negative, or 0) 

and the "benefit" scores from speech recognition tests quantifying IGCIP changes. The results are depicted in 

Table 2 as correlation coefficients between BabyBio sentence 

recognition in noise at +5 and +10 dB signal-to-noise ratio (SNR) and 

TACL change scores(~) as well as GFTA change scores(~). 

Asterisks indicate significance. There were a number of significant 

correlations between IGCIP gain for speech recognition in noise and 

measures of receptive language and speech production. These results 

suggest that incidental gains in receptive language and speech 

production are associated with IGCIP benefit. This is an important clinical finding because it indicates that 

IGCIP can potentially benefit speech and language outcomes for pediatric Cl recipients. The pediatric cases 

herein demonstrated speech and language growth that was proportional to the amount of benefit provided by 

individualized IGCIP and rovide relimina estimates of the effect sizes to ower the ro osed research. 

TABLE2 ATACL 

vocabulary 

ATACL 

granvnatical 

morphemes 

ATACL 

elaborated 

sfflences 

A 

GFTA 

BabyBio 

+5dB 0.12 0,31 • 0.20 

BabyBio 

•10dB 0.37" 0.36' o.ss· 0.49" 

BabyBio 

eollepoed 

acrossSNR 

o.,s· 0.57' 0.2 1· 0 .30' 

Our 1st aim is to compare pre- and post- IGCIP spectral and temporal resolution as well as word and 

non-word repetition (1 13,114) for pediatric Cl recipients. Our 2nd aim is to explore the complex relationships 

amongst spectral and temporal resolution, speech recognition, PA, and reading outcomes. Our 3rd aim is to 

compare pre- and post-lGCIP raw scores on standardized tests of receptive language as well as speech 

production of pediatric Cl users as these relate to spectral and temporal resolution and speech recognition. 

Our hypotheses are: 1) improved intracochlear spatial selectivity afforded by IGCIP will result in significant 

positive gain in spectral and/or temporal resolution and the magnitude of this gain will be significantly 

associated with gains in auditory comprehension (word and non-word repetition in quiet and noise), controlling 

for baseline levels of working memory and speech recognition, 2) spectral and/or temporal resolution as well 

as speech recognition will be associated with gain (change) in speech recognition and PA and that these, in 

turn, will significantly predict reading ability, and 3) spectral and/or temporal resolution as well as speech 

recognition will be associated with gain (change) in speech production and receptive language. Although the 

aggregate assessment protocol appears ambitious, with the exception of the PA, working memory, and the full 

complement of acoustic analyses, all procedures have been completed in children in our pilot and preliminary 

studies (4,20) and Camarata et al. (77) administered a more extensive battery (including standardized 

measures of PA) in 56 children with mild-to-moderate hearing loss, documenting feasibility of the proposed 

procedures. 

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Research Strategy 

0.28 
-- --

--

Contact PD/Pl: Gifford, Rene H 

Participants. The participants will be 60 pediatric Cl recipients between the ages of 6 and 12 years. 

This age range was chosen as it is crucial for the development of speech, language, and literacy [e.g., (5)] and 

because 32 of the 41 participants (78%) in our preliminary studies were in this range and all were able to 

complete the proposed auditory test battery. Additionally, all measures of speech, language, PA, working 

memory, and literacy are routinely completed in this age range and have age normative data. Note that as 6- to 

12-year olds are relatively consistent responders to the testing procedures herein, the reliability coefficients are 

>0.90 according to the test manuals; thus the SEM of these scores will be relatively narrow. None of the 

participants will have confounding diagnoses such as autism spectrum disorder, neurological disorder, or 

general cognitive impairment. Children must have at least one Cl, < 3 years of age at implantation, and 

bilateral sensorineural hearing loss. Comprehensive audiological testing will be completed with all children as 

will the speech, language, PA, and reading assessments. We will collect and store child and family variables 

known to influence hearing, speech, and language outcomes such as chronological age at assessment, age at 

Cl, age at identification, etiology, Cl daily wear time [via datalogging (115, 116)], nonverbal cognition, gender, 

maternal level of education, socioeconomic status, family size, and preschool educational environment [i.e. 

mainstream preschool, parent-infant program, listening and spoken language (10, 15,1 17, 118)]. 

Design Overview. The proposed research is a relatively straight-forward, double blind, waitlist 

controlled RCT. The total initial sample (n=72) will be randomly assigned to either immediate IGCIP 

intervention (n=36) or a deferred waitlist condition (n=36). Both groups will be monitored for 24 months (Table 

3), with testing at time 1 (baseline), time 2 (2 months), time 3 (6 months), and time 4 (12 months). After 12 

months, the deferred treatment group will receive the IGCIP intervention and testing will then continue for both 

groups at time 5 (14 months), time 6 (18 months), and time 7 

- (24 months). At completion, we will have 12 months of data on 

untreated growth, 12 months of treated growth in the deferred 

group, and 24 months of growth in the immediate IGCIP group. 

Note that "growth" can be positive, negative or neutral within in 

this design. Importantly, a between-group comparison of 

TABLE 3 

.........,_. 1 2 

fflO 

-

• 12 

fflO 

1S 1• 

fflO 

11

- M 

fflO 

._.,_ - X X X X X X X 

X X X X X X X X X 

ll,bJocllve X X X X X X X 

..,.__

---· X X X X X X X 

~PA.&- X X X 

..SmartPhone app at home treated and untreated growth will be completed for data 

collected at 12 months. The study also permits comparison of growth at 24 months between groups 

(immediate vs. deferred treatment), which provides strong testing of IGCIP intervention effects. 

We will ensure optimization of Cl mapping including Cl-aided thresholds in the range of 20 to 25 dB HL 

from 250 through 6000 Hz (119,120) as well as verification of upper stimulation levels via electrically evoked 

stapedial reflex thresholds (ESRTs) (121- 123). For unilateral Cl users with a hearing aid in the non-Cl ear, we 

will verify hearing aid settings via real-ear measures (124 ). If clinical Cl mapping was not completed per this 

protocol, we will program the child's Cl and wait at least 2 months prior to completing a baseline assessment. If 

middle ear status does not allow ESRT measurements (e.g., effusion and/or PE tubes), upper stimulation 

levels will be obtained behaviorally, per clinical protocol. We will also complete thorough listening checks and 

test external equipment for signs of malfunction at every study visit. 

Procedures 

IGCIP. IGCIP provides an automated electrode position analysis accounting for non-rigid variations in 

individualized cochlear anatomy requiring pre- and post-implant CT for all study participants. Pre- and postoperative CT scans are considered standard of care treatment for all Cl recipients at Vanderbilt given the 

electrode information provided by the image-guided analysis. We will define the electrode-to-modiolus interface 

by calculating distance-versus-frequency curves and then implementing a minimum error neural network to 

determine which electrodes for which their local minima (shortest electrode to modiolar distance) would be 

completely encompassed by adjacent electrodes. The goal is to maximize the number of active electrodes [>8 

electrodes (125, 126)] but also eliminate electrodes providing "redundant" electrical stimulation (i.e. channel 

interaction) or extracochlear electrodes. With IGCIP deactivation, we hypothesize a reduction in channel 

interaction which should increase spatial selectivity, and hence spectrotemporal resolution and speech 

recognition in noise. For bilateral Cl users, IGCIP will be implemented for just 1 Cl, targeting the poorer 

performing ear or the 2nd Cl ear in the absence of interaural performance differences. This has been the IGCIP 

approach for all previous studies (4,71, 127) and offers built-in control of the non-lGCIP ear as well as the 

bilateral Cl condition (also see data presented in Preliminary Studies). 

Spectral, Temporal, and Spectrotemporal Resolution. All tasks of spectral, temporal and 

spectrotemporal resolution will utilize a 3-interval, 2-alternative forced-choice procedure with broadband noise 

(125 to 8000 Hz) presented at 65 dB SPL in the sound field. For spectral resolution, the participant will be 

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Research Strategy 
asked to discriminate between noises with a flat spectrum and those with spectral modulation at rates of 0.5 

and 1.0 cyc/oct—these rates have been shown to be significantly correlated with various measures of speech 

recognition (60,61,128). Temporal resolution will be assessed using amplitude modulation detection tasks in 

which the listener is asked to discriminate between noises with a flat temporal envelope and those with 

sinusoidal amplitude modulation at rates of 4, 32, and 128 Hz. These rates were chosen to define the plateau 

of the temporal modulation transfer function (4-32 Hz) as well as the sloping portion of the function (128 Hz) 

[e.g., (129)]. 4 Hz is also highly relevant for speech as it represents the peak modulation rate of the speech 

envelope modulation transfer function (130). Temporal modulation threshold will be expressed in 20 log m 

(dB), where m is the modulation index (0 to 1). Spectrotemporal resolution will be assessed using a stimulus 

with both spectral (1 cyc/oct) and temporal modulation (4 or 32 Hz) (131). Spectrotemporal modulation 

thresholds will be expressed in spectral modulation depth (dB) for each of the temporal modulation rates. For 

measures we will use a 2-down, 1-up tracking procedure to track 70.7% (132). For all tasks, cartoon images 

an animal are time locked with the auditory stimulus and displayed on a touchscreen monitor. The child is 

asked to identify which interval was “different” and responds via touchscreen display. We include auditory and 

visual feedback throughout the experiment with the goal of maintaining the child’s interest in the task. We have 

experience administering and interpreting these tasks in this age range as discussed in Preliminary Studies. 

No prior study has described longitudinal auditory function for spectral, temporal, or spectrotemporal resolution 

in pediatric CI users in this age range within the context of an intervention-based RCT. 

Speech Recognition. We will assess speech recognition in each CI ear alone as well as the bilateral 

aided condition (bilateral CI or CI plus contralateral hearing aid) including monosyllabic words, non-words, as 

well as sentences in quiet and co-located noise (+5 dB SNR) with speech presented at 60 dB SPL in quiet and 

65 dB SPL in noise. We will use CNC (106) monosyllables, non-word repetition tasks (114,133), BabyBio 

sentences (107) presented in quiet and at +5 dB SNR, as well as the BKB-SIN test (108). We will also obtain 

adaptive speech receptive threshold for HINT sentences (134) presented at 0 degrees with semi-diffuse 

noise originating from 45 to 315 degrees as described in our previous publications (1,2). The semi-diffuse 

noise will be fixed at 72 dB SPL [typical restaurant noise level (135,136)] and the HINT sentences will be 

varied adaptively to yield 50% correct. CNC, BabyBio, and BKB-SIN are all recommended by the Pediatric 

Minimum Speech Test Battery (3) and thus hold high clinical relevance. Further, all measures have a sufficient 

number of lists allowing for longitudinal administration without repetition. We chose an SNR of +5 dB for fixed 

SNR assessment given that children aged 6-12 years spend ~80% of their day in noise including classrooms, 

school cafeterias, and playgrounds (137) and +5 dB is representative of the mean SNR encountered in 

everyday environments for elementary school-aged children (114-117). The additional measure of non-word 

repetition should be more sensitive to manipulations of IGCIP spatial selectivity and subsequent spectral 

resolution as non-words do not hold lexical meaning (114,139). Despite the ubiquity of the speech recognition 

measures, there are no published data documenting the longitudinal performance trajectory for these 

measures of speech recognition and thus these data offer high clinical value. 

