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BACKGROUND: Vestibular rehabilitation (VR) is a commonly employed treatment method for disorders of dizziness and imbalance. Access to a clinic for rehabilitation appointments can be challenging for a person experiencing dizziness. Telehealth may offer a comparable alternative to clinic-based VR for some patients. OBJECTIVE: The objective of this study was to determine the efficacy of telehealth-based VR compared to traditional clinic-based VR, as measured with the Dizziness Handicapped Inventory (DHI) in a retrospective sample of patients with vestibular conditions. METHODS: This is a retrospective, multi-institutional review from May 2020 to January 2021. Three study groups were analyzed: a telehealth group, a hybrid group, and a clinic based control group. Treatment efficacy was measured using the DHI. A repeated measures ANCOVA was performed to compare changes between the groups and across timepoints. RESULTS: The repeated measures ANCOVA was not significant for the interaction of groups (control, telehealth, and hybrid) by time (pre and post) (pâ>â0.05). However, there was a significant main effect for time (pre and post) (pâ<â0.05). Specifically, all groups improved DHI scores from pre to post treatment with mean differences of control: 31.85 points, telehealth: 18.75 points, and hybrid: 21.45 points. CONCLUSION: Findings showed that in-clinic, telehealth, and hybrid groups demonstrated a decrease in DHI scores, indicating self-reported improvements in the impact of dizziness on daily life. Continued research is recommended to explore the efficacy of using telehealth in assessing and treating vestibular conditions.
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PURPOSE: To map healthcare utilized by subjects with chronic otitis media, with or without cholesteatoma and perform a cost analysis to determine key drivers of healthcare expenditure. METHODS: A registry study of 656 adult subjects with chronic otitis media that underwent a middle ear surgery between 2014 and 2018. Healthcare contacts related to all publicly funded specialist ENT care, audiological care and primary care for a disease of the ear and mastoid process were extracted. The data are extracted from the Swedish National Patient Registry on subjects that reside in western Sweden. RESULTS: Subjects made 13,782 healthcare contacts at a total cost 61.1 million SEK (6.0 million EUR) between 2014 and 2018. The mean cost per subject was 93,075 SEK (9071 EUR) and ranged between 3971 SEK (387 EUR) and 468,711 SEK (45,683 EUR) per individual. In the most expensive quartile of subjects, mean cost was 192,353 SEK (18,747 EUR) over the 5-year period. These subjects made 3227 ENT contacts (roughly four each year) and 60% of total costs were associated with in-patient ENT care. CONCLUSION: Patients with chronic otitis media are associated with high ENT resource utilization that does not diminish after surgical intervention and the disease places a long-term burden on healthcare systems. Significant costs are attributed to revision surgeries, indicating that these patients could be managed more effectively. In many such cases, reoperation cannot be avoided, especially due to recurrence of cholesteatoma. However, in some patients, when the indication for subsequent surgery is only hearing improvement, alternative options, such as hearing aids or implants, should also be considered. This is especially true in difficult cases, where revision ossiculoplasty is likely.
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Colesteatoma da Orelha Média , Colesteatoma , Otite Média , Adulto , Humanos , Estudos Retrospectivos , Orelha Média/cirurgia , Otite Média/complicações , Otite Média/cirurgia , Colesteatoma/complicações , Atenção à Saúde , Doença Crônica , Colesteatoma da Orelha Média/complicações , Colesteatoma da Orelha Média/cirurgiaRESUMO
Although chronic otitis media is a major cause of conductive and mixed hearing loss, auditory rehabilitation is currently not optimal for this patient group. Planning for hearing rehabilitation must accompany strategies for infection control when surgically managing patients with chronic otitis media. Several barriers prevent adequate hearing restoration in such a heterogeneous patient population. A lack of standardized reporting of surgical interventions, hearing, and quality of life outcomes impedes meta-analyses of existing data and the generation of high- quality evidence, including cost-effectiveness data, through prospective studies. This, in turn, prevents the ability of clinicians to stratify patients based on prognostic indicators, which could guide the decision-making pathway. Strategies to improve reporting standards and methods have the potential to classify patients with chronic otitis media preoperatively, which could guide decision-making for hearing restoration with ossicu- loplasty versus prosthetic hearing devices. Appropriately selected clinical guidelines would not only foster directed research but could enhance patient-centered and evidence-based decision-making regarding hearing rehabilitation in the surgical planning process.
