Combination products and the role of medical device firms.
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Early attempts at spinal arthroplasty in the 1950s yielded limited success. A revival of this procedure occurred in the 1980s and became a realistic treatment option in the 1990s. Both lumbar and cervical arthroplasties have been introduced in the US since 2000 for randomized, prospective studies in accordance with the Food and Drug Administration (FDA) investigational device exemption provisions. In June 2004 the first lumbar arthroplasty device was approved by the FDA for use in the US. It is likely that cervical arthroplasty will soon follow and may be available for widespread use as early as 2006. In this paper the authors review the historical development of cervical arthroplasty.
This paper compares the evidence-based outcomes between cochlear implants and hearing aids during the past several decades. Despite many similarities, there are also some important differences that define the progress for the two disciplines. Perhaps the most significant distinction exists in terms of the difference between the Food and Drug Administration's treatment of hearing aids as Class I medical devices, while cochlear implants are defined as Class III devices. Another point of divergence has been the number of publications in archival, peer-reviewed journals; implant papers have been steadily increasing during the past decade, while hearing aid papers have declined during the same period. The impact of these differences on the past, present, and future of hearing aid and cochlear implant research, technology, and clinical practice is discussed.
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