HSS 3332 Lecture Notes - Lecture 7: Lip Reading, Biocompatibility, Hearing Aid
Document Summary
Medical devices: medical device regulation in canada: a primer. Based on the risks associated with their use, including the degree of invasiveness, duration of contact with the patient, energy transmission hazard, and consequences of device malfunction or failure. Give an example of each class of device. There is no doubt that cochlear implants benefit thousands of people without major risk. Still, even the cochlear implant is not universally accepted as a therapeutic intervention by the profoundly deaf. Some see it as an intrusion into their way of life, claiming that the implant threatens to eliminate their standing as a culture and thus compromise their autonomy [1-4]. Moreover, some contend that, in a community of deaf people, (re)gaining hearing for a single individual could be considered an enhancement, an additional capability on top of what other members of the community have, gained by artificial means.