EB-2 NIW Case Study: Approval for Biomedical Engineer from Argentina

When USCIS reviewed the petition, it agreed on two important points: our client’s work had substantial merit, and he was well positioned to carry it forward. The RFE centered on a third area, national importance. USCIS questioned whether the work would reach beyond individual surgeries and patients to benefit the country on a broader scale. 

That meant connecting the client’s work to outcomes beyond individual patients. The response focused on how his hearing and medical device technologies could move into wider clinical use, support U.S. manufacturing and skilled jobs, and contribute to an area already receiving federal research support. 

Much of the response showed that the work was never limited to a single lab or operating room. Our client’s research was already underway at several U.S. medical centers and universities. The response tied that work to needs the federal government has called national. Federal science agencies have paid to develop the next generation of implantable devices, including the light-based methods at the heart of his work. A report to Congress had also identified limited domestic manufacturing capacity for implantable neural devices. Our client’s plans to build and sell his devices here speak directly to that need. 

The response also documented the scale of hearing loss in the United States and the client’s plans for bringing his technology closer to clinical use. More than 44 million Americans live with hearing loss today, and that number is expected to pass 73 million by 2060. Carrying a device like his from prototype to patients creates skilled engineering and manufacturing jobs across the country. To show the work was concrete and already moving, the response laid out a dated plan for the next 12 to 24 months, from lab testing to clinical studies to early submissions to the U.S. Food and Drug Administration (FDA). It also included letters of recommendation from independent leaders in surgery, research, and industry, among them someone who had already brought cochlear implant technology to market. Their letters explained the need for this work and its potential for broader clinical use. 

USCIS approved the EB-2 NIW petition with Premium Processing on September 12, 2026, following the firm’s response to the Request for Evidence.  

The approval marks a key step toward permanent residency. Once permanent residency is obtained, he will be able to carry his initiative forward and bring the next generation of cochlear implant and related hearing technologies closer to the people who rely on them.