Indian Army Behind the Ear Hearing Aid (Digital) Tender 2026 - MDR, IS 16127, Medical Device Licenses & 25% Quantity Option
Indian Army
Posted:
3 January 2026
Closed:
5 January 2026
GEM
GEM
Indian Army Behind-the-Ear Digital Hearing Aid Tender Patna Bihar 2026 MDR IS 16127
Progress
Issue08-Jul-2026, 8:26 pm
AwardPending
Quantity
18
Bid Type
Two Packet Bid
Tender Overview
The Indian Army, under the Department Of Military Affairs, invites bids for a Behind the Ear Hearing Aid (Digital) in PATNA, BIHAR – 800001. The procurement covers a comprehensive hearing aid kit with multiple accessories, adhering to regulatory standards including MDR 2017 and IS 16127 packing. Key differentiators include mandatory advance sample approval, bulk supply after sample conformity, and option-based expansion up to 25% of bid quantity. Bidders must align with the buyer’s sample-based start of bulk production and ensure delivery schedules reflect potential extensions due to order quantity fluctuations. This tender emphasizes stringent certification, testing, and medical licensing prerequisites.
Technical Specifications & Requirements
- Product name: Behind the Ear Digital Hearing Aid; Device Programming for multiple listening environments; Microphone functionality per model.
- Standards & Compliance: MDR 2017 completion, IS 16127 (Latest) packing, and Electrical Safety Standards.
- Performance & Specs: Maximum OSPL 90, HF Average OSPL 90, HF Average Full on Gain (at 50/60 dB input), Minimum Number of Channels/Bands, Frequency Range, Total Harmonic Distortion at RTG frequencies, Equivalent Input Noise Level, Induction Coil/Telecoil sensitivity.
- Battery & Accessories: Battery type, number of batteries, Ear inserts per hearing aid, external case, and other accessories.
- Warranty & Testing: MDR test reports per batch, medical license validity, manufacturer accreditation, and optional comprehensive warranty via bidding.
- Packaging & Marking: IS 16127 compliant packaging.
- Certifications: Manufacturer’s unit certification and availability of all tests and licenses to buyer at bid or delivery.
Terms, Conditions & Eligibility
- EMD/Financials: Security deposits and related documents per buyer terms; specific EMD not disclosed in data.
- Delivery Terms: Option to increase quantity by up to 25%; delivery period linked to original order timeline with minimum 30 days for added quantity.
- Sample Clause: Post-award, submit 5 days for advance sample approval; non-conformant samples can trigger modification or contract termination.
- Documentation: Submission of GST, PAN, experience proofs, financials, OEM authorizations, test reports, and MDR-compliant certificates as required by the buyer.
- Warranty: Normal warranty with an optional comprehensive warranty that supersedes catalogue terms when chosen.
- Penalties: LD implications and sample-based evaluation applied as per contract framework.
Key Specifications
-
Product: Behind the Ear Digital Hearing Aid
-
Standards: MDR 2017, IS 16127 (Latest) for packaging
-
Key specs: Maximum OSPL 90, HF Average OSPL 90, HF Average Full on Gain at 50/60 dB input
-
Channels/Bands: Minimum required (as per tender, not specified here)
-
Frequency Range, THD at 500/800/1600 Hz, ENL, Telecoil sensitivity
-
Battery: Type and quantity per device
-
Accessories: Ear inserts per unit, external carrying case, other accessories
-
Certifications: Medical device license, unit manufacturing certification, batch test reports
-
Delivery: Option to increase quantity up to 25% with extended delivery timelines
Terms & Conditions
-
EMD and all statutory documents must be submitted per buyer terms
-
Advance sample approval required within 5 days of award
-
Bulk supply contingent on conformity to approved sample
-
Option to increase quantity up to 25% at contracted rates
-
Delivery period adjusted using the extended formula with minimum 30 days
-
Compliance with MDR 2017, IS 16127 packing, and electrical safety standards
-
Warranty: standard plus optional comprehensive warranty via bid
Important Clauses
Payment Terms
Payment terms to be defined in contract; advance sample cost recoveries and standard milestone payments apply per supply schedule.
Delivery Schedule
Delivery starts after final order; extended delivery time for added quantities calculated as (Additional quantity / Original quantity) × Original delivery period, minimum 30 days.
