Subjective and Objective Results With CI Electrode Types

Cochlear Implant Clinical Trial

Official title:

Subjective and Objective Results With CI Electrode Types

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03515473
• Other study ID #: CI-001
• Status: Completed
• Start date: November 13, 2015
• Est. completion date: November 30, 2017

Study information

• Verified date: May 2018
• Source: Szeged University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

Background The authors' aim was to compare the influence of various electrode designs on selected objective and subjective clinical outcomes for cochlear implant recipients using the same model of receiver-stimulator, Cochlear™ Nucleus® Profile Series and sound processor.

Methods A multicenter study with subjects with profound sensorineural hearing loss, who were implanted and followed up in two tertiary centers. A total of 54 ears were implanted with Cochlear™ Nucleus® CI532, 51 with Cochlear™ Nucleus® CI522 and 54 with the Cochlear™ Nucleus® CI512. Implant loss and intraoperative electrophysiological tests (electrically evoked stapedial reflex threshold [ESRT], neural response telemetry threshold [T-NRT] and impedance), postoperative data (C-level, T-level, dynamic range, T-NRT and power consumption) and intracochlear position of the active electrode were analyzed with Nucleus Custom Sound 4.4 software.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 139
• Est. completion date: November 30, 2017
• Est. primary completion date: June 4, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• successful cochlear implantation with CI532 or CI512 or CI522

• gave informed consent

Exclusion Criteria:

• unsuccessful cochlear implantation

Related Conditions & MeSH terms

• Cochlear Implant

Intervention

Device:
• cochlear implant
cochlear implant surgery

Locations

Country	Name	City	State
Hungary	Universitiy of Szeged, Department of Otorhinolaryngology, Head and Neck Surgery	Szeged

Sponsors (1)

Lead Sponsor	Collaborator
Szeged University

Country where clinical trial is conducted

Hungary, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Intraoperative measurements	Intraoperative impedance (kOhm) of the stimulating electrode with different types of cochlear implants.	1 day
Primary	Intraoperative measurements	Electrical stapedial reflex threshold (ESRT; current unit) with different types of cochlear implants	1 day
Primary	Intraoperative measurements	Neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants	1 day
Secondary	Postoperative measurements	Postoperative neural response telemetry threshold (T-NRT; current unit) with different types of cochlear implants	3 months
Secondary	Postoperative measurements	Postoperative comfort level (C-level; current unit) with different types of cochlear implants	3 months
Secondary	Postoperative measurements	Power consumption of different types of cochlear implants	3 months