X26PH13Hearing instruments with wireless communication capatibilities

USER GUIDE Custom models: CIC Remote mICRophone mI nI-Canal ItC (In-the-Canal) & Ite (In-the-eaR) 2 3 uses and can radiate radio frequency energy and, if not installed and used in accordance with the instructions, may cause harmful interference to radio communications. However, there is no guarantee that interference will not occur in a particular installation. If this equipment does cause harmful interference to radio or television reception, which can be determined by turning the equipment off and on, the user is encouraged to try to correct the interference by one or more of the following measures: • Reorient or relocate the receiving antenna. • Increase the separation between the equipment and receiver. • Connect the equipment into an outlet on a circuit different from the one in which the receiver is connected. • Consult the dealer or an experienced radio/TV technician for help. Changes or modifications can void the user ́s authority to operate the equipment Hearing instrument type designations for models included in this user guide are: BO312, FCC ID: X26BO312, BO13, FCC ID: X26BO13, and PH13, FCCID: X26PH13. Please see page 10 and 14 for list of models referring to both types. statement: This device complies with Part 15 of the FCC Rules. Operation is subject to the following two conditions: (1) this device may not cause harmful inter ference, and (2) this device must accept any interference received, including interference that may cause undesired operation. Note: This equipment has been tested and found to comply with the limits for a Class B digital device, pursuant to part 15 of the FCC Rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, 4 5 Intended use Generic air-conduction hearing instruments are wearable sound-amplifying devices intended to compensate for impaired hearing. The fundamental operating principle of hearing instruments is to receive, amplify, and transfer sound to the ear drum of a hearing impaired person. list of countries: Products without wireless functionality are intended for worldwide sales. Products with wireless functionality are intended for sale in countries within the European Eco- nomic Area as well as Switzerland. Specification of restrictions: You are not allowed to operate the equipment within 20 km of the centre of Ny Ålesund, Norway. The products are in compliance with the following regulatory requirements: • In the EU: the device conforms to the Essential Requirements according to Annex I of Council Directive 93/42/EEC for medical devices (MDD) and essential requirements and other relevant provisions of Directive 1999/5/EC (R&TTE). The declaration of conformity may be consulted at www.resound.com • In US: FCC CFR 47 Part 15, subpart C, section 15.249. • Other identified applicable international regulatory requirements in countries outside the EU and US. Please refer to local country requirements for these areas. • Products are categorized as class 2 receiver according to EN 300 440 6 7 Introduction Congratulations on the purchase of your new hearing instruments. ReSound’s innovative sound technology and design, combined with the customised device programming selected by your hearing care professional, will make hearing a more enjoyable experience. Hearing instruments will enable you to hear sounds that you may not have heard in years because of your hearing loss. Practice and a positive attitude are important in learning to use hearing instruments Your ReSound instruments have been adjusted according to your individual hearing loss and needs. Some people adjust quickly to wearing hearing