Investigation of Direct-to-consumer Hearing Aids on Conversation Efficiency and Listening Effort
Phase: NA
Conditions: Hearing Loss, Hearing Loss, Sensorineural, Hearing Loss, Bilateral
Sponsor: Northwestern University

TITLE: InvesƟgaƟon of direct-to-consumer hearing aids on conversaƟon eﬃciency and listening 
eﬀort 
IRB: #STU00217791  
NCT: #NCT05855005 
Date approved: 12/08/2022 

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STUDY TITLE:
Investigation of direct-to-consumer hearing aids on conversation efficiency and listening effort
PRINCIPAL INVESTIGATOR:
Name: Pamela Souza
Department: Communication Sciences and Disorders
Number: 847-491-2433
p-souza@northwestern.edu
CO-INVESTIGATORS:
N/A
STUDENT INVESTIGATOR (complete this section only if the project is student-initiated):
Name: Grace Szatkowski
Department: Communication Sciences and Disorders
Number: 234-706-0495
graceszatkowski2026@u.northwestern.edu
Are you an:
☐ Undergraduate Student
☒ Graduate Student or Medical Student
VERSION DATE:
12/8/2022
RELATED STUDIES: 
(STU00211218) This study has a similar experimental protocol, looking at the benefits of direct-to-
consumer hearing aids for adults with hearing loss and mild cognitive impairment. The proposed study 
listed here will not include adults with cognitive impairment.
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Check any applicable boxes in the table below – you will be asked for further detail on 
these topics later in the protocol form:
Indicate Vulnerable Populations to be enrolled:
☐ Children 
☐ Cognitively Impaired Adults  
☐ Pregnant Women (IF the research activities will affect the pregnancy or the fetus)
☐ Prisoners (or other detained/paroled individuals) 
☐ International Research (check this box if you will collect data from individuals located 
outside the United States)
☐ Research involving external collaborators (some research activities will be carried out by 
individuals not employed by Northwestern or NU affiliates will carry out some research 
activities)
☐ Research has U.S. Federal government funding via one or more direct awards or a sub-
award (i.e., NIH, NSF, other federal agencies or departments)
1.0
Purpose and rationale of the study:
 Hearing loss is the third most common chronic health condition in the United States, affecting 
individuals of any age. According to the National Institute on Deafness and Other Communication 
Disorders approximately 15% of all adults over age 18 in the United States have reported some trouble 
with their hearing, and one in eight people in the United States (about 30 million) aged 12 and older 
have hearing loss in both ears. However, about 28.8 million US adults who could benefit from hearing 
aids do not wear them.
The current model of dispensing hearing aids could be a barrier to adoption by those who could 
benefit from amplification. For instance, the average cost of conventional hearing aids ranges from 
$4000-5000 a pair, and this cost alone is often paid out of pocket due to limited insurance coverage 
for hearing care. Sound quality self-adjustments are highly restricted to the patient and vary based on 
manufacturer preferences and recommendations. Program changes are controlled by a licensed 
audiologist or hearing aid dispenser with the manufacturer’s software for sound quality adjustments. 
Also, appointments are common to fine-tune the hearing aids to meet the patient’s hearing needs, to 
replace the devices, or to repair them. These additional appointments are typically paid for out-of-
pocket. The burden of upkeep, including not just the expense of office visits, but also the regular 
maintenance and care required for proper device functionality, may not only affect patients but their 
family members, loved ones, or caregivers. This is particularly true if transportation to and from 
appointments as well as if the availability of a caregiver or family member is limited. Thus, obtaining 
conventional hearing aids can carry with it the burden of affordability and reliance on the audiologist 
for regular maintenance. Mentioned are a few of many significant factors that could be contributing 
to the statistically low hearing aid adoption rates among adults who need them.
An alternative to conventional hearing aids, direct-to-consumer (DTC) hearing aids, have been 
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available for consumer purchase for years. Originally created as ‘self-fitting’ devices, these were 
marketed as personal sound amplification products, known as PSAPs. PSAPs were not meant to be 
used for hearing loss treatment, but rather more commonly as amplifiers for personal choice or 
recreational use such as for hunting. However, the Food and Drug Administration (FDA) issued a 
proposal in 2021 to make hearing care more accessible for Americans, known as the Over-the-Counter 
Hearing Aid Act, part of the FDA Reauthorization Act of 2017. Unlike PSAPs, DTC hearing aids in this 
Act would be considered a treatment option for hearing loss. Different from conventional hearing aids, 
these devices will not require appointments to an audiologist for adjustments. Due to their 
affordability and easy access, DTC hearing aids have the potential to reach more individuals with 
hearing loss. Despite the many potential benefits that DTC hearing aids could offer, there is little 
research into their use to meet unique patient listening needs and the accuracy of self-guided hearing 
aid fittings. 
