Baltimore HEARS Study: Addressing Hearing Impairment and Social Engagement Through Community-delivered Hearing Care
Phase: NA
Conditions: Age-related Hearing Impairment 1, Personal Communication
Sponsor: Johns Hopkins University

The Baltimore HEARS Study: Hearing Equity Through Accessible Research & Solutions 
ClinicalTrials.gov Identifier: NCT03442296 
Protocol version 6.0 – 7/9/2021
Principal Investigator: Frank Lin, M.D., Ph.D. 
IRB Application Number: IRB00144968 

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Date: 07/09/2021 
Principal Investigator: Frank Lin, M.D., Ph.D. 
Application Number: IRB00144968 
JHM IRB - eForm A – Protocol
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1.
Abstract
a. Provide no more than a one page research abstract briefly stating the problem, the
research hypothesis, and the importance of the research.
Hearing loss is the third most prevalent chronic condition among older adults in the United States, 
but the impact of hearing loss on the social, cognitive, and physical functioning of older adults is often 
underestimated. Hearing loss is independently associated with poorer cognitive functioning, accelerated 
cognitive decline, incident dementia, social isolation, and poorer physical functioning. Large studies on 
the epidemiology of hearing loss and rates of hearing health care, such as data from NHANES, 
demonstrate that the prevalence of hearing loss increases with age, ranging from greater than 45% 
among those aged 70-74 years to greater than 80% for adults 85 years and older with less than 20% of 
adults with hearing loss utilizing hearing aids (Lin et al., 2012).  The NIDCD has called for new 
approaches to improve the affordability and accessibility of hearing health care, and we are investigating 
new models of care to address the gap between the number of people with age-related hearing loss and 
the number of people who use hearing aids.  
Baltimore HEARS (Hearing Health Equity through Accessible Research & Solutions) is a hearing 
care intervention that has been culturally tailored for a minority, low-income population. Previous related 
projects from our research group investigated the use of hearing health care among minority older adults 
with low-income backgrounds, developed the HEARS intervention to provide affordable, accessible 
hearing care to older adults (IRB# 00088278), and investigated the feasibility of delivering the 
intervention through a community health worker (CHW)-delivery model (IRB#00079481). The objective of 
this proposal is to conduct a randomized controlled trial of the HEARS intervention as delivered by an 
audiology-CHW care team. The trial will be conducted in partnership with several Baltimore area 
residences for older adults.   
We will evaluate outcomes at 3-months post-intervention by comparing an immediate treatment 
group versus a 3-month waitlist control group.  The primary outcome is communication function as 
measured by the Hearing Handicap Inventory for the Elderly-Screening (HHIE-S).  Secondary outcomes 
include measures related to social and emotional function, such as quality of life, depression, and 
loneliness. Although the primary outcome will be collected at 3-month post-intervention, participants will 
be followed for 12 months post-intervention in order to obtain data on reflective of longer-term outcomes 
related to the intervention. 
A prior feasibility study of the HEARS intervention (IRB# NA_00088278) demonstrated the 
feasibility, acceptability, and preliminary efficacy of a community-delivered hearing program in reducing 
communication impairment and depressive symptoms (Nieman et al, 2017).  Preliminary observations in 
an ongoing pilot study (IRB# 00079481), suggest similar findings with the intervention delivered by 
trained CHW’s. This randomized controlled trial is a first-in-kind study designed to investigate the effects 
of a community-based hearing care intervention targeting a vulnerable urban population.     
2.
Objectives (include all primary and secondary objectives)
The primary objective of this study is to conduct a randomized controlled trial studying the efficacy of the
HEARS intervention in reducing self-reported hearing handicap as delivered by trained community health

 
 
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workers (CHW). The primary endpoint is change in score on the HHIE-S from baseline to 3-month post-
randomization in the immediate vs. waitlist control group. The project aims to recruit and enroll eligible 
community-dwelling older adult residents from independent, affordable housing to receive the intervention. 
After 3 months of follow-up post-randomization, participants in the waitlist control group will also be offered 
the HEARS hearing intervention. All participants (also referred to as “clients” in the HEARS intervention 
materials) will then be followed observationally for up to 12 months post-intervention.  Participant outcomes 
will be collected through phone calls and in-person visits. Long-term follow-up will provide an understanding 
of both short- and long-term effects of a community-based hearing care program on participants’ 
communication, social, and emotional function.  Outcome measures will assess various domains such as 
communication function, depression, loneliness, and social connectedness, with the primary outcome being 
communication function as measured using the Hearing Handicap Inventory for the Elderly-Screening 
(HHIE-S). 
 
