It is the bane of rock stars, spectators, frontline soldiers and people who insist on using cotton swabs: a ruptured eardrum.
Painful and time-consuming, eardrum repairs often require surgery under general anesthesia resulting in expensive medical bills. In addition, the result is often far from ideal.
Now, a native of Macomb County is seeking approval from the United States Food and Drug Administration for a groundbreaking invention – a device that allows the eardrum to heal itself.
Nicole Black, 28, of Utica, has created a biodegradable device that allows perforations in the eardrum to heal on their own.
The device, called Phonograft, can be used in patients who suffer from ear trauma from exploding bombs like IEDs, chronic infections, or foreign objects like cotton swabs.
The device was designed to mimic the eardrum of the human body. Once the device is placed, the ear will begin to generate new cells as the phonograft slowly breaks down, leaving the ear with only new cells.
“The 3D printable nature of Phonograft and the ability to cut or customize it at the time of surgery means it can be used for any size and location of puncture,” said Black.
The Harvard graduate has been developing Phonograft for six years now. She came up with the idea after visiting Dr. Aaron Remenschneider at the Massachusetts Eye and Ear Hospital in Boston. Remenschneider has worked with many patients who suffered ear injuries in the Boston Marathon bombing.
“Dr. Remenschneider followed the results of many of these patients after their eardrums were delayed with traditional materials… and over time, he found that their results were not ideal,” said Black.
Typically, when a person needs eardrum repair, a tissue taken from their own body called a fascia is used to repair the eardrum.
Black also worked under the guidance of Professor Jennifer Lewis at Harvard University, who has done extensive research in materials science and 3D printing.
The process began once Black began collecting biodegradable materials that were compatible with the human ear. One of the unique characteristics of Phonograft is that the molecules formed after its degradation are molecules already present in the human body. The phonograft is not toxic and will not cause infection in other parts of the ear.
Black is in the process of finalizing the Phonograft material so that it can be transported to different settings, especially in the military, where ear punctures are common among soldiers.
She is also working on designs so that placement of the phonograft in the ear canal can be done while patients are awake. Currently, patients must undergo general anesthesia for this type of procedure.
Phonograft’s overall goal is to make the process as fast, cost effective and efficient as possible.
“The way we’re trying to revolutionize this procedure is to make it a 20-minute clinical procedure. Rather than having to book a full day in advance and show up with a loved one to accompany you with the anesthesia, ideally you could just show up to a clinic, the ENT surgeon could take a phonograft and place it in. your ear canal just with local anesthesia and you could go in and out of there within 20, 30 minutes, ”Black said.
Black predicts that Phonografting could allow doctors to do dozens of eardrum repairs throughout the day or take care of other work. Hospitals could potentially save money as this procedure would only require local anesthesia as opposed to general anesthesia,
More: June Holiday Events in the Detroit Subway Include Movies, Food, Music, and Shopping
More: Michigan to roll back key remaining COVID-19 restrictions on June 22, ahead of schedule
Black is seeking FDA clearance of 510K and hopes the device will be marketable to ear, nose, and throat surgeons by the end of next year or early 2023.
Contact Janelle James: [email protected] and follow her on Twitter @Janelle___J.