The Food and Drug Administration recently approved the Veterans Affairs Department’s request to prescribe a 3D printed experimental device developed internally for a 76-year-old patient who faces a rare form of hearing loss.
“It was collaborative care. There are many diseases, you know. For example, I have lung, heart and liver problems – I mean, I have more problems than problems. But, in this particular case, I could participate in the solution ”, said the veteran patient, Michael Nicoletti. Nextgov Monday. “And they were very open to that. They wanted my opinion. They wanted my feedback. “
The change marks the first time that the FDA has granted VA compassionate use authorization. Moving forward, the department will continue to leverage its 3D printing network to meet the patient’s specific medical needs that may not yet be met by off-the-shelf products. In separate interviews this week, Nicoletti, and Dr. Beth Ripley of VA, reported Nextgov about how the audiological investigational device came to be, the infrastructure that made it possible and what could come next.
“3D printing – I think most of what it does is allow us to do individualized treatment, when we’ve never had the opportunity to do that before,” explained Ripley. “And I think we will continue to grow with that.”
Grabbing straws
Gradually, in recent years, Nicoletti – a Vietnam War veteran living in Summerville, South Carolina – has begun to recognize a clear degradation in his hearing.
“My wife and I really noticed it here at home,” he explained, adding that, while watching TV, he started to realize that she would adjust the volume around 20, at the lower end of the spectrum, but he would need to set up to 50 for really be able to hear it. “I said, ‘Oh, man, there’s really something wrong.’”, He recalled.
“Sure, I visit VA,” observed Nicoletti. There, he learned that he was experiencing conductive hearing loss, which means that the problem was a result of the sound not being able to reach his inner ear as it did in the past due to a blockage, in his case, caused by the collapse of the cartilage.
Nicoletti has an engineering background and has spent more than 30 years of his life designing medical equipment. One night, in his kitchen, he had an idea.
“I noticed that we had a small container with straws. I took a straw out of it and cut about an inch from it – and put it in my ear, ”he said. “The doctors would be crazy because I did that, but anyway, suddenly I’m now sitting there with the TV volume at 20 or 25 – instead of 50. And I’m saying, ‘Well, there is the problem. ‘”
At Ralph H. Johnson VA Medical Center in Charleston, South Carolina, where he receives care, Nicoletti was told that he might need surgery to mitigate his hearing problem. An operation in his 70s was in no way attractive to the patient, so he chose to share his straw-based epiphany about a potential device to essentially open his collapsing ear canal with Charleston VAMC Audiologist Kent Flanagan.
“He was excited about the idea and then we put it into practice,” said Nicoletti, and then Flanagan brought in biomedical engineers Nicole Beitenman and Bethany Baldwin to make the idea a reality. “The good thing is that these young women have what they call a ‘3D printer’ at their disposal, who can create these devices in a matter of minutes,” he noted.
Through the Veterans Health Administration’s integrated 3D printing network, employees were able to use the technology-based features recently acquired at medical facilities to create a personalized straw-inspired device. Innovators across the department involved in this network have taken advantage of advanced printers in various locations in recent years to help tackle a range of veteran-centered problems. So in South Carolina, the patient and the team “came together” to plan a concept for the hearing aid, explained Nicoletti.
Over the course of several months, he and VA staff collaboratively refined and perfected the instrument “by sharpening it to where we are now, where we think we have a viable device to open that channel, without going through the pain and anguish of surgery, “he said. Currently, this device is essentially a 3D printed stent that can be inserted into your ear canal and opened up so that sound can reach it.
After iteratively producing the stent and hitting it, Nicoletti recently did a hearing test using it. The patient said, during this, audiologist Flanagan “jumped for joy because he was so excited about” the remarkable change in his ability to hear with the device.
3D printing has many advantages, including ease of use and ease of replacement if an original is lost or broken, as the agency has a digital file in hand and can recreate the device when necessary. Led by VHA’s 3D Printing Network Director, Dr. Beth Ripley, federal insiders have requested compassionate use authorization from the FDA, which allows specific individual patients to prototype exclusive treatments outside of clinical trials when there are no alternative therapy options comparable.
