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U.S. Phase I preliminary results of use of the Otologics MET Fully-Implantable Ossicular Stimulator

Jenkins, Herman A; Atkins, James S; Horlbeck, Drew; Hoffer, Michael E; Balough, Ben; Arigo, Joseph V; Alexiades, George; Garvis, William
OBJECTIVES: The safety of the Otologics Fully-Implantable MET Ossicular Stimulator was assessed in adult patients with bilateral moderate to severe sensorineural hearing loss. METHODS: Surgical implantation of the ossicular stimulator was performed. A repeated-measure, within-subjects design assessed safety and aided sound field thresholds and speech performances with the subject's own, appropriately fitted, walk-in hearing aid(s) and the Otologics Fully-Implantable MET Ossicular Stimulator. RESULTS: Twenty patients were implanted and activated as part of the Phase I clinical trial. Results demonstrated 10-20 dB of functional gain across audiometric frequencies. Pure tone averages and monaural word recognition scores were slightly better for the walk-in-aided condition, while patient benefit scales favored the postoperative implant-aided conditions. CONCLUSION/SIGNIFICANCE: Although monaural word scores and aided thresholds favored the walk-in-aided condition, preliminary results indicate that the Otologics MET Fully-Implantable Ossicular Stimulator is an alternative to currently available hearing aids in patients with sensorineural hearing loss.
PMID: 17666242
ISSN: 0194-5998
CID: 1472112

Emerging technologies: a glimpse into the future of neurotology--the American Neurotology Society meeting, September 18, 2004, New York City [Meeting Abstract]

Alexiades, George
PMID: 15699712
ISSN: 1531-7129
CID: 1472122

Cranial nerve preservation in surgery for large acoustic neuromas

Roland, J Thomas Jr; Fishman, Andrew J; Golfinos, John G; Cohen, Noel; Alexiades, George; Jackman, Alexis H
Facial nerve outcomes and surgical complication rates for other cranial nerves were evaluated retrospectively after the resection of large acoustic neuromas. The charts of all patients who underwent surgical removal of an acoustic neuroma between 1992 and 2001 at New York University Medical Center were reviewed. Fifty-four patients with tumors measuring 3 cm or larger were included in the study. Four patients had neurofibromatosis type 2, two of whom underwent bilateral removal of acoustic neuromas. Translabyrinthine microsurgical removal of tumor was performed in 47 of 56 cases (84%). In all cases, EMG monitoring, improved sharp microdissection, and ultrasonic aspiration were employed. Facial nerve function was assessed using the House-Brackmann facial nerve grading system immediately after surgery and at follow-up visits. A House-Brackmann grade III or better was achieved in 90% of patients, and a grade II or better was achieved in 84% of patients. Ultimate facial nerve outcome was excellent after the surgical resection of large acoustic neuromas. Preoperative cranial nerve palsies also improved after surgery. The translabyrinthine approach for tumor removal is our treatment of choice for acoustic neuromas 3 cm or larger
PMCID:1151676
PMID: 16145589
ISSN: 1531-5010
CID: 62125

Fluoroscopically assisted cochlear implantation

Fishman, Andrew J; Roland, J Thomas Jr; Alexiades, George; Mierzwinski, Jozef; Cohen, Noel L
HYPOTHESIS: Real-time intraoperative fluoroscopy is a useful adjunct to cochlear implantation in selected cases. The advantages include the avoidance of complications such as extracochlear array placement, intrameatal array insertion, and avoidance of significant bending or kinking. This is particularly useful when implanting a severely abnormal cochlea. BACKGROUND: The technique was initially developed for laboratory study of electrode prototypes in cadaver temporal bones to evaluate insertion dynamics and mechanisms of intracochlear trauma. The technique was subsequently adapted for use in live surgeries. METHODS: Live surgeries were performed using fluoroscopic guidance on nine patients. RESULTS: Five patients were implanted with the Nucleus 24 RCS during preclinical trials. Two patients with severe cochlear malformations were implanted with a Nucleus CI24M straight array. Two patients with severe cochlear ossification were implanted with the Nucleus CI24 double array. Appropriate insertions were achieved without electrode damage in all cases. CONCLUSIONS: Intraoperative fluoroscopy is a useful adjunct to cochlear implantation, which can be performed with minimum risk to the patient and operating room staff if the outlined precautions are taken. Intraoperative fluoroscopy is indicated in cases where the intracochlear behavior of the electrode array cannot be predicted, a condition encountered when implanting new electrode designs, cases with severely malformed inner ears, or cases of severe intraluminal obstruction requiring a double-array insertion
PMID: 14600468
ISSN: 1531-7129
CID: 46078

