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.
Studieoversikt
Status
Intervensjon / Behandling
Detaljert beskrivelse
This PMCF investigation will collect data on the long term use of the Mi2000 TICI retrospectively and prospectively.
Studietype
Registrering (Antatt)
Kontakter og plasseringer
Studiekontakt
- Navn: Florian Schwarze, PhD
- Telefonnummer: +4357788
- E-post: studies@medel.com
Studiesteder
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Liège, Belgia, 4000
- Har ikke rekruttert ennå
- Centre Hospitalier Universitaire de Liège, Department ORL
-
Ta kontakt med:
- Philippe Lefebvre, Prof. Dr.
- E-post: pp.lefebvre@uliege.be
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Belgium
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Antwerp, Belgium, Belgia, 2650
- Har ikke rekruttert ennå
- UZA Antwerpen
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Ta kontakt med:
- Vincent van Rompaey, Prof. Dr.
- Telefonnummer: vincent.vanrompaey@uza.be
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Nadarzyn, Polen, 05-830
- Har ikke rekruttert ennå
- The Institute of Physiology and Pathology of Hearing
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Ta kontakt med:
- Piotr Skarzynski, Prof. Dr.
- E-post: p.skarzynski@csim.pl
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Bavaria
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München, Bavaria, Tyskland, 81377
- Rekruttering
- Klinikum der Universität München, Campus Großhadern
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Ta kontakt med:
- Joachim Müller, Prof. Dr.
- E-post: Joachim.Mueller@med.uni-muenchen.de
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Würzburg, Bavaria, Tyskland, 97080
- Har ikke rekruttert ennå
- Universitätsklinikum Würzburg
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Ta kontakt med:
- Anja Kurz, Dr.
- E-post: Kurz_A@ukw.de
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State of Vienna
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Vienna, State of Vienna, Østerrike, 1090
- Har ikke rekruttert ennå
- AKH Wien
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Ta kontakt med:
- Christoph Arnoldner, Prof. Dr.
- E-post: christoph.arnoldner@meduniwien.ac.at
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Prøvetakingsmetode
Studiepopulasjon
This clinical investigation aims to enrol participants of previous clinical investigations, implanted with the Mi2000 TICI UNICO.
Beskrivelse
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
-
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
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: COHORT
- Tidsperspektiver: OTHER
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
|
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. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Word Test in Quiet
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Nijmegen Cochlear Implant Questionnaire (NCIQ)
Tidsramme: 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
|
|
Speech, Spatial, Quality of Hearing (SSQ12)
Tidsramme: Pre-op to 36 months after first fitting
|
Speech, Spatial and Quality of hearing scale from 0 to 10, higher numbers indicating better outcomes |
Pre-op to 36 months after first fitting
|
Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Word test in quiet
Tidsramme: 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
Tidsramme: through study completion, an average of 60 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 60 months after first fitting
|
|
Health Utility Index Mark 3 (HUI3)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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)
Tidsramme: 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
|
|
Audiogram
Tidsramme: 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
|
Samarbeidspartnere og etterforskere
Etterforskere
- Studieleder: Florian Schwarze, MED-EL
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Nevrologiske manifestasjoner
- Sykdommer i nervesystemet
- Otorhinolaryngologiske sykdommer
- Sensasjonsforstyrrelser
- Øresykdommer
- Hørselsforstyrrelser
- Patologiske tilstander, tegn og symptomer
- Tegn og symptomer
- Hørselstap
- Kirurgiske prosedyrer, operativ
- Proteseimplantasjon
- Otorhinolaryngologiske kirurgiske inngrep
- Otologiske kirurgiske inngrep
- Cochleaimplantasjon
Andre studie-ID-numre
- MED-EL_CRD_2025_04
Plan for individuelle deltakerdata (IPD)
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