Study Stopped
Original study purpose accomplished
Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
IROS
Cochlear-Implanted Recipient Observational Study
1 other identifier
observational
1,518
16 countries
77
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jul 2011
Longer than P75 for all trials
77 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 1, 2011
CompletedFirst Submitted
Initial submission to the registry
November 26, 2013
CompletedFirst Posted
Study publicly available on registry
December 9, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 23, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedResults Posted
Study results publicly available
November 8, 2021
CompletedNovember 8, 2021
November 1, 2020
9 years
November 26, 2013
September 2, 2021
October 8, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (6)
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
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 1 year is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
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 2 years is presented. A positive value indicates improved hearing, a negative value indicates impaired hearing.
Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
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.
Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
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 1 year is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
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 2 years is presented. A positive value indicates an improved quality of life, a negative value indicates impaired quality of life.
Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
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.
Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
Secondary Outcomes (4)
Unaided Hearing Thresholds
Baseline (i.e. pre-implant status) assessed prior to 1st switch-on
Unaided Hearing Thresholds
post-implant at 1 year
Unaided Hearing Thresholds
immediately post-implant
Unaided Hearing Thresholds
post-implant at 2 years
Study Arms (1)
Cochlear® Hearing Implants, hearing loss
Implanted Adolescents and Adults with permanent hearing loss
Interventions
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants
Eligibility Criteria
Primary care routine clinical patients, with permanent hearing loss seeking implant treatment for hearing rehabilitation. Adolescent and Adult patients have limited or no benefit from conventional acoustic hearing aids.
You may qualify if:
- 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
You may not qualify if:
- Individuals excluded from participation in a registry according to national or local regulations
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cochlearlead
Study Sites (77)
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)
Related Publications (3)
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.
PMID: 21221004BACKGROUNDNoble 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.
PMID: 18608531BACKGROUNDMauch 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.
PMID: 34823566DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Jasmin Kaur
- Organization
- Cochlear
Study Officials
- STUDY DIRECTOR
Bart Volckaerts
Cochlear
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Target Duration
- 2 Years
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 26, 2013
First Posted
December 9, 2013
Study Start
July 1, 2011
Primary Completion
June 23, 2020
Study Completion
July 31, 2020
Last Updated
November 8, 2021
Results First Posted
November 8, 2021
Record last verified: 2020-11
Data Sharing
- IPD Sharing
- Will not share