Cochlear Hearing Loss, Deafness
Conditions
Brief summary
The study is about the importance of each follow-up visit after activating a new cochlear implant in addition to evaluating the effectiveness and efficiency of a new programming strategy from Cochlear Americas. Investigators are looking for patients who have recently selected Cochlear Americas as their cochlear implant manufacturer of choice for their upcoming surgery. The aim of this study is to determine if 1) patient outcomes remain stable when reducing follow-up appointments and 2) Cochlear's population mean mapping can produce similar outcomes with patients while additionally reducing appointment times. The hypothesis is that using population mean mapping and reducing the number of follow-up visits after activation will yield similar performance outcomes to a standard of care while decreasing the length of appointment times and number of appointments needed for each patient.
Interventions
OTHERChanges in traditional follow-up
Traditional follow-up includes the following visits after activation: 1-week, 1-month, 3-months, 6-months and 1 year. With the intervention used, the 1-week follow-up is removed.
OTHERPopulation mean mapping
Traditional mapping at activation involves the measurement of at least 5 electrodes (both T-levels and C-levels). The intervention uses a population mean mapping strategy where there is a pre-set dynamic range of 46 CL with a spot check of C-levels.
Sponsors
Massachusetts Eye and Ear Infirmary
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Postlingually deafened * Adults (18+) * New cochlear implant recipients with Cochlear Americas devices; identified prior to activation * Able to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires) * English speakers
Exclusion criteria
* Patients who select other cochlear implant manufactured devices * Pre-lingually deafened * Multiple disabilities * Unable to perform follow-up testing tasks (repeating words/sentences, indicating they heard a sound stimulus, completing questionnaires) * Non-English speakers * Children under the age of 18
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Speech perception scores | 1-year | Speech perception scores via CNC word lists (percentages) at each visit. Scores are from 0 to 100% with 100% being the best. |
| Duration of programming session | 1-year | Time spent programming (seconds) at each visit |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life questionnaire | 1-year | Patient outcomes via the Cochlear Implant Quality of Life-35 Profile questionnaire at each visit. Scores are out of 35 points and higher scores indicate better quality of life. |
| Soundfield detection thresholds | 1-year | Change in soundfield detection thresholds (dB HL) between each visit. Detection thresholds should be between 20 and 35 dB HL and anywhere in that range is good. |
| programming levels | 1-year | Change in programming levels between each visit (converted measure from CL to charge units). There is no indication of good and bad with programming levels, we are just measuring what they are and how stable they are over time. |
Countries
United States
Contacts
CONTACTArenberg
PRINCIPAL_INVESTIGATORJulie Arenberg
Massachusetts Eye and Ear
Outcome results
None listed