Reusable, Transparent, and Reconfigurable N95-equivalent Respirator Masks: Design, Fabrication, and Trials for Enhanced Adoption

Summary

The goal of this observational usability study was to evaluate the comfort, breathability, fit, communication, and user acceptance of the SEEUS95 transparent reusable respirator in healthy adult volunteers. The study aimed to assess whether a transparent respirator could improve the user experience while maintaining the characteristics expected of an N95-equivalent respirator.

The main questions it aimed to answer were:

Is the SEEUS95 transparent respirator comfortable to wear during both short-duration (30-minute) and extended-duration use? Does the transparent design improve communication and participants' perception of being seen and understood compared with conventional opaque respirators? Can participants breathe comfortably while wearing the SEEUS95 respirator? Does the adhesive sealing system provide a secure, comfortable fit across different facial shapes and sizes? What design improvements would increase user acceptance and long-term adoption?

Researchers also collected qualitative feedback regarding facial visibility, social interaction, and overall satisfaction with the transparent respirator design.

Participants

Healthy adult volunteers, 18 years of age and older.

Participants were asked to:

Wear the SEEUS95 transparent respirator for approximately 30 minutes during routine activities.

A subset of participants wore the respirator for an extended-duration evaluation to assess comfort over longer periods.

Complete standardized questionnaires evaluating:

Overall comfort Ease of breathing Facial fit and seal Communication while wearing the mask Visibility of facial expressions Perception of feeling "seen" while interacting with others Willingness to wear the respirator in healthcare, workplace, and public settings Overall satisfaction and recommendations for design improvements Provide qualitative feedback through interviews regarding usability, communication, and daily wear experience.

Primary Outcome Measures Overall user comfort during respirator wear Ease of breathing Quality of fit and facial seal Communication effectiveness enabled by the transparent design User acceptance and likelihood of long-term adoption Secondary Outcome Measures Participant perception of social connection and facial visibility Skin comfort and pressure points Ease of donning and removing the respirator Recommendations for future design refinements

Conditions

• Focus is on Healthy Subjects

Interventions

DEVICE

Reusable, Transparent, and Reconfigurable N95-Equivalent Respirator Masks: Design, Fabrication, and Clinical Trials for Enhanced Adoption

The SEEUS95 is an investigational reusable transparent respirator designed to provide N95-equivalent respiratory protection while improving user comfort, communication, and sustainability. Unlike conventional opaque disposable respirators, the SEEUS95 incorporates a transparent facepiece that allows full visibility of the mouth and facial expressions, facilitating communication and lip-reading during patient care and everyday interactions. The respirator consists of a reusable medical-grade silicone body with a skin-safe adhesive facial seal designed to provide a secure fit across a wide range of facial shapes and sizes without the need for tight elastic straps. The device incorporates replaceable high-efficiency bio-based filter media and is intended to reduce environmental waste associated with single-use disposable respirators.

Sponsors & Collaborators

• SEEUS95 Inc

  lead INDUSTRY

Principal Investigators

• Alice Chun · SEEUS95 Inc

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Model

SINGLE_GROUP

Eligibility

Min Age

18 Years

Max Age

80 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2025-06-26

Primary Completion

2025-08-14

Completion

2025-08-14

FDA Device

Yes

Countries

• United States

Study Locations