The RW-Precision-Coupler Clinical Investigation

NCT04890145 | Completed DMC

• 1 other identifier: 2020VIB010
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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.

Conditions

Hearing Loss

Keywords

Vibrant Soundbridge System; RW-Precision-Coupler

Outcome Measures

Primary Outcomes (1)

• Freiburger Monosyllable Test

  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

Study Arms (1)

Mild to severe hearing loss

EXPERIMENTAL

Device: RW-Precision-Coupler

Interventions

RW-Precision-Coupler DEVICE

Implantation of the RW-Precision-Coupler together with FMT-VORP 503

Mild to severe hearing loss

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• MED-EL Elektromedizinische Geräte GesmbH: lead

Study Sites (1)

Medical School Hannover

Hanover, Germany

Location

MeSH Terms

Conditions

Hearing Loss

Condition Hierarchy (Ancestors)

Hearing Disorders; Ear Diseases; Otorhinolaryngologic Diseases; Sensation Disorders; Neurologic Manifestations; Nervous System Diseases; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Lenarz Thomas, Prof. h.c. Dr.

  Medizinische Hochschule Hannover Klinik und Poliklinik für Hals-Nasen-Ohren-Heilkunde

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 12, 2021
• First Posted: May 18, 2021
• Study Start: May 19, 2021
• Primary Completion: November 26, 2024
• Study Completion: November 26, 2024
• Last Updated: December 3, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)