Mixed Hearing LossNCT05793580
Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a 60-month Longitudinal Study
A study testing Vibrant Soundbridge active middle ear implant in people with Mixed Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mixed Hearing Loss
- What is being tested?
- Vibrant Soundbridge active middle ear implant
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2008to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- fluctuating hearing loss,
- cutaneous disease
- subjects who need an MRI.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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).
Read the 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).
- Conditions
- Mixed Hearing Loss
- Being tested
- Vibrant Soundbridge active middle ear implant
- Keywords
- Active middle ear implant, Vibrant Soundbridge
- Medical subject headings
- Hearing Loss, Mixed Conductive-Sensorineural
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrant Soundbridge active middle ear implantDevice
active middle ear implant
| Study group | Role | What they receive |
|---|---|---|
| VSB arm | Other | longitudinal follow-up of VSB users preoperatively and at 1, 3, 6, 12 and 60 months post-implantation. Receives: Device: Vibrant Soundbridge active middle ear implant |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tonal audiometry
Pure-tone audiograms
Measured: preoperatively
Tonal audiometry
Pure-tone audiograms
Measured: at 1 month post-implantation
Tonal audiometry
Pure-tone audiograms
Measured: at 3 months post-implantation
Tonal audiometry
Pure-tone audiograms
Measured: at 6 months post-implantation
Tonal audiometry
Pure-tone audiograms
Measured: at 12 months post-implantation
Tonal audiometry
Pure-tone audiograms
Measured: at 60 months post-implantation
Secondary outcomes (18)
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Measured: preoperatively
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Measured: at 1 month post-implantation
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Measured: at 3 months post-implantation
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Measured: at 6 months post-implantation
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Measured: at 12 months post-implantation
Word recognition in quiet
Speech recognition test of disyllabic words (Fournier lists).
Measured: 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°.
Measured: 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°.
Measured: 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°.
Measured: 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°.
Measured: 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°.
Measured: 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°.
Measured: at 60 months post-implantation
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Measured: preoperatively
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Measured: at 1 month post-implantation
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Measured: at 3 months post-implantation
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Measured: at 6 months post-implantation
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Measured: at 12 months post-implantation
Speech reception threshold
Speech reception threshold to have 50% of intelligibility on disyllabic words.
Measured: at 60 months post-implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2023
- Study start1 Sep 2008
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mixed Hearing LossStudies of the same condition, open and under way.
- More trials run by MED-EL Elektromedizinische Geräte GmbHThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Prospective longitudinal study
- Masking
- None (open label)
- Enrolment
- 31 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Benoît Godey, Pr, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05793580
- Sponsor's protocol ID
- VSB_longterm_Rennes_study
- Status last verified
- Mar 2023
- First submitted
- 20 Mar 2023
- Last updated
- 3 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Long Term Results With the Vibrant Soundbridge in Patients With Mixed Hearing Loss: a Prospective Multicenter Longitudinal Study Over 60-months
- ClinicalTrials.gov ID
- NCT05793580
- Acronym / sponsor ID
- VSB_longterm_Rennes_study
- Conditions
- Mixed Hearing Loss
- Keywords
- Active middle ear implant, Vibrant Soundbridge
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 1 Sep 2008 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 31 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Prospective longitudinal study
| Arm | Type | Receives |
|---|---|---|
| VSB arm | Other | Device: Vibrant Soundbridge active middle ear implantlongitudinal follow-up of VSB users preoperatively and at 1, 3, 6, 12 and 60 months post-implantation. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (3 listed)
- fluctuating hearing loss,
- cutaneous disease
- subjects who need an MRI.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrant Soundbridge active middle ear implantactive middle ear implant | Device | VSB arm |
Primary outcome
Tonal audiometry
Time frame: preoperatively
Pure-tone audiograms
Tonal audiometry
Time frame: at 1 month post-implantation
Pure-tone audiograms
Tonal audiometry
Time frame: at 3 months post-implantation
Pure-tone audiograms
Tonal audiometry
Time frame: at 6 months post-implantation
Pure-tone audiograms
Tonal audiometry
Time frame: at 12 months post-implantation
Pure-tone audiograms
Tonal audiometry
Time frame: at 60 months post-implantation
Pure-tone audiograms
18 secondary outcomes
Word recognition in quiet
Time frame: preoperatively
Word recognition in quiet
Time frame: at 1 month post-implantation
Word recognition in quiet
Time frame: at 3 months post-implantation
Word recognition in quiet
Time frame: at 6 months post-implantation
Word recognition in quiet
Time frame: at 12 months post-implantation
Word recognition in quiet
Time frame: at 60 months post-implantation
Word recognition in noise
Time frame: preoperatively
Word recognition in noise
Time frame: at 1 month post-implantation
Word recognition in noise
Time frame: at 3 months post-implantation
Word recognition in noise
Time frame: at 6 months post-implantation
Word recognition in noise
Time frame: at 12 months post-implantation
Word recognition in noise
Time frame: at 60 months post-implantation
Speech reception threshold
Time frame: preoperatively
Speech reception threshold
Time frame: at 1 month post-implantation
Speech reception threshold
Time frame: at 3 months post-implantation
Speech reception threshold
Time frame: at 6 months post-implantation
Speech reception threshold
Time frame: at 12 months post-implantation
Speech reception threshold
Time frame: at 60 months post-implantation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Apr 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Benoît Godey, Pr principal investigator
Rennes University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Vibrant Soundbridge active middle ear implant in people with Mixed Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tonal audiometry (time frame: preoperatively). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Apr 2023.