Comparative Study of Non-invasive Adhear Bone Conduction System to Traditional Bone Conduction Hearing Devices
Phase: NA
Conditions: Hearing Loss, Conductive, Hearing Loss, Unilateral
Sponsor: University of Miami

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Adhear Bone Conduction System
Principal Investigator: Hillary Snapp, AuD, PhD
Protocol Number: 20161220
NCT Number: 03533686
February 27, 2023
Version 5
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Protocol Title
Comparative study of non-invasive Adhear bone conduction system to traditional bone 
conduction hearing devices
Objectives*
Aim 1. Determine if non-invasive Adhear is an equally effective treatment solution for unilateral 
profound sensorineural hearing loss when compared to invasive bone anchored implants.
Hypothesis: We hypothesize that non-invasive Adhear bone conduction technology will  provide 
similar benefit to the more invasive bone anchored implant system for unilateral profound 
sensorineural hearing loss.
Aim 2. Non-invasive Adhear is an equally effective treatment solution for conductive hearing loss when 
compared to invasive bone anchored implants.
Hypothesis: We hypothesize that non-invasive Adhear bone conduction technology will provide 
similar benefit to the more invasive bone anchored implant system for conductive hearing loss.
Aim 3. Non-invasive Adhear is a more effective treatment solution for pediatric hearing  loss when 
compared to bone conduction devices worn on a headband.
Hypothesis: We hypothesize that non-invasive Adhear bone conduction technology will increase 
objective and subjective benefit when compared to traditional bone anchored implant 
processors worn on a headband for pediatric conductive hearing loss.
Aim 3a. - To evaluate the validity of the non-invasive ADHEAR bone conduction hearing system in 
children with bilateral or unilateral conductive hearing loss
Aim 3b. To compare the benefits of the non-invasive ADHEAR bone conduction hearing system in 
children with bilateral and unilateral conductive hearing loss to traditional non- invasive 
bone conduction hearing systems worn on a headband.
Background*
Implantable bone conduction technology has been well established as an efficacious and effective 
treatment solution. Despite this, adoption and acceptance rates for implantable bone conduction 
devices are low (Andersen et al, 2006; Desmet et al, 2012; Farber et al, 2012; Kompis et al 2001; Siau 
et al 2015). This has been attributed to aesthetics (Farber et al, 2012); and the need for surgery 
(Farber et al, 2012; Desmet et al, 2012; Siau, 2015). In fact Siau and colleagues suggested that rejection 
of implantable bone conduction technology is as high as 70% with nearly 30% attributed to subject 
opposition to surgery (Farber et al, 2012; Siau et al, 2015). In lieu of implantation, bone conduction 
devices can be anchored to a headband. Non-invasive bone conduction hearing technology is a 
promising alternative to implantable bone anchored systems.  Significant gains in speech perception in 
quiet and in noise can be achieved with both implantable and headband bone conduction devices. 
These basic auditory functions are an essential component for effective communication and daily acts 
of living. Likewise, the inability to perform such functions results in considerable reduction of quality of 
life, social exclusion, vocational limitations, and a high disability and handicap index. Issues related to 
comfort and increased visibility of headband devices, however, have limited the acceptance and use of 
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such systems. The Adhear (MEDEL, Corp) bone conduction hearing system is a novel hearing device 
providing non-invasive direct stimulation of the hearing organ via bone conduction without the need 
for a headband. In the Adjoin system (MEDEL, Corp) the audio processor attaches to a long wear 
adhesive adapter. The adhesive adapter is worn discreetly behind the ear and allows the processor to 
stimulate the temporal bone without the use of a visible headband or implant. This provides optimal 
placement of the processor for maximal stimulation of the hearing organ, as well as a more natural 
placement of the microphone for sound collection. This novel approach overcomes the key limitations 
of current treatment solutions and has the potential to impact individuals with mixed, conductive or 
unilateral hearing loss in substantial ways.
The ability to provide nonsurgical acoustic stimulation by bone conduction without the discomfort and 
stigma associated with using a headband will allow for increased adoption and acceptance, while 
providing the effectiveness of an implantable device. Further, such technology will increase access for 
both adult and pediatric bone anchored implant candidates. Utilizing Adhear technology provides a less 
invasive alternative for patients who are unable or unwilling to undergo bone anchored implant 
surgery and offers an innovative approach to resolving the auditory deficits associated conductive, 
mixed or unilateral profound hearing loss. In short, the outcomes of the proposed study will provide 
direct benefit to patients and improve clinical application.
The safety and effectiveness of bone anchored implants (BAI) for the treatment of conductive, mixed, 
and unilateral profound sensorineural hearing loss (UPSNHL) has been well established. The notable 
