The events of this year have affected everyone, but not necessarily in the same ways. Deaf and hard of hearing individuals face some unique challenges amid the pandemic, perhaps none bigger than the most recognizable symbol of life in the year 2020: the face mask. The spread of disease is not the only thing that face masks can limit the transmission of — they're also pretty effective at limiting communication. At least most are.
It was my pleasure to learn from Allysa Dittmar, co-founder and president of ClearMaskTM, how her company is using what I'll call "why didn't anybody think of this before" technology to help keep people safe without unnecessarily hindering their ability to communicate with each other. I was especially excited to uncover and ultimately surprised by the origin inspiration of the ClearMask (spoiler: it wasn't COVID-19).
Here are the contents of my Q & A with Allysa. The headings are my questions and what follows are her answers.
For anyone who doesn't know, what is the ClearMask and what does it do?
ClearMask is the world’s first fully transparent, FDA-cleared mask optimized for maximum clarity and comfort: making connections more human and providing clearer communication for all.
Who is it designed to help?
By allowing a full view of the face and facial expressions, ClearMask benefits different populations and different kinds of people from all ages and backgrounds, including:
- Deaf and hard of hearing individuals
- Children, especially for early language and socio-emotional development and education
- Older people, especially those who are isolated, experience dementia, or hearing loss
- People experiencing confusion, stress, or anxiety; especially those who are neurodiverse
- People who may not speak the same language
- Interpreters and translators
- Immunosuppressed people and their caretakers
- Essential employees
- Customer-facing employees
- Workers in noisy environments
- Anyone who wants to wear a face mask for protection
The FDA approved the medical version of the ClearMask. What does that mean?
We received U.S. Food and Drug Administration (FDA) clearance on the ClearMask as a class II medical device transparent surgical mask. We also have a non-medical version of the ClearMask currently available at a lower price to meet the demand. The non-medical, consumer face mask similarly helps to improve visual communication and provides protection.
The main difference between the medical and non-medical versions of the ClearMask is the type of user and intended use. The non-medical version is intended for use by consumers and healthcare professions under the FDA’s COVID-19 mask guidelines. Following these guidelines, the non-medical, consumer version is available for use in hospitals and by healthcare providers without objection from the FDA, and may be used when FDA-cleared masks are unavailable. Per the FDA, use of these masks is not recommended in a surgical setting or where significant exposure to liquid bodily or other hazardous fluids may be expected; in a clinical setting where the infection risk level through inhalation exposure is high; or in the presence of a high intensity heat source or flammable gas.
The FDA-cleared, medical version of the ClearMask is intended for use in healthcare settings, such as operating rooms, or other medical procedures such as dental, isolation, and veterinary procedures during which a face mask is necessary to protect both the patient and healthcare personnel from transfer of body fluids, microorganisms, and particulate material.
Additionally, the medical and non-medical versions are constructed using the same design and similar materials, but are manufactured in different facilities using different processes.
Where did the idea come from? Was it in response to COVID-19?
The idea for a fully transparent mask was thought long before the pandemic. Our company was established on September 1, 2017 after I had an adverse surgery experience in 2015. As a deaf person, I heavily rely on visual communication, facial expressions, and lip reading to communicate. Because there were no transparent masks on the market, I was unable to communicate effectively with my surgery team due to the traditional masks blocking everyone’s faces and impeding communication. Since then, ClearMask’s four co-founders set out to develop a fully transparent mask, with product development and FDA submission occurring from September 2017 to December 2019. We received FDA clearance on April 6, 2020. We started taking orders in April 2020 and shipping out orders in May 2020.
Why hasn't anybody thought of doing this before?
When we first started ClearMask in 2017, there were no other fully transparent masks on the market. It was a very novel concept, and when we shared the idea with others, many often expressed surprise or exclamation that no one had thought of such an idea, but that much it made so much sense.
Now, with universal mask wearing during a pandemic, more and more people have started to realize the importance of seeing facial expressions, visual cues, and lip-reading, and how much we all subconsciously rely on visual communication. A simple Google search will show you hundreds of masks being made with transparent windows. The aforementioned masks with transparent windows are often made at home and are not approved by the U.S. Food and Drug Administration.
Having the "stamp of FDA clearance" brings a lot more confidence in a product, and our FDA clearance makes the ClearMask an extremely trusted product in a completely new category. It brings enormous integrity into a product, especially in a rapidly growing market of unregulated products. Products that get FDA clearance go through enormous vetting — including studies and independent lab testing — and brings consumer confidence to a product.
What does the incredible success ClearMask has seemed to enjoy this year tell you?
With a product initially created to help improve visual communication and make healthcare more human, the ClearMask has also been adopted by many different sectors for different purposes. In addition to hospitals, our top customers consist of K-12 schools and universities, childcare programs, state and international governments, and private companies in retail and customer service. The widespread and different use for the ClearMask is a testament to the ClearMask’s innovative, yet simple, universal design.
As driving forces behind product development and innovation, are accessibility and inclusion fads?
People today are becoming more aware of the need for accessibility and inclusion. Customers have told us time and again how much regular masks have taken away the innate ability to connect and see facial expressions. It’s part of what makes us human; over 55% of communication is purely visual and in the face. Many have felt the jarring disconnect with regular masks, and how often we subconsciously rely on facial cues, expressions, and lip-reading.
What do you think other businesses should take away from this?
It’s incredibly important to listen to and immediately react to market demand, and to stay adaptable. Our initial business plan from 2017 does not look like what it is today. Our response to the pandemic is probably the best example of how we quickly adapted to market demands; in the middle of the pandemic, we released the consumer version of the FDA-cleared ClearMask to meet the increased demand.
Do you have any other advice for businesses to become more accessible to their employees and customers?
Talk to your customers to truly understand their needs. When we were in the preliminary stages of designing and creating the ClearMask, we spoke to hundreds of people through formal interviews to better learn and understand who are our potential buyers, users, and beneficiaries, and what they wanted. Had we not done that, our ClearMask design would look extremely different today.
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