NCT04890145CompletedNot Applicable
The RW-Precision-Coupler Clinical Investigation
MED-EL Elektromedizinische Geräte GesmbH2 sites in 1 country5 target enrollmentStarted: May 19, 2021Last updated:
Conditions
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 5
- Locations
- 2
- Primary Endpoint
- Freiburger Monosyllable Test
Study Overview
Brief 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 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
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •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
- •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
Exclusion Criteria
- •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.
- •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.
Outcomes
Primary Outcomes
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
Secondary Outcomes
No secondary outcomes reported
Investigators
Study Sites (2)
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