Hearing Loss
Conditions
Keywords
Cochlear Prosthesis Implantation
Brief summary
The purpose of the feasibility study is to examine audiological outcomes (audiometry and speech perception) and safety (adverse events and adverse device effects) with the Nucleus CI532 cochlear implant in group of adult subjects (n=12) who meet current criteria for cochlear implantation.
Interventions
Sponsors
The Hearing Cooperative Research Centre
Royal Victoria Eye and Ear Hospital
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
1. Meet current cochlear implant indications at the implanting centre 2. In addition to meeting current cochlear implant indications, subjects must also possess preoperative unaided hearing thresholds between 40 to 65 dB HL at 250 & 500Hz in the ear to be implanted. 3. Fluent speaker in the local language used to assess clinical performance 4. Eighteen years of age or older at the time of implantation with no upper age limit
Exclusion criteria
1. Evidence of hearing loss prior to 5 years of age. 2. Sensorineural severe-to-profound hearing loss greater than 20 years at 2 kHz and above. 3. Simultaneous bilateral cochlear implantation or prior cochlear implantation in the ear to be implanted. 4. Additional disabilities that may affect the subject's participation or safety during the clinical investigation. 5. Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery. 6. Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination. 7. Hearing impairment due to lesion or neuropathy of the acoustic nerve, VIII nerve or central auditory pathway. 8. Active middle-ear infection, 9. Tympanic membrane perforation 10. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations that are inherent to the surgical procedure(s) and prosthetic devices 11. Unwillingness or inability of the candidate to comply with all investigational requirements. 12. Patients with existing CSF shunts or drains, existing perilymph fistula, skull fracture or CSF leak. 13. Patients with recurrent episodes of bacterial meningitis.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6 months and 12 months post activation | unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear. |
| Report on Clinical Performance in Quiet and Noise | 3 months, 6 months and 12 months post activation | Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB). |
| Report of Medical/Surgical and Device Related Adverse Events. | 12 months post activation. | Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | Preoperative and 6 months post activation | Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions. |
| Glasgow Benefit Inventory (GBI). | 6 months post activation | Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome. |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Implantation With Nucleus CI532 Cochlear Implant All participants will receive the same treatment - Implantation with Nucleus CI532 cochlear implant.
Nucleus CI532 cochlear implant | 12 |
| Total | 12 |
Baseline characteristics
| Characteristic | Implantation With Nucleus CI532 Cochlear Implant | — |
|---|---|---|
| Age, Continuous | 63 years | — |
| Average Initial Age of Hearing Aid Fitted | 45 years | — |
| Onset of Initial Hearing Loss | 37 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 12 participants | — |
| Severe Hearing Loss | 3 Participants | — |
| Sex: Female, Male Female | 2 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 12 |
| other Total, other adverse events | 7 / 12 |
| serious Total, serious adverse events | 0 / 12 |
Outcome results
Primary
Report of Medical/Surgical and Device Related Adverse Events.
Report of medical/surgical and device related adverse events compared to current approved labeling with regard to type, frequency and seriousness.
Time frame: 12 months post activation.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly procedure related - pinna/behind pain | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly procedure related - dizziness | 2 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly procedure related - drop in hearing | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly procedure related - nausea | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly procedure related - right ear tinnitus | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Procedure related - headache | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Procedure related - incision site pain | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Procedure related - incision site tenderness | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Procedure related - jaw ache | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Procedure related - initial insertion tip foldover | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly device related - pinna/behind pain | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly device related - dizziness | 2 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly device related - drop in hearing | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Possibly device related - nausea | 1 Adverse Events |
| Implantation With Nucleus CI532 Cochlear Implant | Report of Medical/Surgical and Device Related Adverse Events. | Device related - initial insertion top foldover | 1 Adverse Events |
Primary
Report on Clinical Performance in Quiet and Noise
Speech perception assessment with monosyllabic words and sentences percentage correct in competing noise at a fixed signal-to-noise ratio (+5dB).
