Seven years ago Gayle Thear and Andy Unger noticed that children exposed to high noise levels in hospitals’ neonatal-intensive care units took longer to develop than children who weren’t exposed to such high levels of noise.

Thear, currently an educator nurse at New Hanover Regional Medical Center, noted the trends while working at St. Luke’s Hospital in Pennsylvania with Unger, chief of neonatology there at the time.

It lead to Thear’s husband, Ed, starting NEATCap LLC – a medical device development company focused on neonatal health care, especially for preterm infants.

Its first product is NEATCap, a passive noise protection system for premature infants. It’s a headband-like apparatus made of neoprene, plastic and foam, as well as some proprietary adhesion to keep the band from slipping.

“The distinguishing feature is the ear enclosure, which is a low-pass filter that enables lower frequency sound to pass to the infant while simultaneously blocking high-frequency noise,” Ed Thear said recently in an email. “The benefit in lowering the noise level is that it enables premature infants to sleep more and improve their neurological development.”

When initially creating NEATCap, they started with active noise cancellation. But they couldn’t get funding from the National Institutes of Health (NIH) without a guarantee against malfunction. Because they were originally trying to cancel all sound, they had to ensure the device wouldn’t accidentally create, or worse, amplify the sound of the NICU.

“Faced with a significant impediment, we elected to perform research on the in utero environment and concluded that a passive noise protection system may work equally well and not have the [active noise cancellation] issue posed by the NIH,” Ed Thear said.

So they began testing new ideas using Marvin, a medical dummy with microphones embedded in his ears, and recordings from NICUs.

They now have four different designs for different sizes from babies born at 26-32 weeks of gestation. They may also begin making them for full-term babies born addicted to opioids to use as they recover from withdrawal, company officials said.

Unger, now the head of pediatrics at Sacred Heart Hospital in Allentown, Pennsylvania, is a partner in the company, and Los Angeles-based Jack Whalen, a member of the USC Institute for Biomedical Therapeutics, is its biomedical engineer. Fred Kimock serves as lead technologist.

NEATCap recently received a $100,000 grant from the University of Pittsburgh Medical Center for clinical trials at UPMC Hamot hospital in Erie, Pennsylvania, Ed Thear said.

“We are presently developing pilot-scale manufacturing to provide our product for the clinical trials at Hamot hospital,” he said. “Dr. Michael Balsan – chief of neonatology – will be performing the clinical trials in Hamot. The start date for that is in late August 2016.”

The first set of trials will take a couple months, he added. The second set is expected to be conducted by the end of this year or the first quarter of 2017, and then the company will be ready for a full launch, Ed Thear said.