Cochlear Implant, Sensorineural Hearing Loss, Bilateral
Conditions
Brief summary
Use of Artificial Intelligent (AI) technology to assist audiologists in programming cochlear implants.
Interventions
DEVICECommercially available cochlear implant and AI system
Use of AI technology to assist in audiologist's evaluation and programming of cochlear implant recipients
Sponsors
Cochlear
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
12 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Newly implanted and existing recipient Groups (Groups 1 and 2): * Age 12 and older * Monosyllabic word score administered at 60dBA (2 lists) with an appropriately fit hearing aid in the ear to be implanted who are receiving a cochlear implant as standard of care * Group 2: 3 months or greater combined experience with commercially available sound processors * Fluent spoken English skills
Exclusion criteria
* Unrealistic expectations on the part of the subject regarding the possible benefits, risks, and limitations * Additional cognitive, medical or social handicaps that would prevent completion of all study requirements as determined by the Investigational team * Unwillingness or inability of the subject to comply with all investigational requirements * Use of an acoustic component in the implanted ear * Less than 18 active electrodes * Hybrid L Cochlear Implant
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Monosyllabic Word Recognition Scores (CNC) in Quiet | Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month | Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group 1 Newly implanted recipients | 31 |
| Group 2 Existing recipients | 56 |
| Total | 87 |
Baseline characteristics
| Characteristic | Group 1 | Group 2 | Total |
|---|---|---|---|
| Age, Continuous | 63.52 years | 56.98 years | 59.31 years |
| Duration of Device Use | 0 months | 79.30 months | 51.04 months |
| Duration of Hearing Loss | 28.29 years | 28.39 years | 28.35 years |
| Ear Tested Left | 15 participants | 29 participants | 44 participants |
| Ear Tested Right | 16 participants | 27 participants | 43 participants |
| Race and Ethnicity Not Collected | — | — | 0 Participants |
| Sex: Female, Male Female | 15 Participants | 22 Participants | 37 Participants |
| Sex: Female, Male Male | 16 Participants | 34 Participants | 50 Participants |
| Type of Sound Processor Kanso | 0 Participants | 1 Participants | 1 Participants |
| Type of Sound Processor N6 | 0 Participants | 49 Participants | 49 Participants |
| Type of Sound Processor N7 | 0 Participants | 6 Participants | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 31 | 0 / 56 |
| other Total, other adverse events | 17 / 31 | 6 / 56 |
| serious Total, serious adverse events | 5 / 31 | 1 / 56 |
Outcome results
Primary
Change in Monosyllabic Word Recognition Scores (CNC) in Quiet
Monosyllabic word recognition was scored in quiet using Consonant-Nucleus-Consonant (CNC) words. Scores are listed as percentage correct thus a higher score (percentage) means a better outcome.Group 1: Preoperative to postoperative percentage performance after 6 months of cochlear implant use. Group 2: Visit A to Visit B after 1 month of cochlear implant use.
Time frame: Pre-operative/Visit A; Group 1: 6 months; Group 2: 1 month
Population: All participants with complete data set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group 1 | Change in Monosyllabic Word Recognition Scores (CNC) in Quiet | Pre-operative/Visit A | 13.9 percentage of correct words | Standard Deviation 15.2 |
| Group 1 | Change in Monosyllabic Word Recognition Scores (CNC) in Quiet | 6-Month | 60.2 percentage of correct words | Standard Deviation 17.2 |
| Group 2 | Change in Monosyllabic Word Recognition Scores (CNC) in Quiet | Pre-operative/Visit A | 60.1 percentage of correct words | Standard Deviation 23 |
| Group 2 | Change in Monosyllabic Word Recognition Scores (CNC) in Quiet | Visit B (1-Month) | 59.1 percentage of correct words | Standard Deviation 22 |