X26BRIEWireless Hearing Instrument

USER GUIDE RECEIVER-IN-EAR HEARING INSTRUMENT 400344000-GB-14.11-Rev.A.indd 110-12-2014 11:22:24 2 Hearing instrument type designations for models included in this user guide are: BRIE, FCC ID: X26BRIE, IC: 6941C-BRIE; VE312, FCC ID: X26VE312, IC: 6941C-VE312. Please see page 7 for list of models refer- ring to all types. Statement: This device complies with part 15 of the FCC rules and ICES-003 of the IC 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 and CAN ICES-003(B)/NMB-003(B) of the IC rules. These limits are designed to provide reasonable protection against harmful interference in a residential installation. This equipment generates, 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 con- nected. • Consult the dealer or an experienced radio/TV technician for help. Changes or modifications can void the user ́s authority to operate the equipment. 400344000-GB-14.11-Rev.A.indd 210-12-2014 11:22:24 3 Intended use Generic air-conduction hearing instruments are wearable sound-amplifying devices intended to compen- sate 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. The products are in compliance with the following regulatory requirements: • I n 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 Direc- tive 1999/5/EC (R&TTE). • T he declaration of conformity may be consulted at www.resound.com • I n US: FCC CFR 47 Part 15, subpart C. • O ther identified applicable international regulatory requirements in countries outside EU and US. Please refer to local country requirements for these areas. • I n Canada: these hearing instruments are certified under the rules of IC. • J apanese Radio Law and Japanese Telecommunications Business Law Compliance. This device is granted pursuant to the Japanese Radio Law (電波法) and the Japanese telecommunications Business Law (電気通信事業法) This device should not be modified (otherwise the granted designation number will become invalid) • Pa tents US 7,593,537 US 8,00,849 400344000-GB-14.11-Rev.A.indd 310-12-2014 11:22:24 4 Prescription use of this TSG hearing instrument The TSG module should be used as prescribed by your doctor, audiologist or hearing healthcare profes- sional. In order to avoid permanent hearing damages, the maximum daily usage depends on the level of the generated sound. Should you develop any side effects from using the sound generator, such as dizziness, nausea, head- aches, perceived decrease in auditory function or increase in tinnitus perception, you should discontinue use of sound generator and seek medical evaluation. The target population is primarily the adult population over 18 years of age. This product may also be used with children 5 years of age or older. However, children and physically or mentally challenged users will re- quire training by a doctor, audiologist, hearing healthcare professional or the guardian for the insertion and removal of the hearing instrument containing the TSG module. Important notice for prospective sound generator users A tinnitus masker is an electronic device intended to generate noise of sufficient intensity and bandwidth to mask internal noises. It is also used as an aid in hearing external noises and speech. Good health practice requires that a person with a tinnitus condition have a medical evaluation by a licensed physician (preferably a physician who specializes in diseases of the ear) before using a sound generator. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, otolo- gists or otorhinolaryngologists. The purpose of medical evaluation is to assure that all medically treatable conditions that may affect tinnitus are identified and treated before the sound generator instrument is used. The sound generator instrument is 400344000-GB-14.11-Rev.A.indd 410-12-2014 11:22:24 5 ReSound is a registred trade mark of ReSound A/S a tool to generate sounds to be used with appropriate counselling and/or in a tinnitus management program to relieve patients suffering from tinnitus. 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 profes- sional, 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…

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Document Title: Doc. #: Rev. #: External Photos, BRIE, ReSound A Lautrupbjerg 7 P.O. Box 130 DK-2750 Ballerup Denmark Owner/Editor: Local Address, if applicable: Rick Fuss 2601 Patriot Boulevard Glenview, IL 60026 USA Date: 28Oct2014 Specifications according to item number 19078802; HI,LS962-DRW,MBL FRONT REAR Form 0007380 - Rev I GN ReSound Confidential Page 1 of 3 Corp Template Not subject to issue control when printed Printed Date: 6 November 2014 Document Title: Doc. #: Rev. #: External Photos, BRIE, ReSound A TOP SIDE BOTTOM SIDE Form 0007380 - Rev I GN ReSound Confidential Page 2 of 3 Corp Template Not subject to issue control when printed Printed Date: 6 November 2014 Document Title: Doc. #: Rev. #: External Photos, BRIE, ReSound A LEFT SIDE RIGHT SIDE Form 0007380 - Rev I GN ReSound Confidential Page 3 of 3 Corp Template Not subject to issue control when printed Printed Date: 6 November 2014

