2AXQ3G1P1NoviOne Wireless

USER MANUAL Novidan, Inc. NoviOne RIC Wireless Contact: 763 205-3269 [email protected] DRAFT Table of Contents 4 Hearing Aid Parts 5. Introduction and Battery Drawer functions 6. Installing the Battery 7. Inserting and removing the Hearing Aids 8. Fitting your hearing aids 9. Eartip and Dome Types 10. Adjusting the volume & Programs with Switch 11. Programs 12. Mobile App Controls 13. Audio Streaming & Bluetooth Connections 14. Replacing Batteries 15. Replacing Eartips/Domes 16. Maintanence and Care of Devices 2 3 17. Cleaning Speaker and Eartips/Domes 18. Warnings 19. Wireless Information 23. Technical Specifications 24. Troubleshooting 25. Service, Warranty & Repair 26. FDA Information Hearing Aid Parts 4 Introduction Congratulations on your new NoviOne RIC hearing aids! Below is a brief introduction to the product and an explanation on how the hearing aids work. Delivered in this little hearing package is a state-of-the-art set of digital signal processing features based on the latest advances in hearing science. The product has been finely tuned by us to create an elite listening experience. NoviOne was created for the Direct-To-Consumer market to deliver pre-programmed hearing aids for adults with mild to moderate hearing loss. Fully closed position is the ON position. When the battery drawer is in the fully closed posi- tion with a functioning battery installed, it will power on and be ready to use. The OFF position of the battery drawer is located between fully closed and fully open. It is used to turn the hearing device OFF without allowing the battery to fall out of the device. When the device is not in use, use the battery drawer handle to open the battery drawer to the OFF position. This will avoid draining the battery and extend the battery life. This is especially important to do before you go to sleep at night. It is acceptable to completely open the battery drawer as well. The OPEN (fully open) position should be used when changing the battery. In this position, the battery is accessible for removal and replacement. Off On Open Battery Drawer Functions The battery drawer has three positions: ON (fully closed), OFF (partially open), and OPEN. 5 Installing the Battery Before using your hearing aids, a battery must be installed. 1. Using the battery drawer handle, open the battery drawer to the OPEN position. 2. Take a brand new #312 battery, remove the tab from the battery, and place the battery into the battery drawer with the rounded side down into the battery drawer. The flat side of the battery should be up. 3. Push the battery drawer closed to the ON (fully closed) position by pressing on the battery drawer handle past the first click until the battery drawer is completely shut. 4. The hearing aid automatically powers on, after a five second delay, when the battery drawer is in the fully closed (ON) position. The start up default program is Home and the volume will be at the midpoint. Step 1 Remove brown tab Step 2 Step 3 6 Inserting and Removing the Hearing Aids 1. Place the hearing aid behind your ear and hold it in place. 2. Using the other hand if needed, gently insert the eartip/dome into your ear canal until the cable rests against your head. 3. Ensure the eartip/dome is seated securely, all the way in your ear and the device is resting comfortably behind your ear. The cable will prevent you from pushing the eartip/ dome into your ear too far. Right and Left Device Indicators The right device is indicated by the color red on the speaker. The left device is indicated by the color blue on the speaker Correct Incorrect 7 Removing the Hearing Aids from Your Ears 1. Grasp the cable with your thumb and finger. 2. Gently pull the cable directly outward to remove the cable out of your ear canal. 3. Remove the hearing aid from behind your ear. Fitting Your Hearing Aids For best results, the hearing aids should fit properly on and in your ears. Fitting Your Eartip/Dome: First, check the fit of your eartip/dome. Your hearing aids come preinstalled with the size medium closed eartip/dome. In the box, you will find size small, medium, and large eartip/ domes in both open and closed types (see pg 7 “Eartip/Dome Types” for details). A properly fit eartip/dome should feel stable and comfortable in your ear. It should be snug, but should not feel tight. If the eartip/dome backs out of your ear or moves inside your ear canal, try a larger size. If you are experiencing feedback or whistling, try a larger size closed dome. If the eartip/dome feels tight or causes discomfort in your ear, try a smaller size. If the eartip/dome feels like it gets “stuck” when you insert the device, try a smaller size. 8 Eartip/Dome Types Your hearing aids come with two different types of eartips/domes: 1) open; 2) closed. Open eartips/domes have airholes; closed domes have smaller openings. Your hearing aids come preinstalled with the size medium closed domes. Closed domes give fuller, richer sound. They allow for higher volume without feedback or whistling. Open domes may cause feedback or whistling in some ear canals, especially if you turn up the volume. However, they can help keep your ear from feeling “plugged.” • If your ear feels “plugged,” try the open dome. • If sounds are loud or “boomy,” try the open dome. • If sounds aren’t loud enough, try the closed dome. • If you are experiencing feedback or whistling, try the closed dome. If you are using a closed dome and still experiencing feedback, try a larger size closed dome (see pg 6 for details) • If sounds are “tinny,” try the closed dome. In addition to selecting the correct dome type, you will need to ensure you have selected the right size dome for your ear. See pg 6 “Fitting Your Eartip/Dome” for details. ClosedOpen 9 Fitting Your Cable Next, you should check the fit of the cable. Your hearing aids come preinstalled with the size medium cable. The size medium cable fits most ears. Your cable should lie flat against your face with the hear…

