user manual

FCC ID: EOA-24LIVIOM312

Users Manual

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FCCID_4108808

Smartphone Compatible and Universal Connectivity Standard Products O P E R AT I O N S M A N U A L RIC (Receiver-In-Canal)

Table of Contents Hearing Aid Memory Change ����������������������������������������������������� 15 Mute ����������������������������������������������������������������������� 16 Multiflex Tinnitus Level Control ������������������������������� 16 FPO Activity Tracking ����������������������������������������������������� 17 Directional Settings ������������������������������������������������� 17 Telephone Use ��������������������������������������������������������� 17 CROS/BiCROS Technology ��������������������������������������������� 20 Size 312 Battery - Brown Size 312 Battery - Brown Multiflex Tinnitus Technology ��������������������������������������� 21 Fall Alert Introduction ������������������������������������������������������������� 23 Hearing Aid Controls Auto Alert ��������������������������������������������������������������� 23 Rocker Switch Controls p. 13 Manual Alert ����������������������������������������������������������� 23 Alert Cancellation ��������������������������������������������������� 24 Push Button Controls p. 13 Contacts ����������������������������������������������������������������� 24 Auto Alert Sensitivity ����������������������������������������������� 25 Indicators ����������������������������������������������������������������� 26 Adjustment Pairing with an iOS Device ������������������������������������� 27 Table of Contents Mobile Phone Use ��������������������������������������������������� 29 Pairing with an Android Device ������������������������������� 29 Overview Accessories ��������������������������������������������������������������������� 31 Rocker Switch RIC 312 �������������������������������������������������������� 4 Push Button mRIC 312 ������������������������������������������������������� 6 Hearing Aid Care Hearing Aid Care ����������������������������������������������������� 32 Preparation Service and Repair ���������������������������������������������������� 34 Batteries/Battery Indicators ������������������������������������������������ 8 Troubleshooting Guide ������������������������������������������� 35 Insertion and Removal ������������������������������������������������������ 11 Operation Tips for Better Communication �������������������������������������� 36 Power On & Off ���������������������������������������������������������������� 12 Regulatory Information User Controls �������������������������������������������������������������������� 13 Safety Information ��������������������������������������������������� 38 Volume Control ���������������������������������������������������������������� 14 FDA Information ����������������������������������������������������� 39 Volume Control Indicators������������������������������������������������ 15 FCC Information ����������������������������������������������������� 44

4 | Rocker Switch RIC 312 Overview Rocker Switch RIC 312 Overview | 5 Features, Controls and Identification 1. Hearing aid 2. Cable 4 2 3. Receiver 4. Microphone 3 5. Rocker switch (user control) 11 6. Battery compartment (on/off control), location of 1 serial number 7. Location of manufacturer’s name and 5 model name 8. Location of left/right side receiver indicator 9. Instant fit earbud 10. Location of left/right side hearing aid indicator 11. Custom earmold (optional) 7 12. RIC custom power earmold (optional) 12 13. Retention lock 10 6 9 8 13

6 | Push Button mRIC 312 Overview Push Button mRIC 312 Overview | 7 Features, Controls and Identification 1. Hearing aid 4 2 2. Cable 3. Receiver 4. Microphone 5. Push button (user control) 1 3 11 6. Battery compartment (on/off control), location of serial number 7. Location of manufacturer’s name and 5 model name 8. Location of left/right side receiver indicator 9. Instant fit earbud 10. Location of left/right side hearing aid indicator 7 11. Custom earmold (optional) 12. RIC custom power earmold (optional) 12 13. Retention lock 6 10 9 8 13

8 | Preparation Preparation | 9 Batteries Your hearing aid uses a battery as its power source. The battery size can be identified by the brown (312) color code on the packaging. To insert or replace the battery: 1. Use the finger pick on the battery door. 2. Open the battery door gently and remove the 1 2 old battery. 3.  emove the colored tab from the new battery. R For best results, wait 3-5 minutes after removing tab before inserting battery. 4. Insert into the battery door, “+” side up. 5. Close the battery door. Battery Indicators An indicator will sound when the battery voltage is 3 4 low. You have approximately 30 minutes* to replace the battery. An indicator may also sound just before the battery stops working. * Actual time between low battery indicator and shut down will vary depending on 5 environmental noise levels and brand of battery used.