Document Title: Doc. #: Rev. #: Internal photos of BRIE N/A A Lautrupbjerg 7 P.O. Box 130 DK-2750 Ballerup Denmark Owner/Editor: Local Address, if applicable: R. Fuss 2601 Patriot Blvd. Glenview, IL 60026 USA Date: 15Oct2014 Specifications according to item number:19032100 Form 0007380 - Rev I GN ReSound Confidential Page 1 of 3 Corp Template Not subject to issue control when printed Printed Date: 14 November 2014 Document Title: Doc. #: Rev. #: Internal photos of BRIE N/A A SIDE Form 0007380 - Rev I GN ReSound Confidential Page 2 of 3 Corp Template Not subject to issue control when printed Printed Date: 14 November 2014 Document Title: Doc. #: Rev. #: Internal photos of BRIE N/A A TOP/DOWN SIDE Form 0007380 - Rev I GN ReSound Confidential Page 3 of 3 Corp Template Not subject to issue control when printed Printed Date: 14 November 2014

GN Hearing A/S TUV SUD BABT FCB Octagon House, Segensworth Road, Fareham, Hampshire, PO15 5RL Date: December 18, 2014 RF exposure analysis for the equipment BRIE (FCC ID: X26BRIE) 1. Introduction The device BRIE (FCC ID: X26BRIE) is a wireless hearing instrument used to amplify sound from the surrounding to the end user and also receive audio signals through wireless connection to accessories. It contains a multi-mode 2.4GHz radio which operates, time & frequency divided, in either BlueTooth Low Energy mode (BTLE) or a proprietary “Proximity” mode and is intended for use within 20 cm of humans. 2. SAR limits According to § 2.1093 (d) (2) the limits for General Population/Uncontrolled exposure: 0.08 W/kg as averaged over the whole-body and peak spatial-average SAR limit is 1.6 W/kg, averaged over any 1 gram of tissue over the whole body. 3. Compliance criteria: Individual transmitters are deeded to comply with § 2.1093 requirements if the output power of the transmitter meets the conditions specified in section 4.3.1 (Standalone SAR test exclusion) considerations of the document “KDB 447498 D01 General RF Exposure Guidance v05r02”. 4. Compliance calculations : Mode Sub-mode Frequency Average field strength (dBμV/m) Average output power (mW) Evalutation distance per KDB 447498 D01 General RF Exposure Guidance v05r02 - 4.3.1 (mm) SAR Test Exclusion Thresholds per KDB 447498 D01 General RF Exposure Guidance v05r02 - 4.3.1 - 1) (mW) SAR Test Exclusion Thresholds per KDB 447498 D01 General RF Exposure Guidance v05r02 - 4.3.1 - 1) BLE BLE 2402 81,77 0,045 5 10 COMPLIANT 2440 81,87 0,046 5 10 COMPLIANT 2480 81,2 0,040 5 10 COMPLIANT Proximity Proximity 2404 75,57 0,011 5 10 COMPLIANT 2440 75,6 0,011 5 10 COMPLIANT 2478 74,73 0,009 5 10 COMPLIANT Sincerely, By: Lars Hagander Title: Vice president, Corporate Quality Company: GN Hearing A/S, Lautrupbjerg 7, 2750 Ballerup, Denmark Telephone / Fax: +45 45 75 21 00 / +45 45 75 44 29 e-mail: [email protected]

AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932REM.002 Page 1 of 18 2014-12-17 Informe de ensayo nº: Test report No: NIE: 43932REM.002 Test report FCC Rules and Regulations 47 CFR Chapter I Part 15 Subpart B (10-01-13 Edition); ICES-003 ISSUE 5 (2012) & American National standard for Testing Unlicensed Wireless Devices Identificación del objeto ensayado ...................... : Identification of item tested RESOUND Marca ................................................................... : Trade Resound Modelo y/o referencia tipo .................................. : Model and /or type reference BRIE Other identification of the product .................... : S/N: 1500800114 FCC ID: X26BRIE IC ID: 6941C-BRIE Final HW version ................................................ : BRIE Final SW version ................................................. : 4.1.1.0 Características ..................................................... : Features BTLE, Proximity Peticionario ......................................................... : Applicant GN HEARING A/S Lautrupbjerg 7, 2750 Ballerup, Denmark CVR: 55082715 Lars Hagander +45 4575 2100 [email protected] Método de ensayo solicitado, norma ................... : Test method requested, standard FCC Rules and Regulations 47 CFR Chapter I Part 15 Subpart B (10-01-13 Edition); ICES-003 ISSUE 5 (2012) & ANSI C63.4- 2009: American National Standard for Methods of Measurement of RadioNoise Emissions from Low-Voltage Electrical and Electronic Equipment in the Range of 9 kHz to 40 GHz. Resultado .............................................................. : Summary IN COMPLIANCE Aprobado por (nombre / cargo y firma) ........... : Approved by (name / position & signature) Rafael López EMC LAB Manager Fecha de realización ........................................... : Date of issue 2014-12-17 Formato de informe No. ...................................... : Report template No FDT08_15 AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932REM.002 Page 2 of 18 2014-12-17 Index Competences and guarantees ......................................................................................................................... 3 General conditions ......................................................................................................................................... 3 Uncertainty .................................................................................................................................................... 3 Usage of samples ........................................................................................................................................... 4 Test sample description ................................................................................................................................. 4 Test samples supplier .................................................................................................................................... 4 Testing period ................................................................................................................................................ 4 Environmental conditions .............................................................................................................................. 4 Remarks and comments ................................................................................................................................. 5 Testing veredicts ............................................................................................................................................ 6 Appendix A – Test result ............................................................................................................................... 7 Appendix B - Photographs .......................................................................................................................... 17 AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932REM.002 Page 3 of 18 2014-12-17 Competences and guarantees AT4 wireless is a testing laboratory accredited by the National Accreditation Body (ENAC - Entidad Nacional de Acreditación), to perform the tests indicated in the Certificate No. 51/LE 147. This certificate of conformity was issued in accordance with the decision Nº 3/2000 of the Joint Committee established under the Agreement on Mutual Recognition between the European Community and the United States of America. By this decision, AT4 wireless can act as Conformity Assessment Body (CAB) on Electromagnetic Compatibility. This Certificate applies to the samples listed at technical reports. This laboratory is designed by the Federal Communications Commission (ES0004) AT4 wireless is a testing laboratory competent to carry out the tests described in this report. In order to assure the traceability to other national and international laboratories, AT4 wireless has a calibration and maintenance program for its measurement equipment. AT4 wireless guarantees the reliability of the data presented in this report, which is the result of the measurements and the tests performed to the item under test on the date and under the conditions stated on the report and, it is based on the knowledge and technical facilities available at AT4 wireless at the time of performance of the test. AT4 wireless is liable to the client for the maintenance of the confidentiality of all information related to the item under test and the results of the test. The results presented in this Test Report apply only to the particular item under test established in this document. IMPORTANT: No parts of this report …