3. 
Background (briefly describe pre-clinical and clinical data, current experience with 
procedures, drug or device, and any other relevant information to justify the research) 
 
Hearing aids, along with adequate counseling and education, form the foundation of a comprehensive 
approach to hearing health care. Hearing aids can improve audibility, communication, and may help promote 
better general health and social engagement in older adults (Boi et al., 2012). While an important component 
of hearing health care, hearing aids are underutilized. Only 15% of older adults undergo hearing screening 
and less than 20% of older adults with demonstrated hearing loss use hearing aids (Kochkin, 2009; Popelka 
et al., 1998; Gates et al., 1990). This demonstrates a gap in care that the NIDCD, Healthy People 2020, and 
the National Academies of Science, Engineering, and Medicine (NASEM) have identified and, subsequently, 
called for the development of additional models of affordable and accessible hearing health care (Donahue 
et al., 2010; NASEM, 2016). 
One NHANES study found that 8.3% of Blacks and 12.9% of Mexican or Hispanic elderly 
participants as compared to 19.9% of Whites utilized hearing aids on a regular basis and only 12.5% of those 
with < $20,000 household income report hearing aid use as compared to 22.9% with household income of ≥ 
$45,000 (Lin et al.,2011). This study uses the Baltimore HEARS intervention that was developed to aid in 
NIDCD’s charge to deliver hearing health care for all. Baltimore HEARS is an intervention that provides 
affordable and accessible hearing care to minority and low-income older adults. In previous pilot studies 
(IRB# NA_00088278 and IRB#00079481), we used a community-engaged research approach to develop a 
culturally-tailored, community-delivered hearing care intervention that included hearing screening, education 
on age-related hearing loss, communication strategies, and provision of a low-cost over-the-counter 
amplification device. The initial pilot study was delivered by a medical expert (i.e., an ENT resident) and 
demonstrated the feasibility and acceptability of the novel accessible and affordable approach to hearing 
care intervention for low-income, minority older adults. The follow-up pilot study tested the feasibility of 
delivering the hearing loss intervention (HEARS program) in the community through trained CHWs.   
The current study aim is to conduct a RCT of the HEARS intervention delivered by an audiologist-
CHW care team utilizing an immediate treatment and 3-month delayed treatment group of low-income and 
primarily minority older adults living independently in Baltimore.  Lessons and insights acquired through 
direct encounters with pilot participants and advisory board meetings informed the design and procedure of 
the proposed study.  Active engagement with community representatives through a Community Advisory 
Board will be ongoing.  
 
4. 
Study Procedures 
a. Study design, including the sequence and timing of study procedures   
(distinguish research procedures from those that are part of routine care). 
 
PARTICIPANTS 
 
 
The study cohort will consist of older adults (≥ 60 years old) with age-related hearing loss who are 
not currently utilizing a hearing aid or amplification device.  Participants will be encouraged to involve a self-
identified communication partner willing to complete the program alongside them. Communication partners 
are any individuals with whom the participant engages in daily spoken communication.   
 
 A total of 175 participants will be recruited in partnership with Weinberg Senior Living and Catholic 
Charities, local nonprofit agencies that provide and oversee independent, subsidized housing buildings for low-
to-moderate income older adults in Baltimore and local community sites.  Weinberg Senior Living, which 
comprises ~ 1500 units of senior housing in 13+ buildings in the Baltimore area, has been our community 
partner in previous studies (IRB# NA_00088278 and IRB# 00079481) and the current study (IRB#00152093). 

 
 
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Ms. Tiffany Nicolette, Director of Resident Services for Weinberg Senior Living, will assist the study team in 
communicating with building service coordinators and participant recruitment efforts.  We will also work with 
Catholic Charities, which has 20+ building for senior living in the Baltimore metropolitan area. Mr. Arnold Eppel, 
Division Director for Senior Services of Catholic Charities, and his staff will assist the research team in 
recruiting participants and providing space for intervention delivery.  Participants will also be recruited from 
other community sites (such as Baltimore City senior centers and social clubs) and independent senior living 
buildings in Baltimore City.   
 
COMMUNITY PARTNERS & ADVISORY BOARDS 
 
 
The Hearing and Speech Agency (HASA), a nonprofit audiology clinic in Baltimore, is a study partner 
providing meeting space and audiological expertise to support the research team in conducting study-related 
activities. HASA’s Executive Director (Erin Stauder) is a member of the study’s Community Advisory 
Committee and has been in regular communication with the research staff regarding the objectives and 
logistics of the project.  HASA was identified as a study partner given that it is a facility staffed with audiologists 
and maintains community-based initiatives throughout Baltimore.  
 
A Community Advisory Board was previously established to guide the development of the Baltimore 
HEARS intervention.  Members of the Community Advisory Board reflect key stakeholders and primary users 
within the community. Stakeholders include partners such as local, nonprofit hearing agencies, 
representatives from area agencies on aging, and service coordinators from partner agencies providing care 
to older adults. Users within the community include low-income and minority older adults with hearing loss 
and their communication partners. The Community Advisory Board reflects the diversity of our community 
partners in terms of race/ethnicity, age, educational level, and hearing loss status. The study staff meets with 
the Community Advisory Board on a quarterly basis.  
 
