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Electrocochleography for Cochlear Implants: a postoperative study

Electrocochleography for Cochlear Implants: a postoperative study - Electrocochleography for Cochlear Implants

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
NL-OMON
Registry ID
NL-OMON56945
Enrollment
45
Registered
2024-04-12
Start date
2024-10-21
Completion date
Unknown
Last updated
2025-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

deafness, hearing loss

Interventions

None listed

Sponsors

Leids Universitair Medisch Centrum
Lead Sponsor

Eligibility

Age
18 Years to 99 Years

Inclusion criteria

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

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);

Design outcomes

Primary

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

Secondary

MeasureTime frame
Clinically obtained CT-imaging scans to define the electrode location

Countries

Netherlands

Contacts

Public ContactM.J. van Gendt

Leids Universitair Medisch Centrum

KNO-onderzoek@lumc.nl0715262408

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)