The BCI 602 BONEBRIDGE Post-Market Clinical Follow-up Study

  • STATUS
    Recruiting
  • participants needed
    51
  • sponsor
    MED-EL Elektromedizinische Geräte GesmbH
Send
Updated on 5 August 2020
See if I qualify
sensorineural hearing loss
audiometry
mixed hearing loss
deafness

Summary

The Bonebridge system using the BCI 601 is marketed since 2012. Previous prospective, multi-center, non-randomized studies on the BCI 601 Bonebridge performed in adult and paediatric populations have shown a significant improvement in terms of aided sound field (SF) thresholds, word recognition scores (WRS), speech reception thresholds (SRT) and subjective device satisfaction. Safety was established by stable residual hearing and low complication rates. The Bonebridge, implanted in over 600 clinics worldwide, is the world's first active transcutaneous bone conduction implant (BCI) system.

This study now focuses on the further developed BCI 602 (marketed since 2019) that has the same indication criteria and performance characteristics.

The aim of this post-market clinical follow-up (PMCF) study is to provide clinical data for the long-term performance and safety when implanted with the Bonebridge BCI 602 .

Details
Condition Sensorineural hearing loss, Mixed conductive and sensorineural hearing loss, Unilateral hearing loss, Hearing Loss, Hearing Loss, Conductive hearing loss, Bilateral hearing loss
Age 5years - 100years
Treatment Bone Conduction Implant
Clinical Study IdentifierNCT04427033
SponsorMED-EL Elektromedizinische Geräte GesmbH
Last Modified on5 August 2020

Eligibility

 Yes No Not Sure

Inclusion Criteria

Geographically and physically able to return to the investigational site for scheduled evaluations and follow-up appointments
Fluent in the language used in the investigational site and used for evaluation
Signed and dated informed consent before the start of any study-specific procedure and collection of any retrospective data
Subjects meet the indication criteria according to the instructions for use (IFU)
Subject 5 years of age and older
The physician must fully assess the potential risks and benefits for the patient and his/her realistic expectations with the device prior to the decision to implant the BCI 602. The physician must exercise medical judgement and consider the patient's complete medical history
Bonebridge candidates suffer from either
conductive or mixed hearing loss as indicated by audiometric testing with bone conduction thresholds better than or equal to 45 dB HL at 0.5, 1.0, 2.0 and 3.0 kHz
single-sided sensorineural deafness, that is severe-to-profound sensorineural hearing loss in one ear while the other ear has normal hearing (air conduction (AC) should be better than or equal to 20 dB HL measured at 0.5, 1.0, 2.0 and 3.0 kHz)

Exclusion Criteria

A subject whose hearing loss has demonstrated an improving and decreasing fluctuation over a two-year period of >15 dB HL in either direction
Severe, chronic, non-revisable diseases or disorders (vestibular disorder, cancer etc.)
A subject with any psychological (anxiety, depression, hallucinations etc.), emotional (schizophrenia, mania, melancholia etc.) or from that originating physical disorder that would interfere with the ability to perform on test procedures
Simultaneous participation in another clinical trial (on device or on drug) which would interfere with the results of the study
Any active ear infection
Subjects who meet any of the contraindications in the IFU
Evidence that hearing loss is of retrocochlear or central origin (ipsilateral CHL /MHL; contralateral SSD)
Skin or scalp conditions that may preclude attachment of the Audio Processor (AP) or that may interfere with the use of the AP
Skull size or abnormality would preclude appropriate placement of the BCI 602 implant
Intolerant to the materials in the BCI 602 implant
Clear my responses
Read more

How to participate?

Step 1 Connect with a study center
Message sent successfully.
We have submitted the information you provided to the research team at the location you chose. For your records, we have sent a copy of the message to your email address.
If you would like to be informed of other studies that may be of interest to you, you may sign up for Patient Notification Service.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

First name*
Last name*
Email*
Phone number*
Other language

Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

Learn more

If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

Learn more

Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

Learn more

Similar trials to consider

Browse trials for

sensorineural hearing loss
audiometry
mixed hearing loss
deafness

Not finding what you're looking for?

Every year hundreds of thousands of volunteers step forward to participate in research. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.

Sign up as volunteer
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.