instruments in their ears and hearing new sounds; other people may need more time. Please read this manual carefully in order to wholly benefit from the use of your hearing instru- ments. With proper care, maintenance, and usage, your hearing instruments will aid you in better communication for many years. Ask your hearing care professional if you have any ques- tions. ReSound is a registred trade mark of ReSound A/S Hearing instrument model: Battery size: Receiver tube length: Dome size: Left serial number: Right serial number: 8 9 Care and maintenance . . . . . . . . . . . . . . .36 Daily maintenance . . . . . . . . . . . . . . . . . .37 Replacing wax filters . . . . . . . . . . . . . . . . .38 General precautions . . . . . . . . . . . . . . . . .40 General warnings . . . . . . . . . . . . . . . . . . .41 Battery warning Information . . . . . . . . . . .43 Troubleshooting guide . . . . . . . . . . . . . . .44 Technical data . . . . . . . . . . . . . . . . . . . . .52 Warranty and repairs . . . . . . . . . . . . . . . .55 Temperature test, transport and storage information . . . . . . . . . . . . . . . . . .56 Contents Statement . . . . . . . . . . . . . . . . . . . . . . . . .2 Intended use . . . . . . . . . . . . . . . . . . . . . . .4 List of countries . . . . . . . . . . . . . . . . . . . . .4 Introduction . . . . . . . . . . . . . . . . . . . . . . . .6 Description of the hearing instruments . . .10 Getting started . . . . . . . . . . . . . . . . . . . . .16 On/Off function . . . . . . . . . . . . . . . . . . . .16 SmartStart . . . . . . . . . . . . . . . . . . . . . . . .17 Inserting/Replacing the battery . . . . . . . . .18 Low battery indicator . . . . . . . . . . . . . . . .19 Inserting/removing hearing instruments . . .20 Operation of the hearing instrument . . . . .25 Volume control (optional) . . . . . . . . . . . . . .25 Programme button (optional) . . . . . . . . . . .27 Flight mode . . . . . . . . . . . . . . . . . . . . . . .29 Telephone use . . . . . . . . . . . . . . . . . . . . .30 Telecoil . . . . . . . . . . . . . . . . . . . . . . . . . .31 Listen to radio or TV . . . . . . . . . . . . . . . .31 Cellular phones . . . . . . . . . . . . . . . . . . . .32 PhoneNow . . . . . . . . . . . . . . . . . . . . . . .32 Tele-loop systems . . . . . . …

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Document Title: Doc. #: Rev. #: External photos of PH13 XXXXX A Form 0007380 - Rev I Short term confidential Page 1 of 2 Corp Template Not subject to issue control when printed Printed Date: 13 September 2011 GN Hearing A/S Owner/Editor: Local Address, if applicable: Kevin Mikes Lautrupbjerg 7 DK-2750 Ballerup Denmark Date: 01.06.2011 PH13 Antenna inside of device Push Button Battery Door Document Title: Doc. #: Rev. #: External photos of PH13 XXXXX A Form 0007380 - Rev I Short term confidential Page 2 of 2 Corp Template Not subject to issue control when printed Printed Date: 13 September 2011 PH13

Document Title: Doc. #: Rev. #: Internal photos of PH13 XXXXX A Form 0007380 - Rev I Short term confidential Page 1 of 2 Corp Template Not subject to issue control when printed Printed Date: 13 September 2011 GN Hearing A/S Owner/Editor: Local Address, if applicable: Kevin Mikes Lautrupbjerg 7 DK-2750 Ballerup Denmark Date: 1.6.2011 BOTTOM SIDE Antenna feed point Wired connections to Mics, battery contacts, programming contacts Document Title: Doc. #: Rev. #: Internal photos of PH13 XXXXX A Form 0007380 - Rev I Short term confidential Page 2 of 2 Corp Template Not subject to issue control when printed Printed Date: 13 September 2011 TOP SIDE Inside of a finished device

