P03-Implants-JA Sole Source-Med-El_Redacted.pdf
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- MED-EL Corporation
- Solicitation number
- 36C79127D0003
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Justification and Approval for Other Than Full and Open Competition – Auditory Implants
This document is a Justification and Approval (J&A) for non-competitive procurement executed by the Department of Veterans Affairs Enterprise Procurement Office on behalf of the Veterans Health Administration, Prosthetic and Sensory Aids Service (PSAS), and Denver Logistics Service (DLS). The VA seeks to establish a single-award, firm-fixed-price, indefinite delivery/indefinite quantity contract with Med-El to supply auditory implant systems, parts, and accessories over a 10-year performance period (base year plus 9 option years). The estimated contract value for all 10 years is not disclosed in the provided text due to redaction. The contract will support the VA's National Hearing Implant Program by providing customized prescription implants and accessories stocked at DLS warehouses and distributed via the Remote Order Entry System (ROES) to veterans and clinicians.
The justification for sole-source procurement is based on Med-El's proprietary designs and FDA approvals for both Cochlear Implant (Class III) and Auditory Osseointegrated Implant (Class II) systems. Market research determined that only Med-El's OEM implants and accessories can maintain device integrity, as these products contain magnets and proprietary components available exclusively from the manufacturer. The VA conducted vigorous market research, including reviews of published literature, small business databases, and industry engagement at conferences and an October 2025 industry day. Four large manufacturers control 100% of the FDA-approved customized prescription implant market in the United States, with only Med-El meeting VA's technical and supply chain requirements. The statutory authority for this non-competitive action is 41 U.S.C. §3304(a)(1) and implemented through RFO 6.103-1. The justification will be publicized via the Government Point of Entry within 14 days of award, and the VA commits to reconsidering competitive acquisition approaches at contract expiration or if new capable vendors emerge.
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JUSTIFICATION AND APPROVAL
FOR OTHER THAN FULL AND OPEN COMPETITION
AUDITORY IMPLANTS
Identification of the agency, contracting activity, and specific identification of the document as a “Justification for Other Than Full and Open Competition.”
The nature and/or description of the action being approved
A description of the supplies/services required to meet the agency's needs.
The significance of this national contract vehicle is to directly support Veteran care and provide the proprietary Med-El implant systems and accessories needed to maintain the integrity of a Veteran’s device. Med-El’s contract will provide Veterans and clinicians access to Med-El specific implants, parts and accessories, and pricing will be determined fair and reasonable prior to award. Only Med-El’s proprietary parts and accessories will guarantee proper functionality of their AOI and CI products and thus meet the requirement at “Only one responsible source and no other supplies or services will satisfy agency requirements.”
he current AOI and CI contracts administered by were previously competed under full and open competition procedures and the most recent as sole source while the program realigns the Auditory Program requirements with the changes within industry. The four large business Implant manufacturers maintain 100% of the market share in the United States for customized (prescription) implant devices that are Trade Agreement Act and compliant and meet VA’s technical requirement for the supply of related implants and accessories. Market research reflected no resellers of Med-El implants and accessories, and only Med-El could support the requirement.
A notice of the proposed action will be synopsized via the Government Point of Entry in accordance with RFO 5.201, and the agency will make publicly available the justification required by RFO 6.301(a) within 14 days after contract award. Additionally, the VA conducts numerous engagements with industry annually. , PSAS, and DLS hosted an industry day for AOI and CI devices in October 2025 that was synopsized via Contract Opportunities.
Finally, will consider any new entrants to industry that are capable of meeting the VA’s technical requirements, including the FDA. If capable new entrants are discovered, will consider pursuing contract actions directly with these manufacturers.
The execution this national contract vehicle for Med-El will utilize the products that are deemed technically acceptable and pricing that is determined fair and reasonable. The Independent Government Cost Estimate (IGCE) was based on the past frequency of orders and a commodity index related to this industry to escalate the rate of each item.
The Med-El IGCE value for all 10 is estimated to be .
12. Requirements Certification.
13. Approvals in accordance with RFO 6.104 .
File details come from the government source that posted it. Updated .