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Medical Device

Hearing/Ear Implant

Led program for development of a fully implantable hearing device designed to treat moderate to severe hearing loss.

  • Objective

    Create a minimally invasive solution, achieve FDA Class II approval, and enhance patient quality of life.

  • Client

    Confidential

Services Provided

  • Concept Development

    Engaged audiologists and patients to gather insights on desired features and pain points in existing solutions, defining clear product requirements.

  • Design & Prototyping

    Created several iterations of the device to evaluate form factor and audio processing capabilities, focusing on miniaturization and user comfort.

  • Pre-DV Testing

    Conducted rigorous acoustic testing and biocompatibility assessments to ensure safety and functionality.

  • DV Testing

    Executed comprehensive verification tests against design specifications to ensure audio quality and device reliability.

Support Focus

  • Quality Management System

  • Regulatory Submission

  • Packaging Design

  • Risk Documentation

  • Usage, Safety & Compliance Labeling

photo of an operating room taken with wide angle lens, rendered in black and white

Outcomes

  • Positive patient feedback post-launch

  • FDA approval in 12 months

  • $3 million revenue in the first year