Treatment of Eustachian Tube Dysfunction (ETD) and Facial Pain With Combined Acoustic Vibration and Oscillating Expiratory Pressure
Phase: NA
Conditions: Eustachian Tube Dysfunction, Facial Pain
Sponsor: Medical University of South Carolina

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PROTOCOL TITLE: 
Treatment of eustachian tube dysfunction (ETD) and facial pain with combined acoustic 
vibration and oscillating expiratory pressure 
The study will be conducted in compliance with the clinical study protocol, international 
good clinical practice principles (International Conference on Harmonization [ICH]- 
Good Clinical Practice [GCP]), and regulatory authority requirements. 
PRINCIPAL INVESTIGATOR: 
 
Dr. McRackan 
 
   NCT04404036 
 
1.0 
Objectives / Specific Aims 
Aim 1: To determine if combined acoustic vibration and oscillating 
expiratory pressure impacts exhaled nasal Nitric Oxide (NO) in healthy 
controls as a potential mechanism 
Aim 2: To determine the safety and efficacy of combined acoustic vibration 
and oscillating expiratory pressure for treatment of eustachian tube 
dysfunction (ETD). 
Aim 3: To determine the safety and efficacy of combined acoustic vibration 
and oscillating expiratory pressure for treatment of sinus pain/pressure 
2.0 
Background 
 
Eustachian tube dysfunction (Meyer TA, etal) and sinus pain/pressure impact the quality of life 
of millions of Americans (Falco JJ, etal). It is thought that these disorders may be due to positive 
or negative pressure differential between the middle ear or paranasal sinuses. Current treatment 
options for ETD and sinus pressure/pain are typically Valsalva (positive expiratory pressure) 
with the hopes of equalizing pressures between the middle ear space or paranasal sinuses and the 
nasal cavity/external environment. Pharmacologically, nasal steroid sprays can be used to try to 
open the ET and sinus drainage pathways. If this fails, then procedures to include pressure 
equalization tubes (PETs) or balloon eustachian tube/paranasal sinus dilation are offered. 
 
Future treatment options: This study aims to test the safety, efficacy and potential mechanism of 
action of the SinuSonic device on adults with ETD or facial pain/pressure. SinuSonic is a 
medical device that utilizes sound and pressure combined with normal breathing. It has been 
shown to be safe and relieve nasal congestion (Soler ZM, etal). The study will have 3 aims. Aim 
1 will examine healthy controls with no signs of upper respiratory infection, inflammation, or 
ETD to determine if exhaled nasal NO is increased. Acoustic energy (humming) has been shown 
to increase nasal NO dramatically, thus equalization of gas pressures between the middle ear, the 
paranasal sinuses and the nasal cavity may very well explain any efficacy noted. Aim 2 will be 
performed to examine therapeutic efficacy for ETD. Aim 3 will be performed to examine 
therapeutic efficacy for sinus pain/pressure. 
 
3.0 
Intervention to be studied 

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Aim 1: Exhaled NO in healthy controls (N=10) 
• 
Initial intervention: Baseline exhaled nasal NO will be measured using a 
clinically available nasal airflow sampling device at rest. Then using 
SinuSonic devices for 2 exhalations followed by the 30 second NO 
sampling period. We will use 4 SinuSonic devices with frequencies 
between 64Hz and 2,000Hz in random order. Five minutes rest will be 
allowed between trials. The final trial will use 128 Hz for 1 minute. 
Aim 2: Clinical efficacy in subjects with ETD (N=30) 
• 
Baseline: Subjects will complete ETD questionnaire to confirm eligibility. 
Tympanogram will be completed. After confirming eligibility, subjects will 
use the SinuSonic device for 3 minutes in the clinic setting. Immediate 
treatment effect will be assessed with questionnaires. 
• 
Primary timepoint: Subjects will use SinuSonic device twice daily for 3 
minutes in the home setting for 6 weeks. Tympanogram and ET 
questionnaires will be completed. 
Aim 3: Clinical efficacy in subjects with sinus pain/pressure (N=30) 
• 
Baseline: Subjects will complete VAS to confirm eligibility. After 
confirming eligibility, subjects will use the SinuSonic device for 3 minutes 
in the clinic setting. Immediate treatment effect will be assessed with 
questionnaires. 
• 
Primary timepoint: Subjects will use SinuSonic device twice daily for 3 
minutes in the home setting for 4 weeks. Questionnaires will be completed 
at 2 weeks and 4 weeks. 
 
3.1 
Device Instructions 
 
Instructions for use: 
1. Hold the SinuSonic device at a 45-degree angle 
2. Deep breathe 

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3. Hold the SinuSonic to your nose and blow out into the mask of the SinuSonic. The 
goal here is to hear the “target flutter” sound that is desired during treatment with 
the SinuSonic 
4. Put the device over the nose using the nasal mask 
5. Breathe in and out thru the nose if possible. If nasal breathing is not possible it is ok 
to open mouth to breathe in and try and hear the “target flutter” sound when you 
breathe out 
6. You will feel a little resistance to breathe out and a vibration sensation from a 
speaker in the device 
7. Remove the device to “blow the nose” if nasal drainage occurs 
8. Return the device to the nose then breathe in and out thru the nose to try and hear 
the “target flutter” sound 
9. Time of use is 3 minutes of nasal breathing with the device - as tolerated 
3.2 
Device Usage and Safety 
 
The SinuSonic consists of a fully-disposable medical grade silicone nosepiece mounted to a resin 
body. The device is equipped with a flutter valve located at the top of the device which creates 
gentle, self-guided oscillating expiratory resistance. 
 