In order to better understand if DTC hearing aids may be a viable treatment option, it is 
important to consider patient reports. One of the most common complaints reported by patients is 
that listening is effortful, even when speech is loud enough. The Framework for Effortful Listening 
(FUEL) model developed by Pichora-Fuller and colleagues (2016), defines effortful listening as the 
“deliberate allocation of mental resources to overcome obstacles in goal pursuit when carrying out a 
task.” Research has shown that despite individualizing hearing aid programming to meet amplification 
targets as recommended by verification measures of output gain, audibility alone cannot resolve a 
damaged auditory system. Cognitive influence on auditory performance is an important consideration 
to hearing healthcare and the future of DTC devices. The complex process of comprehending and 
responding to incoming auditory stimuli requires intact cognition attuned to individual listening needs 
and differences. To the best of our knowledge, there exists a gap in research regarding cognitive 
processes involved in listening, particularly effort, with DTC hearing devices. 
.
Currently available DTC and OTC devices that will be used for this study are listed here.
1. Bose SoundControl hearing aids: Currently listed within the U.S. Food and Drug Administration 
(FDA) as FDA cleared for regulatory class II as a self-fitting air conduction hearing aid in 2021. 
2. Neosonic MX RIC-R hearing aids: Neosonic hearing aids been cleared and approved by the FDA as 
OTC hearing devices to treat mild to moderate hearing loss in adults over the age of 18 since 2022.
3. MDHearing Volt hearing aids: The MDHearing Volt has been cleared and approved by the FDA as 
medical devices to treat mild to moderate hearing loss in adults over the age of 18 since 2022.
2.0
Enrollment Criteria (who can be in your study and who would not be eligible to 
participate in your study):
Inclusion criteria of participant: 
1. Adults ages 18-90 years
2. Speak English as their primary language 
3. No vision impairment that would interfere with the ability to complete study tasks (i.e., 
legally blind, severe cataracts, or macular degeneration)
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4. Bilateral mild to moderate sensorineural or mixed hearing loss 
5. Pass a cognitive screener
6. Minimum Grade 10 education
7. Ability to attend all study visits
Inclusion criteria of communication partner: 
8. Adults ages 18-90 years
9. Speak English as their primary language 
10. No vision impairment that would interfere with the ability to complete study tasks (i.e., 
legally blind, severe cataracts, or macular degeneration)
11. Normal or corrected-to-normal hearing ability (i.e., use of hearing aids)
12. Pass a cognitive screener
13. Minimum Grade 10 education
14. Ability to attend all study visits
Exclusion criteria of participant/communication partner:
1. Clinically significant unstable or progressive medical conditions, or conditions which, in the 
opinion of the investigator(s) places the participant at unacceptable risk if he or she were to 
participate in the study 
2. History of unresolved communication difficulties following another neurological problem 
(i.e., stroke or brain tumor), neurodevelopmental disorder (i.e., Down’s syndrome), or 
head/neck cancer
3. Diagnosis of dementia or cognitive impairment
4. Positive history of major psychiatric disorder (i.e., schizophrenia, significant untreated 
depression)
5. Co-enrolled in other intervention studies targeting hearing, language, or communication 
strategies
6. History or current fluctuating hearing loss 
7. Evidence of conductive hearing loss 
8. Current active hearing aid wearer (defined as wearing hearing aid(s) at least 4 hours a day 
for most days within the past year)
9. Current active hearing aid wearer within 30-day trial period of purchased hearing aids from 
a licensed provider
For the purposes of test validation and calibration, we may also enroll a small group (n=10) of 
listeners with normal hearing, defined as pure-tone thresholds of 20 dB HL or less at octave 
frequencies between 250 and 4000 Hz. With the exception of having normal hearing, those 
participants will follow the inclusion and exclusion criteria described above. 
We will not include any other special populations (adults unable to consent, individuals under 18 
years of age, pregnant women, or prisoners or other detained individuals).
3.0
Sample Size:
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A study evaluating eye gaze and communication ability with hearing loss during the Diapix 
Conversation Analysis (Davis et al, 2017; DOI: 10.21437/AVSP.2017-3), found a significant 
difference in their group of 19 dyads. Participants had hearing loss. To our knowledge, this is the 
only study with the most comparable methods to our study. 
