Presently, there are no medicines approved for hearing loss. Assistive devices such as hearing aids and cochlear implants are used to address the symptoms of hearing loss. These options, however, do not address the underlying biological cause of SNHL. This study aims to determine if the study drug can help treat the underlying biological causes of SNHL. By participating in this study, you’re helping pave the way for new potential medicines.
Sensorineural Hearing Loss (SNHL) is a type of hearing loss that is typically acquired through excessive noise exposure or loud sounds over extended periods of time. It can also be caused by infections, immune system problems, trauma, toxic exposures to certain medications, or even just getting older.
An underlying cause is a loss of hair cells in the inner ear, which are responsible for converting sound energy into signals sent to the brain. When we lose these cells, they do not come back on their own. SNHL can occur gradually over time or suddenly.
The purpose of this study is to determine the effects FX-322 has on people with hearing loss.
Participants will be randomly assigned to either a group which receives the study drug or a group which receives a placebo (a placebo has no active ingredients). Subjects that received a placebo injection and completed all study visits may have the opportunity to receive a single injection of FX-322 in an open-label study that the sponsor intends to conduct after this study.
Approximately 124 individuals with Sensorineural Hearing Loss will be included in this study.
You may be eligible to participate if you meet these criteria*:
*Other criteria will apply
Before being able to join the Hearing Loss study, we’ll evaluate your medical history to determine if the study is a potential fit. If you are eligible and choose to take part in this study, you will:
All study-related care, including medical tests, tests to confirm eligibility, clinical care, and investigational study drug, will be provided at no cost to participants.
If you are interested in learning more about whether this Hearing Loss Study may be a good fit for you, please submit the intake form. The answers you submit will be used for study purposes only.
Once you submit the form, a member from our team will reach out to you with hearing loss resources and connect you with a member of the research team if you may qualify for this study.
Please note that answering these questions does not obligate you to participate in the study. If you have any questions, simply email [email protected] or call (415) 326-8829.
The study drug is given by an injection through your eardrum into the middle ear. The active ingredients diffuse (move) from the middle ear into the inner ear where the hair cells are located. Injections through the eardrum are commonly performed in the offices of otolaryngologists (ear, nose, and throat doctors). A numbing agent is used, and the drug candidate has been shown to be well tolerated.
We’re committed to ensuring that all participants can easily access study-related care; consequently, all costs related to study specific assessments and procedures will be provided at no cost to you. Additionally, travel related costs may also be reimbursed.
Approximately 124 people with SNHL will participate in this study.
Your participation in this study will last for up to 10 months, during which you may have up to 8 in person study visits. Participation is completely voluntary, and you may discontinue at any time.
We have provided an article on what happens when clinical trials end, including some tips to consider. You can read the article here. Also, you can ask the study team for more specific details relating to this study in particular.
During this phase your physician will ensure that this study is a good fit for you based on the study criteria. This process will include completing the informed consent, a thorough medical history, physical exam, hearing tests, medical testing, and safety assessments.
In this phase, participants are randomly placed into either the study treatment group or the placebo group. The study treatment group will receive the investigational drug, whereas the placebo group will receive matching placebo treatment with no active ingredients. There is a 50% chance you will receive the study drug.
During this phase, participants will receive either the investigational medicine or the placebo via injection into the eardrum. The investigational medicine will be delivered in a single dose with no additional study treatment required after the initial administration.
All participants will have three follow-up visits, and up to two additional
observational visit. These visits will be 30, 60, and 90 days after you receive
your dosage of either the investigational drug or placebo. The observational visits
will be 180 and 270 days after dosing. These visits are for completing safety and
All participants who received placebo and have completed all follow-up visits for
this study, may have the opportunity to participate in an open label study. This
means they will receive an FX-322 injection in their study ear. (No placebo will be
administered at this point). This open label study will begin after all participants have completed all follow-up visits in the double-blind study and all data from the doctor’s offices and clinics has been collected.
Email our application to patients, family members or friends, or contact us with questions.
Need help or have any questions?
Call toll free or text us at (415) 326-8829, email [email protected], or chat with us here.