benefits associated with implantable hearing technology have increased the support for more invasive 
forms of treatment. However, a significant number of patients exist who are unable or unwilling to 
pursue an implantable solution for their hearing loss. Further, in the UPSNHL population, evidence 
suggests that patients can achieve equal benefits with non-invasive solutions (Snapp et al, 2016). For 
conductive and mixed hearing loss, BAIs have been demonstrated to have improved gain and sound 
quality over traditional hearing aids (Mylanus et al, 1995, Mylanus et al, 1998Hol et al, 2005; 
McDermott et al, 2002;) and have been an optimal solution for those who have physiological 
limitations to using traditional hearing aids.
Until now, those who were unwilling or unable to undergo bone anchored implantation were limited 
to bone conduction devices on a headband, a solution that has been plagued with poor acceptance 
due to unfavorable aesthetics and discomfort with long- term use. In this study, subjective and 
objective hearing outcomes utilizing a novel hearing device branded as the Adhear  providing non-
invasive bone conduction stimulation (MEDEL, Corp) will be compared with outcomes using traditional 
BAI technology.
Inclusion and Exclusion Criteria*
All subjects will be prospectively enrolled for study.
Aims 1 and 2 will include adult English speaking patients who are experienced users of BAIs for the 
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indication of either single sided deafness or conductive hearing loss. Experienced will be defined as 
greater than 6 months of device use and no intermittent function of the device within 2 weeks of 
enrollment. Aims 1 and 2 will require retrospective chart review to identify potential study subjects for 
recruitment. Subjects who spontaneously present to the clinic may also be enrolled should the meet 
inclusion criteria. Subjects will be limited to those who have normal hearing by bone conduction 
defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, & 3000 Hz in at least one ear.
Aim 3 will include English speaking children 5 to 17 years of age and their primary guardian who 
present to the clinic for treatment by BAI on a headband device for the indications of single sided 
deafness or conductive hearing loss. Because subjects for aim 3 have not previously been users of a 
BAIs, subjects for aim 3 will be recruited during spontaneous presentation to the clinic. Subjects will 
also be recruited for aim 3 from various sites using flyers and email. Subjects will be limited to those 
who have no prior use of a BAI or bone conduction hearing device, normal hearing by bone 
conduction defined as a pure tone average of 25 dBHL or better at 500, 1000, 2000, & 3000 Hz in at 
least one ear. For those children where this cannot be definitively established, children will be 
included who display clinical signs of normal bone conduction hearing beyond a reasonable doubt and 
may include such evidence as (but not limited to): auditory brainstem response, speech awareness 
thresholds, visual reinforcement audiometry, conditioning play audiometry, CT scans, etc.)
Aims 3 a & b are an extension of Aim 3 and will include pediatric bilateral or unilateral conductive 
hearing loss patients who are between the ages of 2 and 17 years of age and are currently managed by 
the UMEI with a bone conduction device attached to a softband  will be enrolled for study.
Exclusion Criteria:
The study is limited to English speakers, as speech perception measures are only available  in English so 
non-native English speakers do not undergo the standard clinical protocol.
For aim 3, parents of English speaking subjects who do not speak English will not be specifically 
excluded. Due to the high incidence of English speaking children in Spanish speaking homes, for 
primary guardians who speak Spanish, Spanish materials will be provided. Children who have previous 
experience with a BAI or bone conduction hearing device will not be included for study.
Subjects will be screened for any allergies related to adhesives as the experimental device requires use 
of an adhesive adapter. Those reporting allergies to adhesives or highly reactive skin will be excluded 
from study as a precautionary measure.
Procedures Involved*
The medical records of patients who received a bone conduction hearing device follow-up between 
January 1, 2010 through September 23, 2021 will be retrospectively reviewed. We anticipate review 
of approximately 500 medical records. Demographic data for review include gender, age, primary 
spoken language, and etiology. Standard clinical hearing outcome data will be reviewed for both 
groups and will include audiometric thresholds, word recognition ability, and speech perception 
measures. This information will be used to determine study candidates. Those who meet the 
inclusion criterion will be contacted for study participation. Once we have received a minimum of 10 
but no greater than 30 participants for each study group, retrospective review will be completed and 
no new charts will be accessed. Participants will then only be studied prospectively. Demographic 
and audiometric data will be maintained under a unique identifier code linked to the consented study 
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participant for reference to study outcome data.
Study Populations

