Hearing Loss, Bilateral, Hearing Loss, Sensorineural
Conditions
Brief summary
This is a prospective, 1:1 randomized controlled trial of immediate versus delayed cochlear implantation (CI) on hearing handicap, communicative function, loneliness, mental wellbeing, and cognitive functioning. Participants are randomized 1:1 to an immediate cochlear implant intervention group versus a hearing aid control intervention.
Interventions
DEVICECochlear implantation
Unilateral implantation with a commercially approved Nucleus cochlear implant
Sponsors
CogState Ltd.
Syneos Health
Cochlear
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
65 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* Community-dwelling * Proficient in English * Oral communicator * PTA (500, 1000 & 2000 Hz) ≥ 70 dB HL hearing loss duration ≥1 and no more than 30 years * Active daily hearing aid users * HHIE-S score greater than or equal to 24 * MoCA score greater than or equal to 20 * Post-linguistic onset sensorineural hearing loss and meet applicable FDA and/or Medicare candidacy criteria for cochlear implantation * Willing to consent for the study, to be randomized to either group, to utilize bimodal hearing for the duration of the trial (if clinically appropriate), and follow the study protocol
Exclusion criteria
* Prelingual or perilingual severe-to-profound hearing loss * Previous cochlear implantation in either ear * Hearing loss of neural or central origin * Permanent conductive hearing impairment (e.g. otosclerosis) * Medical, audiological, or psychological conductions that might contraindicate participation in the clinical investigation * Self reported disability in 2 or more activities of daily living * Vision impairment worse than 20/40 on a near vision card
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Hearing Handicap | 6 months after enrollment | The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A (Immediate Cochlear Implantation) Group A will consist of 30 individuals who are candidates for cochlear implantation. They will be unilaterally implanted immediately after initial study testing has been completed and then be followed for 12 months after device activation.
Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant | 0 |
| Group B (Delayed Cochlear Implantation) Group B will consist of 30 individuals who are candidates for cochlear implantation. They will continue to wear hearing aids after enrolling in the study and then be unilaterally implanted 6 months after enrollment and followed for 6 more months after device activation.
Cochlear implantation: Unilateral implantation with a commercially approved Nucleus cochlear implant | 1 |
| Total | 1 |
Baseline characteristics
| Characteristic | Group B (Delayed Cochlear Implantation) | Total | Group A (Immediate Cochlear Implantation) |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 1 Participants | 1 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 0 Participants | 0 Participants | 0 Participants |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment United States | 1 Participants | 1 Participants | 0 Participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 1 Participants | 1 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 0 | 0 / 0 |
| other Total, other adverse events | 0 / 0 | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 | 0 / 0 |
Outcome results
Primary
Hearing Handicap
The SSQ-12 is comprised of 12 items using the response format on a scale from 0 to 10, were 0 equals no ability and 10 equals perfect ability. These are divided into three sub-scales and the questions 1-5 are from the speech sub-scale, 6-8 from the spatial, and 9-12 from the qualities sub-scale. The three sub-scales are the average of the questions within. A 'not applicable' option is given for each item. Assessment of the impact of cochlear implantation versus continued hearing aid is then calculated and the theoretical score could vary between -10 to + 10. The higher the score the better benefit and positive score indicates improved hearing, a negative value an impaired hearing.
Time frame: 6 months after enrollment
Population: Data was not collected as the study was terminated due to COVID-19