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

October 8, 2021 updated by: Cochlear

Cochlear-Implanted Recipient Observational 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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

1518

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Argentina
      • Buenos Aires, Argentina
        • Centro de Implantes Cocleares
      • Buenos Aires, Argentina
        • Implantes Cocleares Equipo Multicentrico (ICEM)
      • Caba, Argentina
        • Centro de Investigaciones Otoaudiologicas (CIOA)
      • Córdoba, Argentina
        • Clinca Reina Fabiola
  • Austria
      • St. Pölten, Austria
        • Landesklinikum St. Pölten
  • Belgium
      • Leuven, Belgium
        • University Hospital Leuven
  • Brazil
      • Sao Paulo, Brazil
        • Hospital Edmundo Vasconcelos
  • Colombia
      • Antioquia, Colombia
        • Clinica Orlant
      • Barranquilla, Colombia
        • Te Oigo
      • Bogota, 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
        • Hospital Universitario Clinica San Rafael
      • Bogota, Colombia
        • Mediglobal
      • Bogotá, Colombia
        • Consultorio Prieto
      • Bogotá, Colombia
        • Consultório Plaza
      • Bogotá, Colombia
        • Disaudio
      • Bogotá, Colombia
        • Instituto Nacional de Otologia Garcia Gomez
      • Cali, Colombia
        • Instituto para Niños Ciegos y Sordos
      • Cartagena, Colombia
        • Consultório Velez
      • Ibague, Colombia
        • Consultório Mosquera
      • Manizales, Colombia
        • Consultorio Jaramillo
      • Manizales, Colombia
        • Hospital Santa Sofia
      • Quindio, Colombia
        • Clinica Sagrada Familia
      • Risaralda, Colombia
        • IPS San Rafael
      • Santander, Colombia
        • Audiomedica
      • Zipaquira, Colombia
        • Consultorio Torres
  • France
      • Lille, France
        • CHRU Lille
  • Germany
      • Bad Aibling, Germany
        • HNO Bad Aibling
      • Essen, Germany
        • Universitäts-Hals-Nasen-Ohren-Klinik Essen
      • Frankfurt am Main, Germany
        • Universitätsklinikum Frankfurt
      • Freiburg, Germany
        • Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
      • Güstrow, Germany
        • KMG Kliniken GmbH Güstrow
      • Hannover, Germany
        • Medizinische Hochschule Hannover
      • Münich, Germany
        • Helios München West
      • Tübingen, Germany
        • Eberhard-Karls-Universität Tübingen
      • Ulm, Germany
        • Universitatsklinikum Ulm
      • Wuerzburg, Germany
        • University of Wuerzburg
  • Hungary
      • Szeged, Hungary
        • University of Szeged
  • Netherlands
      • Nijmegen, Netherlands
        • Radboud University
  • Poland
      • Bialystok, Poland
        • Uniwersytecki Szpital Kliniczny W Bialymstoku
      • Bydgoszcz, Poland
        • Szpital Uniwersytecki Nr 2 w Bydgoszczy
      • Bydgoszcz, Poland
        • Wojewodzki Szpital Dzieciecy W Bydgoszczy
      • Kajetany, Poland
        • World Hearing Center
      • Konin, Poland
        • Wojewodzki Szpital Zespolony w Koninie
      • Lodz, Poland
        • Instytut Centrum Zdrowia Matki Polki w Lodzi
      • Lodz, Poland
        • Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
      • Lublin, Poland
        • Samodzielny Publiczny Szpital Kliniczny Nr 4 w Lublinie
      • Opole, Poland
        • Wojewodzkie Centrum Medyczne w Opolu
      • Poznan, Poland
        • Samodzielny Publiczny Szpital Kliniczny nr 2 w Poznaniu
      • Szczecin, Poland
        • Samodzielny Publiczny Szpital Kliniczny nr 1 w Szczecinie
  • Portugal
      • Lisbon, Portugal
        • CUF Infante Santo Hospital
      • Lisbon, Portugal
        • Hospital Lusíadas Lisboa
      • Porto, Portugal
        • Hospital CUF Porto
  • Slovenia
      • Maribor, Slovenia
        • UKC Maribor
  • South Africa
      • Cape Town, South Africa
        • Stellenbosch University
      • Durban, South Africa
        • Durban Cochlear Implant Pogramme, Parklands Hospital
      • Johannesburg, South Africa
        • Johannesburg Cochlear Implant Center, Wits Donald Gordon Medical Centre
  • Spain
      • Alzira, Spain
        • Hospital de La Ribera
      • Barcelona, Spain
        • Hospital De La Santa Creu I Sant Pau
      • Caceres, Spain
        • Hospital San Pedro de Alcantara
      • Madrid, Spain
        • Hospital General Universitario Gregorio Marañon
      • Madrid, Spain
        • Fundacion Jimenez Diaz
      • Pamplona, Spain
        • Hospital Clinica Universitad de Navarra
      • Salamanca, Spain
        • Hospital Clínico Universitario de Salamanca
      • San Sebastian, Spain
        • Hospital Donostia
      • Valencia, Spain
        • Hospital Clinico Universitario de Valencia
      • Valladolid, Spain
        • Hospital Universitario del Río Hortega
      • Zaragoza, Spain
        • Hospital Clinico Universitario Lozano Blesa
  • Sweden
      • Stockholm, Sweden
        • Karolinska Hospital Huddinge
  • Turkey
      • Eskisehir, Turkey
        • Osmangazi University Hospital
      • Istanbul, Turkey
        • Marmara University Hospital
      • Istanbul, Turkey
        • Cerrahpasa University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Cochlear® Hearing Implants, hearing loss
Implanted Adolescents and Adults with permanent hearing loss
Device: Cochlear® Hearing Implants
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire
Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
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
Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 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 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
Time Frame: 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.
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
Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
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
Time Frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 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 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
Time Frame: 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.
Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Unaided Hearing Thresholds
Time Frame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on
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 500 Hz and 4000 Hz
Baseline (i.e. pre-implant status) assessed prior to 1st switch-on
Unaided Hearing Thresholds
Time Frame: post-implant at 1 year
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 500 and 4000 Hz
post-implant at 1 year
Unaided Hearing Thresholds
Time Frame: immediately post-implant
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
immediately post-implant
Unaided Hearing Thresholds
Time Frame: 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
post-implant at 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cochlear

Investigators

  • Study Director: Bart Volckaerts, Cochlear

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

June 23, 2020

Study Completion (Actual)

July 31, 2020

Study Registration Dates

First Submitted

November 26, 2013

First Submitted That Met QC Criteria

December 3, 2013

First Posted (Estimate)

December 9, 2013

Study Record Updates

Last Update Posted (Actual)

November 8, 2021

Last Update Submitted That Met QC Criteria

October 8, 2021

Last Verified

November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEL 5277

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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