Trial · NCT07139327
A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
NCT07139327, Not applicable, Active not recruiting, Cochlear
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults. Trials, record NCT07139327. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07139327
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Pivotal Study to Evaluate the Efficacy and Safety of a Totally Implantable Cochlear Implant (TICI) System in Adults
- NCT number
- NCT07139327
- Status
- Active not recruiting
- Phases
- Not applicable
- Enrollment
- 36 participants, estimated
- Lead sponsor
- Cochlear
- Conditions
- Hearing Loss, Bilateral Sensorineural
- Interventions
- Cochlear Implant
- First posted
- 2025-08-24
- Last updated
- 2026-09-08
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Speech recognition performance in quiet | Preimplantation to 6 months post-activation | Percent correct word score from preimplantation to post-activation |
| Primary | Incidence of adverse events and device deficiencies | Implantation to 6 and 12 months post-activation | Frequency and severity of device and procedure-related adverse events, including device deficiencies |
| Secondary | Speech recognition in quiet and noise | Preimplantation to 12 months post-activation | Percent correct scores for word tests in quiet and speech reception threshold scores for sentence tests in noise |
| Secondary | Speech Spatial Qualities questionnaire (SSQ-12) | Preimplantation to 12 months post-activation | Speech, Spatial, and Qualities of Hearing Scale Global score (SSQ-12). Scores range from 0 to 10, where higher scores indicate greater ability (less hearing disability). |
| Secondary | Cochlear Implant Quality of Life Profile (CIQOL-35) | Preimplantation to 12-months post-activation | Cochlear implant hearing related quality of life score (CIQOL-35). Scored for six health domains (communication, emotional, entertainment, environment, listening effort, and social) each scaled from 0 to 100, where a higher score indicates better health. |
| Secondary | Health Utilities Index (HUI 2/3) | Preimplantation to 12 months post-activation | Health Utilities Index (HUI 2/3) Global score. 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 | Living with Cochlear Implants Questionnaire (LivCI) | Preimplantation to 12 months post-activation | Living with Cochlear Implants Questionnaire (LivCI) evaluates the impact of a hearing device on four domains, Participation (range 0 to 12), Psychosocial \& Wellbeing (range 0 to 21), Stigma (range 0 to 15) and Management \& Aesthetics (range 0 to 18), where a higher domain score indicates positive patient report. |
| Secondary | Patient Satisfaction Survey | 6 to 12 months post-activation | Device satisfaction rating score. Scores range from 1 to 5, where a higher score indicates greater patient satisfaction with the TICI system. |
| Secondary | Short Form (SF)-36 Health Survey | 8 to 10 months post-activation | SF-36 is scored for eight health domains, each scaled from 0 to 100, where a higher score indicates better health. |
| Secondary | Time on air | Initial activation to 12 months post-activation | Hours of TICI System usage |
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/NCT07139327
GET https://conductscience.org/api/trials/v1/NCT07139327/registered