Clinical Trials

This section of our website is intended to provide information on clinical trials that are currently ongoing in the United States. Please keep in mind special rules apply to devices that are in clinical trial:

  • They are only offered at specific clinical trial sites. These trial site clinics are experienced MED-EL hearing implant centers where the staff is specially trained to follow all of the important guidelines for conducting research.
  • They are only available to candidates who meet very specific criteria and who are formally accepted by the site and the company as a clinical trial participant.
  • Candidates must be fully informed of all known or anticipated risks and the expected benefits of participation in the study. Candidates receive specific counseling and sign a detailed informed consent prior to undergoing the surgery.
  • All clinical trial data must be submitted to FDA, accepted, and market approval granted before the device can be made available to the general public.

 

The pages that follow will describe two devices that are currently in clinical trial in the United States:

  • The EAS Electric-Acoustic Stimulation System, which uses the FLEXeas electrode array and the DUET processor, is in trial for adults with normal to moderate hearing levels in the low frequencies, sloping to severe/profound hearing loss in the high frequencies. These individuals currently have too much residual hearing to qualify for a traditional cochlear implant procedure but do not benefit adequately from conventional hearing aids.
  • The Vibrant Soundbridge Middle Ear Implant System, with the FMT strategically placed in the round window, is in trial for adults who have conductive or mixed hearing loss, do not benefit from traditional hearing aids and currently do not qualify for a traditional middle ear implant procedure.


Other Studies

DISCLAIMER - Always contact your hearing implant center and audiologist prior to volunteering to participate in research studies.
New ideas and innovations in hearing implant technology are largely dependent upon research efforts involving existing hearing implant users.  Through the design, management, and/or support of studies that assess existing hearing implants users’ performance with currently available equipment and programming strategies, MED-EL is committed to adding to the scientific knowledge of the hearing healthcare community and using that knowledge to influence the design and development of future technologies.

Opportunities are often available for existing MED-EL hearing implant recipients to participate in ongoing research studies.  Candidacy and participation requirements vary depending upon the specific study project.  Testing, for instance, may involve listening to speech in the presence of varying levels of background noise, or identifying musical instruments, or completing surveys related to your experience with your current hearing implant.

Information related to projects that are currently open for enrollment is provided on this webpage.  If you are a MED-EL hearing implant recipient and are interested in one of these research opportunities, please contact the affiliated research center for further details related to study participation.

Indiana University
DeVault Otologic Research Laboratory

The Indiana University Devault Otologic Research Laboratory is currently seeking research participants ages 3 to 25 who have bilateral or unilateral cochlear implants.

> Click here for more information

Utah State University

From Cache Pitt (Principal Investigator):
 
As a cochlear implant audiologist,  I am usually asked, "Which device would you get?"  I'm betting that almost everyone reading this post has heard the response, "I can't tell you,” or “I want you to choose.”  The current trend in cochlear implants is to allow the patient to have complete responsibility for choosing their device.
 
This has raised the question, "Is it in the best interest of the implant candidate to not make recommendations for manufacturer selection or should professionals be more inclined to suggest a specific manufacturer?"
 
To help answer that question, I have developed a research survey to find out the experiences of implant recipients.
 
If you are willing to complete the survey, I am targeting a specific population:  
 
You need to be 18 years or older and you/your child need(s) to have a cochlear implant for less than one year.   
 
Thank you very much for your participation and please feel free to forward the link on to others who may be interested in completing the survey.
 
click on this link to take the survey:  
https://usu.co1.qualtrics.com/SE/?SID=SV_cI25jc5nVLiYjs1

 

Vanderbilt University
Department of Hearing & Speech Sciences

The Vanderbilt Bill Wilkerson Center is currently seeking adult research participants who have bilateral MED-EL cochlear implants.

> Click here for more information

The Cochlear Implant Laboratory at Vanderbilt Bill Wilkerson Center is currently seeking adult research participants who have either i) a cochlear implant with acoustic hearing in the non­‐implanted ear, ii) a cochlear implant with acoustic hearing in both ears, or iii) bilateral cochlear implants.

> Click here for more information

Arizona State University

Arizona State University is currently seeking adult research participants who have a MED-EL cochlear implant and preserved residual hearing.

> Click here for more information

House Research Institute

House Research Institute is currently seeking research participants who have been implanted with a MED-EL cochlear implant with the standard electrode array.

> Click here for more information

University of Wisconsin Madison
- Waisman Center

The Binaural Hearing and Speech Lab is currently seeking research
participants ages 18-36 months who have bilateral or unilateral
cochlear implants. 

> Click here for more information

Johns Hopkins Listening Center

The Johns Hopkins Listening Center is currently seeking adult research participants implanted with a MED-EL cochlear implant with the Standard Electrode Array.

> Click here for Standard Electrode Array 

The Johns Hopkins Listening Center is currently seeking adult research participants implanted with a MED-EL cochlear implant with the Medium Electrode Array.

> Click here for Medium Electrode Array

• All studies have been approved by an Institutional Review Board (IRB). Informed consent procedures will be obtained from the candidate prior to the initiation of study testing or procedures.

© 2013 MED-EL