“Patients [with early implants] kept doing better than they should have,” he recalled. “The signal from the early implants was pretty elementary. But what no one took into account in those early days is that there was a brain at the other end of that signal.” As an academic researcher, Dr. Miyamoto was asked by 3M (which had bought the proprietary rights to the House implant) to present evidence to the FDA, which until this time had never approved a durable medical device. The FDA later used Dr. Miyamoto as a consultant to help generate testing benchmarks for device approval. (He was a member of the FDA committee but did not participate in the final FDA approval of cochlear implants, to prevent any perceived conflict of interest.)
Explore this issue:April 2013
In the meantime, at his institution, Dr. Miyamoto was building a multidisciplinary team of investigators, which included speech scientists and neuroscientists. Earleen Elkins, PhD, director of the National Institutes of Health’s (NIH) hearing portfolio, approached Dr. Miyamoto, asking him to submit a grant proposal to the NIH demonstrating the safety and efficacy of the implants. The safety issues, especially those surrounding the implantation surgery, were quickly resolved, said Dr. Miyamoto. Showing efficacy was another issue entirely. “We spent quite a bit of our early time just working out test measures and ways to assess deaf patients,” he explained. “We weren’t making them normal, so we could not use regular tests of hearing. We had to establish early baselines ourselves to show that implants made a difference. Every time we got an answer, it brought up 10 new questions.”
Dr. Miyamoto’s cochlear implant laboratory has received NIH funding continuously for 25 years now. “So it was a project that never ended, and it’s continuing to go that way,” he said.
In 1979, while a senior resident at the University of Iowa Medical School, Bruce J. Gantz, MD, now head of the department of otolaryngology-head and neck surgery at the University of Iowa Hospitals and Clinics, met and trained with William House. In early 1981, Dr. Gantz performed the first cochlear implant at his institution, and between 1982 and 1983, he interacted with other key CI pioneers, including Dr. Simmons, Ingeborg and Erwin Hochmair in Vienna, Dr. Chouard in Paris and Graeme Clark in Australia. Dr. Gantz’s vision was to establish the University of Iowa as a center for testing different devices, and his department has received continuous NIH funding since that time.