A System and Process to Improve the Satisfaction With Hearing Health Products
Phase: NA
Conditions: Hearing Loss
Sponsor: University of Minnesota

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PROTOCOL TITLE: Improve the satisfaction with hearing health products 
VERSION DATE: 08/11/2020 
 
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ANCILLARY REVIEWS 
Which ancillary reviews do I need and when do I need them? 
Refer to HRP-309 for more information about these ancillary reviews. 
Select yes or 
no 
Does your study… 
If yes… 
Impact on 
IRB Review 
☐ Yes 
☒ No 
 
Include Gillette resources, staff 
or locations 
Gillette Scientific review and Gillette 
Research Administration approval is 
required.  Contact: 
research@gillettechildrens.com   
Required 
prior to IRB 
submission 
☐ Yes 
☒ No 
Involve Epic, or Fairview 
patients, staff, locations, or 
resources? 
The Fairview ancillary review will be 
assigned to your study by IRB staff 
Contact: ancillaryreview@Fairview.org 
Approval 
must be 
received 
prior to IRB 
committee/ 
designated 
review.   
 
Consider 
seeking 
approval 
prior to IRB 
submission. 
☐ Yes 
☒ No 
Include evaluation of drugs, 
devices, biologics, tobacco, or 
dietary supplements or data 
subject to FDA inspection? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
 
The regulatory ancillary review will be 
assigned to your study by IRB staff 
Contact: medreg@umn.edu  
See 
https://policy.umn.edu/research/indide  
☐ Yes 
☒ No 
Require Scientific Review? Not 
sure? See guidance on next 
page. 
 
ONLY REQURED BIOMEDICAL 
RESEARCH REVIEWED BY FULL 
COMMITTEE 
  
☐ Yes 
☒ No 
Relate to cancer patients, 
cancer treatments, cancer 
screening/prevention, or 
tobacco? 
Complete the CPRC application process.  
Contact: ccprc@umn.edu  
☐ Yes 
☒ No 
Include the use of radiation? 
(x-ray imaging, 
radiopharmaceuticals, external 
beam or brachytherapy) 
 
Complete the AURPC Human Use 
Application and follow instructions on 
the form for submission to the AURPC 
committee. 
Contact: barmstro@umn.edu  
Approval 
from these 
committees 
must be 
received 

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☐ Yes 
☒ No 
Use the Center for Magnetic 
Resonance Research (CMRR) 
as a study location? 
Complete the CMRR pre-IRB ancillary 
review  
Contact: ande2445@umn.edu  
prior to IRB 
approval;  
 
These 
groups 
each have 
their own 
application 
process.  
☐ Yes 
☒ No 
Include the use of 
recombinant or synthetic 
nucleic acids, toxins, or 
infectious agents? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
☐ Yes 
☒ No 
Include the use of human fetal 
tissue, human embryos, or 
embryonic stem cells? 
STOP – Complete the Medical Template 
Protocol (HRP-590) 
☒ Yes 
☐ No 
 
Include PHI or are you 
requesting a HIPAA waiver? 
If yes, HIPCO will conduct a review of this 
protocol. 
Contact: privacy@umn.edu  
☐ Yes 
☒ No 
Use data from the Information 
Exchange (IE)? 
The Information Exchange ancillary 
review will be assigned to your study by 
IRB staff 
Contact: ics@umn.edu  
Approval 
must be 
received 
prior to IRB 
approval. 
 
These 
groups do 
not have a 
separate 
application 
process but 
additional 
information 
from the 
study team 
may be 
required. 
 
☐ Yes 
☒ No 
Use the Biorepository and 
Laboratory Services to collect 
tissue for research? 
STOP – Complete the Medical Template 
Protocol (HRP-590)  
 
The BLS ancillary review will be 
assigned to your study by IRB staff. 
Contact: cdrifka@umn.edu  
☐ Yes 
☒ No 
Have a PI or study team 
member with a conflict of 
interest? 
The CoI ancillary review will be 
assigned to your study by IRB staff 
Contact: becca002@umn.edu  
☐ Yes 
☒ No 
Need to be registered on 
clinicaltrials.gov? 
If you select “No” in ETHOS, the 
clinicaltrials.gov ancillary review will be 
assigned to your study by IRB staff 
Contact: kmmccorm@umn.edu  
☐ Yes 
☒ No 
Require registration in 
OnCore? 
If you select “No” or “I Don’t Know” in 
ETHOS, the OnCore ancillary review will 
be assigned to your study by IRB staff 
Contact: oncore@umn.edu  
Does not 
affect IRB 
approval. 
 
