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Monitoring and improving the FMT placement with video analysis and ABR recording

Monitoring and improving the FMT placement with video analysis and ABR recording - VSB-AcoustiAP

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00035047
Enrollment
15
Registered
2026-06-08
Start date
2025-03-03
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

H90.3

Interventions

Group 1: A pure tone audiogram is performed before and after the operation. Intraoperatively a ABR over the implant with the AcoustiAP system (according to Cebulla et al. 2022) is performed. This can

Sponsors

HNO-Universitätsklinik Bochum
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - adults = 18 years - combined or mixed hearing loss with the inner ear threshold (PTA3) not exceeding 30 dB - not able to wear conventional hearing aids

Exclusion criteria

Exclusion criteria: < 18 years non compliance lack of awareness explantation within 3 months

Design outcomes

Primary

MeasureTime frame
Developing a method for decision making on two different coupling systems for the FMT actuator of the VSB (e.g. incus vs. stapes) or retrograde activation (round window). This should be based on electrophisiological measurements.

Secondary

MeasureTime frame
Comparison between the measurment of the best coupling system before and after wound closure at the end of the operation. What role plays the reconstruction of the middle ear layers and the ear packing on the performance of the VSB? Comparison with the vibrogramm 24 h postoperative and 3 months after surgery. What are the short and long term healing effects and on the acoustic performance of the VSB?

Countries

Germany

Contacts

Public ContactIoana Brill

HNO-Universitätsklinik Bochum

ioana.brill@rub.de+49 234 509 8734

Outcome results

None listed

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