A Scientific Advisory Board was also previously established to guide the scientific development of the 
Baltimore HEARS study.  This committee is comprised of study investigators with expertise in gerontology, 
audiology, otology/otolaryngology, behavioral intervention research, community-based participatory research 
(CBPR), training of CHW’s, and social design.  The study staff meets with the Scientific Advisory Board on a 
quarterly basis.   
 
STUDY DESIGN 
 
 
Initially, the study will be based in several buildings from Weinberg Senior Living and Catholic 
Charities in Baltimore. Additional buildings from either of the two organizations or community sites may be 
added in order to reach recruitment goals.  These community sites will be identified through referrals from 
our CAB members. These include sites such as senior centers and other community sites (such as the Zeta 
and Waxter Senior Centers run by Baltimore City, Rhome and Co-op by Civic Works).where we coordinate 
directly with the directors and leadership of these centers. The study may also recruit participants and build 
partnerships through recruitment opportunities at community events. See Figure 1 for the overall study 
design.   
Recruitment efforts will include posters, flyers, mailings, brochures, and information sessions at each site 
that will be led jointly by trained CHWs and the study team targeting residents who may be eligible as study 
participants and their communication partners.  Following the information sessions, interested potential 
participants will undergo screening by the study staff after providing oral consent.  Given the minimal risk 
involved with hearing screening, oral consent will be given to reduce the time burden on a potential 
participant in the screening process.  Screening involves questions regarding demographics, self-reported 
perceived hearing handicap, and pure-tone audiometric threshold testing.  Hearing screening will be 
conducted using a portable, remote audiometer specifically designed for field-testing without a soundproof 
booth.  When interacting with potential participants, study staff will utilize an amplification device (such as the 
SuperEar or Pocketalker) to ensure individuals are able to hear the study staff.  Potential participants who 
are eligible and interested in participating in the study will be asked to provide their contact information.   
 
 
 
 
 
 
 
 
 
 
 

 
 
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Figure 1: Overall Study Design 
 
 
 
  
Meeting with CHW  
(dotted box) 
Meeting with Study 
Staff (solid box) 
Legend 

 
 
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Once deemed eligible based on review of study criteria, the study team will review the full written 
consent form and study details prior to the start of any study activities with both the study participants and 
their communication partners (if one is available and interested). The written consent form will cover details 
including the study objectives, benefits for participating, steps the study team will take to minimize breach of 
confidentiality, and opt-in/opt-out section for audio-recording.  The purpose of collecting audio-recordings will 
be for study monitoring and quality assurance.  Following written consent, the study staff will obtain baseline 
measures from surveys such as those detailed in Table 1. Following collection of baseline measures, the 
participants will be randomized into one of two groups: 1) immediate treatment group and 2) 3-month 
delayed treatment group, which will function as a control group.  Communication partners will be asked to 
attend meetings with their study participants to complete baseline and follow-up self-report questionnaires 
that assess domains such as third-party disability and program evaluation.  Examples of outcome measures 
for communication partners are detailed in Table 2. 
 
Table 1: Participant baseline surveys  
 
Domain 
Tests 
Number 
of Items 
Time 
Required 
(min) 
Hearing & 
Communication 
Hearing Handicap Inventory 
for the Elderly-Screening 
(HHIE-S) 
10 
2 
Quality of Life 
Adapted Quality of Life – AD 
12 
5 
Social Isolation & 
Loneliness 
UCLA-Loneliness Index-
Revised 
20 
5 
 
Cohen Social Network Index 
12 
5 
Depression 
Patient Health Questionnaire 
(PHQ9) 
9 
2 
Health-related 
Quality of Life 
Short Form-12 (SF12) 
12 
5 
Cognitive Function 
Montreal Cognitive 
Assessment (MoCA) 
11 
10 
Health Literacy 
Rapid Estimate of Adult 
Literacy in Medicine – Short 
Form (REALM-SF) 
7 
2 
Computer Self-
Efficacy 
Modified Computer Self-
Efficacy Scale 
10 
5 
Technology Self-
Efficacy 
Adapted Attitudes Towards 
Computers Questionnaire 
10 
5 
Total 
 
113 
46 
 
 
Table 2: Communication partner baseline surveys  
 
Domain 
Tests 
Number 
of Items 
Time 
Required 
(min) 
Third-Party 
Disability 
Significant Other Scale for 
Hearing Disability (SOS-
HEAR) 
27 
10 
 
Hearing Impairment Impact – 
Significant Other Profile 
20 
5 
Program 
Evaluation 
International Outcome 
Inventory – Alternative 
Interventions, Significant 
Others (IOI-AI-SO) 
14 
10 
Total 
 
61 
25 
 
 

 
 
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The immediate treatment group will receive the intervention from a trained CHW in their community.  
Intervention details are further described below.  Following completion of the intervention with the CHW, the 
study staff will follow-up with the participant at 1 week, 1-month, 2-months, 6-months, and 9-months post-
intervention via phone calls.  At 3-months and 12-months post-intervention, the study staff will schedule to 
meet with the participant in-person to collect primary and secondary outcome measures as well as program 
evaluation. The overall flow for the immediate treatment group is shown in Figure 2.  
 