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Otite Média , Qualidade de Vida , Doença Crônica , Audição , Humanos , Otite Média/cirurgia , Estudos Prospectivos , PesquisaRESUMO
Meningiomas are tumors that arise from arachnoid cells attached to both the pia mater and the inner portion of the arachnoid. They are common intracranial tumors, representing 12-25% of intracranial neoplasms. Intracranial meningiomas can spread extracranially to involve surrounding structures, including the ear and temporal bone. Ectopic meningiomas, described as primary meningiomas with no intracranial involvement, are rare. We describe a case of a primary external auditory canal meningioma with no evidence of intracranial involvement. We present pre-operative imaging findings proving no intracranial involvement prior to surgical intervention. A literature review of this uncommon clinical entity is presented and a discussion regarding its prognosis and treatment is reviewed.
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Meato Acústico Externo , Neoplasias da Orelha/diagnóstico por imagem , Meningioma/diagnóstico por imagem , Neoplasias da Orelha/patologia , Neoplasias da Orelha/cirurgia , Humanos , Meningioma/patologia , Meningioma/cirurgia , Prognóstico , Doenças RarasRESUMO
Extracorporeal video microscopes, or "exoscopes," provide high-definition views of the operative field and are alternatives to the operating microscope or loupes for large-corridor surgical approaches. In this proof-of-concept study, we aim to determine the feasibility of 3-dimensional exoscopes as alternatives to operating microscopes in otology and neurotology, espeically in conjunction with endoscopes. Eleven consecutive cases were performed using 3-dimensional exoscopes in place of, or as adjuncts to, the operating microscope. The exoscope was the sole visualization tool in 7 cases, with 4 including the use of an endoscope or microscope. There were no perioperative complications. Potential subjective advantages include superior ergonomics, compact size, and an equal visual experience for surgeons and observers. Limitations include low lighting in small surgical corridors and pixilation at high magnification. Exoscopes are potentially viable alternatives to the microscope in otologic and neurotologic surgery.
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Imageamento Tridimensional , Microcirurgia/instrumentação , Procedimentos Neurocirúrgicos/instrumentação , Procedimentos Cirúrgicos Otológicos/instrumentação , Base do Crânio/cirurgia , Adulto , Idoso , Idoso de 80 Anos ou mais , Colesteatoma da Orelha Média/diagnóstico por imagem , Colesteatoma da Orelha Média/cirurgia , Feminino , Humanos , Masculino , Processo Mastoide/diagnóstico por imagem , Processo Mastoide/cirurgia , Microcirurgia/métodos , Pessoa de Meia-Idade , Neuroma Acústico/diagnóstico por imagem , Neuroma Acústico/cirurgia , Procedimentos Neurocirúrgicos/métodos , Procedimentos Cirúrgicos Otológicos/métodos , Prognóstico , Estudos de Amostragem , Base do Crânio/diagnóstico por imagem , Resultado do Tratamento , Cirurgia Vídeoassistida/métodosRESUMO
Otosclerosis is a disorder presenting most commonly with unilateral conductive hearing loss. It can present as a mixed hearing loss also. Evaluation for otosclerosis relies on a specific history and physical examination, including tuning fork assessment and audiometric testing. Otosclerosis differs from other etiologies in that symptoms of imbalance are rare, and the ear most commonly appears normal on otoscopy.
