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Cor W R J Cremers - One of the best experts on this subject based on the ideXlab platform.
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active Middle Ear Implantation long term medical and technical follow up implant survival and complications
Otology & Neurotology, 2016Co-Authors: Joost W Zwartenkot, A F M Snik, Cor W R J Cremers, Jef J S Mulder, Emmanuel A M MylanusAbstract:OBJECTIVE: To evaluate the long-term medical and technical results, implant survival, and complications of the semi-implantable vibrant soundbridge (VSB), otologics Middle Ear transducer (MET), and the otologics fully implantable ossicular stimulator (FIMOS). STUDY DESIGN: Retrospective cohort study. PATIENTS: Patients with chronic external otitis and either moderate to severe sensorineural or conductive/mixed hEaring loss. SETTING: Tertiary referral center. INTERVENTION: Implantation with the VSB, MET, or FIMOS. MAIN OUTCOME MEASURES: Medical complications, number of reImplantations, and explantations. RESULTS: Ninety-four patients were implanted, 12 patients with a round window or stapes application. 28 patients were lost to follow-up. The average follow-up duration was 4.4 yEars (range, 1 month-15 yEars). 128 devices were evaluated: (92 VSB, 32 MET, 4 FIMOS). 36 devices (28%) have been explanted or replaced (18 VSB, 14 MET, 4 FIMOS). Device failure was 7% for VSB, 28% for MET, and 100% for FIMOS. In 16 patients (17%) revision surgery (n = 20) was performed. Twenty patients (21%) suffered any medical complication. CONCLUSION: Medical and technical complications and device failures have mostly occurred in the initial period of active Middle Ear implants (AMEI) implementation and during clinical trials or experimental procedures. All four FIMOS had technical difficulties. An important decrease in the occurrence of both medical and technical complications was observed. Application in more recent yEars did not show any complications and the recent device failure rates are acceptable. Magnetic resonance imaging (MRI) incompatibility should be taken into account when indicating AMEI.
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active Middle Ear Implantation for patients with sensorineural hEaring loss and external otitis long term outcome in patient satisfaction
Otology & Neurotology, 2013Co-Authors: Joost W Zwartenkot, Jef J S Mulder, Cor W R J Cremers, Javad Hashemi, A F M SnikAbstract:OBJECTIVE: To study long-term subjective benefit of patients with sensorineural hEaring loss and chronic external otitis who use active Middle Ear implants. DESIGN: Single-subject repeated measures in a preintervention and postintervention design with multiple postintervention measurements (questionnaires). SETTING: Tertiary academic center. PATIENTS: Moderate-to-severe sensorineural hEaring loss (n = 56) with severe chronic external otitis who use the Vibrant Soundbridge (VSB) or Otologics MET Middle Ear implant systems. MAIN OUTCOME MEASURE: Changes in hEaring disability and handicap as evaluated using the Abbreviated Profile of HEaring Aid Benefit (APHAB), the Nijmegen CochlEar Implant Questionnaire (NCIQ), and the Glasgow Benefit Inventory (GBI). RESULTS: Data of 33 patients (mean postoperative duration of 7.5 yr) were available. No difference in subjective results was found between the VSB and Otologics MET patient groups. Total percentage of nonuse was 13%. Long-term APHAB results show a significant decrease in disability for 43% of the patients compared with 54% at 1-yEar postoperative. NCIQ results show a significant benefit for all subdomains with a negative trend over time. The GBI results show a significant long-term increase in quality of life with positive scores for 82% of the assessed patients. CONCLUSION: Long-term postoperative patient satisfaction and quality of life results show a significant difference compared with preoperative measurements, with conventional hEaring aids. A negative trend over time is found on all questionnaires, which might reflect patient aging (increase of hEaring loss) or habituation to a situation with fewer concerns regarding a patient's external otitis.