DELTA Venlighedsvej 4 2970 Hørsholm Denmark Tel. +45 72 19 40 00 Fax +45 72 19 40 01 www.delta.dk VAT No. 12275110 DELTA Test Report TEST Reg. no. 19 Th e r e p or t m us t n o t b e r e pr od uc e d, ex c e pt i n f ul l , wi t h o ut t h e wr i tt e n a p pr ov al o f DE L TA . EMC_RepGen MAIN TEMPLATE V.47 / 2010-05-17 Thi s r e p or t i s i s s u e d u nd er t h e r ul es of DA N A K ( D ani s h A c c r edi ta ti o n) an d I LA C ( In t er n a ti o n al L ab or at or y A c c r e di t ati o n Co o p er ati on ) i nc l u di ng i ts M RA ( M ut u al Re c o g ni ti on A r r a n gem e nt) . F ur t h er i nf or m ati o n c a n b e fo u n d a t ww w .d a n ak . dk a n d w ww .i l ac . or g. Th e r e p or t m us t n o t b e r e pr od uc e d, ex c e pt i n f ul l , wi t h o ut t h e wr i tt e n a p pr ov al o f DE L TA . Radio parameter test ofPH13according to FCC and IC requirements Performed for GN Hearing A/S DANAK-1911580 Projec t no.: T 200361-6 Page 1 of 53 Including 1 annex 14 September 2011 DANAK-1911580 DELTA-T200361-6 Page 2 of 53 JAS/lko Title Radio parameter test of PH13 according to FCC and IC requirements Test object PH13 Report no. DANAK-1911580 Project no. T200361-6 Test period 9 August - 12 September 2011 Client GN Hearing A/S Lautrupbjerg 7 2750 Ballerup Denmark Tel.:+45 45 75 11 11 Contact person Vinnie Nørager E-mail:[email protected] Manufacturer GN Hearing A/S Specifications FCC CFR 47 Part 15, Subpart C Specific rule part 15.249 IC Standard RSS-210, Issue 8:2010 IC Standard RSS-Gen, Issue 3:2010 Results The test objects were found to be in compliance with the specifications, as listed in Section 1 Test personnel Henrik Egeberg Nielsen Jan Askov Claus Momme Thomsen DANAK-1911580 DELTA-T200361-6 Page 3 of 53 JAS/lko Date 14 September 2011 Project Manager Jan Askov Senior Specialist, Wireless DELTA Responsible Jørgen Duvald Christensen Senior Specialist, EMC DELTA DANAK-1911580 DELTA-T200361-6 Page 4 of 53 JAS/lko Table of contentsPage 1.Summary of tests5 2.Test objects6 2.1Test objects6 3.General test conditions8 3.1Test setup during test8 3.2Test sequence9 3.3Radio specifications, receiver and transmitter10 4.Test results11 4.1Antenna requirement11 4.2Peak average correction factor (PACF)12 4.3Measurement of radiated emission14 4.4Measurement of field strength of fundamental29 4.5Measurement of 20 dB bandwidth30 4.6Measurement of band edge compliance34 4.7Measurement of occupied bandwidth, IC38 4.8Measurement of radiated emission, Rx, IC42 5.National registrations and accreditations49 5.1DANAK Accreditation49 5.2FCC Registrations49 5.3VCCI Registrations50 5.4IC Registrations50 6.List of instruments51 Annex 1 Out of band emission table52 DANAK-1911580 DELTA-T200361-6 Page 5 of 53 JAS/lko 1.Summary of tests Tests SRDTest methodsRule SectionResults Antenna requirement Visual inspection 15.203 RSS-Gen, 7.1.2 Passed Measurement of radiated emission ANSI C63.4:2003 15.209 RSS-210, 2.5 & A2.9 Passed Measurement of 20 dB bandwidth ANSI C63.4:2003 15.215(c)Passed Measurement of band edge compliance ANSI C63.4:2003 15.209(a)&15.249(d)(e) RSS-210, 2.5 & A2.9 Passed Measurement of field strength of fundamental ANSI C63.4:2003 15.249(a) RSS-210, 2.5 & A2.9 Passed Measurement of occupied bandwidth IC RSS-Gen:2010 RSS-Gen, 4.6.1Passed Measurement of radiated emission, receiver EN 300 440-1 V1.5.1:2009 RSS-Gen, 6 RSS-210, 2.5 Passed The given result is based on a shared risk principle with respect to the measurement uncertainty. Conclusion The test objects mentioned in this report meet the requirements of the standard stated below. FCC CFR 47 Part 15, Subpart C Specific rule part 15.249 IC Standard RSS-210, Issue 8:2010 IC Standard