Hearing Loss
Conditions
Brief summary
The aim of this study is to investigate the clinical benefit for patients implanted with the Nucleus® CI532 cochlear implant and to demonstrate the atraumatic nature of the electrode design. Nucleus® CI532 has a pre-curved, perimodiolar array, the EA32, which is introduced into the cochlea through a straightening sheath.
Interventions
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Eighteen years of age or older at the time of implantation * Conventional candidate for cochlear implantation with a perimodiolar electrode array according to local criteria (excepting the
Exclusion criteria
that follow) * Native speaker in the local language used to assess clinical performance
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan | up to one month post-surgery | The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Surgeon Questionnaire on Implant Surgery | at time of surgery | To collect experiences using the CI532. At each surgery, the surgeon was asked whether overall the CI532 was easy to handle and the EA32 easy to insert. We counted the number of surgeons who strongly agreed or who agreed. |
| Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months | baseline and 6 months post activation | Change in percent correct speech recognition test scores for implant ear alone and best aided |
| Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire | 6 months post activation | The Glasgow Benefit Inventory is a single time point measure of patient reported benefit. A score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100. |
| Array Proximity to the Modiolus Measured Using the Wrapping Factor | up to one month post-surgery | The ratio of the active array length and the corresponding lateral wall length |
| Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months | baseline and 6 months post activation | We report only the change for the 500 Hz frequency. |
| Number of Adverse Events at Surgery | at time of surgery | — |
| Number of Adverse Events Post Surgery to 6 Months Post-activation | post surgery to 6 months post-activation | — |
| Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months | baseline and 6 months post activation | Rating scale. 0=worst; 10=best |
Countries
Australia, France, Germany, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Nucleus CI532 Cochlear Implant Single arm study. All participants received CI532. | 45 |
| Total | 45 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | Death | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Nucleus CI532 Cochlear Implant |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 21 Participants |
| Age, Categorical Between 18 and 65 years | 24 Participants |
| Age, Continuous | 61 years STANDARD_DEVIATION 15 |
| Sex: Female, Male Female | 23 Participants |
| Sex: Female, Male Male | 22 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 1 / 45 |
| other Total, other adverse events | 30 / 45 |
| serious Total, serious adverse events | 4 / 45 |
Outcome results
Primary
Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan
The position of the electrode array can be completely in scala tympani, completely in scala vestibuli, or may transverse from scala tympani to scala vestibuli. The position can be determined from high resolution flat panel volume tomography (Cone beam) imaging.
Time frame: up to one month post-surgery
Population: One patient was explanted and reimplanted with a different type of device.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Nucleus CI532 Cochlear Implant | Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan | Completely in scala tympani | 44 Participants |
| Nucleus CI532 Cochlear Implant | Scalar Position of Electrode Array Determined With Computer Tomography (CT) Scan | Dislocation in scala vestibuli | 0 Participants |
Secondary
Array Proximity to the Modiolus Measured Using the Wrapping Factor
The ratio of the active array length and the corresponding lateral wall length
Time frame: up to one month post-surgery
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Nucleus CI532 Cochlear Implant | Array Proximity to the Modiolus Measured Using the Wrapping Factor | 0.62 ratio | Standard Deviation 0.05 |
Secondary
Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months
We report only the change for the 500 Hz frequency.
Time frame: baseline and 6 months post activation
Population: Note that some patients had no measurable pre-operative hearing
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Change From Baseline in Air-conduction Pure-tone Hearing Thresholds Via an Audiogram at 6 Months | 20 Decibels |
Secondary
Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months
Rating scale. 0=worst; 10=best
Time frame: baseline and 6 months post activation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Change From Baseline in Hearing Ability Assessed Via Speech Spatial Hearing Qualities Questionnaire at 6 Months | 2.22 units on a scale |
Secondary
Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months
Change in percent correct speech recognition test scores for implant ear alone and best aided
Time frame: baseline and 6 months post activation
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Nucleus CI532 Cochlear Implant | Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months | Quiet Implant Ear | 52.500 Percent correct |
| Nucleus CI532 Cochlear Implant | Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months | Quiet Best Aided | 29.668 Percent correct |
| Nucleus CI532 Cochlear Implant | Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months | 10 db Signal-to-Noise Ratio (SNR) Implant Ear | 63.725 Percent correct |
| Nucleus CI532 Cochlear Implant | Change From Baseline in Speech Recognition in Quiet and Noise at 6 Months | 10 db Signal-to-Noise Ratio (SNR) Best Aided | 33.690 Percent correct |
Secondary
Number of Adverse Events at Surgery
Time frame: at time of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Number of Adverse Events at Surgery | 3 adverse events |
Secondary
Number of Adverse Events Post Surgery to 6 Months Post-activation
Time frame: post surgery to 6 months post-activation
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Number of Adverse Events Post Surgery to 6 Months Post-activation | 32 adverse events |
Secondary
Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire
The Glasgow Benefit Inventory is a single time point measure of patient reported benefit. A score of 0 indicates no benefit; the minimum score is -100 and the maximum is +100.
Time frame: 6 months post activation
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Patient Reported Benefit in Health Status Assessed Via Glasgow Benefit Inventory Questionnaire | 28.1 units on a scale |
Secondary
Surgeon Questionnaire on Implant Surgery
To collect experiences using the CI532. At each surgery, the surgeon was asked whether overall the CI532 was easy to handle and the EA32 easy to insert. We counted the number of surgeons who strongly agreed or who agreed.
Time frame: at time of surgery
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Nucleus CI532 Cochlear Implant | Surgeon Questionnaire on Implant Surgery | 38 Surgeons |