 

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PROTOCOL COVER PAGE 
 
 
Protocol Title 
A system and process to improve the satisfaction with hearing 
health products 
Principal 
Investigator/Faculty 
Advisor 
Name: Peggy Nelson 
Department: Ctr for Applied / Translational Sensory Science 
Telephone Number:612-625-4569 
Email Address: nelso477@umn.edu 
Student 
Investigator 
 
 
 
 
 
Scientific 
Assessment 
Nationally-based, federal funding organizations 
Version 
Number/Date: 
Version 3, September 2023 
 

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REVISION HISTORY 
 
Revision # 
Version Date 
Summary of Changes 
Consent Change? 
1 (v2) 
10/27/20 
Responded to questions from 
10/12 
Y 
2 (v3) 
12/14/20 
Responded to questions, new 
consent template 
y 
3 (v4) 
1/19/21 
Responded to questions, amended 
consent, requested info from 
privacy@umn.edu 
y 
4 (v 5) 
2/18/21 
Minor changes to email process, 
removed HIPAA waiver 
n 
5 (v 6) 
3/2/21 
Checked HIPAA disclosure form, 
clarified data shared with Novidan, 
IDL 
n 
6 
8/5/23 
Changed recruitment, changed 
research team, added Amptify as 
external partner 
y 
7 
9/22/23 
Corrected errors and 
inconsistencies, clarified that 
external team member has no 
other IRB 
y 
8 
1/24/24 
Added ‘other clinics’ to 
recruitment 
y 
 
 
 

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Table of Contents 
 
1.0 
Objectives 
7 
2.0 
Background 
7 
3.0 
Study Endpoints/Events/Outcomes 
7 
4.0 
Study Intervention(s)/Interaction(s) 
8 
5.0 
Procedures Involved 
8 
6.0 
Data Banking 
10 
7.0 
Sharing of Results with Participants 
10 
8.0 
Study Duration 
10 
9.0 
Study Population 
11 
11.0 Number of Participants 
11 
12.0 Recruitment Methods 
11 
13.0 Withdrawal of Participants 
11 
14.0 Risks to Participants 
11 
15.0 Incomplete Disclosure or Deception 
12 
16.0 Potential Benefits to Participants 
12 
17.0 Statistical Considerations 
12 
18.0 Health Information and Privacy Compliance 
12 
19.0 Confidentiality 
15 
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
15 
21.0 Compensation for Research-Related Injury 
16 
22.0 Consent Process 
16 
23.0 Setting 
16 
24.0 Multi-Site Research 
16 
25.0 Coordinating Center Research 
16 
26.0 Resources Available 
16 
27.0 References 
17 
 

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ABBREVIATIONS/DEFINITIONS 
DTC: direct to consumer 
HA: hearing aid 
COSI: Client oriented scale of improvement 
 
 
 

