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

项目总结 在美国，大约4%的人是聋人或重听人，相当于1300多万人。 在这些人中，大约有1200万5岁以上的人听不到正常的对话 即使在使用助听器时也是如此。听力障碍影响到所有年龄段，并对 日常生活。这些挑战在医疗保健环境中尤为严重，沟通不畅会导致 治疗效果不佳，可能会给患者带来严重的和潜在的生命威胁。中的错误 人际沟通是医疗差错和佩戴外科手术的一个重要因素 医护人员和病人的口罩增加了沟通不畅的可能性。外科口罩 是个人防护用品的必备物品，可防止传染病原体，例如 细菌和病毒，但传统的医用口罩可以抑制说话，防止患者和医疗保健 听力有困难的工人无法读唇语。唇读是一种重要的视觉辅助手段 沟通对每个人来说都很重要，但对聋人或重听人来说尤其重要。我们的目标是 完成可预防传染病的透明医用N95口罩的开发 传播并改善医护人员和听力障碍患者之间的沟通。 在第一阶段，我们成功地开发和测试了一种原型医用N95口罩，口罩上有一个透明的 窗口，使患者和医护人员能够看到对方的嘴唇，同时保持保护 面罩的屏障功能。与听力学系的萨姆·阿切森博士合作研究 阿肯色大学小石城分校的言语病理学证实，这种口罩是一种视觉辅助工具，表明 中度或重度至重度听力损失的人群受益于来自 原型面具。获得专利的Faceview MASK™将透明窗口与N95过滤结合在一起 具有杀灭细菌的能力和独特的抗菌涂层。在第二阶段，我们建议优化掩模设计， 建立可扩展的生产流程，并进行进一步测试以支持510(K)审批，NIOSH Faceview口罩™N95外科口罩的批准和商业化。具体地说，我们将1)优化 Faceview面罩™并对最终用户进行调查研究，以确保舒适性和周围有效的密封 航空公司；2)与医疗保健专业人员进行比较产品测试，包括美国标志 语言翻译员收集他们对Faceview面具™与领先的不透明外科N95的看法 口罩；3)执行510(K)许可和Faceview口罩™的NIOSH批准所需的测试； 以及4)在标准的实验室测试和医护人员使用中测试其抗菌性能。

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.