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intraoperative auditory steady state response measurements during vibrant soundbridge Middle Ear Implantation in patients with mixed hEaring loss preliminary results
Otology & Neurotology, 2010Co-Authors: Veronique J O Verhaegen, Cor W R J Cremers, Jef J S Mulder, John F P Noten, Bart M A Luijten, A F M SnikAbstract:OBJECTIVE: To optimize intraoperatively the coupling of the floating mass transducer (FMT) of the Vibrant Soundbridge Middle Ear implant to the round or oval cochlEar window in patients with mixed hEaring loss. STUDY DESIGN: Intraoperative measurement of objective hEaring thresholds using auditory steady state responses (ASSRs). SETTING: Radboud University Nijmegen Medical Centre, tertiary referral hospital. PATIENTS: Four individuals with mixed hEaring loss and, at least no incus, in need for a Middle Ear implant. INTERVENTION: Surgical placement of the Vibrant Soundbridge. ASSR thresholds were measured intraoperatively, whereas FMT coupling to the cochlea was manipulated to find the most effective coupling of the FMT. MAIN OUTCOME MEASURE: Differences in ASSR thresholds between different FMT coupling options within patients. RESULTS: With ASSR, we assessed placement of the FMT in the round window niche, loosely or tightly packed in the niche; creation of a mobile window in case of a fixed stapes footplate; and FMT position coupled to the stapes that afforded vibration in the natural vibration direction or perpendicular to it. Furthermore, test-retest variations in ASSR thresholds were studied. It was shown that differences in ASSR thresholds could be detected, while manipulating the FMT couplings, which were statistically significant. CONCLUSION: Intraoperative ASSR measurement is a good method to study different positions of the FMT and to determine the best position of the FMT for a patient.
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evaluation of the subjective effect of Middle Ear Implantation in hEaring impaired patients with severe external otitis
Journal of The American Academy of Audiology, 2007Co-Authors: A F M Snik, Noortje T L Van Duijnhoven, Jef J S Mulder, Cor W R J CremersAbstract:The subjective benefit of Middle Ear Implantation was studied in a group of 23 hEaring-impaired patients who could not use conventional hEaring aids owing to severe chronic external otitis. Changes in hEaring disability (Abbreviated Profile of HEaring Aid Benefit [APHAB]) and changes in quality of life (Glasgow Benefit Inventory [GBI]) were determined. Mean benefit value on the APHAB for the subscale Ease of Communication was close to the mean reference value for conventional hEaring aids. For the subscales Reverberation and Background Noise, a poorer result was found. Individual analysis of the APHAB scores showed significant benefit in 12 out of the 23 patients. According to the GBI, 16 out of 17 patients reported that Middle Ear Implantation had made a positive impact on their quality of life. It is concluded that Middle Ear Implantation has a positive effect on hEaring difficulties and quality of life in hEaring-impaired subjects who cannot use conventional devices. The APHAB outcomes were not better than those reported for conventional devices.
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estimated cost effectiveness of active Middle Ear Implantation in hEaring impaired patients with severe external otitis
Archives of Otolaryngology-head & Neck Surgery, 2006Co-Authors: A F M Snik, Noortje T L Van Duijnhoven, Emmanuel A M Mylanus, Cor W R J CremersAbstract:OBJECTIVE: To determine the cost-effectiveness of Middle-Ear Implantations in hEaring-impaired patients with severe external otitis in the Netherlands. DESIGN: Cost-effectiveness analysis, using single-subject repeated measures of quality of life and total cost determinations. SETTING: Hospital based. Patients Moderately to severely sensorineurally hEaring-impaired patients (n = 21) with severe chronic external otitis, eligible to receive a Middle-Ear implant. Main Outcome Measure Cost per quality-adjusted life-yEar (QALY), based on scores of the Medical Outcomes Study Short-Form Health()Survey (SF-36) generic quality of life questionnaire. Only direct costs were included in cost calculation of Middle-Ear Implantation. RESULTS: Mean health utility gain was 0.046 (0.012-0.079) (P = .01) measured at the mental component of the SF-36. With a mean profitable time of 19.4 yEars and an overall cost of euro 14,354, minimal cost-effectiveness of Middle-Ear Implantation was euro 16,085/QALY. CONCLUSION: Based on the cost per QALY, Middle-Ear Implantation proved to be a cost-effective and justified health care intervention in the Netherlands.