4.0 
Inclusion and Exclusion Criteria/ Study Population 
Aim 1 exhaled NO: For the exhaled NO portion of the study, we will examine 10 healthy 
control patients with no symptoms of upper airway infection, inflammation or ETD to 
determine impact of SinuSonic upon NO release. 
Inclusion Criteria 
• -Adults 18 years or older with no symptoms of URI, ETD or other ENT conditions 
Exclusion Criteria 
-Sinonasal or ear surgery within last 3 months (including balloon ET dilation) 
-Any ENT condition that may impact upper airway to include sinusitis, otitis, or allergies 
-Upper respiratory illness within last 2 weeks 
-Topical decongestant use in last week 
-Current nasal crusting or ulceration on rhinoscopy 
-History of severe nose bleeding within last 3 months 
-Known pregnancy 
-Allergic sensitivity to silicone or any other component of device 
-Inability to read and understand English 
-Inability to perform treatment due to underlying medical condition 
Aim 2 ETD efficacy: The ETD study population will consist of individuals presenting for 
care at the Otolaryngology clinics at the Medical University of South Carolina with ETD, 
or from the community at large. 
Inclusion Criteria 
• -Adults 18 years or older with diagnosis of ETD by an otolaryngologist 

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• ≥6 months of symptoms duration 
• ≥3 ETD symptoms (ear pressure, feeling that ears are clogged, cracking/popping of ears, 
muffled hearing, tinnitus) 
• ETDQ-7 score ≥ 3 
• Audiogram within the last year 
Exclusion Criteria 
-Sinonasal or ear surgery within last 3 months (including balloon ET dilation) 
-Indwelling ear tubes 
-Tympanic membrane perforation 
-Hx of cholesteatoma, mastoidectomy, tympanoplasty, or ossicular chain reconstruction 
-Patulous ET 
-Hx of Meniere’s disease 
-Moderate or severe nasal valve collapse 
-Grade 3-4 polyps 
-Upper respiratory illness within last 2 weeks 
-Topical decongestant use in last week 
-Current nasal crusting or ulceration on rhinoscopy 
-History of severe nose bleeding within last 3 months 
-Known pregnancy 
-Allergic sensitivity to silicone or any other component of device 
-Inability to read and understand English 
-Inability to perform treatment due to underlying medical condition 
 
Aim 3 Facial pain/pressure efficacy: The facial pain/pressure study population will 
consist of individuals presenting for care at the Otolaryngology clinics or community at 
large with self-reported sinus pain/pressure. 
Inclusion Criteria 
• -Adults 18 years or older who complain of facial pain or pressure 
• ≥3 months of symptoms duration (can be intermittent) 
• Pain/pressure VAS score ≥ 5 
Exclusion Criteria 
-Sinonasal surgery within the last 3 months 
-Grade 3-4 polyps 
-Upper respiratory illness within last 2 weeks 
-Topical decongestant use in last week 
-Current nasal crusting or ulceration on rhinoscopy 
-History of severe nose bleeding within last 3 months 
-Known pregnancy 
-Allergic sensitivity to silicone or any other component of device 
-Inability to read and understand English 
-Inability to perform treatment due to underlying medical condition 

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5.0 
Number of Subjects 
Aim 1, exhaled NO: We anticipate 10 healthy control subjects for the exhaled NO portion 
of the study. 
Aim 2, ETD: This is a pilot study. The anticipated ETD study population is 30 subjects. 
Aim 3, Facial pain/pressure: This is a pilot study. The anticipated facial pain/pressure 
study population is 30 subjects. 
6.0 
Setting 
Research will be conducted at the Medical University of South Carolina. Potential 
participant screening for all subjects across all aims, as well as baseline evaluations, will 
occur in the outpatient ENT clinics. For AIM 2, the 6-week post treatment assessment 
will take place in the outpatient ENT clinics. For AIM 3, follow-up measures will be 
collected remotely using REDCap at 2 and 4 weeks. 
7.0 
Recruitment Methods 
MUSC Otolaryngologists will notify the study coordinator (SC) of potential participants 
through the ENT Clinic. If the patient is interested, the coordinator will approach them 
and explain the study in further detail and begin the informed consent process. 
8.0 
Consent Process 
Patients who are deemed eligible for this study will be approached by the Principal 
Investigator or Co-Investigator in the ENT Clinic at the Medical University of South 
Carolina about the study. A member of the study team will describe in full detail the 
study and the informed consent form to the potential subject. The prospective participant 
will be given adequate time to review the informed consent form and ask any questions 
that they have before the consent is obtained. Participants will be given a signed copy of 
the ICF. 
8.1 
Withdrawal 
At any point during the study, a subject may withdraw from the study. 
9.0 
Study Design / Methods 
This study is designed as a pilot study. 
Data will be collected by the study investigators as well as the subjects themselves 
throughout the entirety of the study. The data will consist of answers from subjects for 
questionnaires asked by the clinicians as well as self-reported answers from the subjects. 
Safety will be monitored throughout the study based on monitoring of adverse events, 
performing nasal, measuring vital signs (i.e. blood pressure, pulse) and weight, and 
through collection of concomitant medication information. 
The period of observation for collection of non-serious adverse events extends from the 
time the subject gives informed consent until completion of the End-of-study visit or 
Early Termination Visit. Serious adverse events (SAE) will be reported from the time of 
informed consent through 30 days after the last use of the SinuSonic. Adverse event data 
listings will be reviewed by SinuSonic at regular intervals throughout the study. In 