Participants randomized to the delayed treatment group will receive a call from study staff 1- and 2-
months after their baseline measures to verify contact information and remind them of their study 
involvement.  They will be scheduled for a visit by study staff 3-months after their baseline visit to collect 
repeat baseline measures.  After this visit, participants will be scheduled to receive the intervention from a 
trained CHW.  Once study staff is notified by the CHW of intervention completion, the study staff will follow-
up with the intervention recipient at 1-week, 1-month, 2-months, 6-months, and 9-months post-intervention 
via phone calls.  At 3-months and 12-months post-intervention, the study staff will schedule to meet with the 
participant to collect primary and secondary outcome measures and program evaluation. CHWs will not be 
involved in any aspect of data collection from study participants and will not have access to collected data. 
The overall flow for the delayed treatment intervention group is shown in Figure 3.  
 
Following all intervention deliveries and follow-up measures (detailed in Table 1 and 2), a post-
intervention focus groups and/or semi-structured interview will be scheduled.  Participants and their 
communication partners are invited to attend sessions designed with gather additional insight into how the 
intervention was perceived and can be improved.  The session will focus on topics, such as the following: 
hearing loss (i.e., What do you think about hearing now? Do you think of it differently? What does your 
hearing mean to you now? How does your hearing loss factor into daily life now? What does hearing loss 
mean in communities like yours? What would you tell your friend or family member about hearing loss?), 
treatment of hearing loss (i.e., What do you think about treating hearing loss? Does it work? What would you 
tell your friend or family member about treating hearing loss?), the Sidekick device (i.e., What did you think 
about the hearing device? How much did you use the hearing device? What would have made it better? 
Something you would use more often? Do you plan to use the hearing device in the future? What would you 
say about the hearing device to your friend or family member?), and about  learning technology (i.e., What 
do you think about how you learned how to use the hearing device? What could make it easier? Better? How 
did the study make it difficult? How did the study make it easier? How would you teach your friend or family 
member to use the hearing device?). 
 
In addition the phone calls between in-person visits with participants, the study team may be in touch 
with participants to maintain updated contact information and participant engagement.  For intervention 
fidelity monitoring, the study team will review audio-recordings of randomly selected HEARS interventions 
between CHW and participant.  This procedure allows the study team to assure the quality and accuracy of 
the intervention.  All participants will have previously indicated their consent to being audio-recorded during 
the written consent process.  The study team will be the sole managers of the audio-recording devices and 
securely store the audio files in an encrypted and password-protected database.   
 
Figure 2: Immediate Intervention Group Participant Flow 
 
 
 
 
 
 
 
 
 
 
 

 
 
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Figure 3: Delayed Intervention Group Participant Flow 
 
 
 
INTERVENTION DESCRIPTION 
 
The HEARS intervention is a community-delivered hearing care intervention that provides education on 
hearing loss, communication strategies, and provision of an over-the-counter amplification device.  The 
program is designed for older adults and has been previously piloted locally in partnership with Weinberg 
Senior Living. The intervention involves two one-hour meetings between the participant and his/her CHW.  
CHW’s will be trained to deliver the HEARS intervention to participants through a separate ongoing study 
(IRB#00152093).  
During the first meeting, the CHW will introduce the HEARS program and review communication 
strategies and basics of age-related hearing loss, as well as options for amplification including the 
differences between over-the-counter amplifiers used in the program versus conventional hearing aids 
typically acquired through audiologists. The second meeting will consist of a step-by-step fitting and 
orientation to the participant’s amplifier of choice. Based on the needs of the participant and the discretion of 
the CHW, additional meetings may occur to ensure the participant is comfortable using his/her amplifier 
independently. .  
The device options used in this current study are similar to devices used in previous studies (IRB 
#NA_00088278). All of the devices are currently available over-the-counter and represent low-cost, self-fit 
amplifiers.  One of the devices, called the Sidekick, was developed by Sound World Solutions (SWS) and 
relies on in-situ fitting and programming.  The device was developed by Stavros Basseas, former chief 
audiological engineer for GNResound, one of the major hearing aid manufacturers, and David Green, a 
MacArthur Fellow and social entrepreneur known for developing disruptive public health-related 
technologies. Dr. Lin (PI) collaborates with David Green, and SWS had previously expressed their 
willingness to work with us on this study.  Although the device is limited compared to the gold standard of 
custom-fitted hearing aids provided conventionally by an audiologist, it provides an affordable, accessible, 
and audiologically sound option that is potentially scalable to others with limited resources.  The SWS 
device, as an amplification device, has undergone testing by SWS and is currently available on the market.  
The FDA, consistent with all personal hearing devices, does not regulate the device.  Additional amplification 
devices (e.g., Sonic Technology Products’ SuperEar SE9000) that will be offered in the study represent other 
models of affordable sound amplifying and listening devices that are available on the market and directly 
available to consumers.  Similar to the SWS device, all devices are considered personal sound amplifier 
products (PSAPs) and are not regulated by the FDA.  
 
