Last updated on April 2018

Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear


Brief description of study

The purpose of this study is to collect patient related benefit data following treatment for permanent hearing loss with a hearing implant from the company Cochlear over a period of 2 years post treatment.

Assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.

Detailed Study Description

The clinical investigation is designed as a prospective repeated measures longitudinal study with intra-subject controls, using a selection of subjective evaluation tools to assess patient related benefits from hearing implant treatment of permanent hearing loss.

Clinically standard self-assessment scales, threshold measures and a general hearing history profile questionnaires for the clinician and implant recipient are made available for selection through an interface to a central electronic platform.

The registry is aimed at collection of data for patients who have already made the decision together with their implant centre clinician for an implant device from the company Cochlear.

Patients are approached for registry participation following implant by the caring clinician on a consecutive and voluntary basis and on condition of signing the patient informed consent.

Monitoring of data entry is included through automated reminders via e-platform and through inherent audit trail.

Clinical Study Identifier: NCT02004353

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Herbert Mauch, Dipl.-Ing.

Centro de Implantes Cocleares
Buenos Aires, Argentina
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Herbert Mauch, Dipl.-Ing.

Implantes Cocleares Equipo Multicentrico (ICEM)
Buenos Aires, Argentina
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Centro de Investigaciones Otoaudiologicas (CIOA)
Caba, Argentina
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University Hospital Leuven
Leuven, Belgium
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Hospital Edmundo Vasconcelos
Sao Paulo, Brazil
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Clinica Orlant
Antioquia, Colombia
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Te Oigo
Barranquilla, Colombia
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Clinica Rivas
Bogota, Colombia
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Consultorio Gutierrez
Bogota, Colombia
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DIAUDIO
Bogota, Colombia
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Hospital de la Policia
Bogota, Colombia
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Hospital San Jose Infantil
Bogota, Colombia
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Hospital Universitario Clinica San Rafael
Bogota, Colombia
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Mediglobal
Bogota, Colombia
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Instituto para Ni os Ciegos y Sordos
Cali, Colombia
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Hospital Santa Sofia
Manizales, Colombia
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Clinica Sagrada Familia
Quindio, Colombia
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IPS San Rafael
Risaralda, Colombia
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Audiomedica
Santander, Colombia
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Consultorio Torres
Zipaquira, Colombia
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HNO Bad Aibling
Bad Aibling, Germany
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Universit ts-Hals-Nasen-Ohren-Klinik Essen
Essen, Germany
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Universit tsklinikum Frankfurt
Frankfurt am Main, Germany
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Universit tsklinik f r Hals-, Nasen- und Ohrenheilkunde
Freiburg, Germany
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Medizinische Hochschule Hannover
Hannover, Germany
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Universit tsklinikum Ulm
Ulm, Germany
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University of Wuerzburg
Wuerzburg, Germany
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University of Szeged
Szeged, Hungary
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Radboud University
Nijmegen, Netherlands
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Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, Poland
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Szpital Uniwersytecki nr 2 w Bydgoszczy
Bydgoszcz, Poland
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Wojewodzki Szpital Dzieciecy w Bydgoszczy
Bydgoszcz, Poland
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World Hearing Center
Kajetany, Poland
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Wojewodzki Szpital Zespolony w Koninie
Konin, Poland
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Instytut Centrum Zdrowia Matki Polki w Lodzi
Lodz, Poland
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Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
Lodz, Poland
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Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, Poland
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Wojewodzkie Centrum Medyczne w Opolu
Opole, Poland
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Samodzielny Publiczny Szpital Kliniczny nr 2 w Poznaniu
Poznan, Poland
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Samodzielny Publiczny Szpital Kliniczny nr 1 w Szczecinie
Szczecin, Poland
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Hospital CUF Porto
Porto, Portugal
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UKC Maribor
Maribor, Slovenia
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Stellenbosch University
Cape Town, South Africa
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Durban Cochlear Implant Pogramme, Parklands Hospital
Durban, South Africa
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Johannesburg Cochlear Implant Center, Wits Donald Gordon Medical Centre
Johannesburg, South Africa
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Hospital de la Ribera
Alzira, Spain
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Hospital de la Santa Creu i Sant Pau
Barcelona, Spain
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Hospital San Pedro de Alcantara
Caceres, Spain
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Fundacion Jimenez Diaz
Madrid, Spain
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Hospital General Universitario Gregorio Maranon
Madrid, Spain
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Hospital Clinica Universitad de Navarra
Pamplona, Spain
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Hospital Clinico Universitario de Salamanca
Salamanca, Spain
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Hospital Donostia
San Sebastian, Spain
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Hospital Clinico Universitario de Valencia
Valencia, Spain
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Hospital Universitario del Rio Hortega
Valladolid, Spain
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Hospital Clinico Universitario Lozano Blesa
Zaragoza, Spain
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Karolinska Hospital Huddinge
Stockholm, Sweden
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Osmangazi University Hospital
Eskisehir, Turkey
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Cerrahpasa University Hospital
Istanbul, Turkey
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Marmara University Hospital
Istanbul, Turkey
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Consultorio Navarro
Bogota, Colombia
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Consultorio Ordonez
Bogota, Colombia
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Consultorio Jaramillo
Manizales, Colombia
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Landesklinikum St. P lten
St. Pölten, Austria
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CHRU Lille
Lille, France
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KMG Kliniken GmbH G strow
Güstrow, Germany
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Eberhard-Karls-Universit t T bingen
Tübingen, Germany
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