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A Word of Caution
CHARLES W. CUMMINGS, MD
Department of Otolaryngology University of Washington School of Medicine Seattle, WA 98195
Arch Otolaryngol Head Neck Surg. 1989;115(1):36.
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| Since this article does not have an abstract, we have provided the first 150 words of the full text PDF and any section headings. |
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To the Editor.—Recently I had the pleasure of chairing the Food and Drug Administration ear, nose, and throat device panel evaluating the premarket approval application for use of the House/3M (House Ear Institute, Los Angeles; 3M, St Paul, Minn) single-electrode cochlear prosthesis for children. Because of the diversity of opinion with respect to the use of such devices in children, I thought it worthwhile to report the findings and make some comments.
There is no doubt that this committee labored long and with anguish before reaching the decision to recommend approval. However, the final recommendations were a product of a unanimous vote. Based on the evidence that the cochlear prosthesis substantially improves speech interpretation in a few and heightened awareness to environmental sounds in many, and additionally has no measurable effect in a few, this ultimate decision was based on the evidence.
The premarket application was approved with the
. . . [Full Text PDF of this Article]
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