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1.0 
Objectives 
1.1 Purpose: Dr. Nelson, Dr. Karen Lawson, Dr. Timothy Beechey and Innovative 
Design Labs Inc. (IDL) proposes to create a cloud-based system which integrates 
advances and techniques from Health and Wellness Coaching (HWC) into the 
Hearing Aid (HA) fitting and trial process. We hypothesize that the integration of 
Health and Wellness Coaching, aided by cloud-based tools, into this process will 
increase patients’ satisfaction and usage of hearing health products. 
2.0 
Background 
2.1 Significance of Research Question/Purpose: The proposed clinical trial aims to 
determine the effectiveness of the proposed system to affect the hearing aid use 
and perceived quality of treatment provided by hearing aid users. This will add to 
the body of evidence both for the benefit of ongoing counseling of hearing aid 
patients and the effectiveness of health coaching for chronic conditions. Clinically 
meaningful outcomes for hearing aid users will be measured using a sufficiently 
powered sample size that can detect a meaningful difference. Inclusion and 
exclusion criteria are described in the attached Clinical Trial sections. 
2.2 Preliminary Data: N/A   
2.3 Existing Literature: As of 2015, 28.8 million U.S. adults could benefit from using 
hearing aids and the prevalence of hearing loss in the United States is predicted to 
rise significantly due to an aging population and the growing use of personal 
listening devices. However, only 28.5% of individuals who could benefit from a HA 
actually wears one. The non-use of hearing aids by people with hearing loss has 
many far-reaching implications for their physical health, mental health, and their 
social life. As the market moves towards a, direct-to-consumer distribution model 
following the 2017 FDA directive, more patients will be receiving therapy for hearing 
loss. While in traditional practice, an audiologist assists the patient with support 
adjusting to their new therapy, there is no person fulfilling that role in the direct-to-
consumer model. Hypothesis: We hypothesize that the integration of Health and 
Wellness Coaching, aided by cloud-based tools, into this process will increase 
patients’ satisfaction and usage of hearing health products 
3.0 
Study Endpoints/Events/Outcomes 
3.1 Primary Endpoint/Event/Outcome: We will test all participants for Client-oriented 
scale of improvement (COSI), and hours of hearing aid use. We will test all 
participants at the time of recruitment and 3 months post-fitting.   We will analyze 
the data for: Change in COSI goal achievement, Change in AQoL-8D score, hours of 
HA use.  The Client Oriented Scale of Improvement (COSI) is a clinically accepted 
outcome measure tool that fits well with the goal of the study as it measures the 
goal progress and perceived improvement in hearing ability of the patient. This 
questionnaire tracks the goals and needs of the patient through their fitting process. 
It allows the patient to qualify their degree of change for each of their needs/goals 

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as "Worse", "No Difference", "Slightly Better", "Better", or "Much Better" and their 
hearing ability.  
3.2 
Secondary Endpoint(s)/Event(s)/Outcome(s): assessment of quality of life (AQoL), 
The Assessment of Quality of Life (AQoL) is a measure of health-related Quality of Life. 
AQoL-8D covers dimensions of Independent Living, Happiness, Mental Health, Coping, 
Relationships, Self-Worth, Pain, and Senses. 
3.3  
4.0 
Study Intervention(s)/Interaction(s) 
5.0 
Description: The proposed clinical trial aims to determine the effectiveness of the 
proposed system to affect the hearing aid use and perceived quality of treatment 
provided by hearing aid users. This will add to the body of evidence both for the benefit of 
ongoing counseling of hearing aid patients and the effectiveness of health coaching for 
chronic conditions. Clinically meaningful outcomes for hearing aid users will be measured 
using a sufficiently powered sample size that can detect a meaningful difference.    
5.1 Study Design: The study will recruit 60 hearing aid users which will be randomized to 
two groups: a control group receiving standard of care and a group with the 
proposed health coaching system. The study will emulate the direct-to-consumer 
(DTC) experience as closely as possible while maintaining appropriate subject 
protections. Participants with self-reported mild to moderate hearing loss (matching 
the expected DTC market) will be recruited. Hearing loss will be measured using 
standard practice (i.e. Real-ear measurements) for later result analysis, but not used 
to adjust fit. Groups will be matched for hearing loss severity, age, and gender. 
5.2 
Study Procedures: Both group one and group two will be provided with hearing 
aids designed for the direct-to-consumer market, manufactured by Novidan. As is typical 
with DTC hearing aids, they come with a “generic” fit designed to approximate the needs 
across a large portion of the hearing aid population. After recruitment and consent (which 
will occur largely over Zoom and telephone, the devices will be supplied to the 
participants by mail rather than in-person to emulate a web-based purchase of DTC 
hearing aids.  
DTC fitting involves using participants’ self-reported hearing status to set baseline hearing 
aid settings.  Hearing aids are adjusted following initial fitting during a zoom session with 
an audiologist.  These procedures are currently being used in clinical settings during the 
pandemic. Both groups will be able to use a companion smartphone application which can 
control basic hearing aid functions and features such as volume, noise reduction, 
environment classification, profile mode, equalizer, etc. Both groups will have access to 
the audiologist for the first session and one followup session. However, only group 2 will 
have the health coaching (HWC) functionality of the application enabled and visible. 
Group 1: Control: This group will be supplied with Novidan DTC hearing aids and 
documentation following standard of care as a control. They will be provided with the 