We will use a SmartPhone app to assess word recognition at the baseline and 12-month visits via 

Bluetooth or direct audio input. One month following baseline and 12-month visits, a caregiver will readminister this test at home. In the event that word recognition has significantly declined relative to the 

immediately preceding visit—using 95% confidence intervals for test-retest variability of word tasks (140)—we 

will offer the option of returning the child to her previous CI map or giving an additional month with follow-up at 

the next scheduled appointment (at either 2 months or 14 months, per Table 3). Neither participant nor 

experimenter will not know whether the child is in the immediate IGCIP or waitlist deferred group. Should the 

child be withdrawn from the study due to negative outcomes, this will require that we break the blind for a given 

participant (see Data Safety and Monitoring Plan); however, we would continue to study auditory, speech, PA, 

language, and reading outcomes over a 2-year period for this child. This will allow us to investigate underlying 

mechanisms responsible for those that are IGCIP responsive (estimated at over 75% of enrolled participants) 

compared to non-responders—an important research question for clinical translation of this technology. 

Subjective questionnaires (Auditory Skills & Quality of Life). We will obtain subjective reports of 

auditory skills as well as overall quality of life for our pediatric participants using validated questionnaires: 

Auditory Skills Checklist [ASC (141)], Parents’ Evaluation of Aural/oral performance of Children [PEACH 

(142)], and Pediatric Quality of Life Inventory [PedsQL 4.0, (143)]. 

Language Ability. Language ability will be measured at two levels: expressive and receptive. 

Additionally, estimates of each domain will have multiple measures including vocabulary, morphology, and 

syntax. Receptive language abilities will be measured using the Receptive One-Word Picture Vocabulary TestContact PD/PI: Gifford, Rene H Research Strategy

 

 

all 

of 

an 

as 

 Page 106
4 [ROWPVT-4 (144)], Peabody Picture Vocabulary Test-4 [PPVT-4 (145)], and the TACL-4 (146) which 

includes separate subscale scores for vocabulary, morphology, and elaborated sentences. The receptive 

composite of the Clinical Evaluation of Language Fundamentals-4 [CELF-4 (147)] will also be administered to 

all participants. Expressive language will be measured using the Expressive One-Word Picture Vocabulary 

Test-4 [EOWPVT (148)], the Structured Photographic Expressive Language Test-3 [SPELT (149)], and the 

expressive composite on the CELF-4 (147). 

Speech production (standardized assessment and acoustic analyses). Because children with 

hearing loss potentially display clinical speech disorders as well as subclinical speech alterations that can be 

detected only within the context of acoustic analysis, we will complete both standardized clinical measures and 

acoustic analyses. Traditionally speaking, due to the large amount of time spent on hand-analyses of speech 

production, a single dependent acoustic measure is chosen ‘a priori’. This is often performed on a normreferenced test of articulation such as the GFTA-3 (150), which we plan to administer; however, we will also 

supplement the GFTA-3 with acoustic analyses of speech samples obtained at each visit. The value of an 

objective speech acoustic analysis is that a very large number of measures can be computed with no 

subjective input thereby allowing us to investigate acoustic measures, or clusters of acoustic measures, that 

are related to the independent variable, i.e. implementation of IGCIP. We audio record the administration of the 

Renfrew bus story (151) as well as asking the child to repeat the Ling 6 sounds and “Twinkle Twinkle Little 

Star”. We will obtain these speech samples at baseline and all subsequent study visits (Table 3). We will use 

Aural Analytics software (152) to obtain automated measures of 1) vocal quality (i.e. harmonic-to-noise ratio), 

2) pitch (F0: mean, stdev, range), 3) articulatory control [articulatory entropy (153)]; the envelope modulation 

spectrum; formant frequencies for consonants and vowels, vowel space; long-term average spectrum; 

speaking rate), and, 4) nasality (energy < 500 Hz). The algorithm for measuring articulation precision was 

calibrated using over 1000 hours of native English speech for adults and children and used to generate a 

normative distribution. In addition, we will manually investigate: a) differentiation between voiceless 

postalveolar affricates /ch/ and voiceless alveolar stop /t/—looking at peak amplitude and spectral mean of the 

fricative portions, b) differentiation of alveolar and postalveolar voiceless fricatives (/s/ vs /sh/), c) whole-word 

variability, and d) presence of atypical error patterns. 

Nonverbal assessment of cognition. Nonverbal cognition will be assessed using the 3rd edition of the 

Leiter International Performance Scale [Leiter-3 (154)]. This is a standardized nonverbal estimate of cognitive 

abilities and was successfully administered with the participants in our pilot studies. All participants must 

exhibit nonverbal cognitive abilities within the typical range for inclusion. Should we identify a child exhibiting 

nonverbal cognitive abilities below the age-normative cutoff, we will refer to the developmental psychologist on 

the Vanderbilt CI Team. 

Working Memory. Three tasks will be used: 1) Numbers Reversed from the Woodcock-Johnson IV 

(155) is a traditional test of memory span in which the child hears progressively longer strings of numbers and 

recalls in backwards order. Numbers will be audiorecorded with calibration and normalization of level (in dB 

SPL) for standardized auditory presentation across all participants and visits. Children will be asked to repeat 

each number prior to testing to ensure accurate recognition. 2) A serial recall task will be used to assess one’s 

ability to use phonological structure to store words in a working memory buffer. This task has been used 

frequently, including pediatric CI users (75,76). The child sits in front of a touchscreen monitor and hears a 

string of 6 non-rhyming consonant-vowel-consonant, high-frequency nouns. After presentation, pictures of the 

6 items appear on the display and the child is asked to touch the pictures in the order heard. The same 6 

words are used across all trials and word recognition is confirmed both before and after testing. The serial 

recall task is used as it is more sensitive to phonological coding than free recall (156). 3) A visual-spatial task 

will be used, to assess working memory in the absence of verbal material. In this task, the touchscreen monitor 

is divided into 6 squares, and squares illuminate one at a time. The child is asked to tap on the squares in the 

order recalled. Reasons for using all three tasks of working memory are as follows: 1) The 1st task is a 

standardized task and will provide standardized scores that can be interpreted according to age norms and 

provide W scores, which are weighted raw scores that yield an estimate of ability level independent of age. 2) 

The 2nd task will assess children’s abilities to use phonological structure in service to verbal working memory. 

Research has shown this task to be especially sensitive to differences in verbal working memory between 

children with NH who have typical language abilities and either children with CIs (referenced above) or children 

with NH, but phonological deficits (157). 3) The 3rd task will assess whether the participants have working 

memory deficits extending beyond simple verbal material. 

PA. As with speech and working memory, we include standardized measures of PA as well as 

additional in-depth measures (developed in consultation with Dr. Nittrouer). PA is defined as the ability to 

Contact PD/PI: Gifford, Rene H Research Strategy

 

 Page 107
Contact PD/Pl: Gifford, Rene H 

segment, discriminate, and operate on phonological units [speech sounds; see (158)]. The Comprehensive 

Test Of Phonological Processing [CToPP-2 (159)] is a norm-referenced and widely used standardized 

assessment of this ability and in our preliminary study of PA in children with hearing loss (94). To obtain 

multiple standardized estimates of PA, we will also administer the Test of Auditory Processing Skills [TAPS-3 

(160)]. Both of these tests have been used extensively in previous studies of PA including several with children 

with Cls (161 ). In addition, Nittrouer and colleagues have developed an individualized set of tasks designed to 

provide an in-depth assessment of PA (8). They have argued that in parallel to subclinical alterations in speech 

production, specific aspects of PA may also illuminate the relationship between impoverished and/or altered 

access to the auditory Cl signal and key aspects of PA. Because of this, in addition to the CToPP and the 

TAPS, we will also be administering the PA battery designed and studied in detail by Nittrouer including: Nonword Repetition, Initial Consonant Discrimination (Same-Different), Initial Consonant Choice, Final Consonant 

Choice, Phoneme Deletion, and Backwards Words (21 ). Although many of these tasks are sub-items on the 

CToPP and/or the TAPS, the in-depth PA battery includes multiple items that are developmentally ordered in 

each of these domains so that we can 1) accurately identify functional level for each skill at intake and 2) have 

sufficient sensitivity to capture short-term growth on one or more of these skills. Because there has been 

considerable variability in the relationships between speech recognition and PA in this population, we 

hypothesize that the IGCIP data will yield insight into the relationship between speech recognition, PA, and 

reading ability as well as receptive language with a specific focus on bootstrapping of PA. 

Reading Ability. Reading ability includes two key factors, decoding and reading comprehension (162); 

we will obtain multiple measures of each of these factors. Standardized tests include the Woodcock Reading 

Mastery Tests [WRMTTM-11 1 (163)] and the Gray Oral Reading Test-5 [GORT-5 (164)]. Both instruments have 

been widely used with typically developing children and children with disabilities and, as with PA, have been 

applied to children with hearing loss in several studies. The WRMTTM-111 includes decoding assessments (e.g., 

letter word identification) and assessment of reading comprehension (e.g., Passage comprehension). Similarly, 

the GORT-5 includes estimates of decoding and reading comprehension including reading vocabulary 

rehension and assa e com rehension. 

Scientific Rigor and Reproducibility and Data Management. Dr. Dietrich (Co-I and biostatistician) will 

provide support for statistical analyses. All data will be stored in REDCap offering a secure, web-based 

application. All data analyses and data sharing will adhere to the NIH's commitment to rigorous and 

transparent research. This will be accomplished through the analytic approach described here, which 

replicates our previous analytical approaches used for studies of adult IGCIP (24,71) and our preliminary study 

of pediatric IGCIP (4). To achieve transparency, methodological details and raw data will be provided in our 

publications (data via sharing and/or supplements) that allow other research teams to reproduce the results. 