 
INTERVENTION TIMING AND ADHERENCE 
 
All analyses will be conducted according to the intention to treat (ITT) principle: participants will be 
analyzed as they were randomized, irrespective of the receipt of treatment. Individuals would be considered 
as not adhering to treatment if they do not complete the two-session intervention (i.e., did not attend all 
scheduled intervention meetings) or do not use the amplification device 1 or more hours per day at 3-months 
post-intervention. 
Please see Statistical Analysis Plan (SAP) in Supplemental Documents for more information.  
  
 

 
 
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PRIMARY OUTCOME DATA COLLECTION MODE AND WINDOW 
Primary outcome survey collection will be allowed up to 6 months post intervention visit (for immediate 
group) or 6 months post-baseline visit (for delayed group).  If a participant is unable to meet in person to 
provide their answers, phone substitution will be allowed after 3 attempts to meet with the participant in 
person.   
If any of the 10 questions are not answered, the primary outcome will be invalid.  The ideal mode of 
collection will be in person, but if this is not possible, phone substitution is allowed.   
Please see Statistical Analysis Plan (SAP) in Supplemental Documents for more information.  
 
 
COVID-19 Protocol 
 
Starting Friday, 3/13/2020, all in-person meetings (including meeting between HEARS Staff and Clients 
and meetings between Teachers and Clients) have been paused due to COVID-19.  
Teachers have been counseled to do all of their troubleshooting over the phone and to postpone all in-
person visits until the end of COVID-19 stay-at-home order is lifted.  If any Client needs a device replacement, 
a staff member will arrange a no-contact drop off with the client and a Teacher can help the client set up the 
device if they have any questions.  The HEARS Trainer is also available to help with phone troubleshooting if 
needed.  
In-person data collection will not permitted and all check-ins will be done via phone.  All clients will 
outstanding primary outcome visits will be prioritized for HHIE collected via phone.  HEARS staff will call clients 
for phone check-ins at their scheduled time to check in on the client and see if they are having any trouble with 
their device. For clients scheduled for a phone-check in, HEARS staff will attempt to get in touch 3 times 
through the client’s primary number and then use all secondary contact methods (email, second number, 
emergency contact) at least once to reach the client.  For clients who are due for their in-person visit, all contact 
attempts are the same as phone check-in attempts with the additional attempt to contact their service 
coordinator to assist with delivering a memo (if they are willing).   
If a client brings up any concerns about COVID-19 or wants to know more resources, a “COVID-19 
Resource guide” is available for study staff to reference some reminders and numbers that could be helpful to 
HEARS Clients.  
For clients due for an in-person survey visit, staff will first collect a phone HHIE and then discuss options 
for collecting the rest of their answers to the HEARS Surveys (Following the COVID-19 Screening script).  The 
screening script will address common limitations including limited cell phone minutes, internet connection, and 
comfort level with using technology. These methods are listed in order of study investigator preference for 
fidelity of data collection: 
1. Zoom (with screen-share) 
2. Skype (with screen-share) 
3. Facetime or other video program (Hangouts, Duo, Facebook, etc) 
4. Phone call with survey printout (printout mailed or delivered to them contact-free) 
5. Phone call without survey printout 
If a client is willing and able to complete additional surveys, a time will be scheduled where a HEARS Staff 
member will ask and collect their answers virtually.  
Virtual surveys will be conducted in the order listed in Section 3 (same as in-person visits) other than if a 
client indicates they are not interested in completing the entire set of surveys.   
Surveys will be prioritized in this order and as many as they are willing to complete will be completed (including 
offering to split up the meetings): 
1. HHIE 
2. UCLA 
3. PHQ9 
4. IOI-AI 
5. Device Use 
6. Program Evaluation 
7. SF-12 
8. SNI 
9. VOL 
10. Tech-SE 
11. HEARS Basic Assessment 
12. LSEQ 
 
b. Study duration and number of study visits required of research participants. 
 

