Product Testing of the FaceView Mask™: Usability Survey
Conditions: Hearing Disability
Sponsor: University of Arkansas

Title:  Product Testing of the FaceView Mask™: Usability Survey 
PI:  Samuel R. Atcherson, Ph.D. 
 
Version #:  8.0 
Date:  1.13.2023  
Page 1 
Protocol template version dated 10.27.2020 
 
 
 
Study Title:  
 
Product Testing of the FaceView Mask™: Usability Survey 
 
Principal Investigator:  
Samuel R. Atcherson, Ph.D. 
 
Department of Audiology and Speech Pathology 
 
College of Health Professions 
University of Arkansas for Medical Sciences 
4301 W. Markham Street, Slot # 711 
Little Rock, AR 72205 
Telephone:  501.686.6860 
Email:  sratcherson@uams.edu 
 
Study location: 
University of Arkansas for Medical Sciences 
4301 W. Markham Street 
Little Rock, AR 72205 
 
 
Background and Rationale 
Approximately 4% of people in the US are either deaf or hard of hearing1, equating to 
more than 13 million people. Of these, approximately 12 million people over the age of 5 
years have difficulty hearing normal conversation even when using a hearing aid1. 
Hearing difficulties affect all age groups and present significant challenges in daily life. 
These challenges are particularly acute in healthcare settings, where miscommunication 
results in suboptimal treatment and can lead to serious and potentially life-threatening 
outcomes for patients2. Errors in interpersonal communication are an important 
contributing factor in medical errors, and the wearing of surgical masks by healthcare 
personnel and patients increases the likelihood of miscommunication. The surgical 
mask is an essential item of personal protective equipment, preventing the transmission 
of infectious agents such as bacteria and viruses, but conventional surgical masks can 
muffle speech and prevent patients and healthcare workers with hearing difficulties from 
being able to lip read3,4. Lip reading is an important visual aid to communication for 
everyone but is particularly important for those who are deaf or hard of hearing5-10. Our 
goal is to complete the development of a transparent surgical N95 respirator mask that 
prevents infectious disease transmission and improves communication among 
healthcare personnel and patients with hearing impairment.  
Objectives 
The investigators will recruit adult participants to complete a usability survey on a 
transparent surgical N95 respirator (i.e., FaceView mask) designed to improve 
communication. The study aims to gather participants’ perceptions of the novel 
transparent surgical N95 respirator vs. a conventional surgical N95 respirator. Following 
fitting of the masks (up to 30 minutes wear time each), the participants will complete a 
questionnaire to provide their perceptions of fit, comfort, ease of use, and benefit to 
communication. 

Title:  Product Testing of the FaceView Mask™: Usability Survey 
PI:  Samuel R. Atcherson, Ph.D. 
 
Version #:  8.0 
Date:  1.13.2023  
Page 2 
Protocol template version dated 10.27.2020 
Study Design and Procedures 
For both objectives, participants will try on both the FaceView Mask™ and the 
conventional surgical N95 respirator in quasi-random order from participant to participant. 
The participants will be informed that both masks meet N95 standards. The participants 
will be fit tested for both masks to ensure that the appropriate size is used. Training for fit 
testing will be performed by trained FaceView Mask, LLC personnel using a standard fit 
testing kit (3M™ Qualitative Fit Test Kit, Sweet) and the PI (and hired graduate student) 
will apply this fitting technique to all participants. The participants will wear each mask for 
up to 30 minutes before completing the study survey. All surgical respirators will be 
immediately discarded after use. Important requirements before fit testing include: 
• No participants with facial hair should be included in the fit testing study. 
• All participants (test subjects and administrators) should view the video at 
http://multimedia.3m.com/mws/media/992396O/3m-respirator-fit-kit-test-
video.mp4 before beginning the study. 
• Test subjects must not eat, drink (other than plain water), smoke, or chew gum in 
the 15 minutes preceding the test. 
 