A F M Snik - One of the best experts on this subject based on the ideXlab platform.
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active Middle Ear Implantation long term medical and technical follow up implant survival and complications
Otology & Neurotology, 2016Co-Authors: Joost W Zwartenkot, A F M Snik, Cor W R J Cremers, Jef J S Mulder, Emmanuel A M MylanusAbstract:OBJECTIVE: To evaluate the long-term medical and technical results, implant survival, and complications of the semi-implantable vibrant soundbridge (VSB), otologics Middle Ear transducer (MET), and the otologics fully implantable ossicular stimulator (FIMOS). STUDY DESIGN: Retrospective cohort study. PATIENTS: Patients with chronic external otitis and either moderate to severe sensorineural or conductive/mixed hEaring loss. SETTING: Tertiary referral center. INTERVENTION: Implantation with the VSB, MET, or FIMOS. MAIN OUTCOME MEASURES: Medical complications, number of reImplantations, and explantations. RESULTS: Ninety-four patients were implanted, 12 patients with a round window or stapes application. 28 patients were lost to follow-up. The average follow-up duration was 4.4 yEars (range, 1 month-15 yEars). 128 devices were evaluated: (92 VSB, 32 MET, 4 FIMOS). 36 devices (28%) have been explanted or replaced (18 VSB, 14 MET, 4 FIMOS). Device failure was 7% for VSB, 28% for MET, and 100% for FIMOS. In 16 patients (17%) revision surgery (n = 20) was performed. Twenty patients (21%) suffered any medical complication. CONCLUSION: Medical and technical complications and device failures have mostly occurred in the initial period of active Middle Ear implants (AMEI) implementation and during clinical trials or experimental procedures. All four FIMOS had technical difficulties. An important decrease in the occurrence of both medical and technical complications was observed. Application in more recent yEars did not show any complications and the recent device failure rates are acceptable. Magnetic resonance imaging (MRI) incompatibility should be taken into account when indicating AMEI.
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active Middle Ear Implantation for patients with sensorineural hEaring loss and external otitis long term outcome in patient satisfaction
Otology & Neurotology, 2013Co-Authors: Joost W Zwartenkot, Jef J S Mulder, Cor W R J Cremers, Javad Hashemi, A F M SnikAbstract:OBJECTIVE: To study long-term subjective benefit of patients with sensorineural hEaring loss and chronic external otitis who use active Middle Ear implants. DESIGN: Single-subject repeated measures in a preintervention and postintervention design with multiple postintervention measurements (questionnaires). SETTING: Tertiary academic center. PATIENTS: Moderate-to-severe sensorineural hEaring loss (n = 56) with severe chronic external otitis who use the Vibrant Soundbridge (VSB) or Otologics MET Middle Ear implant systems. MAIN OUTCOME MEASURE: Changes in hEaring disability and handicap as evaluated using the Abbreviated Profile of HEaring Aid Benefit (APHAB), the Nijmegen CochlEar Implant Questionnaire (NCIQ), and the Glasgow Benefit Inventory (GBI). RESULTS: Data of 33 patients (mean postoperative duration of 7.5 yr) were available. No difference in subjective results was found between the VSB and Otologics MET patient groups. Total percentage of nonuse was 13%. Long-term APHAB results show a significant decrease in disability for 43% of the patients compared with 54% at 1-yEar postoperative. NCIQ results show a significant benefit for all subdomains with a negative trend over time. The GBI results show a significant long-term increase in quality of life with positive scores for 82% of the assessed patients. CONCLUSION: Long-term postoperative patient satisfaction and quality of life results show a significant difference compared with preoperative measurements, with conventional hEaring aids. A negative trend over time is found on all questionnaires, which might reflect patient aging (increase of hEaring loss) or habituation to a situation with fewer concerns regarding a patient's external otitis.
