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

Primary Purpose

Mixed Hearing Loss

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Vibrant Soundbridge active middle ear implant
Sponsored by
MED-EL Elektromedizinische Geräte GesmbH
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Mixed Hearing Loss focused on measuring Active middle ear implant, Vibrant Soundbridge

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: 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. Exclusion Criteria: fluctuating hearing loss, cutaneous disease subjects who need an MRI.

Sites / Locations

  • CHU Rennes

Arms of the Study

Arm 1

Arm Type

Other

Arm Label

VSB arm

Arm Description

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

Outcomes

Primary Outcome Measures

Tonal audiometry
Pure-tone audiograms
Tonal audiometry
Pure-tone audiograms
Tonal audiometry
Pure-tone audiograms
Tonal audiometry
Pure-tone audiograms
Tonal audiometry
Pure-tone audiograms
Tonal audiometry
Pure-tone audiograms

Secondary Outcome Measures

Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Word recognition in noise
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Word recognition in noise
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Word recognition in noise
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Word recognition in noise
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Word recognition in noise
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Word recognition in noise
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.

Full Information

First Posted
March 20, 2023
Last Updated
March 31, 2023
Sponsor
MED-EL Elektromedizinische Geräte GesmbH
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1. Study Identification

Unique Protocol Identification Number
NCT05793580
Brief Title
Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a 60-month Longitudinal Study
Official Title
Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a Prospective Multicenter Longitudinal Study Over 60-months
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Completed
Study Start Date
September 1, 2008 (Actual)
Primary Completion Date
September 1, 2018 (Actual)
Study Completion Date
September 1, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MED-EL Elektromedizinische Geräte GesmbH

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).
Detailed Description
Introduction: 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. AMEIs provide more hearing gain and consistency compared to middle ear surgery plus conventional hearing aids. Coletti et al. (2013) reported on long-term outcomes of patients implanted at the round window (RW) with the VSB. Brkic et al. (2019) presented a large number of subjects (n = 23) with a 20-year follow-up. The limitations of these studies were their retrospective design. The best location for the surgeon to place the VSB's floating mass transducer (FMT) depends on various factors. A meta-analysis showed the hearing results at different FMT sites to be similar. None of these studies compared a FMT placed to a FMT clipped. The impact of the etiology of deafness on a patient's outcome with an AMEI has been poorly studied. Only one study has shown that the difference between inflammatory disease (ID) and non-inflammatory disease (NID) groups was not significant. The main objective: Prospectively assess aided hearing benefits in a 60-month, long-term study including conductive and mixed hearing loss adults implanted with the VSB. Measures are tonal audiometry, pure-tone average (PTA), vocal audiometry in quiet, 50% speech recognition threshold (SRT) in quiet, word recognition in quiet (WRS) at 65 dB sound pressure level (SPL), word recognition in noise (WRSN ; speech at 65 dB SPL and 0°, white noise at 55 dB SPL and 180°. signal-to-noise ratio = 10 dB). The secondary objectives: Comparison of the hearing results according to the FMT site (RW/OW to incus/stapes) Comparison of the hearing results according the type of pathology responsible for the hearing loss (ID to NID). Plan of the study: It is a multicentric, prospective, longitudinal study with 6 tertiary references centres with a follow up over a period of 60 months. Measures will be done on the patient preoperatively and 1, 3, 6, 12 and 60 months post-implantation. Preoperative measures will be done also with hearing aid (HA) and bone-anchored hearing aid on a headband (HBAHA).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mixed Hearing Loss
Keywords
Active middle ear implant, Vibrant Soundbridge

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
Prospective longitudinal study
Masking
None (Open Label)
Allocation
N/A
Enrollment
31 (Actual)

8. Arms, Groups, and Interventions

Arm Title
VSB arm
Arm Type
Other
Arm Description
longitudinal follow-up of VSB users preoperatively and at 1, 3, 6, 12 and 60 months post-implantation.
Intervention Type
Device
Intervention Name(s)
Vibrant Soundbridge active middle ear implant
Intervention Description
active middle ear implant
Primary Outcome Measure Information:
Title
Tonal audiometry
Description
Pure-tone audiograms
Time Frame
preoperatively
Title
Tonal audiometry
Description
Pure-tone audiograms
Time Frame
at 1 month post-implantation
Title
Tonal audiometry
Description
Pure-tone audiograms
Time Frame
at 3 months post-implantation
Title
Tonal audiometry
Description
Pure-tone audiograms
Time Frame
at 6 months post-implantation
Title
Tonal audiometry
Description
Pure-tone audiograms
Time Frame
at 12 months post-implantation
Title
Tonal audiometry
Description
Pure-tone audiograms
Time Frame
at 60 months post-implantation
Secondary Outcome Measure Information:
Title
Word recognition in quiet
Description
Speech recognition test of disyllabic words (Fournier lists).
Time Frame
preoperatively
Title
Word recognition in quiet
Description
Speech recognition test of disyllabic words (Fournier lists).
Time Frame
at 1 month post-implantation
Title
Word recognition in quiet
Description
Speech recognition test of disyllabic words (Fournier lists).
Time Frame
at 3 months post-implantation
Title
Word recognition in quiet
Description
Speech recognition test of disyllabic words (Fournier lists).
Time Frame
at 6 months post-implantation
Title
Word recognition in quiet
Description
Speech recognition test of disyllabic words (Fournier lists).
Time Frame
at 12 months post-implantation
Title
Word recognition in quiet
Description
Speech recognition test of disyllabic words (Fournier lists).
Time Frame
at 60 months post-implantation
Title
Word recognition in noise
Description
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Time Frame
preoperatively
Title
Word recognition in noise
Description
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Time Frame
at 1 month post-implantation
Title
Word recognition in noise
Description
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Time Frame
at 3 months post-implantation
Title
Word recognition in noise
Description
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Time Frame
at 6 months post-implantation
Title
Word recognition in noise
Description
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Time Frame
at 12 months post-implantation
Title
Word recognition in noise
Description
Speech recognition test of disyllabic words (Fournier lists) in noise. Noise = white noise at 55 dB SPL presented at 180°. Speech at 65 dB SPL presented at 0°.
Time Frame
at 60 months post-implantation
Title
Speech reception threshold
Description
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Time Frame
preoperatively
Title
Speech reception threshold
Description
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Time Frame
at 1 month post-implantation
Title
Speech reception threshold
Description
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Time Frame
at 3 months post-implantation
Title
Speech reception threshold
Description
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Time Frame
at 6 months post-implantation
Title
Speech reception threshold
Description
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Time Frame
at 12 months post-implantation
Title
Speech reception threshold
Description
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Time Frame
at 60 months post-implantation

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: fluctuating hearing loss, cutaneous disease subjects who need an MRI.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Benoît Godey, Pr
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Rennes
City
Rennes
ZIP/Postal Code
35000
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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