The AudioNotch Tinnitus Treatment Blog

Please note: the following information does not constitute professional medical advice, and is provided for general informational purposes only. Please speak to your doctor if you have tinnitus.

For people who suffer from tinnitus, life can be very difficult. Constant ringing in their ears can make it virtually impossible to enjoy life on either a personal or professional basis, resulting in perhaps years of frustration. However, as medical science continues to learn more about this condition, more and more research studies are being conducted. One of the most anticipated studies is known as the TACTT2 study, which involves testing the safety and effectiveness of AM-101. An investigational study drug that is injected into the middle ear, AM-101 is a drug that doctors hope one day will relieve people of the problems associated with tinnitus.

What is AM-101
A gel formulation, AM-101 contains the active substance Esketamine. Used for many years in pain management and as an anesthetic, Esketamine is thought to be effective for relieving tinnitus when diluted and prepared for specific use in the ear. In research being conducted at the Michigan Ear Institute, participants will receive either AM-101 or a placebo. They will have a 40 percent chance of receiving the placebo and a 60 percent chance of receiving AM-101, and all participants will receive three injections in one ear or both based on if they have tinnitus in one or both ears.

TACTT2 Study Eligibility
Naturally, to be eligible for the study participants had to meet certain guidelines. Some of the criteria that would exclude people from participating in the study include:

• Fluctuating Tinnitus
• Tinnitus resulting from traumatic head or neck injury
• Known allergies to the study medication
• History of abnormal drug reactions
• Women who are pregnant or currently breast-feeding

While there are guidelines for exclusion, there are also guidelines as to who can participate in the study. Those include:

• Ages 18-75
• Ability to use hearing protection and avoid loud noise exposure
• Ability to protect ear canal and middle ear from water exposure

Patient Safety
Many people who want to participate in a clinical research study naturally have many questions regarding its safety as well as what may happen to them as a result of being given experimental drugs. However, these studies have been designed with patient safety in mind. Because they are double-blind studies, neither the patients, doctors, nor staff will know if the placebo or AM-101 has been given. Yet if a medical emergency occurs, doctors will be able to find out what type of treatment was received. So for those people suffering from tinnitus and who meet the guidelines, the TACTT2 study could be a life-changing experience.