Statistical Analysis. Statistical software (SPSS, STATA, R) will be used for the quantitative 

summarization of data and to test study hypotheses. The reliability of each of the scores from the standardized 

measures will be assessed and evaluated using Cronbach's alpha statistics. All analyses will be done using 

intent-to-treat principles. Statistical significance tests will maintain Type I error rates of no more than 0.05. 

Descriptive statistics will summarize and inspect the distributions of study measures for choosing the 

appropriate modeling procedure for testing hypotheses. See Statistical Analysis Plan and Power Analyses for a 

tabular summary of aims, hypotheses, and associated statistical models. 

Missing data. Randomly missing responses to items within assessment tools will be handled via 

protocols specified by the instrument developers. When there is no protocol, if the participant has completed 

75% or more of the items on a particular instrument, the mean score for that instrument will be calculated using 

available item responses and used in subsequent analyses. In-depth investigations of patterns of missing data 

will be undertaken to assess if data are missing due to random influences or if there are certain study 

conditions (e.g. waitlist control) or participant characteristics (e.g., age, hearing function) that are more or less 

likely to be associated with certain patterns of missing data (i.e. lost to follow-up). We expect that most 

assessments will not be missing at random, thus imputation would not be required. 

Aim 1 and Aim 2: Analysis & hypotheses testing: The outcome variables are auditory, speech 

recognition, PA, and reading gains over various time points (Table 3). Descriptive and graphical summaries of 

trajectories by study group will be conducted initially for detection of outliers and to provide insight into patterns 

of change. Key statistical tests will involve study group (immediate IGCIP vs. waitlist control) comparisons of 

the mean slopes resulting from differences in baseline and post-intervention assessments. Tests will be 

conducted using general linear mixed or multilevel analysis. While randomization ensures equal opportunity for 

Page 108 

Research Strategy 
Contact PD/Pl: Gifford, Rene H 

study conditions, it does not ensure equivalence of baseline values. To control for differences in opportunity for 

change from basel ine and known impact of working memory, the respective measure baseline speech 

recognition and working memory will be included as covariates in the analysis. Within this general multilevel 

statistical approach, hypothesized differences will be tested by assessing the statistical significance of the main 

and interaction effects of study group on time-related contrast in baseline and post-baseline assessment points 

in the outcome variable scores. In other words, we expect that the slope of outcome measure scores in the 

waitlist control group will be nearly '0' while those of immediate IGCIP group will demonstrate a statistically 

significant positive slope. In addition to statistical significance testing, bootstrapping methods will be used to 

generate 95% confidence intervals for all sample descriptive (e.g., group means at each assessment) and 

effect estimates (e.g., r,2 for group effect on linear slope of outcome scores). Because we expect there to be 

correlations amongst the multiple outcome measures, a multivariate approach will provide more unified 

(systemic) statistical test of the intervention effects. 

Aim 3: Analysis and hypothesis testing: We will explore the complex relationships amongst changes 

in the various measures of hearing, speech, and language. Figure 7 displays an example cross-lagged panel 

~ ~ analysis which illustrates the structure for statistical analysis of this 

12-Months 

aim. Analyses comparing the strength of the relationships between Phonological 

Speech Rec awareness the changes in one domain from basel ine to 6-months with the 

changes in another domain from 6-months to 12-months will Baseline !GOP 

Receptivelang maximize the information gained from the longitudinal assessment Auditory 

/ Function l of the multiple domains and enable us to draw some tentative 

Reading causal hypotheses for subsequent research. Bootstrapped 95% comprehensJon Baseline reading confidence intervals will be generated for each of the path comprehenslon Figure 7: Lagged path-analysis model 

coefficients. For all statistical analyses, we will allow for covariates 

associated with the child and family including chronological age at assessment, age at implantation, age at 

identification, working memory, nonverbal cognition, gender, and socioeconomic status (6, 11,97,98). 

Sample size and power. Sample size estimates are based on the desire to detect cl inically meaningful 

effects of the intervention using information from our preliminary studies while maintaining study feasibility. An 

analysis sample of 30 participants per study group will provide 80% statistical power (two-sided a=0.05) for the 

detection of an intervention effect on the trajectories of the hearing, speech, language, PA and reading as 

small as 0.32 (Cohen's d equivalent=0.67, adjusted for basel ine with 17 2 ::::0.2) and 0.35 (Cohen's d equivalent 

=0.74, unadjusted). Differences of this magnitude are considered to be clinically meaningful. Furthermore, the 

statistical power estimates are conservative due to the proposed used of mixed-effects analyses that will 

enable the increased power of treating the repeated assessments as independent values yet appropriately 

adjusting the standard errors for the correlations among those repeated assessments. The proposed final 

sample of 60 will enable detection of a path correlation as small as 0.35 (80% power, 2-tailed a=0.05). 

Correlational values of that magnitude or larger were observed in our preliminary work. Detectable differences 

between the strength of two path coefficients will be 0.4-0.5 (80% power, 2-tailed a=0.05) depending on the 

value of the coefficients and the size each correlation has with other values. The focus of the cross-lagged 

panel analysis will be on generating effect sizes deepening our understanding of the mechanisms underlying 

effects of change in hearing on higher-level PA/speech/language downstream. Accounting for 20% attrition, we 

will enroll 72 atients to achieve a 60-sub·ect sam le. 

We anticipate that some participants will not complete all assessments at all time points, so that there 

will be incomplete data for some participants; we will employ statistical bootstrapping to handle missing data. 

We also anticipate that our personal ized IGCIP plan could be identical to the clinical programming plan. This 

outcome is unlikely, (occurring in 5 cases out of over 200 participants thus far). If this occurs, the participant 

will be withdrawn from the study by the Pis because there would thus be no IGCIP "intervention" to investigate. 

It is also possible that we may find that the IGCIP method does not yield measureable improvement for a given 

participant or may even yield a decrement in performance. Based on our extensive experience working with 

this population, we have found that should a decrement in performance be observed, we will restore the 

patient's previous clinical settings and observe a return-to-basel ine performance; additionally, we intend to 

assess word recognition 1 month following both potential intervention time points (1 month and 13 months) 

from home via SmartPhone to monitor for this possibility. Based on our prel iminary data, only 7% of 

participants exhibited a short-term decrement in word recognition in the Cl ear and none exhibited significant 

decrement in the bilaterally aided condition (i.e. bilateral Cl or Cl plus contralateral hearing aid). 

Page 109 

Research Strategy 
PHS Human Subjects and Clinical Trials Information OMB Number: 0925-0001 and 0925-0002

Expiration Date: 03/31/2020

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Are Human Subjects Involved ● Yes ❍ No 

Is the Project Exempt from Federal regulations? ❍ Yes ● No 

Exemption Number ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5 ❏ 6 ❏ 7 ❏ 8 

Other Requested Information 

Contact PD/PI: Gifford, Rene H Page 110
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Human Subject Studies 

Study# Study Title Clinical Trial? 

Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and Literacy Yes 

Contact PD/PI: Gifford, Rene H 

1 

 Page 111
OMB Number: 0925-0001 and 0925-0002

Expiration Date: 03/31/2020

Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Section 1 - Basic Information (Study 1) 

1.1. Study Title * 

Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and Literacy 

1.2. Is this study exempt from Federal 

Regulations * ❍ Yes ● No 

1.3. Exemption Number ❏ 1 ❏ 2 ❏ 3 ❏ 4 ❏ 5 ❏ 6 ❏ 7 ❏ 8 

1.4. Clinical Trial Questionnaire * 

1.4.a. Does the study involve human participants? ● Yes ❍ No 

1.4.b. Are the participants prospectively assigned to an intervention? ● Yes ❍ No 

1.4.c. Is the study designed to evaluate the effect of the intervention on the 

participants? ● Yes ❍ No 

1.4.d. Is the effect that will be evaluated a health-related biomedical or 

behavioral outcome? ● Yes ❍ No 

1.5. Provide the ClinicalTrials.gov Identifier (e.g. 

NCT87654321) for this trial, if applicable 

Contact PD/PI: Gifford, Rene H Page 112
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Section 2 - Study Population Characteristics (Study 1) 

2.1. Conditions or Focus of Study

❍ Image-Guided Cochlear Implant Programming (IGCIP)

2.2. Eligibility Criteria

Inclusion Criteria

1. children aged 6 to 12 years of age

2. prelingual onset of deafness 

3. at least one CI and bilateral moderate to profound sensorineural hearing loss 

 o for children with a single CI, audiometric thresholds in the non-CI ear must be consistent with at least a moderate to

 profound sensorineural hearing loss

4. cochlear implantation prior to 3 years of age 

5. nonverbal cognitive abilities within the typical range

6. no confounding diagnosis such as autism spectrum disorder, neurological disorder, or general cognitive impairment

7. pre-operative CT scan of head performed as standard of care CI work-up

8. post-operative CT scan--obtained either before enrollment (per VUMC CI program standard of care) or after informed

 consent

Exclusion Criteria:

1. severe anatomical abnormality(s) of the temporal bone.

2. onset of moderate-to-profound sensorineural hearing loss after 2 years of age

3. nonverbal intelligence standard score < 85

2.3. Age Limits Min Age: 6 Years Max Age: 12 Years

2.4. Inclusion of Women, Minorities, and Children S1-1_InclusionOfWomenAndMinorities.pdf

2.5. Recruitment and Retention Plan S1-1_RecruitmentAndRetentionPlan.pdf

2.6. Recruitment Status Not yet recruiting

2.7. Study Timeline S1-1_StudyTimeline.pdf

2.8. Enrollment of First Subject 11/01/2018 Anticipated

Contact PD/PI: Gifford, Rene H Page 113
INCLUSION OF WOMEN, MINORITIES AND CHILDREN 

Women 

No subject will be excluded from participation due to gender or race. The investigators will be blind to race and 

ethnicity of participants prior to enrollment. Since all patients aged 6 to 12 years with bilateral sensorineural 

hearing loss and at least one cochlear implant will be targeted for recruitment. No data exist regarding 

demographics of pediatric cochlear implant (CI) candidates making it difficult to anticipate the ethnic 

composition of this study. However, based on participation demographics of previous studies an equal mix of 

male and females is likely. 

Minorities 

stated in the Human Subjects and Approach sections of this application, we will post IRB approved 

recruitment fliers in the waiting room of the VUMC Audiology and ENT clinics as well as in the adult CI 

programming rooms to recruit experienced adult participants. Every effort will be made to recruit minorities 

for participation. To facilitate this, we will make use of the Vanderbilt Kennedy Center’s Core Research 

Support Services for assistance with participant recruitment. This core is supported by NICHD Grant P30 

HD15052 to the Vanderbilt Kennedy Center for Research on Human Development. This core service provides 

investigators with access to databases for recruitment purposes, and easy access to large scale, statewide, 

linked administrative databases on demographics and health related variables (e.g., birth death, marriage, 

hospital discharge) for pilot testing and research purposes. 