We will plan to collect data on 30 dyads (30 participants and 30 communication partners). We 
anticipate having 20 dyads by the end of our study, with 30 dyads set for room for dropouts. For 
visit 1 of the study, both parties will be required to attend the sessions. For visit 2, the 
communication partner does not need to attend. Historically less than 10% of participants drop out 
of studies within our lab. However, due to COVID19, we anticipate the possibility of higher-than-
average dropouts.
The sample will consist of adults at least 18 years of age and older and their communication partner 
also be at least 18 years of age or older to participate. 
4.0
Recruitment and Screening Methods:
Prior to scheduling any appointments, a brief phone screening will be conducted with the 
participant to obtain basic eligibility criteria (i.e., age, location, availability, language, 
current/previous hearing aid use). Prior to study enrollment, potential participants will agree to 
have their hearing and cognition completed with prior authorization via screening consent form. 
These preliminary screening tests will allow us to exclude ineligible participants from enrolling in 
the study.
Participants will be recruited from a variety of sources: 
1. A within-laboratory participant pool of prospective participants that has been established 
by the primary investigator. Letters and emails will be sent to those who have previously 
agreed to be contacted for new studies.
2. Flyers and brochures posted around Northwestern University’s campus, off-campus 
community bulletin boards, and relevant online community message boards (Nextdoor, 
Facebook).
3. Northwestern University Center for Audiology, Speech, Language, and Learning. Clinicians 
will receive a set of participant criteria. When possible, patients seen for clinic appointments 
that meet the criteria will be provided information about the study.
4. Postings to the investigators’ websites and social media accounts.
5. Direct contact with persons interested in the study referred from outside sources. 
6. Local senior and community activity centers, and local chapters of the Hearing Loss 
Association (HLAA). 
7. Patient registries through the CNADS at Northwestern and the Communication Registry. 
8. Local newspaper advertisements. 
Participants who are interested in the study will contact the study coordinator via phone or email 
provided in the recruitment material. Prior to scheduling any appointments, a brief phone screening 
will be conducted to obtain basic eligibility criteria (i.e., age, location, availability, language, 
current/previous hearing aid use). Prior to study enrollment, potential participants will agree to 
have their hearing evaluated with prior authorization via screening consent form. These preliminary 
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screening tests will allow us to exclude ineligible participants from enrolling in the study. 
5.0
Research Locations:
The main locations are Hearing Aid Lab spaces located in Frances Searle on Northwestern’s Evanston 
Campus, private treatment rooms at Northwestern University Center for Audiology, Speech, 
Language, and Learning (NUCASLL); and the satellite School of Communication’s research space 
located in Abbott Hall on Northwestern University’s downtown campus. Data collection locations 
will be secured and kept in private, research-dedicated spaces that are accessed via key or keypad 
that are not accessible to the general public.  
Some study visits may be conducted remotely via video conferencing software. Research staff will 
conduct these visits from a private space (in their home or in a research lab/clinic) that is secured 
from unintentional access by others not involved with the study. The virtual visits will be conducted 
through a School of Communication Information Technology-approved video-conferencing interface 
(i.e., WebEx, Zoom with password protection). 
6.0
Multi-Site or Collaborative Research: 
N/A
7.0
International Research (where data collection will occur outside the United States 
and U.S. territories, including online activities)
N/A
8.0
Procedures Involved:
Please check the boxes for all applicable data collection procedures you plan to use:
☒One-on-one interviews
☐Focus Groups
☒Questionnaires/surveys
☐Secondary Data Analysis (medical record data, educational records, government, or private sector 
datasets, etc.)
☐Ethnographic observation
☒Physiological measurements (i.e., EEG, EKG, MRI)
☐Biospecimen collection (saliva samples, blood draws, hair samples, etc.)
☐Mobile applications/data collection devices (i.e., Fitbits, actigraphs, etc.)
☒Behavioral decision-making tasks (i.e., puzzles, interactive games, etc.)
☐Physical activities such as walking and other forms of exercise
☒Other procedures (briefly list types of procedures here if not covered by the check-boxes above): 
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_Audiologic Assessment (hearing test and otoscopy), real ear measurement (hearing aid assessment)
Approach: 
This is a within-subjects design and participants will wear hearing aids only during scheduled lab 
visits. Participants will not take the hearing aids outside the lab or home with them. The expected 
total duration of the study is 2-4 visits based on the typical timing of assessments and procedures. 
The range of duration of scheduling and visits will occur at times convenient for the participants. 
Although the study is sectioned into three visits (Eligibility, visit 1, and visit 2) participants can merge 
visits together (such as Eligibility and visit 1) into one visit, or split up a visit (i.e., such as changing 
visit 2 to two separate visits) based on the participant’s schedule and convenience. 
Timeline                                                                                                                                                                    .
