Hearing Loss
Conditions
Keywords
cochlear implant, Sound Processor
Brief summary
Studying usability and gaining feedback of the CP950 Sound Processor in experienced cochlear implant recipients.
Detailed description
One month protocol, with 2 study visits. The aim of the study to is to gain patient and audiologist feedback on their experience and usability with the device and wireless programming pod.
Interventions
DEVICECP950 Sound Processor
An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor
DEVICEWireless programming pod
The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
Yes
Inclusion criteria
1. At least 6 months experience with a Nucleus 24 series or later implant in at least one implanted ear 2. Subjects age 12 and older who are cognitively and developmentally able to complete all study related questionnaires as deemed by the principal investigator or delegated staff 3. At least 3 months experience with the CP810,CP920 or CP910 sound processor 4. Ability to use 2 zinc air batteries with their current program (MAP) 5. Willingness to participate in and to comply with all requirements of the protocol for the duration of the trial
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. Implant types not currently supported by the CP950 sound processor (i.e.,N22)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | 1 month | To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically: 1. Patient Reported Hearing Performance 2. Retention & Comfort 3. Ease of use 4. Use of remote controls 5. Look & feel 6. Reliability 7. Maintenance & use |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Treatment Group All patients will receive the CP950 Sound Processor and be part of the treatment group for one month which is programmed via the wireless programming pod
CP950 Sound Processor: An off-the-ear processor configuration with identical functionality to the commercially approved CP910/920 processor
Wireless programming pod: The CP950 Sound Processor will be programmed by the wireless programming pod, which is needed as the interface to commercially approved programming software | 30 |
| Total | 30 |
Baseline characteristics
| Characteristic | Treatment Group |
|---|---|
| Age, Categorical <=18 years | 1 Participants |
| Age, Categorical >=65 years | 11 Participants |
| Age, Categorical Between 18 and 65 years | 18 Participants |
| Region of Enrollment United States | 30 participants |
| Sex: Female, Male Female | 13 Participants |
| Sex: Female, Male Male | 17 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 30 |
| other Total, other adverse events | 2 / 30 |
| serious Total, serious adverse events | 0 / 30 |
Outcome results
Primary
Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire
To evaluate usability of the CP950 sound processor using the CP950 Take Home Questionnaire for existing cochlear implant users. Specifically: 1. Patient Reported Hearing Performance 2. Retention & Comfort 3. Ease of use 4. Use of remote controls 5. Look & feel 6. Reliability 7. Maintenance & use
Time frame: 1 month
Population: All enrolled subjects
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| All Subjects | Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | Satisfiaction with retention accessory | 22 Participants |
| All Subjects | Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | Satisfaction with hearing performance | 28 Participants |
| All Subjects | Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | Agreed sound processor is comfortable | 27 Participants |
| All Subjects | Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | Agreed sound processor is easy to use | 28 Participants |
| All Subjects | Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | Satisfied with look and feel of processor | 27 Participants |
| All Subjects | Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | Agreed sound processor was reliable | 29 Participants |
| All Subjects | Patient Satisfaction Through Usability of the CP950 Sound Processor as Measured by the CP950 Take Home Questionnaire | Agreed sound processor is easy to clean | 24 Participants |