The attached Targeted/Planned Enrollment Form reflects data obtained from the Vanderbilt University CI lab 

database of implant recipients for whom we have documented ethnic and racial categories. As previously 

mentioned, there are no published studies documenting the demographics of pediatric cochlear implant 

candidates which makes the task of ensuring adequate representation of ethnic and racial categories difficult. 

However, based on the limited data we have in the VUMC CI program database of pediatric implant recipients 

as well as a recently published paper describing racial and ethnic composition of our adult CI candidates at 

Vanderbilt [Holder JT, Reynolds SM, Sunderhaus LW, Gifford RH (2018). Current Profile of Adults Presenting 

Preoperative Cochlear Implant Evaluation. Trends Hear, 22: 1 16], we expect that the ethnic and racial 

diversity of the recruited participants for this study to be different from that of the greater Nashville metropolitan 

areas. Thus the Targeted/Planned Enrollment Form reflects our expected enrollment with respect to ethnic 

and racial diversity. 

Children 

The participants involved in this proposed research are children, ranging in age from 6 to 12 years at the time 

testing. All children will have at least one cochlear implant and bilateral sensorineural hearing loss. This age 

range has been chosen based on our preliminary studies as children in this age range will be able to complete 

all proposed auditory, speech, language, and literacy assessments, as well as the subjective reports of 

listening behaviors and overall quality of life. 

he PIs, Drs. Gifford and Camarata, are an audiologist and speech language pathologist, respectively. Both 

PIs have decades of experience working with children in both clinical and research settings. The Cochlear 

Implant Research Laboratory and the Developmental Disabilities Laboratory are both well equipped and 

designed to accommodate pediatric research participants and their families. 

Contact PD/PI: Gifford, Rene H Inclusion of Women, Minorities, and Children Page 114

 

 

 

 

 

 

 

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RECRUITMENT AND RETENTION PLAN 

Patients will be recruited from the CI program at Vanderbilt University Medical Center, one of the largest 

programs in the United States, with an average of 250 CI recipients annually (65% adult) and over 3000 

recipients since inception in 1996. Over the duration of the study, We anticipate enrollment of 72 study 

participants to achieve our target sample size of 60 completed participants (30 in each group). Each year we 

implant approximately 60 pediatric CI patients. An analysis of all pediatric CI recipients implanted at Vanderbilt 

University Medical Center from January 2011 through December 2017 revealed that we have 206 pediatric CI 

recipients aged 6 to 12 years of age with prelingual onset of bilateral moderate to profound sensorineural 

hearing loss, who were younger than 3 years of age at implantation. However, there are multiple additional 

prospective participants who will reach the age-related criteria over the course of the project. Informed consent 

and assent will take place as per our institution’s IRB policies and be obtained by the PIs, co-Is, and/or other 

appropriately trained member of the research team using an IRB-approved consent form. Retention will be 

promoted by providing the parents and children with detailed information regarding their performance on 

various tasks of auditory processing, speech recognition, speech production, language, and literacy. Following 

each study visit, we will compile a report of each child’s performance to be mailed to the child’s home address 

file. Study participation will provide value-added information regarding a variety of auditory, speech, 

language, and literacy tasks that are not typically included in clinical appointments. 

Contact PD/PI: Gifford, Rene H Recruitment and Retention Plan 

on 

 Page 115
Contact PD/Pl: Gifford, Rene H 

STUDY TIMELINE 

Both study groups will be monitored for 24 months, with testing at time 1 (baseline), time 2 (2 month), time 3 (6 

month), and time 4 (12 month). At the 12-month visit, the deferred treatment group will receive the IGCIP 

intervention. Testing will then continue for both groups including time 5 (14 month), time 6 (18 month), and 

time 7 (24 month). At the conclusion of the project, we will have 12 months of data on untreated growth for the 

deferred group, 12 months of treated growth in the deferred treatment group, and 24 months of treated growth 

in the immediate intervention group. Detailed plans for the study timeline are provided in the table below. 

Year1 Year2 Year3 

• Hire and train full- . Ensure human subjects • Ensure human subjects 

time project 

manager 

(including RCR 

principles) 

• Enroll and train 

PhD student on 

methods, data 

collection, and 

RCR principles 

(ongoing 

instruction) 

• Purchase 

assessment 

materials 

• Verify study 

details posted to 

Months clinicaltrials.gov 1•

3 • Initial 

videoconferencing 

with consultants 

Drs. Nittrouer and 

Bunta 

• Active recruitment 

to enroll large 

number of 

participants in next 

3-month period 

• Obtain 

randomization 

schedule from Dr. 

Dietrich 

• 3 monthly project 

meetings will be 

held 

Months •Active summer 

4-6 enrollmentschool-aged 

children are on 

summer break 

(targeted 

recruitment and 

baseline 

assessment for~ 

12-14 participants 

by the end of 

month 6) 

•3 project meetings 

training and RCR annual training and RCR annual 

course is completed for course is completed for 

all study personnel all study personnel 

. Study visit 3 (6 months • Study visits 5-7 

post baseline) should be completed for all 

completed for all 

participants enrolled in 

Year 1, months 7-9 

•Study visit 4 ( 12 months 

post baseline) 

completed for ~ 7 

enrolled participants 

participants enrolled & 

consented in year 1 

• Study visit 3 (6 months 

post baseline) should be 

completed for all 

participants enrolled in 

Year 2, months 7-9 

from Year 1, months 4-6. Study visit 4 (12 months 

,Active recruitment for 

enrollment in the next 3-

month period 

. 3 monthly project 

meetings will be held 

•Drs. Nittrouer and Bunta 

will visit Vanderbilt 

meeting with all study 

personnel 

•Active summer 

recruitment-schoolaged children are on 

summer break (targeted 

recruitment and baseline 

assessment for~ 12-14 

participants by the end 

of month 6) 

•Study visit 4 (1 2 months 

post baseline) 

completed for ~ 7 

enrolled participants 

from Year 1 months 7-9 

•3 project meetings 

post baseline) completed 

for~ 7 enrolled 

participants from Year 2 

months 4-6 

• Active recruitment for 

enrollment in the next 3-

month period 

• Drs. Nittrouer and Bunta 

will visit Vanderbilt 

meeting with all study 

personnel 

• 3 project meetings 

• Initial manuscript 

preparation commences 

describing spectral, 

temporal and 

spectrotemporal 

processing 

•Active summer 

recruitment (targeted 

recruitment and baseline 

assessment for~ 12-14 

participants by the end of 

month 6) 

•Study visit 4 ( 12 months 

post baseline) completed 

for~ 7 enrolled 

participants from Year 2 

months 7-9 

• Study visits 5 (14 

months), 6 (18 months) 

and 7 (24 months) 

completed for all 

participants enrolled in 

year 1, months 4-6 

Year4 Year 5 

• Ensure human subjects • Ensure human subjects 

training and RCR training and RCR 

annual course is annual course is 

completed for all study completed for all study 

personnel personnel 

• Study visits 5-7 • Study visit 4 ( 12 

completed for all months post baseline) 

participants enrolled in completed for all 

years 1 & 2 and half of enrolled participants 

the participants enrolled from Year 

in year 3 3 

• Study visit 3 (6 months • Study visits 5-7 

post baseline) should completed for all 

be completed for all participants enrolled in 

participants enrolled in years 1-2 and 1⁄2 

Year 3, months 7-9 participants enrolled in 

• Study visit 4 (12 year 3 

months post baseline) • Attend and present at 

completed for~ 7 HEAL 2022 

enrolled participants • 3 project meetings 

from Year 3 months 4-6 

• 3 monthly project 

meetings 

• Videoconferencing with 

consultants Drs. 

Nittrouer and Bunta 

• Manuscript submitted 

describing relationship 

between auditory 

perception and speech, 

language, and literacy 

•Study visit 4 (1 2 months• Study visit 4 (12 

post baseline) will be months post baseline) 

completed for ~ 7 completed for ~ 7 

enrolled participants enrolled participants 

from Year 3 months 7-9 from Year 4 months 7-9 

• Verify that study visit 4 

(12 months post 

baseline) is completed 

for all enrolled 

participants from Year 

3 months 4-6 

• 3 project meetings 

• Attend & present at 

SRCD 2022 

Page 116 

Study Timeline 
Contact PD/Pl: Gifford, Rene H 

• 3 project meetings 

• Attend and present at 

CIAP 2021 

• Study visit data • Study visit data • Study visit data obtained • Attend & present at • Attend & present at 

obtained from obtained from home from home administration ASHA 2022 ASHA2023 

home administration of of SmartPhone app 1 • Study visits 5 (14 • Study visits 5-7 will 

administra months), 6 (18 months) tion of SmartPhone app 1 month following baseline have been completed 

SmartPhone app 1 month following baseline and 2-month visits will be and 7 (24 months) will for all participants 

month following and 2-month completed for all be completed for all enrolled in years 1-3 

baseline and visits will be completed participants enrolled in participants enrolled in • Upon completion of 

2month visits will for all participants Year 3, months 4-6 year 2, months 7-9 visit 7 for the last 

be completed for enrolled in Year 2, • Attend & present at • Study visit 4 (12 enrolled participant, the 

all enrolled months 4-6 ASHA2021 months) will be data will be unblinded 

participants to date • Attend & present at • Enroll ~10 new completed for all allowing for the majority 

• Attend ASHA ASHA2020 participants (winter break) enrolled participants of the statistical 

2019 from Year 3 months 4-6 • Enroll ~5-6 new • Study visits 5 (14 analyses to be 

Months • Enroll ~5-6 new participants (winter months), 6 (18 months) and 1⁄2 participants completed 

7.9 participants break) enrolled in Year 3 and 7 (24 months) • Active data analysis on 

(winter break) months 7-9 • Blinded data will be completed for all unblended dataset • 3 project meetings analyzed and abstract participants enrolled in • 3 project meetings • Manuscript preparation 

prepared for submission year 1, months 7-9 on unblinded datasets 

for • Blinded data will be spanning all aims and 

American Auditory analyzed and abstract experiments 

Society (AAS) prepared for submission • 3 project meetings 2021 as well as for American Cochlear 

Conference on Implant Alliance 

Implantable Auditory (ACIA) 2022, Hearing Prostheses (CIAP) 2021 Across the • 3 monthly project Lifespan (HEAL) 2022, meetings will be held and SRCD 

