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The ethics of cochlear implantation in children
OtolaryngologyHead and Neck Surgery Volume 121 Number 2
100-pm wire is arched against the outer wall except at one basal and one apical point, where it coalesces with the silicone carder. The electrode effectively hugs the inner wall of the model. The explantation feasibility of the array is demonstrated. In temporal bones, x-rays show the electrode and wire widely separated in the basal turn of the scala. Retropositioning invariably causes one third of the electrode to be retracted from the scala. Histological preparation of the bones shows that the wire tends to be partially localized under the spiral ligament and that the electrode hugs the inner wall without visible damage. Conclusion: The difficulty in displacing an electrode array from the lateral to medial wall of the scala tympani is compounded by the fact that the length ratio of inner to outer wall is almost 1 to 2. Retropositioning is a nonintuitive technique that allows matching of these 2 distances regardless of the original insertion depth. The electrode critical specifications (easily implantable, explantable, reimplantable, biocompatible), are met with the present design. Surgical procedure and cochleostomy size are unchanged. The first step in examining mechanical trauma to the inner ear tissues is to focus on temporal bone histopathology, preferably with the electrode in situ. Some trauma is caused to the spiral ligament during the procedure in temporal bones. The critical spiral ganglion remains intact. 8:38 AM
The Ethics of Cochlear Implantation in Children RUI NUNESMD PHD (presenter); Porto Portugal
Objectives: It is accepted that cochlear implants enable deaf patients to realize their potential. Deaf adults are autonomous people who are able to give informed consent for this practice. In deaf children, however, it is claimed that implants are associated with a loss in quality of life. The objectives of this study are to make an analysis of the ethical dilemmas involved in cochlear implantation and to acknowledge why most deaf associations are against this practice. Methods: Having as background Dena Davis ethical theory that every person has a fundamental fight to an open future, I believe that the ethical dimension of cochlear implantation is closely related to a social standard of quality of life. My hypothesis is that if variables like independence, self-esteem, and other personal goals are properly addressed in the evaluation process, and if the family makes the choice of implantation, this should be regarded as being in the child's best interest. Results: It is asserted today that deafness, per se, is not associated with a decreased response rate in nonverbal intelligence tests. When assessing the benefits of cochlear implants, otologists use subjective testing. However, objectivity is an ethical imperative. It follows that in the selection of appropriate candidates, audiological parameters should be complemented with psychological evaluation (cognitive, emotional and familial) before and after the implant procedure.
Scientific Sessions--Monday
P115
Conclusion: Deafness is associated with the lowest educational level and the lowest family income. Notwithstanding the existence of a deaf world, deafness should be considered as an handicap. Therefore, society should provide the means for the fulfillment of a child's right to an open future. If the child belongs to the hearing world, auditory rehabilitation might be necessary to accomplish his or her ethical liberty. 8:46 AM
MED-EL COMBI 40+ System Multi-Center US Clinical Trial Results DARCY N OCHS (presenter); DARLA C FRANZ; KIM JACKSON; Research Triangle Park NC
Objectives: Recent technological advancements have greatly improved the outcome following cochlear implantation. The COMBI 40+ Cochlear Implant System implements new developments in speech processing, which may provide improved speech understanding. A multicenter prospective clinical trial has been conducted in the United States to evaluate the safety and effectiveness of the MED-EL COMBI 40+ Cochlear Implant. Methods: Thirty centers in the United States are participating in the IDE trial for adults (>18 years) and children (18 months to 18 years). Selection criteria include thresholds of 90 dB HL or greater in the higher speech frequencies and no significant benefit from conventional amplification (<20% open-set sentences adults, lack of acquisition, or plateau of auditory skills children). All patients were tested before surgery and at regularly scheduled intervals. Patients were implanted with standard, compressed, or split electrode array devices. The final choice of electrode array was made at the time of surgery. Fitting parameters were freely programmed in order to evaluate performance with normal clinical usage. Results: Adult patients have a mean age of 52 years with a range of 18.7 to 86.8 years. The mean duration of hearing loss in the implanted ear is 24.9 years. Results indicate superior performance for patients with hearing loss less than 25 years and with an unobstructed cochlea (standard electrode array). Results will be reported separately for the more challenging cases (>25 years hearing loss and obstructed cochleae). The mean age of the children is 4.2 years with a range of 14 months to 17 years. Etiology of deafness is as follows: meningitis 31%, Mondini malformation 10%, unknown 41%, and other 18%. Performance on the MAIS parent questionnaire indicates rapid developmental progress. Results on speech perception measures are somewhat limited by the young age of the children (67% are younger than 5 years). Conclusion: As a group, patients performed less well with compressed and split electrode devices than with the standard array. By definition, these patients have surgical anomalies such as severe ossification, Mondini malformation, and osteogenesis imperfecta. Until now, most clinical studies have excluded these patients. In addition, the length along the
