The RW-Precision-Coupler Clinical Investigation

July 13, 2023 updated by: MED-EL Elektromedizinische Geräte GesmbH
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

10

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Mild to severe hearing loss
Device: RW-Precision-Coupler
Implantation of the RW-Precision-Coupler together with FMT-VORP 503

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Freiburger Monosyllable Test
Time Frame: 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
6 months post-operative

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MED-EL Elektromedizinische Geräte GesmbH

Investigators

  • Principal Investigator: Lenarz Thomas, Prof. h.c. Dr., Medizinische Hochschule Hannover Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 19, 2021

Primary Completion (Estimated)

March 31, 2024

Study Completion (Estimated)

March 31, 2024

Study Registration Dates

First Submitted

May 12, 2021

First Submitted That Met QC Criteria

May 12, 2021

First Posted (Actual)

May 18, 2021

Study Record Updates

Last Update Posted (Actual)

July 14, 2023

Last Update Submitted That Met QC Criteria

July 13, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2020VIB010

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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