Mi2000 TICI Follow-up (M2FU)
This Post-Market Clinical Follow-up (PMCF) investigation aims to further collect evidence on safety and performance of the Mi2000 TICI. This PMCF investigation will collect retrospective and prospective clinical data from the use of the Mi2000 TICI and related devices.
This PMCF investigation is performed on a new cochlear implant system, which was previously studied in two pre-market clinical investigations with limited follow-up duration. The purpose of the current clinical investigation is to collect further evidence by collecting clinical data on the use of the Mi2000 TICI.
The Mi2000 TICI is a state-of-the-art cochlear implant, designed to be totally implantable, indicated to treat severe to profound hearing loss, asymmetric hearing loss and single-sided deafness.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
This PMCF investigation will collect data on the long term use of the Mi2000 TICI retrospectively and prospectively.
Tipo de estudio
Inscripción (Estimado)
Contactos y Ubicaciones
Estudio Contacto
- Nombre: Florian Schwarze, PhD
- Número de teléfono: +4357788
- Correo electrónico: studies@medel.com
Ubicaciones de estudio
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Bavaria
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München, Bavaria, Alemania, 81377
- Reclutamiento
- Klinikum der Universität München, Campus Großhadern
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Contacto:
- Joachim Müller, Prof. Dr.
- Correo electrónico: Joachim.Mueller@med.uni-muenchen.de
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Würzburg, Bavaria, Alemania, 97080
- Aún no reclutando
- Universitätsklinikum Würzburg
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Contacto:
- Anja Kurz, Dr.
- Correo electrónico: Kurz_A@ukw.de
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State of Vienna
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Vienna, State of Vienna, Austria, 1090
- Aún no reclutando
- AKH Wien
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Contacto:
- Christoph Arnoldner, Prof. Dr.
- Correo electrónico: christoph.arnoldner@meduniwien.ac.at
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Liège, Bélgica, 4000
- Aún no reclutando
- Centre Hospitalier Universitaire de Liège, Department ORL
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Contacto:
- Philippe Lefebvre, Prof. Dr.
- Correo electrónico: pp.lefebvre@uliege.be
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Belgium
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Antwerp, Belgium, Bélgica, 2650
- Aún no reclutando
- UZA Antwerpen
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Contacto:
- Vincent van Rompaey, Prof. Dr.
- Número de teléfono: vincent.vanrompaey@uza.be
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Nadarzyn, Polonia, 05-830
- Aún no reclutando
- The Institute of Physiology and Pathology of Hearing
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Contacto:
- Piotr Skarzynski, Prof. Dr.
- Correo electrónico: p.skarzynski@csim.pl
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
This clinical investigation aims to enrol participants of previous clinical investigations, implanted with the Mi2000 TICI UNICO.
Descripción
Inclusion Criteria:
- Recipient of an Mi2000 TICI in one of the pre-market studies
- Signed and dated informed consent before the start of any study-specific procedure
Exclusion Criteria:
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Lack of compliance with any inclusion criterion
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Anything that, in the opinion of the Investigator, would
- place the subject at increased risk
- preclude the subject's full compliance with or completion of the study
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: COHORT
- Perspectivas temporales: OTHER
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
|---|---|
|
Mi2000 TICI UNICO recipients
Recipients of a MED-EL Mi2000 TICI UNICO in a previous clinical investigation. |
Participants in this clinical investigation received a totally implantable cochlear implant and will be followed-up for an extended period of time. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Word Test in Quiet
Periodo de tiempo: Pre-op to 36 months after first fitting
|
Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes |
Pre-op to 36 months after first fitting
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Periodo de tiempo: Pre-op to 36 months after first fitting
|
Disease specific Quality of Life, overall score is on a scale from 0 to 100, higher numbers indicating better outcomes |
Pre-op to 36 months after first fitting
|
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Speech, Spatial, Quality of Hearing (SSQ12)
Periodo de tiempo: Pre-op to 36 months after first fitting
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Speech, Spatial and Quality of hearing scale from 0 to 10, higher numbers indicating better outcomes |
Pre-op to 36 months after first fitting
|
Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Word test in quiet
Periodo de tiempo: through study completion, an average of 60 months after first fitting
|
Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes |
through study completion, an average of 60 months after first fitting
|
|
Sentence Test in Noise
Periodo de tiempo: through study completion, an average of 60 months after first fitting
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Oldenburg Matrix Test, results measured in dB signal-to-noise ratio (SNR) with a range of +30 to -10 dB SNR, lower values indicating better outcomes |
through study completion, an average of 60 months after first fitting
|
|
Health Utility Index Mark 3 (HUI3)
Periodo de tiempo: through study completion, an average of 60 months after first fitting
|
Health utility scale: 1.00: Perfect health. 0.00: Death. Negative values: States worse than death. |
through study completion, an average of 60 months after first fitting
|
|
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Periodo de tiempo: through study completion, an average of 60 months after first fitting
|
Disease specific Quality of Life, overall score is on a scale from 0 to 100, higher numbers indicating better outcomes |
through study completion, an average of 60 months after first fitting
|
|
Speech, Spatial, Quality of Hearing (SSQ12)
Periodo de tiempo: through study completion, an average of 60 months after first fitting
|
Speech, Spatial and Quality of hearing scale from 0 to 10, higher numbers indicating better outcomes |
through study completion, an average of 60 months after first fitting
|
|
Hearing Implant Sound Quality Index (HISQUI)
Periodo de tiempo: through study completion, an average of 60 months after first fitting
|
Sound quality score ranging from 19 (very poor sound quality) to 133 (very good sound quality) |
through study completion, an average of 60 months after first fitting
|
|
Tinnitus functional index (TFI)
Periodo de tiempo: through study completion, an average of 60 months after first fitting
|
Tinnitus questionnaire measures the severity and negative impact of tinnitus on a 0 (Not a Problem / Slight Tinnitus) to 100 (Very Big Problem / Very Severe Tinnitus) scale |
through study completion, an average of 60 months after first fitting
|
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Audiogram
Periodo de tiempo: through study completion, an average of 60 months after first fitting
|
Pure-tone air-conduction hearing thresholds will be measured in each ear. The threshold is the lowest sound level, in decibels hearing level (dB HL), at which the participant responds. The outcome is the threshold at each frequency. Higher thresholds mean poorer hearing; lower thresholds better hearing. |
through study completion, an average of 60 months after first fitting
|
Colaboradores e Investigadores
Patrocinador
Investigadores
- Director de estudio: Florian Schwarze, MED-EL
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Estimado)
Finalización del estudio (Estimado)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
- Manifestaciones neurológicas
- Enfermedades del Sistema Nervioso
- Enfermedades Otorrinolaringológicas
- Trastornos sensoriales
- Enfermedades del oído
- Trastornos de la audición
- Condiciones Patológicas, Signos y Síntomas
- Signos y síntomas
- Pérdida de la audición
- Procedimientos quirúrgicos, operativo
- Implantación de prótesis
- Procedimientos quirúrgicos otorhinolaringológicos
- Procedimientos quirúrgicos otológicos
- Implantación coclear
Otros números de identificación del estudio
- MED-EL_CRD_2025_04
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
producto fabricado y exportado desde los EE. UU.
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