clinical trial

Spotlight by CU Innovations

In a recent interview with CU Innovations, Dr. Achim Klug, Professor of Physiology & Biophysics at CU Anschutz, shared exciting developments about a revolutionary treatment for age-related hearing loss that challenges everything we thought we knew about hearing restoration.

The Problem With Current Solutions

Dr. Klug's work addresses a widespread yet often misunderstood condition: central hearing loss, which affects the brain rather than the ears themselves. If you've ever struggled to follow a conversation in a noisy restaurant despite having "perfect hearing" according to traditional tests, you've experienced this phenomenon firsthand. The frustrating reality is that conventional hearing aids can't help with this condition because they're designed to amplify sound at the ear level, not address how the brain processes and filters auditory information.

This affects an astounding number of people—approximately one-third of adults between 40 and 65, and half of those 65 and older. That's millions of people who currently have no effective treatment options.

  • A Novel Approach: Drug Plus Sound

    What makes Dr. Klug's research particularly innovative is the treatment approach itself: a one-month combination therapy pairing medication with specially engineered sound. The goal isn't just temporary relief but lasting, long-term improvement in the brain's ability to isolate sounds of interest from background noise.

    The treatment is designed to be simple, non-invasive, and benign—critical factors for widespread adoption, especially among older populations who may already be managing multiple health conditions.

    From Bats to Breakthrough

    Dr. Klug's path to this discovery is as fascinating as the treatment itself. His career began studying echolocation in bats, drawn initially by scientific curiosity and the opportunity to work in exotic locations. But he recognized the profound medical relevance of these brain circuits in humans and pivoted to understanding what changes during aging—and crucially, how to reverse it.

    His motivation is deeply personal and urgent. As he notes in the interview, affected listeners consistently tell him to "work faster" because they desperately want this treatment. That human element drives the research forward.

    What's Next?

    The timeline is remarkably encouraging. Dr. Klug's team recently received FDA approval for Phase 2 clinical trials and planned to begin enrolling participants in October. The technology has been licensed to Parley Neurotech Inc., led by Dr. Sam Budoff as CEO, and the team is actively seeking venture capital investment to accelerate development and bring the treatment to market.

    Perhaps most exciting are the potential future applications. While the current focus is on age-related hearing loss, the same treatment may benefit people with autism, individuals who've experienced significant noise exposure (including factory workers and military veterans), and those suffering from tinnitus. Each of these populations represents millions more people who could potentially benefit from this groundbreaking approach.

    A Paradigm Shift in Hearing Medicine

    What stands out most about Dr. Klug's work is that it represents the first treatment for hearing loss caused by the brain rather than the ears. This isn't just an incremental improvement—it's a fundamental shift in how we approach hearing restoration, opening up an entirely new category of therapeutic intervention.

    For the millions of people who struggle to hear clearly in everyday situations despite normal ear function, this research offers genuine hope. The combination of solid science, FDA approval, and a clear path to commercialization suggests we may soon see a world where central hearing loss is no longer an untreatable condition but a manageable one.

    As Dr. Klug and his team move forward with clinical trials, they're not just developing a new treatment—they're potentially transforming the lives of millions of people who've been told there's nothing that can help them. That's the kind of innovation that deserves our attention and support.

    Here is the link to the interview.

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Breaking News: FDA Approves Phase II Clinical Trial for Age-Related Hearing Loss

We're thrilled to announce that we've just received FDA approval to launch our Phase II clinical trial targeting a common but often misunderstood form of age-related hearing loss. This milestone represents years of research and brings us one step closer to helping millions of people who struggle with hearing difficulties that traditional hearing aids simply cannot address.

The Hidden Challenge: When Your Brain, Not Your Ears, Is the Problem

Picture this: you're sitting in your favorite restaurant, trying to catch up with an old friend over dinner. The ambiance is lively, conversations buzz at neighboring tables, and despite your best efforts, you find yourself constantly asking "What did you say?" It's not that you can't hear—the sounds are reaching your ears just fine. The problem lies deeper, in the complex neural circuits of your brain that process and make sense of all that incoming auditory information.

  • This type of hearing difficulty affects millions of older adults and represents a fundamentally different challenge from the hearing loss that hearing aids are designed to treat. While hearing aids amplify sound to compensate for damaged hair cells in the ear, they can't fix the age-related changes that occur in the brain's auditory processing centers.

    Understanding Central Auditory Processing

    Your hearing system is far more sophisticated than just your ears. There's an entire neural network—a "brain attached to these ears"—whose job is to process and compute all the sound information streaming in every second. This auditory processing system performs remarkable feats: it can isolate your friend's voice from the cacophony of a busy restaurant, distinguish between important sounds and background noise, and help you focus on what matters most in complex acoustic environments.

    As we age, changes in these brain circuits can significantly impact our ability to process sound effectively. The result? Difficulty following conversations in noisy environments, trouble distinguishing between similar sounds, and frustration in social situations that were once effortless to navigate.

    A Revolutionary Approach: Combining Medicine and Sound Engineering

    Our upcoming Phase II trial will test an innovative combination treatment that targets the brain's auditory processing capabilities directly. This approach pairs a carefully selected pharmaceutical intervention with specially engineered sound therapy—a dual strategy designed to work synergistically to restore neural function.

    What makes this treatment particularly exciting is its potential for lasting impact. We hypothesize that just one month of this combination therapy could restore auditory processing abilities, with benefits persisting for years. If our hypothesis proves correct, this could transform the landscape of age-related hearing loss treatment.

    The Science Behind the Solution

    The engineered sound component of our treatment isn't just any audio—it's precisely designed based on our understanding of how the auditory brain processes information. These therapeutic sounds are crafted to stimulate and repair the neural pathways involved in auditory processing, while the pharmaceutical component works to support the brain's ability to adapt and heal.

    This represents a paradigm shift from simply amplifying sound (the hearing aid approach) to actually repairing and restoring the brain's natural ability to process complex auditory environments.

    Join Us in Making History

    We're actively preparing to begin recruitment for this groundbreaking trial, with enrollment starting within the next month. This is an unprecedented opportunity to be part of research that could benefit not only you but countless others facing similar challenges.

    Are you interested in participating? Here's what you need to know:

    • The trial will test a one-month combination treatment

    • We're looking for participants experiencing difficulty isolating speech in noisy environments aged 45-65

    • This treatment targets brain-based hearing difficulties, not peripheral hearing loss

    • Potential benefits may last for several years

    If you're experiencing the type of hearing difficulties we've described—particularly trouble following conversations in restaurants, meetings, or other noisy environments—we encourage you to reach out.

    How to Get Involved

    To ensure you're contacted when recruitment begins, please email us at clinical_trial@kluglab.org. Our team will add you to our priority contact list and reach out with detailed information about eligibility criteria, study procedures, and next steps as soon as enrollment opens.

    This FDA approval represents more than just a regulatory milestone—it's a beacon of hope for millions of people who have been told "there's nothing that can be done" about their hearing difficulties in noisy environments. We're on the cusp of potentially changing that narrative forever.

    Stay tuned for updates as we move forward with this exciting research. Together, we're not just studying hearing loss—we're working to restore one of our most fundamental connections to the world around us.

    For more information about our research or to express interest in participation, contact us at clinical_trial@kluglab.org. Follow our progress as we work to bring this innovative treatment from the laboratory to patients who need it most.

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