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In Response to Development and Implementation of the Cochlear Implant Quality of Life (CIQOL) Functional Staging System [Letter]

Hammerschlag, Paul E; Coelho, Daniel H; Kohan, Darius
PMID: 36625309
ISSN: 1531-4995
CID: 5410392

Identification of Endolymphatic Hydrops in Meniere's Disease Utilizing Delayed Postcontrast 3D FLAIR and Fused 3D FLAIR and CISS Color Maps

Hagiwara, Mari; Roland, J Thomas Jr; Wu, Xin; Nusbaum, Annette; Babb, James S; Roehm, Pamela C; Hammerschlag, Paul; Lalwani, Anil K; Fatterpekar, Girish
OBJECTIVE: The preferential delayed enhancement of the perilymphatic space enables detection of the non-enhancing endolymphatic hydrops present in patients with Meniere's disease. The aim of this study was to evaluate the diagnostic utility of delayed postcontrast 3D FLAIR images and a color map of fused postcontrast FLAIR and constructive interference steady state (CISS) images in the identification of endolymphatic hydrops in patients with clinically diagnosed Meniere's disease. STUDY DESIGN: Case control, blinded study. SETTING: Tertiary referral center. PATIENTS: Ten patients with Meniere's disease and five volunteer controls. INTERVENTION: Diagnostic. MAIN OUTCOME MEASURE: Two neuroradiologists blinded to the clinical history independently evaluated for the presence of endolymphatic hydrops on the images of both inner ears for test and control subjects. Both the standard gray-scale FLAIR images and the fused color map images were independently reviewed. RESULTS: The gray-scale 3D FLAIR images demonstrated 68.2% sensitivity and 97.4% specificity, and the fused color map images demonstrated 85.0% sensitivity and 88.9% specificity in the identification of endolymphatic hydrops in Meniere's disease. There was significant correlation between the gray-scale 3D FLAIR images and fused color map images with the categorization of involvement (p = 0.002). Inter-evaluator reliability was excellent (kappa = 0.83 for gray-scale images, kappa = 0.81 for fused color map). CONCLUSION: Delayed 3D FLAIR and fused 3D FLAIR-CISS color map images of the inner ears after intravenous contrast administration are potentially useful diagnostic tools in the evaluation of patients with suspected Meniere's disease.
PMID: 25251300
ISSN: 1531-7129
CID: 1259452

Chondromyxoid fibroma of the temporal bone

Gupta, Sachin; Heman-Ackah, Selena E; Harris, Jonathan A; Hagiwara, Mari; Cosetti, Maura K; Hammerschlag, Paul E
PMID: 22772012
ISSN: 1531-7129
CID: 178051

Audiology in the Sudden Hearing Loss Clinical Trial

Halpin, Chris; Shi, Helen; Reda, Domenic; Antonelli, Patrick J; Babu, Seilesh; Carey, John P; Gantz, Bruce J; Goebel, Joel A; Hammerschlag, Paul E; Harris, Jeffrey P; Isaacson, Brandon; Lee, Daniel; Linstrom, Chris J; Parnes, Lorne S; Slattery, William H; Telian, Steven A; Vrabec, Jeffrey T; Rauch, Steven
OBJECTIVE: To report the pretreatment and posttreatment population characteristics and the overall stability of the audiologic outcomes found during the Sudden Hearing Loss Clinical Trial (ClinicalTrials.gov: Identifier NCT00097448). STUDY DESIGN: Multicenter, prospective randomized noninferiority trial of oral versus intratympanic (IT) steroid treatment of sudden sensorineural hearing loss (SSNHL). SETTING: Fifteen academically based otology practices. PATIENTS: Two hundred fifty patients with unilateral SSNHL presenting within 14 days of onset with 50 dBHL or greater pure tone average hearing threshold in the affected ear. INTERVENTION: Either 60 mg/d oral prednisone for 14 days with a 5-day taper (121 patients) or 4 IT doses for 14 days of 40 mg/ml methylprednisolone (129 patients). MAIN OUTCOME MEASURE: Primary end point was change in hearing [dB PTA] at 2 months after treatment. Noninferiority was defined as less than 10 dB difference in hearing outcome between treatments. In this article, pretreatment and posttreatment hearing findings will be reported in detail. RESULTS: A general (and stable) effect of treatment and a specific effect of greater improvement at low frequencies were found in both treatment groups. CONCLUSION: Hearing improvements are stable, and a significantly greater improvement occurs with lower frequency after either oral or IT steroid treatment of SSNHL.
PMCID:3400088
PMID: 22805100
ISSN: 1531-7129
CID: 175808

