Regulating Cochlear Implants: The Legal Response to a Scientific and Cultural Revolution

Abstract

This paper is a case study on the cochlear implant device. The inquiry will explore the important aspects of the device's intended use, its legal regulation, and its moral impact. Through this case study I hope to illustrate how this particular technology distinguishes itself from other medical devices that the Food and Drug Administration regulates. I also examine how well the FDA answers the unique scientific and ethical questions that the device poses. This paper looks at the legal response to cochlear implants through the lense of the implant's societal impact. The research for this paper proceeded in four parts. The first part consisted of reading industry articles, reviews, and manifests in order to understand the hard science of the device. The next part was to understand the regulatory scheme. For that I consulted my Food and Drug law casebook, law review articles that dealt with medical device regulation, and noted cases on the matter. I then tried to ascertain the legal issues that were most pressing to the people who worked directly with the technology. I did this mainly through interviews of clinicians, manufactures, educators, and patients. Finally I consulted books and articles written by or about the leading detractors of the technology, focusing those who oppose it on moral and ethical grounds. This then required me to look towards common law (particularly the field of Family Law) to determine if these detractors had cognizable legal claims.