Customized Auditory Brain Training for Children With Hearing Loss
Phase: PHASE1
Conditions: Hearing Loss
Sponsor: Washington University School of Medicine

 
 
 
 
 
 
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Customized auditory brain training for children with hearing loss 
Principal Investigator:   
Craig Buchman MD 
 
 
 
 
 
 
Version Date/Number:  
V2; 04/30/2020 
 
 
 
 
 

 
 
 
 
 
 
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TABLE OF CONTENTS 
A 
INTRODUCTION ..................................................................................................................... 3 
A1 
STUDY ABSTRACT .............................................................................................................. 3 
A2 
PRIMARY HYPOTHESIS ....................................................................................................... 3 
A3 
PURPOSE OF THE STUDY PROTOCOL .................................................................................. 3 
B 
BACKGROUND ...................................................................................................................... 3 
B1 
PRIOR LITERATURE AND STUDIES ....................................................................................... 3 
B2 
RATIONALE FOR THIS STUDY ............................................................................................... 4 
C 
STUDY OBJECTIVES ............................................................................................................. 4 
C1 
PRIMARY AIM ..................................................................................................................... 4 
D 
STUDY DESIGN ...................................................................................................................... 4 
D1 
OVERVIEW OR DESIGN SUMMARY ....................................................................................... 4 
D2 
SUBJECT SELECTION AND WITHDRAWAL ............................................................................. 4 
2.a 
Inclusion Criteria .......................................................................................................... 4 
2.a 
Exclusion Criteria ......................................................................................................... 5 
2.c 
Subject Recruitment Plans and Consent Process ....................................................... 5 
2.e 
Risks and Benefits ....................................................................................................... 5 
E 
STUDY PROCEDURES .......................................................................................................... 5 
E1 
SCREENING FOR ELIGIBILITY ............................................................................................... 5 
E2 
SCHEDULE OF MEASUREMENTS .......................................................................................... 5 
E3 
SAFETY AND ADVERSE EVENTS .......................................................................................... 7 
E4 
STUDY OUTCOME MEASUREMENTS AND ASCERTAINMENT .. ERROR! BOOKMARK NOT DEFINED. 
F 
STATISTICAL PLAN............................................................................................................... 7 
F1 
SAMPLE SIZE DETERMINATION AND POWER ........................................................................ 7 
F2 
ANALYSIS PLAN ................................................................................................................. 7 
F3 
MISSING OUTCOME DATA ................................................................................................... 7 
G 
DATA HANDLING AND RECORD KEEPING ........................................................................ 7 
G1 
CONFIDENTIALITY AND SECURITY ........................................................................................ 7 
H 
STUDY ADMINISTRATION .................................................................................................... 7 
H1 SUBJECT STIPENDS OR PAYMENTS ......................................................................................... 7 
I 
ATTACHMENTS ..................................................................................................................... 8 
I1 
QUESTIONNAIRES OR SURVEYS ........................................................................................... 8 
J 
REFERENCES ........................................................................................................................ 8 
 
 
 

 
 
 
 
 
 
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A Introduction 
A1 Study Abstract 
Almost 90% of children with hearing loss attend a regular public school classroom and 
95% communicate with spoken language. Depending upon their degree of hearing loss, 
they miss between 30-60% of all spoken material in a classroom setting, even if they 
wear hearing aids. Research has shown that poor speech recognition leads to poor 
academic achievement. This project offers a potential solution to this problem. Our 
research team proposes to determine if web-based auditory training using an unfamiliar 
talker can result in better recognition of the person speech. Hand-held, game-like 
training programs will be used to present speech-in-noise training. Benefits will be 
compared after 4 weeks of required at-home training. 
 
Using a Transfer-Appropriate Processing (TAP) theory of learning as theoretical 
motivation, we will determine the extent to which children benefit from talker-specific 
training. This research, which is based firmly on TAP theoretical underpinnings, will 
provide answers about how best to provide speech recognition training to children with 
hearing loss. 
A2 Primary Hypothesis 
Poor speech recognition leads to poor academic achievement. 
A3 Purpose of the Study Protocol 
To determine if web-based auditory training using an unfamiliar talker can result in better 
recognition of the person speech. 
B Background 
B1 Prior Literature and Studies 
Our research team conducted a number of preliminary studies which give support for 
speech recognition training. 
 
Study 1-We surveyed the 48 OPTION schools in the US (schools for children with 
hearing loss) and received responses from 8. The results of the survey found that these 
OPTION schools provided formal auditory training and these educators who are trained 
in aural rehabilitation and deaf education felt it was a critical part of the child's education. 
Teachers in public school settings who are not trained in deaf education might not be 
providing optimal intervention. 
 
Study 2-We trained adults with game-like computerized auditory training and found that 
short term auditory only training is beneficial and by the use of questionnaires found that 
self confidence, and self impression of speech recognition skills improved. Eighty-seven 
percent of the participants indicated the training was worth their time. 
 
Study 3-We had two children complete our adult version of the computerized auditory 
training and both children showed benefit. 

