the rw-precision-coupler clinical investigation

Conditions: Hearing Loss

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.


Eligibility criteria:
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.

Keywords: vibrant soundbridge system rw-precision-coupler