Hearing Impairment, Sensorineural
Conditions
Brief summary
This clinical study aims to investigate speech performance in quiet with an OTE Sound Processor with modified firmware compared with the commercially available CP1150. The study also investigates CP1110 and CP1150 with Forward Focus.
Detailed description
This study will build on the evidence previously collected on OTE and BTE Sound Processors and will support the design goals for access to the same sound processing algorithms across future OTE and BTE variants, including evidence required on the automation of FF and future implant compatibility.
Interventions
DEVICECP1150 Sound Processor
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor
DEVICECP1150 NF
Speech perception tests whilst the subject is fitted with the CP1150 modified firmware (the addition of notch filters at 978Hz, 1956Hz, 2934Hz, 3912Hz).
DEVICECP1150 + FF
Speech perception tests whilst the subject is fitted with the CP1150 Sound Processor with ForwardFocus.
DEVICECP1110
Speech perception tests whilst the subject is fitted with the CP1110 Sound Processor.
Sponsors
Avania
Cochlear
Study design
Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Aged 18 years or older 2. Post lingually deafened 3. Implanted with the CI600 Series, CI500 Series or Freedom Series 4. At least 6 months experience with a cochlear implant. 5. At least 3 months experience with a CP910/920, CP950, CP1150, or CP1000 Sound Processor 6. MAP Total Stimulation Rate of 7.2kHz or greater 7. Able to score 30% or more with CI alone on a monosyllabic words in quiet test 8. Willingness to participate in and to comply with all requirements of the protocol 9. Fluent speaker in English as determined by the investigator 10. Willing and able to provide written informed consent
Exclusion criteria
1. Additional disabilities that would prevent participation in evaluations. 2. Implant location that would result in undesirable hearing performance or discomfort with an off-the-ear sound processor, as determined by the investigator. 3. Unable or unwilling to comply with the requirements of the clinical investigation, as determined by the Investigator. 4. Investigator site personnel directly affiliated with this study and/or their immediate families; immediate family is defined as a spouse, parent, child, or sibling. 5. Cochlear employees or employees of Contract Research Organisations or contractors engaged by Cochlear for the purposes of this investigation. 6. Currently participating or participated in another interventional clinical study/trial in the past 30 days unless (if less than 30 days) the prior investigation was Cochlear sponsored and determined by the investigator to not impact clinical findings of this investigation. 7. Implanted with other active implantable medical devices (e.g. pacemaker, defibrillator).
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Perception in Quiet Using an CP1150 Sound Processor | One day (in booth testing) | Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality. | One day (in booth testing) | Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with forward focus |
| Speech Perception in Quiet With CP1150 and CP1110 Sound Processors | One day (in booth testing) | Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor |
Countries
Australia
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| All Study Participants (CP1150 SP Compared With Next Generation Signal Processing Technology) All study participants attended a single study visit. At the study visit, subjects underwent hearing assessments. Speech perception tests were carried out in all study participants in a randomized manner with 4 interventions involving the CP1150 Sound Processor, CP1150 with modified firmware, CP1150 Sound Processor with Forward Focus and the CP1110 Sound Processor. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | All Study Participants (CP1150 SP Compared With Next Generation Signal Processing Technology) | — |
|---|---|---|
| Age at hearing implant | 59.2 years STANDARD_DEVIATION 7.64 | — |
| Age, Continuous | 70.6 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 10 participants | — |
| Sex: Female, Male Female | 5 Participants | — |
| Sex: Female, Male Male | 5 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 0 / 10 |
| serious Total, serious adverse events | 0 / 10 |
Outcome results
Primary
Speech Perception in Quiet Using an CP1150 Sound Processor
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with modified firmware.
Time frame: One day (in booth testing)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP1150 NF | Speech Perception in Quiet Using an CP1150 Sound Processor | 13.82 percentage of correct words | Standard Deviation 10 |
| CP1150 | Speech Perception in Quiet Using an CP1150 Sound Processor | 11.53 percentage of correct words | Standard Deviation 10 |
95% CI: [-6.29, 0.29]
Secondary
Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality.
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1150 Sound Processor with forward focus
Time frame: One day (in booth testing)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP1150 NF | Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality. | 11.24 percentage of correct words | Standard Deviation 10 |
| CP1150 | Speech Perception in Quiet Using CP1150 Sound Processor Using Forward Focus Combined With Standard Microphone Directionality. | 11.53 percentage of correct words | Standard Deviation 10 |
95% CI: [-8.04, 3.44]
Secondary
Speech Perception in Quiet With CP1150 and CP1110 Sound Processors
Paired difference in percentage CNC Words correct in quiet with the CP1150 Sound Processor and CP1110 Sound Processor
Time frame: One day (in booth testing)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| CP1150 NF | Speech Perception in Quiet With CP1150 and CP1110 Sound Processors | 11.53 percentage of correct words | Standard Deviation 10 |
| CP1150 | Speech Perception in Quiet With CP1150 and CP1110 Sound Processors | 11.97 percentage of correct words | Standard Deviation 10 |
95% CI: [-2.95, 3.55]