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Evaluation of the neural response telemetry (NRT) capabilities of the nucleus research platform 8: initial results from the NRT trial

Battmer, Rolf D; Dillier, Norbert; Lai, Wai K; Weber, Benno P; Brown, Carolyn; Gantz, Bruce J; Roland, J Thomas; Cohen, Noel J; Shapiro, William; Pesch, Joerg; Killian, Matthijs J; Lenarz, Thomas
The purpose of this study was to evaluate the performance of the new features of the Nucleus Research Platform 8 (RP8), a system developed specifically for research purposes The RP8 consists of a research implant, a speech processor and a new NRT software (NRT v4), and includes comparisons of the different artefact-cancellation methods, NRT threshold, and recovery function measurements. The system has new artefact-suppression techniques and new diagnostic capabilities; their performance has been verified in animal experiments. In this study, NRT data were collected from 15 postlingually deafened adult cochlear implant patients intraoperatively and up to 6 months postoperatively after switch-on. The initial investigation in two clinics in Europe focused primarily on the enhanced NRT capabilities Results from the trial in two European clinics indicate that NRT measurements can be obtained with lower noise levels. A comparison of the different artefact-cancellation techniques showed that the forward-masking paradigm implemented in the Nucleus 3 system is still the method of choice. The focus of this report is on recovery function characteristics, which may give insight into auditory nerve fiber properties with regard to higher stimulation rates
PMID: 15732376
ISSN: 1499-2027
CID: 105546

Cochlear implantation in human immunodeficiency virus-infected patients

Roland, J Thomas Jr; Alexiades, George; Jackman, Alexis H; Hillman, Dean; Shapiro, William
OBJECTIVE: To evaluate the efficacy of cochlear implants in human immunodeficiency virus-infected individuals and correlate these results with a proposed pathophysiological mechanism of human immunodeficiency virus-associated hearing loss. STUDY DESIGN: Retrospective case series and temporal bone analysis of deceased human immunodeficiency virus-positive patients. SETTING: Tertiary care hospital. PATIENTS: Seven human immunodeficiency virus-positive individuals with profound sensorineural hearing loss. INTERVENTION: Cochlear implantation at New York University Medical Center. METHODS: The surgical outcomes and complications were analyzed. Additionally, electron microscopic and immunohistochemical findings of cadaver temporal bone specimens of other known human immunodeficiency virus-positive individuals were reviewed. The performance results of the human immunodeficiency virus-positive cochlear implant patients were then correlated with the previously hypothesized pathophysiological mechanism of human immunodeficiency virus-associated hearing loss. RESULTS: The patients had a varied performance with cochlear implantation, and as a group performance was good. There were no surgical complications or postoperative complications. The good performance of these patients supports the hypothesis that the mechanism of human immunodeficiency virus-associated deafness involves infiltration, malfunction, and premature degeneration of the hair cells and supportive cells of the cochlea. CONCLUSIONS: Human immunodeficiency virus-positive individuals benefit from cochlear implantation without increased surgical risk
PMID: 14600470
ISSN: 1531-7129
CID: 46077

Neural response telemetry in 12- to 24-month-old children

Gordon, Karen A; Ebinger, Kiara A; Gilden, Jan E; Shapiro, William H
The minimum age for cochlear implantation has been reduced to 12 months in an effort to provide auditory stimulation to children with hearing loss during early development. Because behavioral measures in such young children are limited, objective measures such as the electrically evoked compound action potential (EAP) from the auditory nerve are needed to facilitate measurement of stimulation level requirements. We assessed EAPs recorded by the Nucleus 24 neural response telemetry (NRT) system in children who underwent implantation between 12 and 24 months of age. We recorded EAPs in 37 such children (mean age at implantation, 18.1+/-3.6 months). The EAPs were of large amplitude, and thresholds fell between behavioral T and C levels. A correction factor applied to EAP thresholds provided useful predictions of T levels. The EAPs can be used to ensure that even very young children receive auditory stimulation with their cochlear implants upon device activation
PMID: 12018347
ISSN: 0096-8056
CID: 150261

Threshold, comfortable level and impedance changes as a function of electrode-modiolar distance