                       
(1) Eligibility Screening: (Approximately 60-90 minutes, in person) The Eligibility Screening will 
consist of inclusion questionnaires, communication questionnaires, and audiologic assessment. Both 
the participant and communication partner can be present for this visit and will both complete all 
testing for the Eligibility Screening.
If the participant and/or communication partner has had an audiologic assessment within the past 
year, then they are welcome to bring those results with them to their Eligibility Screening. If both 
the participant and communication partner have hearing assessment results from within the past 
year, then both of them will not be required to complete an audiologic assessment in the laboratory. 
If only one or neither member of the dyad has had an audiologic assessment within the past year, 
then the one member or both will complete an audiologic evaluation within the laboratory prior to 
visit 1. 
Inclusion 
Questionnaires
Hearing health and history questionnaire: 
Participants will be asked questions 
regarding their hearing health history in an 
interview style format. If done remotely, 
this can be completed via phone or video 
chat.
MoCA: with a score >24 (within normal 
limits): The Montreal Cognitive assessment 
is a cognitive screening test designed to 
detect mild cognitive impairment. It 
requires approximately 10 minutes and 
assesses short-term recall, visuospatial 
abilities, executive function, attention, 
working 
memory, 
language, 
and 
orientation to time and place. This may be 
administered remotely via phone/video 
chat or in-person.
Data 
Collection 
Time:
 20-30 
minutes
Questionnaires 
have 
no 
risk 
involved 
for 
the 
participant
Communication Communication Participation Item Bank Data 
Questionnaires 
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Questionnaires
(CPIB): This measure was designed for 
hearing 
and 
communication 
across 
different communication disorders and life 
situations. Items probe the extent to which 
the participant’s condition interferes with a 
range of interpersonal speaking situations. 
Unidimensional Relationship Closeness 
Scale (URCS): This questionnaire describes 
the relationship between the participant 
and their communication partner.
Speech Spatial and Quality Scales (SSQ-
12): 
a 
self-assessment 
of 
speech 
understanding, spatial hearing, and other 
qualities of sound on a scale ranging from 0 
to 10, with higher scores towards 10 
suggesting little to no difficulty.
Hearing Handicap Inventory for Adults 
(HHIA): self-assessment scale containing 25 
items of two subscales (emotional and 
social/situational). 
The 
assessment 
measures perception of emotional aspects 
and social limitations perceived by the 
individual with hearing loss.
Collection 
Time: 
30-40 
minutes
have 
no 
risk 
involved 
for 
the 
participant
Audiologic 
Assessment
Otoscopy: Standard clinical procedure to 
look into the ear to observe the eardrum 
and ear canal. 
Audiometry (Air & Bone Conduction): 
Study 
audiologists 
will 
complete 
an 
audiologic evaluation, including: pure-tone 
air conduction thresholds at 0.25, 0.5, 1, 2, 
3, 4, 6, 8 kHz; pure-tone bone conduction 
thresholds at 0.5, 1, 2, 4 kHz; speech 
discrimination in quiet and in noise. If 
medically necessary, tympanometry, a 
measure of middle ear function, may be 
performed. This procedure would be 
necessary if one or more of the following 
conditions are met: the eardrum is not 
clearly visible with otoscopy (whether by 
scarring 
on 
the 
eardrum, 
earwax 
obstructing some view of the eardrum, or 
any other condition that makes viewing the 
Data 
Collection 
Time: 
15-20 
minutes
Otoscopy, 
audiometry, 
and 
QuickSIN 
are 
standard 
clinical 
procedures with no 
risk 
to 
the 
participant.
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eardrum difficult), and/or if the patient 
complains of pressure or fullness of one or 
both ears, and/or if there is a conductive 
component on the audiogram and the 
eardrum appears normal. 
QuickSIN: This is a clinical auditory test that 
consists of low-context sentences in a 
background of 4 talker babble. The speech 
is set to an audible level and the noise is 
gradually increased. Research participants 
verbally repeat as much of the sentence as 
possible.
(2) Visit 1: (Approximately 100-120 minutes) Visit One will consist of the hearing aid fitting and 
verification, and the Diapix Conversation Analysis both in aided and unaided conditions for the 
participant. The communication partner will be present and participate in the Diapix Conversation 
Analysis with the participant. Only the participant will be fit with hearing aids.
A pair of the listed hearing aids will be fit on participants comparing two settings; (1) a self-fit setting 
made by participants following the manufacturer’s recommendations, and (2) an audiologist-fit 
setting. All participants will undergo both an initial self-fit and then complete testing with the 
audiologist-fit settings. Participants will be tested with or without the audiologist-fit settings at 
random with an equal allocation among participants within testing materials. Due to the within-
subject nature of this trial, a blinded trial is not possible. However, every effort will be made to avoid 
comparisons of self-fit and audiologist-fit algorithms to minimize participant and researcher bias in 
verbal and written communication with the participants. 