•3 project meetings 

Months • Verify study visit 3 • Verify study visit 3 (6 • Verify that study visit 3 (6 • Study visit 4 (12 • Active data analysis on 

10-12 (6 months post months post baseline) is months post baseline) is months post baseline) unblinded dataset 

baseline) is completed for all completed for all enrolled completed for 1⁄2 of • Manuscript preparation 

completed for all enrolled participants participants from months enrolled participants on unblinded datasets 

enrolled from from months 1-6, Year 2 1-6 in Year 3 from Year 3, months 7-9 spanning all aims and 

months 1-6, Year 1. Study visit 4 (1 2 months• Study visit 4 (12 months • Verify that study visits 5 experiments 

• Study visit 4 (1 2 post baseline) post baseline) scheduled (14 months), 6 (1 8 • Preparation of Project 

months post completed for 1⁄2 of or completed for 1⁄2 of months) and 7 (24 RPPR 

baseline) enrolled participants enrolled participants from months) are completed • NOTE: Given the 

scheduled or from Year 2, months 4-6 Year 3, months 4-6 (n = for all participants longitudinal nature of 

completed for 1⁄2 of (n = 7) 7) enrolled through year 2, this double-blinded 

enrolled • Study data obtained • Study data obtained from months 1-12 RCT, we anticipate 

participants (n = 7) from home home administration of • 3 project meetings requesting a no-cost 

• Study data administration of SmartPhone app 1 month • Preparation of Year 4 extension year to fully 

obtained from SmartPhone app 1 following baseline and 2- RPPR complete data 

home month following baseline month visits will be dissemination via peeradministration of and 2-month completed for participants reviewed manuscript submissions and 

SmartPhone app 1 visits will be completed enrolled in Year 3, presentation of 

month following for participants enrolled months 7-9 unblinded data 

baseline and 2- in Year 2, months 7-9 • 3 project meetings 

month visits will be • Blinded data will be • Preparation of Year 3 

completed for analyzed and abstract RPPR 

participants will be developed and 

enrolled in months submitted for ASHA 

7-9 2021 on longitudinal 

• Blinded data will auditory perceptual data 

be analyzed and • Attend and present at 

abstract will be AAS 2021 

developed and 

Page 117 

Study Timeline 
Contact PD/Pl: Gifford, Rene H 

submitted for • 3 monthly project 

ASHA 2020 on meetings 

longitudinal • Preparation of Year 2 

auditory perceptual RPPR 

data 

• 3 project meetings 

• Preparation of 

Year 1 RPPR 

Page 118 

Study Timeline 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Inclusion Enrollment Reports 

IER ID# Enrollment Location Type Enrollment Location

Study 1, IER 1 Domestic

Contact PD/PI: Gifford, Rene H Page 119
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

Inclusion Enrollment Report 1 

Using an Existing Dataset or Resource* : ❍ Yes ● No 

Enrollment Location Type* : ● Domestic ❍ Foreign 

Enrollment Country(ies): USA: UNITED STATES

Enrollment Location(s): 

Comments: Estimated total enrollment over 5 year study. We anticipate enrollment of 72 study participants

 to achieve our target goal of 60 completed participants (30 in each group). The numbers shown

 below are for all 72 enrolled participants.

Planned 

Racial Categories 

Ethnic Categories 

Not Hispanic or Latino 

Female Male 

Hispanic or Latino 

Female Male 

Total 

American Indian/ 

Alaska Native 0 0 0 0 0 

Asian 2 2 0 0 4 

Native Hawaiian or 

Other Pacific Islander 0 0 0 0 0 

Black or African 

American 3 3 0 0 6 

White 27 27 2 3 59 

More than One Race 2 1 0 0 3 

Total 34 33 2 3 72 

Cumulative (Actual) 

Racial Categories 

Ethnic Categories 

Not Hispanic or Latino 

Female Male 

Unknown/ 

Not 

Reported 

Hispanic or Latino 

Female Male 

Unknown/ 

Not 

Reported 

Unknown/Not 

Reported Ethnicity 

Female Male 

Unknown/ 

Not 

Reported 

Total 

American Indian/ 

Alaska Native 0 0 0 0 0 0 0 0 0 0 

Asian 0 0 0 0 0 0 0 0 0 0 

Native Hawaiian or 

Other Pacific Islander 0 0 0 0 0 0 0 0 0 0 

Black or African 

American 0 0 0 0 0 0 0 0 0 0 

White 0 0 0 0 0 0 0 0 0 0 

More than One Race 0 0 0 0 0 0 0 0 0 0 

Unknown or 

Not Reported 0 0 0 0 0 0 0 0 0 0 

Total 0 0 0 0 0 0 0 0 0 0 

Contact PD/PI: Gifford, Rene H Page 120 2018-08-16T11:14:30.000-04:00 
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Section 3 - Protection and Monitoring Plans (Study 1) 

3.1. Protection of Human Subjects S1-1_ProtectionOfHumanSubjects.pdf

3.2. Is this a multi-site study that will use the same protocol to

conduct non-exempt human subjects research at more than one

domestic site?

❍ Yes ● No ❍ N/A 

If yes, describe the single IRB plan 

3.3. Data and Safety Monitoring Plan S1-1_DataSafetyMonitoringPlan.pdf

3.4. Will a Data and Safety Monitoring Board be appointed for

this study?

❍ Yes ● No 

3.5. Overall structure of the study team S1-1_StudyTeamStructure.pdf

Contact PD/PI: Gifford, Rene H Page 121
PROTECTION OF HUMAN SUBJECTS 

Risks to Human Subjects 

Human Subjects Involvement, Characteristics, and Design 

We anticipate enrollment of 72 study participants to achieve our target goal of 60 completed participants (30 

in each group). 

The following inclusion and exclusion criteria will be used: 

Inclusion Criteria: 

• children aged 6 to 12 years of age 

• prelingual onset of deafness 

• at least one CI and bilateral moderate to profound sensorineural hearing loss 

o for children with a single CI, audiometric thresholds in the non CI ear must be 

consistent with at least a moderate to profound sensorineural hearing loss 

• cochlear implantation prior to 3 years of age 

• nonverbal cognitive abilities within the typical range 

• no confounding diagnosis such as autism spectrum disorder, neurological disorder, or 

general cognitive impairment 

• pre operative CT scan of head performed as standard of care preoperative CI work up 

• post operative CT scan obtained either before enrollment (per VUMC CI program standard of 

care) or after informed consent, if implanted elsewhere. Note that if an outside implanted 

participant is recruited for study participation, Co I Dr. Labadie has an active IRB approved 

study which will be linked to this study’s IRB application allowing for Xoran CT scanning 

of children aged 6 years and older. Six years of age is the youngest age for which this can 

be reliably completed given the need to sit completely still for 15 seconds. 

Exclusion Criteria: 

• severe anatomical abnormality(s) of the temporal bone (e.g., common cavity, cochlear 

ossification) 

• onset of moderate to profound sensorineural hearing loss after 2 years of age 

• nonverbal intelligence standard score < 85 

The study procedures that participants will undergo are provided in Research Strategy: Approach. 

Sources of Material 

Data collected will consist of the following fields: age at each test point, gender, age at implantation, age at 

hearing loss identification, nonverbal cognition, gender, maternal education, socioeconomic status, family 

size, preschool educational environment (i.e., mainstream preschool, parent infant program, listening and 

spoken language preschool), pre and post operative temporal bone CT scan (stored in centralized data repository), 

date of surgery, study group (blinded until study completion), device, electrode type (perimodiolar, lateral wall), angular 

insertion depth, date of post operative activation of CI, device wear time (via datalogging), as well as all 

data specified in the Approach. 

Research Strategy: Approach 

Data will not be individually identifiable but will be coded to mask participant identity with a master list kept 

by the PIs. Study data will be collected and managed using REDCap electronic data capture tools hosted at 

Vanderbilt. REDCap (Research Electronic Data Capture) is a secure, web based application designed to 

support data capture for research studies, providing: 1) an intuitive interface for validated data entry; 2) audit 

trails for tracking data manipulation and export procedures; 3) automated export procedures for seamless 

data downloads to common statistical packages; and 4) procedures for importing data from external sources. 

(Paul A. Harris, Robert Taylor, Robert Thielke, Jonathon Payne, Nathaniel Gonzalez, Jose G. Conde, 

Research electronic data capture (REDCap) A metadata driven methodology and workflow process for 

providing translational research informatics support, J Biomed Inform. 2009 Apr;42(2):377 81.) 

Contact PD/PI: Gifford, Rene H Protection of Human Subjects Page 122

 

 

 

 

 

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Potential Risks 

The investigation involves a new method of programming cochlear implants based on a comparison of pre 

and post operative CT scans. The risk to the patient is radiation exposure due to the postoperative CT scan; 

however, we complete postoperative scanning routinely for all CI recipients at VUMC (unless declined by 

the patient) given that the information gained by the scan and image processing has been determined by 

the Vanderbilt CI team to offer significant clinical value to the patient for CI programming optimization (e.g., 

identification of extracochlear electrodes, tip foldover). The other portions of the research namely 

deactivating CI electrodes are within the scope of practice of audiologists for CI programming and thus 

utilize CI clinical software that is FDA approved and regulated. Oversight for all study procedures will be 

rovided by the Vanderbilt’s Institutional Review Board and managed by the study PIs. 

Regarding radiation risk, Vanderbilt has both traditional multi slice CT scanners (MSCT) as 

well as flat panel volumetric computerized tomography (fpVCT) machines. All machines are 

FDA cleared for temporal bone CT scanning and undergo annual inspection from the 

Department of Radiology and Radiological Sciences, Division of Radiological Sciences per 

state regulations. Oversight will be provided by the Radiation Review Committee, part of 

Vanderbilt’s Human Research Protection Program.

Adequacy of Protection against Risks 

Recruitment and Informed Consent 

Patients will be recruited from the CI program at Vanderbilt University Medical Center, one of the largest 

programs in the United States, with an average of 250 CI recipients annually (65% adult) and over 3000 

recipients since inception in 1996. Over the duration of the study, We anticipate enrollment of 72 study 

participants to achieve our target sample size of 60 completed participants (30 in each group). Each year we 

implant approximately 60 to 80 pediatric CI patients. An analysis of all pediatric CI recipients implanted at 

Vanderbilt University Medical Center from January 2011 through December 2017 revealed that we have 251 

pediatric CI recipients aged 6 to 12 years of age with prelingual onset of bilateral moderate to profound 

sensorineural hearing loss, who were younger than 3 years of age at implantation. However, there are over 220 

additional prospective participants already being followed by our center who will reach the age inclusion criteria 

over the course of the project. Informed consent and assent will take place as per our institution’s IRB policies 

and be obtained by the PIs, co Is, and/or other appropriately trained member of the research team using an 

IRB approved consent form. 

