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Sign Language Studies

American Annals of the Deaf

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Surgical Consent: Bioethics and Cochlear Implantation

Linda Komesaroff, Editor

Introduction

This current time is a critical moment in the field of deafness internationally. More than twenty years since the first cochlear implant system gained clearance for use by adults in the United States, the cochlear implant has become the dominant approach to treating congenital deafness among people in most Western countries. In 1987, approximately 500 people throughout the world had cochlear implants (Slee 1987); by the following year, more than 3,000 people had been implanted (Randal 1988, 11). The first cochlear implant system for use by children (from the age of two years) gained clearance in 1990 from the Food and Drug Administration in the United States; the minimum age for implantation dropped to eighteen months in 1998 and to twelve months the following year. Babies as young as five months are now being implanted. As the age at implantation has dropped, the number of implant recipients has continued to soar.

In 1990, an estimated 5,000 people had implants worldwide (Christiansen and Leigh 2002). In 1997, the figure rose to 16,000; by 2002, it was almost 60,000; and according to 2005 data, there are nearly 100,000 implant recipients (National Institute on Deafness and other Communication Disorders 2002, 2006). Christiansen and Leigh (2002) add a caveat to implantation statistics: the number of users is less than the number of recipients, although this number is unknown.

Cochlear, the leading manufacturer of cochlear implants in the world, reportedly accounts for 70 percent of the global cochlear implant market—and considers that percentage as only 10 percent of the potential market (Cochlear 2005). Its chief executive officer, Chris Roberts, predicts that bilateral implantation (the implantation of devices in both ears) could be routine within the decade, telling Business Week Online that “current implant patients could end up being excellent repeat customers” (Einhorn 2005). The company currently sells its products to more than seventy countries and continues to expand its export base into the United States, Asia Pacific, Europe, and the Middle East through an aggressive program of global penetration. In many regions, implantation is made possible through sponsored medical programs that are financed by governments or charitable donations.

The recent announcement of an inquiry by the U.S. Department of Justice into Cochlear America’s relationships with healthcare professionals again plunged this industry into the headlines. The economic implication of such a move dominated the business pages of the national and international press, as did an earlier report of deaths from meningitis linked to U.S. implants (see Komesaroff, this volume). The result was a drop in the share price and reported downturn in Cochlear’s sales across Europe. It was not long, however, before the market recovered and the manufacturer again reported all-time records in the company’s profitability and return to shareholders (Cochlear 2005). Economic imperatives—such as the global market place, the commercialization of medical intervention, and the effect of negative publicity—are critical to the discussion of cochlear implantation.


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