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.
Study Type
OBSERVATIONAL
Enrollment
1,518
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
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
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
...and 67 more locations
Time frame: 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.
Time frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: post-implant at 2 years