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1.
J Vestib Res ; 2024 Jun 15.
Article in English | MEDLINE | ID: mdl-38905068

ABSTRACT

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) (p > 0.05). However, there was a significant main effect for time (pre and post) (p < 0.05). 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.

2.
Eur Arch Otorhinolaryngol ; 280(1): 175-181, 2023 Jan.
Article in English | MEDLINE | ID: mdl-35731293

ABSTRACT

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.


Subject(s)
Cholesteatoma, Middle Ear , Cholesteatoma , Otitis Media , Adult , Humans , Retrospective Studies , Ear, Middle/surgery , Otitis Media/complications , Otitis Media/surgery , Cholesteatoma/complications , Delivery of Health Care , Chronic Disease , Cholesteatoma, Middle Ear/complications , Cholesteatoma, Middle Ear/surgery
3.
J Int Adv Otol ; 18(4): 365-370, 2022 Jul.
Article in English | MEDLINE | ID: mdl-35894534

ABSTRACT

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.


Subject(s)
Otitis Media , Quality of Life , Chronic Disease , Hearing , Humans , Otitis Media/surgery , Prospective Studies , Research
4.
Am J Otolaryngol ; 43(1): 103215, 2022.
Article in English | MEDLINE | ID: mdl-34536924

ABSTRACT

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.


Subject(s)
Ear Canal , Ear Neoplasms/diagnostic imaging , Meningioma/diagnostic imaging , Ear Neoplasms/pathology , Ear Neoplasms/surgery , Humans , Meningioma/pathology , Meningioma/surgery , Prognosis , Rare Diseases
5.
Otolaryngol Head Neck Surg ; 160(2): 364-367, 2019 02.
Article in English | MEDLINE | ID: mdl-30598049

ABSTRACT

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.


Subject(s)
Imaging, Three-Dimensional , Microsurgery/instrumentation , Neurosurgical Procedures/instrumentation , Otologic Surgical Procedures/instrumentation , Skull Base/surgery , Adult , Aged , Aged, 80 and over , Cholesteatoma, Middle Ear/diagnostic imaging , Cholesteatoma, Middle Ear/surgery , Female , Humans , Male , Mastoid/diagnostic imaging , Mastoid/surgery , Microsurgery/methods , Middle Aged , Neuroma, Acoustic/diagnostic imaging , Neuroma, Acoustic/surgery , Neurosurgical Procedures/methods , Otologic Surgical Procedures/methods , Prognosis , Sampling Studies , Skull Base/diagnostic imaging , Treatment Outcome , Video-Assisted Surgery/methods
6.
Otolaryngol Clin North Am ; 51(2): 319-326, 2018 Apr.
Article in English | MEDLINE | ID: mdl-29395113

ABSTRACT

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.


Subject(s)
Hearing Loss, Conductive/etiology , Hearing Loss, Mixed Conductive-Sensorineural/etiology , Otosclerosis/diagnostic imaging , Otosclerosis/physiopathology , Audiometry, Pure-Tone , Audiometry, Speech , Humans , Medical History Taking , Temporal Bone/diagnostic imaging , Tomography, X-Ray Computed
7.
Otol Neurotol ; 39(3): 299-305, 2018 03.
Article in English | MEDLINE | ID: mdl-29342054

ABSTRACT

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 30 dB HL low-frequency pure-tone average (250-1000 Hz) 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.


Subject(s)
Acoustic Stimulation/instrumentation , Cochlear Implants , Hearing Aids , Hearing Loss, Sensorineural/surgery , Treatment Outcome , Adolescent , Adult , Aged , Cochlear Implantation , Female , Humans , Male , Middle Aged , Prospective Studies , Speech Perception/physiology , Surveys and Questionnaires , Young Adult
8.
Otol Neurotol ; 37(8): 1084-91, 2016 09.
Article in English | MEDLINE | ID: mdl-27380538

ABSTRACT

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.


Subject(s)
Bone Conduction/physiology , Hearing Aids , Hearing Loss, Unilateral/surgery , Osseointegration , Adult , Aged , Female , Hearing , Hearing Loss, Sensorineural/surgery , Humans , Male , Middle Aged , Noise , Prospective Studies , Speech Perception , Surveys and Questionnaires
9.
Auris Nasus Larynx ; 43(5): 485-8, 2016 Oct.
Article in English | MEDLINE | ID: mdl-26976547

ABSTRACT

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.


Subject(s)
Cochlear Implantation/methods , Cochlear Implants , Hearing Loss, Sensorineural/rehabilitation , Cochlea , Humans , Minimally Invasive Surgical Procedures/methods , Round Window, Ear , Speech Perception
10.
Neurosurg Focus ; 36(1 Suppl): 1, 2014 Jan.
Article in English | MEDLINE | ID: mdl-24380531

ABSTRACT

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 .