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addition, SinuSonic will be alerted of Adverse Events of interest via automated emails 
programmed in the EDC system. Patient compliance will be assessed via weekly phone 
calls from study coordinator. 
9.1 
Schedule of Events 
 
 
 
 
Aim 2: ETD efficacy 
in N=30 patients 
Screening and 
baseline assessment 
Primary timepoint 
for outcomes 
Week 
0 
6 + 1 
Informed consent 
X 
Inclusion/exclusion 
criteria 
X 
Medical history 
X 
Rhinology, otoscopy 
X 
X 
Vital signs 
X 
Distribution of 
Sinusonic 
X 
X 
ETDQ-7 
X 
X 
ETD VAS 
questionnaire 
X 
X 
Tympanogram 
X 
X 
 
Aim 3: Facial 
pain/pressure in 
N=30 patients 
Screening 
and baseline 
assessment 
Primary 
timepoint 
for 
outcomes 
Secondary 
timepoint 
for 
outcomes 
Week 
0 
2 
4 
Informed consent 
X 
Inclusion/exclusion 
criteria 
X 
Medical history 
X 
Rhinology, 
otoscopy 
X 
Aim 1: NO in N=10 
controls 
Screening and 
baseline assessment 
Day 
0 
Informed consent 
X 
Inclusion/exclusion 
criteria 
X 
Medical history 
X 
Rhinology, otoscopy 
X 
Vital signs 
X 
Exhaled nasalNO at 
30 seconds and 5 min 
X 

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Vital signs 
X 
Distribution of 
Sinusonic 
X 
Pain/pressure VAS 
X 
X 
X 
BPI-SF 
X 
X 
X 
MPQ-SF 
X 
X 
X 
 
 
 
 
10.0 
Data Management 
All analyses and graphs will be performed with SPSS 24.0, Sample Power 3.0, and Sigma 
Plot 10.0 (SPSS, Chicago, IL.). Disease information and demographic variables, such as 
age, gender, race, quality of life (QOL) scores, and VAS scores will be summarized using 
frequencies, means, and standard deviation as appropriate.  Aim 1 nasal NO metrics will 
be compared between baseline vs 10 seconds and baseline vs 3 minutes. Aim 2 metrics 
(ETDQ-7, ETD VAS and tympanogram) will be compared between baseline and 6 
weeks. Aim 3 metrics (VAS, BPI-SF, MCQ-SF) will be compared between baseline vs 2 
weeks and baseline vs 4 weeks. Categorical variables will be compared using Chi Square 
or McNemar’s test.  Continuous variables will be compared using One-Way ANOVA 
with repeated measures follow by post-hoc analysis. Data regarding safety and patient 
satisfaction will be summarized for each time point. A p-value ≤0.05 will be considered 
statistically significant. Due to the exploratory nature of this study, no p-value correction 
(ie Bonferroni) will be applied. 
11.0 
Provisions to Monitor the Data to Ensure the Safety of Subjects 
Safety will be monitored throughout the study based on the monitoring of adverse events, 
performing nasal exams, measuring vital signs (i.e. blood pressure, pulse) and weight, 
and through the collection of concomitant medication information. 
The period of observation for collection of non-serious adverse events extends from the 
time the subject gives informed consent until the completion of the End-of-Study visit or 
Early Termination Visit. Serious adverse events (SAE) will be reported to the MUSC 
IRB and to the sponsor from the time of informed consent through 30 days after the last 
use of the SinuSonic. Adverse event data listings will be reviewed by Principal 
Investigator and the research team at regular intervals throughout the study. 
12.0 
Risks to Subjects 
There is a risk of a loss of confidentiality of your personal information as a result of 
participation in this study. 
There are risks to subjects using the SinuSonic device. Subjects may experience a degree 
of pain due to use of the device. This degree of pain is unknown. There may also be risk 
of nose bleeds or crusting around the nasal cavity. 

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The Rhinoscopy may activate the gag reflex. Additionally, nasal discomfort, nose bleeds, 
spasms, and coughing may also occur. 
13.0 
Potential Benefits to Subjects or Others 
 
This study is for research purposes only. There is no direct benefit to you from your 
participation in the study. Information learned from the study may help other people in the 
future. 
14.0 
Sharing of Results with Subjects 
Information about the subjects (including your identifiable private information) may have 
all of their identifiers removed and used for future research studies. 
Records of the subjects’ participation in this study will be held confidential except as 
disclosure is required by law or as described in the ICF. 
15.0 
Payment 
For participating in this study, participants will be compensated with a $50 Visa gift card 
per visit for a maximum of $50 for the Control group, $100 for the ETD groups and $150 
for the Facial Pain/Pressure groups. 
18.0 
Devices 
Dispensing and storage of SinuSonic devices will be done by the study team. All 
SinuSonic devices will be stored on the 11th floor of Rutledge Tower in Room 1126 and 
locked in a cabinet for ambient storage. The device will be dispensed in the Outpatient 
Sinus Clinic.  Only study participants will receive the SinuSonic for use. 