Saunders, Elaine; Cohen, Lawrence; Aschendorff, Antje; Shapiro, William; Knight, Michelle; Stecker, Mathias; Richter, Benhard; Waltzman, Susan; Tykocinski, Michael; Roland, Tom; Laszig, Roland; Cowan, Robert
OBJECTIVE: The study investigated the hypothesis that threshold and comfortable levels recorded from cochlear implant patients would reduce, and dynamic range increase, as distance of the electrode from the modiolar wall (radial distance) decreases. Two groups of cochlear implant patients participated; one group using the Nucleus' 24 Contour electrode array, and one group using the Nucleus standard straight (banded) array. The Nucleus 24 Contour array has been shown in temporal bone studies to lie closer to the modiolus than the banded array. The relationship of electrode impedance and radial distance is also investigated. DESIGN: The study, conducted at three centers, evaluated 21 patients using the Contour array, and 36 patients using the banded array. For each patient, threshold, comfortable levels and dynamic range were measured at four time points. Common ground electrode impedance was recorded clinically from each patient, at time intervals up to 12 wk. An estimate of the radial distance of the electrode from the modiolus was made by analysis of Cochlear view x-rays. RESULTS: Threshold and comfortable levels were significantly lower for the Nucleus 24 Contour array than for the banded array. However, dynamic range measurements did not show the predicted increase. In a majority of subjects, a significant correlation was found between the estimated radial distance of the electrode from the modiolus and the measured threshold and comfortable levels. This trend was not observed for dynamic range. The analysis indicates that other factors than radial distance are involved in the resultant psychophysical levels. Clinical impedance measures (common ground) were found to be significantly higher for the Contour array. However, the electrodes on the Contour array are half-rings, which are approximately only half the geometric size of the full rings as electrodes of the standard array. When the geometric electrode area in the two array designs are normalized, the trends in the electrode impedance behavior are similar. CONCLUSIONS: The results support the hypothesis that the relationship between the radial distance of the electrode and the psychophysical measures are influenced by patterns of fibrous tissue growth and individual patient differences, such as etiology and neural survival. Impedance measures for the Nucleus 24 Contour electrode array were higher than the banded electrode array, but this is primarily due to the reduction in electrode surface area. The different outcomes in impedance over time suggest differences in the relative contributions of the components of impedance with the two arrays
PMID: 11883764
ISSN: 0196-0202
CID: 141146

Cochlear reimplantation: surgical techniques and functional results

Alexiades G; Roland JT Jr; Fishman AJ; Shapiro W; Waltzman SB; Cohen NL
OBJECTIVES/HYPOTHESIS: The most common indication for cochlear reimplantation is device failure. Other, less frequent indications consist of 'upgrades' (e.g., single to multichannel), infection, and flap breakdown. Although the percentage of failures has decreased over time, an occasional patient requires reimplantation because of device malfunction. The varying designs of internal receiver/stimulators and electrode arrays mandate an examination of the nature and effects of reimplantation for the individual designs. The purpose of the current study was to investigate the reimplantation of several implant designs and to determine whether differences in surgical technique, anatomical findings, and postoperative performance exist. STUDY DESIGN: Retrospective chart review. METHODS: The subjects were 33 of 618 severely to profoundly deaf adults and children who had implantation at the New York University Medical Center (New York, NY) between February 1984 and December 2000. The subjects had previously had implantation with either a single-channel 3M/House (House Ear Institute, Los Angeles, CA) or 3M/Vienna (Technical University of Vienna, Vienna, Austria) device or with one of the multichannel Clarion (Advanced Bionics, Sylmar, CA), Ineraid (Smith & Nephew Richards, TN), or Nucleus (including the Contour) devices (Cochlear Corp., Englewood, CO) before reimplantation. RESULTS: Length of use before reimplantation ranged from 1 month to 13 years and included traumatic and atraumatic (electronic) failures, as well as device extrusion or infection. Results indicated that postoperative performance was either equal to or better than scores before failure. None of the devices explanted caused damage that precluded the implantation of the same or an upgraded device. These findings support the efficacy and safety of internal implant designs as related to the maintenance of a functional cochlea for the purpose of reimplantation. CONCLUSIONS: Cochlear reimplantation can be performed safely and without decrement to performance. The number of implanted electrodes at reinsertion were either the same or greater in all cases
PMID: 11568614
ISSN: 0023-852x
CID: 24631

Intrathecal treatment of neoplastic meningitis due to breast cancer with a slow-release formulation of cytarabine

