A Pilot Study to Assess Performance of a New Low-Cost Mobile Health Based Prototype Tympanometer
Conditions: Hearing Loss
Sponsor: University of Arkansas

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 1 
Study Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
 
Principal Investigator:  
Susan Emmett, MD, MPH 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 543 
Little Rock, AR 72205 
Telephone:  +1 (501) 603 1212 
Email:  SDEmmett@uams.edu 
 
 
Sub-Investigator (s): 
Samantha Robler, PhD, AuD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 543 
Little Rock, AR 72205 
Telephone:  +1 (907) 434 0433 
Email:  SKRobler@uams.edu 
 
Jeanette Lee, PhD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street 
Little Rock, AR 72205 
Telephone:  +1 (501) 526-6712 
Email:  JYLee@uams.edu 
 
 
Shayu Deshpande, PhD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 543 
Little Rock, AR 72205 
Telephone:  +1 (501) 526-7126 
Email:  SDeshpande@uams.edu 
 
Partners:  
Allison Gill, AuD 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 547-05 
Little Rock, AR 72205 
Telephone:  +1 (501) 686 5940 
Email:  ACGill@uams.edu 
 
Holly Pruss, AuD 
Arkansas Children’s  
1 Children's Way, Little Rock, AR 72202 
Telephone: +1 (501) 364 6691 
Email: PrussHD@archildrens.org 
 
Medical Monitor:  
John Dornhoffer, MD 
 
Study location: 
University of Arkansas for Medical Sciences 
 
Arkansas Children’s  
 
NCT#: 
NCT05666505 
 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 2 
Table of Contents 
 
Table of Contents ....................................................................................................................... 2 
Abbreviations ............................................................................................................................. 3 
Background and Rationale ......................................................................................................... 4 
Specific Aims ............................................................................................................................. 5 
Investigational Device ................................................................................................................ 5 
Study Design and Procedures .................................................................................................... 7 
Study Population ........................................................................................................................ 8 
Inclusion Criteria ................................................................................................................ 9 
Exclusion Criteria ............................................................................................................... 9 
Recruitment ........................................................................................................................ 9 
Risks and Benefits ..................................................................................................................... 9 
Data Safety Monitoring Plan ......................................................................................................10 
Data Handling and Recordkeeping............................................................................................10 
Safety and Adverse Experiences ..............................................................................................11 
Definitions .........................................................................................................................11 
IRB Reporting ....................................................................................................................15 
Sponsor Reporting ............................................................................................................16 
Clinical Site Monitoring ..............................................................................................................16 
Deviations and Violations ..........................................................................................................17 
Protocol Deviation .............................................................................................................17 
Protocol Violation ..............................................................................................................17 
Study Stopping/Pausing ....................................................................................................17 
Data Analysis ............................................................................................................................18 
Pilot Validation Analysis ....................................................................................................18 
Machine Learning Algorithm Analysis ................................................................................19 
Ethical Considerations ..............................................................................................................19 
Compensation ...................................................................................................................20 
Data Storage and Sharing .........................................................................................................20 
Dissemination of Data ...............................................................................................................20 
References ...............................................................................................................................21 
 
 
 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 3 
Abbreviations 
AC 
Arkansas Children’s  
ADEs 
Adverse Device Effects 
AE 
Adverse Event 
APR 
Annual Progress Report  
CFR 
Code of Federal Regulations 
FDA 
United States Food and Drug Administration 
IEC 
International Electrotechnical Commission 
IRB 
Institutional Review Board 
LMICs 
Low- and middle-income countries 
mHealth  
Mobile Health 
ML 
Machine Learning  
ORRA 
Office of Research Regulatory Affairs 
PI 
Principal Investigator 
RCA 
Root Cause Analysis 
REDCap 
Research Electronic Data Capture  
SAE 
Serious Adverse Event 
SD 
Secure Digital 
UADE 
Unanticipated Adverse Device Effect 
UAMS 
University of Arkansas for Medical Sciences 
UPIRTSO 
Unanticipated Problem Involving Risks to Subjects or Others 
 