Hearing Aid 
Fitting 
& 
Verification 
Hearing Aid Fitting: The participant will be 
instructed on how to insert the hearing aid 
into their ear(s) and will follow step-by-step 
instructions on a hearing aid application on a 
cell phone to fine-tune the hearing aid to their 
preferred settings. Then, the audiologist will 
made additional adjustments using hearing 
aid verification process to fine-tune the 
hearing aid to the participant’s audiologic 
pure tone thresholds.
Hearing 
Aid 
Verification: 
Hearing 
aid 
verification involves the use of a soft probe tip 
microphone into the ear canal with the 
hearing aid situated in the ear canal correctly. 
The participant will hear sentences of soft, 
average, and loud intensity as the software is 
measuring the output gain of the hearing aid 
Data 
Collection 
Time:
 15-30 
minutes
Hearing aid fitting 
and verification are 
standard 
clinical 
procedures. 
Minimal to no risk for 
hearing aid fitting: 
patient may perceive 
hearing aids as louder 
than anticipated, and 
adjustments will be 
made to ensure the 
hearing 
aids 
are 
programmed 
to 
a 
comfortable listening 
level 
that 
is 
not 
hazardous to hearing. 
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and comparing it to the recommended NAL-
NL2 targets based on the participant’s 
audiometric pure tone thresholds.
Minimal to no risk for 
hearing 
aid 
verification: 
during 
verification, 
participant will have a 
very 
soft, 
flexible 
probe 
tube 
microphone placed in 
the ear to measure 
the output of the 
hearing aid as it is 
sitting 
in 
the 
participant’s ear. The 
probe tip may feel 
“ticklish” or may feel 
odd 
in 
the 
participant’s 
ear 
canal. Efforts will be 
made to ensure the 
participant 
is 
comfortable 
during 
all procedures.
Participant 
is 
welcome to take a 
break at any time 
without 
consequence.
Diapix 
Conversation 
Analysis
Diapix Conversation Analysis: Consists of 
derived measures including proportion of 
trouble sources, proportion of unsuccessful 
repairs, proportion of complex repairs: 
video and audio recording will be collected 
from 
each 
participant/communication 
partner dyad at two timepoints: pre-fitting 
(unaided), and wearing the hearing aid 
(aided). Conversation data will be collected at 
one of our research sites, or remotely. If 
conversation 
data 
is 
collected 
in 
a 
participant’s home or remotely, study staff 
will survey the environment removing (or 
positioning recording equipment to avoid 
recording) any personally identifying or 
sensitive 
information 
(i.e., 
mail 
with 
addresses, pictures of young children or 
unconsented 
individuals, 
personal 
Data 
Collection 
Time:
70-90 
minutes
Minimal to no risk: 
Minimal 
risk 
of 
boredom or minimal 
fatigue with task. 
Participant 
is 
welcome to take a 
break at any time 
without 
consequence.
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documents) prior to recording. If in person, 
the study team will replace these items once 
data have been collected as part of the 
session clean-up routine. Conversation data 
will be collected using standardized Diapix 
conversation 
tasks. 
The 
participant-
communication partner pair will be seated 
approximately 3-5 feet apart with a barrier 
between them and will be instructed to 
describe standardized picture stimuli from to 
their partner (partner is not able to see the 
primary 
speaker’s 
picture 
but 
has 
a 
companion picture of their own). The goal of 
the conversation task is to have the partner 
use the primary speaker’s description to 
identify up to 12 objects that are missing on 
their picture, but present on the primary 
speaker’s picture. The Diapix sampling 
method is a standard approach for
collecting conversation samples (Baker & 
Hazan, 2011). The Diapix pictures are freely 
available to the research and clinical 
community and can be found through the 
Northwestern 
Online 
Speech/Corpora 
Archive and Analysis Resource (OSCAAR;
Kendall, 
2010; 
http://oscaar.ling.northwestern.edu/). 
(3) Visit 2 (Approximately 60 minutes): The second visit will consist of tasks of executive functioning 
(Stroop Task, Flanker Task) and a physiological measurement (pupillometry) to measure listening 
effort during the Rapid Recall Task (RRT). Only the participant will attend visit 2.
Tasks 
of 
Executive 
Functioning
Stroop Task: This is a measure that assesses 
reaction time and conscious versus automatic 
visual 
processing. 
This 
test 
takes 
approximately 5 minutes to administer. 
