David Akbari, Au.D., Ccc-A, F-Aaa Email & Phone Number

Minneapolis, MN, US

United States

Arden Hills, Minnesota, United States

Authored and secured 510(k) marketing clearance for the Lumen 155-SF (K223911). Ongoing and increasing commercialization handoff and people leadership responsibilities in this regulatory role. Responsible for ongoing compliance, privacy, HIPAA, cybersecurity, biocompatibility, GDPR, CE mark maintenance, and audit findings in support of continued compliance.

Arden Hills, Minnesota, United States

In a role of increasing responsibility, played a major role in securing the 510(k) clearances for K223137 and K223848.

Arden Hills, Minnesota, United States

Leading engagement of a highly talented clinical research team to ensure scientific integrity and report deliverables. Responsible for the work output of a team of 8. Clinicaltrials.gov NCT05117905

Arden Hills, Minnesota, United States

Responsible for a team of 2 direct reports. Managed scientific audiology treatment applications at the company broadly including clinical trial design for additional categories of FDA clearance for air conduction hearing aids. Designed and implemented human driven data capture research methodologies to improve R&D product acceptance to a variety of.

Arden Hills, MN

Directed all aspects of audiology service delivery at the company, focused on the employee hearing health program, over-the-counter hearing aid initiatives, and human-centered trials of new market opportunities including mapping aspects of the care delivery experience and translating uncertain consumer expectations into product acceptance.

Arden Hills, MN

Developed Verification and Validation measures consistent with FDA guidance for products in development. Worked on an interdisciplinary team to translate marketing challenges and design inputs to consumer product acceptance through R&D activity with research plans, defining clear project objectives, and excellent creative and analytical skills. Clinical.

Worked in continuation of the Product Development Specialist role, with restructured organizational design.

Worked under the guidance of faculty at University of Minnesota Center for Applied and Translational Sensory Science collecting data for Intricon concerning hearing device usability and clinical product performance of what would become the first FDA-registered self-fitting hearing aid technology in the United States. Involved in continual product.

Guidepoint is a leading expert network which provides consultation and data services for global companies. The goal of this role is to provide professional opinions and expert advice for a variety of clients in different industries related to medical devices, hearing science, and audiology topics.

Doctor Of Audiology, (Au.D.)

Master Of Arts (M.A.), Speech-Language-Hearing Sciences

Activities and Societies: National Student Speech-Language-Hearing Association (NSSLHA), President

Bachelor'S Degree, (B.M.), Music Synthesis

Now called "Electronic Production and Design (EPD)" https://college.berklee.edu/electronic-production-design