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intraoperative auditory steady state response measurements during vibrant soundbridge Middle Ear Implantation in patients with mixed hEaring loss preliminary results
Otology & Neurotology, 2010Co-Authors: Veronique J O Verhaegen, Cor W R J Cremers, Jef J S Mulder, John F P Noten, Bart M A Luijten, A F M SnikAbstract:OBJECTIVE: To optimize intraoperatively the coupling of the floating mass transducer (FMT) of the Vibrant Soundbridge Middle Ear implant to the round or oval cochlEar window in patients with mixed hEaring loss. STUDY DESIGN: Intraoperative measurement of objective hEaring thresholds using auditory steady state responses (ASSRs). SETTING: Radboud University Nijmegen Medical Centre, tertiary referral hospital. PATIENTS: Four individuals with mixed hEaring loss and, at least no incus, in need for a Middle Ear implant. INTERVENTION: Surgical placement of the Vibrant Soundbridge. ASSR thresholds were measured intraoperatively, whereas FMT coupling to the cochlea was manipulated to find the most effective coupling of the FMT. MAIN OUTCOME MEASURE: Differences in ASSR thresholds between different FMT coupling options within patients. RESULTS: With ASSR, we assessed placement of the FMT in the round window niche, loosely or tightly packed in the niche; creation of a mobile window in case of a fixed stapes footplate; and FMT position coupled to the stapes that afforded vibration in the natural vibration direction or perpendicular to it. Furthermore, test-retest variations in ASSR thresholds were studied. It was shown that differences in ASSR thresholds could be detected, while manipulating the FMT couplings, which were statistically significant. CONCLUSION: Intraoperative ASSR measurement is a good method to study different positions of the FMT and to determine the best position of the FMT for a patient.
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evaluation of the subjective effect of Middle Ear Implantation in hEaring impaired patients with severe external otitis
Journal of The American Academy of Audiology, 2007Co-Authors: A F M Snik, Noortje T L Van Duijnhoven, Jef J S Mulder, Cor W R J CremersAbstract:The subjective benefit of Middle Ear Implantation was studied in a group of 23 hEaring-impaired patients who could not use conventional hEaring aids owing to severe chronic external otitis. Changes in hEaring disability (Abbreviated Profile of HEaring Aid Benefit [APHAB]) and changes in quality of life (Glasgow Benefit Inventory [GBI]) were determined. Mean benefit value on the APHAB for the subscale Ease of Communication was close to the mean reference value for conventional hEaring aids. For the subscales Reverberation and Background Noise, a poorer result was found. Individual analysis of the APHAB scores showed significant benefit in 12 out of the 23 patients. According to the GBI, 16 out of 17 patients reported that Middle Ear Implantation had made a positive impact on their quality of life. It is concluded that Middle Ear Implantation has a positive effect on hEaring difficulties and quality of life in hEaring-impaired subjects who cannot use conventional devices. The APHAB outcomes were not better than those reported for conventional devices.
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estimated cost effectiveness of active Middle Ear Implantation in hEaring impaired patients with severe external otitis
Archives of Otolaryngology-head & Neck Surgery, 2006Co-Authors: A F M Snik, Noortje T L Van Duijnhoven, Emmanuel A M Mylanus, Cor W R J CremersAbstract:OBJECTIVE: To determine the cost-effectiveness of Middle-Ear Implantations in hEaring-impaired patients with severe external otitis in the Netherlands. DESIGN: Cost-effectiveness analysis, using single-subject repeated measures of quality of life and total cost determinations. SETTING: Hospital based. Patients Moderately to severely sensorineurally hEaring-impaired patients (n = 21) with severe chronic external otitis, eligible to receive a Middle-Ear implant. Main Outcome Measure Cost per quality-adjusted life-yEar (QALY), based on scores of the Medical Outcomes Study Short-Form Health()Survey (SF-36) generic quality of life questionnaire. Only direct costs were included in cost calculation of Middle-Ear Implantation. RESULTS: Mean health utility gain was 0.046 (0.012-0.079) (P = .01) measured at the mental component of the SF-36. With a mean profitable time of 19.4 yEars and an overall cost of euro 14,354, minimal cost-effectiveness of Middle-Ear Implantation was euro 16,085/QALY. CONCLUSION: Based on the cost per QALY, Middle-Ear Implantation proved to be a cost-effective and justified health care intervention in the Netherlands.
