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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
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
        • Universitatsklinikum 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 Clínico Universitario de Valencia
      • Valladolid, Spain
        • Hospital Universitario del Río Hortega
      • Zaragoza, Spain
        • Hospital Clínico 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cochlear

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2011

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 23, 2020

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 31, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 26, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 3, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 9, 2013

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 8, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 8, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
November 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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