Study Population 
A goal of 200 participants is desired with a minimum of 125 to meet study targets. We will 
be contacting known persons (not cold contacts) with ability to share study brochure by 
e-mail:  
1) across the UAMS campus (e.g., College Deans, Center Directors, Program 
Directors);  
2) surrounding clinics; 
3) American Sign Language interpreter education at the University of Arkansas at 
Little Rock (Program Director) 
4) Arkansas School for the Deaf (Superintendent and/or Assistant to the 
Superintendent); and 
5) Communications Plus+ Interpreter Services, Inc. (owner and operator) 
 
In the event that recruitment numbers are low in Little Rock, AR, the PI has contacts in 
San Francisco, CA, Ann Arbor, MI, and Rochester, NY who belong to the healthcare 
community, Deaf and hard of hearing community, or both.  If needed, recruiters at these 
three additional sites will be hired to recruit 25 participants per site. Approvals for IRB 
amendments will be sought, and if necessary, IRB approvals will be obtained at those 
additional sites. 
Compensation 
The participants will each receive a $25 gift card as compensation for their participation 
in the study. As the subjects’ active participation in this study ends with the completion of 
the survey, there is no retention plan. 

Title:  Product Testing of the FaceView Mask™: Usability Survey 
PI:  Samuel R. Atcherson, Ph.D. 
 
Version #:  8.0 
Date:  1.13.2023  
Page 3 
Protocol template version dated 10.27.2020 
Inclusion Criteria 
• Study participants must be at least 18 years old, have no health conditions that 
would prevent them from safely wearing an N95 respirator (e.g., severe asthma, 
chronic obstructive pulmonary disease), read in English and communicate in 
English or American Sign Language, and be able to provide or arrange their own 
transportation to the study location. 
• The ages of the participants are expected to reflect the demographics of the 
healthcare workforce from which they will be recruited (typically 18-65 years). 
• There will not be any exclusion of subjects based on racial/ethnic background. It 
is expected that the races and ethnicities represented in these studies will reflect 
the overall demographics of the workforce involved. 
Exclusion Criteria 
• Prospective participants with facial hair. 
• Children are to be excluded from the proposed research project because the 
current FaceView Mask™ is designed for adults. 
• Adults who are non-English communicators. 
• Any adult with health conditions that would prevent them from safely wearing an 
N95 respirator (e.g., severe asthma, chronic obstructive pulmonary disease). 
Risks and Benefits 
When testing surgical mask that makes contact with the skin of the wearer, there is the 
potential for study participants to experience an allergic reaction to the mask material.  
 
N95-grade surgical respirators are designed to filter the air breathed by the wearer, and 
there is the potential for study participants to experience some restricted airflow. 
 
The information obtained from the participants will not jeopardize them in any way and 
will be deidentified.  
 
The information obtained through this product testing study will inform the final design of 
a novel transparent surgical N95 respirator that will improve communication among 
healthcare workers and patients. Therefore, the participants are likely to benefit from the 
product that the proposed research supports. 
 
There are no transparent surgical N95 respirators currently on the market. Successful 
testing of the FaceView Mask™ surgical N95 respirator will lead to commercialization of 
this novel product to improve communication between healthcare workers and deaf 
patients in situations requiring the use of N95-grade surgical respirators (e.g., when there 
is a risk of exposure to respiratory pathogens). Healthcare workers with hearing difficulties 
and those working in noisy environments may also benefit from this novel surgical N95 
respirator. The FaceView Mask™ is designed to improve communication and reduce the 
risk of medical errors. The inclusion of an antimicrobial coating on the FaceView Mask™ 
will provide additional protection against respiratory pathogens and reduce fomite 

Title:  Product Testing of the FaceView Mask™: Usability Survey 
PI:  Samuel R. Atcherson, Ph.D. 
 
Version #:  8.0 
Date:  1.13.2023  
Page 4 
Protocol template version dated 10.27.2020 
transmission of these pathogens that may occur through handling of the mask by the 
wearer. 
 
An understanding of the needs of healthcare workers with regard to this novel N95 
respirator (e.g., size, shape, fit, and comfort) will improve the effectiveness of the design 
and lead to a significant advance in personal protective equipment (PPE). 
 