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AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 1 of 48 2014-12-05 FCC LISTED, REGISTRATION NUMBER: 720267 IC LISTED REGISTRATION NUMBER IC 4621A-1 Informe de ensayo nº: Test report No: NIE: 43932RRF.002 Test report USA FCC Part 15.249, 15.209 CANADA RSS-210, RSS-Gen Radio Frequency Devices. Operation within the bands 902 - 928 MHz, 2400 - 2483.5 MHz, 5725 - 5875 MHz, and 24.0 - 24.25 GHz. License-Exempt Radio Apparatus (All Frequency Bands): Category I Equipment. General Requirements for Compliance of Radio Apparatus. Identificación del objeto ensayado ...................... : Identification of item tested Wireless hearing instrument Marca ................................................................... : Trade RESOUND Modelo y/o referencia tipo .................................. : Model and /or type reference BRIE Other identification of the product .................... : Commercial name: RESOUND FCC ID: X26BRIE IC: 6941C-BRIE Final HW version ................................................ : BRIE Final SW version ................................................. : 4.1.1.0 Serial number ....................................................... : 15 00800268 / 15 00800054 Características ..................................................... : Features Bluetooth LE and Proximity radio Peticionario ......................................................... : Applicant GN HEARING A/S Lautrupbjerg 7, 2750 Ballerup. Denmark CVR: 55082715 Contact person: Lars Hagander Telephone: + 45 4575 2100 e-mail: [email protected] Método de ensayo solicitado, norma ................... : Test method requested, standard USA FCC Part 15.249 10-1-13 Edition: Operation within the bands 902 - 928 MHz, 2400 -2483.5 MHz, 5725–5875 MHz, and 24.0–24.25 GHz. CANADA RSS-210 Issue 8 (December 2010). CANADA RSS-Gen Issue 4 (November 2014). ANSI C63.10-2013: American National Standard for Testing Unlicensed Wireless Devices. Resultado .............................................................. : Summary IN COMPLIANCE Aprobado por (nombre / cargo y firma) ........... : Approved by (name / position & signature) A. Llamas RF Lab. Manager AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 2 of 48 2014-12-05 Fecha de realización ........................................... : Date of issue 2014-12-05 Formato de informe No. ...................................... : Report template No FDT08_15 AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 3 of 48 2014-12-05 Index Competences and guarantees ......................................................................................................................... 4 General conditions ......................................................................................................................................... 4 Uncertainty .................................................................................................................................................... 4 Usage of samples ........................................................................................................................................... 4 Test sample description ................................................................................................................................. 5 Test samples supplier .................................................................................................................................... 5 Testing period ................................................................................................................................................ 5 Environmental conditions .............................................................................................................................. 6 Remarks and comments ................................................................................................................................. 7 Testing verdicts ............................................................................................................................................. 8 Appendix A – Test result “Bluetooth Low Energy” ...................................................................................... 9 Appendix B – Test result “Proximity radio” ............................................................................................... 29 AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 4 of 48 2014-12-05 Competences and guarantees AT4 wireless is a laboratory with a measurement facility in compliance with the requirements of Section 2.948 of the FCC rules and has been added to the list of facilities whose measurements data will be accepted in conjuction with applications for Certification under Parts 15 or 18 of the Commission's Rules. Registration Number: 720267. AT4 wireless is a laboratory with a measurement site in compliance with the requirements of RSS 212, Issue 1 (Provisional) and has been added to the list of filed sites of the Canadian Certification and Engineering Bureau. Reference File Number: IC 4621A-1. In order to assure the traceability to other national and international laboratories, AT4 wireless has a calibration and maintenance program for its measurement equipment. AT4 wireless guarantees the reliability of the data presented in this report, which is the result of the measurements and the tests performed to the item under test on the date and under the conditions stated on the report and, it is based on the knowl…

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AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 1 of 7 2014-12-05 Appendix C - Photographs AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 2 of 7 2014-12-05 EQUIPMENT FOR CONDUCTED MEASUREMENTS AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 3 of 7 2014-12-05 EQUIPMENT FOR RADIATED MEASUREMENTS AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 4 of 7 2014-12-05 GENERAL SET-UP FOR RADIATED MEASUREMENTS AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 5 of 7 2014-12-05 TEST SET-UP FOR RADIATED MEASUREMENTS BELOW 1 GHz AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 6 of 7 2014-12-05 TEST SET-UP FOR RADIATED MEASUREMENTS ABOVE 1 GHz AT4 wireless, S.A. Parque Tecnológico de Andalucía, c/ Severo Ochoa nº 2 · 29590 Campanillas · Málaga · España www.at4wireless.com · C.I.F. A29 507 456 Report No: (NIE) 43932RRF.002 Page 7 of 7 2014-12-05 TEST SET-UP FOR CONDUCTED MEASUREMENTS