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19.0 
DATA SAFETY MONITORING AND REPORTING 
 
Safety data listings will be reviewed by Principal Investigator, Co-Investigators, and the research 
team at regular intervals throughout the study. 
Safety will be monitored throughout the study based on monitoring of adverse events, 
performing nasal exams, measuring vital signs (ie blood pressure, pulse) and weight, and through 
collection of concomitant medication information. 
The period of observation for collection of non-serious adverse events extends from the time the 
subject gives informed consent until completion of the End-of-study visit or Early Termination 
Visit. Serious adverse events (SAE) will be reported to the MUSC IRB and to the sponsor from 
the time of informed consent through 30 days after the last use of the SinuSonic. Adverse event 
data listings will be reviewed by the principal investigator, co-investigators, and the research 
team at regular intervals throughout the study. 
All AEs, regardless of seriousness or relationship to SinuSonic use, spanning from the signature 
of the informed consent form until the end of the study as defined by the protocol for that patient, 
are to be reported to the Healthy Humming, LLC. All AEs which follow the MUSC IRB 
qualifications will also be reported to the MUSC IRB within 24 hours of site knowledge of the 
event. 
The Investigator will take appropriate measures to follow all AEs until clinical recovery is 
complete and laboratory results have returned to normal, or until progression has been stabilized, 
or until death, in order to ensure the safety of the patients. This may imply that observations will 
continue beyond the last planned visit per protocol, and that additional investigations may be 
requested by the monitoring team up to as noticed by Healthy Humming, LLC. 
In the case of occurrence of an SAE, the Investigator will immediately (within 24 hours) report 
the event to Healthy Humming, LLC and to the MUSC IRB, as applicable. 

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References 
Meyer TA, O'Malley EM, Schlosser RJ, Soler ZM, Cai J, Hoy MJ, Slater PW, Cutler JL, 
Simpson RJ, Clark MJ, Rizk HG, McRackan TR, D'Esposito CF, Nguyen SA. A Randomized 
Controlled Trial of Balloon Dilation as a Treatment for Persistent Eustachian Tube Dysfunction 
With 1-Year Follow-Up. Otol Neurotol. 2018 Aug;39(7):894-902 
 
Falco JJ, Thomas AJ, Quin X, Ashby S, Mace JC, Deconde AS, Smith TL, Alt JA. Lack of 
correlation between patient reported location and severity of facial pain and radiographic burden 
of disease in chronic rhinosinusitis. Int Forum Allergy Rhinol. 2016 Nov;6(11):1173-1181. 
 
Soler ZM, Nguyen SA, Salvador C, Lackland T, Desiato VM, Storck K, Schlosser RJ. Safety and 
efficacy of a novel device combining acoustic vibration with oscillating expiratory pressure for 
the treatment of nasal congestion. Int Forum Allergy Rhinol (in press). 

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SMOKING HISTORY 
 
APPENDICES 
 
AIM 1, CONTROL PATIENTS, EXHALED NO: 
Baseline medical history and exam 
 
 
 
DEMOGRAPHIC AND CLINICAL VARIABLES (If not previously collected): 
Age at enrollment (years): 
 
Gender: 
Male 
Female 
 
What is/was your profession (current/retired)?  
 
 
 
  
LANGUAGE, ETHNICITY, RACE, MARITAL STATUS 
 
Please mark one of the following categories which describes your native language: 
 
 American English 
 Other: please specify   
 
 
Please mark one of the following categories which describes your ethnicity: 
 Not Hispanic or Latino 
 Hispanic or Latino 
 
Please mark one or more of the following categories which describes your race: 
 American Indian or Alaska Native 
 Asian 
 Black or African American 
 Native Hawaiian or Other Pacific Islander 
 White 
 Other 
 
Subject ID#: 
SinuSonic Study 
PI: McRackan 
_ Subjects Initials: 
_ 
 
 
1. Do you currently smoke tobacco products? 
Yes 
No 
(If No please go to question 2) 

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CURRENT MEDICATION USAGE 
 Nasal steroid sprays (Flonase, Nasonex, etc) 
□Yes 
□No 
 Nasal antihistamine spray (Astelin, etc) 
□Yes 
□No 
 Oral antihistamines (Allegra, Claritin, Benedryl, etc) 
□Yes 
□No 
 Oral decongestant (Sudafed, etc) 
□Yes 
□No 
 Mucolytic (Mucinex, etc) 
□Yes 
□No 
 Luekotriene (Singulair, etc) 
□Yes 
□No 
 
COMORBID MEDICAL CONDITIONS: Check box and provide details if present 
 Depression history:   □Resolved/past diagnosis  □Present/medicated 
□Present/not medicated 
 Anxiety history: 
□Resolved/past diagnosis  □Present/medicated 
□Present/not medicated 
 Obstructive Sleep Apnea:  □Currently being treated 
□History / No current treatment 
 Allergic rhinitis:  
 