Oral vs intratympanic corticosteroid therapy for idiopathic sudden sensorineural hearing loss: a randomized trial

Rauch, Steven D; Halpin, Christopher F; Antonelli, Patrick J; Babu, Seilesh; Carey, John P; Gantz, Bruce J; Goebel, Joel A; Hammerschlag, Paul E; Harris, Jeffrey P; Isaacson, Brandon; Lee, Daniel; Linstrom, Christopher J; Parnes, Lorne S; Shi, Helen; Slattery, William H; Telian, Steven A; Vrabec, Jeffrey T; Reda, Domenic J
CONTEXT: Idiopathic sudden sensorineural hearing loss has been treated with oral corticosteroids for more than 30 years. Recently, many patients' symptoms have been managed with intratympanic steroid therapy. No satisfactory comparative effectiveness study to support this practice exists. OBJECTIVE: To compare the effectiveness of oral vs intratympanic steroid to treat sudden sensorineural hearing loss. DESIGN, SETTING, AND PATIENTS: Prospective, randomized, noninferiority trial involving 250 patients with unilateral sensorineural hearing loss presenting within 14 days of onset of 50 dB or higher of pure tone average (PTA) hearing threshold. The study was conducted from December 2004 through October 2009 at 16 academic community-based otology practices. Participants were followed up for 6 months. INTERVENTION: One hundred twenty-one patients received either 60 mg/d of oral prednisone for 14 days with a 5-day taper and 129 patients received 4 doses over 14 days of 40 mg/mL of methylprednisolone injected into the middle ear. MAIN OUTCOME MEASURES: Primary end point was change in hearing at 2 months after treatment. Noninferiority was defined as less than a 10-dB difference in hearing outcome between treatments. RESULTS: In the oral prednisone group, PTA improved by 30.7 dB compared with a 28.7-dB improvement in the intratympanic treatment group. Mean pure tone average at 2 months was 56.0 for the oral steroid treatment group and 57.6 dB for the intratympanic treatment group. Recovery of hearing on oral treatment at 2 months by intention-to-treat analysis was 2.0 dB greater than intratympanic treatment (95.21% upper confidence interval, 6.6 dB). Per-protocol analysis confirmed the intention-to-treat result. Thus, the hypothesis of inferiority of intratympanic methylprednisolone to oral prednisone for primary treatment of sudden sensorineural hearing loss was rejected. CONCLUSION: Among patients with idiopathic sudden sensorineural hearing loss, hearing level 2 months after treatment showed that intratympanic treatment was not inferior to oral prednisone treatment. TRIAL REGISTRATION: clinicaltrials.gov Identifier: NCT00097448
PMID: 21610239
ISSN: 1538-3598
CID: 134325

Psychometric validity of the Cochlear Implant Function Index (CIFI): a quality of life assessment tool for adult cochlear implant users

Coelho, Daniel H; Hammerschlag, Paul E; Bat-Chava, Yael; Kohan, Darius
Objective The Cochlear Implant Function Index (CIFI) is created to assess adult cochlear implant (CI) auditory effectiveness in real world situations. Our objective is to evaluate the CIFI as a reliable psychometric tool to assess 1) reliance on visual assistance, 2) telephone use, 3) communication at work, 4) 'hearing' in noise, 5) in groups, and 6) in large room settings. Study Design Based upon Guttman scaling properties, the CIFI elicits implanted respondent's functional level with auditory independence from Level 1 (still requiring signing) to level 4 (without any help beyond CI). A blinded, retrospective questionnaire is anonymously answered by cochlear implant recipients. Setting CI centers of tertiary care medical centers, CI support group, and an interactive web page of a hearing and speech center in a large metropolitan region. Subjects 245 respondents from a varied adult CI population implanted for one month to 19 years prior to answering the questionnaire. Intervention An assessment tool of CI function. Main Outcome Measure A coefficient of reproducibility (CR) for the Guttman scale format equal or greater than 0.90, indicating good scalability. Results CR in the CIFI was above 0.90. Effective scalability and mean scores from 2.5 to 3.5 for the six areas examined (1.00-4.00) were achieved. Conclusion The psychometric properties of this user friendly survey demonstrate consistently good scalability. Based on these findings, the CIFI provides a validated tool that can be used for systematic comparisons between groups of patients or for follow-up outcomes in patients who use cochlear implants. Further study is indicated to correlate CIFI scores with sound and speech perception scores.
PMID: 19165814
ISSN: 1754-7628
CID: 93203