Study retention will be promoted by providing the parents and children with detailed information regarding 

their performance on various tasks of auditory processing, speech recognition, speech production, language, 

and literacy. Following each study visit, we will compile a report of each child’s performance to be mailed to

the child’s home address on file. Study participation will provide value added information regarding a variety 

auditory, speech, language, and literacy tasks that are not typically included in clinical appointments. 

Protection Against Risk 

Patients will be closely followed for any adverse events related to the study through individual pre and 

post intervention visits. Any adverse events will be reported to the IRB according to each institution’s

olicy and procedures. 

The confidentiality of the patients will be assured through adherence to HIPAA guidelines. Results will be 

abulated in a digitally maintained database as follows: (a) Data will not be individually identifiable but will be 

coded to mask participant identity, (b) A master list will be kept by the PIs, (c) Hard copies of data sheets will 

be stored in locked offices, (d) Digital data will be stored on password protected computers, (e) Data will be 

kept for a minimum of 6 years after the research is complete, (f) Only research personnel will have access to 

the data. 

Data Safety Monitoring Plan. 

The PIs provide oversight of the study. The PIs will be responsible for recording and reporting adverse 

events to the IRB in a timely fashion according to institutional policies. To date, no adverse events have 

Contact PD/PI: Gifford, Rene H Protection of Human Subjects Page 123

 

 

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been recorded for the 41 pediatric CI participants in the preliminary study. We will continue to follow all 

regulatory requirements including timely reporting of adverse events to our IRB, careful adherence to strict 

inclusion/exclusion criteria, and at least annual reporting of progress. Given the primary risk of the study is 

drop in speech recognition abilities for the experimental ear, we anticipate that our IRB will deem this a 

minimal risk study (as it has our preliminary study) which does not require a Data Safety Monitoring Board 

(DSMB). Should the IRB request a DSMB we will organize such from investigators within the Vanderbilt 

community who have no association with either the current study and/or the PI and co I’s. To accomplish 

this, we will utilize Vanderbilt’s NIH funded Institute for Clinical and Translational Research. Additionally, our 

team will continue to meet at least monthly (as we currently do) to update patient enrollment and address any 

concerns brought up by participants and/or members of the research team. 

6.1.3 Potential Benefits of the Proposed Research to Human Subjects and Others 

The potential benefits of the research are to improve outcomes for pediatric CI recipients. Our goal is to gain a 

better understanding of underlying mechanisms driving speech understanding for pediatric CI recipients and to 

investigate the This is done by deactivating individual electrodes which, based on geometric position determined 

by CT scanning, are interfering with neighboring electrodes. Our preliminary data show statistically significant 

improvement in audiological and quality of life metrics in long term CI users. This study will investigate whether 

similar improvements are seen in a large group of pediatric CI recipients. 

Importance of the Knowledge to be Gained 

successful, IGCIP could becom e a preferred method of CI programming for pediatric CI recipients 

improving patient performance and satisfaction. Further, the knowledge of outcomes for children with CI on 

measures of speech understanding, speech production, language, and literacy at various time points with 

different audiologic intervention holds great empirical and as well as clinically translational relevance as 

these data are not widely available in the peer reviewed literature. 

Contact PD/PI: Gifford, Rene H Protection of Human Subjects Page 124

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Data Safety Monitoring Plan. To date, no adverse events have been recorded for the nearly 300 adult and 

pediatric study participants who have been enrolled in our preliminary studies, thus far. We propose to 

continue to follow all regulatory requirements including timely reporting of adverse events to our IRB (within 

10 days of the event), careful adherence to strict inclusion/exclusion criteria, and at least annual reporting of 

progress. Given the primary risk is radiation exposure secondary to the postoperative CT scan, we anticipate 

that our institutional review board (IRB) will deem this a minimal risk study (as it has with our preliminary 

studies) which does not require a Data Safety Monitoring Board (DSMB). In fact, all CI recipients at VUMC are 

already routinely scanned postoperatively because the CI clinical team has determined that the radiation risk 

relatively low (i.e. equivalent to a cross country airline flight) and the information to be gained is high for 

audiologic and otologic management of the CI recipient and optimization of CI programming. Because this 

project poses minimal risk and involves a single site, data and safety of the project will be monitored by the 

IRB at Vanderbilt University School of Medicine and the principal investigators of the project in conjunction 

with Dr. Labadie, who is an otologic surgeon in the VUMC CI program and Co I on this project. 

Prospective assignment of one or more human subjects. All participants will receive intervention; however, half 

the participants will be randomly assigned to immediate intervention and the other half will be assigned to 

the deferred intervention group using a waitlist control study design. Randomization to IGCIP or waitlist IGCIP 

will occur after written informed consent and will proceed in the same way for both testing periods. As 

described in the Approach, we will be using identical procedures for all participants regardless of arm to which 

they randomize including generation of an IGCIP plan, and longitudinal assessments performed by an 

audiologist and speech language pathologist. 

randomization schedule will be generated by Co I and study statistician, Mary Dietrich, PhD, and provided to 

the PIs (Gifford and Camarata) prior to study commencement. To ensure equal numbers of participants in each 

arm, a computer generated, permuted blocking algorithm (blocks of 4 participants) will be used to develop the 

schedule. The schedule will be password protected and saved on an encrypted server housed at the 

Vanderbilt Bill Wilkerson Center. As described in the Approach, we will be using identical procedures for all 

participants regardless of arm to which they randomize including (a) post operative CT scanning, (b) 

generation of an IGCIP plan, and (c) longitudinal assessments performed by an audiologist and speech 

language pathologist. 

Blinding. Both the experimenters and the participants will be blinded. The experimenters will be notified of the 

randomization for a given participant on the day of the baseline visit. Only the PIs and Co I Dr. Dietrich, who 

will generate the randomization scheme, will know whether the participant is in the intervention or deferred 

waitlist group until the end of the study. Neither PI nor Dr. Dietrich will be personally administering 

assessments nor scoring tests for the participants. 

Provisions for breaking the blind. To ensure that IGCIP does not impair auditory only word recognition an 

important ethical control in this clinical trial we will use a SmartPhone app, (e.g., Hear Coach) to assess word 

recognition during the respective baseline as well as at 1 month and 13 months following enrollment as 

neither the participants nor the tester will know whether the subject is in the immediate or deferred intervention 

group. Words will be transmitted from the SmartPhone app via Bluetooth or direct audio input at a comfortable 

level. Study staff will administer the assessment at baseline; a caregiver will be asked to re administer 

smartphone word task at home during the subsequent periods. In the event that word recognition has 

decreased relative to scores obtained during the previous study visit using 95% confidence interval data for 

test retest variability of word recognition tasks containing 25 items we will offer the option of returning the 

child to a previous program or giving the child one additional month of study participation to be followed up at 

the regularly scheduled appointment for each group (Table 3). Note that it is possible that there will be some 

cases where no changes were made to the child's previous program for those in the deferred intervention. If no 

changes have been made to the child’s CI program as in the case of the waitlist deferred group at the 1 

month post enrollment appointment we would not expect changes in word recognition. However, should there 

an aberrant/unexplained change in the child’s hearing status and a change in word recognition without a 

change to the CI 

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Evaluation of the effects of the intervention on one or more health related biomedical or behavioral outcomes 

The evaluation of the intervention (IGCIP) will be assessed using various measures of basic auditory function 

(spectral and temporal resolution), speech understanding, speech production, language (expressive and 

receptive), phonological awareness, and literacy. We will also be tracking outcomes longitudinally on 

subjective measures of auditory function (ASC completed by primary caregiver), communication in quiet and 

noise (PEACH completed by primary caregiver), and PedsQL 4.0 (completed by both child participant and 

primary caregiver). 

Contact PD/PI: Gifford, Rene H Data and Safety Monitoring Plan Page 126

 

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OVERALL STRUCTURE OF THE STUDY TEAM 

The proposed research is a collaboration between an audiologist (Gifford) and a speech language pathologist 

(Camarata) collaborating with an otologist (Labadie), engineers, (Labadie, Noble, Dawant), and a 

biostatistician (Dietrich). We have two external consultants, Susan Nittrouer, PhD and Ferenc Bunta, PhD who 

are experts in phonological processing and speech production, respectively. We will have a project manager 

who is yet to be identified. This project will be overseen by the PI’s, Drs. Gifford and Camarata with input at 

monthly project meetings and regular ongoing interaction with our co-investigators, consultants, and project 

manager. 

Contact PD/PI: Gifford, Rene H Overall Structure of the Study Team Page 127
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Section 4 - Protocol Synopsis (Study 1) 

4.1. Brief Summary

The proposed research is a relatively straight-forward, double-blind, wait-list controlled randomized clinical trial (RCT) design.

 The total sample (n = 72) will be randomly assigned to either immediate IGCIP intervention (n = 36) or a deferred waitlist

 condition (n = 36). Both groups will be monitored for 24 months, with testing at time 1 (baseline), time 2 (2 months), time 3 (6

 months), and time 4 (12 months). After 12 months, the deferred treatment group will receive the IGCIP intervention. Testing

 will then continue at time 5 (14 months), time 6 (18 months), and time 7 (24 months). At the conclusion of the project, we

 will have 12 months of data on untreated growth, 12 months data of treated growth in the deferred treatment group, and 24

 months of growth in the immediate IGCIP treatment group.

4.2. Study Design

4.2.a. Narrative Study Description

This project provides a unique opportunity to examine whether individualized, image-guided CI programming (IGCIP)

 significantly improves outcomes in pediatric CI patients. The proposed research activities will examine the impact of

 personalized IGCIP in pediatric patients on measures of basic auditory function (spectral and temporal processing),

 word and non-word recognition, speech production, language, phonological processing, and reading comprehension

 using a randomized wait-list control treatment design. A total sample of 72 children with CIs aged six to twelve

 years old will be enrolled in the project: half (n = 36) will be randomized to an immediate IGCIP condition and half

 to a 12 month waitlist control condition. The waitlisted participants (n = 36) will undergo IGCIP after 12 months of

 monitoring and then followed for an additional 12 months after the IGCIP intervention has been provided (total time

 in the study: 24 months). Those immediately provided with IGCIP will also be followed for a total of 24 months. All

 participants will undergo extensive audiological as well as speech, language, and reading assessments in addition to

 comprehensive audiological assessment at baseline as well as at regular intervals: 2, 6, 12, 14, 18, and 24 months. We

 will use predictor analyses to determine the impact of immediate and deferred IGCIP on subsequent auditory, speech,

 language, and literacy outcomes.

