The RW-Precision-Coupler Clinical Investigation

Inclusion Criteria:

• Geographically and physically able to return to the investigational site forscheduled 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-specificprocedure

• The physician must fully assess the potential risks and benefits for thepatient prior to the decision to implant the RW-Precision-Coupler. Thephysician must exercise medical judgment and consider the patient's completehospital 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 conductionthreshold levels at or within the levels listed below:

• For a patient with conductive or mixed hearing loss, pure tonebone-conduction threshold levels at or within the levels listed below:

• A patient shall present with an ear anatomy that can facilitatepositioning of the FMT in contact with a suitable vibratory structure ofthe ear.

• A patient with sensorineural hearing loss shall be a current user of anacoustic 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 towear or benefit from conventional hearing aids for medical reasons.

• A patient shall be psychologically and emotionally stable with realisticexpectations of the benefits and limitations of the Soundbridge

Exclusion Criteria:

• Simultaneous participation in another clinical trial (on device or on drug) whichwould 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 theRWP-Coupler.

• if a patient is known to be intolerant of the materials used in theRWP-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 inor about the ear.

• A patient whose hearing loss has demonstrated an improving and decreasingfluctuation over a two-year period of 15 dB in either direction.

• A patient with any physical, psychological, or emotional disorder thatwould interfere with surgery or the ability to perform on test andrehabilitation procedures.

• A patient with a skin or scalp condition that may preclude attachment ofthe audio processor with a magnet.