Text truncated - open the document above for the full version.

FCC ID: 2AXQ3G1P1 External Photos The exterior of the product is the same for the left and the right.

FCC ID: 2AXQ3G1P1 Label and Location on Box

FCC ID: 2AXQ3G1P1 Internal Photos The same PCBA and copper antenna are used for a left or right hearing aid. RF Section Antenna feed SIP with Radio RF Section Antenna feed SIP with Radio RF Section Antenna feed RF Section with copper wire antenna attached Hearing Aid with Right Antenna, Right Side View The antenna is wrapped one direction for a Right Antenna, and the opposite direction for a Left Antenna. Hearing Aid with Right Antenna, Left Side View Antenna feed Hearing Aid with Right Antenna, Top View Hearing Aid with Right Antenna, Bottom View Hearing Aid with Right Antenna, Front View Hearing Aid with Right Antenna, Back View Hearing Aid with Left Antenna, Right Side View Hearing Aid with Left Antenna, Left Side View Antenna feed Hearing Aid with Left Antenna, Top View Hearing Aid with Left Antenna, Bottom View Hearing Aid with Left Antenna, Front View Hearing Aid with Left Antenna, Back View

FCC ID: 2AXQ3G1P1 Antenna Information The antenna is a monopole made of copper wire. The peak gain of the antenna in the assembled product is -1.12 dBi. The antenna is permanently attached and inside the product enclosure.

This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. EAR-Controlled Data - This document contains technical data whose export and reexport/retransfer is subject to control by the U.S. Department of Commerce under the Export Administration Act and the Export Administration Regulations. The Department of Commerce’s prior written approval may be required for the export or re- export/retransfer of such technical data to any foreign person, foreign entity or foreign organization whether in the United States or abroad. More: https://www.bis.doc.gov/index.php/forms-documents/regulations-docs/14-commerce-country-chart/fileT Novidan, Inc. Kamen RIC FCC 2.1093:2021 Bluetooth Low Energy Report: NOVI0007.2 CERTIFICATE OF EVALUATION 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing Last Date of Evaluation: Tuesday, May 4, 2021 Novidan, Inc. EUT: Kamen RIC RF Exposure Evaluation Standards Specification Method FCC 2.1093:2021 FCC 447498 D01 General RF Exposure Guidance v06 Results Method Clause Description Applied Results Comments 4.3.1 SAR Test Exclusion Yes Pass None Deviations From Evaluation Standards None Approved By: Donald Facteau, Process Architect Report No. NOVI0007.2EAR-Controlled Data2/10 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. NOVI0007.2EAR-Controlled Data3/10 ACCREDITATIONS AND AUTHORIZATIONS 2021.02.26 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC 17065 as a product certifier. This allows Element to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Recognized as an EU Notified Body validated for the EMCD and RED Directives. United Kingdom BEIS – Recognized by the UK as an Approved Body under the UK Radio Equipment and UK EMC Regulations. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: https://www.nwemc.com/emc-testing-accreditations Report No. NOVI0007.2EAR-Controlled Data4/10 FACILITIES 2020.12.15 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-11 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 NVLAP NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200630-0 NVLAP Lab Code:201049-0 NVLAP Lab Code: 200629-0 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. NOVI0007.2EAR-Controlled Data5/10 PRODUCT DESCRIPTION 2018-07-17 Client and Equipment Under Evaluation Information Company Name: Novidan, Inc. Address: 672 Mendelssohn Avenue North City, State, Zip: Golden Valley, MN 55427 Evaluation Requested By: John Becker EUT: Kamen RIC Date of Evaluation: Tuesday, May 4, 2021 Information Provided by the Party Requesting the Evaluation Functional Description of the Equipment: The Kamen RIC is a hearing aid that contains a Bluetooth 5.0 single-mode Bluetooth Low Energy radio, operating at frequencies of 2400 MHz to 2483.5 MHz.The largest dimension of the product is 3 cm. Objective: To demonstrate compliance with FCC RF exposure requirements for 2.1093 portable devices. Report No. NOVI0007.2EAR-Controlled Data6/10 RF Exposure Condition 2018-07-17 The following RF Exposure conditions were used for the assessment documented in this report: Intended …

