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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	12 December 2020
Main ID:	NCT02004353
Date of registration:	26/11/2013
Prospective Registration:	No
Primary sponsor:	Cochlear
Public title:	Observation of Benefits for Patients Implanted With a Hearing Implant of the Company Cochlear IROS
Scientific title:	Cochlear-Implanted Recipient Observational Study
Date of first enrolment:	July 2011
Target sample size:	1518
Recruitment status:	Terminated
URL:	https://clinicaltrials.gov/show/NCT02004353
Study type:	Observational [Patient Registry]
Study design:
Phase:

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

Contacts

Name:	Bart Volckaerts
Address:
Telephone:
Email:
Affiliation:	Cochlear

Key inclusion & exclusion criteria

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

Age minimum: 10 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Hearing Loss

Intervention(s)

Device: Cochlear® Hearing Implants

Primary Outcome(s)

Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [Time Frame: post-implant at 1year]

Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [Time Frame: post-implant at 2 years]

Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [Time Frame: Baseline (i.e. pre-implanted status) assessed prior to 1st switch-on]

Patient Related Benefits- Improvement in general quality of life assessed via Health Utility Index Mark III questionnaire [Time Frame: Baseline (i.e. pre-implanted status) assessed prior to 1st switch-on]

Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [Time Frame: post-implant at 1 year]

Patient Related Benefits - Improvements in Hearing ability assessed via Speech Spatial Hearing Qualities questionnaire [Time Frame: post-implant at 2 years]

Secondary Outcome(s)

Unaided hearing thresholds [Time Frame: post-implant at 2 years]

Unaided hearing thresholds [Time Frame: post-implant at 1 year]

Unaided hearing thresholds [Time Frame: immediately post-implant (optional)]

Unaided hearing thresholds [Time Frame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on]

Secondary ID(s)

CEL 5277

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

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