Minimum of 10 established adult unilateral profound sensorineural hearing loss recipients 
of bone anchored implants

Minimum of 10 established adult conductive hearing loss recipients of bone anchored 
implants

Minimum of 10 new pediatric headband bone conductive device  candidates.

Minimum of 10 guardians of the pediatric population involved

Minimum of 15 established pediatric unilateral conductive hearing loss patients 
currently fit with a bone conduction device on a softband.

Minimum of 10 established bilateral conductive hearing loss patients currently fit with a 
bone conduction device on a softband.
Study Design
Aims 1&2

Experienced adult bone anchored implant recipients with either unilateral profound 
sensorineural hearing loss or conductive hearing loss will be enrolled for study. Subjects will be 
given the Adhear hearing system on trial for 2 weeks ± 90 days. Prior to dispensing of the 
experimental system, function of the subject’s implant system will be verified. Custom pre-
post subjective measures will be administered. Subjects will undergo behavioral measures of 
benefit in the 1) implant aided condition and 2) the Adhear Aided condition

Conditions will be randomized by subject and will consist of the following:
o
Speech perception in noise ability using the BKBSIN (Etymotic, Elk Grove, IL) 
adaptive tests for speech front, noise front (0º/0º azimuth), speech poorer ear, 
noise better ear (90º/270º azimuth), speech better ear, noise poorer ear (90º/270º 
azimuth)
o
Soundfield aided narrow band signal thresholds – better ear plugged
o
Soundfield aided speech reception thresholds – better ear plugged

At 2 weeks ± 90 days, subjects will undergo behavioral measures of benefit in the Adhear 
aided condition. Tests will be repeated using the subjects own processor on a soft headband to 
evaluate transcutaneous stimulation.

Conditions will be randomized by subject and will consist of the following:
o
Speech perception in noise ability using the BKBSIN (Etymotic, Elk Grove, IL) 
adaptive tests for speech front, noise front (0º/0º azimuth), speech poorer ear, 
noise better ear (90º/270º azimuth), speech better ear, noise poorer ear (90º/270º 
azimuth)
o
Soundfield aided narrow band signal thresholds – better ear plugged
o
Soundfield aided speech reception thresholds – better ear plugged
Aim 3

Pediatric conductive hearing loss patients who are between the ages of 5 and 15 years of age 
and present to the UMEI hearing rehabilitation by bone conduction technology along with 
their primary guardian will be enrolled for study. Subjects will be evaluated in two phases:
o
Phase 1 – random assignment to trial with either a traditional bone conduction 
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device on a headband or an Adhear hearing system for 3 weeks ± 90 days. Pediatric 
and parent subjective questionnaires will be administered prior to and at the end of 
phase 1.
o
Phase 2- trial with system alternate to that which was assigned for phase 1. Pediatric 
and parent subjective questionnaires will be administered prior to and at the end of 
phase 2.
Objective and behavioral outcome measures.
o
Data logging of device use
o
Soundfield aided narrowband signal thresholds – better ear plugged
o
Soundfield aided speech reception thresholds – better ear plugged
o
Word recognition ability using PBK words and speech shaped noise at +5dB SNR for 
soft at 35, 45, and 55 dB for speech front, noise front (0º/0º azimuth)

