PROJECT SUMMARY
Hearing loss, innate and acquired, occurs in over 37.5 million Americans and globally in over 360 million
people. To compensate, many with hearing impairment rely on the combination of audio information and visual
cues from the face, cheeks, nose and eyes to facilitate speech understanding. In healthcare settings, this
important visual communication is severely hindered by the ubiquitously used surgical facemask, which covers
the nose, mouth, cheeks and chin. This leads to a breakdown in communication that can increase the risk for
miscommunication and medical errors.
A transparent surgical mask has the potential to improve speech understanding in patients with hearing loss
and improve patient-caregiver communication for all individuals. Unfortunately, previous attempts have failed
due to limitations in materials and design. The patented design of the FaceView MaskTM provides this
transparency by utilizing a clear, anti-fog central panel. The mask also contains a silane-based antimicrobial on
the outer fabric, allowing it to offer similar benefits as currently used surgical masks in addition to providing visual
access to the face. A preliminary study has demonstrated that an early stage prototype of the FaceView MaskTM
increased speech understanding in participants with differing degrees of hearing loss in the presence and
absence of multi-talker babble.
The overall goal of this STTR Phase I project is to evaluate the potential of the FaceView MaskTM to improve
speech understanding in subjects with hearing loss. This will be accomplished through three specific aims. In
Aim 1, FaceView MaskTM prototypes will undergo biocompatibility testing in accordance with ISO 10993 (Part 1)
guidelines including cytotoxicity, sensitization, and irritation testing. In Aim 2, Dr. Atcherson (Associate Professor
in the Department of Audiology, University of Arkansas at Little Rock) will conduct human subjects research to
assess the impact that the FaceView MaskTM has on speech understanding in normal hearing subjects and
subjects with hearing impairment. In Aim 3, nurses and dental staff will assess comfort during daily use and
healthcare personnel preference for the FaceView MaskTM in comparison to conventional paper masks. The
conclusion of this Phase I work will allow for large, multi-site clinical trials in Phase II and further FDA-mandated
characterization.
The FaceView MaskTM, an innovative transparent facemask, has the potential to enhance patient-caregiver
communication and decrease dangerous medical errors, improving safety and the healthcare experience for
millions of patients worldwide, especially for those who suffer hearing impairment.
