Indian Army Behind the Ear Hearing Aid (Digital) Tender 2026 - MDR, IS 16127, Medical Device Licenses & 25% Quantity Option
Indian Army
Bid Publish Date
04-Jun-2026, 10:36 am
Bid End Date
15-Jun-2026, 11:00 am
Progress
Quantity
12
Bid Type
Two Packet Bid
The Indian Air Force, Department of Military Affairs, is inviting bids for Behind the Ear Hearing Aid (Digital) devices in the Kanpur/Lucknow region. The procurement focuses on BTE digital hearing aids with MDR 2017 compliance and IS 16127 packaging standards. Key eligibility includes a three-year minimum operating history and a nearby service centre, plus OEM authorization. Two BASLP audiologists with valid RCI registration must support ENT OPD trials at 7AFH. Optional comprehensive warranty is available via bidding. This opportunity targets suppliers with medical device manufacturing or distribution capabilities and established service networks in Uttar Pradesh.
Behind the Ear Digital Hearing Aid with adjustable tone and AGC/Compression
Standards: MDR 2017 compliance; IS 16127 for packing/marking and dimensions
Electrical safety standards; Maximum OSPL 90 and HF Average OSPL 90
Minimum number of channels/bands; specified frequency range
THD at 500/800/1600 Hz (RTG position); Equivalent Input Noise level
Induction coil/Telecoil sensitivity at 10 mA/m; Low battery indicator
Device dimensions as per IS 16127 (Latest); 3-year warranty; accessory kit including ear inserts and external case
Batch test reports required; OEM authorization; service/warranty terms
OEM authorization and BASLP audiologist support are mandatory
MDR 2017 compliance and IS 16127 packaging standards required
Quantity may vary up to 50% with extended delivery timelines
GST-compliant invoicing via GeM; EFT mandate; payment terms aligned with supplier submission and delivery milestones
Delivery period may be extended proportionally with increased quantity; minimum 30 days adjustment when option clause exercised
Penalties applicable as per contract for delays; LD terms to be specified in purchase order
Minimum 3 years of operation experience in medical devices or hearing aids
Shop and service centre located near Kanpur/Lucknow with regional support
BASLP audiologists with valid RCI registrations attached to bid
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Behind the Ear Hearing Aid (Digital) (Q2)
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Main Document
CATALOG Specification
ATC
GEM_GENERAL_TERMS_AND_CONDITIONS
Indian Army
Indian Army
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Indian Army
JALANDHAR, PUNJAB
Tender Results
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| Category | Specification | Requirement |
|---|---|---|
| GENERAL FEATURES | Product Name | Behind the Ear Hearing Aid (Digital) |
| GENERAL FEATURES | Device Programming | Programmable Through Software |
| GENERAL FEATURES | Microphone | Omni-Directional |
| STANDARD | Conformity to Standards | IS 16127 (Latest) |
| PRODUCT SPECIFICATION | Maximum OSPL 90 | 105 to 135 dB SPL |
| PRODUCT SPECIFICATION | HF Average OSPL 90 | 100 to 135 dB SPL |
| PRODUCT SPECIFICATION | Minimum Number of Channels/Bands | 12, 16 |
| PRODUCT SPECIFICATION | Frequency Range | Atleast 200 to 4500 Hz for 105 to 115dB output and 200 to 4000 Hz for 115 to 135 db |
| PRODUCT SPECIFICATION | Total Harmonic Distortion at 500, 800 and 1600 Hz at RTG Position | ≤ 7 % |
| PRODUCT SPECIFICATION | Equivalent Input Noise Level | ≤ 30 dB SPL |
| PRODUCT SPECIFICATION | Induction Coil/Telecoil with Sensitivity (at 10mA/m) | 75 dB (Min) |
| PRODUCT SPECIFICATION | Low Battery indicator | Yes |
| PRODUCT SPECIFICATION | Dimension as per IS 16127 (Latest) | Yes |
| CONTROLS PROVIDED ON EACH HEARING AID | Minimum Number of Program for Different Listening Conditions | 4 |
| CONTROLS PROVIDED ON EACH HEARING AID | AGC/Compression | Yes |
| CONTROLS PROVIDED ON EACH HEARING AID | Provision of Adjusting Tone | Through Programming |
