Hearing LossIROSNCT02004353
Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear
An observational study of Hearing Loss, run by Cochlear at 77 sites in 16 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- Cochlear® Hearing Implants
- Type of treatment
- Medical device
- How many people
- 1,518 participants
- Where
- 77 sitesin 16 countries
- Study dates
- Jul 2011to 31 Jul 2020
- How long will I take part?
- 2 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Individuals excluded from participation in a registry according to national or local regulations
Trial locations and contacts
77 sites in 16 countries.
77 sites in 16 countries
Colombia24 sites
Clinica Orlant
Antioquia
Te Oigo
Barranquilla
Clinica Rivas
Bogotá
Consultorio Gutierrez
Bogotá
Consultorio Navarro
Bogotá
Consultorio Ordonez
Bogotá
Consultorio Prieto
Bogotá
Consultório Plaza
Bogotá
DIAUDIO
Bogotá
Disaudio
Bogotá
Hospital de la Policia
Bogotá
Hospital San Jose Infantil
Bogotá
Hospital Universitario Clinica San Rafael
Bogotá
Instituto Nacional de Otologia Garcia Gomez
Bogotá
Mediglobal
Bogotá
Instituto para Niños Ciegos y Sordos
Cali
Consultório Velez
Cartagena
Consultório Mosquera
Ibague
Consultorio Jaramillo
Manizales
Hospital Santa Sofia
Manizales
Clinica Sagrada Familia
Quindío
IPS San Rafael
Risaralda
Audiomedica
Santander
Consultorio Torres
Zipaquirá
Poland11 sites
Uniwersytecki Szpital Kliniczny w Bialymstoku
Bialystok
Szpital Uniwersytecki nr 2 w Bydgoszczy
Bydgoszcz
Wojewodzki Szpital Dzieciecy w Bydgoszczy
Bydgoszcz
World Hearing Center
Kajetany
Wojewodzki Szpital Zespolony w Koninie
Konin
Instytut Centrum Zdrowia Matki Polki w Lodzi
Lodz
Uniwersytecki Szpital Kliniczny nr 1 w Lodzi
Lodz
Samodzielny Publiczny Szpital Kliniczny nr 4 w Lublinie
Lublin
Wojewodzkie Centrum Medyczne w Opolu
Opole
Samodzielny Publiczny Szpital Kliniczny nr 2 w Poznaniu
Poznan
Samodzielny Publiczny Szpital Kliniczny nr 1 w Szczecinie
Szczecin
Spain11 sites
Hospital de la Ribera
Alzira
Hospital de la Santa Creu i Sant Pau
Barcelona
Hospital San Pedro de Alcantara
Cáceres
Hospital Donostia
Donostia / San Sebastian
Fundacion Jimenez Diaz
Madrid
Hospital General Universitario Gregorio Maranon
Madrid
Hospital Clinica Universitad de Navarra
Pamplona
Hospital Clinico Universitario de Salamanca
Salamanca
Hospital Clinico Universitario de Valencia
Valencia
Hospital Universitario del Rio Hortega
Valladolid
Hospital Clinico Universitario Lozano Blesa
Zaragoza
Germany10 sites
HNO Bad Aibling
Bad Aibling
Universitäts-Hals-Nasen-Ohren-Klinik Essen
Essen
Universitätsklinikum Frankfurt
Frankfurt am Main
Universitätsklinik für Hals-, Nasen- und Ohrenheilkunde
Freiburg im Breisgau
KMG Kliniken GmbH Güstrow
Güstrow
Medizinische Hochschule Hannover
Hanover
Helios München West
Münich
Eberhard-Karls-Universität Tübingen
Tübingen
Universitätsklinikum Ulm
Ulm
University of Wuerzburg
Würzburg
Argentina4 sites
Centro de Implantes Cocleares
Buenos Aires
Implantes Cocleares Equipo Multicentrico (ICEM)
Buenos Aires
Centro de Investigaciones Otoaudiologicas (CIOA)
Caba
Clinca Reina Fabiola
Córdoba
Portugal3 sites
CUF Infante Santo Hospital
Lisbon
Hospital Lusiadas Lisboa
Lisbon
Hospital CUF Porto
Porto
South Africa3 sites
Stellenbosch University
Cape Town
Durban Cochlear Implant Pogramme, Parklands Hospital
Durban
Johannesburg Cochlear Implant Center, Wits Donald Gordon Medical Centre
Johannesburg
Turkey (Türkiye)3 sites
Osmangazi University Hospital
Eskişehir
Cerrahpasa University Hospital
Istanbul
Marmara University Hospital
Istanbul
About this study
Official title: 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.
