Hearing Loss
Conditions
Keywords
Vibrant Soundbridge System, RW-Precision-Coupler
Brief 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.
Interventions
DEVICERW-Precision-Coupler
Implantation of the RW-Precision-Coupler together with FMT-VORP 503
Sponsors
MED-EL Elektromedizinische Geräte GesmbH
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Freiburger Monosyllable Test | 6 months post-operative | Investigate the improvement of unaided pre-activation Word Recognition Scores (WRS) to 6 months post-operation aided WRS with RW-Precision-Coupler |
Countries
Germany
Outcome results
None listed