Hearing Loss
Conditions
Keywords
Cochlear® Hearing Implants
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.
Interventions
DEVICECochlear® Hearing Implants
Market approved hearing implants including: Nucleus Cochlear implants, Nucleus Auditory Brainstem Implants, Cochlear Baha implants, Cochlear Acoustic Implants
Sponsors
Cochlear
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
10 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 1 year | 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. |
| 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 1 year | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Unaided Hearing Thresholds | Baseline (i.e. pre-implant status) assessed prior to 1st switch-on | 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 |
Countries
Argentina, Austria, Belgium, Brazil, Colombia, France, Germany, Hungary, Netherlands, Poland, Portugal, Slovenia, South Africa, Spain, Sweden, Turkey (Türkiye)
Participant flow
Recruitment details
1518 participants were recruited in 77 centers from July 2011 to 31 July 2020
Participants by arm
| Arm | Count |
|---|---|
| Cochlear® Hearing Implants Nucleus Cochlear implants, Cochlear Baha implants, Cochlear Acoustic Implants | 1,506 |
| Total | 1,506 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Voluntary participation | 1,334 |
Baseline characteristics
| Characteristic | Cochlear® Hearing Implants |
|---|---|
| Age, Customized <18 | 48 Participants |
| Age, Customized 18-34 | 351 Participants |
| Age, Customized 35-44 | 194 Participants |
| Age, Customized 45-54 | 268 Participants |
| Age, Customized 55-64 | 293 Participants |
| Age, Customized >64 | 348 Participants |
| Age, Customized Unknown | 4 Participants |
| Region of Enrollment Argentina | 62 participants |
| Region of Enrollment Austria | 2 participants |
| Region of Enrollment Belgium | 7 participants |
| Region of Enrollment Brazil | 2 participants |
| Region of Enrollment Colombia | 396 participants |
| Region of Enrollment France | 36 participants |
| Region of Enrollment Germany | 292 participants |
| Region of Enrollment Hungary | 47 participants |
| Region of Enrollment Netherlands | 2 participants |
| Region of Enrollment Poland | 193 participants |
| Region of Enrollment Portugal | 20 participants |
| Region of Enrollment Slovenia | 16 participants |
| Region of Enrollment South Africa | 200 participants |
| Region of Enrollment Spain | 197 participants |
| Region of Enrollment Sweden | 3 participants |
| Region of Enrollment Turkey | 31 participants |
| Sex: Female, Male Female | 789 Participants |
| Sex: Female, Male Male | 717 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
Population: For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI512 cochlear implant | 0.166 Score on a scale | Standard Error 0.0212 |
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI522 cochlear implant | 0.22 Score on a scale | Standard Error 0.032 |
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI532 cochlear implant | 0.15 Score on a scale | Standard Error 0.034 |
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | Baha bone conduction hearing implant | 0.12 Score on a scale | Standard Error 0.03 |
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.
Time frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years
Population: For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.There were too few Baha participants at 2 years to conduct a statistical analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI512 cochlear implant | 0.175 Score on a scale | Standard Error 0.0255 |
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI522 cochlear implant | 0.28 Score on a scale | Standard Error 0.04 |
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI532 cochlear implant | 0.15 Score on a scale | Standard Error 0.042 |
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.
Time frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
Population: For all devices with 50 or more participants with baseline data, analysis of the HUI3 data was performed.There were too few Baha participants at 3 years to conduct a statistical analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI532 cochlear implant | 0.27 Score on a scale | Standard Error 0.087 |
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI512 cochlear implant | 0.123 Score on a scale | Standard Error 0.0311 |
| Cochlear® Hearing Implants | Change in General Quality of Life Assessed Via Health Utility Index Mark III Questionnaire | CI522 cochlear implant | 0.22 Score on a scale | Standard Error 0.051 |
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.
Time frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 1 year
Population: For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | Baha bone conduction hearing implant | 2.2 Score on a scale | Standard Error 0.21 |
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI512 cochlear implant | 2.73 Score on a scale | Standard Error 0.148 |
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI522 cochlear implant | 2.1 Score on a scale | Standard Error 0.24 |
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI532 cochlear implant | 2.1 Score on a scale | Standard Error 0.27 |
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.
Time frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 2 years
Population: For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI512 cochlear implant | 2.95 Score on a scale | Standard Error 0.179 |
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI522 cochlear implant | 2.4 Score on a scale | Standard Error 0.31 |
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI532 cochlear implant | 2.5 Score on a scale | Standard Error 0.33 |
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | Baha bone conduction hearing implant | 1.9 Score on a scale | Standard Error 0.65 |
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.
Time frame: Baseline (i.e. pre-implanted status, prior to 1st switch-on) and post-implant at 3 years
Population: For all devices with 50 or more participants with baseline data, analysis of the SSQ data was performed.There were too few Baha participants at years 3 to conduct a statistical analysis.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI512 cochlear implant | 2.74 Score on a scale | Standard Error 0.217 |
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI522 cochlear implant | 2.4 Score on a scale | Standard Error 0.39 |
| Cochlear® Hearing Implants | Change in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire | CI532 cochlear implant | 2.6 Score on a scale | Standard Error 0.67 |
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
Time frame: Baseline (i.e. pre-implant status) assessed prior to 1st switch-on
Population: Results are for Baha participants. For the contra-lateral ear, data not received for all participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Unaided Hearing Thresholds | Air conduction-implanted ear | 71.7 Decibel | Standard Deviation 21.6 |
| Cochlear® Hearing Implants | Unaided Hearing Thresholds | Bone conduction-implanted ear | 34.1 Decibel | Standard Deviation 24.4 |
| Cochlear® Hearing Implants | Unaided Hearing Thresholds | Air conduction-contralateral year | 36.7 Decibel | Standard Deviation 26.5 |
| Cochlear® Hearing Implants | Unaided Hearing Thresholds | Bone conduction-contralateral ear | 18.1 Decibel | Standard Deviation 15.7 |
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
Time frame: post-implant at 1 year
Population: Results are for Baha participants. For the contra-lateral ear, data not received for all participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cochlear® Hearing Implants | Unaided Hearing Thresholds | Air conduction-Implanted ear | 60.2 Decibel | Standard Deviation 24.2 |
| Cochlear® Hearing Implants | Unaided Hearing Thresholds | Bone conduction-implanted ear | 29.4 Decibel | Standard Deviation 20 |
| Cochlear® Hearing Implants | Unaided Hearing Thresholds | Air conduction- Contralateral ear | 37.5 Decibel | Standard Deviation 24.5 |
| Cochlear® Hearing Implants | Unaided Hearing Thresholds | Bone conduction-Contralateral ear | 18.1 Decibel | Standard Deviation 13.8 |
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
Time frame: immediately post-implant
Population: Data not received due to voluntary participation of participants.
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
Time frame: post-implant at 2 years
Population: Data not received due to voluntary participation of participants.