P03-Implants-JA Sole Source-Cochlear Americas _Redacted.pdf

DEPARTMENT OF VETERANS AFFAIRS

555 CORPORATE CIRCLE

GOLDEN, CO 80401

JUNE 18, 2026

JUSTIFICATION AND APPROVAL

FOR OTHER THAN FULL AND OPEN COMPETITION

AUDITORY IMPLANTS

Title 41 United States Code (U.S.C.) § 3304(a)(1)

Identification of the agency, contracting activity, and specific identification of the document as a “Justification for Other Than Full and Open Competition.”

This Justification and Approval (J&A) for Other Than Full and Open Competition is executed by the Office of Acquisition Logistic on behalf of the U.S. Department of Veterans Affairs (VA), Veterans Health Administrati , Prosthetic and Sensory Aids Service (PSAS) and Denver Logistics Service (DLS).

The nature and/or description of the action being approved.

This action will permit the noncompetitive establishment of a new national contract vehicle with Cochlear Americas to provide uditory mplant ystems and accessories.

The planned contract type is a single-award firm-fixed price indefinite delivery/ indefinite quantity multiple year contract with a performance period that includes a base year and 9 option years. This action is a follow-on contract to establish the next generation contract vehicles for VA’s ational Hearing Implant Program and directly supports the contracted c tomized (prescription) hearing aid device contracts in that it supplies sole source Cochlear Americas implants and accessories to the Veterans who need a Cochlear Americas device in addition to accessories.

The estimated dollar value for this 10 year performance period for the Cochlear Americas auditory implant systems, parts and accessories is not to exceed

. The contract ceiling was established using FY 26 through FY 36 anticipated program spend.

A description of the supplies/services required to meet the agency's needs.

To support VA’s Auditory Implant Program managed by the DLS, a robust supply chain for ordering and delivery of customized (prescription) implants and accessories are required to ensure that Veteran needs are met. This current original

The Cochlear Americas implants and accessories supplies will be stocked at DLS warehouse and distributed once orders are placed in the DLS’s Remote Order Entry System (ROES) and shipped out to the Veteran or their clinician.

VA clinicians require a wide range of customized (prescription) auditory implant systems to treat Veteran’s unique medical needs which directly reflects the wide range of accessories needed for Cochlear Americas’ prescribed auditory implants.

VA’s objective is to establish a sole-source contract with Cochlear Americas to continue the volume-based standardized pricing and direct access for the ordering and delivery of their proprietary implants and accessories. A sole-source contract will ensure consistency and availability of the proprietary products will remain accessible to Veterans.

A. Cochlear Implant System:

Cochlear implants are surgically implanted devices for Veterans with severe-to-profound sensorineural hearing loss who receive little benefit from hear aids. The regulates manufactures of and lassifie as Class III devices. Class III medical devices are the highest-risk products, requiring the strictest regulatory oversight as these devices sustain or support human life. For manufacturers to sell in the United States, they must first show FDA that their implants are safe and effective; therefore, only FDA approved devices are able to procured in the United States. As a matter of policy, FDA does not rate or recommend brands of or medical facilitates that implant them.

C system consists of two primary components:

An internal which receives electrical impulses via the receiver/stimulator and sends them to electrodes placed in the cochlea, whereupon the auditory nerve and central auditory nervous systems are stimulated, and sound is perceived.

A sound processor which picks up the sound from the environment, converts the sound to electrical pulses, and sends them across to the receiver/stimulator.

Current implementation uses an external processor that sends the signal across the intact skin to the implanted receiver/stimulator

B. Auditory Osseointegrated Implant System

Auditory Osseointegrated Implant (AOI) system is a hearing device that provides an auditory signal through bone conduction and is a surgically placed implant that delivers sound to the organ of hearing via direct bone conduction. The osseointegrated implant is permanently affixed to the skull (typically the mastoid bone) and are suitable for Veterans who have sufficient hearing sensitivity in one inner ear but varying

The execution this national contract vehicle for Cochlear Americas 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 Cochlear Americas IGCE value for all 10 year period of performance is estimated to be

A description of the market research conducted and the results.

In accordance with RFO Part 10 and VAAR Part 810, VA has conducted vigorous market research to arrive at the most suitable approach for acquiring Customized (prescription) Auditory Implant Devices and associated accessories to maintain the necessary supply chain. The market research for his requirement was a collaborat effort with , PSAS and DLS. The market research report documents all research conducted to include various avenues researched such as literature published by the manufacturers, a review of databases such as the Small Business Administration’s Dynamic Small Business Search and VetCert, the issuance of I’s, and a review of similar items for comparison. As demonstrated in the market research report, these supplies are not readily available on any existing government agency contract vehicle, and the current contract is utilized by other agencies such as and Indian Health Services to meet Veteran’s needs.

Market research reflected that supplies are not readily available on any existing

. ased on the unique requirements of the implant device and associated accessories, only Cochlear Americas can provide the necessary parts and accessories that will ensure the hearing implant device maintains its integrity. Many of the auditory implants, sound processors and components, are proprietary to Cochlear Americas and not available to other resellers. As a result of the market research, the Contracting Officer has determined that Cochlear Americas is the only contractor capable of meeting the VA’s requirements for these proprietary implants and accessories.

Any other facts supporting the use of other than full and open competition.

The VA has a continuing need for proprietary auditory implant systems, parts and accessories to support its hearing devices that VA prescribes to Veterans. Cochlear Americas is the OEM manufacturer and owns all rights to the technical data and specifications of the hearing aid devices, parts, and accessories. These OEM auditory implants and accessories are procurable only from the OEM manufacturer and considered proprietary to Cochlear Americas as no other manufacturer is in legal possession of the necessary parts and accessories