Clinical trial NCT02004353: Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
Official title: Cochlear-Implanted Recipient Observational Study
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Hearing Loss
Keywords: Cochlear® Hearing Implants
Lead sponsor: Cochlear
Sponsor class: INDUSTRY
First posted: 2013-12-09
Enrollment: 1518
Sex: ALL
Minimum age (years): 10
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

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.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* Individuals excluded from participation in a registry according to national or local regulations

Primary outcomes:
measure: Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
timeFrame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
measure: Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
timeFrame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years
measure: Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
timeFrame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
measure: Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
timeFrame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
measure: Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
timeFrame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years
measure: Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire
timeFrame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
Secondary outcomes:
measure: Unaided Hearing Thresholds
timeFrame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on
measure: Unaided Hearing Thresholds
timeFrame: post-implant at 1 year
measure: Unaided Hearing Thresholds
timeFrame: immediately post-implant
measure: Unaided Hearing Thresholds
timeFrame: post-implant at 2 years
Other outcomes:
Locations:
city: Buenos Aires
country: Argentina
facility: Centro de Implantes Cocleares
city: Buenos Aires
country: Argentina
facility: Implantes Cocleares Equipo Multicentrico (ICEM)
city: Caba
country: Argentina
facility: Centro de Investigaciones Otoaudiologicas (CIOA)
city: Córdoba
country: Argentina
facility: Clinca Reina Fabiola
city: St. Pölten
country: Austria
facility: Landesklinikum St. Pölten
city: Leuven
country: Belgium
facility: University Hospital Leuven
city: Sao Paulo
country: Brazil
facility: Hospital Edmundo Vasconcelos
city: Antioquia
country: Colombia
facility: Clinica Orlant
city: Barranquilla
country: Colombia
facility: Te Oigo
city: Bogota
country: Colombia
facility: Clinica Rivas
city: Bogota
country: Colombia
facility: Consultorio Gutierrez
city: Bogota
country: Colombia
facility: Consultorio Navarro
city: Bogota
country: Colombia
facility: Consultorio Ordonez
city: Bogota
country: Colombia
facility: DIAUDIO
city: Bogota
country: Colombia
facility: Hospital de la Policia
city: Bogota
country: Colombia
facility: Hospital San Jose Infantil
city: Bogota
country: Colombia
facility: Hospital Universitario Clinica San Rafael
city: Bogota
country: Colombia
facility: Mediglobal
city: Bogotá
country: Colombia
facility: Consultorio Prieto
city: Bogotá
country: Colombia
facility: Consultório Plaza
city: Bogotá
country: Colombia
facility: Disaudio
city: Bogotá
country: Colombia
facility: Instituto Nacional de Otologia Garcia Gomez
city: Cali
country: Colombia
facility: Instituto para Niños Ciegos y Sordos
city: Cartagena
country: Colombia
facility: Consultório Velez
city: Ibague
country: Colombia
facility: Consultório Mosquera
city: Manizales
country: Colombia
facility: Consultorio Jaramillo
city: Manizales
country: Colombia
facility: Hospital Santa Sofia
city: Quindio
country: Colombia
facility: Clinica Sagrada Familia
city: Risaralda
country: Colombia
facility: IPS San Rafael
city: Santander
country: Colombia
facility: Audiomedica
city: Zipaquira
country: Colombia
facility: Consultorio Torres
city: Lille
country: France
facility: CHRU Lille
city: Bad Aibling
country: Germany
facility: HNO Bad Aibling
city: Essen
country: Germany
facility: Universitäts-Hals-Nasen-Ohren-Klinik Essen
city: Frankfurt am Main
country: Germany
facility: Universitätsklinikum Frankfurt
city: Freiburg
country: Germany
facility: Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
city: Güstrow
country: Germany
facility: KMG Kliniken GmbH Güstrow
city: Hannover
country: Germany
facility: Medizinische Hochschule Hannover
city: Münich
country: Germany
facility: Helios München West
city: Tübingen
country: Germany
facility: Eberhard-Karls-Universität Tübingen
city: Ulm
country: Germany
facility: Universitätsklinikum Ulm
city: Wuerzburg
country: Germany
facility: University of Wuerzburg
city: Szeged
country: Hungary
facility: University of Szeged
city: Nijmegen
country: Netherlands
facility: Radboud University
city: Bialystok
country: Poland
facility: Uniwersytecki Szpital Kliniczny w Bialymstoku
city: Bydgoszcz
country: Poland
facility: Szpital Uniwersytecki nr 2 w Bydgoszczy
city: Bydgoszcz
country: Poland
facility: Wojewodzki Szpital Dzieciecy w Bydgoszczy
city: Kajetany
country: Poland
facility: World Hearing Center
city: Konin
country: Poland
facility: Wojewodzki Szpital Zespolony w Koninie
city: Lodz
country: Poland
facility: Instytut Centrum Zdrowia Matki Polki w Lodzi
city: Lodz
country: Poland
facility: Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
city: Lublin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
city: Opole
country: Poland
facility: Wojewodzkie Centrum Medyczne w Opolu
city: Poznan
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 2 w Poznaniu
city: Szczecin
country: Poland
facility: Samodzielny Publiczny Szpital Kliniczny nr 1 w Szczecinie
city: Lisbon
country: Portugal
facility: CUF Infante Santo Hospital
city: Lisbon
country: Portugal
facility: Hospital Lusiadas Lisboa
city: Porto
country: Portugal
facility: Hospital CUF Porto
city: Maribor
country: Slovenia
facility: UKC Maribor
city: Cape Town
country: South Africa
facility: Stellenbosch University
city: Durban
country: South Africa
facility: Durban Cochlear Implant Pogramme, Parklands Hospital
city: Johannesburg
country: South Africa
facility: Johannesburg Cochlear Implant Center, Wits Donald Gordon Medical Centre
city: Alzira
country: Spain
facility: Hospital de la Ribera
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
city: Caceres
country: Spain
facility: Hospital San Pedro de Alcantara
city: Madrid
country: Spain
facility: Fundacion Jimenez Diaz
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Pamplona
country: Spain
facility: Hospital Clinica Universitad de Navarra
city: Salamanca
country: Spain
facility: Hospital Clinico Universitario de Salamanca
city: San Sebastian
country: Spain
facility: Hospital Donostia
city: Valencia
country: Spain
facility: Hospital Clinico Universitario de Valencia
city: Valladolid
country: Spain
facility: Hospital Universitario del Rio Hortega
city: Zaragoza
country: Spain
facility: Hospital Clinico Universitario Lozano Blesa
city: Stockholm
country: Sweden
facility: Karolinska Hospital Huddinge
city: Eskisehir
country: Turkey
facility: Osmangazi University Hospital
city: Istanbul
country: Turkey
facility: Cerrahpasa University Hospital
city: Istanbul
country: Turkey
facility: Marmara University Hospital
Study officials:
affiliation: Cochlear
name: Bart Volckaerts
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.
citation: 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.