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Recruiting NCT03745560

Intraoperative EABR for Decision Making

Observational Vestibular Schwannoma Hearing Loss

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Vestibular Schwannoma, Hearing Loss. Basic parameters: 18 years — 99 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Austria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

Simultaneous Translabyrinthine Surgery of Vestibular Schwannoma and Cochlear Implantation with Intraoperative EBERA and Correlation to Hearing Results - a Pilot Study

Overview

In this study patients undergoing simultaneous translabyrinthine vestibular schwannoma resection and cochlear implantation are included. The goal of the study is to correlate the eABR results with postoperative hearing results.

Detailed description

Patients undergoing translabyrinthine vestibular schwannoma resection are included in the study. Preoperatively an eABR is carried out, as well as before and after tumor resection.

Postoperatively patients are fitted with a cochlear implant as routinely carried out. The postoperative hearing results with cochlear implant are correlated to the eABR results. The study is an observational study since eABR measurements are not part of the study. A correlation between eABR results categorized in three groups (good response, weak response, no response) with monosyllable understanding with cochlear implant (measured with Freiburger monosyllables test).

Primary outcome measures

  • Correlation of eABR results to postoperative hearing results [Time frame: 2 years]

Eligibility criteria

Inclusion criteria

  • Patients between 18 and 99 years undergoing translabyrinthine vestibular schwannoma resection
  • Patients wanted hearing rehabilitation with a cochlear implant

Exclusion criteria

  • patients who do not want to be part of the study

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Case-only

Study locations

Austria · 1 center
  • AKH, MUW — Vienna

Publications

  • Gadenstaetter AJ, Auinger AB, Gerlitz M, Riss D, Yildiz E, Roessler K, Matula C, Dahm V, Arnoldner C. Long-Term Follow-Up After Translabyrinthine IAC Tumor Removal With Simultaneous Cochlear Implantation. Otol Neurotol. 2025 Dec 1;46(10):1310-1315. doi: 10.1097/MAO.0000000000004313. Epub 2025 Nov 12. PMID 39284021

Identifiers

NCT: NCT03745560 · 1111/2017

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