RSS-Gen, Issue 3:2010. The test results relate only to the objects tested. DANAK-1911580 DELTA-T200361-6 Page 6 of 53 JAS/lko 2.Test objects 2.1Test objects Photo 2.1.1 Picture of test object (measures 27 x 40 x 21 mm). Test object 2.1.1 Name of test objectPH13 Model / typePH13 Part no.PH13 Serial no.08 FCC IDX26PH13 IC ID6941C-PH13 ManufacturerGN Hearing A/S Supply voltage1.3 VDC (Zinc Air battery) Software versionSpurious emission firmware: Tx and Rx Delta Test App 2.2 : 01.06.11 Cycle time0.5 ms / 1.0 ms CommentsSupplied by external power supply or battery DANAK-1911580 DELTA-T200361-6 Page 7 of 53 JAS/lko Test object 2.1.2 Name of test objectPH13 Model / typePH13 Part no.PH13 Serial no.09 FCC IDX26PH13 IC ID6941C-PH13 ManufacturerGN Hearing A/S Supply voltage1.3 VDC (Zinc Air battery) Software versionSpurious emission firmware: Tx and Rx Delta Test App 2.2 : 01.06.11 Cycle time0.5 ms / 1.0 ms CommentsSupplied by external power supply or battery DANAK-1911580 DELTA-T200361-6 Page 8 of 53 JAS/lko 3.General test conditions 3.1Test setup during test Figure 3.1.1 Block diagram of test object with external cables. All test objects were running special test software. During test, the test objects were in continuous Tx mode or continuous Rx mode. (Normal modulation, normal data packets with optimized repetition rate) Tests were performed at three frequencies: Low frequency:2404 MHz Middle frequency:2440 MHz High frequency:2478 MHz During relevant tests, the battery was replaced by an external DC power supply. External power supple is not used under intended use. Intended use PH13 is a hearing aid used for alleviation of hearing loss. It can receive audio signals and be configured via the radio link. External DC power supply Test object PH13/312 Radio link Audio DANAK-1911580 DELTA-T200361-6 Page 9 of 53 JAS/lko 3.2Test sequence The tests described in this test report were performed in the following sequence: 1.Measurement of radiated emission, Rx, IC 2.Measurement of 20 dB bandwidth 3.Measurement of occupied bandwidth, IC 4.Measurement of field strength of fundamental 5.Measurement of radiated emission 6.Measurement of band edge compliance 7.Inspection of antenna requirement 8.Peak average correction factor (PACF) DANAK-1911580 DELTA-T200361-6 Page …

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DELTA Venlighedsvej 4 2970 Hørsholm Denmark Tel. +45 72 19 40 00 Fax +45 72 19 40 01 www.delta.dk VAT No. 12275110 Photos Radio parameter test ofPH13according to FCC and IC requirements Performed for GN Hearing A/S Page 1 of 7 This exhibit is an extract of DELTA Test Report T200361-6 DANAK-1911580 14 September 2011 containing only the photos of the test set-ups DELTA-T200361-6 Page 2 of 7 JAS/lko Photo 4.3.1Test setup regarding measurement of radiated emission. DELTA-T200361-6 Page 3 of 7 JAS/lko Photo 4.3.2Test setup regarding measurement of radiated emission. Photo 4.3.3Test setup regarding measurement of radiated emission. DELTA-T200361-6 Page 4 of 7 JAS/lko Photo 4.3.4Test setup regarding measurement of radiated emission. Photo 4.3.5Test setup regarding measurement of radiated emission. DELTA-T200361-6 Page 5 of 7 JAS/lko Photo 4.5.2Test setup regarding measurement of 20 dB bandwidth. Photo 4.6.3Test setup regarding measurement of band edge compliance. DELTA-T200361-6 Page 6 of 7 JAS/lko Photo 4.7.4Test setup regarding measurement of occupied bandwidth, IC. Photo 4.8.5Test setup regarding measurement of radiated emission, Rx, IC. DELTA-T200361-6 Page 7 of 7 JAS/lko Photo 4.8.6Test setup regarding measurement of RX radiated emission, Rx, IC. Photo 4.8.3Test setup regarding measurement of radiated emission, Rx, IC.