10 | Preparation Preparation | 11 Helpful Hints Insertion and Removal • NEVER FORCE THE BATTERY DOOR SHUT; To insert the earbud or this could result in serious damage. If the door earmold: will not close securely, check that the battery is inserted correctly. 1. Hold the cable at the bend in front of the receiver with your • Do not open the battery door too far or thumb and forefinger. Gently 1 damage is likely to occur. insert the receiver into your • Dispose of used batteries immediately in ear canal. the proper waste or recycling container. 2. Wrap the hearing aid over • Batteries vary in size and performance. Your the top of your ear, carefully hearing professional is your best source for placing it behind your ear. lifespan estimates and verification that you 3. Place the retention lock inside are using the proper size and type. the bowl of your ear. 2 WARNINGS To remove the earbud or earmold: Batteries are dangerous if swallowed. To help prevent the accidental ingestion of batteries: • Remove the retention lock from the bowl of your ear. Keep out of reach of children and pets. • Remove the hearing aid from Check your medications before taking them – behind your ear. batteries have been mistaken for pills. 3 • Grasp the receiver with your Never put batteries in your mouth, as they thumb and forefinger. Gently can easily be swallowed. pull out of your ear canal. Do not pull with the hearing aid NATIONAL BUTTON BATTERY case, as this may damage the INGESTION HOTLINE: 202-625-3333 connection.

12 | Operation Operation | 13 Helpful Hints User Controls • Minor irritation and/or inflammation may occur Your hearing aid’s user control may have been as your ear becomes accustomed to having an customized by your hearing professional. Ask object in it; if so, please contact your hearing your hearing professional how the user control professional. There are several different sizes of on your hearing aid is set. earbuds and custom earmolds that may be more comfortable. Available User Control Functionality • If an actual allergic reaction occurs, alternative The user control on your hearing aid earmold materials are available; contact your can respond differently depending hearing professional. on how long you activate (press) the button. Your hearing aid is capable • Severe swelling, discharge from the ear, excessive of having one function assigned to wax or other unusual conditions warrant immediate a short press (press and release) and consultation with a physician. one function assigned to a long press (press and hold). The options Power On & Off selected on the next page indicate how your particular user controls To turn ON: are configured. Insert a battery and completely close the battery door. Your hearing aid has a power‑on delay which Tap Gesture may require a few seconds. You may hear a tone Your hearing aid may support an indicating that your hearing aid is powered on. additional user control. This control can be configured by your To turn OFF: hearing professional to start/stop Open the battery door until the battery is no longer streamed audio from a Starkey touching the battery contacts. Hearing Technologies accessory by tapping your ear twice.

14 | Operation Operation | 15 Assigned User Control Settings Continue to activate the user control until you reach the desired loudness. Start/Stop Volume Memory Mute Multiflex Accessory NOTE: If 10 minutes or more have passed since the Control Change Tinnitus Level Streaming last volume change, the volume will automatically Short Press decrease before it increases. (Press and Release) Volume Control Indicators Long Press (Press and Hold) Your hearing professional may enable audible Tap Gesture* indicators, which highlight the current volume position.  Volume Level Tone *Hearing aid may support Volume Control Volume Max 5 Beeps ••••• Volume Step(s) Short Tone – Power On Volume Level Volume Home (Power on volume level) 3 Beeps ••• Your hearing aid has been set to a specific volume level (Volume Home) determined by your hearing Volume Step(s) Short Tone – professional. If sounds are generally too loud or too Volume Min Single Beep • soft, please contact your hearing professional for advice and adjustment. Rocker Switch Volume Control  y hearing aid is configured with the following M control: If your rocker switch is configured to control volume, pressing the top part of the switch increases the Press and Release Volume Control volume while pressing the lower portion of the switch Press and Hold Volume Control decreases volume. Sprinkler Volume Control Memory Change If your user control is configured as a sprinkler volume Your hearing professional may create multiple control, each time you activate the user control, the memories within your hearing aid. These additional volume of your hearing aid changes.

