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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Cochlear-Implanted Recipient Observational Study

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: Cochlear® Hearing Implants


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 10 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cochlear® Hearing Implants, hearing loss<br>Implanted Adolescents and Adults with permanent hearing loss | Device: Cochlear® Hearing Implants<br>* Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Cochlear® Hearing Implants