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Audilogical results of passive middle ear prostheses

Audilogical results of passive middle ear prostheses

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
DRKS
Registry ID
DRKS00040585
Enrollment
200
Registered
2026-06-09
Start date
2026-07-01
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

Chronic middle ear conditions

Interventions

Group 1: As part of their standard surgery, patients will take part in a study-specific data collection process, which will be carried out both during the operation and post-operatively. Additional to

Sponsors

Klinik für Hals-Nasen-Ohren Heilkunde Universitätsklinikum Göttingen
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Inclusion criteria

Inclusion criteria: Chronic middle ear disease Capacity to consent

Exclusion criteria

Exclusion criteria: The patient does not have a chronic middle ear condition The patient is not capable of giving consent

Design outcomes

Primary

MeasureTime frame
The primary endpoint of the study is the improvement in hearing performance, measured as the change in air-conduction threshold or air-bone gap on a pure-tone audiogram, comparing preoperative measurements with defined postoperative measurements. Measurements are taken preoperatively, 14 days to 8 weeks after surgery, between 12 and 16 months after surgery, and between 24 and 36 months after surgery.

Secondary

MeasureTime frame
Secondary endpoints are additional factors that may influence hearing outcomes: gender, age, type of prosthesis, length of prosthesis, underlying medical condition, preoperative otorrhoea, condition of the mucous membrane, condition of the ossicular chain, date of surgery, type of surgery, revision surgery, complications.

Countries

Germany

Contacts

Public ContactNicholas Bevis

Klinik für Hals-Nasen-Ohren Heilkunde Universitätsmedizin Göttingen

nicholas.bevis@med.uni-goettingen.de05513964229

Outcome results

None listed

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