Summary: PNQ Health has received FDA clearance for its Class II Software as a Medical Device (SaMD) digital health platform, offering a holistic telemedicine-based approach to treat tinnitus by addressing over 200 underlying conditions.

Three Key Takeaways:

  1. Holistic Tinnitus Treatment: PNQ Health’s platform integrates signal monitoring with internal medicine consultation, providing a comprehensive at-home solution that addresses both the auditory symptoms and underlying causes of tinnitus.
  2. Adaptive and Non-Invasive: The platform offers customized treatment plans tailored to individual patient needs, which can be self-administered under clinical supervision via telemedicine, avoiding invasive procedures.
  3. Innovative Telemedicine Model: PNQ Health’s approach leverages machine learning (ML) and AI to refine treatment strategies, empowering patients and offering an affordable, effective solution for tinnitus management.

PNQ Health has received FDA Clearance as a Class II, Software as a Medical Device (SaMD) for its digital health platform designed to treat tinnitus.

Tinnitus Treatment

PNQ Health’s fully integrated patient care model is designed to treat tinnitus by addressing over 200 underlying conditions that contribute to the symptoms of tinnitus. Unlike traditional approaches that focus solely on the auditory aspect, PNQ Health’s model integrates signal monitoring management with internal medicine consultation support via telemedicine, offering a holistic and effective solution for patients that is administered at home and supported by a national network of tele-health medical experts.

Tinnitus is often misunderstood as an auditory issue; however, it is a symptom imbalance resulting from various underlying conditions that alter the patient’s internal state, says PNQ Health.

“PNQ Health’s therapy and care model is truly unique in that it not only suppresses the tinnitus signal but also allows patients to identify and remove the underlying triggers.” says Andrew Grossman, MD, MBA, PNQ Health founder and Chairman of the Board. “This dual approach ensures comprehensive care and more sustainable outcomes for individuals suffering from tinnitus. Additionally, our ongoing development of clinical data and patient outcomes databases allows us to continually refine and improve our treatment strategies.”

Further reading: ​​New Insights on Tinnitus Revealed in Apple Hearing Study

Harnessing Clinical Best Practices

“PNQ Health’s Fully Integrated Patient Care Model is rooted in clinical best practices,” says Robert Hasel, DDS and co-founder of PNQ Health. “We recognize that tinnitus is an imbalance in the body’s internal state rather than a purely auditory problem.” 

Key features of the PNQ Health clinical practice include:

  • Comprehensive Treatment: Addressing both the signal and the underlying cause of tinnitus.
  • Customized Protocols: Each patient receives a unique treatment plan tailored to their specific needs.
  • Adaptive Treatment: Modifications are made as new experience data is gathered, ensuring optimal care.
  • Non-Invasive: Our approach avoids invasive procedures, making it safer for patients.
  • Self-Administered Under Clinical Supervision: Patients can manage their therapy with clinical oversight via telemedicine.
  • Affordable: No up-front capital expenditure is required, with a budget-friendly nominal monthly subscription.

“PNQ Health’s model offers a distinct competitive advantage in the market. PNQ Health represents the industry’s first comprehensive care delivery platform via telemedicine,” says Kurtis Goos, chief executive officer and Board member of PNQ Health. “Our self-guided therapy empowers patients by giving them ownership and control over their care. Individualized treatment protocols are enhanced by integrated Machine Learning (ML) and AI, underscoring our commitment to bring innovative and effective solutions to a largely underserved market.”

The company is currently in a Series A capital raise and seeking strategic and financial partners and investors. PNQ plans to use the funds to scale the business for commercialization and business operations.

Photo: Dreamstime