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

Hearing Loss Clinical Trial

— IROS  

Official title:

Cochlear-Implanted Recipient Observational Study

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02004353
• Other study ID #: CEL 5277
• Status: Terminated
• Start date: July 2011
• Est. completion date: July 31, 2020

Study information

• Verified date: November 2020
• Source: Cochlear
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 1518
• Est. completion date: July 31, 2020
• Est. primary completion date: June 23, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 10 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Hearing Loss

Intervention

Device:
• Cochlear® Hearing Implants
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants

Locations

Country	Name	City	State
Argentina	Centro de Implantes Cocleares	Buenos Aires
Argentina	Implantes Cocleares Equipo Multicentrico (ICEM)	Buenos Aires
Argentina	Centro de Investigaciones Otoaudiologicas (CIOA)	Caba
Argentina	Clinca Reina Fabiola	Córdoba
Austria	Landesklinikum St. Pölten	St. Pölten
Belgium	University Hospital Leuven	Leuven
Brazil	Hospital Edmundo Vasconcelos	Sao Paulo
Colombia	Clinica Orlant	Antioquia
Colombia	Te Oigo	Barranquilla
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	Bogota
Colombia	Consultório Plaza	Bogotá
Colombia	Consultorio Prieto	Bogotá
Colombia	Disaudio	Bogotá
Colombia	Instituto Nacional de Otologia Garcia Gomez	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	Quindio
Colombia	IPS San Rafael	Risaralda
Colombia	Audiomedica	Santander
Colombia	Consultorio Torres	Zipaquira
France	CHRU Lille	Lille
Germany	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
Germany	KMG Kliniken GmbH Güstrow	Güstrow
Germany	Medizinische Hochschule Hannover	Hannover
Germany	Helios München West	Münich
Germany	Eberhard-Karls-Universität Tübingen	Tübingen
Germany	Universitätsklinikum Ulm	Ulm
Germany	University of Wuerzburg	Wuerzburg
Hungary	University of Szeged	Szeged
Netherlands	Radboud University	Nijmegen
Poland	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
Portugal	CUF Infante Santo Hospital	Lisbon
Portugal	Hospital Lusiadas Lisboa	Lisbon
Portugal	Hospital CUF Porto	Porto
Slovenia	UKC Maribor	Maribor
South Africa	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
Spain	Hospital de la Ribera	Alzira
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital San Pedro de Alcantara	Caceres
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 Donostia	San Sebastian
Spain	Hospital Clinico Universitario de Valencia	Valencia
Spain	Hospital Universitario del Rio Hortega	Valladolid
Spain	Hospital Clinico Universitario Lozano Blesa	Zaragoza
Sweden	Karolinska Hospital Huddinge	Stockholm
Turkey	Osmangazi University Hospital	Eskisehir
Turkey	Cerrahpasa University Hospital	Istanbul
Turkey	Marmara University Hospital	Istanbul

Sponsors (1)

Lead Sponsor	Collaborator
Cochlear

Countries where clinical trial is conducted

Argentina,  Austria,  Belgium,  Brazil,  Colombia,  France,  Germany,  Hungary,  Netherlands,  Poland,  Portugal,  Slovenia,  South Africa,  Spain,  Sweden,  Turkey, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
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.	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.	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.	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.	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.	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.	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	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	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	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	post-implant at 2 years