 Previous allergy testing (blood test or skin prick): 
□Yes 
□No 
 Immunotherapy shots for allergies: 
□Yes 
□No 
□Currently 
 Non-allergic rhinitis □Yes 
□No 
 Asthma 
□Yes 
□No 
 Chronic rhinosinusitis 
□Yes 
□No 
 Nasal polyps 
□Yes 
□No 
 Viral upper respiratory infection   □Yes 
□No 
 Prior ear/sinus surgery 
□Yes 
□No 
 Migraine headache history:  □Resolved/past diagnosis  □Present/medicated   □Present/not medicated 
 
 
 
 
 Height (ft/in):  
 
 Weight (lbs):  
 
How many tobacco products do you use in a day?  
 Singles 
Packs 

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Baseline exhaled NO measurements 
 
 
Resting peak:   
 
 
 
10 second peak:   
 
 
 
3 minute peak:  
 
Rhinoscopy: 
Septal Deviation:    None    Mild    Moderate     Severe Nasal 
valve collapse: None Mild Moderate Severe Bleeding:
None 
Yes 
Crusting: 
None 
Yes 
Otoscopy: 
Normal 
Abnormal findings:  
 

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AIM 1: DAY 1 REPEAT EXAMINATION 
 
Rhinoscopy: 
 
Septal Deviation:    None    Mild    Moderate     Severe Nasal 
valve collapse: None Mild Moderate Severe Bleeding:
 
None 
Yes 
Crusting: 
None 
Yes 
 
Otoscopy: 
Normal        Abnormal findings:  
 
 
Day 1 exhaled NO measurements 
 
 
Resting peak:   
 
 
 
10 second peak:   
 
 
 
3 minute peak:  
 
 
 
Day 1 patient satisfaction/safety 
 
 
How much pain did you experience using device? None 
Mild 
Moderate 
Severe 
Would you use device again? 
Yes 
No 
Would you recommend device to others? 
Yes 
No 

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AIM 2, ETD: Patient Medical History and exam 
 
 
 
DEMOGRAPHIC AND CLINICAL VARIABLES (If not previously collected): 
Age at enrollment (years): 
 
Gender: 
Male 
Female 
 
What is/was your profession (current/retired)?  
 
 
 
  
LANGUAGE, ETHNICITY, RACE, MARITAL STATUS 
 
Please mark one of the following categories which describes your native language: 
 
 American English 
 Other: please specify   
 
 
Please mark one of the following categories which describes your ethnicity: 
 Not Hispanic or Latino 
 Hispanic or Latino 
 
Please mark one or more of the following categories which describes your race: 
 American Indian or Alaska Native 
 Asian 
 Black or African American 
 Native Hawaiian or Other Pacific Islander 
 White 
 Other 
 
 
Subject ID#: 
SinuSonic Study 
PI: McRackan 
_ Subjects Initials: 
_ 
SMOKING HISTORY 
1. Do you currently smoke tobacco products? 
Yes 
No 
(If No please go to question 2) 
How many tobacco products do you use in a day?  
 Singles 
Packs 
CURRENT MEDICATION USAGE 

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 Nasal steroid sprays (Flonase, Nasonex, etc) 
□Yes 
□No 
 Nasal antihistamine spray (Astelin, etc) 
□Yes 
□No 
 Oral antihistamines (Allegra, Claritin, Benedryl, etc) 
□Yes 
□No 
 Oral decongestant (Sudafed, etc) 
□Yes 
□No 
 Mucolytic (Mucinex, etc) 
□Yes 
□No 
 Luekotriene (Singulair, etc) 
□Yes 
□No 
 
 
COMORBID MEDICAL CONDITIONS: Check box and provide details if present 
 Depression history:   □Resolved/past diagnosis  □Present/medicated 
□Present/not medicated 
 Anxiety history: 
□Resolved/past diagnosis  □Present/medicated 
□Present/not medicated 
 Obstructive Sleep Apnea:  □Currently being treated 
□History / No current treatment 
 Allergic rhinitis:  
 
 Previous allergy testing (blood test or skin prick): 
□Yes 
□No 
 Immunotherapy shots for allergies: 
□Yes 
□No 
□Currently 
 Non-allergic rhinitis □Yes 
□No 
 Asthma 
□Yes 
□No 
 Chronic rhinosinusitis 
□Yes 
□No 
 Nasal polyps 
□Yes 
□No 
 Viral respiratory infection   □Yes 
□No 
 Prior ear/sinus surgery 
□Yes 
□No 
 Migraine headache history:  □Resolved/past diagnosis  □Present/medicated   □Present/not medicated 
 
 
 
 
 Height (ft/in):  
 
 Weight (lbs):  
 

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Rhinoscopy: 
Septal Deviation:    None    Mild    Moderate     Severe Nasal 
valve collapse: None Mild Moderate Severe Bleeding:
None 
Yes 
Crusting: 
None 
Yes 
Otoscopy: 
□Normal   □Retracted no effusion  □Effusion 
Valsalva: 
□Successful   □Not successful 
Tympanogram type: 
A 
B 
C 

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AIM 2, ETD: Baseline Questionnaires 
 
 
 
PATIENT QUESTIONS 
 
 
How long have you had eustachian tube problems? <3 months 3-6 months 6-12 months  1-3 year >3 years 
OVER THE LAST FEW MINUTES, HOW TROUBLESOME HAVE THE FOLLOWING SYMPTOMS BEEN? 
PLEASE PLACE A MARK ON THE LINE. 
 