Jaeckle, K A; Phuphanich, S; Bent, M J; Aiken, R; Batchelor, T; Campbell, T; Fulton, D; Gilbert, M; Heros, D; Rogers, L; O'Day, S J; Akerley, W; Allen, J; Baidas, S; Gertler, S Z; Greenberg, H S; LaFollette, S; Lesser, G; Mason, W; Recht, L; Wong, E; Chamberlain, M C; Cohn, A; Glantz, M J; Gutheil, J C; Maria, B; Moots, P; New, P; Russell, C; Shapiro, W; Swinnen, L; Howell, S B
DepoCyte is a slow-release formulation of cytarabine designed for intrathecal administration. The goal of this multi-centre cohort study was to determine the safety and efficacy of DepoCyte for the intrathecal treatment of neoplastic meningitis due to breast cancer. DepoCyte 50 mg was injected once every 2 weeks for one month of induction therapy; responding patients were treated with an additional 3 months of consolidation therapy. All patients had metastatic breast cancer and a positive CSF cytology or neurologic findings characteristic of neoplastic meningitis. The median number of DepoCyte doses was 3, and 85% of patients completed the planned 1 month induction. Median follow up is currently 19 months. The primary endpoint was response, defined as conversion of the CSF cytology from positive to negative at all sites known to be positive, and the absence of neurologic progression at the time the cytologic conversion was documented. The response rate among the 43 evaluable patients was 28% (CI 95%: 14-41%); the intent-to-treat response rate was 21% (CI 95%: 12-34%). Median time to neurologic progression was 49 days (range 1-515(+)); median survival was 88 days (range 1-515(+)), and 1 year survival is projected to be 19%. The major adverse events were headache and arachnoiditis. When drug-related, these were largely of low grade, transient and reversible. Headache occurred on 11% of cycles; 90% were grade 1 or 2. Arachnoiditis occurred on 19% of cycles; 88% were grade 1 or 2. DepoCyte demonstrated activity in neoplastic meningitis due to breast cancer that is comparable to results reported with conventional intrathecal agents. However, this activity was achieved with one fourth as many intrathecal injections as typically required in conventional therapy. The every 2 week dose schedule is a major advantage for both patients and physicians.
PMCID:2363714
PMID: 11161370
ISSN: 0007-0920
CID: 720392

Cochlear Implants in Children

Waltzman, Susan B; Shapiro, William H
PMCID:4172230
PMID: 25425894
ISSN: 1084-7138
CID: 1359832

Open-set speech perception in congenitally deaf children using cochlear implants

Waltzman SB; Cohen NL; Gomolin RH; Green JE; Shapiro WH; Hoffman RA; Roland JT Jr
OBJECTIVE: To assess and document the development of open-set speech recognition in congenitally deaf children implanted with the Nucleus multichannel cochlear prosthesis at < 5 years of age. STUDY DESIGN: The study group consisted of 38 consecutively chosen children in whom the decision to proceed with implantation had already been made. PATIENTS AND SETTING: Congenitally profoundly deaf children were implanted with the Nucleus multichannel cochlear implant at < 5 years of age and followed at NYU Medical Center for a period of 1-5 years. MAIN OUTCOME MEASURES: Open-set speech perception was evaluated preoperatively and postoperatively using the following: the Glendonald Auditory Screening Procedure (GASP) word subset, the GASP sentence subtest, Phonetically Balanced Kindergarten monosyllabic word lists, Common Phrases test, Multisyllabic Lexical Neighborhood test, and Lexical Neighborhood test. RESULTS: Correlation coefficients were calculated between scores at each interval and age at implantation; one-way analyses of variance were performed independently. Results showed that all subjects had significant open-set speech recognition at the time of the last postoperative evaluation. Thirty-seven of the children use oral language as their sole means of communication. CONCLUSIONS: Multichannel cochlear implants provide significant and usable open-set speech perception in congenitally deaf children given implants at < 5 years of age
PMID: 9149829
ISSN: 0192-9763
CID: 12321

Perception and production results in children implanted between 2 and 5 years of age

Waltzman S; Cohen NL; Gomolin R; Green J; Shapiro W; Brackett D; Zara C
PMID: 9042482
ISSN: 0065-3071
CID: 12419

Changes in electrical thresholds over time in young children implanted with the Nucleus cochlear prosthesis

Shapiro W; Waltzman S
PMID: 7668624
ISSN: 0096-8056
CID: 6866