Read the 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.
- Conditions
- Hearing Loss
- Being tested
- Cochlear® Hearing Implants
- Keywords
- Cochlear® Hearing Implants
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cochlear® Hearing ImplantsDevice
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants
| Study group | Role | What they receive |
|---|---|---|
| Cochlear® Hearing Implants, hearing loss | Implanted Adolescents and Adults with permanent hearing loss Receives: Device: Cochlear® Hearing Implants |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
Secondary outcomes (4)
Unaided Hearing Thresholds
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
Measured: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on
Unaided Hearing Thresholds
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
Measured: post-implant at 1 year
Unaided Hearing Thresholds
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
Measured: immediately post-implant
Unaided Hearing Thresholds
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
Measured: post-implant at 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2013 (estimated)
- Study startJul 2011
- Primary completion23 Jun 2020
- Study completion31 Jul 2020
Why it stopped: Original study purpose accomplished
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- More trials run by CochlearThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,518 participants (actual)
- Target duration
- 2 Years
Sponsor and investigators
- Lead sponsor
- Cochlear
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Bart Volckaerts, Study director, Cochlear
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02004353
- Sponsor's protocol ID
- CEL 5277
- Acronym
- IROS
- Status last verified
- Nov 2020
- First submitted
- 26 Nov 2013
- Last updated
- 8 Nov 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
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.
PubMed 21221004Noble 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.
PubMed 18608531Hua H, Lewis AT. Job satisfaction and quality of life in adult users of bone conduction hearing devices pre-and post-implantation: a 1-year follow-up study. Int J Audiol. 2024 Feb;63(2):99-105. doi: 10.1080/14992027.2022.2158380. Epub 2022 Dec 24.
PubMed 36565300Mauch 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.
PubMed 34823566
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cochlear-Implanted Recipient Observational Study
- ClinicalTrials.gov ID
- NCT02004353
- Acronym / sponsor ID
- IROS / CEL 5277
- Conditions
- Hearing Loss
- Keywords
- Cochlear® Hearing Implants
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Original study purpose accomplished
- Enrolment
- 1,518 participants (actual)
- Lead sponsor
- CochlearIndustry (pharma, biotech, devices)
- Study start
- Jul 2011
- Primary completion
- 23 Jun 2020 (actual)
- Study completion
- 31 Jul 2020 (actual)
- First posted
- 9 Dec 2013 (estimated)
- Results
- Posted 8 Nov 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 2 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cochlear® Hearing Implants, hearing loss | – | Device: Cochlear® Hearing ImplantsImplanted Adolescents and Adults with permanent hearing loss |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Individuals excluded from participation in a registry according to national or local regulations
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cochlear® Hearing ImplantsMarket approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants | Device | Cochlear® Hearing Implants, hearing loss |
Primary outcome
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.
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.
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.
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.
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.
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.
4 secondary outcomes
Unaided Hearing Thresholds
Time frame: 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
Time frame: immediately post-implant
Unaided Hearing Thresholds
Time frame: post-implant at 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 21221004Maes 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.
- Background: PubMed 18608531Noble 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.
- Derived from this study: PubMed 36565300Hua H, Lewis AT. Job satisfaction and quality of life in adult users of bone conduction hearing devices pre-and post-implantation: a 1-year follow-up study. Int J Audiol. 2024 Feb;63(2):99-105. doi: 10.1080/14992027.2022.2158380. Epub 2022 Dec 24.
- Derived from this study: PubMed 34823566Mauch 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.
- Individual participant dataSharing planned: No
Related trials for Hearing Loss
RecruitingObservational study
Impact of Vestibular Function on Deaf Infants' Activities of Daily Living
Vestibular Dysfunction, Hearing Loss
Recruiting
HEARS-NPS: Addressing Hearing Loss as a Common Unmet Contributor of Neuropsychiatric Symptoms
Alzheimer Disease, Dementia
Not yet recruiting
Hearing Intervention Effects on Brain and Language Development in Children With Bilateral Mild Hearing Loss
Hearing Loss, Bilateral
RecruitingObservational study
Natural History of Autosomal Dominant Hearing Loss
Hearing Loss
RecruitingObservational study
Retrospective Analysis of Speech Performance Using the HiRes Ultra and HiRes Ultra 3D Cochlear Implant
Cochlear Hearing Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Bart Volckaerts study director
Cochlear
77 sites in 16 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hearing Loss, run by Cochlear at 77 sites in 16 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 8 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 77 sites in Colombia, Poland, Spain, Germany, Argentina and 11 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 8 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02004353, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Nov 2021.