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Perda Auditiva Condutiva/etiologia , Perda Auditiva Condutiva-Neurossensorial Mista/etiologia , Otosclerose/diagnóstico por imagem , Otosclerose/fisiopatologia , Audiometria de Tons Puros , Audiometria da Fala , Humanos , Anamnese , Osso Temporal/diagnóstico por imagem , Tomografia Computadorizada por Raios XRESUMO
OBJECTIVE: To demonstrate the safety and effectiveness of the MED-EL Electric-Acoustic Stimulation (EAS) System, for adults with residual low-frequency hearing and severe-to-profound hearing loss in the mid to high frequencies. STUDY DESIGN: Prospective, repeated measures. SETTING: Multicenter, hospital. PATIENTS: Seventy-three subjects implanted with PULSAR or SONATA cochlear implants with FLEX electrode arrays. INTERVENTION: Subjects were fit postoperatively with an audio processor, combining electric stimulation and acoustic amplification. MAIN OUTCOME MEASURES: Unaided thresholds were measured preoperatively and at 3, 6, and 12 months postactivation. Speech perception was assessed at these intervals using City University of New York sentences in noise and consonant-nucleus-consonant words in quiet. Subjective benefit was assessed at these intervals via the Abbreviated Profile of Hearing Aid Benefit and Hearing Device Satisfaction Scale questionnaires. RESULTS: Sixty-seven of 73 subjects (92%) completed outcome measures for all study intervals. Of those 67 subjects, 79% experienced less than a 30âdB HL low-frequency pure-tone average (250-1000âHz) shift, and 97% were able to use the acoustic unit at 12 months postactivation. In the EAS condition, 94% of subjects performed similarly to or better than their preoperative performance on City University of New York sentences in noise at 12 months postactivation, with 85% demonstrating improvement. Ninety-seven percent of subjects performed similarly or better on consonant-nucleus-consonant words in quiet, with 84% demonstrating improvement. CONCLUSION: The MED-EL EAS System is a safe and effective treatment option for adults with normal hearing to moderate sensorineural hearing loss in the low frequencies and severe-to-profound sensorineural hearing loss in the high frequencies who do not benefit from traditional amplification.
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Estimulação Acústica/instrumentação , Implantes Cocleares , Auxiliares de Audição , Perda Auditiva Neurossensorial/cirurgia , Resultado do Tratamento , Adolescente , Adulto , Idoso , Implante Coclear , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Estudos Prospectivos , Percepção da Fala/fisiologia , Inquéritos e Questionários , Adulto JovemRESUMO
OBJECTIVE: To determine how best to modify osseointegrated (OI) devices or environmental settings to maximize hearing performance. STUDY DESIGN: Prospective cohort study. SETTING: Tertiary referral center. PATIENTS: Fourteen adults with single-sided deafness (SSD) with a minimum of 6 months OI usage and nine bilaterally normal hearing controls INTERVENTIONS: : Speech in noise (SIN) and localization ability were assessed in a multi-speaker array (R-Space) with patients repeating sentences embedded in competing noise and verbally indicating the source speaker, respectively. MAIN OUTCOME MEASURES: SIN and localization were assessed with multiple OI microphone settings-fixed-directional, omnidirectional, and adaptive-as well as an unaided (OI off) condition. Participants completed the Abbreviated Profile of Hearing Aid Benefit questionnaire. RESULTS: Localization performance remains compromised for OI users with a high number of front-back confusions, but rapid learning using the fixed-directional microphone setting improved localization of sounds on the device side despite poorer localization of sounds on the normal-hearing side. SIN performance is greatly enhanced with speech presented to the contra hearing ear rather than the OI device side. Subjective report of hearing ability is highly predictive of objective SIN measures. CONCLUSIONS: Clinicians should consider implementing a fixed-directional microphone setting for improved localization for sounds behind the OI device, but inform patients of the trade-off in performance on the normal-hearing side. For better hearing in noise, clinicians should counsel OI recipients to orient the speech signal to their normal hearing ear rather than their OI device. The background noise subscale of the abbreviated profile of hearing aid benefit (APHAB) provides a meaningful metric by which to assess SIN performance of OI device users.
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Condução Óssea/fisiologia , Auxiliares de Audição , Perda Auditiva Unilateral/cirurgia , Osseointegração , Adulto , Idoso , Feminino , Audição , Perda Auditiva Neurossensorial/cirurgia , Humanos , Masculino , Pessoa de Meia-Idade , Ruído , Estudos Prospectivos , Percepção da Fala , Inquéritos e QuestionáriosRESUMO
INTRODUCTION: Preservation of residual hearing in cochlear implantation is a main concern for patients and otologists. New electrode arrays as well as development of minimally invasive technique have allowed the expansion of indication criteria for cochlear implantation. The loss of residual low-frequency hearing is thought to be the result of many factors. Opinions differ in regards with the electrodes array characteristics, the surgical implantation technique and the pharmacological therapy used. OBJECTIVE: The aim of this research is to analyze the available information pertaining to hearing preservation with cochlear implantation. RESULTS: Both cochleostomy and round window approaches are adequate, but should rely on the anatomic position of the round window membrane. No electrode design had a higher rate of hearing preservation, either a standard or shorter length was used, or a straight or contoured array. The speed of insertion has a significant impact on hearing preservation and vestibular function. A slow insertion should be used for all cochlear implant insertion, hearing preservation or not. However, the optimal speed of insertion is still unclear. Moreover, the use of steroids regardless of the route or the timing, along with intraoperative topical steroids, had a positive impact on hearing preservation. CONCLUSION: Classic atraumatic insertion maneuvers, very slow and delicate insertion and the use of intraoperative corticosteroids improve hearing outcomes. Whichever the surgeon's preferences, all surgical modifications are aimed at the same goal: protection of the delicate intracochlear structures with preservation of residual low-frequency hearing to improve speech perception abilities.