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mobile application allowing for the monitoring of data for study analysis and personal 
control of their hearing aids, but not HWC features.  
Group 2: HWC Intervention: This group will also be supplied with the Novidan DTC 
hearings aids and documentation, same as the control group, but will be supplied the 
enhanced mobile application that allows for participation in health coaching features. 
They will be assigned to a health coach and will have coaching sessions scheduled. 
Health Coaching is a methodology that differs from health education or counseling. It 
builds on a foundation of fifty years of research in adult development, social psychology, 
organizational leadership, behavioral and positive psychology, and neuroscience. 
Theoretical models that inform coaching include self-determination theory, motivational 
interviewing, transtheoretical model, social cognitive theory, internal family systems, 
locus of control, and nonviolent communication.  Health Coaching competencies translate 
the scientific foundation of theory and research into relationships designed to facilitate 
lasting changes of mindset and behavior. Health Coaches assume that people have strong 
intrinsic resources and strengths, can access the self-motivation needed to function 
autonomously and competently, and are able to realize positive change within a safe and 
confidential alliance, where they are inspired, respected, and supported.  
The primary goal of the health coaching will be connecting the client’s values and desires 
for optimal wellbeing to their consistent use of their HAs. The coaches focus on nurturing 
client self-empowerment so that they are equipped and supported to make optimal 
behavioral and health care decisions.  Additionally, the coaching would address the 
psychosocial aspects of having a HA, and the ability to discuss problems about their HAs 
with professionals in an effective manner. 
For the purposes of this study, 1-2 credentialed health coaches (minimum requirement of 
bachelor’s degree and NBC-HWC)  will be employed under the budget plan of the study, 
and they will be trained to provide coaching support specifically for this population, with 
an understanding of the nature of the study.  A bio-profile of the health coach(s) will be 
made available in the client information materials. Volunteers for the study will have 
agreed to be randomized to an arm that either does or does not include coaching.  To 
participate in the coaching arm, they will have to commit to a minimum of 4 visits over 60-
90 days, but will have availability, at their own discretion, to access the coach as often as 
it serves their progress, with a maximum of 8 visits in 90 days.  After completion of initial 
assessment instruments, participants will be connected with their coach virtually through 
the developed platform. The health coach will review the coaching agreement and 
consent to record the coaching session (if applicable).  If the coaching session is recorded 
(optional) they will obtain consenting virtual signatures from clients.  Sessions will be up 
to 50 min. for the initial session, and 20-30 min. for follow-ups, and provided through a 
virtual A/V platform.  Scheduling with their coach will also be managed through the 
developed platform.  Coaching notes and instruments will be completed within the 
communication platform, and will be accessible to the coaches and researchers only. 
 

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Data Collection and Analysis: We will test all participants for Client-oriented scale of 
improvement (COSI), assessment of quality of life (AQoL), and hours of hearing aid use. All 
surveys will be completed remotely.  Participants will have the option of completing them 
using a fillable online form delivered via email, or using pen/paper through the mail. We 
will test all participants at the time of recruitment and 3 months post-fitting.   
Note: the AQoL survey asks “do you ever feel like hurting yourself?”  If the participant 
answers “often or all the time” we will follow up: 
 
Please check the most appropriate box: 
A. 
 I have a professional mental health provider and have adequate, on-going care.  No intervention 
needed. 
B. 
I have a primary care physician who is helping me manage my mental health challenges. No 
intervention needed. 
C. 
I have a primary care provider or clinic, but I have not engaged with them around my mental 
health.  Please contact your provider to be seen urgently about your thoughts of self-harm.  
D. 
I have health insurance, but no regular provider.  Please contact your insurance provider and ask 
for urgent referral for mental health services. 
E. 
I have no resources or support for mental health services.  Please contact the NAMI MN Crisis 
number for immediate support: **274747 or text MN to 741741 
 
At the end of the study, participants will be asked if they’re willing to answer some open 
ended questions regarding the app. This will be done by study personnel via zoom, phone, 
or in person.   These include: 
-how easy was the app to use 
-what challenges did you experience 
-do you have any suggestions or comments 
 