Not troublesome 
Worst thinkable/troublesome 
 
  
 
Ear pressure 
Feeling that ears are clogged 
Cracking/popping of ears 
 
Muffled hearing 
 
Tinnitus (noise in ears) 
 
OVERALL ASSESSMENT OF EAR and 
EUSTACHIAN TUBE PROBLEMS 
 

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BASELINE ETDQ-7 
 
Next to each question, circle the number that best describes how you feel. 
 
During the past 1 
month, how much of 
a problem was each 
of the following? 
No problem 
Moderate Problem 
Severe Problem 
Pressure in the ears? 
1 
2 
3 
4 
5 
6 
7 
Pain in the ears? 
1 
2 
3 
4 
5 
6 
7 
A feeling that your 
ears are clogged or 
“under water”? 
1 
2 
3 
4 
5 
6 
7 
Ear problems when 
you have a cold or 
sinusitis? 
1 
2 
3 
4 
5 
6 
7 
Crackling or popping 
sounds in the ears? 
1 
2 
3 
4 
5 
6 
7 
Ringing in the ears? 
1 
2 
3 
4 
5 
6 
7 
A feeling that your 
hearing is muffled? 
1 
2 
3 
4 
5 
6 
7 
 
Do you get these symptoms in one ear only or both ears? 
 
Left ear only 
Right ear only 
Both ears 
 
 
INCLUSION CRITERIA (all must be yes): 
 
Does patient have ETD sx for >6mos? 
Yes 
No 
Is ETDQ-7 score > 3? 
Yes 
No 
Does patient have > 3 ETD symptoms above? 
Yes 
No 

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AIM 2, ETD: Follow Up Questionnaire 5 minutes 
 
FOLLOW UP ETD VAS 5 MINUTES 
 
 
 
OVER THE LAST FEW MINUTES, HOW TROUBLESOME HAVE THE FOLLOWING SYMPTOMS BEEN? 
PLEASE PLACE A MARK ON THE LINE. 
 
Not troublesome 
Worst thinkable/troublesome 
 
  
 
Ear pressure 
Feeling that ears are clogged 
Cracking/popping of ears 
 
Muffled hearing 
 
Tinnitus (noise in ears) 
 
OVERALL ASSESSMENT OF EAR and 
EUSTACHIAN TUBE PROBLEMS 
 

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AIM 2, ETD: 6-Week Follow Up Questionnaires 
 
 
 
 
Objective Evaluation 
 
 
Rhinoscopy: 
 
Bleeding: 
None 
Yes 
Crusting: 
None 
Yes 
 
Otoscopy: 
 □Normal   □Retracted no effusion   □Effusion 
Valsalva: 
□Successful   □Not successful 
Tympanogram type: 
A 
B 
C 
 
 
 
 
 
OVER THE LAST FEW MINUTES, HOW TROUBLESOME HAVE THE FOLLOWING SYMPTOMS BEEN? 
PLEASE PLACE A MARK ON THE LINE. 
 
Not troublesome 
Worst thinkable/troublesome 
 
  
 
Ear pressure 
Feeling that ears are clogged 
Cracking/popping of ears 
 
Muffled hearing 
 
Tinnitus (noise in ears) 
 
OVERALL ASSESSMENT OF EAR and 
EUSTACHIAN TUBE PROBLEMS 
 

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6 WEEK ETDQ-7 
 
Next to each question, circle the number that best describes how you feel. 
 
During the past 1 
month, how much of 
a problem was each 
of the following? 
No problem 
Moderate Problem 
Severe Problem 
Pressure in the ears? 
1 
2 
3 
4 
5 
6 
7 
Pain in the ears? 
1 
2 
3 
4 
5 
6 
7 
A feeling that your 
ears are clogged or 
“under water”? 
1 
2 
3 
4 
5 
6 
7 
Ear problems when 
you have a cold or 
sinusitis? 
1 
2 
3 
4 
5 
6 
7 
Crackling or popping 
sounds in the ears? 
1 
2 
3 
4 
5 
6 
7 
Ringing in the ears? 
1 
2 
3 
4 
5 
6 
7 
A feeling that your 
hearing is muffled? 
1 
2 
3 
4 
5 
6 
7 
 
Do you get these symptoms in one ear only or both ears? 
 
Left ear only 
Right ear only 
Both ears 

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Change in eustachian tube symptoms and use of device 
 
Please rate changes in your nasal symptoms and use of device. 
 
Symptom 
None 
Mild 
Moderate 
High 
Improvement in ear pressure 
0 
1 
2 
3 
Improvement in ear clogging 
0 
1 
2 
3 
Improvement in cracking/popping of 
ears 
0 
1 
2 
3 
Improvement in muffled hearing 
0 
1 
2 
3 
Improvement in tinnitus (noise in ears) 
0 
1 
2 
3 
Improvement in ear pain 
0 
1 
2 
3 
Improvement in ear problems with cold 
or sinus infection 
0 
1 
2 
3 
Overall improvement in ear symptoms 
0 
1 
2 
3 
Tolerability 
Pain with use of device 
None 
Mild 
Moderate 
Severe 
Comfort and ease of use 
Poor 
Low 
Moderate 
High 
Bleeding: 
Yes 
No 
 
 
 
 
 
Week 6 patient satisfaction 
 
 
Would you use device again? 
Yes 
No 
Would you recommend device to others? 
Yes 
No 

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AIM 3, SINUS PAIN/PRESSURE: Baseline Medical History and exam 
 
 
 
DEMOGRAPHIC AND CLINICAL VARIABLES (If not previously collected): 
Age at enrollment (years): 
 
Gender: 
Male 
Female 
 
What is/was your profession (current/retired)?  
 
