Discuss on Tinnitus Talk Forum

Carl LeBel, PhD, Chief Development Officer for Frequency TherapeuticsThe company we interviewed for this episode, Frequency Therapeutics, is the subject of the most active thread on the Tinnitus Talk forum, with nearly 1 million views. So of course, we wanted to hear from them directly!

Frequency Therapeutics is working on a new hearing regeneration treatment. Preliminary results suggest the drug might work particularly well to improve speech intelligibility, something which traditional hearing aids have not been able to achieve.

We spoke with Carl LeBel, PhD, the company’s Chief Development Officer, about how the drug was discovered, whether it might benefit tinnitus, and why speech intelligibility should be the primary measure of hearing. We also touch on the burning question of when FX-322 might hit the market.

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Skip to: 00:00 Introduction to Carl LeBel and Frequency Therapeutics.

We think this is just a huge unmet medical need and we’re glad to be kind of where we are right now but want to go fast.

Skip to: 12:52 What is FXX-322 and how does it work?

Skip to: 24:48 Results of Phase 1 study.

Based on our Phase I study that we did in 2018, we see this remarkable improvement in particular in speech intelligibility in many subjects.

Skip to: 36:00 Potential effects on tinnitus and speech intelligibility.

Skip to: 44:56 Does it work for all?

Skip to: 49:28 What differentiates FX-322 from other approaches.

Skip to: 54:37 Hidden hearing loss, noise trauma and ototoxic-induced tinnitus.

We’ve heard it described as hidden hearing loss, but it’s only hidden because people haven’t been looking in the frequency range that we think one needs to look.

Skip to: 61:52 Getting the drug to market.

Skip to: 68:00 Debriefing – our impressions.

Skip to: 79:46 Debriefing – technical concepts explained.

Discuss this episode on the Tinnitus Talk Forum, or submit a reply below.

Comments (22)
    • Hello, I’ve had hearing damage in both ears since 1995. I was a musician but gave up playing music due to hearing damage, tinnitus and noise sensitivity that I have suffered with in the 25 years when I originally damaged my hearing. I’m a 58 year old man.

      Thank you.

  1. Wonderful – and we all wish you the best – but please hold on to the importance of MUSIC. Hearing an audiologist on your video talking (as they nearly all do) about tests running only from 250 Hz up, I continue to despair.

    Yes, speech must have priority, just as you say, but the legacy of restricted testing continues to hamper development, whether with drugs, implants or ordinary in-ear aids.

    Music is a social bond, alongside conversation. For some of us, music is key to our work. Music goes down to 40 all the time, to 30 sometimes, and even 16 – but fair enough, that might be an octave too far. Remember also that a naturally strong LF response in an ear may compromise speech frequencies. It needs measuring!

    At long last, in UK, there’s a study (Leeds University) into the needs of musical people. Currently, hearing aids fall far short. Our National Institute for Clinical Excellence gives four words to music in its advice to audiologists – and tells me it’s unlikely to revisit that for three or four years.

    • I love and need music, and love them low frequencies, but my understanding about tinnitus is that a primary reason for it is high frequency loss, and for me at least, the tinnitus is the biggest problem.

  2. I’m 45 and have had permanent hearing loss/ tinnitus since I was in my 20’s. I have maskers and been to every audiologist in Eugene/Portland.

    Can I please be part of any of your trials? I have been given maskers, hearing aids… Tinnitus has had a huge impact on my life and my dream is to just get rid of the noise. I’d do anything, pay anything… I’ve been scammed a lot with remedies and this sounds like the first real breakthrough.

    The origination of my tinnitus is a firecracker going off in right ear 20 years ago.

  3. Hello!

    I am from Colombia, hearing loss and tinnitus are worse here!

    I am a teacher. You know the noise levels are always increasing! I hope doctors can find a cure for both situations! Best wishes!

  4. As I understand from previous clinical trials, FX-322 improves your understanding of words, but on hearing test you have no improvement?

    • Hi Christian, this is Hazel from the Tinnitus Talk Podcast. I can’t speak on behalf of the company, but my understanding is that they focussed on clarity of speech improvements for Phase 1 of the trial; I am not sure if standard hearing tests were applied or not. But according to this source, they will apply standard hearing tests for Phase 2: https://clinicaltrials.gov/ct2/show/NCT04120116#contacts. Look under “primary outcome measures” for more details on that they are measuring.

  5. I have severe tinnitus and hyperacusis due to proximity to a battery when it exploded – December 2013. I would be interested in the clinical trials as well. I am learning ASL and I block sound. I can be overexposed to sound and then I pass out.

  6. Hello, I have a 16 year old that got SSHL in one ear 2 1/2 years ago out of the blue. We had never heard of something like this and that it also comes with tinnitus.

    I’m hoping FX-322 will work. She has profound hearing loss and I just wonder if this can help her recoup some or all of her hearing loss?

    Would you mind sharing the names of the ENT in San Antonio, Texas? We live there. I feel for all these people suffering a great deal. This changes many things, not just the hearing loss and annoying tinnitus, but it makes you feel tired, lose sense of direction and location, sensitivity to certain sounds, headaches and dizziness or lightheadedness.

    Thank you for all your hard work, Tinnitus Talk, Tinnitus Hub and Frequency Therapeutics!

    • Hi Idalia, this is Hazel from the Tinnitus Talk Podcast. Thank you for the kind words, it’s much appreciated! I’m very sorry to hear about your daughter.

      You can see where the Phase 1 clinical trial that you refer to was carried out here: https://clinicaltrials.gov/ct2/show/NCT03616223 (scroll down to “Locations”). I hope that helps and best of luck!

  7. I am a 73-year-old man who has suffered from traumatic noise induced severe hearing loss and tinnitus since I served a year in the Army Field Artillery in Vietnam war in 1971-1972. My hearing loss has become worse as I age and my tinnitus is extremely loud 24/7 with no relief ever.

    Your research gives me hope that I might be able to hear silence again before I die.

    I would be willing to help you in your research and clinical trials in any way possible.

    I live in San Antonio, TX. I have 70% VA disability for hearing loss and tinnitus.

    • This will not help pulsatile tinnitus because pulsatile tinnitus is caused by abnormalities in the neck, jaw, shoulder that irritates the auditory nerve, and not by hearing loss.

  8. I am wondering if you could envision FX-322 as a possible therapeutic for someone with cochlear otosclerosis? I understand this disease process is different from what your current study is looking at, but wondering if it is something you could potentially see as something to investigate in the future, once the medication has been approved?

    I have both conductive and sensorineural loss. Stable for a year.

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