 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 4 
Background and Rationale 
An estimated 1.6 billion people are living with hearing loss globally, making it the third 
leading impairment worldwide [1].  Unfortunately, over 80% of affected individuals 
reside in low- and middle-income countries (LMICs) with limited access to hearing care 
[2, 3]. Childhood hearing loss has well-known, lifelong implications for language 
development, school achievement, and future employment opportunities [4-12]. The 
World Health Organization estimates that up to 75% of childhood hearing loss in LMICs 
is preventable due to the high prevalence of infection-related hearing loss in low 
resource settings [3]. 
School health programs are well-known to be critical for delivery of preventive 
healthcare in LMICs and rural underserved settings. School hearing screening is 
especially critical for identification and management of childhood hearing loss in low 
resource settings, where newborn screening is often unavailable and the majority of 
hearing loss is due to ear infections [13, 14]. However, not all types of hearing loss can 
be identified by the screening methods commonly used in low-resource settings. To be 
effective, screening must account for the type and prevalence of hearing loss in a given 
population. Most screening programs only use pure-tone screening and are not 
equipped to identify middle ear disease common in populations with a high prevalence 
of infection-related hearing loss [15]. A major reason for this gap is that tympanometer, 
a device used to clinically identify middle ear disease, is not typically used for screening 
because it is expensive and designed for use and interpretation by trained 
professionals. 
Our overarching goal is to develop and validate a mobile health (mHealth) based 
tympanometer with machine learning support for laypersons to transform this 
technology into a low-cost tool that could be broadly disseminated in LMICs and 
underserved rural areas, where the burden of hearing loss is greatest. In collaboration 
with Duke Biomedical Engineering team and hearX, a commercial partner and spin off 
company from the University of Pretoria, along with funding through the National 
Institutes of Health (R21), we have developed a prototype mHealth tympanometer that 
will be integrated with software on an Android smartphone. We have also developed a 
machine learning (ML) algorithm that will support lay users. Large clinical validation 
studies are required for commercialization of this device but a form factor evaluation 
and pilot validation study are first necessary to finalize the design of the device and 
complete the first testing in human ears. These critical steps will ensure the prototype 
and ML algorithm are ready for large-scale testing. 
In this study, we will focus on the pilot evaluation of the prototype in adult and pediatric 
participants from University of Arkansas for Medical Sciences (UAMS) and Arkansas 
Children’s (AC) respectively.  UAMS and AC will be responsible for the pilot validation 
data collection; Duke University, where the prototype was developed, will be responsible 
for refinements based on data obtained from the study; and University of Pretoria/hearX, 
collaborators on the software development to run to mHealth tympanometer and experts 
in technology development, will provide guidance as needed for the hardware refinement 
and the impact on subsequent integration with the software. 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 5 
Specific Aims 
The study consists of two aims: 
1. A pilot evaluation of the accuracy and performance of the prototype device 
compared to commercial tympanometer in pediatric and adult population 
[approximately 60 ears].  
2. Testing of the ML algorithm using prototype data from the pilot validation study. 
Results from the ML algorithm will be compared with audiologist interpretation.  
Investigational Device 
The device under investigation is a lay friendly mHealth tympanometer, a medical 
device for objectively evaluating middle ear function. The tympanic membrane, or 
eardrum, facilitates hearing by transmitting sound vibrations from the outer ear to the 
middle ear. A tympanometer can evaluate if the eardrum is functioning normally by 
applying an acoustic tone and varying air pressure in a measured way. The result is a 
graphical display quantifying the properties of the eardrum known as a tympanogram 
(see Fig 1). A typical test takes about 10-15 seconds to complete. 
  
Fig 1. Example graphical display of tympanograms and the 3 common classifications. 
 
Tympanograms can then be classified into types (Type A, B, C) that help to determine if 
an eardrum has fluid behind it, is retracted, or perhaps has a perforation, all common 
ear disease states. Type A indicates normal ear function, and types B and C indicate 
abnormal middle ear function.  
Commercial tympanometers contain 4 main parts: a speaker, microphone, pump, and 
manometer. However, commercial tympanometers are expensive and designed to be 
used by highly trained hearing healthcare specialists, such as audiologists.  The 
mHealth tympanometer being developed will function the same as a commercial device 
and contain the same core components. We will use a low-cost pump or replace the 
pump with a small syringe for applying controlled pressure (similar to the commercial 
tympanometer) to the ear canal to measure the pressure change of the eardrum (see 
Fig 2) [16]. The device will also be Bluetooth enabled for the wireless transmission of 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 6 
tympanogram results to a smartphone device and/or UAMS laptop. This device is being 
designed to adhere to the international standards established by International 
Electrotechnical Commission (IEC) 60645-5 (ELECTROACOUSTICS – AUDIOMETRIC 
EQUIPMENT – Part 5: Instruments for the measurement of aural acoustic 
impedance/admittance). 
 
 
Fig 2. Prototype mHealth tympanometer 
 
Like all tympanometer devices, the mHealth tympanometer works by placing a probe 
into the outer portion of the ear canal where the measurement process will automatically 
initiate once a hermetic or airtight seal is obtained. The mHealth tympanometer has 
been designed to work with commercially available probe tips (see Fig 3a and 3b).  
 
 
 
Fig 3. Commercial tympanometry ear tips and visual of placement in outer ear canal. 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 7 
Once a seal is obtained with the probe gently placed in the outer portion of the ear, the 
speaker will generate a calibrated tone into the ear canal, as specified by IEC 60645-5. 
The reflected sound in the ear canal will be measured by the microphone in the device 
and the values transmitted via Bluetooth to an Android based smartphone and/or UAMS 
laptop will display the tympanogram result (see Fig 4). The tympanogram will be 
generated using an application (app) developed by our hearX collaborators. This display 
is similar to that generated by commercial tympanometers, and it is this graphical 
display that will be reviewed and interpreted by the audiologist.  
 
 
Fig 4. Beta graphical output from the hearX application on the Android smartphone for 
each of the common tympanogram classifications. 
 