16 | Operation Operation | 17 memories can be accessed by activating the user Activity Tracking control on your hearing aid. Your hearing aid may support a sensor that is capable If your user control is configured for memory of tracking daily physical activity and reporting it to changes, each time you activate the user control, the the Thrive Hearing Control app. This feature can be memory of your hearing aid will increment through used to view daily step count, minutes of activity and the available memories. to obtain reminders to get up and move throughout Memory Indicators the day. Physical activity is a component of your Thrive score. Your hearing professional may enable an audible indicator, which is presented while making a memory Directional Settings change. The indicator defaults to a voice identifying Your hearing aid has directional microphones to help which memory your hearing aid is in. improve speech understanding in noisy situations. Mute Ask your hearing professional about your particular directional settings. If your hearing aid is configured with mute functionality, a long press and hold of the user control will mute your hearing aid. If enabled by My hearing aids have the following your hearing professional, you may hear an indicator telephone setting(s): prior to the hearing aid muting. To unmute your Automatic Telephone Memory. See below. hearing aid, press the button again and audio will be restored.  anual Telephone Memory. See next page. M (Memory # _________________ ). Multiflex Tinnitus Level Control None Your user control can also adjust the level of your Multiflex Tinnitus stimulus. Please refer to the section labeled Multiflex Tinnitus Technology (page 21) for Telephone Use further information. Some hearing aids can be customized with features to help you effectively communicate on the telephone. Ask your hearing professional about your telephone solution.

18 | Operation Operation | 19 Automatic Telephone Memory General Telephone Use These options activate the telephone memory Some hearing aids work best by automatically when used with a hearing aid compatible holding the phone close to, but telephone. To use, place the telephone receiver on not fully covering your ear. In some your ear as you normally would and the hearing aid instances, if you encounter whistling will automatically select the telephone memory. It (feedback), tilt the receiver at an might be necessary to move the telephone receiver angle until the whistling stops. slightly to find the best reception. Once the telephone Additionally, the hearing aid in the is removed from the ear, the hearing aid will switch non-phone ear (ear opposite the phone) may switch to a telephone back to the last used memory. setting to reduce background NOTE: Consult with your hearing professional if your sounds. Your hearing professional hearing aid does not switch to the telephone memory can provide instructions and automatically, if it is enabled. techniques for your specific needs. Manual Telephone Memory Ear-to-Ear Phone Streaming Manual access allows you to switch the hearing The telephone memory in your hearing aid may be aids into a telephone memory, as needed. Ask equipped with an ear-to-ear phone streaming option. your hearing professional which memory you When you enter your telephone memory, the audio should access for manual telephone use. from your telephone will be streamed from the phone ear’s hearing aid to the opposite ear’s hearing aid. This allows you to hear the telephone conversation in both ears. Ask your hearing professional about your particular telephone settings.

20 | CROS/BiCROS Technology Multiflex Tinnitus Technology | 21 Introduction Introduction A Contralateral Routing of Signals (CROS) hearing Multiflex Tinnitus Technology can be used as a part system is a type of hearing aid that is used to treat of a tinnitus treatment program. Multiflex Tinnitus unilateral hearing loss. It takes sound from the ear with Technology plays a tinnitus stimulus through the poorer hearing and transmits it to the ear with better hearing aid. The tinnitus stimulus is programmed hearing. CROS only picks up sound from the unaidable according to your hearing loss, and your hearing ear, while BiCROS picks up sound from both ears. This professional can adjust the settings of the tinnitus helps the patient to receive sounds from both sides of stimulus to meet your needs. the head without the head-shadow effect. Sprinkler Stimulus Control Balance Control Your hearing system uses the button to adjust the If your user control is configured as a sprinkler stimulus balance between the hearing aid and the transmitter. control, each time you activate the user control, the This control adjusts the level of sound coming from stimulus level in your hearing aid changes. the transmitter. Press and release the button until Sprinkler stimulus control is configured by default to the desired level is reached. Each press and release automatically decrease in level before it increases. changes the balance level one increment. To make the stimulus level louder, activate the user NOTE: Balance Control is only applicable for BiCROS control. Repeat this motion until you are at the memories. minimum setting. The next time you activate the user control, the level will increase one step. Continue to CROS Streaming activate the user control until you reach the desired Your hearing system is equipped with a CROS loudness. transmitter. When you enter a memory with either NOTE: If 10 minutes or more have passed since the CROS or BiCROS streaming enabled, audio from last stimulus level change, the level will automatically the transmitter is streamed to your hearing aid. decrease before it increases. When CROS streaming begins you may hear an alert tone. If for any reason the CROS stream is unexpectedly interrupted you may also hear an alert tone. Please ask your hearing professional about your particular settings.

