Sensorineural Hearing Loss
Conditions
Brief summary
The primary objective of this study is to assess the usability of a Cochlear implant system.
Detailed description
Measure participant ratings on satisfaction of a Cochlear implant system via use of validated and non-validated questionnaires.
Interventions
DEVICENucleus 7 Cochlear Implant System
A new cochlear implant sound processor system.
Sponsors
Cochlear
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 100 Years
Healthy volunteers
Yes
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. Fluent 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 on a sentence in babble test
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 |
|---|---|---|
| Cochlear implant subjects' ratings on hearing performance, connectivity, streaming, phone use, comfort, retention, ease of use and controls obtained with their own Sound Processor and the CP1000 Sound Processor. | One year | Non-inferiority of subjects' overall satisfaction ratings for the CP1000 Sound Processor and related components measured following 3 months of use, compared to subjects' overall satisfaction rating for their own Sound Processor and related components measured at study onset. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Speech perception performance of the CP1000 Sound Processor in quiet and in noise. | One year | Data to substantiate the speech perception scores of the subjects for different quiet and noise conditions for different configurations of sound processor and / or accessories. |
Countries
Australia
Outcome results
None listed