PROJECT SUMMARY
Approximately 4% of people in the US are either deaf or hard of hearing, 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 aid. 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 patients. 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 read. Lip reading is an important visual aid to
communication for everyone but is particularly important for those who are deaf or hard of hearing. 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.
In Phase I, we successfully developed and tested a prototype surgical N95 respirator mask with a transparent
window that enables patients and healthcare workers to see each other’s lips while maintaining the protective
barrier function of the mask. A collaborative study with Dr. Sam Atcherson of the Department of Audiology and
Speech Pathology at the University of Arkansas at Little Rock validated the mask as a visual aid, showing that
groups with either moderate or severe-to-profound hearing loss benefitted from the visual input from the
prototype mask. The patented FaceView Mask™ combines the transparent window with both N95 filtration
capability and a unique antimicrobial coating to kill bacteria. In Phase II, we propose to optimize the mask design,
establish a scalable production process, and conduct further testing to support 510(k) clearance, NIOSH
approval, and commercialization of the FaceView Mask™ surgical N95 respirator. Specifically, we will 1) optimize
the FaceView Mask™ and conduct a survey study with end users to ensure comfort and an effective seal around
the airways; 2) conduct comparative product testing with healthcare professionals, including American Sign
Language interpreters to gather their perceptions of the FaceView Mask™ vs. a leading opaque surgical N95
respirator mask; 3) perform testing required for 510(k) clearance and NIOSH approval of the FaceView Mask™;
and 4) test its antimicrobial performance both in a standard laboratory test and in use by healthcare workers.
