The RW-Precision-Coupler Clinical Investigation

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.