All prototypes will be tracked by a unique label that will allow a comprehensive, 
retrospective analysis to be performed.  
Study Design and Procedures 
Pilot Validation: The proposed pilot validation study at UAMS and AC audiology clinics 
involves a comparative investigation of a commercially available tympanometer with a 
minimal risk lay-friendly (mHealth) tympanometer prototype. The pilot validation will be 
conducted in consented adults and children presenting to the Audiology Clinics of 
UAMS and AC. The study will evaluate device performance compared to a commercial 
tympanometer in patients with various middle ear pathologies, including occluding 
cerumen, effusion, perforation, retraction, otosclerosis, cholesteatoma, ossicular chain 
discontinuity, myringitis, and tympanosclerosis. Data acquired from the pilot validation 
will also be used with our machine learning algorithm to determine how well it works 
with prototype data and the if there will be a need for further refinement.  
Convenience sampling will be used to recruit patient participants. We will recruit 
approximately 20 adult patients who present to the UAMS clinic and approximately 10 
pediatric patients presenting to audiology at AC. We will enroll participants until we have 
complete data from 60 ears. Patients with various middle ear pathologies (see above) 
will be selected to evaluate if the prototype is able to provide the expected 
tympanogram output, type A, B, and C. 
Eligible patients will be invited to participate, and the consent form reviewed. Consented 
participants will receive their audiological services as scheduled, with the addition of 
prototype measurements to their appointment. The audiology appointment will include 
routine ear and hearing measures, such as otoscopy (visual ear exam) and pure tone 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 8 
testing. The prototype device will be conducted before the commercial tympanometry. 
Audiologists will be asked to complete the prototype measurement and interpretation 
prior to the commercial device to limit bias in study results.  We anticipate approximately 
3 audiologists from UAMS and 2 audiologists from AC being involved in the study. 
Audiologists will be provided initial training and a demonstration of the prototype device 
and given instruction on how to troubleshoot and who to contact should an 
unanticipated problem occur. The tympanometric measurement takes roughly 10-15 
seconds per ear to collect. We anticipate the prototype measurement and data entry will 
take no more than 5 minutes to complete during the audiological appointment.    
The resulting tympanograms from the prototype device and the clinical tympanometer 
will be interpreted by the audiologist and entered in a secure Research Electronic Data 
Capture (REDCap) database.  The audiologist will also answer a few brief questions 
during/after testing each participant in a REDCap form on device performance for both 
the prototype and commercial tympanometers.  
Specifically, the order of events will be as follows: 
1. Audiologist will test each ear of the participant with the prototype device and 
interpret the tympanogram. These findings will be entered in a secure Research 
Electronic Data Capture (REDCap) database in real time using a tablet or 
computer. 
2. Next, the audiologist will test each ear of the participant with a commercial 
tympanometer, interpret the results and enter them in the database as described 
above. 
3. The audiologist will complete 4 questions on each device performance between 
testing with each device (steps 1 and 2) if time permits, or after completion of 
testing with both the devices, and document it in a secure REDCap database. 
Testing machine learning algorithm: The performance of the machine learning 
algorithm will be tested by using raw data from the prototype mHealth tympanometer 
obtained from the pilot validation study. The ML will interpret the raw tympanometric 
data and classify the results into Type A, B, and C. The classification by the ML 
algorithm will be compared to audiologists’ interpretation, and concordance will be 
assessed. The audiologists interpreting the data will be blind to the ML algorithm and 
the ML algorithm will not be provided the audiologist interpretation.  
Study Population 
The study population consists of patient participants presenting to the UAMS and AC 
Audiology Clinics for audiological evaluation. The goal is to enroll enough participants to 
have a total of 60 ears (40 adult ears and 20 pediatric ears) with data from both the 
prototype and commercial tympanometers. If test results cannot be obtained, which can 
happen in some ears with tympanometry, then we will enroll additional participants until 
we reach 40 adult ears with data from both devices and 20 pediatric ears with data from 
both devices. This may involve inviting up to 20 adults and 20 children to participate in 
the study. 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 9 
Inclusion Criteria 
• Individuals, 1-year old and older 
• Presenting to the UAMS or AC Audiology Clinics for evaluation where 
tympanometry is warranted for testing at the discretion of the audiologist 
• Presence of various middle ear health states/pathologies that result in Type A, B, 
C tympanograms; examples include normal, occluding cerumen, effusion, 
perforation, retraction otosclerosis, cholesteatoma, ossicular chain discontinuity, 
myringitis, and tympanosclerosis  
• English-speaking  
Exclusion Criteria 
• Children or adults with cognitive disabilities 
• Unable to provide consent/assent  
• Individuals who are unable to sit still 
• Any other condition, that, in the opinion of the investigator, might interfere with 
the safe conduct of the study or place the participant at increased risk 
Recruitment 
Qualifying patients presenting for audiology evaluation will be approached by study 
staff, prior to their appointment inquiring about their interest in study participation. The 
study team will review the clinical schedule in partnership with the clinical team for 
eligible participants. Eligibility will be determined by review of the reason for visit on 
audiology schedules, as well as presenting findings on otoscopy suggestive of middle 
ear pathology and the need for tympanometry. Findings suggestive of middle ear 
pathology include ear symptoms, such as pain, pressure, fullness, and draining. 
Tympanometry is also indicated in any patients with present or history of ear surgery 
and/or mixed/conductive hearing loss. Study personnel will review the informed consent 
form and enroll those who express interest (adults 18 years of age and older). In the 
case of eligible children, interested parents/guardians will be similarly approached by 
study staff, and an informed consent form will be reviewed, and signature obtained from 
parent/guardian. A written assent form will be reviewed with children aged 7 and older, 
along with informed consent of parent/guardian.  For children aged 6 and younger, 
informed consent will be obtained from the parent/guardian and no consent will be 
obtained from the child. 
Risks and Benefits 
This mHealth tympanometer prototype is designed to function the same as 
commercially available technology, which are Class II medical devices. Our prototype is 
being designed to adhere to the relevant IEC standards. Commercial tympanometers 
are considered minimal risk devices.  Our investigational device has implemented best 
design practices to maintain that minimal risk classification, including safeguards in 
hardware and software to limit pressure excursions. The prototype devices will be 
manufactured by a medical device development company with approved Quality 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 10 
Management Systems and International Organization for Standardization 13485:2016 
compliance.  
A risk to participants is the potential for loss of confidentiality of study data.  Measures 
to protect the confidentiality of study data will be implemented as described in the Data 
Handling and Recordkeeping section below.  
There will be no direct benefits to participants; however, knowledge gained from the 
study could potentially benefit patients in the future. 
Data Safety Monitoring Plan 
The Principal Investigator (PI) has overall responsibility for assuring safety, conducting 
the study, gathering study data, overseeing the data safety plan, and complying with 
reporting requirements with assistance from the sub-investigators and study staff, under 
the guidance of the Institutional Review Board (IRB) and the study Sponsor (UAMS 
Office of Research Regulatory Affairs, ORRA). Safety will be monitored by assessment 
of adverse events AEs throughout the study. The PI Susan Emmett, MD MPH or 
designated sub-investigator Samantha Robler, PhD AuD will assess all AEs for 
seriousness, relatedness (attribution), and expectedness. (See Safety and Adverse 
Experiences section below). 
John Dornhoffer, MD will serve as the Medical Monitor and will be a resource to the 
clinical investigators and the Sponsor for advice about management of all AEs (serious 
and non-serious). He will not be involved in other aspects of the study. The Medical 
Monitor will independently review all Grade 3 or higher AEs as well as all serious 
adverse events (SAEs) related to the investigational device submitted by the study team 
in real time to ensure good clinical practice and to identify safety concerns quickly. 
Grade 3 AEs are severe or medically significant (but not immediately life-threatening), 
resulting in hospitalization, or prolongation of hospitalization. The Medical Monitor’s 
review will include AEs and SAEs with the PI’s assessments of attribution and severity 
as well as any quality assurance issues that have emerged. These reviews will examine 
whether risks of participation remain acceptable under the present protocol, 
modifications are needed, or the study needs to be halted. 
The Medical Monitor may choose to halt the study temporarily if serious concerns arise 
regarding participant safety. If the study is prematurely terminated or suspended, the PI 
will promptly inform study participants, the IRB, and Sponsor and will provide the 
reason(s) for the termination or suspension. Study participants will be contacted, as 
applicable, and be informed of changes to study visit schedule. If only suspended the 
study may resume once all concerns have been addressed, and satisfy the Sponsor, 
IRB, and/or the United States Food and Drug Administration (FDA). 
Data Handling and Recordkeeping 
No identifying information will be collected about the participant other than their signed 
consent. The consent form, which will be collected electronically, will be stored 
separately in a secure REDCap database. Participants will be assigned a unique study 
code that will be used to identify all study data.  Participant information such as age, 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 11 
gender, race, date of test, type of ear pathology present, if any, and prototype details, 
such as device ID number and ID numbers of major components of the prototype, will 
be recorded in secure REDCap database. The tympanometric data from the prototype 
device will be read by an Android app and/or UAMS laptop for the audiologist to 
interpret the result in real time. The Android devices and/or UAMS laptop will adhere to 
UAMS/AC mobile device requirements for research.  
Data collected will be stored in internal storage as well as on a secure digital (SD) card 
and will be copied daily to a secure REDCap database and/or UAMS Box account. Data 
from the prototype and the Android app and/or UAMS laptop will contain no identifying 
information. Only the appropriate study staff will have access to study data. These de-
identified data will be stored separately from the Informed Consent Forms, which will be 
the only source linking unique study identifiers with participants’ identities. Data will be 
stored on a UAMS password-protected server accessible only by the PI and study staff.  
The PI will carefully monitor study procedures to ensure the quality of the data and the 
integrity of the study. 
Participant study data collected using the devices will be destroyed after completion of 
the study. Audit documentation, consents, and other related records will be kept for 7 
years. Records will be kept for 7 years after final reporting or publication and then 
destroyed by shredding or deletion from computers per all applicable UAMS institutional 
policies and federal regulations. Deidentified data will be stored electronically indefinitely. 
Safety and Adverse Experiences 
Following consent, safety will be measured by assessment of AEs (serious and non-
serious) through the duration of the study. All corroborative information related to the 
AEs will be documented in the electronic medical record of the participant and filed with 
the source documents in secure REDCap database. 
Definitions 
Adverse Event (AE) 
An AE is any untoward, unintended, unfavorable, or undesirable medical occurrence, 
symptom, sign (including an abnormal laboratory finding), illness/disease, or experience 
that develops or worsens in severity during the course of the study, regardless of 
relatedness to the investigational device. This includes any new medical problem, or 
exacerbation of an existing problem, experienced by a participant while enrolled in the 
study, whether or not it is considered device related. Each AE is a unique 
