The RW-Precision-Coupler Clinical Investigation

Hearing Loss Clinical Trial

Official title:

The RW-Precision-Coupler Clinical Investigation

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04890145
• Other study ID #: 2020VIB010
• Status: Recruiting
• Phase: N/A
• Start date: May 19, 2021
• Est. completion date: March 31, 2024

Study information

• Verified date: July 2023
• Source: MED-EL Elektromedizinische Geräte GesmbH
• Contact: Severin Fürhapter, PhD
• Phone: +4357788
• Email: allclinicalresearchvibrant[@]medel.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 10
• Est. completion date: March 31, 2024
• Est. primary completion date: March 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hearing Loss

Intervention

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

Locations

Country	Name	City	State
Germany	Medical School Hannover	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
MED-EL Elektromedizinische Geräte GesmbH

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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