Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants. (BELPS)
Bern Long-term Performance and Safety of MED-EL Cochlear Implants: a Retrospective Anonymized Analysis of Existing Data From the Local Clinical Database
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized. The data extraction is performed as a one-time process. Following the analysis of the extracted dataset, the study is considered complete.
The study does not foresee any active participation of patients or seeking for consent.
This retrospective anonymized database analysis is performed on all MED-EL cochlear implants registered in the local database of the Department of Otolaryngology, Head and Neck Surgery, Audiology, Inselspital, University of Bern.
The aim of this project is to generate evidence on the clinical effectiveness of cochlear implants based on long term real-world data gathered from clinical routine across a large and diverse population.
Assessed performance outcome measures include word test in quiet results, speech perception in noise results, and patient related outcome measures/questionnaires, as available. Safety assessment is based on data related to revision surgeries, explantations, reimplantations, and any other recorded device related complications. Imaging data (X-ray, CT, MRI) are not used in this study.
調査の概要
詳細な説明
This study is a single center, non-interventional, retrospective, post-market observational study. Data will be extracted retrospectively from the local clinical database of the site and will be fully anonymized. The data extraction is performed as a one-time process. Following the analysis of the extracted dataset, the study is considered complete.
The study does not foresee any active participation of patients or seeking for consent.
This retrospective anonymized database analysis is performed on all MED-EL cochlear implants registered in the local database of the Department of Otolaryngology, Head and Neck Surgery, Audiology, Inselspital, University of Bern.
The aim of this project is to generate evidence on the clinical effectiveness of cochlear implants based on long term real-world data gathered from clinical routine across a large and diverse population.
Assessed performance outcome measures include word test in quiet results, speech perception in noise results, and patient related outcome measures/questionnaires, as available. Safety assessment is based on data related to revision surgeries, explantations, reimplantations, and any other recorded device related complications. Imaging data (X-ray, CT, MRI) are not used in this study.
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Jasmine Rinnofner
- 電話番号：+43577881694
- メール：jasmine.rinnofner@medel.com
研究連絡先のバックアップ
- 名前：Martin Eisendle
- 電話番号：+43577881694
- メール：martin.eisendle@medel.com
研究場所
-
-
-
Bern、スイス、3010
- Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
-
コンタクト：
- Martin Kompis, Prof. Dr. med. Dr. sc. techn.
- 電話番号：+41316323300
- メール：martin.kompis@insel.ch
-
コンタクト：
- Christoph Schmid
- 電話番号：+41316323383
- メール：christoph.schmid@insel.ch
-
主任研究者：
- Martin Kompis, Prof. Dr. med. Dr. sc. techn.
-
副調査官：
- Christoph Schmid
-
-
参加基準
適格基準
就学可能な年齢
- 子
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Implanted with a MED-EL cochlear implant
- First implantation at Inselspital Bern
- Implanted later than 31st December 1995
Exclusion Criteria:
- Lack of compliance with any inclusion criteria
- Patients implanted with either a custom-made device or with a study device prior CE-marking
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
|
MED-EL cochlear implant recipients
The cohort includes all patients registered in the sites local database who were implanted with an approved MED-EL cochlear implant at the investigational site since 01st January 1996.
To be included for analysis data from the pre-operative assessment and from at least one post-operative assessment must be available.
|
The cochlear implant (CI) is one of the most successful neural prostheses developed to date.
It offers artificial hearing to individuals with profound sensorineural hearing loss and with insufficient benefit from conventional hearing aids.
The first implants provided a limited sensation of sound.
The benefit for users of these early systems was mostly a facilitation of lip-reading based communication rather than an understanding of speech.
Considerable progress has been made since then.
Today, cochlear implantation is the recommended treatment for subjects presenting with a permanent sensorineural hearing loss.
Modern, multichannel implant systems feature complex speech processing strategies, high stimulation rates and multiple sites of stimulation in the cochlea.
Equipped with such a state-of-the-art system, the majority of recipients today can communicate orally without visual cues and can even use the telephone.
他の名前：
|
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 Recognition Score in % correct over time
時間枠：Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.
|
The primary objective of this retrospective observational study is to evaluate speech performance in quiet over time of MED-EL cochlear implant users, measured as the percentage of words recognized correctly.
|
Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.
|
その他の成果指標
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Speech Recognition Threshold in noise (SRT 50) measured in dB SNR over time
時間枠：Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.
|
SRT in noise is defined as the level difference in decibels (dB SNR) between speech signal and noise at which 50% (SRT50) of the words presented can be correctly identified.
SNR is a measure of the relative levels of a desired signal (such as speech) compared to background noise.
It is expressed in decibels (dB SNR) and indicates how much louder the signal is than the noise.
|
Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.
|
|
Speech, Spatial and Qualities of Hearing Scale (SSQ) 12
時間枠：Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.
|
The Speech, Spatial, and Qualities of Hearing Scale (SSQ12) questionnaire is a 12 item sensitive and specific measure to assess the impact of hearing loss on speech perception, sound localization, and QoL.
The SSQ12 minimum score is 0, the maximum score is 120.
The higher the score obtained, the lower the difficulty experienced by the patient.
|
Outcome measures will be assessed based on availablity of the respective data from pre-operative assessment through the following post-implantation follow-up periods: 6 weeks, 6 months, 1-, 2-, 5-, 10-, 15-, 20-years and last available follow-up.
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (推定)
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_2026_02
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。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。