representation of a specific event used for medical documentation and scientific 
analysis. 
Serious Adverse Event (SAE) 
SAEs are a subset of AEs. AEs are classified as serious or non-serious. An event is 
“serious” if it involves considerable detriment or harm to one or more persons (who may 
or may not be participants) or required intervention to prevent one or more persons from 
experiencing considerable detriment or harm. An SAE is any untoward medical 
occurrence that results in any of the following: 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 12 
• 
Death - (i.e., the AE actually causes or leads to death), 
• 
Life-threatening experience - (i.e., the AE, in the investigator’s opinion, places a 
participant at immediate risk of death. It does not include an AE that, had it 
occurred in a more severe form, might have caused death), 
• 
Inpatient hospitalization or prolongation of existing hospitalization, 
• 
Persistent or significant disability/incapacity (i.e., the AE results in substantial 
disruption of the participant’s ability to conduct normal life functions), 
• 
Congenital anomaly/birth defect in participant’s offspring, 
• 
Any other important medical event that, based upon appropriate medical 
judgment, may jeopardize the participant and may require medical or surgical 
intervention to prevent one of the outcomes listed above. Examples include 
allergic bronchospasm requiring intensive treatment in an emergency room or at 
home, blood dyscrasias or convulsions that do not result in inpatient 
hospitalization, the development of drug dependency or drug abuse, suicidal 
ideation or attempts, or the unintentional revealing of some genetic information to 
insurers. 
The term AE encompasses all adverse events. AEs are either serious (SAE) or non-
serious (non-SAE). To avoid confusion, as the terms “serious” and “severe” are not 
synonymous, the following clarification is given: The term “severe” is often used to 
describe the intensity (severity) of a specific event (as in mild, moderate or severe 
myocardial infarction); the event itself; however, may be of relatively minor medical 
significance (such as a severe headache). This is not the same as “serious”, which is 
based on participant/event outcome or action usually associated with events that pose a 
threat to a participant’s life or functioning. Seriousness (not severity) serves as a guide 
for defining regulatory reporting obligations [ICH-E2A(II)(B)]. 
Unanticipated Adverse Device Effects (UADEs) 
A UADE is any serious adverse effect on health or safety, or any life-threatening 
problem, or death caused by, or associated with, a device; if that effect, problem, or 
death was not previously identified in nature, severity, or degree of incidence in the 
investigational plan, or application (including supplementary application); or any other 
unanticipated serious problem associated with a device that relates to the rights, safety, 
or welfare of participants [21 CFR 812.3(s)]. Adverse device effects (ADEs) include any 
event that is a result of a use error or intentional misuse as well as any AE resulting 
from insufficiencies or inadequacies in the instructions for use, the deployment, the 
implantation, the installation, the operation, or any malfunction of the investigational 
device. 
Relatedness 
An AE is related if more likely than not it was caused by the research activity or if there 
is evidence to suggest a causal relationship to the study. Attribution categories are as 
follows: 
• 
Definite - The AE is clearly related to study treatment. The AE onset occurs in a 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 13 
plausible time relationship to study treatment and other contributing factors (e.g. 
concurrent disease or concomitant medications/treatments) can be ruled out. 
• 
Probable - The AE is likely related to study treatment. The AE onset occurs in a 
plausible time relationship to study treatment and the influence of other 
contributing factors (e.g., concurrent disease or concomitant 
medications/treatments) is unlikely. 
• 
Possible - The AE may be related to study treatment. The AE onset occurs in a 
plausible time relationship to study treatment; though, other factors (e.g., 
concurrent disease or concomitant medications/treatments) may have 
contributed to it. 
• 
Unlikely - The AE is doubtfully related to study treatment. The AE onset does not 
occur in a plausible time relationship to study treatment, and other contributing 
factors (e.g., concurrent disease or concomitant medications/treatments) are 
likely. 
• 
Unrelated - The AE is clearly NOT related to study treatment. There is not a 
causal relationship between the AE and the study treatment. 
Expectedness 
Unexpected AEs are those not listed in the device manual, protocol, or not identified. 
This includes AEs for which the specificity, nature, intensity, severity, incidence, or 
frequency is not consistent with the description in the device manual or protocol. 
Study Period 
Following consent, baseline/pre-existing conditions will be recorded and assessed until 
initiation of use of the study intervention. All AEs will then be recorded and assessed 
from the time of the initiation of study intervention through the end of the study visit in 
AE Case Report Forms. All AEs will be documented in the participant record (captured 
in source documents, including but not limited to the electronic medical record).  
Monitoring, Recording, and Reporting of AEs 
All participants will be monitored for AEs (serious and non-serious) during their 
participation in the study. AE data collection and reporting, which are required as part of 
every study, are done to ensure the safety of participants enrolled in the studies and 
those who will enroll in future protocols. 
All AEs occurring during the study period whether volunteered by the participant; 
discovered by study personnel during questioning; or detected through physical 
examination, observation of clinical symptoms, laboratory, pathological, radiological, or 
surgical findings, or other appropriate means must be recorded and reported 
appropriately. AEs are to be reported in a routine fashion and at scheduled times during 
the study. Certain AEs must be reported in an expedited fashion to allow for timely 
monitoring of participant safety and care. 
Pre-existing Conditions 
A pre-existing medical condition is any condition, laboratory abnormality, or physical 
finding with an onset date at the start of the study (prior to the initiation of the use of any 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
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IRB# 274552 
Date: 
03/7/2024 
Page 14 
study intervention). 
Pre-existing medical conditions should be reported as part of the participant’s medical 
and surgical history. All relevant historical medical conditions (as determined and 
documented by Investigator/ Clinician) that are known/diagnosed prior to the start of 
study procedures are to be recorded in the medical record. For the purposes of this 
study, pre-existing conditions may include presence of ear symptoms such as ear pain, 
draining, pressure, fullness, tinnitus, otorrhea, and/or presence of middle ear disease 
such as perforation, otosclerosis, cerumen impaction, retraction, effusion, ossicular 
chain discontinuity, cholesteatoma, myringitis, or tympanosclerosis. Any medical 
condition that is present at the time that the participant is consented will be considered 
as baseline and not reported as an AE. However, if the study participant’s condition 
deteriorates or exacerbates at any time during the study period, it will be recorded as an 
AE. A pre-existing medical condition should be re-assessed throughout the trial and 
reported as an AE only if the frequency, severity, or character of the condition worsens 
during the study. When reporting such events, it is important to convey the concept that 
the pre-existing condition has changed by including applicable descriptors (e.g., “more 
frequent headaches”). All AEs, which completely resolve and then recur, should be 
recorded as a new AE, regardless of relatedness. In addition to new AEs, any increase 
in the severity or frequency of a pre-existing condition that occurs during the study 
period is considered an AE. 
Diagnosis versus Signs and Symptoms 
If known at the time of reporting that a sign or symptom is one component of a 
diagnosis or syndrome, the diagnosis or syndrome should be reported as the AE (e.g., 
record only liver failure or hepatitis rather than jaundice, asterixis, and elevated 
transaminases). However, if a constellation of signs and/or symptoms cannot be 
medically characterized as a single diagnosis or syndrome at the time of reporting, it is 
acceptable to report the information currently available. If a diagnosis is subsequently 
established, it should be reported as follow-up information. 
Hospitalizations for Medical or Surgical Procedures 
If a participant is hospitalized to undergo a medical or surgical procedure as a result of 
an AE, document the event responsible for the procedure, not the procedure itself, as 
the SAE. For example, if a participant is hospitalized to undergo coronary bypass 
surgery, record the heart condition that necessitated the bypass as the SAE. 
Hospitalizations or prolonged hospitalization required to allow efficacy measurement for 
the study, for scheduled therapy of the target disease, or for diagnostic or elective 
surgical procedures for pre-existing conditions do not require reporting. 
Follow-Up of AEs 
The clinical course of each event should be followed until resolution, stabilization, or 
until it has been determined that study participation is not the cause. If an AE does not 
return to baseline, the resolution date is recorded as “ongoing”. Any AEs/SAEs that are 
still ongoing at the end of the study period must be followed for up to 30 days to 
determine the final outcome. Any SAE occurring more than 30 days after the study 
period and is considered possibly/probably/definitely attributable to the investigational 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 15 
device must be recorded and reported immediately to the Sponsor. 
After testing with the prototype mHealth tympanometer and at the end of the scheduled 
audiology visit, participants will be evaluated for any potential AEs related to the device 
or study.  This will be documented in the participant record. Any AEs discovered during 
this contact will be assessed, documented and reported according to the investigational 
plan as outlined in this section. 
Assessment of AEs 
Each reported AE or SAE will be described by its duration (i.e., start and end dates), 
regulatory seriousness criteria if applicable, suspected relationship to the investigational 
device (see following guidance), and actions taken. To ensure consistency of AE 
causality assessments, investigators should apply the following general guideline. 
The reporting of these events depends on the characteristics of the event: 
1. Seriousness (grading of event) 
2. Relatedness to use of the investigational device or study procedure 
3. Expectedness 
Steps to Determine if the Event Requires Expedited Reporting: 
1. Identify/describe the type of event. 
2. Grade the severity of the event as follows: Mild, Moderate, Severe. 
3. Determine whether the AE is related to the investigational device. Attribution 
categories are as follows: Definite, Probable, Possible, Unlikely, and Unrelated. 
4. Determine expectedness of event. Expected events are those previously 
identified resulting from use of the investigational device. An AE is considered 
unexpected when the type or severity of the event is not listed in the protocol or 
device manual. 
Expedited Reporting of AEs 
The PI is responsible for ensuring that all AEs/SAEs observed or reported during the 
study are collected and reported to the Sponsor and the UAMS IRB in accordance with 
21 CFR 812. 
The PI/study staff should immediately report to the Sponsor any SAE, regardless of 
relatedness to the study, including those listed in the protocol or device manual, along 
with an assessment of whether there is a reasonable possibility that the device caused 
the event. Investigators should immediately notify the Sponsor of any adverse device 
effect within 24 hours of first learning of the event. UADEs should be reported using the 
MedWatch Form FDA 3500A. Although an event may be considered ‘serious’ based on 
previous criteria and should be reported to ORRA immediately, not all SAEs or ADEs 
meet IRB expedited reporting criteria. 
IRB Reporting 
Any serious or immediately life-threatening AE, including those resulting in death, 
occurring while the participant is actively participating in the study will be reported to the 
UAMS IRB. Only AEs meeting the Unanticipated Problem Involving Risks to 
Participants or Others (UPIRTSO) criteria will need to be reported to the UAMS IRB 
within the required 10-day allotment of being notified of the event. UPIRTSO requires 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 16 
that an unanticipated problem meet the following qualifications: a) unanticipated or 
unexpected; b) related to the research; and c) involves new or increased risk to the 
participant(s) (including physical, psychological, economic, or social harm). Examples of 
other UPIRTSOs include theft of a computer containing participant information or 
incarceration of a participant (if not approved for research on prisoners). UPIRTSO may 
or may not result in actual harm. 
 
