Auditory Implants -CIs_AOIs-Minimum Technical Requirements 07152025.pdf

This document is a technical requirements specification for auditory implant systems, specifically Cochlear Implants (CIs) and Auditory Osseointegrated Implants (AOIs) for the Department of Veterans Affairs. The document details two primary implant groups with five technical categories each, including internal implant devices, sound processors, implant kits, wireless devices/applications, and accessories/replacement parts. Key technical requirements include FDA approval (Class II or III), biocompatibility, wireless capabilities, battery options, compatibility with hearing aid technologies, and specific performance specifications like microphone directionality, output frequency ranges, and telemetry capabilities.

The technical requirements outline precise specifications for each implant component, such as internal cochlear implant devices needing 12 standard electrode array channels, sound processors requiring multiple program options, and wireless accessories supporting volume changes and status checks. The document is part of a Request for Information (RFI) for a future recompete contract, with responses due by August 11, 2025, and a potential industry meeting scheduled for October 2025 in Golden, Colorado. The solicitation targets surgical appliance and supplies manufacturing (NAICS 339113) and is being conducted by the VA's National Acquisition Office in conjunction with the Veteran Health Administration's Prosthetic Sensory Aid Services.