Hearing LossNCT04890145
The RW-Precision-Coupler Clinical Investigation
A study testing RW-Precision-Coupler in people with Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
Trial summary
The RW-Precision-Coupler Clinical Investigation is prospective, non-randomized, open label, single subjects repeated measures, longitudinal monocentric trial. The primary aim of this pre-market clinical investigation is to evaluate the clinical performance and safety of VSB together with the VSB RWP-Coupler in the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Hearing Loss
- What is being tested?
- RW-Precision-Coupler
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteGermany
- Study dates
- 19 May 2021to 26 Nov 2024
- 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
- Geographically and physically able to return to the investigational site for scheduled evaluations and follow-up appointments
- Fluent in the German language
- Persons of 18 years of age or older
- Signed and dated informed consent before the start of any study-specific procedure
- The physician must fully assess the potential risks and benefits for the patient prior to the decision to implant the RW-Precision-Coupler. The physician must exercise medical judgment and consider the patient's complete hospital record (also called medical history)
- No previous active middle ear implant surgery performed in the implanted ear
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- The following indication for VORP503:
- For a patient with sensorineural hearing loss, pure-tone air conduction threshold levels at or within the levels listed below:
- For a patient with conductive or mixed hearing loss, pure tone bone-conduction threshold levels at or within the levels listed below:
- A patient shall present with an ear anatomy that can facilitate positioning of the FMT in contact with a suitable vibratory structure of the ear.
- A patient with sensorineural hearing loss shall be a current user of an acoustic hearing aid and have used this aid for at least 4 hours (average) per day for at least 3 months prior to evaluation, or shall not be able to wear or benefit from conventional hearing aids for medical reasons.
- A patient shall be psychologically and emotionally stable with realistic expectations of the benefits and limitations of the Soundbridge
Who cannot join
- Simultaneous participation in another clinical trial (on device or on drug) which would interfere with the results of the study
- Pregnancy or lactation
- Contraindication for RWP-Coupler Sizer:
- if a patient is known to be intolerant of the materials used in the RWP-Coupler.
- if a patient is known to be intolerant of the materials used in the RWP-Coupler Sizer.
- in case of a fixed stapes footplate.
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- Contraindication for VORP503:
- A patient is known to be intolerant of the materials used in the implant (medical grade silicone elastomer, medical grade epoxy and titanium).
- A patient with retrocochlear, or central auditory disorders.
- A patient with nonresponsive active ear infection and/or chronic fluid in or about the ear.
- A patient whose hearing loss has demonstrated an improving and decreasing fluctuation over a two-year period of 15 dB in either direction.
- A patient with any physical, psychological, or emotional disorder that would interfere with surgery or the ability to perform on test and rehabilitation procedures.
- A patient with a skin or scalp condition that may preclude attachment of the audio processor with a magnet.
Trial locations and contacts
1 site in 1 country.
About this study
The RW-Precision-Coupler Clinical Investigation is prospective, non-randomized, open label, single subjects repeated measures, longitudinal monocentric trial. The primary aim of this pre-market clinical investigation is to evaluate the clinical performance and safety of VSB together with the VSB RWP-Coupler in the treatment of hearing loss. As secondary aims are to evaluate the clinical performance of VSB together with RWP-Coupler by measuring Sound Field audiometry (SF), to evaluate the safety of VSB together with RWP-Coupler by measuring bone conduction (BC) thresholds and collecting and assessing adverse events.
- Conditions
- Hearing Loss
- Being tested
- RW-Precision-Coupler
- Keywords
- Vibrant Soundbridge System, RW-Precision-Coupler
- Medical subject headings
- Hearing Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RW-Precision-CouplerDevice
Implantation of the RW-Precision-Coupler together with FMT-VORP 503
| Study group | Role | What they receive |
|---|---|---|
| Mild to severe hearing loss | Experimental | Not described Receives: Device: RW-Precision-Coupler |
What is being measured
The primary outcome is the main question the study is designed to answer.
Freiburger Monosyllable Test
Investigate the improvement of unaided pre-activation Word Recognition Scores (WRS) to 6 months post-operation aided WRS with RW-Precision-Coupler
Measured: 6 months post-operative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2021
- Study start19 May 2021
- Primary completion26 Nov 2024
- Study completion26 Nov 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hearing LossStudies of the same condition, open and under way.
- 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
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 5 participants (actual)
Sponsor and investigators
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Lenarz Thomas, Prof. h.c. Dr., Principal investigator, Medizinische Hochschule Hannover Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04890145
- Sponsor's protocol ID
- 2020VIB010
- Status last verified
- Dec 2024
- First submitted
- 12 May 2021
- Last updated
- 3 Dec 2024
- Results posted
- No
- Data monitoring committee
- Yes
- 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 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The RW-Precision-Coupler Clinical Investigation
- ClinicalTrials.gov ID
- NCT04890145
- Acronym / sponsor ID
- 2020VIB010
- Conditions
- Hearing Loss
- Keywords
- Vibrant Soundbridge System, RW-Precision-Coupler
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 5 participants (actual)
- Lead sponsor
- MED-EL Elektromedizinische Geräte GmbHIndustry (pharma, biotech, devices)
- Study start
- 19 May 2021 (actual)
- Primary completion
- 26 Nov 2024 (actual)
- Study completion
- 26 Nov 2024 (actual)
- First posted
- 18 May 2021 (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.
The RW-Precision-Coupler Clinical Investigation is prospective, non-randomized, open label, single subjects repeated measures, longitudinal monocentric trial. The primary aim of this pre-market clinical investigation is to evaluate the clinical performance and safety of VSB together with the VSB RWP-Coupler in the treatment of hearing loss. As secondary aims are to evaluate the clinical performance of VSB together with RWP-Coupler by measuring Sound Field audiometry (SF), to evaluate the safety of VSB together with RWP-Coupler by measuring bone conduction (BC) thresholds and collecting and assessing adverse events.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mild to severe hearing loss | Experimental | Device: RW-Precision-Coupler |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Geographically and physically able to return to the investigational site for scheduled evaluations and follow-up appointments
Key exclusion criteria (13 listed)
- Simultaneous participation in another clinical trial (on device or on drug) which would interfere with the results of the study
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 |
|---|---|---|
| RW-Precision-CouplerImplantation of the RW-Precision-Coupler together with FMT-VORP 503 | Device | Mild to severe hearing loss |
Primary outcome
Freiburger Monosyllable Test
Time frame: 6 months post-operative
Investigate the improvement of unaided pre-activation Word Recognition Scores (WRS) to 6 months post-operation aided WRS with RW-Precision-Coupler
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 Dec 2024.
- 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.
Lenarz Thomas, Prof. h.c. Dr. principal investigator
Medizinische Hochschule Hannover Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing RW-Precision-Coupler in people with Hearing Loss, run by MED-EL Elektromedizinische Geräte GmbH at 1 site in Germany.
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 12 inclusion and 13 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 Dec 2024. 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 Germany. 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?
Freiburger Monosyllable Test (time frame: 6 months post-operative). 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 Dec 2024; AzTrials last refreshed its copy on 31 Oct 2026.