N/A
N=20
Intracochlear Potentials: Volta Study
Hearing Loss
Bottom Line
View on ClinicalTrials.gov: NCT02852330 ↗Enrolled (actual)
20
Serious AEs
5.0%
Results posted
May 2021
Primary outcome: Primary: Normative Voltage Tomography Data — 19; 1; 19; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- SA16 research software (Device); CS19 (1.6.2) (Device)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Cochlear
- Primary completion
- Oct 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Normative Voltage Tomography Data |
19; 1; 19; 1 | — |
Summary
Collection of normative voltage tomography data during and/or immediately after electrode insertion into the cochlea using Surgical Assistant (SA16) research software and postoperatively at activation, three and twelve months post-activation with CS19 research software in adults who are receiving a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear implant.
Eligibility Criteria
Inclusion Criteria
- Meet current cochlear implant indications at the implanting centre for a Cochlear Nucleus CI512, CI422, CI522 or CI532 cochlear implant
- Aged 18 years and older at the time of implantation.
Exclusion Criteria
- Recipient of a Nucleus 24 ABI device
- Medical or psychological conditions that contraindicate undergoing general anaesthesia or surgery.
- Ossification, malformation or any other cochlear anomaly, such as common cavity, that might prevent complete insertion of the electrode array, as confirmed by medical examination.
- Unwillingness or inability of the candidate to comply with all investigational requirements.
Data sourced from ClinicalTrials.gov (NCT02852330). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.