STARKEY LABORATORIES INC

Starkey Laboratories Inc. specializes in the manufacturing and maintenance of electromedical and electrophysiological devices, with a dominant focus on hearing aids and related auditory support systems. The company provides end-to-end solutions including the production of FDA-regulated hearing instruments, field service for device repair and calibration, and logistical support for distributed healthcare delivery networks. Their technical expertise encompasses precision electroacoustic engineering, firmware integration for assistive listening devices, and compliance with medical device quality systems under ISO 13485 and FDA 21 CFR Part 820. Starkey’s ability to deliver both new equipment and ongoing maintenance services within tight operational timelines distinguishes them as a trusted provider for mission-critical auditory care programs. The contractor maintains a strong, sustained relationship with the Department of Veterans Affairs and the Department of Health and Human Services, supplying hearing aids and repair services to VA medical centers and HHS-funded tribal and rural health clinics. For the VA, they support national hearing aid procurement and maintenance contracts, ensuring continuity of care for veterans with sensorineural hearing loss. For HHS, they enable access to hearing assistance in underserved communities through targeted task orders for Indian Health Service facilities and community health centers. Their primary industry focus is on NAICS 334510, where they design and manufacture Class II medical devices compliant with ANSI/ASA S3.22 and IEC 60118 standards. They also provide specialized repair services under NAICS 811210, demonstrating proficiency in microelectronics repair, battery replacement, and acoustic calibration of hearing instruments. This dual capability positions them uniquely in the federal medical equipment supply chain. Starkey Laboratories Inc. is a mid-sized manufacturing and service entity headquartered in Eden Prairie, Minnesota, with no federal certifications on record. Their operational footprint is national, serving government healthcare networks across all 50 states through direct delivery and service logistics, with no indication of foreign manufacturing or subcontracting.