 
 
 
 
 
 
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Study 4-We conducted a TAP-style assessments on 36 adult participants with hearing 
loss who trained 20 hours with our computerized training program. The pre and post 
assessments included items spoken by the talker who was used during training and 
items spoken by an unfamiliar talker. The largest gains were seen by items spoken by 
the trained talker supporting the need for a TAP style of training. 
 
Study 5-We have developed a number of tests to be used with children for both training 
and assessment purposes. The tests include: The Children's Audiovisual Enhancement 
Test, The Illustrated Sentence Test, The GIST test, and the Tri-Bas test. 
 
Study 6-We brought back four of our adult participants who completed our auditory 
training. After the completion of the original AT, there scores at the 12 month test 
session had dropped compared to their post and 3-month scores. They received 6 hours 
of additional auditory training which we called "booster training" and their scores 
improved compared to their 12-mo scores. 
 
Study 7-We currently have a "take-home" training component with our adult auditory 
training program. The participants are sent home with a hand held device with the 
training games. Of the participants who have completed this training, they are averaging 
approximately 6 hours of play over a 3-month period. If you removed the participants 
who did not play at all at home, the average is over 8 hours over the three month time 
period. These results are encouraging for our take-home portion of this current study for 
children. 
B2 Rationale for this Study 
This research, which is based firmly on TAP theoretical underpinnings, will provide 
answers about how best to provide speech recognition training to children with hearing 
loss. 
C Study Objectives 
C1 Primary Aim 
Determine to what extent web-based auditory brain training with the speech of a here-to-
fore unfamiliar communication partner results in better recognition of that person's 
speech. 
D Study Design  
D1 Overview or Design Summary 
Hand-held, game-like training programs will be used to present speech-in-noise training. 
Benefits will be compared after 4 weeks of required at-home training. 
D2 Subject Selection and Withdrawal  
2.a 
Inclusion Criteria  
All participants will be between the ages of 6-12 years with bilateral sensorineural 
hearing loss and will use either a hearing aid(s), cochlear 

 
 
 
 
 
 
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implant(s)(CI) or a combination of both. 
2.a 
Exclusion Criteria  
Individuals less than 6 years of age or greater than 12 years of age or with vision worse 
than 20/40 corrected will be excluded. 
2.b 
Subject Recruitment Plans and Consent Process 
A team member will recruit potential participants by telephone via recruitment list 
from REC, RPR, AudBase, and current lab database of previous participants. 
Potential participants who see a flier, advertisement, or who are referred from an 
outside source will call our lab. A team member will describe the study using the 
telephone script. If they pass the telephone screening (as in, their child passes 
the screening qualifications) and are interested participating then the study is 
described in detailduring the informed consent process over the telephone. The 
participant will have an opportunity to ask any questions about the study during 
the consent process. A participant can refuse to participate at any time during the 
recruitment process or any time during the study. 
2.c 
Risks and Benefits 
There are no forseeable risks. 
 
Participants have the potential to hear better/function better in noisy listening 
environments.  Participation in this study allows us to better understand how children 
with hearing loss function in different types of listening environments when listening to a 
variety of speakers. These findings can potentially lead to better clinical applications in 
the area of auditory training and aural rehabilitation. 
D. Study Procedures  
D1 Screening for Eligibility 
We will need the individual's name, phone number, and hearing status to see if they 
meet the criteria. 
D2 Schedule of Measurements 
FOCUS GROUP (n=10): 
Two focus groups will take place (approximately 5 children per focus group). The 
children will have completed the “Enhancing children’s everyday communication: Talker 
specific speech recognition training” program (IRB # 201602007). 
 
Each focus group session will last approximately 1.5 hour. After providing consent 
participants will be grouped in a kid-friendly room at the Central Institute for the Deaf 
with the researcher and the other children. For the first 20-30 minutes the children will be 
discussing a hypothetical scenario about a child with hearing loss, and the last 40-50 
minutes the children will answer specific questions about the training program, their 
experiences during the training program and questions about themselves. The sessions 
will be audio and/or videotaped for later transcription. The focus groups will take place at 
our labs at Washington University.  The focus groups will be audio/videotaped for later 

 
 
 
 
 
 
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transcription and for use in educational settings (examples, conferences or 
presentations). 
 
HOME TRAINING GROUP (n=25): 
All home training and assessments will take place remotely with the assessments 
administered via the take home device.  Responses will be monitored by the 
experimenter using a phone or online communication software when available.  One pre-
training assessment (baseline) will be administered. It will take approximately 1-1.5 
hours over 1-2 days 
-The parent will complete a case history for their child.  The examiner will record their 
responses on the case history form. 
-Participant will complete the COSI while the tester records the participant's responses 
on the form. 
-The participant will complete a device/setting check. The tester will record the 
participants responses on the form. -The participant's aided hearing will be checked 
using an online hearing screener.  -The Ling 6 will be administered. . For the Ling 6, 
each participant will hear six sounds at three different levels (sot, but audible, 
comfortable, and loud but comfortable). The participant will repeat the sound they hear 
at each level. 
 