5.3 
Individually Identifiable Health Information: We will obtain audiometric hearing 
thresholds directly from participants. We have completed the HIPCO survey and 
that is attached.   
6.0 
Data Banking: N/A 
7.0 
Sharing of Results with Participants: N/A 
8.0 
Study Duration 
8.1 Describe: 
● 
Individual participants will be followed for 3 months post-fitting. 
● 
All study participants will be enrolled within 18 months 

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● 
The project will last 2 years. 
9.0 
Study Population 
9.1 Inclusion Criteria: Age 18 – 85 years, with hearing loss appropriate for DTC hearing 
aids and cognitive abilities to use the software. 
9.2 Exclusion Criteria: inability to use the software with standard assist 
9.3 Screening: Hearing will be screened remotely and ability to use the software will be 
monitored by study staff. 
10.0 Vulnerable Populations: N/A 
11.0 Number of Participants 
11.1 Number of Participants to be Consented: 60-80 participants will be consented 
12.0 Recruitment Methods 
12.1 
Recruitment Process: We will recruit participants through Amptify clinics and 
through U of M and related clinics.  Clinical audiologists involved in fitting devices through 
partner Amptify clinics and through related clinics will recruit 5 – 10 participants each. We 
will use HearingTrial.com (see attached) to screen. Clinics will be reimbursed $150 for 
each participant recruited.   
12.2 Source of Participants: There will be no other source for recruiting participants. 
12.3 Identification of Potential Participants: Participants will self-identify, and we will 
follow up with audiologic testing to confirm eligibility.  Dr. Nelson, Dr. Conchas or Dr. 
Teece  will make initial contact with potential participants.     
12.4 Recruitment Materials: Attached 
12.5 Payment: Participants will be paid $150 upon completion of the project. 
13.0 Withdrawal of Participants 
13.1 
Withdrawal Circumstances: Participants will be withdrawn if they do not wear the 
hearing devices within 2 weeks of fitting. 
13.2 
Withdrawal Procedures: If participants withdraw we will not continue to collect 
data or to use their data. 
13.3 
Termination Procedures: Same as above. 
14.0 Risks to Participants 
  
14.1 Foreseeable Risks:There are no foreseeable risks.  
14.2 Reproduction Risks:N/A 
14.3 Risks to Others: N/A 

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15.0 Incomplete Disclosure or Deception 
15.1 Incomplete Disclosure or Deception: N/A 
16.0 Potential Benefits to Participants 
16.1 Potential Benefits: There are no foreseeable benefits to participation. 
17.0 Statistical Considerations 
17.1 
Data Analysis Plan: The UMN will recruit up to 60 participants with mild to 
moderately severe hearing loss who are representative of the direct-to-consumer hearing 
aid market. We will attempt a rolling enrollment with two arms randomized between 
hearing aid without health coaching (control) and hearing aid with health coaching.  
17.2 
 Power analysis: In recent studies examining the effects of counseling on hearing 
aid satisfaction [41] showed a 16% and 18% improvement in hearing aid satisfactions after 
1 and 2 sessions respectively when using goal-oriented counseling compared to standard 
of care informational counseling. Based on this study we have estimated an effect size of 
.55 relative to baseline measures of COSI of 3.77 from [53]. With this effect size a sample 
of 58 individuals will provide 80% power at the p < 0.05 level. For this reason, we plan to 
collect data in a total of 60 subjects. To ensure we reach the necessary number of 
participants extra individuals will be recruited if we have participants drop out of the 
study. 
17.3 
Statistical analysis: At the conclusion of the study, the usual descriptive statistics 
and graphs (as appropriate) will be generated. The primary HA outcomes of hours of HA 
use (data-logged), HA perceived benefit (COSI), and quality of life metrics (AQoL) will be 
analyzed using linear regression models with the group as the single predictor and the 
group adjusted with additional variables such as demographic (age, sex, etc.) Relevant 
analyses will then be repeated for identified subgroups in the main study.   All  analyses 
will be conducted at α=0.05 level of significance using R statistic software. 
17.4 Data Integrity: Dr. Nelson will be responsible for data checking and integrity. 
18.0 Health Information and Privacy Compliance 
Individually Identifiable Health Information: for guidance regarding the use, collection, storage 
and sharing outside of the covered entity of identifiable health information please see: UMN 
Privacy Office Policies and/or Fairview Health Services Privacy Policies, and UMN HIPAA 
Agreement Templates. For research conducted at Gillette Children’s Specialty Healthcare refer to 
Gillette Research Administration for guidance. 
Under the HIPAA Privacy Rule, research studies at the University are permitted to use and 
disclose protected health information with the authorization of the research participants, or 
without individual authorization in limited circumstances.  
18.1 
Select which of the following is applicable to your research: 

