The RW-Precision-Coupler Clinical Investigation

Ki vehet részt

• 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

Ki nem vehet részt

• 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