Status:
COMPLETED
The RW-Precision-Coupler Clinical Investigation
Lead Sponsor:
MED-EL Elektromedizinische Geräte GesmbH
Conditions:
Hearing Loss
Eligibility:
All Genders
18+ years
Phase:
NA
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 clinic...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 19 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 26 2024
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04890145
Start Date
May 19 2021
End Date
November 26 2024
Last Update
December 3 2024
Active Locations (1)
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1
Medical School Hannover
Hanover, Germany