Although the first (CI) was implanted by Dr. William House and John Doyle in 1961 in California it would take over 20 years of continuous research and development and significant data collection to obtain FDA approval and scientific acceptance.
Dr. House’s initial device was eventually rejected by the body because implanted electronics lasted only a few months before shorting out due to leaking body fluids. In 1964 Blair Simmons and Robert White of Stanford University placed a 6-channel electrode in the cochlea. Around this same time, improvements in pacemaker technology sparked Dr. House’s interest in pursuing the development of an improved and biocompatible Cochlear implant.
In 1967 House partnered with Engineer Jack Urban to produce the first hardwire five-electrode system and placed it in three patients. In 1972, Dr. House and his collaborators went on to produce the first wearable device, featuring a centering coil and using an attaching magnet.
Over 1000 people were implanted from 1972 to the mid-1980s. The single-channel device was well tolerated and provided many users with significant speechreading enhancement. However, convincing the scientific community continued to be challenging.
Changing the view of the Scientific Community
In 1977, Dr. House devised a new strategy to bring CIs to market using a multi-center study to provide proof that patients were benefiting from the procedure. He said, “The scientists won’t listen to us, but if something good happens for patients, they’re going to have to listen to them.” https://www.enttoday.org/article/history-of-the-cochlear-implant/?singlepage=1
In 1978 Dr. House contacted his young mentor, Dr. Richard T. Myamoto, MD, who had just completed his fellowship in neurotology and moved to Indiana University Riley Hospital for Children as an assistant professor. Through his fellowship at House Ear Institute, Dr. Myamoto had seen first-hand how people with early implants kept doing better than they should have. He stated, “What no one took into account in those early days is that there was a brain at the other end of that signal.” Dr. Myamoto agreed to participate in the study noting there wasn’t any treatment for sensorineural deafness at the time.
At the same time, 3M asked for Dr. Myamoto’s help in presenting evidence to the FDA which had never approved a durable medical device. (3M owned the proprietary rights to the House Implant).
The results of the trial concluded that CIs were beneficial to patients. Dr. House’s perseverance paid off, and in 1984 the FDA approved the House/3M Single-Channel Cochlear Implant for use in deaf adults, calling it the first device to replace a human sense.