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.
연구 개요
상세 설명
This PMCF investigation will collect data on the long term use of the Mi2000 TICI retrospectively and prospectively.
연구 유형
등록 (추정된)
연락처 및 위치
연구 연락처
- 이름: Florian Schwarze, PhD
- 전화번호: +4357788
- 이메일: studies@medel.com
연구 장소
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Bavaria
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München, Bavaria, 독일, 81377
- 모병
- Klinikum der Universität München, Campus Großhadern
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연락하다:
- Joachim Müller, Prof. Dr.
- 이메일: Joachim.Mueller@med.uni-muenchen.de
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Würzburg, Bavaria, 독일, 97080
- 아직 모집하지 않음
- Universitätsklinikum Würzburg
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연락하다:
- Anja Kurz, Dr.
- 이메일: Kurz_A@ukw.de
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Liège, 벨기에, 4000
- 아직 모집하지 않음
- Centre Hospitalier Universitaire de Liège, Department ORL
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연락하다:
- Philippe Lefebvre, Prof. Dr.
- 이메일: pp.lefebvre@uliege.be
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Belgium
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Antwerp, Belgium, 벨기에, 2650
- 아직 모집하지 않음
- UZA Antwerpen
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연락하다:
- Vincent van Rompaey, Prof. Dr.
- 전화번호: vincent.vanrompaey@uza.be
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State of Vienna
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Vienna, State of Vienna, 오스트리아, 1090
- 아직 모집하지 않음
- AKH Wien
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연락하다:
- Christoph Arnoldner, Prof. Dr.
- 이메일: christoph.arnoldner@meduniwien.ac.at
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Nadarzyn, 폴란드, 05-830
- 아직 모집하지 않음
- The Institute of Physiology and Pathology of Hearing
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연락하다:
- Piotr Skarzynski, Prof. Dr.
- 이메일: p.skarzynski@csim.pl
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
This clinical investigation aims to enrol participants of previous clinical investigations, implanted with the Mi2000 TICI UNICO.
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 관찰 모델: COHORT
- 시간 관점: OTHER
코호트 및 개입
그룹/코호트 |
개입 / 치료 |
|---|---|
|
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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Word Test in Quiet
기간: Pre-op to 36 months after first fitting
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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
|
2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Nijmegen Cochlear Implant Questionnaire (NCIQ)
기간: Pre-op to 36 months after first fitting
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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)
기간: 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
|
기타 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Word test in quiet
기간: 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
|
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Sentence Test in Noise
기간: 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
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Health Utility Index Mark 3 (HUI3)
기간: through study completion, an average of 60 months after first fitting
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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
|
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Nijmegen Cochlear Implant Questionnaire (NCIQ)
기간: 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)
기간: 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
|
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Hearing Implant Sound Quality Index (HISQUI)
기간: through study completion, an average of 60 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 60 months after first fitting
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Tinnitus functional index (TFI)
기간: through study completion, an average of 60 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 60 months after first fitting
|
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Audiogram
기간: through study completion, an average of 60 months after first fitting
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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
|
공동 작업자 및 조사자
수사관
- 연구 책임자: Florian Schwarze, MED-EL
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MED-EL_CRD_2025_04
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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