 
 
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The study will take place over approximately 18 months.  Details are summarized in Figure 4.  
 
 
Figure 4: Overall Study Design and Timeline 
 
 
 
 
 

 
 
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An information session with a follow-up hearing screening will require an estimated total of 90 
minutes.  The meeting will introduce the study and HEARS program to interested participants, and screen 
consenting participants for study eligibility.  Information sessions will be delivered by trained CHW’s and the 
study staff. 
 
Following attendance at an information session, study staff will meet with interested residents to 
obtain oral screening consent to undergo hearing screening and to gather other screening measures related 
to eligibility criteria.  The participant will be advised about his/her eligibility. If eligible participants are 
interested in proceeding, the study staff will review the study, the associated written consent form, and obtain 
written consent.   Participants will then complete baseline measurements and be randomized into either the 
immediate or delayed treatment groups.  The baseline questionnaires will take approximately 45-50 minutes 
to complete.   
 
Participants assigned to the immediate treatment group will be assigned a CHW.   Once assigned to 
a CHW, the participant will meet with his/her assigned CHW to complete the intervention.  The intervention 
will take place over two sessions and will take a total of approximately 120-150 minutes across two separate 
meetings.  Follow-up evaluations at 1-week, 1-month, 2-months, 6-months, and 9-months post-intervention 
will be conducted via phone and will take approximately 10-15 minutes.   Follow-up evaluations at 3-months 
and 12-months post-intervention will be conducted in-person by study staff with the participants and will take 
approximately 90 minutes per visit.  In total, participants in the immediate treatment group will have contact 
with Baltimore HEARS study staff and CHW a minimum of 10 times. (see Figure 4 for overall study flow) 
 
Participants assigned to the delayed treatment group will receive a call from study staff 1- and 2-
months following their baseline visit.  They will then be scheduled for a 3-month repeat baseline visit with 
study staff that will take approximately 90 minutes.  Following this visit, participants will be assigned a CHW 
and receive the intervention as outlined above.  Follow-up evaluations at 1-week, 1-month, 2-months, 6-
months, and 9-months post-intervention will be conducted via phone and will take approximately 10-15 
minutes.  3-month and 12-month post-intervention visits will be conducted in-person by study staff with the 
participants and will take approximately 90 minutes.   In total, participants in the delayed treatment group will 
have contact with Baltimore HEARS study staff and CHW a minimum of 13 times (see Figure 4 for overall 
study flow).  Of note, all participant visits, from the information session to follow-up visits, will be conducted at 
the participant’s building. 
 
 
c. Blinding, including justification for blinding or not blinding the trial, if applicable.   
 
Study participants and data collectors will be unblinded as to randomization status. Participants will 
know which intervention group they are assigned to. Study staff collecting data will also be aware of 
group assignment depending on whether the participant is using the hearing device that is provided with 
the HEARS intervention. Study stuff analyzing trial data for the primary endpoint will be blinded to 
treatment group status. 
 
d. Justification of why participants will not receive routine care or will have current therapy 
stopped. 
 
Not applicable. There is no current standard of care for routine audiologic testing or hearing loss 
treatment in older adults. A recent United States Preventative Services Task Force report concluded 
that there was insufficient evidence to recommend screening or treatment for hearing loss in adults 50 
years and older (Moyer, 2012).   
 
e. Justification for inclusion of a placebo or non-treatment group.  
 
All participants will receive the study intervention, either in the immediate group or the 3 month delayed 
treatment group. 
 
f. Definition of treatment failure or participant removal criteria. 
 
The intervention (“treatment”) consists of aural rehabilitation, which includes basic education on age-
related hearing loss and communication strategies, and provision of an over-the-counter amplifier.  The 
session will include fitting the device and a step-by-step orientation to the device. Treatments would be 

 
 
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considered a failure if individuals do not complete the two-session intervention (i.e., did not attend all 
scheduled intervention meetings). 
 
g. Description of what happens to participants receiving therapy when study ends or if a 
participant’s participation in the study ends prematurely. 
 
After participants complete the intervention, they may continue to use the amplifier and communication 
strategies to their needs. Contact information for Sound World Solutions and Sonic Technology 
Products customer support, the device manufacturers, will also be provided and available to 
participants. We will also provide all participants with contact information for hearing care professionals 
who they can follow-up with if desired. The PI of the study is an otolaryngologist with expertise in 
hearing loss. 
 
