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.
Обзор исследования
Статус
Вмешательство/лечение
Подробное описание
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.
Тип исследования
Регистрация (Оцененный)
Контакты и местонахождение
Контакты исследования
- Имя: Jasmine Rinnofner
- Номер телефона: +43577881694
- Электронная почта: jasmine.rinnofner@medel.com
Учебное резервное копирование контактов
- Имя: Martin Eisendle
- Номер телефона: +43577881694
- Электронная почта: martin.eisendle@medel.com
Места учебы
-
-
-
Bern, Швейцария, 3010
- Inselspital, Universitätsspital Bern, Department of Otolaryngology, Head and Neck Surgery, Audiology
-
Контакт:
- Martin Kompis, Prof. Dr. med. Dr. sc. techn.
- Номер телефона: +41316323300
- Электронная почта: martin.kompis@insel.ch
-
Контакт:
- Christoph Schmid
- Номер телефона: +41316323383
- Электронная почта: christoph.schmid@insel.ch
-
Главный следователь:
- Martin Kompis, Prof. Dr. med. Dr. sc. techn.
-
Младший исследователь:
- Christoph Schmid
-
-
Критерии участия
Критерии приемлемости
Возраст, подходящий для обучения
- Ребенок
- Взрослый
- Пожилой взрослый
Принимает здоровых добровольцев
Метод выборки
Исследуемая популяция
Описание
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
Учебный план
Как устроено исследование?
Детали дизайна
Когорты и вмешательства
Группа / когорта |
Вмешательство/лечение |
|---|---|
|
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.
Другие имена:
|
Что измеряет исследование?
Первичные показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Word Recognition Score in % correct over time
Временное ограничение: 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.
|
Другие показатели результатов
Мера результата |
Мера Описание |
Временное ограничение |
|---|---|---|
|
Speech Recognition Threshold in noise (SRT 50) measured in dB SNR over time
Временное ограничение: 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
Временное ограничение: 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.
|
Соавторы и исследователи
Даты записи исследования
Изучение основных дат
Начало исследования (Оцененный)
Первичное завершение (Оцененный)
Завершение исследования (Оцененный)
Даты регистрации исследования
Первый отправленный
Впервые представлено, что соответствует критериям контроля качества
Первый опубликованный (Действительный)
Обновления учебных записей
Последнее опубликованное обновление (Действительный)
Последнее отправленное обновление, отвечающее критериям контроля качества
Последняя проверка
Дополнительная информация
Термины, связанные с этим исследованием
Ключевые слова
Дополнительные соответствующие термины MeSH
- Неврологические проявления
- Заболевания нервной системы
- Оториноларингологические заболевания
- Расстройства чувствительности
- Ушные заболевания
- Нарушения слуха
- Патологические состояния, признаки и симптомы
- Признаки и симптомы
- Потеря слуха
- Глухота
- Диагностические методы и процедуры
- Диагноз
- Хирургические процедуры, оперативные
- Имплантация протеза
- Оториноларингологические хирургические процедуры
- Слуховые испытания
- Диагностические методы, Отологические
- Отологические хирургические процедуры
- Кохлеарная имплантация
- Аудиометрия
Другие идентификационные номера исследования
- MED-EL_CRD_2026_02
Планирование данных отдельных участников (IPD)
Планируете делиться данными об отдельных участниках (IPD)?
Информация о лекарствах и устройствах, исследовательские документы
Изучает лекарственный продукт, регулируемый FDA США.
Изучает продукт устройства, регулируемый Управлением по санитарному надзору за качеством пищевых продуктов и медикаментов США.
продукт, произведенный в США и экспортированный из США.
Эта информация была получена непосредственно с веб-сайта clinicaltrials.gov без каких-либо изменений. Если у вас есть запросы на изменение, удаление или обновление сведений об исследовании, обращайтесь по адресу register@clinicaltrials.gov. Как только изменение будет реализовано на clinicaltrials.gov, оно будет автоматически обновлено и на нашем веб-сайте. .