Data Handling and Recordkeeping 
We will collect all data using RedCap, and completed surveys will not collect personal 
identifying information or PHI. Therefore, the data are already de-identified/anonymized 
and untraced back to the participant. 
The PI will carefully monitor study procedures to protect the safety of research subjects, 
the quality of the data and the integrity of the study.   
At the conclusion of the study, the data will be retained and remain 
deidentified/anonymous, and later destroyed in accordance with institutional policy. 
 
Data Analysis 
As this is a product survey, and not a treatment or intervention project, all data will be 
reported using descriptive statistics in the aggregate. 
 
Ethical Considerations 
This study will be conducted in accordance with all applicable government regulations 
and University of Arkansas for Medical Sciences research policies and 
procedures.  This protocol and any amendments will be submitted and approved by the 
UAMS Institutional Review Board (IRB) to conduct the study.   
This is a minimal risk study and a waiver of documentation of consent is requested. The 
research involves no more than minimal risk to the subjects and the only record linking 
the subject and the study would be the consent document and the principal risk is the 
breach of confidentiality.  
The study team will recruit via word of mouth and by emailing the study brochure to 
people known to the study team. The study will be fully explained to the participant prior 
to engaging in any activities. All participants will be given a copy of the study brochure 
for their records. Study participation will be taken as agreement to participate.  
 
Dissemination of Data 
Results of this study may be used for presentations, posters, or publications. The 
publications will not contain any identifiable information that could be linked to a 
participant.   
 

Title:  Product Testing of the FaceView Mask™: Usability Survey 
PI:  Samuel R. Atcherson, Ph.D. 
 
Version #:  8.0 
Date:  1.13.2023  
Page 5 
Protocol template version dated 10.27.2020 
References 
1. Mitchell, R. E. How Many Deaf People Are There in the United States? Estimates From the 
Survey of Income and Program Participation. The Journal of Deaf Studies and Deaf 
Education 11, 112-119, doi:10.1093/deafed/enj004 (2005). 
2. Henn, P., OʼTuathaigh, C., Keegan, D. & Smith, S. Hearing Impairment and the Amelioration 
of Avoidable Medical Error: A Cross-Sectional Survey. J Patient Saf, 
10.1097/PTS.0000000000000298, doi:10.1097/PTS.0000000000000298 (2017). 
3. Mendel, L. L., Gardino, J. A. & Atcherson, S. R. Speech understanding using surgical 
masks: a problem in health care? J Am Acad Audiol 19, 686-695 (2008). 
4. Goldin, A., Weinstein, B. & Shiman, N. How Do Medical Masks Degrade Speech Reception? 
The Hearing Review (2020). 
5. Jaekl, P., Pesquita, A., Alsius, A., Munhall, K. & Soto-Faraco, S. The contribution of dynamic 
visual cues to audiovisual speech perception. Neuropsychologia 75, 402-410 (2015). 
6. Sumby, W. H. & Pollack, I. Visual contribution to speech intelligibility in noise. The Journal of 
the Acoustical Society of America 26, 212-215 (1954). 
7. Grant, K. W., Walden, B. E. & Seitz, P. F. Auditory-visual speech recognition by hearing-
impaired subjects: Consonant recognition, sentence recognition, and auditory-visual 
integration. The Journal of the Acoustical Society of America 103, 2677-2690 (1998). 
8. Grant, K. W., Tufts, J. B. & Greenberg, S. Integration efficiency for speech perception within 
and Across sensory modalities by normal-hearing and hearing-impaired individuals. The 
Journal of the Acoustical Society of America 121, 1164-1176 (2007). 
9. Jerger, S., Damian, M. F., Tye-Murray, N. & Abdi, H. Children use visual speech to 
compensate for non-intact auditory speech. Journal of Experimental Child Psychology 126, 
295-312 (2014). 
10. Thomas, S. M. & Jordan, T. R. Contributions of oral and extraoral facial movement to visual 
and audiovisual speech perception. Journal of Experimental Psychology: Human Perception 
and Performance 30, 873 (2004). 
Appendices 
See survey instrument in Documents.