5. 
Inclusion/Exclusion Criteria 
 
Participant inclusion criteria:  
• 
Age 60 years or older  
• 
English-speaking 
• 
Aural-oral verbal communication as primary communication modality   
• 
Post-lingual hearing loss (Audiometric pure tone averages [0.5-4kHz] in both ears >25 dB) 
• 
Does not currently use a hearing amplification device or hearing aid 
• 
Signed informed consent to participate in all study related activities 
• 
Willing to regularly use listening device once provided for the remainder of their time in the 
study   
• 
Hearing handicap as measured by HHIE-S score >8  
• 
Able to follow study instructions 
 
Recipient/participant Exclusion criteria:     
• 
Individuals who do not fulfill inclusion criteria  
• 
Evidence of ear disease or pathology requiring further medical evaluation 
 
Participants are not required to have a communication partner, but they are encouraged to participate in the 
intervention with an individual they speak to regularly.  For participants who have a communication partner, 
eligibility criteria is as follows: 
 
Communication Partner Inclusion criteria:  
• 
Age 18 years or older 
• 
Speak to the participant on a daily basis 
• 
English-speaking 
• 
Aural-oral verbal communication as primary communication modality 
• 
Able to accompany participant to all intervention sessions & study team meetings 
• 
Able to follow study instructions 
 
Communication Partner Exclusion criteria:     
• 
Individuals who do not fulfill inclusion criteria  
 
6. 
Drugs/ Substances/ Devices 
 
a. The rationale for choosing the drug and dose or for choosing the device to be used. 
 
As previously discussed, the devices utilized in this study are low-cost, self-fit amplifiers that are 
currently available over-the-counter, directly to consumers, the Sound World Solutions (SWS) Sidekick 
and Sonic Technology’s SuperEar SE9000.  Neither of these devices are medical devices regulated by 
the FDA.  
 
b. Justification and safety information if FDA approved drugs will be administered for non-
FDA approved indications or if doses or routes of administration or participant 
populations are changed.  N/A 

 
 
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c. Justification and safety information if non-FDA approved drugs without an IND will be 
administered. N/A 
 
7. 
Study Statistics 
 
a. Primary outcome variable. 
 
The Hearing Handicap Inventory for the Elderly Screening Version (HHIE-S), a 10-item 
questionnaire to assess perceived effects of hearing loss on communication function (Ventry & 
Weinstein, 1983).   
 
b. Secondary outcome variables. 
 
See Table 1 for a list of the types of outcome variables we will utilize in the study. We plan to 
assess hearing and communication function as well as social and emotional function. Screening will 
involve hearing assessment, and an assessment of cognitive function, which may be utilized in final 
analyses as a covariate.  We anticipate refining the surveys administered to participants based on initial 
experience with the first few study participants/recipients given potential issues with wording and/or time 
considerations.   
 
c. Statistical plan including sample size justification and interim data analysis. 
 
 
Please see Statistical Analysis Plan (SAP) in Supplemental Documents.  
 
d. Early stopping rules. N/A 
 
8. 
Risks 
a. Medical risks, listing all procedures, their major and minor risks and expected frequency. 
 
Audiometric screening will be performed by a trained study staff member.  Audiometric findings will 
be reviewed and interpreted by trained professionals with a background in audiology and/or 
otolaryngology. Referrals for further medical evaluation will be provided as needed (e.g., impacted 
cerumen, etc.). 
Although pure-tone thresholds will be obtained, the evaluation will not reflect a comprehensive 
audiologic exam.  If desired, participants will also be referred to the Hearing and Speech Agency of 
Baltimore (HASA), a non-profit organization located in Northwest Baltimore.  HASA provides full hearing 
testing and hearing aid fittings on a sliding scale as a resource to individuals with hearing loss and 
limited resources. A representative at HASA has agreed to be named as a resource for further testing, if 
needed. From a medical standpoint, any potential participants with concerning findings acquired from 
pure-tone thresholds will be referred to their primary care physician, or Dr. Frank Lin’s otology clinic, for 
further evaluation.   
There is also risk of loss of confidentiality. Participants and CHWs are embedded in the same 
community, and it may be readily apparent who is participating in the study.  The questionnaires will 
involve information on social, communicative and mental functioning, which could be theoretically 
sensitive information or may make participants uncomfortable. However, these data are only gathered by 
study staff and will not be available to the CHWs.  Focus groups and semi-structured interviews will 
involve themes related to hearing loss, potential treatments and related barriers, their experiences and 
feedback related to the HEARS program.  All participants will be informed about the topics of discussion 
prior to the sessions in order for them to make informed decisions regarding participation.  Personal 
information may be disclosed during the course of the sessions.  All sessions will be audio-recorded, and 
will be transcribed for data analysis.  All participants will be informed of the audio recording and specifics 
will be included in the consent form.  Given the nature of focus groups and semi-structured interviews, 
involving more than one participant, confidentiality cannot be assured.  All participants will be informed 
regarding procedures to maintain confidentiality and will be asked not to repeat what is said during the 
sessions.   