All other AEs should be recorded and reported to the UAMS IRB at Continuing Review 
and on the Annual Progress Report (APR). 
The Investigators must report any UADE to the IRB within 10 working days after 
learning of it. 
Sponsor Reporting  
The Sponsor will be promptly notified of all potential SAEs/UADEs by the 
investigator/study staff using the MedWatch Form FDA 3500A. The Sponsor will 
evaluate all potential SAEs/UADEs and report these evaluations in accordance with 21 
CFR 812. 
The results of any UADE evaluation by the Sponsor, regardless of the findings, must be 
reported to the FDA and the IRB 10 working days after the Sponsor learns of the 
potential UADE. 
All other SAEs not expeditiously reported will be reported to the Sponsor for the APR 
and submitted to the IRB at the time of Continuing Review. 
All deaths that occur during the study period will be reported to the Sponsor as soon as 
possible, preferably within 24 hours, but no later than 48 hours, of learning of the 
participant’s death, regardless of relatedness to the device or the study. A death due to 
a terminal condition of the research participant would be considered anticipated and not 
related to the research. 
The Sponsor will report deaths in accordance with 21 CFR 812. 
Clinical Site Monitoring 
Clinical site monitoring will be conducted by the UAMS ORRA to ensure that the rights 
and well-being of human participants are protected, that the reported trial data are 
accurate, complete, and verifiable from source documents, and that the conduct of the 
trial is in compliance with the currently approved protocol/amendment(s), International 
Council of Harmonisation good clinical practices, and applicable regulatory 
requirements. 
Monitoring specialists from the UAMS ORRA will conduct periodic, comprehensive 
monitoring (either on-site or remote) as determined by a protocol specific monitoring 
plan, which will be provided to the Investigator by ORRA Monitoring Unit. 
 