 
 
  
LANGUAGE, ETHNICITY, RACE, MARITAL STATUS 
 
Please mark one of the following categories which describes your native language: 
 
 American English 
 Other: please specify   
 
 
Please mark one of the following categories which describes your ethnicity: 
 Not Hispanic or Latino 
 Hispanic or Latino 
 
Please mark one or more of the following categories which describes your race: 
 American Indian or Alaska Native 
 Asian 
 Black or African American 
 Native Hawaiian or Other Pacific Islander 
 White 
 Other 
 
Subject ID#: 
SinuSonic Study 
PI: McRackan 
_ Subjects Initials: 
_ 
SMOKING HISTORY 
1. Do you currently smoke tobacco products? 
Yes 
No 
(If No please go to question 2) 
How many tobacco products do you use in a day?  
 Singles 
Packs 

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CURRENT MEDICATION USAGE 
 Nasal steroid sprays (Flonase, Nasonex, etc) 
□Yes 
□No 
 Nasal antihistamine spray (Astelin, etc) 
□Yes 
□No 
 Oral antihistamines (Allegra, Claritin, Benedryl, etc) 
□Yes 
□No 
 Oral decongestant (Sudafed, etc) 
□Yes 
□No 
 Mucolytic (Mucinex, etc) 
□Yes 
□No 
 Luekotriene (Singulair, etc) 
□Yes 
□No 
 
COMORBID MEDICAL CONDITIONS: Check box and provide details if present 
 Depression history:   □Resolved/past diagnosis  □Present/medicated 
□Present/not medicated 
 Anxiety history: 
□Resolved/past diagnosis  □Present/medicated 
□Present/not medicated 
 Obstructive Sleep Apnea:  □Currently being treated 
□History / No current treatment 
 Allergic rhinitis:  
 
 Previous allergy testing (blood test or skin prick): 
□Yes 
□No 
 Immunotherapy shots for allergies: 
□Yes 
□No 
□Currently 
 Non-allergic rhinitis □Yes 
□No 
 Asthma 
□Yes 
□No 
 Chronic rhinosinusitis 
□Yes 
□No 
 Nasal polyps 
□Yes 
□No 
 Viral respiratory infection   □Yes 
□No 
 Prior ear/sinus surgery 
□Yes 
□No 
 Migraine headache history:  □Resolved/past diagnosis  □Present/medicated   □Present/not medicated 
 
 
 
 
 Height (ft/in):  
 
 Weight (lbs):  
 

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Rhinoscopy: 
Septal Deviation:    None    Mild    Moderate     Severe Nasal 
valve collapse: None Mild Moderate Severe Bleeding:
None 
Yes 
Crusting: 
None 
Yes 
Otoscopy: 
Normal 
Abnormal findings:  
 

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AIM 3, SINUS PAIN/PRESSURE: Baseline questionnaires 
 
 
 
PATIENT QUESTIONS 
How long have you had sinus or facial pain/pressure? <3 months 3-6 months 6-12 months  1-3 year >3 
years 
OVER THE LAST WEEK, HOW WOULD YOU RATE YOUR AVERAGE SINUS OR FACIAL 
PAIN/PRESSURE? 
None 
Worst 
possible 
Sinus or facial pain/pressure 
 
 
 
INCLUSION CRITERIA (all must be yes): 
 
Does patient have sinus pain/pressure for > 3mos? 
Yes 
No 
 
Is VAS score > 5? 
Yes 
No 

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AT THIS EXACT MOMENT, HOW WOULD YOU RATE YOUR SINUS OR FACIAL 
PAIN/PRESSURE? 
 
None 
Worst 
possible 
Sinus or facial pain/pressure 
 
 
 
 
 
Place an X over an area where you typically experience sinus or facial pain/pressure (mark 
all that apply) 
 

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BASELINE Brief Pain Inventory-Short Form (BPI-SF) 
 

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BASELINE McGill Pain Questionnaire – Short Form 
(MPQ-SF) 
1) 
The words below describe average pain. Circle the one number that represents the degree to which you feel that type of pain. 
Please limit yourself to a description of your pain in the Sinuses or Face 
 
 
A. Throbbing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
B. Shooting: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
C. Stabbing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
D. Sharp: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
E. Cramping: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
F. Gnawing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
G. Hot-Burning: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
H. Aching: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
I. Heavy: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
J. Tender: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
K. Splitting: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
L. Tiring-Exhausting: None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
M. Sickening: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
N. Fearful: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
O. Punishing-Cruel: None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
 
2) Please rate your SINUS or facial pain by circling the one number that tells how much pain you have RIGHT NOW. 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
No 
Pain as bad as 
Pain 
you can imagine 
 
3) Evaluate overall intensity of total pain experience.  Please limit yourself to a description of the pain in your SINUS area or face only. 
Place a check 
mark (✓) in the appropriate column: 
 
Evaluate 
0 
No pain 
1 
Mild 
2 
Discomforting 
3 
Distressing 
4 
Horrible 
5 
Excruciating 

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AIM 3, SINUS PAIN/PRESSURE: Immediate (5 minute) Questionnaire 
 
 
 
 
PATIENT QUESTIONS 
 
AFTER USING THE DEVICE, HOW WOULD YOU RATE YOUR SINUS OR FACIAL 
PAIN/PRESSURE? 
 