Aim 3a
Pediatric unilateral conductive hearing loss patients who are between the ages of 2 and 17 
years of age and are currently managed by the UMEI with a bone conduction device attached 
to a softband will be enrolled for study. Subjects will be given the ADHEAR bone conduction 
system on trial for 2 weeks ± 90 days. Subjects will be evaluated over 2 experimental visits.
o
VISIT 1: Assessment of subject’s bone conduction device on the headband and 
initiation of ADHEAR trial

Prior to dispensing of the experimental system, function of the subjects 
current bone conduction device will be verified.

Subjective measures will be administered to determine benefit and 
satisfaction with the subject’s own device on the headband.

Subjects will undergo behavioral measures of benefit with own bone 
conduction device on a headband

Subjects will be provided ADHEAR bone conduction hearing system
o
VISIT 2:

Subjective measures will be administered to determine benefit and 
satisfaction with the ADHEAR bone conduction hearing system

Subjects will undergo behavioral measures of benefit with ADHEAR bone 
conduction hearing system

ADHEAR system will be returned to the research site upon completion  of the 
trial
Objective and behavioral outcome measures unilateral conductive hearing loss subjects:
o
Data logging of device use (parent and subject report)
o
Soundfield aided narrowband signal thresholds – better ear plugged
o
Soundfield aided Ling thresholds – better ear plugged using the DSLio - Ling 6(HL) 
test (v2.0) which provides calibrated, pre-recorded Ling 6 sounds (m, u, a, i, sh, s) for 
use in measuring unaided or aided thresholds.
o
Soundfield aided speech reception thresholds using Calibrated and pre-recorded 
Auditec Spondee lists– better ear plugged
o
Word recognition ability using the Auditec Inc PBK-50 words. The majority of subjects 
enrolled are expected to be between the ages of 3 and 7 and the PBK word list offers 
the most age appropriate assessment of word recognition ability  for this age group, 
while also allowing for accurate assessment of audibility in older children under aided 
condition. In those children who are not able to repeat words reliably, a detection 
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task will be conducted. Tests will be conducted in the soundfield with the better ear 
plugged for soft (35 dB) and average (50 dB) speech inputs at speech front, noise front 
(0º/0º azimuth)

Aim 3b
Pediatric bilateral conductive hearing loss patients who are between the ages of 2 and 17 
years of age and are currently managed by the UMEI with a bone conduction device attached 
to a softband will be enrolled for study. Subjects will be given the ADHEAR bone conduction 
system on trial for 4 weeks ± 7 days. Subjects will be evaluated over 3- 4 experimental visits.
o
VISIT 1: Assessment of subject’s bone conduction device on softband and 
initiation of ADHEAR trial

Prior to dispensing of the experimental system, function of the subject’s 
current bone conduction device will be verified.

Subjective measures will be administered to determine benefit and 
satisfaction with the subject’s own device on the softband.

Subjects will undergo behavioral measures of benefit with own bone 
conduction device on a softband. It is anticipated that the majority of  bilateral 
conductive hearing loss subjects will be unilaterally fitted. Subjects will be 
tested in their everyday listening condition

Subjects will be provided ADHEAR bone conduction hearing system unilaterally

In those who are bilaterally fit with a bone conduction device, testing will be 
conducted unilaterally. To maintain the child’s everyday listening condition, 
participants will be fit with 2 ADHEARs (i.e. bilateral). T
o
VISIT 2 (2 weeks ± 90 days):

Subjective measures will be administered to determine benefit and 
satisfaction with the ADHEAR bone conduction hearing system

Subjects will undergo behavioral measures of benefit with ADHEAR  bone 
conduction hearing system unilaterally