 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 17 
Deviations and Violations 
Protocol Deviation  
Any unintentional change, divergence, or departure from the study design or procedures 
defined in the protocol. Protocol deviations will be tracked and compiled in a Protocol 
Deviation Log. Deviations that potentially cause concern for the participant’s health, 
safety, or rights will be reported to the Sponsor as soon as possible for guidance on 
reporting. 
Protocol Violation  
A change to, or non-compliance with, the IRB-approved procedures without prior 
Sponsor and IRB approval (excluding changes made to eliminate apparent immediate 
hazard to participants). A violation may affect health, safety, or rights of a participant. 
Any violation will be reported immediately to the Sponsor for guidance on reporting. 
If the protocol deviation/protocol violation does not represent a significant alteration in 
the approved protocol and/or affect the safety or welfare of the participant, it will be 
reported to the UAMS IRB at the time of Continuing Review. If the protocol 
deviation/violation represents a significant alteration in the approved protocol and/or if it 
affects the safety or welfare of the participant, it must be reported to the Sponsor and 
UAMS IRB immediately. 
Study Stopping/Pausing 
This study is low risk, and no adverse experiences are anticipated. The device is being 
designed with adherence to all the safety considerations established in IEC 60645-5. 
Each device will be labeled with a unique identifier that will correlate with specific 
hardware and firmware versions to allow performance and any adverse events to be 
recorded and a full root cause analysis (RCA) to be performed.  If there are concerns 
during measurement such as discomfort reported by the patient, or device malfunction 
reported by the clinician, testing will be stopped immediately. The issue will be 
documented, reported to the PI, and the device will no longer be used until a full RCA 
has been performed. If this issue can be resolved immediately, then testing will be 
restarted with the participant. If the issue cannot be resolved immediately (i.e., within 
the duration of the clinical appointment), then the data will be considered incomplete 
and additional participants will be recruited in order to meet recruitment goal of 40 adult 
ears with complete data and 20 child ears with complete data. The participant will still 
receive the $20 gift card. While both ears will be tested, if data can only be obtained in 
one ear, the participant will still be considered to have completed the study as long as 
results from both the devices can be obtained for that ear.  Any safety concerns will be 
reported to the PI, ORRA, and the UAMS IRB. Any event related to changes in consent 
form, protocol, or inadvertent disclosure of confidential information will be reported to 
the IRB. 
 