 
 
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Participant data and audio recordings will be kept on an encrypted and password-protected 
computers and database.  Participants’ data will be stored under coded identifiers, to which only the PI, 
co-investigator, and research coordinator have the key code. 
 
 
b. Steps taken to minimize the risks. 
 
Study personnel will receive training in regards to informed consent, confidentiality, and privacy 
requirements prior to study involvement and certifications will be maintained regularly.  The PI will be 
available by phone to speak to research staff, participants or prospective participants regarding methods 
utilized in the study to minimize risks.  All participant information, audio recordings, and data will be 
secured through the use of coded identifiers, locked filing cabinets, and password-protected computers 
and databases. Participants will be provided with phone numbers for the study staff in the event that they 
have any problems or questions. 
 
c. Plan for reporting unanticipated problems or study deviations. 
 
 
HEARS Protocol Deviations and Violations by Category 
DATA COLLECTION PROCESS: 
• Data collector failed to save data leading to data loss (re-surveying not an option). 
• Data collector failed to save data but participant is re-surveyed 
• Missing data points due to data collector entry error (within measures) 
• Only partial outcomes measures were collected due to study window 
INTERVENTION DELIVERY: 
• Participant did not receive intervention 
• Intervention started but not completed 
• Intervention delivery outside window 
o Study team delays intervention 
o Interventionist delays intervention 
o Participant delays intervention 
3 MONTH STUDY VISIT: 
• 3 MONTH STUDY VISIT outside window 
o Study team delays visit 
o Participant delays visit 
o Participant unable to schedule visit (due to traveling, physical health, unable to contact) 
ADVERSE EVENT 
• Adverse event during study visit (study related) 
• Adverse event during study visit (non-study related) 
• Adverse event outside of study visit (study related) 
• Adverse event outside of study visit (non-study related) 
 
All protocol deviations will be reported to the principal investigator and documented in the 
participant’s study chart.  Adverse events (such as death or serious adverse event) requiring IRB 
notification will be reported to IRB in a timely manner.  
 
d. Legal risks such as the risks that would be associated with breach of confidentiality. 
 
We do not anticipate any substantial legal risks, including those related with breach of 
confidentiality.  Focus group and semi-structured interview participants will be informed that they are 
being recorded during sessions and all will be asked to maintain confidentiality.  All data on social, 
communicative and mental functioning will be kept secure and cannot be used, outside the context of a 
complete neuropsychological examination, for purposes of cognitive status or competency.   
 
e. Financial risks to the participants. 
 
We do not anticipate any financial risks to either the participants or interventionists (CHW’s). 
 
9. 
Benefits 

 
 
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a. 
Description of the probable benefits for the participant and for society. 
 
Intervention participants will obtain audiometric screenings to assist in the identification of a 
possible hearing loss.  If a hearing loss is suggested, they will receive additional information regarding 
hearing loss, its impact, and potential treatments.  Intervention participants will be provided with an 
amplification device and receive training on how to use and set-up the device along with aural 
rehabilitation counseling to assist with maximizing management of their hearing loss.  Consenting 
participants will be able to share in the experience of the new device with a community user network.  
Participants will receive communication and technical support with on-site trained CHWs.   
For society, the study will provide insight into how hearing loss is perceived and addressed among 
low-income and minority older adults, populations who have traditionally had limited access to hearing 
health care resources.  The established roles of the trained CHW’s will also highlight the inherent values 
of these community members and their advantage in having greater access and capability to assisting 
fellow members of their community in offering basic hearing care.  
 
10. 
Payment and Remuneration 
a. 
Detail compensation for participants including possible total compensation, 
proposed bonus, and any proposed reductions or penalties for not completing the 
protocol. 
 
All participants will receive a device and training materials through the HEARS intervention. No 
reductions or penalties will incur for not completing the intervention. Communication partners are 
considered volunteers who accompany their participant counterpart at all intervention and study 
team meetings.  For any participants and communication partners who participate in the post-
intervention focus group, $20 compensation is offered.  See Table 4 for summary. 
 
 
 
 
 
Table 4. Participant and communication partners compensation plan. 
 
Information 
Session & 
Screening 
Consent & 
Baseline 
Measures 
Intervention 
Follow-up 
Assessments  
(3 month post) 
Follow-up 
Assessments  
(12 month 
post) 
Post-
intervention 
Focus Group 
Participant 
-- 
-- 
Device & 
Training 
materials 
-- 
-- 
$20 
Communication 
Partner 
-- 
-- 
-- 
-- 
-- 
$20 
 
11. 
Costs 
a. 
Detail costs of study procedure(s) or drug (s) or substance(s) to participants and 
identify who will pay for them. 
 
Participants will not be assessed any costs.  The study will purchase the devices directly and supply 
them to the study participants.  The study participants will receive audiometric screening, the device, 
and all educational and counseling materials and support during the duration of the study at no cost.