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Implante Coclear/métodos , Implantes Cocleares , Perda Auditiva Neurossensorial/reabilitação , Cóclea , Humanos , Procedimentos Cirúrgicos Minimamente Invasivos/métodos , Janela da Cóclea , Percepção da FalaRESUMO
The indications for cochlear implantation continue to extend to patients with increased levels of residual hearing. Single-sided deafness and tinnitus are currently under various clinical trials as even further expansion of the application of cochlear implant device and programming technology is underway. This video details a round window and hearing preservation approach for cochlear implant placement, and incorporates the most recent advances in surgical technique. The video can be found here: http://youtu.be/bDqkbboXrU4 .
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Implante Coclear , Implantes Cocleares , Perda Auditiva/cirurgia , Microcirurgia , Janela da Cóclea/cirurgia , Audiometria de Tons Puros , Implante Coclear/métodos , Audição/fisiologia , Humanos , Microcirurgia/métodosRESUMO
OBJECTIVES: There are currently no agreed-upon criteria to establish candidacy for bilateral cochlear implants (CIs). This study categorized practice patterns for establishing bilateral CI candidacy. METHODS: A postal survey was sent to all practices performing CIs in the United States and Canada. The survey queried centers regarding candidacy criteria for bilateral implantation, testing parameters, definition of 'best aided condition', use of testing in noise, localization, and quality-of-life questionnaires. The survey was resent to non-responding centers 4 weeks after the initial mailing. RESULTS: The overall response rate was 40%. 'Best aided condition' (70%) and hearing in noise (52%) were used to establish bilateral candidacy, while 45% of centers offered bilateral implants to all candidates. The majority of respondents defined 'best aided' as hearing aids only (57% non-exclusive) or CI and hearing aid together (57%). Only 25% considered a CI alone as best aided. Nearly 5% considered no aiding to be the best aided. Sound localization was used by 8% of respondents for candidacy assessment. Reimbursement affected candidacy decision for 45%. There was variability in stimulus levels (60, 50, 45, and 55 dB), signal-to-noise ratios, and speaker orientations used. DISCUSSION: There are no consistent criteria to assess patients for bilateral CIs. This practice variation makes comparing outcomes across centers challenging and leaves open the possibility of having external standards imposed by regulators or payors. Standardization of candidacy assessment is necessary to develop best practices for bilateral cochlear implantation both to optimize patient outcomes and to ensure the continuity of coverage for these services.
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Implante Coclear/métodos , Implante Coclear/estatística & dados numéricos , Implantes Cocleares , Surdez/cirurgia , Seleção de Pacientes , Qualidade de Vida , Adulto , Fatores Etários , Audiometria/métodos , Canadá , Criança , Pré-Escolar , Implante Coclear/efeitos adversos , Estudos Transversais , Surdez/diagnóstico , Feminino , Humanos , Masculino , Pessoa de Meia-Idade , Padrões de Prática Médica , Medição de Risco , Percepção da Fala/fisiologia , Inquéritos e Questionários , Resultado do Tratamento , Estados UnidosRESUMO
PURPOSE OF REVIEW: This review addresses four key areas of controversy in the prevention of common complications of pediatric cochlear implant surgery: reducing meningitis risk, managing acute otitis media (AOM) in the cochlear implant population, assessing the optimum age for implanting a child to take advantage of the critical periods of language acquisition, and managing the social risk in defining ethical issues still surrounding cochlear implant in children. RECENT FINDINGS: Improved surgical techniques and the replacement of Prenvar-7 with Prenvar-13 significantly reduce the risk of cochlear implant related meningitis. AOM within 2 months of cochlear implant placement requires aggressive management to reduce the risk of complication. Tympanostomy tubes do not increase the risk of otitis media or meningitis and should be used when appropriate according to accepted AOM standards. Although the controversy over cochlear implant and the dissolution of Deaf Culture is decreasing, the use of cochlear implant in children remains an area for open dialogue between groups to ensure children are treated appropriately. Discussions ought to be based on fact and scientific evidence. SUMMARY: Although cochlear implants remain the gold standard for hearing restoration in children with severe to profound hearing loss, several issues remain controversial and are in need of further scientific exploration.
