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

Terminated

Brief 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.

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.

Recruitment & 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

Primary Outcome Measures

Name	Time	Method
Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire	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.
Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire	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.

Secondary Outcome Measures

Name	Time	Method
Unaided Hearing Thresholds	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

Locations (77): 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, Argentina
Landesklinikum St. Pölten
🇦🇹
St. Pölten, Austria
University Hospital Leuven
🇧🇪
Leuven, Belgium
Hospital Edmundo Vasconcelos
🇧🇷
Sao Paulo, Brazil
Clinica Orlant
🇨🇴
Antioquia, Colombia
Te Oigo
🇨🇴
Barranquilla, Colombia
Clinica Rivas
🇨🇴
Bogota, Colombia
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Centro de Implantes Cocleares
🇦🇷Buenos Aires, Argentina