 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 18 
Data Analysis 
Pilot Validation Analysis 
Analyses for the pilot validation will include: 1) comparison of categorical classifications 
of tympanogram types for the commercial vs prototype devices; 2) evaluating potential 
intra-participant correlation between ears; 3) assessing differences in numerical 
measures between the commercial and prototype tympanometer; and 4) evaluating 
performance of mHealth tympanometer and commercial tympanometer.  
1) For each device, commercial and prototype, tympanograms with be categorized 
into one of 3 categories:  A, B and C.  To assess the agreement between the two 
devices with respect to categories, Bowker’s test of symmetry and the Kappa 
coefficient conventional methods to assess agreement, will be used.  For the 
initial analysis, both tympanograms will be performed for each ear and no 
adjustments will be made for participants (i.e., most will have both ears included).   
2) To assess the potential effect of participant and ear status (normal, diseased) for 
participants where both ears are included, each participant’s ears will be 
characterized as (both normal, both diseased, one diseased and one normal).  
Within those categories, the number of ears for which there is concordance 
between the two tympanograms for each participant will be 0, 1 or 2.  Pearson’s 
chi-square test will be used to compare the three groups defined by ear status 
with respect to the distributions of the number of ears with concordance. 
3) The Wilcoxon signed rank test will be used to determine if the differences in the 
numerical measures (ear canal volume, static admittance and tympanometric 
peak pressure) obtained from the commercial and prototype devices are 
significantly different from zero.  No adjustment for multiple testing is planned.  
4) Audiologist assessment of the mHealth and commercial tympanometers will be 
captured through questionnaires which assess 4 performance measures using a 
5-point Likert scale.  For each performance measure, the Kappa coefficient and 
Bowker’s test of symmetry will be used to assess agreement between the two 
mHealth and commercial tympanometers with respect to responses. 
A minimum of 30 participants will be enrolled.  Both ears will be used for each patient 
enrolled, with enrollment remaining open until 60 ears (40 adult and 20 pediatric ears) 
are accrued to ensure that there are sufficient number of ears for analysis.  It is possible 
that more than 30 participants will be required to accrue 60 ears if we are unable to 
obtain a tracing on one or both ears in certain patients (such as due to a draining ear, 
which inhibits formation of a seal). We anticipate consenting no more than 40 
individuals to reach the enrollment goal of 30 participants. With a sample size of 30 
participants (60 ears), a null hypothesis where kappa is 0 (no correlation between 
devices) can be tested against the alternative hypothesis of kappa of 0.3 using a two-
sided 0.05 significance level with a power of 0.89.  

