A Transparent Surgical Mask to Improve Patient/Caregiver Communication, Minimize Errors and Increase Patient Satisfaction

Period of Performance: 07/03/2017 - 06/30/2018


Phase 1 STTR

Recipient Firm

Faceview Mask, LLC
Principal Investigator


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.