Phonocath - An endovascular medical device to objectively evaluate Pulsatile Tinnitus

Project Summary
This Phase I STTR project spearheaded by VDF Industries, in collaboration with UCSF, aims to
radically improve the diagnosis of Pulsatile Tinnitus (PT). PT is a form of tinnitus characterized by the
perception of a heartbeat-synchronous sound that can be incredibly distressing, often leading to severe
depression or anxiety in 60% of sufferers. Accurately diagnosing PT is paramount as it can lead to
effective treatment of the underlying vascular anomaly, thus alleviating the auditory symptoms, risks of
the underlying vascular disease, and the profound associated psychiatric conditions. However, current
diagnostic procedures are invasive, lengthy, and uncomfortable, necessitating 3-6 hours of testing by
skilled neurointerventionalists (NIRs) and often resulting in significant pain and distress for patients who
must remain conscious and communicative throughout the process.
Recognizing the urgent need for a more patient-friendly diagnostic tool, VDF Industries has
initiated the development of Phonocath, a novel, single-use, highly navigable, endovascular medical
device designed to objectively assess PT. Preliminary development has produced Phonocath
prototypes capable of localizing the PT source in benchtop models. The next phase is to refine these
devices into a more practical lower profile microcatheter, integrating advanced microsensor technology
for enhanced navigability and precision in human patients.
The project encompasses three primary objectives: the design and production of a new
microcatheter prototype, validation of the Phonocath device using in vitro patient-specific 3D printed
flow models, and the validation of the PT evaluation procedure using hybrid models that combine 3D
printed bodies and human cadaver heads. These steps are critical to producing a batch of Phonocath
devices ready for regulatory verification and validation.
Upon successful completion of these objectives, VDF Industries intends to engage with the FDA
to discuss the design and regulatory pathway for a first-in-human study, with the ultimate goal of
commercializing the Phonocath System. A subsequent STTR Phase II proposal will seek to fund
biocompatibility testing for the microcatheter and safety testing for the user interface unit, paving the
way for human trials to establish the safety and efficacy of the Phonocath device in clinical practice.
The successful development of Phonocath has the potential to transform the standard of care for PT
patients, offering a swift, accurate, and minimally invasive diagnostic alternative to the current arduous
procedures.

Grant Number: 1R41DC022504-01
NIH Institute/Center: NIH
Principal Investigator: Matthew Amans