Subjective and objective measurement methods for determining the coupling quality of the Vibrant Soundbridge to middle ear structures

Subjective and objective measurement methods for determining the coupling quality of the Vibrant Soundbridge to middle ear structures - Measurements for coupling the VSB

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

DRKS

Registry ID

DRKS00036598

Enrollment

Registered

2025-04-28

Start date

2025-04-01

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

Conductive or combined hearing loss

Interventions

Group 1: All patients who are treated with a VSB in the period: 01.04.2025-28.02.2030.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Persons who are supplied with a VSB from MED-EL

Exclusion criteria

Exclusion criteria: People with neurological limitations or pre-existing conditions

Design outcomes

Primary

Measure	Time frame
All patients with a VSB until 28.02.2030. The study aims to objectively check and verify the coupling to existing middle ear structures. Measurements are taken pre-operatively, intra-operatively and post-operatively: One to two days after the operation, for the initial fitting; four weeks after the initial fitting; and 12 months after the initial fitting.	—

Countries

Germany

Contacts

Public ContactPascale Sandmann

Universitätsklinik für HNO-Heilkunde am evangelischen Krankenhaus Oldenburg

Pascale.Sandmann@evangelischeskrankenhaus.de0049-441-236-9698

Outcome results

None listed

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