Safety of high-dose corticosteroids for the treatment of autoimmune inner ear disease

Alexander, Thomas H; Weisman, Michael H; Derebery, Jennifer M; Espeland, Mark A; Gantz, Bruce J; Gulya, A Julianna; Hammerschlag, Paul E; Hannley, Maureen; Hughes, Gordon B; Moscicki, Richard; Nelson, Ralph A; Niparko, John K; Rauch, Steven D; Telian, Steven A; Brookhouser, Patrick E; Harris, Jeffrey P
OBJECTIVE: To report the adverse effects associated with prolonged high-dose prednisone for the treatment of autoimmune inner ear disease (AIED). STUDY DESIGN: Prospective data collected as part of a multicenter, randomized, controlled trial for the treatment of corticosteroid-responsive AIED with methotrexate. SETTING: Tertiary referral centers. PATIENTS: One hundred sixteen patients with rapidly progressive, bilateral sensorineural hearing loss. INTERVENTION: All patients completed a 1-month course of prednisone (60 mg/d). In Phase 2, 67 patients with improvement in hearing underwent a monitored 18-week prednisone taper, resulting in 22 weeks of prednisone therapy at an average dose of 30 mg per day. Thirty-three patients were randomized to receive methotrexate in Phase 2. Thirty-four patients received prednisone and placebo. MAIN OUTCOME MEASURE: Adverse events (AE) in patients treated with prednisone only. RESULTS: Of 116 patients, 7 had to stop prednisone therapy during the 1-month challenge phase due to AE. Of 34 patients, 5 were unable to complete the full 22-week course of prednisone due to AE. The most common AE was hyperglycemia, which occurred in 17.6% of patients participating in Phase 2. Weight gain was also common, with a mean increase in body mass index of 1.6 kg/m2 (95% confidence interval, 0.77-2.3) during the 22-week steroid course. Patients entering Phase 2 were followed for a mean of 66 weeks. No fractures or osteonecrosis were reported. CONCLUSION: Although high-dose corticosteroids are associated with known serious side effects, prospective data in the literature are limited. The present study suggests that with appropriate patient selection, monitoring, and patient education, high-dose corticosteroids are a safe and effective treatment of AIED
PMID: 19395984
ISSN: 1537-4505
CID: 133706

Treatment of corticosteroid-responsive autoimmune inner ear disease with methotrexate: a randomized controlled trial

Harris, Jeffrey P; Weisman, Michael H; Derebery, Jennifer M; Espeland, Mark A; Gantz, Bruce J; Gulya, A Julianna; Hammerschlag, Paul E; Hannley, Maureen; Hughes, Gordon B; Moscicki, Richard; Nelson, Ralph A; Niparko, John K; Rauch, Steven D; Telian, Steven A; Brookhouser, Patrick E
CONTEXT: A number of therapies have been proposed for the long-term management of corticosteroid-responsive, rapidly progressive, bilateral sensorineural hearing loss (autoimmune inner ear disease [AIED]). Methotrexate has emerged as the benchmark agent but has not been rigorously evaluated for hearing improvement in patients with AIED. OBJECTIVE: To assess the efficacy of long-term methotrexate in maintaining hearing improvements achieved with glucocorticoid (prednisone) therapy in patients with AIED. DESIGN, SETTING, AND PARTICIPANTS: A randomized, double-blind, placebo-controlled trial conducted from February 3, 1998, to November 5, 2001, of 67 patients with rapidly progressive, bilateral sensorineural hearing loss at 10 tertiary care centers in the United States. INTERVENTION: Randomization to either oral methotrexate (15 to 20 mg/wk; n = 33) or placebo (n = 34), in combination with an 18-week prednisone taper. Follow-up examinations, including audiometric evaluation, were performed at 4, 8, 12, 24, 36, 48, and 52 weeks, or until hearing loss was documented. MAIN OUTCOME MEASURE: Maintenance of hearing improvement achieved from prednisone treatment. RESULTS: Sixty-seven patients (57.8%) enrolled in the prednisone challenge experienced hearing improvement. Twenty-five patients (37%) experienced hearing improvements in both ears. Of the individuals who reached study end points, 24 (80%) of 30 end points were because of measured hearing loss in the methotrexate group and 29 (93.5%) of 31 end points were because of measured hearing loss in the placebo group (P =.15). Methotrexate was no more effective than placebo in maintaining the hearing improvement achieved with prednisone treatment (hazard ratio, 1.31; 95% confidence interval, 0.79-2.17; P =.30). CONCLUSION: Methotrexate does not appear to be effective in maintaining the hearing improvement achieved with prednisone therapy in patients with AIED
PMID: 14532316
ISSN: 1538-3598
CID: 93204

