Trial · NCT07893860
Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
NCT07893860, Not applicable, Not yet recruiting, Cochlear
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus. Trials, record NCT07893860. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07893860
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Effect of a Totally Implantable Cochlear Implant on Tinnitus Severity in Adults With Preoperative Tinnitus
- NCT number
- NCT07893860
- Status
- Not yet recruiting
- Phases
- Not applicable
- Enrollment
- 14 participants, estimated
- Lead sponsor
- Cochlear
- Conditions
- Sensorineural Hearing Loss, Tinnitus
- Interventions
- Cochlear implant
- First posted
- 2026-10-26
- Last updated
- 2026-11-10
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Evaluate the impact of the TICI G2 Clinical Investigation System usage on Tinnitus Handicap Inventory (THI) ratings | Preoperative baseline to 6- months post-activation | Mean within-subject change in THI score. The THI measures tinnitus severity. The score ranges from Slight or No handicap (Grade 1): 0-16, Mild (Grade 2): 18-36, Moderate (Grade 3): 38-56, Severe (Grade 4): 58-76 to Catastrophic (Grade 5): 78-100 |
| Secondary | Evaluate the change to speech perception using the TICI G2 Clinical Investigation System with external hearing (EH) compared with baseline in the ear to be implanted | Pre-operative baseline to 6-months post-activation | Mean within subject change in speech in quiet from baseline as measured by word recognition using external hearing (sound processor on) |
| Secondary | Evaluate the change to speech perception using the TICI G2 Clinical Investigation System with invisible hearing (IH) compared with baseline in the ear to be implanted | Pre-operative baseline to 6-months post-activation | Mean within subject change in speech in quiet from baseline as measured by word recognition using invisible hearing (sound processor off) |
| Secondary | Evaluate the subjective ratings of hearing ability in the preferred bilateral listening mode | Pre-operative baseline to 6-months post-activation | Mean within subject change in the global score of the Speech, Spatial and Qualities of Hearing Scale (SSQ12). Scores range from 0 to 10, where higher scores indicate greater ability (less hearing disability). |
| Secondary | Evaluate the overall health status as measured by the Health Utilities Index (HUI2/3) | Pre-operative baseline to 6-months post-activation | Mean within subject change in the global score of the Health Utilities Index (HUI2/3). Scores range from -0.36 to 1.00, where a negative score represents a state "worse than dead" and a top score of 1.00 is "perfect health". |
| Secondary | Evaluate the impact of the TICI G2 Clinical Investigation System usage on THI ratings | Pre-operative baseline to 3-months post-activation | Mean within-subject change in THI score. The THI measures tinnitus severity. The score ranges from Slight or No handicap (Grade 1): 0-16, Mild (Grade 2): 18-36, Moderate (Grade 3): 38-56, Severe (Grade 4): 58-76 to Catastrophic (Grade 5): 78-100 |
| Secondary | Characterize the device usage over time of TICI G2 Clinical Investigation System | Activation to 6-months post-activation | Average daily time on air, collected through software data logs of device use. |
Source ClinicalTrials.gov
Outcomes0
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
None in this release.
Results by group0
Each measurement the trial posted, group by group, in the words and numbers it posted.
None in this release.
Participant flow0
How many started, completed or left each group, period by period.
None in this release.
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals0
The totals the trial posted for each group.
None in this release.
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT07893860
GET https://conductscience.org/api/trials/v1/NCT07893860/registered