Participants are instructed to read black text 
that indicate the names of colors, as quickly as 
possible. The second part of the assessment 
includes participants seeing colored lines, and 
they are instructed to name the colors on the 
page as quickly as they can. The third part of 
administration is the participant will then be 
given a list of color names, where they say the 
color of each word, not read the text itself. For 
example, if the word “yellow” was written in 
Data 
Collection 
Time: 
10-15 
minutes
Minimal to no risk: 
Boredom 
and 
minimal fatigue may 
occur during testing. 
Participant 
is 
welcome to take a 
break at any time 
without 
consequence. 
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green ink, the correct response is “green”. 
Participants are timed for each of the three 
segments. 
The Flanker Test: We will administer two tasks 
tapping this interference control ability and 
compute a z-score aggregate to obtain a stable 
estimate. 
In 
the 
arrow 
flanker 
task, 
participants see a > or < sign, surrounded by 
two > or < signs on either side (i.e., >>>>>, 
<<><<). Their task is to focus on the middle 
sign and decide whether that sign is pointing 
to the left or the right as quickly and as 
accurately as possible by pressing one of the 
two buttons (left or right). The reaction time 
difference between the compatible (i.e., 
>>>>>) and incompatible stimuli (i.e., <<><<) 
will be used to index interference control 
ability. In the letter flanker task, participants 
will see either a letter G or H in the middle, 
surrounded by two Gs or Hs on either side (i.e., 
HHHHH, GGHGG). Participants’ task is to focus 
on the middle letter and determine as quickly 
and as accurately as possible whether it is a G 
or an H. Again, the reaction time difference 
between the compatible (i.e., HHHHH) and 
incompatible (GGHGG) stimuli will be used as 
the index of interference control ability.
Pupillometry 
& 
Recall 
Repeat Task 
(RRT)
(Data 
Collection 
Time: 30-40 
minutes)
Pupillometry: a measurement of pupil size, is 
correlated with task difficulty in a variety of 
research focused on cognition. Task difficulty, 
or listening effort, during conversation is a 
useful measure of how effortful auditory 
processing 
is 
to 
the 
participant. 
The 
participant will be asked to rest their chin on a 
fixed chin rest and press their forehead on a 
cushioned support rest. Participant will be 
asked to fixate on a dot during the duration of 
testing. Testing will be completed with the 
Recall Repeat Task (RRT) during pupillometry 
recording. Pupillometry data collection will 
measure dilations of the pupil and record 
these dilations using EyeLink software. 
Recall Repeat Task (RRT): an auditory only 
speech-in-noise task that assesses auditory 
Data 
Collection 
Time: 
30-40 
minutes
Minimal 
risk 
to 
participants: Minimal 
to no risk include 
boredom with the 
task 
and 
minor 
fatigue from sitting 
still and maintaining 
a 
stable 
head 
position during the 
task. Participant is 
welcome to take a 
break at any time 
without 
consequence.
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working memory and reported listening effort 
by participants. The participant is presented 
with a list of pre-recorded sentences that they 
are asked to repeat back and to recall 15 
seconds after repeating back a list of 6 
sentences. After the participant recalls the 
sentences heard, they are asked to rate on a 
scale of 1 to 10 how effortful they found the 
listening situation to be and are asked to 
provide an estimated time of how long they 
are willing to spend listening to speech-in-
noise condition. Responses are recorded by 
the examiner in the testing interface, which is 
not visible to the participant.
For this study, we will not need to access any participant’s pre-existing HIPAA or PHI protected 
medical or health information or data. Also, we will not need to access any secondary data that is 
not HIPAA protection or contains PHI.
We will not use mobile apps for data collection during this study.
How the student will check in with the PI: 
The student (Grace Szatkowski) will be in constant communication with the primary investigator 
(Pamela Souza) throughout the study, and should risks arise, will contact the primary investigator.
Grace Szatkowski is a state-licensed (IL) audiologist with expertise in performing the tasks involved 
in this study.
9.0
Research with Vulnerable Populations 
N/A
10.0
Incomplete Disclosure or Deception:
N/A
11.0
Consent Process: 
Prior to enrollment, potential participants will have a hearing and cognitive test with 
authorization by a screening consent form. These tests will allow us to exclude 
potential participants from enrolling in the study who are ineligible based upon their 
hearing or cognitive status. If participant is eligible based upon their screening results, 
they will be enrolled in the study with separate consent. These 45-minute tests are 
built into the study design of the eligibility tasks, and do not require additional visits. 
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If a participant is not eligible to participate based upon the screening consent, they 
can authorize future contact with the consent’s optional element and authorize the 
lab to retain the screening audiogram.