100-pm wire is arched against the outer wall except at one basal and one apical point, where it coalesces with the silicone carder. The electrode effectively hugs the inner wall of the model. The explantation feasibility of the array is demonstrated. In temporal bones, x-rays show the electrode and wire widely separated in the basal turn of the scala. Retropositioning invariably causes one third of the electrode to be retracted from the scala. Histological preparation of the bones shows that the wire tends to be partially localized under the spiral ligament and that the electrode hugs the inner wall without visible damage. Conclusion: The difficulty in displacing an electrode array from the lateral to medial wall of the scala tympani is compounded by the fact that the length ratio of inner to outer wall is almost 1 to 2. Retropositioning is a nonintuitive technique that allows matching of these 2 distances regardless of the original insertion depth. The electrode critical specifications (easily implantable, explantable, reimplantable, biocompatible), are met with the present design. Surgical procedure and cochleostomy size are unchanged. The first step in examining mechanical trauma to the inner ear tissues is to focus on temporal bone histopathology, preferably with the electrode in situ. Some trauma is caused to the spiral ligament during the procedure in temporal bones. The critical spiral ganglion remains intact. 8:38 AM
The Ethics of Cochlear Implantation in Children RUI NUNESMD PHD (presenter); Porto Portugal
Objectives: It is accepted that cochlear implants enable deaf patients to realize their potential. Deaf adults are autonomous people who are able to give informed consent for this practice. In deaf children, however, it is claimed that implants are associated with a loss in quality of life. The objectives of this study are to make an analysis of the ethical dilemmas involved in cochlear implantation and to acknowledge why most deaf associations are against this practice. Methods: Having as background Dena Davis ethical theory that every person has a fundamental fight to an open future, I believe that the ethical dimension of cochlear implantation is closely related to a social standard of quality of life. My hypothesis is that if variables like independence, self-esteem, and other personal goals are properly addressed in the evaluation process, and if the family makes the choice of implantation, this should be regarded as being in the child's best interest. Results: It is asserted today that deafness, per se, is not associated with a decreased response rate in nonverbal intelligence tests. When assessing the benefits of cochlear implants, otologists use subjective testing. However, objectivity is an ethical imperative. It follows that in the selection of appropriate candidates, audiological parameters should be complemented with psychological evaluation (cognitive, emotional and familial) before and after the implant procedure.
Scientific Sessions--Monday
P115
Conclusion: Deafness is associated with the lowest educational level and the lowest family income. Notwithstanding the existence of a deaf world, deafness should be considered as an handicap. Therefore, society should provide the means for the fulfillment of a child's right to an open future. If the child belongs to the hearing world, auditory rehabilitation might be necessary to accomplish his or her ethical liberty. 8:46 AM
MED-EL COMBI 40+ System Multi-Center US Clinical Trial Results DARCY N OCHS (presenter); DARLA C FRANZ; KIM JACKSON; Research Triangle Park NC
Objectives: Recent technological advancements have greatly improved the outcome following cochlear implantation. The COMBI 40+ Cochlear Implant System implements new developments in speech processing, which may provide improved speech understanding. A multicenter prospective clinical trial has been conducted in the United States to evaluate the safety and effectiveness of the MED-EL COMBI 40+ Cochlear Implant. Methods: Thirty centers in the United States are participating in the IDE trial for adults (>18 years) and children (18 months to 18 years). Selection criteria include thresholds of 90 dB HL or greater in the higher speech frequencies and no significant benefit from conventional amplification (<20% open-set sentences adults, lack of acquisition, or plateau of auditory skills children). All patients were tested before surgery and at regularly scheduled intervals. Patients were implanted with standard, compressed, or split electrode array devices. The final choice of electrode array was made at the time of surgery. Fitting parameters were freely programmed in order to evaluate performance with normal clinical usage. Results: Adult patients have a mean age of 52 years with a range of 18.7 to 86.8 years. The mean duration of hearing loss in the implanted ear is 24.9 years. Results indicate superior performance for patients with hearing loss less than 25 years and with an unobstructed cochlea (standard electrode array). Results will be reported separately for the more challenging cases (>25 years hearing loss and obstructed cochleae). The mean age of the children is 4.2 years with a range of 14 months to 17 years. Etiology of deafness is as follows: meningitis 31%, Mondini malformation 10%, unknown 41%, and other 18%. Performance on the MAIS parent questionnaire indicates rapid developmental progress. Results on speech perception measures are somewhat limited by the young age of the children (67% are younger than 5 years). Conclusion: As a group, patients performed less well with compressed and split electrode devices than with the standard array. By definition, these patients have surgical anomalies such as severe ossification, Mondini malformation, and osteogenesis imperfecta. Until now, most clinical studies have excluded these patients. In addition, the length along the