None 
Worst possible 
Sinus or facial pain/pressure 

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AIM 3, SINUS PAIN/PRESSURE: 2 week Questionnaire 
 
 
 
 
PATIENT QUESTIONS 
 
OVER THE LAST WEEK, HOW WOULD YOU RATE YOUR AVERAGE SINUS OR FACIAL 
PAIN/PRESSURE? 
 
None 
Worst 
possible 
Sinus or facial pain/pressure 
 
 
 
 
 
 
 
 
 
 
 
IMMEDIATELY AFTER USING THE DEVICE, HOW WOULD YOU RATE YOUR SINUS OR 
FACIAL PAIN/PRESSURE? 
 
None 
Worst 
possible 
Sinus or facial pain/pressure 

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2 WEEK: Brief Pain Inventory-Short Form (BPI-SF) 
 

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2 WEEK: McGill Pain Questionnaire – Short Form 
(MPQ-SF) 
2) 
The words below describe average pain.  Circle the one number that represents the degree to which you feel that type of pain. 
Please limit yourself to a description of your pain in the Sinuses or Face 
 
 
A. Throbbing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
B. Shooting: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
C. Stabbing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
D. Sharp: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
E. Cramping: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
F. Gnawing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
G. Hot-Burning: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
H. Aching: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
I. Heavy: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
J. Tender: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
K. Splitting: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
L. Tiring-Exhausting: None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
M. Sickening: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
N. Fearful: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
O. Punishing-Cruel: None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
 
2) Please rate your SINUS or facial pain by circling the one number that tells how much pain you have RIGHT NOW. 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
No 
Pain as bad as 
Pain 
you can imagine 
 
3) Evaluate overall intensity of total pain experience.  Please limit yourself to a description of the pain in your SINUS area or face only. 
Place a check 
mark (✓) in the appropriate column: 
 
Evaluate 
0 
No pain 
1 
Mild 
2 
Discomforting 
3 
Distressing 
4 
Horrible 
5 
Excruciating 

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Week 2 patient satisfaction/safety 
 
 
How much pain did you experience using device? None 
Mild 
Moderate 
Severe 
Bleeding after using device? None Mild Moderate 
Severe 
Would you use device again? 
Yes 
No 
Would you recommend device to others? 
Yes 
No 

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AIM 3, SINUS PAIN/PRESSURE: 4 week Questionnaire 
 
 
 
 
PATIENT QUESTIONS 
 
OVER THE LAST WEEK, HOW WOULD YOU RATE YOUR AVERAGE SINUS OR FACIAL 
PAIN/PRESSURE? 
 
None 
Worst 
possible 
Sinus or facial pain/pressure 
 
 
 
 
 
 
 
 
 
 
 
IMMEDIATELY AFTER USING THE DEVICE, HOW WOULD YOU RATE YOUR SINUS OR 
FACIAL PAIN/PRESSURE? 
 
None 
Worst 
possible 
Sinus or facial pain/pressure 

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4 WEEK: Brief Pain Inventory-Short Form (BPI-SF) 
 

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4 WEEK: McGill Pain Questionnaire – Short Form 
(MPQ-SF) 
3) 
The words below describe average pain.  Circle the one number that represents the degree to which you feel that type of pain. 
Please limit yourself to a description of your pain in the Sinuses or Face 
 
 
A. Throbbing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
B. Shooting: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
C. Stabbing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
D. Sharp: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
E. Cramping: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
F. Gnawing: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
G. Hot-Burning: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
H. Aching: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
I. Heavy: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
J. Tender: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
K. Splitting: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
L. Tiring-Exhausting: None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
M. Sickening: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
N. Fearful: 
None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
O. Punishing-Cruel: None (0) 
Mild (1) 
Moderate (2) 
Severe (3) 
 
2) Please rate your SINUS or facial pain by circling the one number that tells how much pain you have RIGHT NOW. 
 
0 
1 
2 
3 
4 
5 
6 
7 
8 
9 
10 
No 
Pain as bad as 
Pain 
you can imagine 
 
3) Evaluate overall intensity of total pain experience.  Please limit yourself to a description of the pain in your SINUS area or face only. 
Place a check 
mark (✓) in the appropriate column: 
 
Evaluate 
0 
No pain 
1 
Mild 
2 
Discomforting 
3 
Distressing 
4 
Horrible 
5 
Excruciating 

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Week 4 patient satisfaction/safety 
 
 
How much pain did you experience using device? None 
Mild 
Moderate 
Severe 
Bleeding after using device? None Mild Moderate 
Severe 
Would you use device again? 
Yes 
No 
Would you recommend device to others? 
Yes 
No