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Implante Coclear , Implantes Cocleares , Complicações Pós-Operatórias/prevenção & controle , Fatores Etários , Criança , Pré-Escolar , Implante Coclear/ética , Humanos , Lactente , Desenvolvimento da Linguagem , Meningite/prevenção & controle , Ventilação da Orelha Média , Otite Média/prevenção & controleRESUMO
OBJECTIVE: To design an international standard to be used when reporting reliability of the implanted components of cochlear implant systems to appropriate governmental authorities, cochlear implant (CI) centers, and for journal editors in evaluating manuscripts involving cochlear implant reliability. STUDY DESIGN: The International Consensus Group for Cochlear Implant Reliability Reporting was assembled to unify ongoing efforts in the United States, Europe, Asia, and Australia to create a consistent and comprehensive classification system for the implanted components of CI systems across manufacturers. SETTING: All members of the consensus group are from tertiary referral cochlear implant centers. INTERVENTIONS: None. MAIN OUTCOME MEASURE: A clinically relevant classification scheme adapted from principles of ISO standard 5841-2:2000 originally designed for reporting reliability of cardiac pacemakers, pulse generators, or leads. RESULTS: Standard definitions for device failure, survival time, clinical benefit, reduced clinical benefit, and specification were generated. Time intervals for reporting back to implant centers for devices tested to be "out of specification," categorization of explanted devices, the method of cumulative survival reporting, and content of reliability reports to be issued by manufacturers was agreed upon by all members. The methodology for calculating Cumulative survival was adapted from ISO standard 5841-2:2000. CONCLUSION: The International Consensus Group on Cochlear Implant Device Reliability Reporting recommends compliance to this new standard in reporting reliability of implanted CI components by all manufacturers of CIs and the adoption of this standard as a minimal reporting guideline for editors of journals publishing cochlear implant research results.
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Implantes Cocleares/normas , Falha de Equipamento , Implante Coclear , HumanosRESUMO
OBJECTIVE: To present an updated version of the original Facial Nerve Grading Scale (FNGS), commonly referred to as the House-Brackmann scale. STUDY DESIGN: Controlled trial of grading systems using a series of 21 videos of individuals with varying degrees of facial paralysis. RESULTS: The intraobserver and interobserver agreement was high among the original and revised scales. Nominal improvement is seen in percentage of exact agreement of grade and reduction of instances of examiners differing by more then one grade when using FNGS 2.0. FNGS 2.0 also offers improved agreement in differentiating between grades 3 and 4. CONCLUSION: FNGS 2.0 incorporates regional scoring of facial movement, providing additional information while maintaining agreement comparable to the original scale. Ambiguities regarding use of the grading scale are addressed.
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Doenças do Nervo Facial/fisiopatologia , Paralisia Facial/fisiopatologia , Índice de Gravidade de Doença , Assimetria Facial/etiologia , Assimetria Facial/patologia , Doenças do Nervo Facial/complicações , Doenças do Nervo Facial/patologia , Paralisia Facial/etiologia , Humanos , Variações Dependentes do Observador , Reprodutibilidade dos Testes , Sorriso/fisiologia , Sincinesia/etiologia , Sincinesia/fisiopatologia , Gravação em VídeoRESUMO
Counseling patients who are diagnosed with vestibular schwannomas, formerly known as acoustic neuromas, can be challenging. The health care provider has the responsibility to explain, in understandable language, to the patient or legal representative the proposed treatment options, risks and complications associated with each form of treatment, and alternatives to treatment, including no therapy. Patients should be encouraged to gather information before making a treatment decision. For the physicians managing these patients, information should be delivered in a balanced way to ensure patient understanding of their options leading to adequate informed consent.
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Consentimento Livre e Esclarecido/história , Neuroma Acústico/história , Educação de Pacientes como Assunto/história , História do Século XXI , Humanos , Neuroma Acústico/terapiaRESUMO
We present a case of Scedosporium apiospermum otomycosis in an immunocompetent 62-year-old woman presumably inoculated as a child in Vietnam. She had life-long recurrent symptoms of chronic otomastoiditis and otorrhea. The organism was identified in an unexpected wound infection after a modified radical mastoidectomy done for chronic otitis media. Treatment consisted of local debridement of necrotic tissue, topical wound care, and long-term systemic antifungals.