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☐ My research does not require access to individual health information and 
therefore assert HIPAA does not apply.   
☒ I am requesting that all research participants sign a HIPCO approved HIPAA 
Disclosure Authorization to participate in the research (either the standalone 
form or the combined consent and HIPAA Authorization). 
☐ I am requesting the IRB to approve a Waiver or an alteration of research 
participant authorization to participate in the research. 
Appropriate Use for Research:   
☐ An external IRB (e.g. Advarra) is reviewing and we are requesting use of the 
authorization language embedded in the template consent form in lieu of the U 
of M stand-alone HIPAA Authorization.  Note: External IRB must be serving as 
the privacy board for this option. 
 
18.2 
Identify the source of Private Health Information you will be using for your 
research (Check all that apply)   
☐ I will use the Informatics Consulting Services (ICS) available through CTSI (also 
referred to as the University's Information Exchange (IE) or data shelter) to pull 
records for me 
☒ I will collect information directly from research participants. 
☐ I will use University services to access and retrieve records from the Bone 
Marrow Transplant (BMPT) database, also known as the HSCT (Hematopoietic 
Stem Cell Transplant) database. 
☐ I will pull records directly from EPIC. 
☐ I will retrieve record directly from axiUm / MiPACS 
☐ I will receive data from the Center for Medicare/Medicaid Services  
☐ I will receive a limited data set from another institution  
18.3 
Explain how you will ensure that only records of patients who have agreed to have 
their information used for research will be reviewed. 
18.4 
Approximate number of records required for review: N/A/ 
18.5 
Please describe how you will communicate with research participants during the 
course of this research.  Check all applicable boxes 
☐ This research involves record review only. There will be no communication with 
research participants. 

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☐ Communication with research participants will take place in the course of 
treatment, through MyChart, or other similar forms of communication used 
with patients receiving treatment.  
☒ Communication with research participants will take place outside of treatment 
settings. If this box is selected, please describe the type of communication and 
how it will be received by participants.  
 
-We will communicate with participants using encrypted email (Proofpoint) and 
zoom during the COVID period.  We have read email and zoom policies and will 
abide by those. 
 
  
18.6 
Access to participants 
We will not access any medical records not provided by participants 
themselves. 
18.7 Location(s) of storage, sharing and analysis of research data, including any links to 
research data (check all that apply).   
☐ In the data shelter of the Information Exchange (IE)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the Bone Marrow Transplant (BMT) database, also known as the HSCT 
(Hematopoietic Stem Cell Transplant) Database  
 ☐ Store 
☐ Analyze 
☐ Share 
☒ In REDCap (recap.ahc.umn.edu)  
 ☒ Store 
☒ Analyze 
☒ Share 
☐ In Qualtrics (qualtrics.umn.edu) 
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In OnCore (oncore.umn.edu)  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In the University’s Box Secure Storage (box.umn.edu) 
 ☒ Store 
☒ Analyze 
☒ Share 
☐ In an AHC-IS supported server. Provide folder path, location of server and IT 
Support Contact:  
 ☐ Store 
☐ Analyze 
☐ Share 
☐ In an AHC-IS supported desktop or laptop.  
Provide UMN device numbers of all devices: 

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 ☐ Store 
☐ Analyze 
☐ Share 
☐ Other.   
Indicate if  data will be collected, downloaded, accessed, shared or stored using a 
server, desktop, laptop, external drive or mobile device (including a tablet computer 
such as an iPad or a smartform (iPhone or Android devices) that you have not 
already identified in the preceding questions 
☐I will use a server not previously listed to collect/download research data 
☐I will use a desktop or laptop not previously listed 
☐I will use an external hard drive or USB drive (“flash” or “thumb” drives) not 
previously listed  
☐I will use a mobile device such as an tablet or smartphone not previously listed 
 
18.8 Consultants. Vendors. Third Parties. N/A  
Novidan, Inc is a vendor providing the hearing devices. Innovative Design Labs is the PI 
 
18.9 
Links to identifiable data: N/A 
 
18.10 Sharing of Data with Research Team Members. De-identified data will be shared 
with Novidan and IDL team members using Box. 
 
