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Intraoperative measurement of the inner ear for hearing preservation and monitoring of inner ear function with continuous measurement of cochlear-microphone potentials

Intraoperative measurement of the inner ear for hearing preservation and monitoring of inner ear function with continuous measurement of cochlear-microphone potentials - CM-Study

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00032195
Enrollment
72
Registered
2024-07-09
Start date
2024-06-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

H90.2

Interventions

Group 1: 36 adult patients from the CI waiting list with a pure tone hearing threshold less than or equal to 80 dB(HL) at 500 Hz: Intraoperative measurements: during implantation, the surgeon is given

Sponsors

HNO-Universitätsklinik Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: - patients from the CI waiting list - 18 years or older - <= 100 dB in 2 following freaquencies pure ton audiogram, speech understanding in the Freiburger Testing or <= 100dB potential inthe click-EBR (e.g. positive subjective or objective testing) - postlinual deaf persons - good cooperation - good german skills

Exclusion criteria

Exclusion criteria: - less then 18 years old - decision making not possible - pre- or perilingual deaf - retrocochleare deafness - poor cooperation - preexisting CI experience - poor german skills

Design outcomes

Primary

MeasureTime frame
Reduction of the surgical trauma in various phases of surgery (drilling, opening of the round window, during and after electrode insertion) with the aim of hearing preservation

Secondary

MeasureTime frame
Correlation between intraoperative CM results, postoperative CM results and hearing preservation Specificity of CM results regarding electrode carrier during and after insertion Mapping of the functional OHCs in CI patients, intra- and postoperatively Development of a statistical cochlear model, for an estimation of the CI rehabilitation results Correlation of ECochG results with QoL scores and postoperative acoustic results with the CI in two patient groups: with and without residual hearing Effect of an acoustic feedback signal to the surgeon for the temporal reference during electrode insertion

Countries

Germany

Contacts

Public ContactIoana Brill

HNO-Universitätsklinik Bochum

ioana.brill@rub.de

Outcome results

None listed

Source: DRKS (via WHO ICTRP) · Data processed: Feb 4, 2026