Electrocochleography for Cochlear Implants: a postoperative study

• Conditions: deafness; hearing loss; 10019243

• Registration Number: NL-OMON56945
• Lead Sponsor: eids Universitair Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Pending
• Sex: Not specified
• Target Recruitment: 45

Inclusion Criteria

- Subject meets the normal clinical candidacy criteria (functional speech
perception scores below 80%) for cochlear implantation.
- Subjects are implanted with the Advanced Bionics cochlear implant system
- Subjects have 80 dB or better pure tone unaided audiometric thresholds at
125, 250 or 500 Hz in the (to-be) implanted ear.
- Subjects have agreed to participate in the study via written informed consent.
- Subjects should be able to understand the written informed consent form.
- Subjects are at least 18 years of age

Exclusion Criteria

Disorders other than a hearing impairment that could affect the study results,
such as psychiatric disorders or physical disorders that would limit their
ability to undergo testing (e.g., movement disorders, blindness etc);

Study & Design

• Study Type: Observational non invasive
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The main study parameters will be the eCochG responses, more specifically, the<br /><br>amplitudes and the phase of the cochlear microphonic (CM) receptor potential,<br /><br>the summating potential (SP) and the compound action potential (CAP). In<br /><br>addition, the audiometric thresholds, electric field imaging, and insertion<br /><br>depth of electrode will be evaluated.</p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Clinically obtained CT-imaging scans to define the electrode location</p><br>