Subjects will be provided ADHEAR bone conduction hearing system  bilaterally

In those who are bilaterally fit at time of enrollment, testing will be conducted 
bilaterally with the ADHEARs, and trial will discontinue.
o
VISIT 3 (4 weeks ± 90 days):

Subjective measures will be administered to determine benefit and satisfaction 
with the ADHEAR bone conduction hearing system

Subjects will undergo behavioral measures of benefit with ADHEAR bone 
conduction hearing system bilaterally

Time and subject permitting subjects will be tested in bilateral softband 
condition, otherwise this will be completed in an additional visit (4)
Objective and behavioral outcome measures bilateral conductive hearing loss subjects:
o
Data logging of device use (parent and subject report)
o
Soundfield aided narrowband signal thresholds bilaterally aided
o
Soundfield aided Ling thresholds using the DSLio - Ling 6(HL) test (v2.0) which  provides 
calibrated, pre-recorded Ling 6 sounds (m, u, a, i, sh, s) for use in measuring unaided 
or aided thresholds.
o
Soundfield aided speech reception thresholds
o
Word recognition ability using the Auditec Inc PBK-50 words under bilaterally aided 
conditions. Tests will be conducted in the soundfield with the better ear plugged for 
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soft (35 dB) and average (50 dB) speech inputs at speech front, noise front (0º/0º 
azimuth)
Subjective outcome measures
In light of COVID-19 restrictions, the subjective questionnaires will be collected over the phone given 
that the subjects and/or guardian cannot come into the clinic. A verbal addendum will be read to the 
participant(s) over the phone to confirm they agree with the new changes. The questionnaires will be 
administered after participant gives verbal consent.
Subjective questionnaires (included in this submission) will be administered prior to and at the end of 
each phase to the subject. A parent proxy of the subjects questionnaire will also be administered to 
the subjects guardian to gauge parent/guardian perception of benefit with bone conduction 
technology. These subjective questionnaires will be given pre- and post-evaluation to both the subject 
and his/her guardian in order to determine the impact of bone conduction technology on subject and 
guardian perceptions of benefit. The pediatric questionnaire uses images to help ensure the child 
understands the response choices. Additionally both the child and the guardian will fill out the 
questionnaire with a study team member present so that they may ask for clarification if/when 
necessary. For the pediatric questionnaire 2 practice questions are included to ensure the child 
understands the question and response format and is capable of completing the questionnaire 
reliably. Note that the questionnaire given prior to assignment of a device will inlcude only questions 1 
- 15 for the guardian version and only questions 1 - 18 for the pediatric version since the remaining 
questions are device-specific. The unabridged full version of the questionnaire will be administered at 
both the end of phase 1 and phase 2.
Data and Specimen Banking*
All the previously described data will be stored on the PI’s computer and used for analyses purposes in 
room 526 of the clinical research building at the University of Miami Medical Center located at 1120 
NW 14th street, 5th Floor, Miami FL, 33136. It will be password protected, and unique identifiers used 
for subject protection. Data will not be distributed, except in the form of peer- reviewed publication or 
oral presentation maintain the confidentiality of the subjects.
Data Management*
Data to collected includes: Gender, age, language, etiology and type of hearing loss, treatment ear, 
audiometric data including thresholds and speech outcomes, prior hearing treatment, date of activation 
or device use, aided thresholds, aided speech in noise performance, hours of device use, and 
subjective outcomes (see questionnaires included).
All the previously described data will be stored on the PI’s computer and used for analyses purposes in 
room 526 of the clinical research building at the University of Miami Medical Center located at 1120 
NW 14th street, 5th Floor, Miami FL, 33136. It will be password protected, and unique identifiers will be 
used for subject protection. Descriptive statistics will be used to report demographic (e.g. age and 
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gender) data. Quantitative data will be presented as mean, standard deviation (SD) and range 
(minimum and maximum); qualitative data will be presented as frequencies and percentages. 
Inferential statistics will be applied to detect differences in speech in noise performance as a function 
of transcranial attenuation. For this purpose, parametric Student’s t-tests or nonparametric Wilcoxon 
signed rank tests will be performed, depending on the data distribution. Statistical significance will be 
set to p<0.05. The subjective questionnaires will be summarized by visit using descriptive summaries. 