4.2.b. Primary Purpose Treatment

4.2.c. Interventions

Type Name Description 

Other Signal processing

intervention of a biomedical

device

This is a signal processing intervention of an FDA approved biomedical

 device for study participants that have received the cochlear implant

 based on clinical recommendations (i.e. not study related). Based on

 image processing of pre- and post-implant CT, cochlear segmentation,

 electrode scalar localization, and definition of the electrode-to-neural

 interface, we will manipulate the stimulus delivery of the incoming signal

 within the FDA approved clinical software and thereby is within the

 electrical and clinical specifications of the FDA approved device and

 accompanying software.

4.2.d. Study Phase Early Phase 1 (or Phase 0)

Is this an NIH-defined Phase III Clinical Trial? ❍ Yes ● No 

4.2.e. Intervention Model Sequential

4.2.f. Masking ❍ Yes ● No 

❏ Participant ❏ Care Provider ❏ Investigator ❏ Outcomes Assessor 

4.2.g. Allocation N/A 

4.3. Outcome Measures

Type Name Time Frame Brief Description 

Contact PD/PI: Gifford, Rene H Page 128
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Primary Spectral resolution (spectral

modulation detection or SMD)

6 months post intervention The spectral modulation detection (SMD) task

 of spectral resolution will use a 3-interval,

 2-alternative forced-choice procedure. The

 participant will discriminate between flat-spectrum

 and spectrally-modulated noise presented at 65

 dB SPL. We will use a broadband stimulus and

 assess spectral modulation rates of 0.5 and 1.0

 cycle per octave. Threshold will be expressed in

 modulation depth (in dB) for each modulation rate

 tested.

Secondary Temporal resolution

(sinusoidal amplitude

modulation (SAM) detection)

6 months post intervention The temporal resolution task includes sinusoidal

 amplitude modulation (SAM) detection with a 3-

interval, 2-alternative forced-choice procedure.

 The participant will discriminate between noises

 with a flat temporal envelope and sinusoidal

 amplitude modulation. We will use a broadband

 stimulus at 65 dB SPL and assess amplitude

 modulation rates of 4, 32, and 128 Hz. SAM

 threshold will be expressed in 20 log m (in dB),

 with m representing the modulation index (0 to 1).

Other Spectro-temporal modulation

(STM)

6 months post intervention The spectro-temporal modulation (STM) task

 will use a 3-interval, 2-alternative forced-choice

 procedure. STM sensitivity will be measured

 using a broadband stimulus that has both spectral

 (1-cycle per octave) and temporal modulation

 (4- or 32-Hz SAM). We will use a 2-down, 1-up

 tracking procedure to track 70.7% correct on the

 psychometric function for all measures. STM

 threshold will be expressed in spectral modulation

 depth (in dB) for each of the temporal modulation

 rates tested.

4.4. Statistical Design and Power S1-1_StatisticalDesignPower.pdf

4.5. Subject Participation Duration 24 months

4.6. Will the study use an FDA-regulated intervention? ❍ Yes ● No 

4.6.a. If yes, describe the availability of Investigational

Product (IP) and Investigational New Drug (IND)/

Investigational Device Exemption (IDE) status

4.7. Dissemination Plan S1-1_DisseminationPlan.pdf 

Contact PD/PI: Gifford, Rene H Page 129
Contact PD/Pl: Gifford, Rene H 

STATISTICAL ANALYSIS PLAN AND POWER ANALYSES 

Data Management. Dr. Dietrich (Co-I and biostatistician) will provide support for statistical analyses. All 

data will be stored in REDCap offering a secure, web-based application. 

Scientific Rigor and Reproducibility. All data analyses and data sharing will adhere to the NIH's 

commitment to rigorous and transparent research. This will be accomplished through the analytic approach 

described here, which replicates our previous analytical approaches used for studies of adult IGCIP (24, 72) 

and our preliminary study of pediatric IGCIP (4). To achieve transparency, details will be reported that allow 

other research teams to reproduce the results. Furthermore, raw data will be presented in tables and 

appendices of our publications and will be made available upon request (within the scope and limits of IRB 

approved data sharing). 

Statistical Analysis. Overall strategy. Statistical software (SPSS, STATA, R) will be used for the 

quantitative summarization of data and to test study hypotheses. The reliability of each of the scores from the 

standardized measures will be assessed and evaluated using Cronbach's alpha statistics. All analyses will be 

done using intent-to-treat principles. Statistical significance tests will maintain Type I error rates of no more 

than 0.05. Descriptive statistics will summarize and inspect the distributions of study measures for choosing 

the appropriate modeling procedure for testing hypotheses. A summary of aims, hypotheses, and associated 

statistical models are shown below in Table 4. 

Missing data. Randomly missing responses to items within assessment tools will be handled via 

protocols specified by the instrument developers. When there is no protocol, if the participant has completed 

HYPOTHESES 

AIM 1 

D significant positive 

short-term gain in 

auditory function for 

children receiving 

IGCIP 

AIM2 

D differential growth in 

auditory function will 

predict growth in PA, 

which will predict 

mediated growth for 

reading measures 

AIM3: 

D significant positive 

growth in speech & 

language; this growth 

Will be predicted by the 

relative improvement in 

auditory function from 

the IGCIP 

TABLE 4 

MEASURES 

D Spectral, 

temporal, & 

spectro-temporal 

resolution 

D Speech 

recognition 

D Subjective 

questionnaires 

(auditory & quality 

of life) 

AIM2 

D PA (Tests & 

Tasks) 

o Reading 

outcomes (Tests} 

D Control for 

working memory 

(Tests & Tasks) 

AIM3 

D Language (Tests 

of expressive, 

receptive. and 

narrative) 

D Speech 

production (Tests 

and Acoustic 

Analysis) 

STATISTICAL MODELS 

D Descriptive statistics of all 

measures 

o Bootstrapped 95% confidence 

intervals for all effects 

o Statistical Control of Potential 

Confounds: Covary baseline levels 

of nonverbal cognition, working 

memory, and speech recognition 

D Mixed-effects modeling: Test the 

differential effect of IGCIP on the 

trajectories of change in auditory 

function. 30/group. Minimum 

detectable effect size = 0.67 (SDs at 

endpoint); traditional Cohen effect 

sizes d = 0.210.510.8 -

small/medium/large. 

o Cross-lagged panel and path 

analysis: Test the mediation effect 

of key factors on reading outcomes 

(e.g., phonological awareness on the 

relationship between auditory 

function/speech recognition on 

reading ability and speech 

production). Minimum detectable 

path coefficient 0.35 (-12% shared 

variance) 

Dz-test of independent path 

coefficients. Test for differences in 

the size ofthe path coefficients 

between the two study groups. 

75% or more of the items on a particular 

instrument, the mean score for that instrument 

will be calculated using available item 

responses and used in subsequent analyses. 

In-depth investigations of patterns of missing 

data will be undertaken to assess if data are 

missing due to random influences or if there 

are certain study conditions (e.g. waitlist 

control) or participant characteristics (e.g., 

age, hearing function) that are more or less 

likely to be associated with certain patterns of 

missing data (i.e. lost to follow-up). We expect 

that most assessments will not be missing at 

randomization, thus imputation would not be 

appropriate. 

Aim 1 and Aim 2: Analysis & 

hypotheses testing: The outcome variables 

are auditory function, speech recognition, PA, 

working memory, and reading gains over 

various time points (Approach, Table 3). 

Descriptive and graphical summaries of 

trajectories by study group will be conducted 

initially for detection of outliers and to provide 

insight into patterns of change. Key statistical 

tests will involve study group (IGCIP vs. waitlist control) comparisons of the mean slopes resulting from 

differences in baseline and post-intervention assessments. Tests will be conducted using general linear mixed 

or multilevel analysis. While randomization ensures equal opportunity for study conditions, it does not ensure 

equivalence of baseline values. If it is found that group baseline values differ, baseline scores will be included 

as a covariate in the analysis as will potential confounds such as baseline intellectual level and working 

memory ability. Within this general multilevel statistical approach, hypothesized differences will be tested by 

assessing the statistical significance of the main and interaction effects of study group on time-related contrast 

in baseline and study assessment points in the outcome variable scores. In other words, we expect that the 

slope of outcome measure scores in the waitlist control group will be nearly '0' while those of immediate IGCIP 

group will demonstrate a statistically significant positive slope. In addition to statistical significance testing, 

bootstrapping methods will be used to generate 95% confidence intervals for all sample descriptive (e.g., 

group means at each time of assessment) and effect estimates (e.g., eta-squared for group effect on linear 

slope of the outcome scores). Because we expect there to be correlations amongst the multiple outcome 

Page 130 

Statistical Design and Power 
Contact PD/Pl: Gifford, Rene H 

measures, a multivariate approach will provide more unified (systemic) statistical test of the intervention 

effects. 

Aim 3: Analysis and hypothesis testing: The focus of this aim is to explore the complex relationships 

among changes in the various measures of hearing, speech, and language. As an example of this approach, 

Figure 7 displays an example cross-lagged panel analysis which illustrates the structure for statistical analysis 

of this aim. Via comparisons of the strength of the relationships between the changes in one domain at time 1 

with the changes in another domain at time 2, etc., 

this type of analysis will maximize the information 

Baselinelll Baseline 6-Months 12-Months 

hearing gained from the longitudinal assessment of the

multiple domains and inform additional causal ,---­ Phonologicallll 

awareness 

Reading 

comprehension 

Speech!J\ec SpeechlJtec hypotheses for subsequent research. Bootstrapped 

95% confidence intervals will be generated for each 

BaselinelJGCIP of the path coefficients. For all statistical analyses, 

Auditorylll Auditorylll we will allow for covariates associated with the child 

/ Function Function and family including chronological age at 

assessment, age at Cl, age at identification, 

Baselinelleadin nonverbal cognition, working memory, gender, and 

comprehension Figure 7: Lagged path-analysis model. socioeconomic status (10, 15, 119, 120). 