| ELECTRICAL REQUIREMENTS | Battery | 1.3V |
| ELECTRICAL REQUIREMENTS | Battery Type | Zinc Air Battery |
| ACCESSORIES | Number of Ear Insert Provided with Each Hearing Aid | Two Different sizes of ear Insert, Three Different sizes of ear Insert |
| ACCESSORIES | External Carrying Case | Yes |
| PACKING AND MARKING | Packing and Marking As per IS 16127 (Latest) | Yes |
| CERTIFICATIONS | Compliance to Medical Device Rule (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Availability of Valid Medical License for the product issued from the competent authority defined under Drugs and Cosmetic Act 1940 and Rules made there under as amended till date | Yes |
| CERTIFICATIONS | Manufacturing unit certification | ISO: 13485 (Latest) |
| CERTIFICATIONS | Availability of Test Report for each supplied batch/product as per Medical Device Rule (MDR) 2017 as amended till date | Yes |
| CERTIFICATIONS | Submission of all necessary certifications, licenses and test reports to the buyer at the time of bid submission or along with supplies as per buyer requirement | Yes |
| CERTIFICATIONS | Electrical Safety Standards | IEC/EN 60601 or equivalent BIS Standard |
| WARRANTY | Warranty in years (Option of comprehensive warranty is available through bidding only, which if opted will supersede normal warranty in the catalogue) | 2 Or higher |
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GST registration certificate
PAN card
Copy of Cancelled Cheque
EFT Mandate certified by Bank
OEM authorization certificate / letter
BASLP audiologist certificates with RCI registration
Proof of address showing Kanpur/Lucknow area presence
Auditable service centre details
Medical device license (as per MDR 2017 and Drugs and Cosmetics Act 1940)
Product test reports per MDR 2017 (batch-wise)
Bidders must meet eligibility: 3+ years operation, Kanpur/Lucknow service presence, BASLP audiologists with RCI, and OEM authorization. Submit PAN, GST, EFT mandate, and OEM certs with bid. Ensure MDR 2017 compliance and IS 16127 packaging. Include batch test reports and 3-year warranty option if chosen.
Required documents include GST certificate, PAN, Cancelled Cheque, EFT mandate, OEM authorization letter, BASLP audiologist registrations, proof of address near 7AFH, and medical device license. Also attach device test reports per MDR 2017 and service center details for Kanpur/Lucknow.
Devices must meet MDR 2017; IS 16127 packaging; Maximum OSPL 90 and HF Average OSPL 90; minimum channels/bands, specified frequency range; THD at 500/800/1600 Hz; EIN; Telecoil sensitivity; Low battery indicator; dimensions per IS 16127; 3-year warranty.
Delivery timelines may adjust if the quantity changes up to 50% under the option clause, with a minimum 30-day extension. Payment terms align with GeM invoicing after GST confirmation; EFT mandate must be active; GST invoice upload is mandatory during bid and procurement.
Bidder must provide OEM authorization letter or certificate for the offered hearing aid, whether direct OEM or authorized distributor, including contact details. Service and warranty support must be demonstrable within Kanpur/Lucknow region.
Product carries a minimum of 3 years warranty from issue date; optional comprehensive warranty is available via bid and, if chosen, supersedes catalogue warranty. Warranty includes service, parts, and support for the hearing aid device and accessories.
Bid must include MDR compliance documentation, Medical Device license, IS 16127 packaging test reports, and batch-wise test reports. Include electrical safety compliance certificates, and BASLP/RCl registrations for attending ENT OPD trials at 7AFH.
Bidder must deploy two BASLP audiologists with valid RCI registration who will attend ENT OPD on OPD days for fitting and tuning. Provide copies of certificates and confirm availability in Kanpur/Lucknow region for regular trials.
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Main Document
CATALOG Specification
ATC
GEM_GENERAL_TERMS_AND_CONDITIONS