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Original study purpose accomplished
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cochlear® Hearing Implants, hearing loss | Implanted Adolescents and Adults with permanent hearing loss |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Device | Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Baseline (i.e. pre-implant status) assessed prior to 1st switch-on |
| Unaided Hearing Thresholds |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Bart Volckaerts | Cochlear | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Centro de Implantes Cocleares | Buenos Aires | Argentina | ||||
| Implantes Cocleares Equipo Multicentrico (ICEM) |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21221004 | Background | 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. | |
| 18608531 | Background | 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. |
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1518 participants were recruited in 77 centers from July 2011 to 31 July 2020
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| ID | Title | Description |
|---|---|---|
| FG000 | Cochlear® Hearing Implants | Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 4, 2015 | Aug 23, 2021 |
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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 |
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 | 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 | 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 |
| 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 | Ibague | 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) |
| 36565300 | Derived | Hua 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. |
| 34823566 | Derived | 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. |
| COMPLETED |
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| NOT COMPLETED |
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Participants with baseline data recorded in the database.
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| ID | Title | Description |
|---|---|---|
| BG000 | Cochlear® Hearing Implants | Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Count of Participants | Participants |
| |||||||||||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||||||||||||||||
| Race (NIH/OMB) | Data not collected. | Count of Participants | Participants |
| ||||||||||||||||||||||||
| Region of Enrollment | Number | participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed. | Posted | Mean | Standard Error | Score on a scale | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year |
|
|
| |||||||||||||||||||||||||||
| Primary | 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. | For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed. | Posted | Mean | Standard Error | Score on a scale | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years |
|
| ||||||||||||||||||||||||||||
| Primary | 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. | For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.There were too few Baha participants at years 3 to conduct a statistical analysis. | Posted | Mean | Standard Error | Score on a scale | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years |
|
| ||||||||||||||||||||||||||||
| Primary | 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. | For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed. | Posted | Mean | Standard Error | Score on a scale | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year |
|
| ||||||||||||||||||||||||||||
| Primary | 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. | For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.There were too few Baha participants at 2 years to conduct a statistical analysis. | Posted | Mean | Standard Error | Score on a scale | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years |
|
| ||||||||||||||||||||||||||||
| Primary | 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. | For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.There were too few Baha participants at 3 years to conduct a statistical analysis. | Posted | Mean | Standard Error | Score on a scale | Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Results are for Baha participants. For the contra-lateral ear, data not received for all participants. | Posted | Mean | Standard Deviation | Decibel | Baseline (i.e. pre-implant status) assessed prior to 1st switch-on |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Results are for Baha participants. For the contra-lateral ear, data not received for all participants. | Posted | Mean | Standard Deviation | Decibel | post-implant at 1 year |
|
| ||||||||||||||||||||||||||||
| Secondary | 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 | Data not received due to voluntary participation of participants. | Posted | immediately post-implant |
|
| |||||||||||||||||||||||||||||||
| Secondary | 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 | Data not received due to voluntary participation of participants. | Posted | post-implant at 2 years |
|
|
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Deaths, serious adverse events and non-serious adverse events were not assessed.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Cochlear® Hearing Implants | Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants | 0 | 0 | 0 | 0 | 0 | 0 |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jasmin Kaur | Cochlear | +41612058238 | jakaur@cochlear.com |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Nov 5, 2019 | Aug 23, 2021 | SAP_001.pdf |
| ID | Term |
|---|---|
| D034381 | Hearing Loss |
| ID | Term |
|---|---|
| D006311 | Hearing Disorders |
| D004427 | Ear Diseases |
| D010038 | Otorhinolaryngologic Diseases |
| D012678 | Sensation Disorders |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| 35-44 |
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| 45-54 |
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| 55-64 |
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| >64 |
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| Unknown |
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| Unknown or Not Reported |
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| Hungary |
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| Portugal |
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| Spain |
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| Austria |
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| Netherlands |
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| Sweden |
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| Turkey |
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| Belgium |
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| Poland |
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| Brazil |
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| South Africa |
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| Slovenia |
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| France |
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| Germany |
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| CI532 cochlear implant |
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| Baha bone conduction hearing implant |
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