Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
- Conditions
- Hearing Loss
- Interventions
- Device: Cochlear® Hearing Implants
- Registration Number
- NCT02004353
- Lead Sponsor
- Cochlear
- Brief Summary
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 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.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 1518
- Post-lingually deafened adults and adolescents who are newly implanted AND prior to first switch-on of their external device
- 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
- Individuals excluded from participation in a registry according to national or local regulations
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Cochlear® Hearing Implants, hearing loss Cochlear® Hearing Implants Implanted Adolescents and Adults with permanent hearing loss
- Primary Outcome Measures
Name Time Method Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years A health utility value of 1.00 indicates perfect health while a score of 0.00 indicates death. The change from baseline to post-implant at 3 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years A scale from 0 to 10 is used, where 0 represents "can not hear at all" and 10 "hear perfectly". The change from baseline to post-implant at 3 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
- Secondary Outcome Measures
Name Time Method Unaided Hearing Thresholds post-implant at 2 years Unaided hearing thresholds for bone and air conduction for the implanted and non-implanted ear to monitor clinically significant changes over time for frequencies between 125Hz and 8000 Hz
Trial Locations
- Locations (77)
University Hospital Leuven
🇧🇪Leuven, Belgium
Landesklinikum St. Pölten
🇦🇹St. Pölten, Austria
Mediglobal
🇨🇴Bogota, Colombia
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
Hospital Edmundo Vasconcelos
🇧🇷Sao Paulo, Brazil
Clinica Orlant
🇨🇴Antioquia, Colombia
Te Oigo
🇨🇴Barranquilla, Colombia
Clinica Rivas
🇨🇴Bogota, Colombia
Consultorio Gutierrez
🇨🇴Bogota, Colombia
Consultorio Navarro
🇨🇴Bogota, Colombia
Consultorio Ordonez
🇨🇴Bogota, Colombia
DIAUDIO
🇨🇴Bogota, Colombia
Hospital de la Policia
🇨🇴Bogota, Colombia
Hospital San Jose Infantil
🇨🇴Bogota, Colombia
Consultorio Prieto
🇨🇴Bogotá, Colombia
Hospital Universitario Clinica San Rafael
🇨🇴Bogota, Colombia
Consultório Plaza
🇨🇴Bogotá, Colombia
Disaudio
🇨🇴Bogotá, Colombia
Instituto Nacional de Otologia Garcia Gomez
🇨🇴Bogotá, Colombia
Consultório Velez
🇨🇴Cartagena, Colombia
Consultório Mosquera
🇨🇴Ibague, Colombia
Consultorio Jaramillo
🇨🇴Manizales, Colombia
Hospital Santa Sofia
🇨🇴Manizales, Colombia
IPS San Rafael
🇨🇴Risaralda, Colombia
Audiomedica
🇨🇴Santander, Colombia
Consultorio Torres
🇨🇴Zipaquira, Colombia
HNO Bad Aibling
🇩🇪Bad Aibling, Germany
Universitäts-Hals-Nasen-Ohren-Klinik Essen
🇩🇪Essen, Germany
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
🇩🇪Freiburg, Germany
KMG Kliniken GmbH Güstrow
🇩🇪Güstrow, Germany
Medizinische Hochschule Hannover
🇩🇪Hannover, Germany
Helios München West
🇩🇪Münich, Germany
Universitätsklinikum Ulm
🇩🇪Ulm, Germany
University of Wuerzburg
🇩🇪Wuerzburg, Germany
University of Szeged
🇭🇺Szeged, Hungary
Uniwersytecki Szpital Kliniczny w Bialymstoku
🇵🇱Bialystok, Poland
Radboud University
🇳🇱Nijmegen, Netherlands
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
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
Hospital de la Ribera
🇪🇸Alzira, Spain
Johannesburg Cochlear Implant Center, Wits Donald Gordon Medical Centre
🇿🇦Johannesburg, South Africa
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital San Pedro de Alcantara
🇪🇸Caceres, Spain
Fundacion Jimenez Diaz
🇪🇸Madrid, Spain
Hospital General Universitario Gregorio Maranon
🇪🇸Madrid, Spain
Hospital Clinica Universitad de Navarra
🇪🇸Pamplona, Spain
Hospital Clinico Universitario de Valencia
🇪🇸Valencia, Spain
Hospital Donostia
🇪🇸San Sebastian, Spain
Hospital Universitario del Rio Hortega
🇪🇸Valladolid, Spain
Hospital Clinico Universitario Lozano Blesa
🇪🇸Zaragoza, Spain
Karolinska Hospital Huddinge
🇸🇪Stockholm, Sweden
CHRU Lille
🇫🇷Lille, France
Osmangazi University Hospital
🇹🇷Eskisehir, Turkey
Cerrahpasa University Hospital
🇹🇷Istanbul, Turkey
Marmara University Hospital
🇹🇷Istanbul, Turkey
Hospital Clinico Universitario de Salamanca
🇪🇸Salamanca, Spain
Universitätsklinikum Frankfurt
🇩🇪Frankfurt am Main, Germany
Eberhard-Karls-Universität Tübingen
🇩🇪Tübingen, Germany
Instituto para Niños Ciegos y Sordos
🇨🇴Cali, Colombia
Clinica Sagrada Familia
🇨🇴Quindio, Colombia
Instytut Centrum Zdrowia Matki Polki w Lodzi
🇵🇱Lodz, Poland