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.
Přehled studie
Postavení
Podmínky
Intervence / Léčba
Detailní popis
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.
Typ studie
Zápis (Odhadovaný)
Kontakty a umístění
Studijní kontakt
- Jméno: Jasmine Rinnofner
- Telefonní číslo: +43577881694
- E-mail: jasmine.rinnofner@medel.com
Studijní záloha kontaktů
- Jméno: Martin Eisendle
- Telefonní číslo: +43577881694
- E-mail: martin.eisendle@medel.com
Studijní místa
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Bern, Švýcarsko, 3010
- Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
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Kontakt:
- Martin Kompis, Prof. Dr. med. Dr. sc. techn.
- Telefonní číslo: +41316323300
- E-mail: martin.kompis@insel.ch
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Kontakt:
- Christoph Schmid
- Telefonní číslo: +41316323383
- E-mail: christoph.schmid@insel.ch
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Vrchní vyšetřovatel:
- Martin Kompis, Prof. Dr. med. Dr. sc. techn.
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Dílčí vyšetřovatel:
- Christoph Schmid
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Metoda odběru vzorků
Studijní populace
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
Kohorty a intervence
Skupina / kohorta |
Intervence / Léčba |
|---|---|
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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.
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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.
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Word Recognition Score in % correct over time
Časové okno: 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.
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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.
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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.
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Další výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Speech Recognition Threshold in noise (SRT 50) measured in dB SNR over time
Časové okno: 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.
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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.
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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.
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Speech, Spatial and Qualities of Hearing Scale (SSQ) 12
Časové okno: 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.
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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.
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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.
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Spolupracovníci a vyšetřovatelé
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Odhadovaný)
Primární dokončení (Odhadovaný)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Klíčová slova
Další relevantní podmínky MeSH
- Neurologické projevy
- Nemoci nervového systému
- Otorinolaryngologická onemocnění
- Poruchy vnímání
- Nemoci uší
- Poruchy sluchu
- Patologické stavy, příznaky a symptomy
- Příznaky a symptomy
- Ztráta sluchu
- Hluchota
- Diagnostické techniky a postupy
- Diagnóza
- Chirurgické postupy, operativní
- Implantace protézy
- Otorhinolaryngologické chirurgické zákroky
- Testy sluchu
- Diagnostické techniky, otologické
- Otologické chirurgické zákroky
- Kochleární implantace
- Audiometrie
Další identifikační čísla studie
- MED-EL_CRD_2026_02
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