NCT05793580

Brief 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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2008

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
10 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

March 20, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 31, 2023

Completed
Last Updated

April 3, 2023

Status Verified

March 1, 2023

Enrollment Period

10 years

First QC Date

March 20, 2023

Last Update Submit

March 31, 2023

Conditions

Mixed Hearing Loss

Keywords

Active middle ear implantVibrant Soundbridge

Outcome Measures

Primary Outcomes (6)

  • Tonal audiometry

    Pure-tone audiograms

    preoperatively

  • Tonal audiometry

    Pure-tone audiograms

    at 1 month post-implantation

  • Tonal audiometry

    Pure-tone audiograms

    at 3 months post-implantation

  • Tonal audiometry

    Pure-tone audiograms

    at 6 months post-implantation

  • Tonal audiometry

    Pure-tone audiograms

    at 12 months post-implantation

  • Tonal audiometry

    Pure-tone audiograms

    at 60 months post-implantation

Secondary Outcomes (18)

  • Word recognition in quiet

    preoperatively

  • Word recognition in quiet

    at 1 month post-implantation

  • Word recognition in quiet

    at 3 months post-implantation

  • Word recognition in quiet

    at 6 months post-implantation

  • Word recognition in quiet

    at 12 months post-implantation

  • +13 more secondary outcomes

Study Arms (1)

VSB arm

OTHER

longitudinal follow-up of VSB users preoperatively and at 1, 3, 6, 12 and 60 months post-implantation.

Device: Vibrant Soundbridge active middle ear implant

Interventions

Vibrant Soundbridge active middle ear implantDEVICE

active middle ear implant

VSB arm

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adult patient (\>= 18 years old) speaking French
  • with mixed hearing loss on at least one side
  • with a maximum bone conduction (BC) threshold of 45 dB hearing level (HL) at 500 Hz, 50 dB HL at 1000 Hz, 55 dB HL at 1500 Hz, and 60 dB HL at 2000 Hz.
  • with a 20 dB minimum air-bone gap (defined as the difference between bone- and air conduction thresholds).
  • with stable BC thresholds over the previous 24 months, and no sufficient benefit with the HA.

You may not qualify if:

  • fluctuating hearing loss,
  • cutaneous disease
  • subjects who need an MRI.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

CHU Rennes

Rennes, 35000, France

Location

MeSH Terms

Conditions

Hearing Loss, Mixed Conductive-Sensorineural

Condition Hierarchy (Ancestors)

Hearing LossHearing DisordersEar DiseasesOtorhinolaryngologic DiseasesSensation DisordersNeurologic ManifestationsNervous System DiseasesSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Benoît Godey, Pr

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
OTHER
Intervention Model
SINGLE GROUP
Model Details: Prospective longitudinal study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 20, 2023

First Posted

March 31, 2023

Study Start

September 1, 2008

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

April 3, 2023

Record last verified: 2023-03

Data Sharing

IPD Sharing
Will not share

Locations

FR(1)