P03-Implants-JA Sole Source-Oticon Medical_Redacted.pdf

This is a Justification and Approval for Other Than Full and Open Competition executed by the Department of Veterans Affairs Enterprise Procurement Office on behalf of the Veterans Health Administration, Prosthetic and Sensory Aids Service, and Denver Logistics Service.

The VA seeks to establish a sole-source, single-award firm-fixed-price indefinite delivery/indefinite quantity contract with Oticon Medical for a 10-year performance period (base year plus 9 option years) to supply auditory implant systems, parts, and accessories. The contract will support the VA's National Hearing Implant Program managed by Denver Logistics Service, with supplies stocked at DLS warehouses and distributed through the Remote Order Entry System to Veterans and clinicians. The estimated 10-year contract value is redacted but established using Fiscal Years 2026 through 2036 anticipated program spend. The requirement encompasses two primary device types: Cochlear Implant (CI) Systems, classified by FDA as Class III devices requiring rigorous safety and efficacy approval, and Auditory Osseointegrated Implant (AOI) Systems, classified as Class II devices with special controls. Oticon Medical is FDA-approved for CI devices and cleared for AOI devices, possessing proprietary implant designs and accessories that cannot be replaced with third-party products without voiding warranties and compromising device integrity. Market research confirmed that no resellers distribute Oticon Medical implants and accessories, and only Oticon Medical can support the requirement. The four large implant manufacturers control 100 percent of the customized prescription implant market in the United States. The justification cites 41 U.S.C. § 3304(a)(1) as statutory authority for the sole-source award, and concurrent awards are being made to three additional manufacturers for AOI and CI products under the same effort.