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Bilateral Validation of Electrical Promontory Stimulation Under General Anesthesia: A Prospective Exploratory Study

Bilateral Validation of Electrical Promontory Stimulation Under General Anesthesia: A Prospective Exploratory Study - BiVaP

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
DRKS
Registry ID
DRKS00038541
Enrollment
10
Registered
2025-11-24
Start date
2026-08-01
Completion date
Unknown
Last updated
2026-06-22

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

Conditions

Indications for the implantation of a Cholea implant

Interventions

Group 1: Patients > 18 years of age who undergo auditory nerve testing as part of pre-diagnostic testing for cochlear implants . Patients undergo 1-2 times per month auditory nerve testing using the p

Sponsors

Uniklinik Essen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: > 18 years of age who have undergone a promontory test (auditory nerve test) as part of the cochlear implant pre-diagnostics and have given their consent to participate in the study

Exclusion criteria

Exclusion criteria: Patients younger than 18 years of age Patients older than 18 years of age who have not undergone a promontory test (auditory nerve test) and/or who have refused to participate in the study Patients without a promontory test (auditory nerve test) as part of the pre-diagnostic assessment for cochlear implants

Design outcomes

Primary

MeasureTime frame
Correlation of the auditory nerve test with the actual hearing status of this ear, as determined by subjective and objective audiological procedures (tone audiogram, BERA, or other available data). Comparison of hearing test results between the affected and healthy sides.

Secondary

MeasureTime frame
The usefulness of repositioning the cochlear implant when the results are not clearly interpretable.

Countries

Germany

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Jun 29, 2026