Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
NCT ID: NCT02004353
Last Updated: 2021-11-08
Study Results
Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.
View full resultsBasic Information
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TERMINATED
1518 participants
OBSERVATIONAL
2011-07-31
2020-07-31
Brief Summary
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Assessment of benefits is based on standard questionnaires of hearing ability and quality of life in general.
Detailed Description
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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.
Conditions
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Keywords
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Cochlear® Hearing Implants, hearing loss
Implanted Adolescents and Adults with permanent hearing loss
Cochlear® Hearing Implants
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants
Interventions
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Cochlear® Hearing Implants
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants
Eligibility Criteria
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Inclusion Criteria
* Unilateral, bilateral simultaneous recipients of any implant device(s) available with market approval from the company Cochlear®
* Children 10 years or older and in accordance with local regulations and product labelling
* Mentally capable to respond to self-administered assessment scales
* Willingness to participate and sign the Patient Informed Consent form
Exclusion Criteria
10 Years
ALL
No
Sponsors
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Cochlear
INDUSTRY
Responsible Party
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Principal Investigators
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Bart Volckaerts
Role: STUDY_DIRECTOR
Cochlear
Locations
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Centro de Implantes Cocleares
Buenos Aires, , Argentina
Implantes Cocleares Equipo Multicentrico (ICEM)
Buenos Aires, , Argentina
Centro de Investigaciones Otoaudiologicas (CIOA)
Caba, , Argentina
Clinca Reina Fabiola
Córdoba, , Argentina
Landesklinikum St. Pölten
Sankt Pölten, , Austria
University Hospital Leuven
Leuven, , Belgium
Hospital Edmundo Vasconcelos
São Paulo, , Brazil
Clinica Orlant
Antioquia, , Colombia
Te Oigo
Barranquilla, , Colombia
Clinica Rivas
Bogotá, , Colombia
Consultorio Gutierrez
Bogotá, , Colombia
Consultorio Navarro
Bogotá, , Colombia
Consultorio Ordonez
Bogotá, , Colombia
Consultorio Prieto
Bogotá, , Colombia
Consultório Plaza
Bogotá, , Colombia
DIAUDIO
Bogotá, , Colombia
Disaudio
Bogotá, , Colombia
Hospital de la Policia
Bogotá, , Colombia
Hospital San Jose Infantil
Bogotá, , Colombia
Hospital Universitario Clinica San Rafael
Bogotá, , Colombia
Instituto Nacional de Otologia Garcia Gomez
Bogotá, , Colombia
Mediglobal
Bogotá, , Colombia
Instituto para Niños Ciegos y Sordos
Cali, , Colombia
Consultório Velez
Cartagena, , Colombia
Consultório Mosquera
Ibagué, , Colombia
Consultorio Jaramillo
Manizales, , Colombia
Hospital Santa Sofia
Manizales, , Colombia
Clinica Sagrada Familia
Quindío, , Colombia
IPS San Rafael
Risaralda, , Colombia
Audiomedica
Santander, , Colombia
Consultorio Torres
Zipaquirá, , Colombia
CHRU Lille
Lille, , France
HNO Bad Aibling
Bad Aibling, , Germany
Universitäts-Hals-Nasen-Ohren-Klinik Essen
Essen, , Germany
Universitätsklinikum Frankfurt
Frankfurt am Main, , Germany
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Freiburg im Breisgau, , Germany
KMG Kliniken GmbH Güstrow
Güstrow, , Germany
Medizinische Hochschule Hannover
Hanover, , Germany
Helios München West
Münich, , Germany
Eberhard-Karls-Universität Tübingen
Tübingen, , Germany
Universitätsklinikum Ulm
Ulm, , Germany
University of Wuerzburg
Würzburg, , Germany
University of Szeged
Szeged, , Hungary
Radboud University
Nijmegen, , Netherlands
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok, , Poland
Szpital Uniwersytecki nr 2 w Bydgoszczy
Bydgoszcz, , Poland
Wojewodzki Szpital Dzieciecy w Bydgoszczy
Bydgoszcz, , Poland
World Hearing Center
Kajetany, , Poland
Wojewodzki Szpital Zespolony w Koninie
Konin, , Poland
Instytut Centrum Zdrowia Matki Polki w Lodzi
Lodz, , Poland
Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
Lodz, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin, , Poland
Wojewodzkie Centrum Medyczne w Opolu
Opole, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 2 w Poznaniu
Poznan, , Poland
Samodzielny Publiczny Szpital Kliniczny nr 1 w Szczecinie
Szczecin, , Poland
CUF Infante Santo Hospital
Lisbon, , Portugal
Hospital Lusiadas Lisboa
Lisbon, , Portugal
Hospital CUF Porto
Porto, , Portugal
UKC Maribor
Maribor, , Slovenia
Stellenbosch University
Cape Town, , South Africa
Durban Cochlear Implant Pogramme, Parklands Hospital
Durban, , South Africa
Johannesburg Cochlear Implant Center, Wits Donald Gordon Medical Centre
Johannesburg, , South Africa
Hospital de la Ribera
Alzira, , Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital San Pedro de Alcantara
Cáceres, , Spain
Hospital Donostia
Donostia / San Sebastian, , Spain
Fundacion Jimenez Diaz
Madrid, , Spain
Hospital General Universitario Gregorio Maranon
Madrid, , Spain
Hospital Clinica Universitad de Navarra
Pamplona, , Spain
Hospital Clinico Universitario de Salamanca
Salamanca, , Spain
Hospital Clinico Universitario de Valencia
Valencia, , Spain
Hospital Universitario del Rio Hortega
Valladolid, , Spain
Hospital Clinico Universitario Lozano Blesa
Zaragoza, , Spain
Karolinska Hospital Huddinge
Stockholm, , Sweden
Osmangazi University Hospital
Eskişehir, , Turkey (Türkiye)
Cerrahpasa University Hospital
Istanbul, , Turkey (Türkiye)
Marmara University Hospital
Istanbul, , Turkey (Türkiye)
Countries
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References
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Maes IH, Joore MA, Cima RF, Vlaeyen JW, Anteunis LJ. Assessment of health state in patients with tinnitus: a comparison of the EQ-5D and HUI mark III. Ear Hear. 2011 Jul-Aug;32(4):428-35. doi: 10.1097/AUD.0b013e3181fdf09f.
Noble W, Tyler R, Dunn C, Bhullar N. Unilateral and bilateral cochlear implants and the implant-plus-hearing-aid profile: comparing self-assessed and measured abilities. Int J Audiol. 2008 Aug;47(8):505-14. doi: 10.1080/14992020802070770.
Mauch H, Kaur J, Irwin C, Wyss J. Design, implementation, and management of an international medical device registry. Trials. 2021 Nov 25;22(1):845. doi: 10.1186/s13063-021-05821-5.
Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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CEL 5277
Identifier Type: -
Identifier Source: org_study_id