Transforming Tinnitus Treatment: How Otoharmonics and StarFish Medical Brought the Levo System to Market
A Sound Solution for Tinnitus Sufferers
Tinnitus, often described as a persistent ringing in the ears, affects millions of individuals, making it difficult to sleep, concentrate, or simply enjoy daily life.
Despite the prevalence of this condition, effective treatment options have been limited. Otoharmonics, a Portland-based company, set out to change that with the Levo System—a groundbreaking, patient-centered solution that delivers customized sound therapy during sleep.
However, transforming this vision into a market-ready, FDA-cleared medical device required a partner with deep expertise in medical device design and regulatory navigation. Enter StarFish Medical—a full-service medical device development company with a track record of bringing innovative healthcare technologies to life. Together, they embarked on a complex journey to develop, refine, and launch the Levo System, ensuring it met the highest clinical, technological, and regulatory standards.
Overcoming Obstacles to Bring an Innovative Device to Life
When Otoharmonics approached StarFish Medical, they had a promising technology with immense potential, but they also faced formidable challenges. The Levo System needed to integrate consumer electronics—iPads and iPods—as core components of a medical device, a novel approach that introduced unique regulatory and technical hurdles.
Additionally, the system required personalized sound therapy, which meant designing custom earbuds for patients while ensuring safety, efficacy, and usability. Managing sound output, data security, and compliance with FDA regulations added further complexity. With so many moving parts, Otoharmonics needed a partner capable of both technical execution and strategic guidance. StarFish Medical stepped up to the challenge, employing a risk-based approach to ensure that every aspect of the device met stringent medical and usability standards.
Engineering a Patient-Focused Solution
Developing a medical device that relies on consumer hardware posed a unique set of engineering challenges. StarFish Medical took a methodical approach, working closely with Otoharmonics to ensure that the Levo System not only delivered the desired therapeutic outcomes but also adhered to regulatory requirements for safety and efficacy.
Designing for Safety and Compliance
Since the Levo System used iPads and iPods as key components, StarFish Medical needed to ensure these consumer-grade devices met medical device standards. This involved evaluating power supply configurations, charging scenarios, and device integration, ensuring compliance with IEC 60601, the standard for medical electrical equipment.
Custom Earbud Development
To deliver personalized sound therapy, StarFish Medical designed and manufactured patient-specific custom earbuds. These earbuds needed to provide precise sound output while ensuring comfort and safety for extended nighttime use.
Software Innovation
Ensuring seamless software integration with Apple devices was critical. StarFish Medical developed software solutions to control sound output, maintain compatibility with iOS updates, and conduct rigorous regression testing to prevent unintended software conflicts.
Regulatory Expertise
StarFish Medical played a pivotal role in guiding Otoharmonics through the FDA submission process. By addressing key regulatory concerns early in development and compiling the necessary documentation, they helped secure 510(k) clearance for the Levo System—making it the first Apple hardware Class II device cleared by the FDA.
From Concept to Market: A Collaborative Journey
Navigating the path from concept to market-ready medical device required a structured and iterative approach. StarFish Medical and Otoharmonics worked hand-in-hand, ensuring that each phase of development aligned with the overarching goal of delivering an effective, user-friendly solution for tinnitus sufferers.
- Understanding the End-User Needs: The teams conducted in-depth research on patient experiences with tinnitus, identifying pain points in existing treatment options and ensuring the Levo System would provide meaningful relief.
- Iterative Design and Prototyping: Prototypes were tested extensively to refine the sound therapy experience, improve user interaction, and ensure reliability.
- Regulatory Readiness and Testing: With medical device regulations evolving rapidly, StarFish Medical worked proactively to validate the Levo System’s design and compile the required documentation for regulatory approval.
- Manufacturing and Market Introduction: Once the Levo System was cleared by the FDA, StarFish Medical supported Otoharmonics in ramping up production and preparing for a successful commercial launch.
Transforming Patient Lives with Proven Results
Bringing the Levo System to market was not just about overcoming technical and regulatory challenges—it was about improving lives. The impact has been profound:
FDA Clearance and Industry Recognition
The Levo System became the first Apple hardware Class II medical device to receive FDA clearance. It also won the top prize in the Digital Health Products and Mobile Medical Apps category at the 19th Annual Medical Design Excellence Awards.
Measurable Patient Outcomes
Clinical studies showed that after three months of Levo System therapy, patients experienced an average reduction of perceived tinnitus sound by 62%, with a 77% decrease in their Tinnitus Functional Index (TFI) scores.
Improved Quality of Life
Patients reported significant improvements in sleep, concentration, and overall well-being, underscoring the real-world impact of the technology.
Partnering for Innovation in Medical Devices
The collaboration between Otoharmonics and StarFish Medical is a testament to what’s possible when medical technology companies partner with the right development experts. By combining Otoharmonics’ vision with StarFish Medical’s engineering and regulatory expertise, the Levo System successfully navigated a complex development process and emerged as a pioneering solution in tinnitus therapy.
If your company is looking to develop an innovative medical device, StarFish Medical can help you navigate the challenges of design, engineering, and regulatory approval. Contact us today to learn how we can bring your vision to life.
