SBIR-STTR Award

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.

Public Health Relevance Statement:
PROJECT NARRATIVE Facial cues can improve effective communication and are critical for people with hearing impairment. However, the pervasive use of facemasks in healthcare obscures visual cues, increasing the risk for medical miscommunication. The FaceView MaskTM, a transparent surgical mask, will improve patient-caregiver communication, especially for patients with hearing loss, and decrease the prevalence of medical errors in healthcare settings by providing visual access to the face.

Project Terms:
Air; Alzheimer's Disease; American; Animal Hospitals; antimicrobial; Arkansas; Audiology; Bacteria; base; biomaterial compatibility; Burn Units; Caregivers; Cause of Death; Cheek structure; chemotherapy; Chin; Client satisfaction; Clinic; Communication; Country; Cues; cytotoxicity; Dangerousness; Dental Offices; Dental Staff; design; Development; Diabetes Mellitus; Discipline of Nursing; drug distribution; Environment; Environment and Public Health; experience; Eye; Face; Facial Expression; Fogs; Goals; Guidelines; Health; Health Personnel; Healthcare; Hearing; hearing impairment; Hospitals; Human Subject Research; Impairment; improved; Individual; Infectious Agent; innovation; irritation; Legal patent; malignant breast neoplasm; Masks; Medical; Medical Errors; microbial; mid-career faculty; Movement; Multi-Institutional Clinical Trial; Noise; Nose; Nurses; Nursing Staff; Operative Surgical Procedures; Oral cavity; Paper; Participant; pathogen; patient safety; Patients; Pharmacy facility; Phase; Postoperative Period; preference; Prevalence; prevent; Prevention; prototype; Provider; Registered nurse; Reporting; Risk; Safety; Silanes; Small Business Technology Transfer Research; Speech; Testing; Textiles; United States Food and Drug Administration; Universities; Visual; Work

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 conversationeven when using a hearing aid. Hearing difficulties affect all age groups and present significant challenges indaily life. These challenges are particularly acute in healthcare settings, where miscommunication results insuboptimal treatment and can lead to serious and potentially life-threatening outcomes for patients. Errors ininterpersonal communication are an important contributing factor in medical errors, and the wearing of surgicalmasks by healthcare personnel and patients increases the likelihood of miscommunication. The surgical maskis an essential item of personal protective equipment, preventing the transmission of infectious agents such asbacteria and viruses, but conventional surgical masks can muffle speech and prevent patients and healthcareworkers with hearing difficulties from being able to lip read. Lip reading is an important visual aid tocommunication for everyone but is particularly important for those who are deaf or hard of hearing. Our goal isto complete the development of a transparent surgical N95 respirator mask that prevents infectious diseasetransmission 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 transparentwindow that enables patients and healthcare workers to see each other's lips while maintaining the protectivebarrier function of the mask. A collaborative study with Dr. Sam Atcherson of the Department of Audiology andSpeech Pathology at the University of Arkansas at Little Rock validated the mask as a visual aid, showing thatgroups with either moderate or severe-to-profound hearing loss benefitted from the visual input from theprototype mask. The patented FaceView Mask™ combines the transparent window with both N95 filtrationcapability 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, NIOSHapproval, and commercialization of the FaceView Mask™ surgical N95 respirator. Specifically, we will 1) optimizethe FaceView Mask™ and conduct a survey study with end users to ensure comfort and an effective seal aroundthe airways; 2) conduct comparative product testing with healthcare professionals, including American SignLanguage interpreters to gather their perceptions of the FaceView Mask™ vs. a leading opaque surgical N95respirator 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.

Public Health Relevance Statement:
PROJECT NARRATIVE Conventional surgical masks are essential items of personal protective equipment, preventing the transmission of infectious agents, such as bacteria and viruses, but they can muffle speech and prevent patients and healthcare workers with hearing difficulties from being able to lip read, increasing the likelihood of miscommunication and medical errors. Our goal is to extend our successful Phase I work to complete the development of a transparent surgical N95 respirator mask (FaceView Mask™) that prevents infectious disease transmission and improves communication among healthcare personnel and patients with hearing impairment. The FaceView Mask™ will have diverse potential applications wherever N95 respirators are used.

Project Terms:
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