Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a 60-month Longitudinal Study
NCT ID: NCT05793580
Last Updated: 2023-04-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
31 participants
INTERVENTIONAL
2008-09-01
2018-09-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Implantation of an Auditory Brainstem Implant for the Treatment of Incapacitating Unilateral Tinnitus
NCT02630589
This Clinical Investigation Assesses the Safety and Performance of a New Beamformer for MED-EL Cochlear Implant Recipients.
NCT07213505
Auditory Performances With Different Stimulation Depths in Cochlear Implanted Subjects Using a Fine Structure Strategy
NCT04591093
Evaluation of Middle Ear Implantation
NCT00451503
Benefits of Bimodal Streaming With MED-EL Cochlear Implants and Starkey Hearing Aids
NCT07028619
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
OTHER
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
VSB arm
longitudinal follow-up of VSB users preoperatively and at 1, 3, 6, 12 and 60 months post-implantation.
Vibrant Soundbridge active middle ear implant
active middle ear implant
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Vibrant Soundbridge active middle ear implant
active middle ear implant
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* cutaneous disease
* subjects who need an MRI.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
MED-EL Elektromedizinische Geräte GesmbH
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Benoît Godey, Pr
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
CHU Rennes
Rennes, , France
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
VSB_longterm_Rennes_study
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.