NCT02852330

Intracochlear Potentials: Volta Study

Intracochlear Potentials: Intraoperative and Post-operative Measurement Clinical Investigation

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Cochlear · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

The clinical investigation will gather impedance and transimpedance (voltage tomography) data intraoperatively and post-operatively which can be used to characterize the electrical properties of the living cochlea. The Surgical Assistant Research Tool (SA16) research software is a software tool developed by Cochlear Limited. The use of the SA16 research software in the current clinical investigation is intended to support Cochlear's research into the development of implant telemetry based surgical tools. The SA16 research software is designed to perform a series of predefined measurements with minimal intervention both during and immediately following electrode insertion using telemetry from the implant via the Sound Processor to the computer. These measurements include real time continuous measurements, intended for use during the electrode insertion portion of the surgical procedure, and baseline measurements following the completion of electrode insertion. The SA16 research software will be used in the current clinical investigation in adults who meet current indications for cochlear implantation in Australia. The SA16 research software is not for use with patients who are receiving an implant that directly contacts neural tissue, such as auditory brainstem implants (ABI). CS19 (1.6.2) software will be used to collect voltage tomography measurements post-implantation.

Conditions

• Hearing Loss

Interventions

Type	Name	Description
DEVICE	SA16 research software	Software for measurement of voltage tomography intraoperatively.
DEVICE	CS19 (1.6.2)	Software for measurement of voltage tomography post-operatively.

Timeline

• Start date: 2017-07-10
• Primary completion: 2018-10-10
• Completion: 2018-10-10
• First posted: 2016-08-02
• Last updated: 2025-02-10
• Results posted: 2021-05-25

Locations

2 sites across 1 country: Australia