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

Cochlear

Status: Completed

Conditions: Hearing Loss

Treatments: Device: Objective measures with CSEP

Study type: Observational

Funder types: Industry

Identifiers

NCT03294681

CLTD5676

Details and patient eligibility

About

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

Enrollment: 153 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

153 participants in 1 patient group

Cochlear Implant Recipients

Treatment:

Device: Objective measures with CSEP