cochlear monitoring Cochleography
Conditions
Interventions
Cochlear implantation
Cochlear Response Telemetry
electrocochleogram
monitoring
Sponsors
Cochlear Ltd
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: * Candidate for cochlear implantation according to local indications * 18 years of age or older at the time of enrolment * Pre-operative audiometric threshold in the implanted ear at 500 Hz of better than or equal to 80 dB HL * Willingness to participate in and to comply with all requirements of the protocol
Exclusion criteria
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/nerve anatomy on pre-operative CT or MRI imaging (excluding a mild Mondini malformation or Large Vestibular Aqueduct Syndrome) * Deafness due to lesions of the acoustic nerve or central auditory pathway * Diagnosis of auditory neuropathy * Active middle-ear infection * Additional handicaps that would prevent participation in evaluations * Unrealistic expectations on the part of the subject, regarding the possible benefits, risks and limitations that are inherent to the procedure and investigational device
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Deterioration in average low frequency post-operative hearing threshold levels (HTLs) at 4-6 weeks post-surgery in the implanted ear for subjects with compromised Cochear Microphonics (CM) compared to subjects with preserved CM during surgery. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Deterioration in average low frequency post-operative HTLs at 3 months post-activation in the implanted ear for subjects with compromised CM compared to subjects with preserved CM during surgery. 2. Association of pre-operative high frequency HTLs with onset of CM response during electrode array insertion. 3. Safety data in the form of adverse events where they occur. | — |
Countries
The Netherlands
Outcome results
None listed