18.11 Storage and Disposal of Paper Documents: Paper files with identified data will be 
stored in a locked box in Elliott Hall S30.  They will be shredded 7 years after 
completion of the study. 
19.0 Confidentiality 
19.1 Data Security:  Only de-identified data will be shared on Box. Identified data will be 
on paper only, locked in the Elliott hall cabinet.    
20.0 Provisions to Monitor the Data to Ensure the Safety of Participants 
The study has minimal risk.  Data will be monitored by Dr. Nelson.  The safety of the 
participants will be monitored by Dr. Nelson. 
 
20.1 Data Integrity Monitoring. 
Dr. Nelson will check the data monthly and will discuss with the team in monthly meetings  

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Data Safety Monitoring.   
Dr. Nelson will check the data monthly and will discuss with the team in monthly meetings  
 
21.0 Compensation for Research-Related Injury N/A 
22.0 Consent Process 
We will follow “SOP: Informed Consent Process for Research (HRP-090)” and “SOP: Written 
Documentation of Consent (HRP-091).” 
22.1 Consent Process (when consent will be obtained): 
Consent will be obtained via email and confirmed by phone and zoom during COVID.  We will 
send the consent form and a cover email: 
Attached is the consent form. We would like you to read the form, and we are also including a 
summary here:    In order to agree to do the study, in lieu of signing a hard copy consent form 
(which you can do if you print, sign, scan and email it back to me ) I will ask you to send me a 
brief description of the study as well as specific statement: 
 
"I have read the consent form for the study. I have discussed the project with a member of the 
research team. I agree to participate in this study. I understand that I may withdraw at any time 
without prejudice." 
 
If you have any questions or comments let me know! Once you send me your consent statement 
we can go from there and set up a first meeting.    
● 
   
22.2 Waiver or Alteration of Consent Process (when consent will not be obtained, 
required information will not be disclosed, or the research involves deception):  N/A 
● 
. 
22.3 Adults Unable to Consent: (N/A) 
23.0 Setting 
23.1 Research Sites: The University  Center for Applied and Translational Research will 
recruit all partipants and will conduct all studies.  Research will happen in CATSS or 
in the participants’ homes through remote connection.   
24.0 Multi-Site Research N/A   
25.0 Coordinating Center Research N/A 
25.1  
26.0 Resources Available 
Resources Available: We will be working with Innovative Design Labs (health coaching 
 
software developer), and Novidan,Inc (hearing aid hardware provider) 

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27.0 References 
Bainbridge, K.E. & Ramachandran, V. (2014). Hearing aid use among older United States adults: The National 
Health and Nutrition Examination Survey, 2005-2006 and 2009-2019. Ear and Hearing 35 (3) 289-294. 
doi:10.1097/01.aud.0000441036.40169.29 
Cox, RM, & Alexander, GC. (1995) The abbreviated profile of hearing aid benefit. Ear and Hearing 16. 176-
186. 
Cox RM, Alexander GC. (1999) Measuring Satisfaction with Amplification in Daily Life: the SADL scale. Ear 
Hear. 20(4):306-20. 
Dillon, H. (1997) Client Oriented Scale of Improvement (COSI) and its relationship to several other measures 
of benefit and satisfaction provided by hearing aids J Am Acad Audiol 8(1):27-43. 
Nelson, P., Gregan, M., Perry, T., & VanTasell, D. (2018) "Self-adjusted amplification parameters  produce 
 
large between-subject variability and preserved speech intelligibility in noise”, Trends in  Hearing. 22. 1 – 13. 
 
doi.org/10.1177/2331216518798264