Time frame: 3 months, 6 months and 12 months post activation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Quiet baseline, untreated ear | 22 percentage of correct words | Standard Deviation 15.4 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Baseline quiet, treated ear | 10.4 percentage of correct words | Standard Deviation 8.7 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Quiet, electronic alone 3 months | 29.9 percentage of correct words | Standard Deviation 7.9 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Quiet, electronic alone 6 months | 31.9 percentage of correct words | Standard Deviation 8.7 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Quiet, electronic alone 12 months | 32.8 percentage of correct words | Standard Deviation 7.8 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Quiet, hybrid hearing 3 months | 27.4 percentage of correct words | Standard Deviation 9.7 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Quiet, hybrid hearing 6 months | 27.0 percentage of correct words | Standard Deviation 11.6 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Quiet, hybrid hearing 12 months | 25.3 percentage of correct words | Standard Deviation 8.1 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Noise baseline, untreated ear | 48.2 percentage of correct words | Standard Deviation 36.8 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Noise baseline, treated ear | 25.2 percentage of correct words | Standard Deviation 28.3 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Noise, electric alone 3 months | 81.7 percentage of correct words | Standard Deviation 17.2 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Noise, electric alone 6 months | 80.8 percentage of correct words | Standard Deviation 23.2 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Noise, electric alone 12 months | 85.1 percentage of correct words | Standard Deviation 14.8 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Noise, hydrid hearing 3 months | 77.5 percentage of correct words | Standard Deviation 18.8 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Noise, hybrid hearing 6 months | 72.0 percentage of correct words | Standard Deviation 29.3 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Clinical Performance in Quiet and Noise | Noise, hybrid hearing 12 months | 83.7 percentage of correct words | Standard Deviation 10.8 |
Primary
Report on Degree of Hearing as Measured by Pure Tone Audiogram
unaided audiogram at time intervals indicated above in ear to be implanted and implanted ear.
Time frame: 6 months and 12 months post activation
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6 months, 250 Hz : Function <= 70 dB HL | 5 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6 months, 250 Hz : Preserved 70 > dB HL <= 90 | 2 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6 months, 250 Hz : Preserved > 90 dB HL | 2 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6 months, 500 Hz : Function <= 70 dB HL | 0 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6 months, 500 Hz : Preserved 70 > dB HL <= 90 | 4 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6 months, 500 Hz : Preserved > 90 dB HL | 4 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6months, 750 Hz : Function <= 70 dB HL | 0 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6months, 750 Hz : Preserved 70 > dB HL <= 90 | 4 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 6months, 750 Hz : Preserved > 90 dB HL | 2 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 250 Hz : Function <= 70 dB HL | 4 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 250 Hz : Preserved 70 > dB HL <= 90 | 3 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 250 Hz : Preserved > 90 dB HL | 2 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 500 Hz : Function <= 70 dB HL | 0 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 500 Hz : Preserved 70 > dB HL <= 90 | 5 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 500 Hz : Preserved > 90 dB HL | 3 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 750 Hz : Function <= 70 dB HL | 0 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 750 Hz : Preserved 70 > dB HL <= 90 | 4 participants |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Degree of Hearing as Measured by Pure Tone Audiogram | 12 months - 750 Hz : Preserved > 90 dB HL | 2 participants |
Secondary
Glasgow Benefit Inventory (GBI).
Effect of intervention (implantation with CI532 cochlear implant) will be assessed at 6 months post activation with the Glasgow Benefit Inventory (GBI). Glasgow Benefit Inventory (GBI) is a measure of patient reported benefit developed especially for otorhinolaryngological interventions where scores range from -100 to 100, where a higher score corresponds to a better benefit outcome and a negative score value corresponds to a worse outcome.
Time frame: 6 months post activation
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Implantation With Nucleus CI532 Cochlear Implant | Glasgow Benefit Inventory (GBI). | General Benefit | 66.7 score on a scale |
| Implantation With Nucleus CI532 Cochlear Implant | Glasgow Benefit Inventory (GBI). | Social Benefit | 43.1 score on a scale |
| Implantation With Nucleus CI532 Cochlear Implant | Glasgow Benefit Inventory (GBI). | Physical Benefit | 15.3 score on a scale |
| Implantation With Nucleus CI532 Cochlear Implant | Glasgow Benefit Inventory (GBI). | Average Benefit | 54 score on a scale |
Secondary
Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ)
Effect of intervention (implantation with CI532 cochlear implant) will be assessed by the change in SSQ scores from preoperative to 6 months post activation, where scores follow a system of 0 = not at all and 10 = perfectly in response to questions.
Time frame: Preoperative and 6 months post activation
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Implantation With Nucleus CI532 Cochlear Implant | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | Baseline - Speech Hearing | 4.2 score on a scale | Standard Deviation 2.3 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | Baseline - Spatial Hearing | 3.9 score on a scale | Standard Deviation 2.1 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | Baseline - Qualities of Hearing | 4.7 score on a scale | Standard Deviation 2.3 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | Baseline - Overall SSQ | 4.3 score on a scale | Standard Deviation 2.1 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | 6 Month - Speech Hearing | 5.9 score on a scale | Standard Deviation 2.6 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | 6 Month - Spatial Hearing | 5.4 score on a scale | Standard Deviation 2.7 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | 6 Month - Qualities of Hearing | 6.5 score on a scale | Standard Deviation 2.4 |
| Implantation With Nucleus CI532 Cochlear Implant | Report on Patient Reported Outcome Measures for Speech, Spatial and Qualities of Hearing Scale (SSQ) | 6 Month - Overall SSQ | 6.0 score on a scale | Standard Deviation 2.4 |