CENTRAL MARKS DEPARTMENT II (Legal) Our Ref: CMD-II(L)/16: February 2015

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1 CENTRAL MARKS DEPARTMENT II (Legal) Our Ref: CMD-II(L)/16: February 2015 Subject: Finalization and Implementation of STI for IS 16127:2013, Behind the Ear (BTE) Hearing Aids Digital. CRO has finalized the STI for IS 16127:2013, Behind the Ear (BTE) Hearing Aids Digital being the first application on all India basis processed at GZBO. The tentative finalized STI DOC: STI/16127/1 Dec.2014 has been approved by DDGC on A copy of the tentative finalized STI DOC: STI/16127/1 Dec.2014 is enclosed for perusal and comments. The comments if any may be forwarded direct to the custodian BO (GZBO) within 30 days for taking suitable action at their end. In case no comments are received by them, the custodian BO shall inform CMD-II with recommendation for treating the tentative STI as final for certification of IS 16127:2013. Head, CMD-II (Legal) (Sunil Kumar) Sc. F Circulated to all ROs/BOs/SBOs/BIS Labs. Copy to: i)head ITS for hosting on Intranet & website. ii)head (LITD) iii)head (MSD) iv)head (GZBO)

2 SCHEME OF TESTING AND INSPECTION FOR CERTIFICATION OF BEHIND THE EAR (BTE) HEARING AIDS DIGITAL ACCORDING TO IS : Laboratory - A laboratory shall be maintained, which shall be suitably equipped and staffed, where different tests and inspections given in the specification shall be carried out. 1.1 Testing apparatus shall be checked and calibrated periodically and records of such checks shall be maintained. 2. Records All records of tests and inspection shall be maintained in suitable forms approved by the Bureau. 2.1 Copies of any records and charts that may be required by the Bureau shall be made on request. 3. Marking 3.1 BIS Certification Marking - The hearing aid and/or the hearing aid manual may also be marked with the Standard Mark. 3.2 Each hearing aid shall be indelibly and clearly marked with the following information: a) Name and/or trade-mark of the manufacturer; b) Model; and c) Serial Number 3.3 Marking of control setting shall be as per Annex C of IS : Each hearing aid must be packed with an instruction manual to furnish, a) Name or trade-mark of the manufacturer; b) Type and rating of the battery; c) Precaution to be taken in the of use hearing aid; d) Method of adjusting gain control; and e) Any other useful information the manufacturer would like to furnish. 3.5 The manufacturer shall specify the maximum current consumption in the instruction manual. 4. Levels of control -The tests and inspections, as indicated in Table 1 and at the levels of control specified therein, shall be carried out on whole production of the factory covered by this scheme and appropriate records and charts maintained in accordance with paragraph 2 above. All the production which conforms to the Indian standard IS16127 : 2013 which is covered by the license shall be marked with certification mark.

3 4.1 On the basis of test and inspection results, decision regarding conformity or otherwise of hearing aids to the requirements specified in IS : : 2013 shall be made. 5. In respect of all other clauses of the specification and at all stages of manufacture, the factory shall maintain appropriate controls and checks to ensure that their product conforms to various requirements of the specification. 6. It is recommended that, as far as possible, each consignment of the raw materials should be accompanied by a test certificate or incoming Q.C. should be carried out as per a plan. 7. Samples - The licensee shall supply, free of charge, the samples required in accordance with regulation of the Bureau of Indian Standards from his factory or godowns. The Bureau shall pay for the samples taken by it from the open market. 8. Replacement - whenever a complaint is received soon after the goods with standard mark have been purchased and used, and if there is adequate evidence that the goods have not been misused, defective goods are replaced free of cost by the licensee in case the complaint is proved to be genuine and the warranty period (where applicable) has not expired. The final authority to judge conformity of the product to the Indian standard shall be with the Bureau. 9. Suspension of Marking - The marking of the product shall be suspended under Intimation to the Bureau if, at any time, there is some difficulty in maintaining the conformity of the product to the specification, or the testing equipment goes out of order, or if directed to do so by the Bureau for any reason. The marking may be resumed as soon as the defects are removed or when the Bureau gives the permission to do so. The information of marking shall also be sent to the Bureau. 10. The licensee shall send to the Bureau a statement showing - Opening stock, Quantity produced, Quantity shipped and Closing stock for B.I.S. certified and marked products. The records should be maintained from 1 st January to 31 st December. This statement is required to be forwarded to the Bureau on/or before 31 st January for the preceding year.

4 IS : : 2013 BEHIND THE EAR (BTE) HEARING AIDS DIGITAL Test Details Levels of Controls Requirement Test Method Reference No. of Samples Frequency 5.1 Design and Workmanship 5.1 IS : : Power Supply Housing 5.3 Battery Compartment & Ear Insert Dimensions & Mass & External Case Each Hearing Aid 5.5 Controls (a,b,c), 5.5.2, & Maximum Saturation Sound (a) & Pressure level (OSPL 90) 8.1.3(a) HF Average OSPL (b) & 8.1.3(b) HF average full-on gain (at50/60 db input) (d) & 8.1.3(c) Frequency range (c) & 8.1.3(d)

5 Requirement Test Method Reference No. of Samples Frequency Total Harmonic Distortion (e) & 8.1.3(e) Induction Coil Sensitivity (if telecoil is provided) (at 10mA/m) (Table 1) (viii) Each Hearing Aid Internal noise from the hearing aid in terms of equivalent input noise level (f) one Each control unit Battery Current (g) 7.4 of IS : 2013 Effect of Tone control positions on frequency Range (v) IS : : 2013 AGC Characteristics (if applicable) (ix) one Once in three months Environmental tests: Climatic tests, dry heat at 40 o C for 2 h x(a) Environmental tests: Drop test x(b)

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