Indian Air Force Behind the Ear Hearing Aid Digital Tender Kanpur/Lucknow UP 2026 MDR 2017 IS 16127

Tender Overview

The Indian Air Force invites bids for a Behind the Ear Digital Hearing Aid (BTE) under the Department of Military Affairs. The procurement emphasizes MDR 2017 compliance, IS 16127 packaging standards, and availability of a valid medical license. Near Kanpur/Lucknow, bidders should anticipate OEM authorization requirements, audiologist support, and trial/fitment at buyer premises. Key differentiators include mandatory OEM authorization, multiple accessories, and a minimum five-year shelf life. The scope centers on universal BTE digital hearing devices for ENT OPD use, with on-site trials and commissioning expectations.

Technical Specifications & Requirements

• Product/Service: Behind the Ear Digital Hearing Aid with device programming, microphone, and user-adjustable tone controls
• Standards & Certifications: MDR 2017 compliance; IS 16127 (Latest) packing; Electrical Safety Standards; Medical License validity; Manufacturing unit certification; batch test reports per MDR 2017
• Performance & Specs: Maximum OSPL 90, HF Average OSPL90, minimum number of channels/bands, specified frequency range, THD at 500/800/1600 Hz, EIN, telecoil sensitivity at 10 mA/m, low battery indicator; dimension per IS 16127; minimum programs and AGC/Compression; adjustable tone; battery type and number of batteries/cell (minimum six cells) provided
• Accessories & Packaging: External carrying case, number of ear inserts, complete set of batteries, ear moulds, and minimum six batteries per unit; packing and marking per IS 16127
• Vendor requirements: OEM authorization or original service provider certificate; 3-year experience with service center near 7AFH area; at least two audiologists with RCI registration; trial samples at buyer site during evaluation

Terms, Conditions & Eligibility

• Documentation on Bid Submission: PAN and GSTIN, cancelled cheque, EFT Mandate; OEM authorization/certification from manufacturer; proof of medical license and MDR compliance; test reports as per MDR; GST portal GST payment screenshot on invoicing
• Delivery & Warranty: option clause allows up to 50% quantity variation; shelf life minimum of five years; comprehensive warranty option may supersede catalogue warranty
• Eligibility & Experience: established company with ≥3 years in related field; nearby service center; audiologist team with BASLP/DHLS and valid RCI registrations; OEM authorization certificate required
• Other: supplier must upload GST invoice/scans on GeM; supply includes batteries, ear moulds, and at least six cells; bid must include OEM authorization certificate and complete testing reports