Development of an Extracochlear Device to Restore Hearing

1 Project Summary 2 Sensorineural hearing loss (SNHL) affects over one third of US adults aged between 65 and 74, over a half of 3 adults over 75 years old, and over 460 million people worldwide. Since SNHL commonly affects the high 4 frequencies first, many of these patients complain that they “can hear but can’t understand.” This is because 5 patients can hear sound because of relatively good residual low frequency hearing, but they struggle to 6 understand speech, which relies on the higher frequencies that these patients have lost. The inability to 7 understand speech can profoundly degrade patients’ quality-of-life, and the links to social withdrawal, isolation, 8 depression, and dementia have been well established. With 3.3 million adults in the US already affected by this 9 form of hearing loss and with the number increasing as the population ages, this represents a major and growing 10 public health challenge. 11 Hearing aids cannot provide benefit for these patients, and the only available treatment is a cochlear implant. 12 These are irreversible and come with a 50% risk of residual hearing loss, causing most patients to forgo 13 treatment. Thus, there remains a large unmet clinical need for treatments that can improve SNHL patients’ ability 14 to understand speech by restoring high-frequency hearing without damaging residual low-frequency hearing. 15 Auricle Health, Inc., is building an extracochlear device that uses cochlear nerve stimulation to restore high- 16 frequency hearing with a minimally invasive implant that will be reversible and will not damage residual hearing. 17 The Auricle team came out of the Stanford Biodesign Innovation Program and validated their solution with 18 stakeholders ranging from patients to neurotologists, audiologists, and regulatory and reimbursement experts. 19 The team has built initial prototypes of an electrode array and demonstrated feasibility of their approach in a 20 clinical study at Stanford. 21 In Phase I, the team will refine key design requirements and build and test more sophisticated prototypes. 22 We will refine the electrode design and attachment method to the cochlea to achieve consistent electrical 23 connection with the underlying tissue. Next, we will demonstrate that we can establish good electrical contact 24 with our prototype electrode and stimulate the cochlear nerve in an acute animal model. Finally, we will conduct 25 a chronic animal study to evaluate the durability of the electrode attachment and long-term tissue responses to 26 the implant. Successful completion of these aims will advance the design of the device and validate the safety 27 and functionality of the approach. Building on this foundation, in Phase II we will finalize electrode design and 28 conduct animal studies in large animals to confirm the device’s effectiveness and safety. Ultimately, we hope to 29 bring hearing back to patients through a non-destructive and minimally invasive approach.