S E J Connor - One of the best experts on this subject based on the ideXlab platform.
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active Middle Ear Implantation imaging in the pre operative planning and post operative assessment of the vibrant soundbridgetm
British Journal of Radiology, 2020Co-Authors: Christian Burd, Irumee Pai, S E J ConnorAbstract:Active Middle Ear implants augment sound waves and directly stimulate the Middle Ear structures. The most frequently utilised active Middle Ear implant is the Vibrant Soundbridge TM (VSB).CT plays a vital role in appropriate patient selection and surgical planning of active Middle Ear implant surgery. The VSB TM offers a number of options for implant placement. The ideal location is influenced by the patient's Middle Ear and mastoid anatomy as well as the type and severity of the hEaring loss. CT provides important information on the surgical access to the Middle Ear and helps determine the most appropriate implant site by assessing the adjacent Middle Ear anatomy and the continuity of the ossicular chain. Post-operative active Middle Ear implant imaging may be indicated in the setting of poor auditory outcomes and when revision surgery is being considered so as to assess for suboptimal implant placement or migration.This pictorial review will describe the VSB TM Middle Ear device and explain the role of imaging in both the pre-operative and post-operative settings.
Konrad Konradsson - One of the best experts on this subject based on the ideXlab platform.
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evaluation of cost utility in Middle Ear Implantation in the nordic school a multicenter study in sweden and norway
Cochlear Implants International, 2014Co-Authors: Lennart Edfeldt, Karin Stromback, Joakim Grendin, Marie Bunne, Henrik Harder, Markus Peebo, Mans Eegolofsson, Carlmagnus Petersson, Konrad KonradssonAbstract:To evaluate the cost-effectiveness of using an active Middle Ear implant (AMEI) Middle Ear implant for hEaring rehabilitation.Prospective, multicenter, single-subject repeated study in six tertiary...
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evaluation of cost utility in Middle Ear Implantation in the nordic school a multicenter study in sweden and norway
Acta Oto-laryngologica, 2014Co-Authors: Lennart Edfeldt, Karin Stromback, Joakim Grendin, Marie Bunne, Henrik Harder, Markus Peebo, Mans Eegolofsson, Carlmagnus Petersson, Konrad KonradssonAbstract:Conclusion: HEaring restoration using an active Middle Ear implant (AMEI) is a highly cost-effective treatment for a selected group of patients with no other possibilities for auditory rehabilitati ...
Lennart Edfeldt - One of the best experts on this subject based on the ideXlab platform.
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evaluation of cost utility in Middle Ear Implantation in the nordic school a multicenter study in sweden and norway
Cochlear Implants International, 2014Co-Authors: Lennart Edfeldt, Karin Stromback, Joakim Grendin, Marie Bunne, Henrik Harder, Markus Peebo, Mans Eegolofsson, Carlmagnus Petersson, Konrad KonradssonAbstract:To evaluate the cost-effectiveness of using an active Middle Ear implant (AMEI) Middle Ear implant for hEaring rehabilitation.Prospective, multicenter, single-subject repeated study in six tertiary...
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evaluation of cost utility in Middle Ear Implantation in the nordic school a multicenter study in sweden and norway
Acta Oto-laryngologica, 2014Co-Authors: Lennart Edfeldt, Karin Stromback, Joakim Grendin, Marie Bunne, Henrik Harder, Markus Peebo, Mans Eegolofsson, Carlmagnus Petersson, Konrad KonradssonAbstract:Conclusion: HEaring restoration using an active Middle Ear implant (AMEI) is a highly cost-effective treatment for a selected group of patients with no other possibilities for auditory rehabilitati ...