Current: Clinical Trial for Sudden Hearing Loss at 3000 N. Halsted Office

Just a Day or Two Ago, Your Hearing Was Just Fine, Then, out of nowhere…

about-hearing-headerYou could only hear muffled noises in one ear. Your hearing in the other ear is fine, but there’s no explanation as to why your hearing in the one ear is suddenly so reduced.

There are many possible reasons for sudden hearing loss in one ear. Unfortunately, you may never know why or how it happened. What’s most important, though, is that you review your treatment options as soon as possible. Untreated sudden hearing loss has the potential to become permanent hearing loss.

One Option to Quickly Consider…

Is the ASSENT clinical research study offered at Chicago ENT. The ASSENT clinical research study is an investigational drug that has been developed to protect hearing and nerve cells following sudden hearing loss. Participants must contact Chicago ENT immediately within 72 hours of onset sudden hearing loss. If the hearing in one of your ears suddenly seems muffled or greatly reduced, consider this research study of an investigational treatment for sudden hearing loss.

Who is Eligible to Participate in the ASSENT Study?

To pre-qualify for this study, you must:

  • Be 18 years of age or older
  • Have had sudden hearing loss within 72 hours of beginning the study treatment
  • Not have had hearing loss from noise, air pressure change, or head trauma

Before you can join this study, you will be screened to find out if you are eligible.  If you are found to be eligible, and you agree to participate in this study, you will be randomly assigned by chance to one of three treatment groups.

Two treatment groups will receive the investigational drug and one will receive placebo. You have a 2 in 3 (66%) chance of receiving the investigational drug and a 1 in 3 (33%) chance of receiving placebo.

In addition to investigational drug (in one of two doses or placebo), all subjects can receive corticosteroid therapy, currently the most common standard therapy for sudden hearing loss.

What is the Cost to Participate in the ASSENT Study?

All study-related visits, tests, and study medication will be provided to participants at no cost. In addition, reimbursement for study-related time and travel may be provided.

More About the Clinical Trial and Duration of the Study

In the ASSENT study, doctors and researchers want to compare the investigational drug, called AM-111, to placebo, which looks like the investigational drug, but contains no active medication. The investigational drug is a gel that is administered into the ear within 72 hours of onset. Researchers believe it may reduce inflammation and help restore normal  hearing if it is administered as soon as possible after sudden hearing loss.

You will be asked to return to the study clinic at Chicago ENT for at least 4 followup visits. Your total study participation will last about 13 weeks and include 5 scheduled study clinic visits.