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Retrospective Analysis of Performance and Safety of MED-EL Cochlear Implants. (BELPS)

7 settembre 2026 aggiornato da: MED-EL Elektromedizinische Geräte GesmbH

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

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.

Tipo di studio

Osservativo

Iscrizione (Stimato)

700

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Backup dei contatti dello studio

Luoghi di studio

  • Svizzera
      • Bern, Svizzera, 3010
        • Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Martin Kompis, Prof. Dr. med. Dr. sc. techn.
        • Sub-investigatore:
          • Christoph Schmid

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Bambino
  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Metodo di campionamento

Campione non probabilistico

Popolazione di studio

The study population 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.

Descrizione

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

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

Coorti e interventi

Gruppo / Coorte
Intervento / Trattamento
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.
Dispositivo: Cochlear implantation
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.
Altri nomi:
  • CI
  • Hearing implant

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Word Recognition Score in % correct over time
Lasso di tempo: 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.

Altre misure di risultato

Misura del risultato
Misura Descrizione
Lasso di tempo
Speech Recognition Threshold in noise (SRT 50) measured in dB SNR over time
Lasso di tempo: 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
Lasso di tempo: 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.

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Collaboratori

Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 ottobre 2026

Completamento primario (Stimato)

1 novembre 2026

Completamento dello studio (Stimato)

1 novembre 2026

Date di iscrizione allo studio

Primo inviato

11 agosto 2026

Primo inviato che soddisfa i criteri di controllo qualità

17 agosto 2026

Primo Inserito (Effettivo)

20 agosto 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

9 settembre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

7 settembre 2026

Ultimo verificato

1 settembre 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • MED-EL_CRD_2026_02

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

Sì

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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