Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms

The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.

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Key information

Conditions

Hearing Loss Ear Diseases Hearing Disorders Nervous System Diseases Neurologic Manifestations Otorhinolaryngologic Diseases Pathological Conditions, Signs and Symptoms Sensation Disorders Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

HEARing CRC, Carlton, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Candidate for cochlear implantation with the CI532 or CI512 devices
18 years of age or older at the time of enrolment
Normal cochlea anatomy, established via pre-operative Computer Tomography
Willingness to participate in and to comply with all requirements of the protocol

Exclusion criteria

Prior cochlear implantation in the ear to be implanted
Ossification or any other cochlear anomaly that might prevent complete insertion of the electrode array
Abnormal cochlear anatomy on pre-operative Computer Tomography or Magnetic Resonance Imaging
Additional handicaps that would prevent participation in evaluations
Pregnant and breast feeding women, prisoners, or anyone in custody
Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure

Treatment and study plan

Objective measures with CSEP

Device

Objective measures to be conducted with Custom SoundTM EP 5 software and the CP900 series sound processor in CI532 and CI512 Cochlear Implant recipients

Primary outcomes

Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over

Time frame: at surgery, within one minute

Measured with Custom SoundTM EP 5. It took one minute to measure all electrodes in surgery.

Intraoperative transimpedance measures from 148 ears without fold-overs (as evidenced by radiographic imaging) were analysed to assess the specificity of the algorithm.

Sponsors and collaborators

Lead sponsor

Cochlear

Industry

Registry information

Official study title

Trans-impedance Matrix

Important dates

Study start: 2017
Primary completion: 2019
Study completion: 2019
First posted: Sep 27, 2017
Registry last updated: Jun 29, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed