ADA is pleased to share exciting news of a broad national clinical trial that may benefit both you and your patients by helping you personalize your care even further. Emerging new drug therapies may enable audiologists to help patients improve speech clarity. One such drug candidate is FX-322, a regenerative therapy that has already shown clinically significant results in trials. A national clinical trial, led by Frequency Therapeutics, will investigate a single dose of FX-322, delivered via injection through the eardrum on the round window where it diffuses into the cochlea.
Frequency Therapeutics is looking to recruit subjects into the trial and is asking audiologists from around the country to refer patients into this important study. With 30 sites across the country, it’s likely there is a trial site close to your practice. If not, your patients may still participate and will be compensated to travel. Qualifying referrals will be screened at one visit, then accepted subjects will return for seven additional visits.
Patients qualifying for referral into the trial must:
- Be between the ages of 18 and 65 years of age
- Have a documented medical history of acquired, adult-onset, sensorineural hearing loss associated with noise-induced SNHL or sudden onset SNHL
- Have had a hearing test (audiogram) at least 6 months ago or longer showing a pure-tone average (500, 1000, 2000 and 4000 Hz) between 35 and 85 dBHL
Knowledge of new and innovative treatment options add to the value audiologists provide to patients and reinforce the role of audiology as a clinical doctoring profession. A future where pharmaceuticals add to hearing intervention possibilities will provide new opportunities for audiologists and align with ADA’s entrepreneurial spirit.
Here are some additional resources about Frequency’s science, clinical trial details, and how you can participate:
- Video presentations from a Hearing Loss Association of America national webinar on the company’s science, findings to-date, and how to engage in this national trial (trial information starts at 20:30).
- The trial enrollment website, which includes a map of site locations.
- A letter to audiologists about how you and your patients may benefit from being involved in the trial from an audiologist many of you know, former head of head audiology at Mass Eye and Ear and now a leader at Frequency, Kevin Franck, Ph.D.
If you have additional questions, you may contact Dr. Kevin Franck at