The following tests of speech perception ability will be administered at baseline: 
-BKB-SIN 
-Words in noise (training stimuli) (familiar talkers from training) 
Sentences in noise(Illustrated sentence test stimuli (IST)) (unfamiliar talkers) 
-Phrases in Quiet (bound morpheme stimuli) (familiar talkers from training) 
 
The online training will consist of game-like activities developed for 6-12 year old 
children with hearing loss. Each child will complete 16 hours of online auditory training. 
They will be provided with a user name and password to the online training system that 
is not their real name to protect their identity. Training is spread over approximately 30 
days. They will be asked to average about 36 minutes per day of training 7 days a week.  
They will have the opportunity to make up training if they miss any days. We will provide 
a hand-held tablet for them to use during the training. The training is computerized 
game-like auditory training. During game play they listen and make judgments about 
what was heard. Responses will be recorded and stored as potential secondary outcome 
measures. 
 
Training Games: 
1. 
DefendEAR- auditory discrimination and auditory attention 
2. 
HoopstEAR- bound morpheme training game 
3. 
Simon’s EAR- word memory, like the classic Simon’s game  
4. 
Match EAR- Auditory concentration game, can play with 4, 8 or 12 cards 
5. 
Time TravelEAR- word-level discrimination 
6. 
EARplane- works on processing speed 
 
 
After the completion of the 16 hours of training the participant will be scheduled for a 
post assessment which will include the Ling, device/setting questionnaire, all the same 
primary outcome measures taken at baseline, and a training satisfaction questionnaire. 

 
 
 
 
 
 
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D3 Safety and Adverse Events  
No adverse events are anticipated however the study team will monitor through weekly 
phone calls. 
 
E Statistical Plan  
E1  Sample Size Determination and Power 
Sample size (N=20) for the proposed study is calculated based on findings from previous 
studies using the same type of outcome measures. This effect size was selected for the 
power calculation because their training protocol is similar to the one proposed for the 
current study. Using this design, power to detect an effect size as great or greater than 
that reported our previous studies will exceed 0.8. 
E2 Interim Monitoring and Early Stopping 
We will monitor progress in the software to be sure participants are following protocol. 
E3  Analysis Plan 
Quantitative data from the main experiment will be analyzed with ANOVA to assess the 
effect of training on speech recognition for two talker conditions (familiar and unfamiliar) 
and to assess subjective changes indicated by the questionnaire rating-scale responses. 
Qualitative data from the focus groups will be analyzed using established procedures 
recommended by J. Eliot, (2005). Using narrative in social research: Qualitative 
and quantitative approaches. Thousand Oaks, CA: Sage. 
E4 Missing Outcome Data 
Participants with missing data will not be included in the analyses for that outcome 
measure. 
F Data Handling and Record Keeping  
F1 Confidentiality and Security 
Study numbers will be assigned and used in place of names.  Only the study team will 
have access to the corresponding study names and study numbers. 
G Study Administration 
G1 Subject Stipends or Payments  
Participants will be paid $10/hour for the time spent training ($160).  If the child 
completes the 16 hours of at-home training and all of the assessments a tablet and 
speaker will be given to the child.  
 
 

 
 
 
 
 
 
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H  Attachments  
H1  Informed consent documents 
• 
Informed consent – Focus Group 
• 
Informed consent – Home Training 
H2  Questionnaires or surveys 
• 
BKB-SIN List 
• 
Bound Morpheme stimuli 
• 
Device/Setting questionnaire 
• 
COSI Child 
• 
Training Satisfaction Questionnaire Post 
• 
GIST (IST) stimuli 
• 
Fast Word List 
• 
Training Word List 
 
I References 
Barcroft, J., Sommers, M., Tye-Murray, N., Mauzé, E., Schroy, C., & Spehar, B. 
(2011). Tailoring auditory training to patient needs with single and multiple 
talkers: Transfer-appropriate gains on a four-choice discrimination test. 
International Journal of Audiology, 50(11), 1802–1808.  
 
Barcroft, J., Spehar, B., Tye-Murray, N., & Sommers, M. (2016). Task-and talker-
specific gains in auditory training. Journal of Speech, Language, and Hearing 
Research, 59(4), 862-870.  
 
Sommers, M. S., Tye-Murray, N., Barcroft, J., & Spehar, B. (2015). The effects of 
meaning-based auditory training on behavioral measures of perceptual effort in 
individuals with impaired hearing. Seminars in Hearing, 36(4), 263-272.  
 
Tye-Murray, N., Sommers, M., Mauzé, E., Schroy, C., Barcroft, J., & Spehar, B. 
(2012). Using patient perceptions of relative benefit ad enjoyment to assess 
auditory training. Journal of the American Academy of Audiology, 23(8), 623–
634.  
 
Tye-Murray, N., Spehar, B., Sommers, M., & Barcroft, J. (2016). Auditory training 
with frequent communication partners. Journal of Speech, Language, and 
Hearing Research, 59(4), 871-875.  
 
Tye-Murray, N., Spehar, B., Barcroft, J., & Sommers, M. (2017). Auditory training 
for adults who have hearing loss: A comparison of spaced versus massed 

 
 
 
 
 
 
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practice schedules. Journal of Speech, Language, and Hearing Research, 60(8), 
2337-2345.