The RW-Precision-Coupler Clinical Investigation

Study Overview
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Brief Summary
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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.

Official Title
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The RW-Precision-Coupler Clinical Investigation

Conditions
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Hearing Loss

Intervention / Treatment
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* Device: RW-Precision-Coupler


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Mild to severe hearing loss<br> | Device: RW-Precision-Coupler<br>* Implantation of the RW-Precision-Coupler together with FMT-VORP 503<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 6 months post-operative | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Vibrant Soundbridge System, RW-Precision-Coupler