For numeric measures the change from baseline will be calculated and inferential tests applied. For 
categorical measures, a shift from baseline will be presented demonstrating the subjects as being 
better, the same, or worse.
Risks to Subjects*
The risks to the subjects will be minimal. At most, a breach of confidentiality composes the majority 
of the risk. We will take extensive measures to protect confidentiality and to ensure data security.
The proposed device, Adhear (MEDEL Corp.) is now FDA approved. (see attached correspondence). 
Further the application for use is compatible with the currently marketed headband bone anchored 
device (see 510k #K002913 https://510k.directory/clearances/K002913 ) and the processor is 
compatible with current approved processors (see 510k’s K090720 
https://510k.directory/clearances/K090720 , K132278 https://510k.directory/clearances/K132278 , 
K110996 https://510k.directory/clearances/K110996 , K161123
https://510k.directory/clearances/K161123 , K100360 https://510k.directory/clearances/K100360 ) 
and presents no new concerns about safety and effectiveness. The novel component to Adhear is 
the long-wear adhesive which provides an aesthetically appealing alternative to the use of a 
headband with virtually no discomfort. Use of the headband applies a constant pressure to the bone 
and skin which can lead to indentation of the skin and discomfort (van der Pouw et al., 1999). Long-
wear medical grade adhesives have wide range application and have been shown to be safe for over-
the-counter use for such applications as would care dressing, skin-bonded monitoring devices, drug 
or therapeutic delivery systems, transdermal patches, etc.
Because of their widespread commercial use, we do not anticipate any increased risk over that which 
is reasonably expected in the general population for use of such adhesives. We will take extra 
precautions to reduce any risk by excluding subjects who report a known skin sensitivity or allergen 
to adhesives. Further, we will enforce strict adherence to manufacturer specifications for use of the 
long-wear adhesive.
Potential Benefits to Subjects*
The present study has the potential to benefit the included subject directly as well as future patients 
undergoing treatment for conductive hearing loss or single sided deafness. Children and their 
guardians who enroll in aim 3 of this study may directly benefit from the anticipated increased 
adoption and acceptance of this technology over current BAI systems. In the long term, such a solution 
may provide a long-term non-surgical solution for both children and adults. Therefore, patients may 
benefit from the investigation and findings contained within. The data generated from this 
investigation will help audiologists and otolaryngologists determine the benefits and limitations to 
non-invasive alternatives to traditional BAIs.
Vulnerable Populations*
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The study will include children.
Setting
The study will take place in the Department of Otolaryngology for patients seen in the Department of 
Otolaryngology for BAI services.
Resources Available
The PI and Co-investigators are well qualified to perform the described study protocol. We have an 
established clinic with a long history of evaluation and management of individuals who use BAIs. 
Further, the PI has an established research profile resulting in peer-reviewed publication on the 
described topic. The Department of Otolaryngology has 2 study coordinators to assist in management 
of study procedures.
Prior Approvals
N/A
Recruitment Methods
For Aims 1&2 the medical records of patients who received a bone conduction hearing device follow-
up between January 1, 2010 through September 23, 2021 will be retrospectively reviewed. We 
anticipate review of approximately 500 medical records. Demographic data for review include gender, 
age, primary spoken language, etiology. Standard clinical hearing outcome data will be reviewed for 
both groups and will include audiometric thresholds, word recognition ability, speech perception 
measures. This information will be used to determine study candidates. Those who meet the inclusion 
criterion will be contacted for study participation. Potential subjects will be contacted by phone 
and/or email to participate (see attachment). Once we have received a minimum of 10 but no greater 
than 30 participants for each study group, retrospective review will be completed and no new charts 
will be accessed. Participants will then only be studied prospectively. Demographic and audiometric 
data will be maintained under a unique identifier code linked to the consented study participant for 
reference to study outcome data.
For Aim 3, pediatric patients who spontaneously present to the clinic for BAI evaluation with their 
guardian and meet inclusion criteria will be informed of the study. If the patient and the guardian 
express interest the study purpose, procedures, benefits, limitations, duration, voluntary nature, costs, 