Sample size and power. Sample size estimates are based on the desire to detect clinically meaningful 

effects of the intervention using information from our preliminary studies while maintaining study feasibility. An 

analysis sample of 30 participants per study group will provide 80% statistical power (two-sided a=0.05) for the 

detection of an intervention effect on the trajectories of the hearing, speech, language, PA and reading as 

small as 0.32 (Cohen's d equivalent=0.67, adjusted for baseline with r, 2~0.2) and 0.35 (Cohen's d equivalent 

=0.74, unadjusted). Differences of this magnitude are considered to be clinically meaningful. Furthermore, the 

statistical power estimates are conservative due to the proposed used of mixed-effects analyses approaches 

that will enable the increased power of treating the repeated assessments as independent values yet 

appropriately adjusting the standard errors for the correlations among those repeated assessments. The 

proposed final sample of 60 will enable detection of a path correlation as small as 0.35 (80% power, 2-tailed 

a=0.05). Correlational values of that magnitude or larger were observed in our preliminary work. Detectable 

differences between the strength of two path coefficients will be 0.4-0.5 (80% power, 2-tailed a=0.05) 

depending on the value of the coefficients and the size each correlation has with other values. The focus of the 

cross-lagged panel analysis will be on generating effect sizes deepening our understanding of the 

mechanisms underlying effects of change in hearing on higher-level PA/speech/language downstream. 

Accounting for 20% attrition, we will enroll 72 patients to achieve a GO-subject sample. 

Page 131 

Statistical Design and Power 
DISSEMINATION PLAN 

We intend to publish data originating from this project in a timely manner in peer-reviewed scientific journals. 

Data will also be presented at national and international scientific meetings (e.g., American Auditory Society, 

American Speech-Language-Hearing Association, American Cochlear Implant Alliance, Society for Research 

in Child Development, Hearing Across the Lifespan). In addition to published papers and conference 

presentations, unpublished data will be discussed openly with other laboratories and investigators to 

encourage diversity of analysis and opinion, and to foster collaborative relationships. 

We plan to provide summary updates for this project on the PIs’ lab websites to help educate clinicians, 

outside researchers, consumers, as well as current and prospective families on the current project and 

findings. 

The data collected for this project will be saved to our centralized data repository managed by Drs. Gifford 

and Dawant. We anticipate that the de-identified database will ultimately be available and useful to all 

clinicians and clinician-scientists for various research-related purposes. 

Data analyses and data sharing will be consistent with the NIH’s commitment to promoting rigorous and 

transparent research (see Data Analysis, Approach, Research Strategy). To achieve transparency, details 

will be reported that allow other research teams to reproduce the results and raw data will be made available 

in tables and appendices of our publications. 

Contact PD/PI: Gifford, Rene H Dissemination Plan Page 132
Tracking Number: GRANT12696653 Funding Opportunity Number: PA-18-334 Received Date: 

2018-08-16T11:14:30.000-04:00 

Delayed Onset Studies 

Delayed 

Onset 

Study# 

Study Title Anticipated Clinical 

Trial? 

Justification 

The form does not have any delayed onset studies 

Contact PD/PI: Gifford, Rene H Page 133
MULTIPLE PI LEADERSHIP PLAN 

ROLES AND RESPONSIBILITIES 

Dr. Gifford and Dr. Camarata will be co PIs for this project. Given the distinct areas of expertise for the two PIs, 

the roles and responsibilities for each PI are rather straightforward: 

• Dr. Gifford will be responsible for overseeing all research activities relevant to auditory perception. 

o Dr. Gifford will be responsible for overseeing participant recruitment given her role as director of 

the Cochlear Implant Program in the Department of Hearing and Speech Sciences at the 

Vanderbilt Bill Wilkerson Center. 

• Dr. Camarata will be responsible for overseeing all research activities relevant to speech, language, 

and literacy. 

o Dr. Camarata will be responsible for the mentorship of the SLP graduate research assistant. 

• Drs. Gifford and Camarata will share mentorship of the PhD student who will be working across both 

areas of specialty with outcomes for pediatric CI recipients as his/her research focus. 

Further, Drs. Gifford and Camarata will be provided with monthly budget reports for the project. Both will review 

the fiscal data and will briefly discuss at the monthly project meeting (discussed below). 

COMMUNICATION PLAN 

. Gifford and Dr. Camarata 

have been collaborating on the preliminary studies 

and project development since 2013. Thus there is a history of across laboratory communication which will be 

continued and strengthened throughout the duration of this project. We will hold monthly project meetings 

during which all study personnel housed in each laboratory will discuss project progress, present preliminary 

data for group discussion, identify concerns regarding participant recruitment progress and data collection, and 

map project goals for the following month, quarter, and year. 

SCIENTIFIC DIRECTION 

The direction of the research is spelled out in detail in our Research Plan. Deviations from the defined 

Research Plan will be made only if both PIs agree. 

RESOLVING CONFLICTS 

Because we will be following a well defined research plan and a history of collaboration, we anticipate few, if 

any conflicts. However, should a conflict arise, disagreement will be referred to an arbitration committee 

including two independent senior faculty from Vanderbilt University Medical Center and one independent 

senior faculty member from an outside institution, the latter of whom both PIs will be required to mutually agree 

upon. The members of the arbitration committee will not be involved in either PIs’ lines of research. 

PUBLICATION AND INTELLECTUAL PROPERTY POLICIES 

Publications arising from this project will include both Dr. Gifford and Dr. Camarata as authors. For publications 

focusing on auditory outcomes, Dr. Gifford will serve as senior author. For publications focusing on speech, 

language, and/literacy outcomes, Dr. Camarata will serve as senior author. 

CHANGE IN PI LOCATION 

one of the PIs moves to a new institution, we will transfer the relevant portion of the grant to the new 

institution. In the event that a PI cannot carry out his/her duties at the new institution, a new PI will be recruited 

as a replacement at the home institution, Vanderbilt University Medical Center. 

BUDGET ALLOCATION 

Please see budget justification for allocation of resources. 

Contact PD/PI: Gifford, Rene H Multiple PD/PI Leadership Plan Page 134

 

 

 

 

 

 

 

 

 

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Gifford RH, Dorman MF, Skarzynski H, Lorens A, Polak M, Driscoll CLW, et al. Cochlear implantation 

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Uhler K, Warner-Czyz A, Gifford R, Group PW. Pediatric Minimum Speech Test Battery. J Am Acad 

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Noble JH, Hedley-Williams AJ, Sunderhaus L, Dawant BM, Labadie RF, Camarata SM, et al. Initial 

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156. Melby-Lervag M, Hulme C. Serial and free recall in children can be improved by training: evidence for 

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157. Nittrouer S, Miller ME. The development of phonemic coding strategies for serial recall. Appl 

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158. Gillon GT. Phonological Awareness. 2nd editio. New York, NY: Guilford Press; 2017. 

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161. Ching TY, Cupples L. Phonological Awareness at 5 years of age in Children who use Hearing Aids or 

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Contact PD/Pl: Gifford, Rene H 

VANDERBILT UN IVERS I T Y MEDICAL CENTE R 

OFFICE OF SPONSORED PROGRAMS 

Main Fax (6 15-343-2447) 

Letter of Intent to Establish a Consortium 

Title of Application: 

Image-Guided Cochlear Implant Programming: Pediatric Speech, Language, and Literacy 

Applicant/Pdme Institution: Vanderbilt University Medical Center 

Principal Investigator: Renee Gifford/Stephen Camarata 

Cooperatiog/Subrccipicnt Institution: _V_a_n_d_e_rb_i_lt_U_n_iv_e_rs_i_ty__________ 

Co-Investigator: Jack Noble 

Costs requested by Cooperating Institution 

Proposed Effective Date: 04/01/2019 

04/01/201 9-03/31/2024 First Budget Year: 04/01/2019-03/31 /2020 Project Period: 

Direct Costs: Direct Costs: 

F & A Costs: F & A Costs: 

Total: Total: 

Completion of this fom1 signifies that this proposal has been reviewed, approved, and certified for accuracy by the appropriate 

institutional official. The appropriate programmatic and administrative personnel of each organization involved in this grant 

application are aware of the awarding agency's policy and are prepared to establish the necessary inter-organizational 

agreement(s) consistent with that policy. The amounts shown above appear in the application; however, Vanderbilt University 

Medical Center reserves the right to negotiate terms and conditions if and when the award is made. 

Applicant/Prime Institution Cooperating/Su brecipient Institution 

Vanderbilt University Medical Center Vanderbilt University 

Name of Institution Name of Institution 

Signature of Authorized Official 

D. Clinton Brown, Director, Office of Sponsored Programs D. Janiece Harrison. Director, Sponsored Programs Adminstralion 

Name & Title of Authori,.:ed Oflicial 

Date 

Consortium/Contractual Arrangements 

Eff-:ctivc Date: 2/ 16/18 
Statement of Work

The primary goal of this project is to evaluate the effects of Image-Guided Cochlear Implant

Programming (IGCIP) techniques on basic auditory function, speech understanding, language 

abilities, speech production, and literacy outcomes in pediatric CI recipients. The Vanderbilt

University site will be in responsible for development, maintenance, and analysis of the imaging 

data repository and for the creation of IGCIP plans for the 60 cochlear implant recipients that will 

participate in this study.

Contact PD/PI: Gifford, Rene H Consortium/Contractual Arrangements Page 144
RESOURCE SHARING PLAN 

Data Sharing Plan: 

Intellectual property and data generated under this project will be administered in accordance with both 

University and NIH policies, including the NIH Statement on Sharing Research Data (Notice: NOT OD 03 032) 

issued on February 26, 2003. 

We intend to publish data originating from this project in a timely manner in peer reviewed scientific journals. 

Data will also be presented at national and international scientific meetings (e.g., American Auditory Society, 

American Speech Language Hearing Association, American Cochlear Implant Alliance, Society for Research 

in Child Development, Hearing Across the Lifespan). In addition to published papers and conference 

presentations, unpublished data will be discussed openly with other laboratories and investigators to 

encourage diversity of analysis and opinion, and to foster collaborative relationships. 

We plan to provide summary updates for this project on the PIs lab websites to help educate clinicians, 

outside researchers, consumers, as well as current and prospective families on the current project and 

findings. 

he data collected for this project will be saved to our centralized data repository managed by Drs. Gifford 

(PI), Camarata (PI), and Dawant (Co I). We anticipate that the de identified database will ultimately be 

available and useful to all clinicians and clinician scientists for various research related purposes. 

ata analyses and data sharing will be consistent with the NIH’s commitment to promoting rigorous and 

transparent research (see Data Analysis, Approach, Research Strategy). To achieve transparency, details 

will be reported that allow other research teams to reproduce the results and raw data will be made available 

in tables and appendices of our publications. 

Sharing Model Organisms: Not applicable 

Genome Wide Association Studies (GWAS): Not applicable 

Contact PD/PI: Gifford, Rene H Resource Sharing Plan(s) Page 147

 

 

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