“Allowing access to this Experimental 3D Printed Audiological Device is the only practical way to provide a satisfactory non-surgical solution to this patient’s collapsed ear canals to help mitigate the conductive hearing loss it causes and improve his quality of life” , wrote the FDA in a letter to Ripley approving the use of the stent by Nicoletti, which was shared with Nextgov this week.
“This is the first time we’ve signed up for compassionate use – and the FDA was really fantastic,” said Ripley, noting that there were a lot of roundtrip conversations and “they changed that in 14 days.”
For her, it is an initial, but promising, result of VA’s newly developed system to help facilitate these patient-specific 3D printed device creations.
Just the beginning
A trained radiologist, Ripley interprets medical images, such as x-rays or ultrasound, for diagnosis and treatment planning.
“3D printing has been a longstanding love and really an extension of that for me,” she explained, noting that her goal is to revolutionize patient care by bringing these two-dimensional images into 3D space. In addition to pre-surgical planning, assistive technology devices, prostheses and now devices compatible with the patient, she said that there is “a whole world that has been opened up to VHA through 3D printing”.
Patients often bring their own ideas to the table to fix personal ailments, but Ripley said that two “somewhat haphazard” developments in recent years have helped VA to bridge the gap between the simple concept and the wearable device.
The first was the incorporation of 3D printing in many of its hospitals, allowing frontline personnel to innovate, prototype, iterate and design things they would normally never be able to do. Some VA facilities were using emerging technology in 2017 – but that year, the department’s intention to establish a fully integrated 3D printing network really came to fruition. That network has expanded to 60 hospitals since then, with VA’s print sites nearly doubling amid the COVID-19 pandemic, as manufacturing tools could help solve the medical supply chain problems that affect the country.
“And the next really important element for us is that, during the pandemic, we accelerated our efforts to bring three VHA hospitals into the regulatory space by registering with the FDA and incorporating a quality management system, which is basically a kind of a whole philosophy on how to design, test and make devices safe, ”explained Ripley. “So 3D printing, plus this FDA record meant that – for the first time – when that veteran came into the office and said, ‘I have an idea’, not only was the team able to say, ‘hey, I can do and create a prototype ‘, but we can also take the next step and say,’ Hey, now we can get in touch with the FDA, tell them about this device and what we want to do – and really be able to do it internally under the appropriate quality guidance. ‘”
Accelerated by the global health emergency, this movement occurred around the fall of 2020, when the FDA demanded official records for the production of nasal swabs, of which there was a great need.
“So, that kind of pushed us over that limit, right, just jump and do that. And again, as I said, it’s lucky in a way, because now that we’ve done that, we realize that now, you know, we’re a manufacturer. We are doing this. Can we manufacture other devices – and what better device to manufacture than the one we could never buy? ”Ripley explained. “These unique devices that may seem trivial to a large-scale third-party manufacturer, but are essential for our patients. And those are the types of devices that I really think you’ll see VA focusing on for years to come. “
In a shorter timeframe, Ripley said VA insiders will work to continue to develop the new system and focus on training the broader workforce to employ 3D printing capabilities.
“We are very excited to bring this technology to more veterans,” she noted, “and that means that we need more employees who know how to do it.”
Network officials are also discussing the best patient-centered use cases applicable in this space. It’s all so new that the department still doesn’t have a formal admission process to follow when a veteran has a concept for 3D printed treatment, although Ripley said they are trying to quickly translate what they learned in those first few months into a new way. robust for innovation.
“I think 3D printing has had a really profound impact on patient care – and everything we do is really patient-specific,” she said.
And while that initial initial approval only confirms Nicoletti’s specific treatment, Ripley confirmed that the department is now working with the FDA to expand its use to more veterans who may need it. A little bit of foundation must be done before it can be authorized as safe for a larger patient population.
The original patient approved to use it would like to see this happen.
“I cannot say enough about the treatment I received from [the VA team], and the interest and your kindness ”, said Nicoletti. “And now my hope is that it will certainly work for me, but I hope that – when talking to the speech therapist, he indicates that there are several people every year who have the same problem – this is a solution for them. That way, other vets can get their hearing back. ”