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Micetoma/microbiologia , Otite/microbiologia , Scedosporium/isolamento & purificação , Antifúngicos/uso terapêutico , Diagnóstico Diferencial , Feminino , Seguimentos , Humanos , Pessoa de Meia-Idade , Micetoma/diagnóstico , Micetoma/terapia , Otite/diagnóstico , Otite/terapia , Tomografia Computadorizada por Raios X , TimpanoplastiaRESUMO
This article serves as a concise review of cerebrospinal fluid metabolism and intracranial pressure regulation for otolaryngologists and lateral skull base surgeons. It examines the methodologies for maintaining cerebrospinal fluid homeostasis by preventing and treating acute elevations of intracranial pressure encountered during lateral skull base surgery.
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Pressão Intracraniana/fisiologia , Procedimentos Neurocirúrgicos/métodos , Base do Crânio/cirurgia , Derivações do Líquido Cefalorraquidiano , Humanos , Imageamento por Ressonância Magnética , Base do Crânio/anatomia & histologiaRESUMO
Counseling patients who are diagnosed with vestibular schwannomas, formerly known as acoustic neuromas, can be challenging. The health care provider has the responsibility to explain, in understandable language, to the patient or legal representative the proposed treatment options, risks and complications associated with each form of treatment, and alternatives to treatment, including no therapy. Patients should be encouraged to gather information before making a treatment decision. For the physicians managing these patients, information should be delivered in a balanced way to ensure patient understanding of their options leading to adequate informed consent.
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Comportamento de Escolha , Consentimento Livre e Esclarecido , Neuroma Acústico/patologia , Neuroma Acústico/cirurgia , Educação de Pacientes como Assunto , Aconselhamento/métodos , Humanos , Microcirurgia/métodos , Neuroma Acústico/radioterapia , Técnicas EstereotáxicasRESUMO
OBJECTIVE: To propose a standard definition of "out of specification" for cochlear implants and a paradigm for inclusion of category C of the ISO standard 5841-2:2000 for reporting in cumulative survival statistics. HYPOTHESIS: A standard definition of "out of specification" and consistent reporting by manufacturers of cochlear implants will create a fair and consistent representation of cumulative survival. This will allow discernment of differences between manufacturers for reliability and for detection of trends in reliability between model types from the same manufacturer. DESIGN: Three separate meetings with representatives of the three manufacturers of cochlear implants marketed in the United States were staged over a 13-mo period. Standard questions, created by the authors, were addressed by each representative to determine the current state of device reliability reporting. Results were presented to clinicians at the William House Cochlear Implant study Group and the Implantable devices sub-committee of the American Academy of Otolaryngology (2004, 2005) and at the 8th International Cochlear Implant Conference (2004) for feedback. After assimilation of feedback by all parties, the standard was written and reviewed by representatives from each manufacturer for accuracy of data. RESULTS: A complaint-driven standard was developed. A "cochlear implant" as an internal device placed and skin closed in surgery. An internal device is "out of specification" when one or more technical characteristics is outside the limits of normal function and results in explantation or non-use by the patient." Children will be reported separately from adults, each model of device will be reported on annually, a minimum of 200 devices must be in each model group for Cumulative Survival Reporting (CSR). Confidence limits are set at 95%. Explants will be determined to be "biological" or "technical." Technical explants are included in CSR reports. Devices failing to meet specifications set by the manufacturer, not in use but still in situ due to patient choice not to be re-implanted are considered category C and included in CSR reports. Implants that cannot be classified at explant are placed in an "under investigation" category while evaluation is completed. If no classification is made by 6 months, these devices will be included in the CSR report. Notification to the implant center regarding "in" or "out of specification" will be made within 60 d of the explant arriving at the manufacturer with final root cause of failure reported to centers when complete. Information will be passed on to patients by members of the implant team. A standardized form will be created to provide the manufacturers with necessary patient information to guide reliability analysis, including performance after re-implant. CONCLUSIONS: The standard for reliability reporting described in this paper improves patient care by presenting data which are understandable to clinicians delivering cochlear implant services. It fosters fair and accurate reporting without discriminating or granting perceived advantage to any manufacturer. This standard provides a basis for reporting research related to or including device reliability in the medical literature.