Mi2000 TICI - Post-market Implantation Study (TUPIS)
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 prospectively collect clinical data from the use of the Mi2000 TICI and related devices.
This PMCF investigation is performed on a cochlear implant system newly introduced to the market, which was previously studied in two pre-market clinical investigations. The purpose of the current clinical investigation is to collect further evidence by collecting additional clinical data on the use of the Mi2000 TICI.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Estimado)
Fase
- No aplica
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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Würzburg, Alemania
- Aún no reclutando
- Universitätsklinikum Würzburg
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Contacto:
- Kristen Rak, Prof. Dr.
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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, Dr.med.
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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, Dr.med.
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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.
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Poland
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Nadarzyn, Poland, Polonia, 05-830
- Aún no reclutando
- The Institute of Physiology and Pathology of Hearing
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Contacto:
- Piotr Skarzynski, Prof. Dr.
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
Inclusion Criteria:
- Minimum age of eighteen (18) years at time of enrolment
- Bilateral sensorineural hearing loss with no or limited benefit from a hearing aid (>70 dB HL PTA4(500, 1000, 2000, 4000Hz))
- Post-lingual onset of deafness
- No or limited benefit from hearing aids for less than 10 years and an expected benefit from cochlear implantation
- A maximum score of 50% on a word test in the language of the test center in the ear to be implanted in the best aided condition
- Fluency in the test language with excellent proficiency, as appropriate to perform speech testing
- Functional auditory nerve
- General health condition, psychological and emotional condition deemed compatible with the treatment and tests performed in this study
- Pre-operative assessment according to the local professional standards
- Candidate is highly motivated and has realistic expectations about the expected benefit of the implant and shall understand the importance of returning to the implant center for regular speech processor programming, assessment sessions and training
- Realistic expectations, as deemed appropriate by the implanting surgeon/implant board
- 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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Previously having received an implant on the location chosen for placing the cochlear implant
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Having received a hearing implant from another manufacturer than MED-EL on the contralateral ear
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Pre-existing condition known to necessitate MRI scans after implantation of the Mi2000 TICI
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Women being pregnant or nursing
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The individual is known to be intolerant of the materials used in the implant or other required accessories
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Absence of cochlear development
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The cause of deafness is non-functionality of the auditory nerve and/or the upper auditory pathway
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Medical contra-indications to middle ear and/or inner ear surgery, and/or anesthesia
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External or middle ear infections are present
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The tympanic membrane is perforated in the ear to be implanted
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Anatomic abnormalities are present that would prevent appropriate placement of the stimulator housing in the bone of the skull, or prevent placement of the chosen electrode array into the cochlea (including ossification of the cochlea)
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The psychological status of the individual is unstable
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The individual has unrealistic expectations
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Acute cholesteatoma
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History of vestibular schwannoma
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Unstable Meniere's disease
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Auditory Neuropathy
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Epilepsy not responding to treatment
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Permanent inability and/or unwillingness to participation in post-operative care and rehabilitation
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Known intellectual disability and/or psychological diseases
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Participation in other pharmacological clinical trials within four weeks prior to enrolment
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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
- Propósito principal: Tratamiento
- Asignación: N / A
- Modelo Intervencionista: Asignación de un solo grupo
- Enmascaramiento: Ninguno (etiqueta abierta)
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: TICI recipients
Participants in this clinical investigation will be implanted with an Mi2000 TICI totally cochlear implant |
Participants in this clinical investigation will receive a totally implantable cochlear implant. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Word Test in Quiet
Periodo de tiempo: Pre-op to 6 months after first fitting
|
Word recognition in quiet, on a scale from 0 to 100% correct, higher scores indicate better outcomes |
Pre-op to 6 months after first fitting
|
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Sentence Test in Noise
Periodo de tiempo: Pre-op to 6 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 |
Pre-op to 6 months after first fitting
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Health Utility Index Mark 3 (HUI3)
Periodo de tiempo: Pre-op to 6 months after first fitting
|
Health utility scale: 1.00: Perfect health. 0.00: Death. Negative values: States worse than death. |
Pre-op to 6 months after first fitting
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Nijmegen Cochlear Implant Questionnaire (NCIQ)
Periodo de tiempo: Pre-op to 6 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 6 months after first fitting
|
|
Change in body sound perception
Periodo de tiempo: through study completion, an average of 12 months after first fitting
|
Participant reported scale on body sound perception (0 - no disturbance to 10 - very disturbing) |
through study completion, an average of 12 months after first fitting
|
|
Change in stigma perception
Periodo de tiempo: through study completion, an average of 12 months after first fitting
|
Participant reported scale on stigma perception (0 - no stigmatization to 10 - strong stigmatization) |
through study completion, an average of 12 months after first fitting
|
|
Change in comfort perception
Periodo de tiempo: through study completion, an average of 12 months after first fitting
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Participant reported scale on stigma perception (0 - not comfortable to 10 - very comfortable) |
through study completion, an average of 12 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 12 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 12 months after first fitting
|
|
Sentence Test in Noise
Periodo de tiempo: through study completion, an average of 12 months after first fitting
|
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 12 months after first fitting
|
|
Health Utility Index Mark 3 (HUI3)
Periodo de tiempo: through study completion, an average of 12 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 12 months after first fitting
|
|
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Periodo de tiempo: through study completion, an average of 12 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 12 months after first fitting
|
|
Speech, Spatial, Quality of Hearing (SSQ12)
Periodo de tiempo: through study completion, an average of 12 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 12 months after first fitting
|
|
Hearing Implant Sound Quality Index (HISQUI)
Periodo de tiempo: through study completion, an average of 12 months after first fitting
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Sound quality score ranging from 19 (very poor sound quality) to 133 (very good sound quality) |
through study completion, an average of 12 months after first fitting
|
|
Tinnitus Functional Index (TFI)
Periodo de tiempo: through study completion, an average of 12 months after first fitting
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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 12 months after first fitting
|
|
Audiogram
Periodo de tiempo: through study completion, an average of 12 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 12 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_2026_03
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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