Telemedicine
Conditions
Brief summary
The purpose of this study is to demonstrate the safety and efficacy of Nucleus cochlear implant programming via telecommunication.
Detailed description
Cochlear implant recipients will undergo remapping at a location remote from their audiologist via telehealth. Audiologists will use an internet meeting platform to remotely log into the subject's computer and control the programming software. Remote programming sessions will be completed both with and without the assistance of a trained facilitator, and speech understanding will be tested in between mapping sessions.
Interventions
DEVICECustom Sound
Custom Sound is the programming software used to program Nucleus cochlear implants.
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
* Individuals aged greater than 12 years that are native English speakers and are capable of completing the study evaluation as deemed by their primary audiologist * Unilateral or bilateral cochlear implant recipients of a CI24RE, CI422 or CI500 series implant who are in possession of a backup sound processor * A minimum of 12 months' experience with a CP800 or CP900 series sound processor, and current MAP programmed within 12 months prior to Visit 1 * Willingness to participate in and to comply with all requirements of the protocol * Able to demonstrate protocol competence as confirmed by primary audiologist
Exclusion criteria
* Unrealistic expectations on the part of the subject, regarding the possible benefits, risks, and limitations of remote service delivery * Unwillingness or inability of the candidate to comply with all investigational requirements * Additional handicaps that would prevent or restrict participation in the audiological evaluations * Inability to demonstrate basic technological skills for simple computer-based tasks and device connecting after training by primary audiologist
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech Perception on Monosyllabic Word Test, CNC Words | 2-4 weeks post remote programming session | Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Remote Programming Group Subjects will undergo remote programming of Nucleus cochlear implants via Custom Sound software using an online interactive meeting platform.
The intervention is the programming of the cochlear implant, the experimental aspect is the remote delivery method.
Custom Sound: Custom Sound is the programming software used to program Nucleus cochlear implants. | 40 |
| Total | 40 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | Remote Programming Group | — |
|---|---|---|
| Age, Continuous | 45.2 years STANDARD_DEVIATION 26 | — |
| Internal Implant Model CI24R | 3 Participants | — |
| Internal Implant Model CI24RE | 23 Participants | — |
| Internal Implant Model CI422 | 8 Participants | — |
| Internal Implant Model CI500 series | 6 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Region of Enrollment United States | 40 participants | — |
| Sex: Female, Male Female | 22 Participants | — |
| Sex: Female, Male Male | 18 Participants | — |
| Sound Processor Model Nucleus 5 | 17 Participants | — |
| Sound Processor Model Nucleus 6 | 23 Participants | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 40 |
| other Total, other adverse events | 1 / 40 |
| serious Total, serious adverse events | 0 / 40 |
Outcome results
Primary
Speech Perception on Monosyllabic Word Test, CNC Words
Subjects will listen to and repeat monosyllabic words from the Consonant Nucleus Consonant word test measured by percentage of words correct to examine their speech perception abilities after each remote programming session.
Time frame: 2-4 weeks post remote programming session
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Remote Programming Group | Speech Perception on Monosyllabic Word Test, CNC Words | Live Audiologist MAP | 70.5 percentage of words correct | Standard Deviation 18.6 |
| Remote Programming Group | Speech Perception on Monosyllabic Word Test, CNC Words | Facilitated Remote MAP | 72.4 percentage of words correct | Standard Deviation 18.7 |
| Remote Programming Group | Speech Perception on Monosyllabic Word Test, CNC Words | Unassisted Remote MAP | 72.5 percentage of words correct | Standard Deviation 21.3 |