The RW-Precision-Coupler Clinical Investigation

NCT ID: NCT04890145

Last Updated: 2024-12-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 5 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-05-19
• Study Completion Date: 2024-11-26

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Mild to severe hearing loss

Group Type: EXPERIMENTAL

RW-Precision-Coupler

Intervention Type: DEVICE

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

Interventions

RW-Precision-Coupler

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

Intervention Type: DEVICE

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MED-EL Elektromedizinische Geräte GesmbH

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lenarz Thomas, Prof. h.c. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Medical School Hannover

Hanover, , Germany

Countries

Germany

Other Identifiers

2020VIB010

Identifier Type: -

Identifier Source: org_study_id