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

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

153 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-10-03

Study Completion Date

2019-05-29

Brief Summary

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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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Detailed Description

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Conditions

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Hearing Loss

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cochlear Implant Recipients

Objective measures with CSEP

Intervention Type 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

Interventions

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Objective measures with CSEP

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

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No