Text truncated - open the document above for the full version.

This report must not be used to claim product certification, approval, or endorsement by NVLAP, NIST, or any agency of the U.S. Government. This Report shall not be reproduced, except in full without written approval of the laboratory. Novidan, Inc. Kamen FCC 15.247:2021 Bluetooth Report: NOVI0007.3, Issue Date: May 3, 2021 NVLAP LAB CODE: 200881-0 CERTIFICATE OF TEST 2018-09-14 Product compliance is the responsibility of the client; therefore, the tests and equipment modes of operation represented in this report were agreed upon by the client, prior to testing. The results of this test pertain only to the sample(s) tested. The specific description is noted in each of the individual sections of the test report supporting this certificate of test. This report reflects only those tests from the referenced standards shown in the certificate of test. It does not include inspection or verification of labels, identification, marking or user information. As indicated in the Statement of Work sent with the quotation, Element’s standard process is to always use the latest published version of the test methods even when earlier versions are cited in the test specification. Issuance of a purchase order was de facto acceptance of this approach. Otherwise, the client would have advised Element in writing of the specific version of the test methods they wanted applied to the subject testing. Last Date of Test: March 2, 2021 Novidan, Inc. EUT: Kamen Radio Equipment Testing Standards Specification Method FCC 15.247:2021 ANSI C63.10:2013 Results Method Clause Test Description Applied Results Comments 6.2 Powerline Conducted Emissions No N/A Not required for a battery powered EUT. 11.6 Duty Cycle Yes N/A 11.8.2 Occupied Bandwidth Yes Pass 11.9.1.1 Output Power Yes Pass 11.9.1.1 Equivalent Isotropic Radiated Power Yes Pass 11.10.2 Power Spectral Density Yes Pass 11.11 Band Edge Compliance Yes Pass 11.11 Spurious Conducted Emissions Yes Pass 11.12.1, 11.13.2, 6.5, 6.6 Spurious Radiated Emissions Yes Pass Deviations From Test Standards None Approved By: Eric Brandon, Department Manager Report No. NOVI0007.32/62 REVISION HISTORY 2018.07.17 Revision Number Description Date (yyyy-mm-dd) Page Number 00 None Report No. NOVI0007.33/62 ACCREDITATIONS AND AUTHORIZATIONS 2019.03.08 United States FCC - Designated by the FCC as a Telecommunications Certification Body (TCB). Certification chambers, Open Area Test Sites, and conducted measurement facilities are listed with the FCC. A2LA - Accredited by A2LA to ISO / IEC 17065 as a product certifier. This allows Element to certify transmitters to FCC and IC specifications. NVLAP - Each laboratory is accredited by NVLAP to ISO 17025 Canada ISED - Recognized by Innovation, Science and Economic Development Canada as a Certification Body (CB) and as a CAB for the acceptance of test data. European Union European Commission – Within Element, we have a EU Notified Body validated for the EMCD and RED Directives. Australia/New Zealand ACMA - Recognized by ACMA as a CAB for the acceptance of test data. Korea MSIT / RRA - Recognized by KCC’s RRA as a CAB for the acceptance of test data. Japan VCCI - Associate Member of the VCCI. Conducted and radiated measurement facilities are registered. Taiwan BSMI – Recognized by BSMI as a CAB for the acceptance of test data. NCC - Recognized by NCC as a CAB for the acceptance of test data. Singapore IDA – Recognized