An interventional study of Cochlear implantation in Hearing Loss, Sensorineural and Hearing Loss, Bilateral, sponsored by Cochlear. Terminated at 8 sites in United States. Open to participants aged 65 Years to 85 Years. Per ClinicalTrials.gov, last updated 2022-12-22.
Sponsored by Cochlear · Not applicable, Interventional, and Treatment
Among 31 studies in Hearing Loss, Sensorineural by Cochlear — 2 open to participants now, 6 under way, none of them phase 3. Hearing Loss, Sensorineural · Cochlear.
Among the 31 studies in Hearing Loss, Sensorineural by Cochlear, this one is the 26th largest by enrollment of the 27 interventional ones, is one of 2 that started in 2019, is one of 27 with no phase, and was the 13th registered.
346 studies on the registry are indexed under Hearing Loss, Sensorineural; 100 are open to participants now.
This study's enrollment of 1 is below the median of 32 across 247 interventional studies indexed under Hearing Loss, Sensorineural.
Browse Hearing Loss, Sensorineural studies →2 of the 31 studies in Hearing Loss, Sensorineural by Cochlear are open now, in 2 countries. Each count lists the studies.
Of the 70 Hearing Loss, Sensorineural studies recruiting now, 39 (56%) set no upper age limit and 19 (27%) stop at 75 or younger; 26 take children under 18; 17 take healthy volunteers.
This study: 65 Years to 85 Years · all sexes · no healthy volunteers.
The full table on the hub →31 studies; the count open now beside each. This study's row is marked.
First in 2006; this study’s year is marked. 2 started in 2019.
Median enrollment 20 across the 27 interventional studies, 29 across the 4 observational. Of the 24 that completed or were terminated, 19 (79%) have results posted.
Cochlear is the lead sponsor of 92 studies on the registry; 9 are open to participants now.
Of its 17 completed or terminated interventional studies of FDA-regulated products, 15 (88%) have results posted.
2 of the studies in Hearing Loss, Sensorineural by Cochlear that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07139327CochlearA Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults | 2027-04 |
| NCT06642935CochlearA Study to Explore Improved Features and a Simplified Treatment Approach for a Totally Implantable Cochlear Implant (TICI) Research System in Adults With Severe Hearing Loss | 2027-11 |
Among the 31 studies in Hearing Loss, Sensorineural by Cochlear, from their registry updates:
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Device: 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.
Device: Cochlear implantation
Unilateral implantation with a commercially approved Nucleus cochlear implant
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
| Milestone | Group A (Immediate Cochlear Implantation) | Group B (Delayed Cochlear Implantation) |
|---|---|---|
| Started | 0 | 1 |
| Completed | 0 | 0 |
| Not completed | 0 | 1 |
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.
No measurements were reported for this outcome.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Group A (Immediate Cochlear Implantation) | — | — | — |
| Group B (Delayed Cochlear Implantation) | — | — | — |
Study terminated due to COVID 19
| Age, Categorical(Participants) | Group A (Immediate Cochlear Implantation) | Group B (Delayed Cochlear Implantation) | Total |
|---|---|---|---|
| <=18 years | 0 | 0 | 0 |
| Between 18 and 65 years | 0 | 0 | 0 |
| >=65 years | 0 | 1 | 1 |
| Sex: Female, Male(Participants) | Group A (Immediate Cochlear Implantation) | Group B (Delayed Cochlear Implantation) | Total |
|---|---|---|---|
| Female | 0 | 0 | 0 |
| Male | 0 | 1 | 1 |
| Race and Ethnicity Not Collected(Participants) | Group A (Immediate Cochlear Implantation) | Group B (Delayed Cochlear Implantation) | Total |
|---|---|---|---|
| Count of participants | — | — | 0 |
| Region of Enrollment(Participants) | Group A (Immediate Cochlear Implantation) | Group B (Delayed Cochlear Implantation) | Total |
|---|---|---|---|
| United States | 0 | 1 | 1 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Mar 2019 to primary completion in Jan 2020, 9 months.
Results were first posted in Dec 2022, 2 years 11 months after primary completion.
How these figures are worked out, and which studies are left out of them.
This study is terminated, as verified in Nov 2022. You cannot join it, but the record below documents what was studied.
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