Hearing Loss, Sensorineural
Conditions
Brief summary
Acceptance of CP950 sound processor with experienced CP810/CP910/CP920 BTE sound processor users.
Interventions
DEVICECP950 OTE Sound processor
CP950 is Off The Ear (OTE) Cochlear Implant Sound Processor
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Intervention model description
Repeated measures, single-subject experiment. Each subject received the same treatment.
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Eighteen years of age or older 2. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear 3. At least 3 months experience with the CP810,CP920 or CP910 sound processor 4. Native speaker in the language used to assess speech perception performance 5. Willingness to participate in and to comply with all requirements of the protocol 6. Able to score 30% or more at +15 SNR with CI alone
Exclusion criteria
1. Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and prosthetic device 2. Additional disabilities that would prevent participation in evaluations 3. Nucleus 22 Implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score. | 14 days | Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings. During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor. Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor . | in booth testing 1 day. | Signal to noise ratio (measured in decibels) providing 50% speech intelligibility for sentences presented in noise to evaluate the benefit from microphone directionality with the CP950 OTE (Off the ear) sound processor. |
| Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor | In booth testing 1 day | Two lists of twenty sentences presented from front speaker with 4 Talker babble noise presented from rear-half speakers. Higher the percentage of correct words means better outcome. |
Participant flow
Pre-assignment details
Protocol stated up to 25 number of participants. 23 were enrolled, with 3 electing to withdraw from the study before completion.
Participants by arm
| Arm | Count |
|---|---|
| All Participants All participants enrolled in the study | 23 |
| Total | 23 |
Baseline characteristics
| Characteristic | All Participants | — |
|---|---|---|
| Age, Categorical <=18 years | 0 Participants | — |
| Age, Categorical >=65 years | 7 Participants | — |
| Age, Categorical Between 18 and 65 years | 16 Participants | — |
| Age, Continuous | 57 years | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment Australia | 23 participants | — |
| Sex: Female, Male Female | 13 Participants | — |
| Sex: Female, Male Male | 10 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 19 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score.
Each subject used the Investigational device (CP950) for take home use to obtain subjective ratings. During the take home use, A subjective questionnaire was asked them to recall and rate how their hearing performance with the Investigational device CP950 OTE processor compared to their hearing performance with their own CP810, CP910 or CP920 BTE processor. Likert scale was used for each rating in the questionnaire for at home usage ( with the values ranging from) : 1 = much worse; 2 = somewhat worse; 3 = No difference; 4 = somewhat better; 5 = much better.
Time frame: 14 days
| Arm | Measure | Value (MEAN) |
|---|---|---|
| All Participants | Acceptability Ratings for the CP950 Sound Processor Compared to Subjects' Own Processors, Summarized by the Overall Hearing Performance Score. | 3.6 Units on a likert scale |
Secondary
Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor
Two lists of twenty sentences presented from front speaker with 4 Talker babble noise presented from rear-half speakers. Higher the percentage of correct words means better outcome.
Time frame: In booth testing 1 day
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Percentage of Correct Words Scored With Sentences in Noise With the CP950 Sound Processor | 49.82 percentage of correct words. | Standard Deviation 3.9 |
Secondary
Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor .
Signal to noise ratio (measured in decibels) providing 50% speech intelligibility for sentences presented in noise to evaluate the benefit from microphone directionality with the CP950 OTE (Off the ear) sound processor.
Time frame: in booth testing 1 day.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| All Participants | Speech Reception Threshold (SNR50) for Sentence Testing in Noise With CP950 Sound Processor . | 4 decibles | Standard Error 0.5 |