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

Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a Prospective Multicenter Longitudinal Study Over 60-months

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).

Study Overview

• Status: Completed
• Conditions: Mixed Hearing Loss
• Intervention / Treatment: Device: Vibrant Soundbridge active middle ear implant

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).

• Study Type: Interventional
• Enrollment (Actual): 31
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Rennes, France, 35000
    • Chu Rennes

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: VSB arm; 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; active middle ear implant

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Word recognition in quiet	Speech recognition test of disyllabic words (Fournier lists).	preoperatively
Word recognition in quiet	Speech recognition test of disyllabic words (Fournier lists).	at 1 month post-implantation
Word recognition in quiet	Speech recognition test of disyllabic words (Fournier lists).	at 3 months post-implantation
Word recognition in quiet	Speech recognition test of disyllabic words (Fournier lists).	at 6 months post-implantation
Word recognition in quiet	Speech recognition test of disyllabic words (Fournier lists).	at 12 months post-implantation
Word recognition in quiet	Speech recognition test of disyllabic words (Fournier lists).	at 60 months post-implantation
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°.	preoperatively
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°.	at 1 month post-implantation
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°.	at 3 months post-implantation
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°.	at 6 months post-implantation
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°.	at 12 months post-implantation
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°.	at 60 months post-implantation
Speech reception threshold	Speech reception threshold to have 50% of intelligibility on disyllabic words.	preoperatively
Speech reception threshold	Speech reception threshold to have 50% of intelligibility on disyllabic words.	at 1 month post-implantation
Speech reception threshold	Speech reception threshold to have 50% of intelligibility on disyllabic words.	at 3 months post-implantation
Speech reception threshold	Speech reception threshold to have 50% of intelligibility on disyllabic words.	at 6 months post-implantation
Speech reception threshold	Speech reception threshold to have 50% of intelligibility on disyllabic words.	at 12 months post-implantation
Speech reception threshold	Speech reception threshold to have 50% of intelligibility on disyllabic words.	at 60 months post-implantation

Collaborators and Investigators

• Sponsor: MED-EL Elektromedizinische Geräte GesmbH

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2008
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: March 20, 2023
• First Submitted That Met QC Criteria: March 30, 2023
• First Posted (Actual): March 31, 2023

Study Record Updates

• Last Update Posted (Actual): April 3, 2023
• Last Update Submitted That Met QC Criteria: March 31, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Active middle ear implant; Vibrant Soundbridge
• Additional Relevant MeSH Terms: Nervous System Diseases; Neurologic Manifestations; Otorhinolaryngologic Diseases; Ear Diseases; Sensation Disorders; Hearing Disorders; Hearing Loss; Deafness; Hearing Loss, Mixed Conductive-Sensorineural
• Other Study ID Numbers: VSB_longterm_Rennes_study

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No