Seeing is Believing—And Hearing

Clear-Window Surgical Masks Are a Lifesaver for Patients with Hearing Loss

WRITTEN BY

David Copithorne

Content Director

19 November 2019

Everything was going smoothly when Dr. Anne McIntosh went into labor with her first baby. Overcoming the obstacles of her deafness, McIntosh leveraged her ability to lipread to communicate with her doctor, her husband, and the nurses that attended her labor. But more than 25 hours later, she was still in labor. And when her doctor determined a C-section was needed, she confronted a problem that many people with hearing loss experience in hospitals everyday.

Sudden isolation

When McIntosh was moved into the operating room, all there—the anesthesiologist, the delivery doctor, the nurses, and her husband—were required to wear full surgical garb. And all wore traditional mouth-concealing surgical masks. No longer able to read lips, McIntosh was completely cut off from the team providing her care.

How a new face mask is changing the face of health care

"How a new face mask is changing the face of health care." Closed captions are available on this video. If you are using a mobile phone, please enable captions by clicking on the three small dots.

Overwhelmed with Anxiety

McIntosh was overwhelmed with anxiety. Would she be able to understand important medical questions and directions quickly enough to avoid problems? Tired and alarmed, she feared that poor communication might lead to harm for her or the baby. Luckily, her husband was there to communicate. The C-section went without incident, and she delivered a healthy baby girl.

But McIntosh never forgot the terrible feeling of helplessness she experienced in that potentially life-or-death moment. “In a matter of minutes, I went from being a doctor with a PhD who could communicate and articulate well, to a numbed, tired, fatigued patient who was counting on mercies and miracles,” she says. She realized that all of that stress and anxiety could have been avoided if she had simply been able to read the lips of the medical providers who were there to help her deliver their daughter. She knew there had to be a better way.

Where there’s a will, there’s a way

“I decided then and there that if there wasn’t a solution available, I would create one,” she says. McIntosh did some research and discovered there were no FDA-approved surgical masks on the market that provided a clear window enabling patients to see care providers’ lips when they were speaking. So, she decided to develop a product for them.

Accessible Surgical Masks Fb

The Communicator(tm) Clear Window Surgical Mask eliminates lipreading problems while providing FDA-approved ASTM Level 1 protection. Dr. Anne McIntosh featured in right-hand image.

It took several years, but the product she created in partnership with Prestige-America, The Communicator™ Clear Window Surgical Mask from Safe ‘n Clear, finally won FDA approval and hit the market at the end of 2017. The mask, with a simple clear plastic window that’s specially treated to reduce fogging, completely eliminates lipreading problems while providing FDA-approved ASTM Level 1 protection.

McIntosh felt The Communicator’s time had come. Patients and caregivers have become increasingly concerned about airborne pathogens. And use of surgical masks has become common, not just in the operating room, but for routine appointments in medical settings as well. McIntosh assumed that The Communicator mask was a clear case of “if you build it, they will come.” She launched the product and waited for the world to beat a path to her door.

Embracing change for better communication

“But that’s when the real work started,” she says. It turns out hospitals and the medical establishment are set in their ways and slow to embrace change. “Even when there are simple and seemingly obvious solutions to common problems, they just keep doing things the way they’ve always done them.”

McIntosh went door to door, demonstrating her mask in dozens of hospitals and medical practices. And when she got their attention, she found a receptive audience.

Alicia Booth of Designated Interpreters works in hospitals providing American Sign Language interpretation to help doctors and patients communicate more effectively. She says many caregivers have long wondered why such a mask wasn’t readily available.

“For many years we have been waiting for the approval of a clear mask to use in all hospitals,” she says. Once she and her colleagues tried the Safe’N’Clear mask, there was no turning back. “We really love it. It is a clear mask that does not fog, has FDA approval and can be used with patients or in the operating room.”

SafeNClear Communicator Mask Review

"SafeNClear Communicator Mask Review." Closed captions are available on this video. If you are using a mobile phone, please enable captions by clicking on the three small dots.

More value from a Made-in-America mask

As CEO of her new business, McIntosh also encountered unexpected manufacturing and distribution hurdles. Many masks purchased by hospitals are produced in China, where the cost of labor is very low. Undeterred, McIntosh was committed to keeping her mask Made-in-America, as she felt quality controls would be more strictly enforced. But that increased her manufacturing and end-product costs.

McIntosh encountered another hurdle when she discovered that many medical equipment suppliers bundle bulk quantities of surgical masks as a free sales incentive for hospitals that buy their products. This has led many medical professionals to view surgical masks as commodities that should be inexpensive.

Overcoming the hurdles, Safe’N’Clear has ramped up sales, and McIntosh says her company has brought down costs for large-volume purchases to as low as 67 cents per mask. That’s still more than what you pay for the traditional mass-produced masks. But McIntosh says she is having success in communicating the additional value that a mask with a clear window provides.

Poor communication leads to expensive medical liabilities

McIntosh, who holds a PhD in communications science and disorders from the University of Texas, cites statistics from a 2015 Crico Strategies survey that determined 30% of malpractice claims over a five-year period occurred as a result of communication breakdowns. An article she co-authored with Bill Holahan, JD, “The Math Works: Reduce Communication-Related Medical Errors by Investing Upfront,” references a significant finding: of the 23,000 malpractice cases studied in the Crico Strategies survey, more than 7,000 “could have been prevented with clearer, more visible communication.” Those failures were linked to more than 1,700 deaths and to $1.7 billion in medical malpractice costs incurred by medical providers.

“Even when you take deafness out of the equation, conventional masks can create problems. They muffle speech and make it more difficult to understand your provider even when you can hear well,” she says. “For example, how often does your dentist pull down the mask to talk to you? It isn’t just to show off that million-dollar smile.”

Another important factor for hospitals and medical practices is compliance. She says The Communicator masks provide an auxiliary aid to help hospitals meet the “Effective Communication” requirement of the Americans with Disabilities Act of 1990 and the “Primary Consideration” provision of the Affordable Care Act of 2010. Both require caregivers to take steps, including provision of translators and sign-language interpreters, to ensure safe and effective communication with patients.

How often does your dentist pull down the mask to talk to you? It isn’t just to show off that million-dollar smile.

Dr. Anne McIntosh

“In some instances, what’s more expensive? A surgical mask with a clear window, or an ASL interpreter?” she asks. Interpreters love the mask because they are equipped with mask protection; however, not all deaf people know sign language. Sometimes you need both—the interpreter and the mask. “It’s not just a matter of convenience—better communication is a dollars-and-sense issue that will provide better and more efficient care, avoid liabilities, reduce the costs of compliance, and return dollars to the bottom line.

Healthy competition means the product is catching on

In the two years since the world’s first FDA-approved medical mask with a clear window hit the market, The Communicator has started to catch on and sales are increasing. And—no surprise—it has started to attract competition. One startup, ClearMask, LLC, was founded by a team with ties to the Johns Hopkins Bloomberg School of Public Health, and has raised money and developed their own product. They are going through the FDA approval process now.

McIntosh isn’t concerned. She seeks collaboration, partnerships, alliances, education, and advocacy among companies and products with the goal being to break down barriers to communication, and to provide inclusion and accessibility for everyone.

“My goal is to see that the problem is solved. The more solutions that are available, the fewer patients there will be who have to experience the kind of helplessness and anxiety I did,” she says. “And if every hospital in the country decides to start using Communicator masks as a first option, there will be plenty of demand for products from us and others.”