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

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

Electrode to modiolus proximity: a fluoroscopic and histologic analysis

Roland JT Jr; Fishman AJ; Alexiades G; Cohen NL
HYPOTHESIS: This study was conducted to evaluate the electrode to modiolus proximity of two commonly used electrodes (Nucleus and Clarion) and a new prototype electrode. BACKGROUND: Theoretical advantages of modiolus-hugging cochlear implant electrodes include reduced stimulus energy requirements, more efficient power management and longer battery life, more discreet ganglion cell population stimulation, and reduced facial nerve stimulation. METHODS: Fluoroscopic analysis and histologic surface preparation analysis of electrode position and trauma. RESULTS: The Nucleus straight electrode occupied an outer wall position in the scala tympani. The Clarion electrode occupied a more intermediate position. The actively coiling prototype electrode was modiolus hugging but caused more trauma than the other two electrodes tested. CONCLUSIONS: The optimal modiolus-hugging atraumatic intracochlear electrode does not currently exist
PMID: 10733187
ISSN: 0192-9763
CID: 8521

Stability of the cochlear implant array in children

Roland JT Jr; Fishman AJ; Waltzman SB; Alexiades G; Hoffman RA; Cohen NL
OBJECTIVE: To determine cochlear implant electrode stability in the young patient. Electrode migration due to future skull growth was a concern that led to prohibiting implantation in children less than 2 years of age. Recently, the high level of performance achieved by young implantees has led to a re-evaluation of this lower age limit, requiring an assessment of the effects of skull growth over time. STUDY DESIGN: Prospective radiographic analysis of electrode position of cochlear implants in young children. METHODS: Twenty-seven children implanted with the Nucleus (Cochlear Corp., Denver, CO) or Clarion (Advanced Bionics Inc., Sylmar, CA) multi-channel cochlear prostheses were subjects for this study. Follow-up radiographic studies were obtained for a period of 1 month to 5 years after implantation. The age at time of implantation ranged from 14 months to 5 years. An intraoperative modified Stenver's view plain radiograph was obtained as a baseline. After implantation, on a yearly basis transorbital Stenver's and base views were obtained for comparative purposes. Additional radiographs were obtained whenever a change in performance or electrode map caused suspicion for extrusion. Electrode position was determined using a computer graphics enhancement technique whereby image contrast filters enhanced the visibility of the electrode array and surrounding bony structures. RESULTS: An analysis of the data revealed no migration of the electrode array over time. CONCLUSIONS: The confirmation of the stability of the electrode array alleviates the concern of the effects of skull growth on cochlear implantation in young children
PMID: 9707228
ISSN: 0023-852x
CID: 7765

Replantation of the amputated nose [Case Report]

Miller PJ; Hertler C; Alexiades G; Cook TA
OBJECTIVE: To assess the effectiveness of replantation in the treatment of nasal amputations. DESIGN: Retrospective chart review. SETTING: A university medical center. RESULTS: In no case did the replant survive completely, and in all cases revision surgery was required. However, in all cases, the resulting deformity was less than the original defect. In our pediatric patients, reconstruction with cartilage grafting and a midline forehead flap was successful and demonstrated proportionate and appropriate growth. CONCLUSIONS: It is our belief that replantation serves many therapeutic functions. At the very least, there is the psychological/emotional factor that is involved in attempting to replace a native body part that has been severed. Also, it is difficult to persuade parents and patients that the amputated tissue that has been handled with kid gloves by paramedics, maintaining its pink 'alive' color, is ultimately doomed to failure. Forehead flaps and conchal cartilage grafts are more willingly accepted after a 'failed' replantation than as primary reconstructions. In every instance, we believe, the ultimate defect will be smaller than the original deformity. Certainly, the need for vestibular lining reconstruction is far less. Thus, the ultimate healed defect from the replantation greatly facilitates final nasal reconstruction
PMID: 9708718
ISSN: 0886-4470
CID: 12082