Monday, June 29, 2009

NAD's 1991 position statement on Cochlear Implants

For historical purposes - AFA is sharing the National Association of the Deaf (NAD) 1991 public position statement on Cochlear Implants
To see their current position statement on CI (approved in 2000) go to:

to see and sign AFA's petition to the FDA for an impartial and independent investigation into the long term physical, psychological, social, and cultural impacts of CI on infants and youths - go to:
petition in ASL

Cochlear Implants in Children
A Position Paper of the National Association of the Deaf (1991)

Background. On June 27, 1990, the Food and Drug Administration approved the marketing of the Nucleus 22-channel cochlear prosthesis for surgical implantation in children aged two through seventeen. (Commercial distribution for postlingually-deafened adults was authorized in 1985; investigational trials began in adolescents, age ten to seventeen, the same year and in young children, age two through nine, in November 1986.) This recent FDA approval of marketing childhood implants, recommended by its Ear, Nose and Throat Devices Panel, was based on a submission by the manufacturer, the Cochlear Corporation, which reported on a total of 200 implanted children, ages two through seventeen, who had bilateral, profound sensorineural deafness.

The position of the National Association of the Deaf. The NAD deplores the decision of the Food and Drug Administration which was unsound scientifically, procedurally, and ethically.

Scientific errors. Implantation of cochlear prostheses in early-deafened children remains highly experimental. There is no evidence of material benefit from the device in this population and there has been no evaluation of the long-term risks. There is no evidence that the speech perception of these children is materially enhanced and there is evidence that many profoundly deaf children would have better, however limited, speech perception with conventional hearing aids than with implants. There is no evidence that early-implanted children will do better at acquiring English than they would with noninvasive aids or with no aids whatever. There is no evidence that early-implanted children will have greater educational success, and reason to doubt that they will since children with severe hearing losses do scarcely better in school than those with profound losses. The FDA Panel has required the device packaging to include the warning that congenitally deaf children may derive no benefit from the device but the evidence for that conclusion is also strong for children deafened below the age of three and possibly age five or later.

Current programs of research on cochlear implant with children are conducted without regard to the quality of life that the child will experience as a deaf adult implant user. It is presently unknown whether the implant, and the profound commitment of parent and child to aural/oral training that is generally required, will delay the parents' and the child's acceptance of the child's deafness and their acquisition of sign communication; and the costs associated with these likely delays have not been assessed. The impact of the implant and the associated aural/oral training on the integration of the child as an adolescent and adult into the deaf community, on the child's social, intellectual and emotional development and mental health have not been assessed. This failure alone to consider the impact of the implant on the child's future quality of life qualifies the implant programs as highly experimental -- just what the World Federation of the Deaf deplored when it resolved, "[Implant developments are] encouraging for persons deafened after some years of hearing [but] experimentation with young deaf children is definitely not encouraged."

Procedural errors. The FDA erred in failing to consult formally with organizations of deaf Americans and with deaf leaders and scholars knowledgeable about the acquisition and use of sign communication and English in deaf children, the psycho-social development and education of deaf children, and the social organization and culture of the American Deaf community. The research evidence makes abundantly clear that early-deafened implanted children will rely on sign communication in school and in much of their lives; many, perhaps most of these children will become or already are members of the American Deaf Community. Otologists, speech and hearing scientists, manufacturers, parents and members of the FDA staff were all consulted formally by the FDA in arriving at its decision; its failure to consult deaf spokespersons represents, if an oversight, gross ignorance concerning growing up deaf in America, or, if willful, an offense against fundamental American values.

Ethical errors. Experimentation on children is ethically offensive particularly in these circumstances: new and high technology that entails invasive surgery and tissue destruction is used not for life saving but for putative life enhancement; adults such as these children will become, when given the option of such prostheses, overwhelmingly decline them; the parents who make the decision for the child are often poorly informed about the deaf community, deaf heritage and culture, and communication modes available to deaf people and their families. Finally, the decision to surgically implant a young deaf child is ethically unsound for a more fundamental reason. There is now abundant scientific evidence that, as the deaf community has long contended, it comprises a linguistic and cultural minority. Many Americans, perhaps most, would agree that as a society we should not seek the scientific tools nor use them, if available, to change a child biologically so he or she will belong to the majority rather than the minority -- even if we believe that this biological engineering might reduce the burdens the child will bear as a member of a minority.

The National Association of the Deaf advocates the following course of action: (1) The Food and Drug administration should withdraw marketing approval and revise the procedures employed for evaluating proposals for authorization of cochlear implants in children. (2) The National Institute on Deafness and Other Communicative Disorders should fund research on the present population of implanted children which will allow a comprehensive assessment of risks and benefits for the child that include social adjustment, mental health and quality of life issues. Pending the outcome of those studies, the Institute should not fund any additional implanting of early-deafened children unless an overriding need for that experimentation on children can be shown and conducted on a small number under highly controlled circumstances with comprehensive evaluation. In all research concerning deaf children, the Institute should require for new or continued funding that research programs involve deaf leaders and experts on the cultural aspects of deafness. Research programs that implant children with cochlear prostheses should include measures of material enhancement of speech reception and production, such as open-set recognition of ordinary conversation in moderately noisy environments, with and without lipreading support. The Institute should further convene meetings of medical ethicists, otologists, audiologists, deaf leaders and scholars of the cultural aspects of deafness to examine the ethical issues underlying research and practice in childhood cochlear implant, and it should fund research on these ethical issues. (3) Implant teams at hospitals around the United States should refuse to surgically implant early-deafened children and should provide a copy of this position statement to parents requesting such implantation for their children. Parents should also be provided with printed information concerning organizations of deaf persons in their community and other sources of information about the deaf community, its culture and its language and heritage.

Prepared by the Task Force on Cochlear Implants in Children Dr. Harlan Lane, Chair; Dr. Barbara Brauer, Dr. Larry Fleischer, Joyce Groode, Nathie Marbury, and Michael Schwartz, Esq. Submitted 12/23/90; approved by the NAD Board of Directors, 2/2/91.