by IDA as a CAB for the acceptance of test data. Israel MOC – Recognized by MOC as a CAB for the acceptance of test data. Hong Kong OFCA – Recognized by OFCA as a CAB for the acceptance of test data. Vietnam MIC – Recognized by MIC as a CAB for the acceptance of test data. SCOPE For details on the Scopes of our Accreditations, please visit: https://www.nwemc.com/emc-testing-accreditations Report No. NOVI0007.34/62 FACILITIES 2019.03.08 California Labs OC01-17 41 Tesla Irvine, CA 92618 (949) 861-8918 Minnesota Labs MN01-10 9349 W Broadway Ave. Brooklyn Park, MN 55445 (612)-638-5136 Oregon Labs EV01-12 6775 NE Evergreen Pkwy #400 Hillsboro, OR 97124 (503) 844-4066 Texas Labs TX01-09 3801 E Plano Pkwy Plano, TX 75074 (469) 304-5255 Washington Labs NC01-05 19201 120 th Ave NE Bothell, WA 98011 (425)984-6600 NVLAP NVLAP Lab Code: 200676-0 NVLAP Lab Code: 200881-0 NVLAP Lab Code: 200630-0 NVLAP Lab Code:201049-0 NVLAP Lab Code: 200629-0 Innovation, Science and Economic Development Canada 2834B-1, 2834B-3 2834E-1, 2834E-3 2834D-1 2834G-1 2834F-1 BSMI SL2-IN-E-1154R SL2-IN-E-1152R SL2-IN-E-1017 SL2-IN-E-1158R SL2-IN-E-1153R VCCI A-0029 A-0109 A-0108 A-0201 A-0110 Recognized Phase I CAB for ISED, ACMA, BSMI, IDA, KCC/RRA, MIC, MOC, NCC, OFCA US0158 US0175 US0017 US0191 US0157 Report No. NOVI0007.35/62 MEASUREMENT UNCERTAINTY TMU.2015.07.10 Measurement Uncertainty When a measurement is made, the result will be different from the true or theoretically correct value. The difference is the result of tolerances in the measurement system that cannot be completely eliminated. To the extent that technology allows us, it has been our aim to minimize this error. Measurement uncertainty is a statistical expression of measurement error qualified by a probability distribution. A measurement uncertainty estimation has been performed for each test per our internal quality document QM205.4.6. The estimation is used to compare the measured result with its "true" or theoretically correct value. The expanded measurement uncertainty (K=2) can be found included as part of the applicable test description page. Our measurement data meets or exceeds the measurement uncertainty requirements of the applicable specification; therefore, the test data can be compared directly to the specification limit to determine compliance. The calculations for estimating measurement uncertainty are based upon ETSI TR 100 028 (or CISPR 16-4-2 as applicable), and are available upon request. The following table represents the Measurement Uncertainty (MU) budgets for each of the tests t…

Text truncated - open the document above for the full version.

XMit 2020.03.25.0 MN08_BENCH 001.jpg MN08_BENCH 002.jpg DIRECT CONNECT SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 SE 001.jpg SE 002.jpg 2 Report No. NOVI0007.32/8 SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 SE 003.jpg SE 004.jpg 4 Report No. NOVI0007.33/8 SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 SE 005.jpg SE 006.jpg 6 Report No. NOVI0007.34/8 SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 SE 007.jpg SE 008.jpg 8 Report No. NOVI0007.35/8 SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 SE 009.jpg SE 010.jpg 10 Report No. NOVI0007.36/8 SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 SE 011.jpg SE 012.jpg 12 Report No. NOVI0007.37/8 SPURIOUS RADIATED EMISSIONS photo PSA-ESCI 2020.06.24.2 photos PSA-ESCI 2020.06.24.2 SE 013.jpg SE 014.jpg 14 Report No. NOVI0007.38/8