Frequency Therapeutics — Hearing Loss Regeneration

#1,741
Ozwel said:
Then how do you explain that most people with hear loss don't have tinnitus?
Click to expand...
Watch the video, it explains a theory as to why not everyone with hearing loss develops tinnitus but 90% of people with tinnitus have hearing loss. From what I've read 20-40% of people with hearing loss also have tinnitus.
 
#1,746
Well in regards to that, we might as well shut this thread down until frequency posts another news bulletin or they wrap up this phase of their trial and report their findings. I also wouldnt call us communicating ideas while we seek answers "pollution".
Onsdag said:
And phase 2 and phase 3 take an average of 5-7 years so we'll be waiting a while to know if it works.
Click to expand...
well, phase 2 is happening now and scheduled to last 3 - 4 months, so you're wrong.
 
#1,747
https://www.clinicaltrials.gov/ct2/...equency+Therapeutics&cond=Hearing+Loss&rank=1
Here is information about a single-phase study of FX-322.

As a criteria for inclusion in the test, noise-induced hearing loss or sudden hearing loss is indicated. About ototoxicity nothing is said, I do not know if it is included in the concept of "sudden hearing loss".
Inclusion Criteria:

  1. Adult aged 18-65 years.
  2. Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for >6 months.
  3. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
  4. Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception or an intrauterine device and condoms) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.
Exclusion Criteria:

  1. Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in either ear. This includes a current tympanostomy tubes.
  2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
  3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
  4. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  5. Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
  6. History of clinically significant vestibular symptoms at the discretion of the investigator.
  7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
  8. History of head or neck radiation treatment or exposure.
  9. History of substance abuse within 2 years of the Screening Visit.
  10. Positive urine pregnancy test or breast-feeding.
  11. Any known factor, condition or disease that, in the view of the investigator, might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease or suicidal tendencies.
Contacts and Locations
 
#1,749
IvanRus said:
https://www.clinicaltrials.gov/ct2/...equency+Therapeutics&cond=Hearing+Loss&rank=1
Here is information about a single-phase study of FX-322.

As a criteria for inclusion in the test, noise-induced hearing loss or sudden hearing loss is indicated. About ototoxicity nothing is said, I do not know if it is included in the concept of "sudden hearing loss".
Inclusion Criteria:

  1. Adult aged 18-65 years.
  2. Established diagnosis of stable sensorineural hearing loss (no changes of 10 dB or more at any frequency) by standard audiometric measures for >6 months.
  3. Documented medical history consistent with hearing loss being caused by noise exposure or sudden sensorineural hearing loss (documented audiogram at least 6 months prior to screening required).
  4. Female subjects must be of non-childbearing potential or will need to utilize two methods of highly effective contraception during the study participation (e.g. hormonal contraception or an intrauterine device and condoms) or remain abstinent. Male subjects should use condoms with spermicide during the course of the study or remain abstinent. Subjects should not donate sperm or ova during the study period.
Exclusion Criteria:

  1. Perforation of tympanic membrane or other tympanic membrane disorders that would interfere with the delivery and safety assessment of an intratympanic medication or reasonably be suspected to affect tympanic membrane healing after injection in either ear. This includes a current tympanostomy tubes.
  2. Any conductive hearing loss of 10 dB or more at two or more frequencies in either ear.
  3. A pure tone average of 70 dB or greater at 500Hz, 1000Hz, 2000Hz, and 4000Hz in the ear to be injected.
  4. Active chronic middle ear disease or a history of major middle ear surgery, as an adult, in the ear to be injected.
  5. Subject has had an intratympanic injection in either ear within 6 months of the screening visit.
  6. History of clinically significant vestibular symptoms at the discretion of the investigator.
  7. History of clinically significant systemic autoimmune disease (e.g. rheumatoid arthritis, Sjogren's syndrome, multiple sclerosis, psoriasis).
  8. History of head or neck radiation treatment or exposure.
  9. History of substance abuse within 2 years of the Screening Visit.
  10. Positive urine pregnancy test or breast-feeding.
  11. Any known factor, condition or disease that, in the view of the investigator, might interfere with treatment compliance, study conduct or interpretation of the results such as psychiatric disease or suicidal tendencies.
Contacts and Locations
Click to expand...
i could never get in because the satanic pure tonal audiogram says I have perfect hearing.
 
#1,750
reading about the company's first trial, which was in australia...were any results ever released regarding success of the treatment? i know it was a safety trial and not supposed to be testing the effectiveness, but i'm still curious and can't find much online.
also, i'm ignorant so maybe this was a fear for no reason but...so the dormant cells stick around for a while in our bodies? ears, specifically? as i understand it, the gel which gets injected will wake up dormant inner ear hair cells. my concern being, if i've had ear issues for a long time, are my cells still viable? i will assume the answer is yes because it looks like the recent study makes no mention of a time window (such as only people that have been having issues for less than three years).
 