Labyrinthine fistula: an unreported complication of the Grote prosthesis [Case Report]

Gadre, A K; Hammerschlag, P E
OBJECTIVES: To alert the otological surgeon that labyrinthine fistula is a rare and avoidable complication of the Grote hydroxyapatite ceramic external auditory canal (EAC) prosthesis. The reasons for its causation and strategies to prevent its formation are discussed. STUDY DESIGN: Case study and retrospective review of the literature. METHODS: Labyrinthine fistula that occurred after the use of the Grote hydroxyapatite ceramic EAC prosthesis is presented. The literature is reviewed retrospectively for various methods of reconstruction of the EAC following canal wall down mastoidectomy. Strategies and principles are outlined to avoid complications associated with reconstruction of the mastoid and EAC. RESULTS: The Grote hydroxyapatite (HA) prosthesis is a reliable prosthesis for reconstruction of the external auditory canal (EAC) in the absence of a draining mastoid cavity or cholesteatoma and with adequate soft tissue cover. Contact of the medial end of the prosthesis with the lateral semicircular canal must be avoided. Immobilization or rigid fixation and avoidance of infection are essential for optimal prosthesis stability and osseointegration. Covering the prosthesis with vascularized soft tissue appears to be important for the achievement of a successful reconstruction. CONCLUSION: The Grote prosthesis is safe and effective provided it does not contact the lateral semicircular canal, is stabilized, and covered by vesicular tissue, in the absence of infection
PMID: 11359158
ISSN: 0023-852x
CID: 93205

Auricular reconstruction: indications for autogenous and prosthetic techniques

Thorne CH; Brecht LE; Bradley JP; Levine JP; Hammerschlag P; Longaker MT
Learning Objectives: After studying this article, the participant should be able to: 1. Describe the alternatives for auricular reconstruction. 2. Discuss the pros and cons of autogenous reconstruction of total or subtotal auricular defects. 3. Enumerate the indications for prosthetic reconstruction of total or subtotal auricular defects. 4. Understand the complexity of and the expertise required for prosthetic reconstruction of auricular defects.The indications for autogenous auricular reconstruction versus prosthetic reconstruction with osseointegrated implant-retained prostheses were outlined in Plastic and Reconstructive Surgery in 1994 by Wilkes et al. of Canada, but because of the relatively recent Food and Drug Administration approval (1995) of extraoral osseointegrated implants, these indications had not been examined by a surgical unit in the United States. The purpose of this article is to present an evolving algorithm based on an experience with 98 patients who underwent auricular reconstruction over a 10-year period. From this experience, the authors conclude that autogenous reconstruction is the procedure of choice in the majority of pediatric patients with microtia. Prosthetic reconstruction of the auricle is considered in such pediatric patients with congenital deformities for the following three relative indications: (1) failed autogenous reconstruction, (2) severe soft-tissue/skeletal hypoplasia, and/or (3) a low or unfavorable hairline. A fourth, and in our opinion the ideal, indication for prosthetic ear reconstruction is the acquired total or subtotal auricular defect, most often traumatic or ablative in origin, which is usually encountered in adults. Although prosthetic reconstruction requires surgical techniques that are less demanding than autogenous reconstruction, construction of the prosthesis is a time-consuming task requiring experience and expertise. Although autogenous reconstruction presents a technical challenge to the surgeon, it is the prosthetic reconstruction that requires lifelong attention and may be associated with late complications. This article reports the first American series of auricular reconstruction containing both autogenous and prosthetic methods by a single surgical team
PMID: 11373570
ISSN: 0032-1052
CID: 20645