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 19 
Machine Learning Algorithm Analysis 
The categorizations of the tympanogram (Type A, B, C) classified by the algorithm will 
be compared with the audiologists’ interpretations.  To assess agreement between the 
audiologist and the algorithm, Kappa analysis and Bowker’s test of symmetry will be 
performed.  
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and UAMS research policies and procedures.  This protocol and any amendments will 
be submitted and approved by the IRB as required.  
For recruitment and eligibility determination, a partial HIPAA waiver will be obtained. 
PHI access under the partial HIPAA waiver will entail using the clinic schedule to screen 
for potential participants by their age and reason for visit. Reason for visit will be used to 
determine middle ear status and whether tympanometry is likely to be performed as part 
of the clinical visit.  
For eligible participants and parents/guardian of eligible children, informed consent 
using IRB-approved consent materials, will be obtained before the participant begins 
any study procedures and will be performed electronically using a secure REDCap 
database. All participants for this study will be provided an electronic informed consent 
form (e-consent) describing this study in language understandable to the study 
population.  
Consent materials will provide sufficient information for participants/parent/guardian to 
make an informed decision about participation in this study.  The person obtaining 
consent will thoroughly explain what the participants/parent/guardian need to know 
about the study, including study requirements, and study risks and benefits.  
The consent process will take place while the prospective participant is attending their 
audiology evaluation in the audiology clinic. The consent discussion will occur prior to 
routine tympanometry.  Participation privacy will be maintained, and questions regarding 
participation will be answered.  No coercion or undue influence will be used in the 
consent process.  
This consent form must be signed by the participant or parent/guardian and the person 
obtaining the consent.  An e-consent form will be presented to the 
participants/parent/guardian for review, which may be electronically signed. The 
participant/parent/guardian will receive an electronic copy of the signed consent form 
execution, and if requested, a hard copy will be provided. The informed consent process 
will be documented in the electronic medical record.  We will obtain informed consent 
for adults 18 years and older. In case of eligible children, informed consent will be 
obtained from parent/guardian and an assent will be sought from children 7 years and 
above in accordance with UAMS IRB Policy 17.1 Special Populations: Children in 
Research and parental consent will be obtained. 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 20 
Compensation 
Adult participants and families of child participants will receive a $20 electronic gift (e-
gift) card after completing the study. Participants will complete a gift card form in 
REDCap that will be separate from study data. The e-gift card will be provided through  
UAMS approved e-gift card system and sent to the participant’s (or caregiver’s) email 
address. If the participant prefers not disclosing their email address in REDCap, a 
research email account will be used to process the e-gift card and a printout of the e-gift 
card will be provided to the participant.  
Data Storage and Sharing 
Data from the study will be stored in electronic medical records, paper forms, a secure 
REDCap database and/or UAMS Box. Any deidentified data from the study necessary 
for refinement of the device will be shared with our biomedical engineer collaborators at 
Duke University. This pilot validation study will support a larger NIH-funded R33 grant 
application, with University of Pretoria, our commercial collaborator hearX, and Duke 
University as partners. Data from the validation study will be shared with our partners as 
needed to prepare the R33 grant application, which involves a larger clinical validation 
study. Duke University, University of Pretoria, and hearX will have access to deidentified 
data that will be shared via a secure REDCap database. Deidentified raw data and 
aggregate findings of the study will be shared with these collaborators for the continued 
co-development of the mHealth tympanometer. 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. The 
publications will not contain any identifiable information that could be linked to a 
participant. The study will be listed on ClinicalTrials.gov, and information will be updated 
in a timely manner in accordance with FDA and institutional requirements. 
 
 

Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 21 
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Title: 
"Pilot Validation of a Prototype Mobile Health Tympanometer" 
PI: 
Susan Emmett, MD, MPH 
Institution: 
University of Arkansas for Medical Sciences 
 
Version #: 
5 
Protocol 
IRB# 274552 
Date: 
03/7/2024 
Page 22 
12. Jung D, Bhattacharyya N: Association of hearing loss with decreased 
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