The RW-Precision-Coupler Clinical Investigation

The RW-Precision-Coupler Clinical Investigation

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.

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.