#1,751
Ken.Oh said:
reading about the company's first trial, which was in australia...were any results ever released regarding success of the treatment? i know it was a safety trial and not supposed to be testing the effectiveness, but i'm still curious and can't find much online.
also, i'm ignorant so maybe this was a fear for no reason but...so the dormant cells stick around for a while in our bodies? ears, specifically? as i understand it, the gel which gets injected will wake up dormant inner ear hair cells. my concern being, if i've had ear issues for a long time, are my cells still viable? i will assume the answer is yes because it looks like the recent study makes no mention of a time window (such as only people that have been having issues for less than three years).
Click to expand...

Yes, that it was tolerated.

There is nothing online that says anything about its effectiveness. We can only make inferences.

The patent information explains how they use the dormant cells to make new hair cells and also make more progenitor (dormant) cells.

The dormant cells aren't floating around your body, they line the base of the cochlea.

Are your cells still viable? Are mine? We don't know yet.

Go to MPP page 132 and start reading my posts even up through today. I've basically posted everything from medical papers that can possibly be known by us about this technology. Please ignore the bad memes and silly stuff.
https://www.tinnitustalk.com/threads/my-posting-place.23694/page-132
 
#1,754
Can someone explain "We are focusing on noise induced hearing loss"?

If they are just regenerating hair cells, why does it matter whether it is noise induced, or from another cause, like ear infections, antibiotics, natural decay, ect.?
 
#1,755
#1,756
Gorbeh3 said:
Can someone explain "We are focusing on noise induced hearing loss"?

If they are just regenerating hair cells, why does it matter whether it is noise induced, or from another cause, like ear infections, antibiotics, natural decay, ect.?
Click to expand...
I'm not sure but think it's due to the emergency response of the limbic system being involved. Loud noise, damaged hardware, brain compensates, limbic system regulates the compensation. By isolating 'noise induced tinnitus' the results of the study address this specific model. Which seems to be the majority of the 10 million sufferers of severe tinnitus.
 
#1,757
Gorbeh3 said:
Can someone explain "We are focusing on noise induced hearing loss"?

If they are just regenerating hair cells, why does it matter whether it is noise induced, or from another cause, like ear infections, antibiotics, natural decay, ect.?
Click to expand...
In some other press releases such as the requirements for the phase 1/2 trial they also mention that SSHL and other causes can be eligible for inclusion in the trial.
 
#1,758
LAnative said:
I wonder if there are any members involved in the FX-322 trail. And if so will they be able to discuss it with us?
Click to expand...
Sent my hearing test to them yesterday. First one was 30db loss at 4K 2nd was 35. My loss drops to 40db at 6k. I think I'll get in because I'm very healthy otherwise and fairly young compared to most people with hearing loss.
 
#1,759
Deathtotinni said:
Sent my hearing test to them yesterday. First one was 30db loss at 4K 2nd was 35. My loss drops to 40db at 6k. I think I'll get in because I'm very healthy otherwise and fairly young compared to most people with hearing loss.
Click to expand...

Don't say that tinnitus is your primary complaint otherwise they pry wont let you in.
 
#1,760
Deathtotinni said:
Sent my hearing test to them yesterday. First one was 30db loss at 4K 2nd was 35. My loss drops to 40db at 6k. I think I'll get in because I'm very healthy otherwise and fairly young compared to most people with hearing loss.
Click to expand...
@Deathtotinni if you don't mind me asking do you know how you got your HL? Was it from skull fracture (displayed as your cause of T)?
 
#1,762
Gorbeh3 said:
Can someone explain "We are focusing on noise induced hearing loss"?

If they are just regenerating hair cells, why does it matter whether it is noise induced, or from another cause, like ear infections, antibiotics, natural decay, ect.?
Click to expand...

On second thought, Frequency Therapeutics is probably heavily funded by military/government due to war veterans/IED's.

This may explain why "We are focusing on noise induced hearing loss".
 
#1,763
#1,765
that is great news
if the phase 2 tests are good we can have the drug synthetized and try the injection on ourselves well before it will be released
phase 3 and approval may take 5 year or more
 
#1,766
I want a DAM cure please this is no way for a person to live its nothing but pure suffering a suffering that only a person with it knows I sent my hearing tests to these guys months ago they where rude and did not care what I was going through my loss starts at 6000 going down to 40db at 8000 its 45db my brain sounds like a lazer cutting glass it started when I was a strong 40year old that was four years ago now I look like a dying 80year old man im so done with it all there is nothing they can do there is not even a little hope of nothing its all about how they can get money :( im so tired of this noise sorry for venting just a bad day wishing these Dr.s carried but they DONT NONE OF THEM DO
 
#1,767
#1,768

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