P03-Implants-JA Sole Source-Advanced Bionics _Redacted.pdf
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- Solicitation number
- 36C79127D0001
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Justification and Approval for Other Than Full and Open Competition – Auditory Implant
This document is a Justification and Approval (J&A) for noncompetitive procurement of auditory implant systems and accessories from Advanced Bionics, executed by the Department of Veterans Affairs (VA), Veterans Health Administration, Prostatic and Sensory Aids Service (PSAS), and Denver Logistics Service (DLS) on June 18, 2026. The procurement establishes a single-award, firm-fixed-price, indefinite delivery/indefinite quantity national contract vehicle with a 10-year performance period (base year plus 9 option years). The estimated contract ceiling for fiscal years 2026 through 2036 is $148 million, with the Independent Government Cost Estimate (IGCE) value for the 10-year performance period specified as a redacted amount. The VA seeks to procure customized prescription cochlear implants (Class III FDA-regulated devices) and auditory osseointegrated implants (Class II FDA-regulated devices), plus associated proprietary parts and accessories exclusively from Advanced Bionics, the original equipment manufacturer (OEM).
The justification establishes that only Advanced Bionics can satisfy agency requirements pursuant to 41 U.S.C. § 3304(a)(1) and RFO 6.103-1, citing proprietary product features, FDA approvals, proven manufacturing capability, and ability to maintain an established supply chain through DLS warehouses and the Remote Order Entry System (ROES). Market research determined that only four large manufacturers produce FDA-approved customized prescription implant devices, with no approved resellers available, and that Advanced Bionics' proprietary components are required to maintain device integrity and warranty. The VA conducted industry engagement including an industry day in October 2025 and attends annual audiology conferences. The procurement will be publicized via the Government Point of Entry within 14 days of award, and the justification will be made publicly available in accordance with RFO 5.201 and 6.301(a). Products will be distributed to Veterans or clinicians upon order placement, with selection based on patient medical need and audiologist recommendation rather than price.
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DEPARTMENT OF VETERANS AFFAIRS
ACQUISITION SERVICE
555 CORPORATE CIRCLE
GOLDEN, CO 80401
JUSTIFICATION AND APPROVAL
FOR OTHER THAN FULL AND OPEN COMPETITION
AUDITORY IMPLANT
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 statutory authority permitting other than full and open competition.
A statement demonstrating the unique qualification of the proposed contractor or the nature of the action requires use of the authority cited.
A description of efforts to ensure that offers were solicited from as many potential sources as is practicable. Include whether or not a notice was or will be publicized as requirement by subpart RFO subpart 5.2.
The anticipated dollar value of the proposed acquisition, including options if applicable, and a determination by the Contracting Officer that the anticipated cost to the Government will be fair and reasonable.
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