Status:
COMPLETED
Collection and Characterization of Objective Measures to Explore the Specificity of Algorithms
Lead Sponsor:
Cochlear
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Brief Summary
The aim of this descriptive study is to collect and describe the characteristics of objective measures to explore the specificity of algorithms.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
October 3 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
May 29 2019
Estimated Enrollment :
153 Patients enrolled
Trial Details
Trial ID
NCT03294681
Start Date
October 3 2017
End Date
May 29 2019
Last Update
June 29 2020
Active Locations (6)
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1
HEARing CRC
Carlton, Australia
2
Hals-Nasen-Ohren-Klinik Universitätsklinikum Erlangen
Erlangen, Germany
3
Klinik für Hals-, Nasen-, Ohrenheilkunde Universitätsklinikum Frankfurt Goethe-Universität
Frankfurt am Main, Germany
4
Universitätsklinikum Schleswig- Holstein - Campus Kiel Klinik für Hals-, Nasen-, Ohrenheilkunde, Kopf- und Halschirurgie
Kiel, Germany