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.
調査の概要
詳細な説明
This PMCF investigation will collect data on the long term use of the Mi2000 TICI retrospectively and prospectively.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Florian Schwarze, PhD
- 電話番号：+4357788
- メール：studies@medel.com
研究場所
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-
State of Vienna
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Vienna、State of Vienna、オーストリア、1090
- まだ募集していません
- AKH Wien
-
コンタクト：
- Christoph Arnoldner, Prof. Dr.
- メール：christoph.arnoldner@meduniwien.ac.at
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-
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Bavaria
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München、Bavaria、ドイツ、81377
- 募集
- Klinikum der Universität München, Campus Großhadern
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コンタクト：
- Joachim Müller, Prof. Dr.
- メール：Joachim.Mueller@med.uni-muenchen.de
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Würzburg、Bavaria、ドイツ、97080
- まだ募集していません
- Universitätsklinikum Würzburg
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コンタクト：
- Anja Kurz, Dr.
- メール：Kurz_A@ukw.de
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-
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Liège、ベルギー、4000
- まだ募集していません
- Centre Hospitalier Universitaire de Liège, Department ORL
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コンタクト：
- Philippe Lefebvre, Prof. Dr.
- メール：pp.lefebvre@uliege.be
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Belgium
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Antwerp、Belgium、ベルギー、2650
- まだ募集していません
- UZA Antwerpen
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コンタクト：
- Vincent van Rompaey, Prof. Dr.
- 電話番号：vincent.vanrompaey@uza.be
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Nadarzyn、ポーランド、05-830
- まだ募集していません
- The Institute of Physiology and Pathology of Hearing
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コンタクト：
- Piotr Skarzynski, Prof. Dr.
- メール：p.skarzynski@csim.pl
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-
参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
サンプリング方法
調査対象母集団
This clinical investigation aims to enrol participants of previous clinical investigations, implanted with the Mi2000 TICI UNICO.
説明
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
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 観測モデル：COHORT
- 時間の展望：OTHER
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
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. |
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Word Test in Quiet
時間枠：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
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Nijmegen Cochlear Implant Questionnaire (NCIQ)
時間枠：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)
時間枠：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
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Word test in quiet
時間枠：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
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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)
時間枠：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
時間枠：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
|
協力者と研究者
捜査官
- スタディディレクター：Florian Schwarze、MED-EL
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- MED-EL_CRD_2025_04
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
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