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Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a 60-month Longitudinal Study

NCT05793580 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 31

Last updated 2023-04-03

No results posted yet for this study

Summary

Vibrant Soundbridge (VSB, MED-EL, Innsbruck) Active middle ear implants (AMEI) can benefit patients who are unable to use conventional hearing aids (HA) due to medical reasons, discomfort or unsuccessful rehabilitation. Long-term prospective longitudinal studies are lacking on the VSB notably for conductive and mixed hearing loss. The main aim of the present study was to prospectively assess aided hearing benefits in a 60-month, long-term study including conductive and mixed hearing loss adults implanted with the VSB. The secondary objective was to compare the hearing results according to the Floating Mass Transducer (FMT) site (Round/oval window (RW/OW) vs incus/stapes) and the type of pathology responsible for the hearing loss (Inflammatory vs non-inflammatory disease, ID vs NID).

Conditions

  • Mixed Hearing Loss

Interventions

DEVICE

Vibrant Soundbridge active middle ear implant

active middle ear implant

Sponsors & Collaborators

  • MED-EL Elektromedizinische Geräte GesmbH

    lead INDUSTRY

Principal Investigators

  • Benoît Godey, Pr · Rennes University Hospital

Study Design

Allocation
NA
Purpose
OTHER
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-09-01
Primary Completion
2018-09-01
Completion
2018-09-01

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05793580 on ClinicalTrials.gov