22 | Multiflex Tinnitus Technology Fall Alert | 23 Up/Down Tinnitus Stimulus Control Introduction If your user control is configured as a dedicated up/ Fall Alert can be used to notify others should you fall down stimulus control, each time you activate the user or experience a non-fall-related event. This feature control, the stimulus level in your hearing aid always can be configured to send an SMS text message to changes in a specific direction (either up or down). predefined contacts. Fall Alert can be configured to For example, a short press and release may increase send automated and/or manually-initiated alerts. the stimulus level while a long press and hold may decrease the stimulus level in your hearing aid. Auto Alert If Auto Alert has been activated in the Thrive Hearing Some user controls can be set for the right hearing aid Control app on your smartphone, the sensors in your to increase stimulus level and the left hearing aid to hearing aid(s) will monitor your head movement to decrease stimulus level. detect a fall automatically. When a fall is detected, a Rocker Switch Tinnitus Stimulus Control text message will be initiated by the Thrive app on If your rocker switch is configured for Tinnitus Stimulus your smartphone. An SMS text message will be sent Control, pressing the top part of the switch increases to a maximum of three predefined contacts, notifying the stimulus level while pressing the bottom part of them of the detected fall event. The SMS text the switch decreases the stimulus level. message will contain a link from which each contact can confirm receipt of the message and view a map, indicating your location. My hearing aid is configured with the WARNING: Auto Alert may not detect 100 percent following control: of falls. Press and Release Tinnitus Stimulus Control. Manual Alert Press and Hold Tinnitus Stimulus Control. If the user control on your hearing aid(s) has been configured for Manual Alert by your hearing professional, and there is a confirmed contact in the Thrive app, a long “press and hold” of the user control will initiate an alert text message by the Thrive app on your smartphone. An SMS text message will

24 | Fall Alert Fall Alert | 25 be sent to a maximum of three predefined contacts, Auto Alert Sensitivity notifying them of the alert. The SMS text message will You can adjust your Auto Alert Sensitivity in the contain a link from which each contact can confirm Thrive app. Increasing the sensitivity may increase the receipt of the message and view a map, indicating likelihood of detecting a fall. Decreasing the sensitivity your location. may help reduce the probability of false alerts. Alert Cancellation WARNING: Decreasing the Auto Alert Sensitivity may An Auto Alert or Manual Alert can be cancelled from prevent some falls from being detected by your Fall either your hearing aid(s) or your smartphone. To Alert system. cancel an SMS alert text message from your hearing For example, Auto Alert may not detect a fall if: aid(s), press the user control on either hearing aid. Fall • The Sensitivity setting is not appropriate for Alert messages can be cancelled within the 60 or 90 the user. second preselected cancellation time following alert initiation. It may take up to 20 seconds for a fall alert • The fall is very slow, or you slide down gradually. to be automatically initiated. • You get up and begin walking immediately after a fall. Contacts As a reminder, you can initiate a Manual Alert if Auto You can identify up to three contacts to whom you Alert does not detect a fall. Manual Alert must be would like alert text messages sent. You must enter configured by your hearing professional before it can the name and smartphone number for each contact be used. into the Thrive app on your smartphone. Each of your contacts will receive an SMS text message prompting WARNING: Auto Alert may initiate false-alerts. To them to confirm participation in your Fall Alert system. prevent false-alert text messages from being sent to your Contact(s), you may cancel the alert from either your smartphone or by pressing the user control on either hearing aid.

26 | Fall Alert Adjustment | 27 Indicators Pairing Your Hearing Aid with an iOS Device Speech indicators will play through your hearing aid(s) To adjust your hearing aid with your iOS device, when: you must pair the two together so they can communicate. Please follow the instructions • You have successfully initiated a Manual Alert. to pair your iOS device and your hearing aid. • A fall has been automatically detected. 1. Ensure Bluetooth® is enabled on your iOS • At least one Contact has confirmed receipt of the device. Within the Settings menu go to alert text message. Bluetooth and toggle to On. • You have successfully cancelled an alert via the 2. Locate, then tap the Settings icon on your user control on the hearing aid. iOS device. A tonal indicator will play through your hearing aid(s) 3.  ithin the Settings menu go to General > W when: Accessibility > MFi Hearing Devices. • There has been a communication failure during 4. While the iOS device searches for the hearing the transmission of an alert text message. aids, open and close the battery door on your hearing aids. This puts the hearing aids in • There has been a communication failure during pairing mode. the cancellation of an alert text message. • You will see your hearing aid name (e.g. “Chris WARNING: To reduce Fall Alert communication Hearing Aids”) when the iOS device first failures: discovers your hearing aids. • Your hearing aid(s) need to be powered on, • If your name does not appear in the “Devices” paired and connected with your smartphone list within 5-7 seconds, tap Accessibility in the using Bluetooth. upper left corner, then tap MFi Hearing Devices. • The mobile device must be powered on, with the Thrive app open (in the foreground or background). • The mobile device must have a connection to the internet (via a cellular network or WiFi).