Consents may be obtained via hard copy or digitally via RedCAP, depending on 
participant preference.  In either case, all subjects will provide their consent to study 
procedures to the investigator or her research assistants. An unlimited amount of 
time will be provided to the participant to ensure they have adequately reviewed the 
consent form and all questions have been addressed by study staff. Following the 
subject’s opportunity to read the consent document, study staff will review each 
section with participant to clarify the study or any procedure and ensure 
understanding. Additionally, consent forms may be provided to a potential research 
participant before a study visit is scheduled so they may take extra time to review 
before committing to participation. 
RedCAP: The participant will be consented electronically using REDCap. The participant will 
be required to “sign” by typing their name and enter the date. The participant will be able to 
review the consent form as many times as they need to, go back and forth through sections, 
and take their time before providing their consent. They may save their progress on the form 
and return to it at a later time if needed. The participant may contact a study team member 
as needed to provide any clarifications regarding any part of the consent form via phone, 
email or video before deciding to provide their consent. All information required for informed 
consent will be available on the eConsent forms. Consent forms for this study do not have 
any associated external material or hyperlinks. In order to ensure the identity of the signer, 
the REDCap consent form can only be accessed by the email address that it is sent to (i.e., 
the email address provided by the participant). In addition, the participant will be provided 
with a predetermined passcode via phone or video. At the time of accessing the electronic 
consent form, the participant must enter the passcode which will be internally compared 
with the stored version entered by the study team member. The participant will be granted 
entry only if the passcode matches. The participant will have the option of saving a copy of 
their signed eConsent forms as PDFs. A study team member will review the submitted 
eConsent form and electronically sign and date as confirmation. 
Hard Copy: All physical consent forms are stored in a locked file cabinet drawer within 
the Hearing Aid lab (a locked laboratory). All participants will be offered copy of their 
signed consent form unless they explicitly decline a copy. 
12.0
Waiver of Participant Signature on Consent Form:
N/A
13.0
Waivers and Alterations of Consent Information:
N/A
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14.0
Financial Compensation:
Upon completion of study tasks, participants will be paid an hourly rate for participation 
($20/hr). Payment will be made at the conclusion of each study visit. If a subject decides 
to withdraw from the study before its completion, s/he will still be paid $20 per hour for 
the time spent performing study tasks up to that point. In the event that a participant is 
removed from the study without their consent, compensation will be pro-rated based 
upon the duration the participant remained compliant with study tasks and procedures. 
Participants will be compensated at the above rate in the form of cash, a Hyperwallet 
Virtual Card, or a physical PNC Visa provided by Northwestern University, depending on 
participant’s preference. The card will be issued after the completion of the study visit 
at which point the participant will be emailed instructions for the card activation 
process. 
Parking will be provided to all participants, whether at the Evanston or Downtown 
campus, in the form of validation. 
15.0
Audio/Video Recording/Photography
All visits will be audio and video-recorded to determine the effectiveness of the study 
treatment. 
Audio/video recording of testing:

Identified with a unique identifier (no personal health information).

Audio/video data will be stored on a dedicated server managed by the 
Northwestern University School of Communication Hearing Aid Laboratory (HALAB).

Audio/video data will be uploaded directly to the HALAB Research Group server via 
a secure Northwestern University network.

Audio/video data will be accessible only by trained research staff involved with this 
protocol.

Audio/video data will be stored in compliance with Northwestern policies 
https://research.northwestern.edu/sites/research/files/policies/Research_Data.pdf.

Data will be stored indefinitely post final data analyses OR Conversation recordings 
will be stored indefinitely on the HALAB Research group server.
16.0
Potential Benefits of this Research: 
Although participants in this study may not directly benefit from participation, the study 
would provide them with the opportunity to learn about their hearing and ask questions 
about hearing aids without sales pressure. Participants who were unsure if they would 
benefit from hearing aids may find their experience informative in deciding how to manage 
their hearing loss. All participants in the study will have the opportunity to receive 
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counseling at the end of the study, done by the investigator, including listening 
recommendations tailored to their individual speech understanding, memory, and 
attention. They will have a chance to ask questions and receive information about options 
for their hearing loss (outside of the study). 
17.0
Potential Risks to Participants:
All study procedures pose minimal risk to study participants and are not substantially 
different from those associated with typical hearing. Some of the study tasks can be boring, 
or repetitive.  If a participant wishes to discontinue testing at any point, they may choose to 
do so without any consequence. 