Subject(s)
Cochlear Implantation , Cochlear Implants , Hearing Loss/surgery , Microsurgery , Round Window, Ear/surgery , Audiometry, Pure-Tone , Cochlear Implantation/methods , Hearing/physiology , Humans , Microsurgery/methods
11.
Cochlear Implants Int ; 13(2): 86-92, 2012 May.
Article in English | MEDLINE | ID: mdl-22333494

ABSTRACT

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.


Subject(s)
Cochlear Implantation/methods , Cochlear Implantation/statistics & numerical data , Cochlear Implants , Deafness/surgery , Patient Selection , Quality of Life , Adult , Age Factors , Audiometry/methods , Canada , Child , Child, Preschool , Cochlear Implantation/adverse effects , Cross-Sectional Studies , Deafness/diagnosis , Female , Humans , Male , Middle Aged , Practice Patterns, Physicians' , Risk Assessment , Speech Perception/physiology , Surveys and Questionnaires , Treatment Outcome , United States
12.
Curr Opin Otolaryngol Head Neck Surg ; 19(5): 358-62, 2011 Oct.
Article in English | MEDLINE | ID: mdl-21825997

ABSTRACT

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.


Subject(s)
Cochlear Implantation , Cochlear Implants , Postoperative Complications/prevention & control , Age Factors , Child , Child, Preschool , Cochlear Implantation/ethics , Humans , Infant , Language Development , Meningitis/prevention & control , Middle Ear Ventilation , Otitis Media/prevention & control
14.
Otol Neurotol ; 31(8): 1190-3, 2010 Oct.
Article in English | MEDLINE | ID: mdl-20864879

ABSTRACT

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.


Subject(s)
Cochlear Implants/standards , Equipment Failure , Cochlear Implantation , Humans
15.
Otolaryngol Head Neck Surg ; 140(4): 445-50, 2009 Apr.
Article in English | MEDLINE | ID: mdl-19328328

ABSTRACT

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.


Subject(s)
Facial Nerve Diseases/physiopathology , Facial Paralysis/physiopathology , Severity of Illness Index , Facial Asymmetry/etiology , Facial Asymmetry/pathology , Facial Nerve Diseases/complications , Facial Nerve Diseases/pathology , Facial Paralysis/etiology , Humans , Observer Variation , Reproducibility of Results , Smiling/physiology , Synkinesis/etiology , Synkinesis/physiopathology , Video Recording
16.
Neurosurg Clin N Am ; 19(2): 379-92, viii, 2008 Apr.
Article in English | MEDLINE | ID: mdl-18534346

ABSTRACT

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.


Subject(s)
Informed Consent/history , Neuroma, Acoustic/history , Patient Education as Topic/history , History, 21st Century , Humans , Neuroma, Acoustic/therapy
17.
Am J Otolaryngol ; 28(4): 254-6, 2007.
Article in English | MEDLINE | ID: mdl-17606042

ABSTRACT

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.


Subject(s)
Mycetoma/microbiology , Otitis/microbiology , Scedosporium/isolation & purification , Antifungal Agents/therapeutic use , Diagnosis, Differential , Female , Follow-Up Studies , Humans , Middle Aged , Mycetoma/diagnosis , Mycetoma/therapy , Otitis/diagnosis , Otitis/therapy , Tomography, X-Ray Computed , Tympanoplasty
18.
Otolaryngol Clin North Am ; 40(3): 455-62, viii, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17544691

ABSTRACT

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.


Subject(s)
Intracranial Pressure/physiology , Neurosurgical Procedures/methods , Skull Base/surgery , Cerebrospinal Fluid Shunts , Humans , Magnetic Resonance Imaging , Skull Base/anatomy & histology
19.
Otolaryngol Clin North Am ; 40(3): 521-40, viii-ix, 2007 Jun.
Article in English | MEDLINE | ID: mdl-17544694

ABSTRACT

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.


Subject(s)
Choice Behavior , Informed Consent , Neuroma, Acoustic/pathology , Neuroma, Acoustic/surgery , Patient Education as Topic , Counseling/methods , Humans , Microsurgery/methods , Neuroma, Acoustic/radiotherapy , Stereotaxic Techniques
20.
Ear Hear ; 28(2 Suppl): 91S-94S, 2007 Apr.
Article in English | MEDLINE | ID: mdl-17496656

ABSTRACT

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.


Subject(s)
Cochlear Implants/standards , Humans , Reproducibility of Results
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