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

Completed

• Conditions: Hearing Loss
• Interventions: Device: Objective measures with CSEP

• Registration Number: NCT03294681
• Lead Sponsor: Cochlear

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-09-15
• Study First Submitted QC: 2017-09-22
• Study First Posted: 2017-09-27
• Study Start: 2017-10-03
• Primary Completion: 2019-05-29
• Study Completion: 2019-05-29
• Results First Submitted: 2020-05-20
• Status Verified: 2020-06
• Results First Submitted QC: 2020-06-26
• Last Update Submitted: 2020-06-26
• Results First Posted: 2020-06-29
• Last Update Posted: 2020-06-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 153

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Cochlear Implant Recipients	Objective measures with CSEP	-

Primary Outcome Measures

Name	Time	Method
Specificity (%) of Transimpedance Measurement to Identify Electrode Fold-over	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.

Trial Locations

Locations (6)

HEARing CRC; 🇦🇺 Carlton, Australia

Klinik für Hals-, Nasen-, Ohrenheilkunde Universitätsklinikum Frankfurt Goethe-Universität; 🇩🇪 Frankfurt am Main, Germany

Hals-Nasen-Ohren-Klinik Universitätsklinikum Erlangen; 🇩🇪 Erlangen, Germany

Universitätsklinikum Schleswig- Holstein - Campus Kiel Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie; 🇩🇪 Kiel, Germany

Complejo Hospitalario Universitario Insular Materno Infantil; 🇪🇸 Las Palmas de Gran Canaria, Spain

Clinica Universitaria de Navarra; 🇪🇸 Pamplona, Spain