Some participants may find the hearing aid settings used in this study to be loud or sharp in 
comparison to their unaided hearing. These are all normal and expected consequences of 
being fit new hearing aids; many patients get used to hearing aids and find their perceived 
sound quality improves over time. Some adjustments can also be made to improve sound 
quality for the participant if the hearing aids are making them uncomfortable. Real ear 
measures, part of the standard of care for hearing aid fittings, involve a soft floppy tube 
being placed in the ear canal. Some participants may find the sensation strange or ticklish 
during insertion and removal, which takes less than a minute. Pupillometry, which involves 
the use of a chin rest, requires the head remain still in the rest for the duration of the task 
(about 30 minutes). Efforts will be made to ensure comfort of the participant prior to testing. 
There are no anticipated physical risks associated with this study. There are no anticipated 
social or legal risks. Providing free parking will minimize economic risks. There are no costs 
associated with the study intervention itself.  
Participants will be free to withdraw from the study at any point in time. If a participant 
withdraws from the study, all data collected up to that point can be used by the investigator 
unless the participant indicates they would like to have their data removed from the study. 
Once a participant is unable to continue with the study, compensation will end. 
As part of the protocol, potential impairments not previously known to the participants may 
be revealed (hearing loss, cognitive changes, depression). When these do occur, the study 
team will provide support to the individual receiving this information. Additionally, 
participants will be encouraged to discuss the results of the screening measures with their 
family physician.
Although unlikely, participants may be withdrawn from the study if a trained experimenter 
determines that the participant's continuation presents immediate, clear risk to either the 
participant or the experimenters’ physical, mental, or emotional well-being. Participants 
may also be withdrawn from the study if they are unable to participate fully in study 
activities (i.e. tolerate an effective level of amplification). Data from withdrawn participants 
will be retained and may be used in data analysis if the withdrawal occurred for reasons that 
do not affect the integrity of the collected data.
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18.0
Provisions to Protect Participant Privacy and Data Confidentiality:
During the consent process, participants will be informed that their identifiable data 
will be used, but that their information will be stored separately from their study 
number in a secured location. Each participant will receive a study code that will be 
used for all study data. The only link between identifiable data and a study code will 
be on a password protected HIPAA-approved server with server security managed by 
Northwestern School of Communication computer staff. Any physical data containing 
identifiable participant information (i.e. consent documents) are kept under lock and 
key and are accessible only by study staff. All research staff will be trained in 
appropriate Human Subjects protection procedures, including confidentiality.
Participant confidentiality will be ensured by storing data without subject identifiers. Any 
recordings will be stored using a subject ID number in the file name. Data files are password 
protected and can only be accessed by authorized lab members. Hard copy data are stored in 
locked file cabinets within a restricted-access laboratory space. All study staff complete 
training in ethical procedures for working with human subjects and in HIPAA regulations
Electronically stored data is accessible only to study staff via password-protected files. 
We will use REDCap (Research Electronic Data Capture), a secure database software 
that is HIPAA compliant. 
19.0
Data Monitoring Plan to Ensure the Safety of Participants:
Treatment fidelity checklists will be completed for all treatment sessions.  This will help 
ensure that the safety and welfare of participants are prioritized at all times.
Untoward events associated with the intervention will be monitored by study staff 
periodically and any unanticipated treatment effects will be documented in the research 
record.  If emergency services are required, standard university policies will be followed 
to access care for the participant.
20.0
Long-term Data and Specimen Storage and Sharing: 
No identifiable data will be shared outside of the study team. De-identified data from this 
study may be shared with the research community at large to advance science and health 
research. We will remove or code any personal information before files are shared with 
other researchers to ensure that, by current scientific standards and known methods, no 
one will be able to identify participants from the information we share.
21.0
Qualifications of Research Team to Conduct the Research:
The Principal Investigator, Pamela Souza, PhD, CCC-A, FAAA, is a licensed audiologist and 
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an experienced researcher at Northwestern University. Her primary areas of research 
expertise are in aging, cognition, and hearing aids.  She has worked as a clinical 
audiologist for over 20 years.  Her primary areas of clinical expertise are in hearing aid 
fitting and auditory rehabilitation for older adults, including clinical experience with 
patients who have MCI or dementia.  
Student Investigator, Grace Szatkowski, AuD, FAAA, is a licensed audiologist and PhD 
student at Northwestern University. Primary interests in research include cognition, 
hearing aids, and aging. She graduated with a Bachelor of Arts in Speech and Hearing 
Science in 2016 from the University at Buffalo and went on to graduate with a Doctorate 
in Audiology in 2021 from the University of Akron. Clinical expertise includes adult 
auditory rehabilitation, hearing aid fittings, and electrophysiology.   
Research staff will be trained in strategies for communicating with adults who 
have hearing loss.
IRB #: STU00217791-MOD0002 Approved by NU IRB for use on or after 12/8/2022