Penalties/Liquidated Damages
Penalties may apply for late delivery and non-conformance to approved samples; exact LD rates to be specified in the contract.
Bidder Eligibility
-
Experience in supplying medical devices or hearing aids with MDR compliance
-
Valid medical device license under Drugs and Cosmetic Act 1940 and amendments
-
Manufacturing unit certification and ISO/IEC or equivalent quality certifications
-
Financial capacity to sustain up to 25% quantity fluctuations
Additional Tender Data
Commercial Details
Tender Category
Goods
Bid To RA
No
Bid To RA Enabled
Yes
Item Category
Behind the Ear Hearing Aid (Digital) (Q2)
Delivery Details
Max Delivery Days
15
Delivery Locations
1
Delivery Cities
Patna
Delivery Locations
| Consignee | Address | City | State | Pincode | Quantity | Delivery Days | Additional Requirement |
|---|---|---|---|---|---|---|---|
| - | Patna | Patna | - | - | 18 | 15 | - |
Authority Records
MINISTRY OF DEFENCEMILITARY AFFAIRS DEPARTMENT
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Document Filing
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Documents 3
GeM-Bidding-9579273.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS
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GEM
Tender Results
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Technical Specifications
1 Item
Item #1 Details
View Catalog| 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 | HF Average Full on Gain (at 50/60 dB input) | 40 dB (Min) |
| PRODUCT SPECIFICATION | Minimum Number of Channels/Bands | 12 |
| 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 |
| ELECTRICAL REQUIREMENTS | Number of Batteries Provided | 1, 2 |
| ACCESSORIES | Number of Ear Insert Provided with Each Hearing Aid | Three Different sizes of ear Insert |
| ACCESSORIES | External Carrying Case | Yes |
| ACCESSORIES | Other Accessories Provided | Cleaning Brush, Cleaning Cloth |
| 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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Historical Data
Required Documents
1
GST registration certificate
2
PAN card
3
Experience certificates for similar hearing aid supply
4
Financial statements (latest audited)
5
EMD/Security deposit documentation
6
Technical bid documents demonstrating MDR compliance
7
OEM authorizations or manufacturer certification
8
Test reports per MDR 2017 for supplied batches
9
Electrical safety certification
10
Medical device license under Drugs and Cosmetics Act
Frequently Asked Questions
Key insights about BIHAR tender market
How to bid for the behind the ear hearing aid tender in Patna?
Bidders must submit GST and PAN, MDR compliance certificates, OEM authorizations, and batch test reports. Include experience proofs, financial statements, and the advance sample plan. The buyer requires IS 16127 packing adherence and medical device license validity.
What documents are required for hearing aid procurement in Bihar?
Required docs include GST certificate, PAN, experience certificates for similar supply, audited financials, MDR test reports, medical license under Drugs and Cosmetic Act, OEM authorization, and manufacturing unit certification. Submit with technical bid and as per T&C.
What are the technical specifications for the hearing aid in this tender?
Specifications include Maximum OSPL 90, HF Average OSPL 90, HF Average Full on Gain, Minimum Channels/Bands, Frequency Range, and THD at specified frequencies. Must comply with IS 16127 packing and MDR 2017 requirements.
What is the required delivery timeline and quantity expansion rule?
Delivery follows original order terms; quantity may be increased up to 25% during contract. Extended delivery time uses formula: (Additional quantity ÷ Original quantity) × Original delivery period, minimum 30 days.
What are the essential certifications for hearing aid suppliers to bid?
Essential certifications include Medical Device Rule (MDR) 2017 compliance, valid medical license under Drugs and Cosmetic Act, Manufacturing unit certification, and periodic test reports for each batch.
What is the role of advance sample approval in this tender?
Within 5 days of award, submit an advance sample for buyer approval. If approved, bulk production follows; if not, modifications are requested or contract terminated. Delays in approval may shift the delivery schedule without LD.
Which standards govern packaging and electrical safety for this bid?
Packaging must comply with IS 16127 (Latest); electrical safety standards must be met for medical devices per MDR 2017. Ensure all packaging and safety requirements are included in technical bid and delivery.
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Documents 3
GeM-Bidding-9579273.pdf
Main Document
CATALOG-Specification-1
CATALOG Specification
GEM General Terms and Conditions Document
GEM_GENERAL_TERMS_AND_CONDITIONS