and risks will be explained in detail. Children over the age of seven will assent participation. We will 
provide information about the study in a language understandable to the participant, answer all 
questions in terms understandable to the child, use written and verbal explanations, and obtain 
voluntary agreement to participate. The assent document will be written in language at an appropriate 
level of readability.
Subjects for Aim 3 will also be recruited by flyer or email advertisement. Flyers  will be posted at the 
following locations:
University of Miami at the Clinical Research Building, UHealth Plantation, UHealth Boca, UHealth Palm 
Beach, UHealth Lennar and Miami Children’s  Hospital Division of Audiology.
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Potential subjects will also be identified through the UMiamiHealthResearch.org platform. On the 
UMiamiHealthResearch.org platform, potential subjects will be able to contact the study team if they 
are interested in participating in the study. A study team member will then follow-up with the 
potential subject via telephone or email to determine interest and eligibility for the study (see “Script 
for Screening Phone Call”).
There is no financial compensation for participation in this study.
Local Number of Subjects
60
Confidentiality
To ensure confidentiality of the information shared with the investigative team, all information 
pertaining to a subject will be given a coded number. All data will be stored under this code number 
and not the subject’s name. Records which link subjects’ identification with their code number will be 
kept in a locked file on a password protected computer that only the PI has access to and stored 
separately from the subject data. All computer files that include study data will be stored on a 
computer with password security and only IRB approved individuals will have access to these codes. 
The investigator and her co-investigators will consider these records confidential to the extent 
permitted by law. Identifiable records and results will not be included in any publication, and collected 
data will not be used in any other studies without a subject’s expressed permission.
Provisions to Protect the Privacy Interests of Subjects
N/A
Consent Process
Due to COVID 19, we also will be consenting remotely. When consenting remotely, we will follow the 
recommendations provided by both University of Miami and the FDA. Potential subjects will be called 
and/or emailed for recruitment and if agreed to participate, a zoom meeting and/or RedCap 
econsenting application will be used for the consenting process; a witness will be present in the zoom 
call. All steps will be documented in the format attached.
It is possible that while our study is limited to English speaking patients, the parents of some patients 
included for aim 3 may be non-english speakers. Because only a maximum of 15 subjects will be 
enrolled for aim 3 it is anticipated that only a small number of subjects (<5) may be enrolled whose 
guardians will not understand English. Based on population data for Miami-Dade, we expect this to be 
limited to Spanish speakers. For those participants all required documents will be translated into 
Spanish. Further a native Spanish speaker and certified medical translator will be present for consent 
and all test sessions.
When determining whether a child is capable of assenting, the ages, maturity, and psychological state 
of the child will be taken into account. The PI will consider the child’s experience and level of 
understanding, ensure the child is cooperative and agreeable to participation, and ensure the child’s 
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rights are maintained. As with adult consents, assent will be conducted in a manner and location that 
ensures participant privacy, Giving adequate information about the study in a language 
understandable to the participant, Providing adequate opportunity for the participant to consider all 
options, Responding to the participant’s questions, Ensuring the participant has understood the 
information provided, Obtaining the participant’s voluntary agreement to participate, and Continuing 
to provide information as the participant or research requires.
Process to Document Consent in Writing
N/A
Authorization for Use and Disclosure of Protected Health  Information 
(HIPAA)
Type of Request:
Waiver of Authorization (to waive the requirement for signature and date)  approved due to current 
COVID-19 pandemic.
Confirm that you will destroy the Protected Health Information (PHI) you and/or  your Study Team 
acquire receive from JHS and/or UHealth at the earliest opportunity. 
  I confirm
Confirm that the Protected Health Inform (PHI) you acquire from JHS and/or UHealth will not be re-
used or disclosed to any other person or entity, except as required by law or for authorized oversight 
of the research study or for other research for which the use or disclosure of PHI is permissible.
    I confirm
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