28 | Adjustment Adjustment | 29 You are now ready to use your iOS device to adjust Mobile Phone Use your hearing aid. You can adjust either with the native Your hearing aid is designed to work with a iOS controls or with Thrive Hearing Control. smartphone. When the hearing aid is paired and To access the native iOS hearing aid controls, triple- powered on, incoming phone calls will route click the Home button (On the iPhone 8 or earlier automatically to your hearing aid. When your hearing versions. Please consult Apple support for iPhone X aid is not powered on, incoming calls route only to options.) on your iOS device. From this screen you your smartphone. can adjust the volume, select memory or use your iOS allows you to select a preference for how audio iOS device as a remote microphone. (call audio and media audio) is routed from your Select Start Live Listen to stream the iOS device smartphone to your hearing aids. microphone input directly into your hearing aid. Point the iOS device microphone toward the audio source. Pairing Your Hearing Aid with an To minimize background noise and provide the best Android Device signal, place the iOS device as close to the source To adjust your hearing aid with your Android as possible. device, you must pair the two together so they Right Volume/Left Volume allows you to increase can communicate. Please follow the instructions and decrease volume for each hearing aid individually. to pair your device and your hearing aid. Turn off Adjust Independently to make changes to 1. Locate, then tap the Settings icon on both hearing aids simultaneously. your device. Normal indicates the name of a memory setting in 2. Select Bluetooth. the hearing aid. You can select from any memories 3. In this screen, if Bluetooth appears Off, change shown in the list to change the hearing aid to that the settings to On. Then, open and close the memory setting. battery door on your hearing aids (this puts your hearing aids into pairing mode).

30 | Adjustment Accessories | 31 4. Under Paired devices you will see your first name Accessories followed by hearing aid (e.g. Michelle H/As) when There are several accessories that allow you to control the device first discovers the hearing aids. If your and maximize the full potential of your hearing aids. name does not appear in the “Devices” list within Available functionality includes: 5-7 seconds, tap Accessibility in the upper left corner, then tap Hearing Devices. • Ability to adjust your hearing aids using a remote control 5. Tap the hearing aid name to connect each hearing aid to the device. • Ability to transmit television audio directly to your hearing aids 6. Pairing is complete. • Ability to transmit remote microphone audio directly to your hearing aids Consult with your hearing professional to determine which accessories may be best for you.

32 | Hearing Aid Care Hearing Aid Care | 33 Hearing Aid Care Keep your hearing aids clean. Heat, moisture and foreign substances can result in poor performance. • Use a cleaning brush or soft cloth to clean debris from around the user control, microphone and battery compartment; inspect the receiver, earbud and wax guard regularly. • Never use water, solvents, cleaning fluids or 1 2 oil to clean your hearing aid. Your hearing professional can provide further information on additional maintenance procedures for your hearing aid, if needed. Hear Clear™ Receiver Wax Guards 3 RIC hearing aids integrate disposable Hear Clear earwax protection. The innovative wax guards prevent earwax accumulation in the hearing aid receiver. When you need to replace your wax guards, please follow these instructions: 1. Insert empty end of the application stick into used wax guard in hearing aid. 2. Pull straight out (do not twist) on stick to remove used wax guard. 3. Use opposite end of stick to firmly insert clean wax guard straight into hearing aid. 4. Pull straight out (do not twist) to remove stick and discard 4

34 | Hearing Aid Care Hearing Aid Care | 35 Helpful Hints Troubleshooting Guide • When not wearing your hearing aid, open the battery door to allow any moisture to evaporate. SYMPTOM POSSIBLE SOLUTIONS • Do not take apart your hearing aids or insert CAUSES the cleaning tools inside them. Low battery Replace battery • When not in use, remove the batteries completely; place your hearing aid in the storage Blocked Clean or replace wax earmold/earbud guard as needed container and store: Not Loud Enough Contact your hearing –– In a dry, safe place Hearing change professional –– Away from direct sunlight and heat Clean microphone and to avoid extreme temperatures Debris buildup receiver with brush –– Where you can easily find them Low battery Replace battery –– Safely out of reach from children Inconsistent Performance Blocked Clean or replace wax and pets earmold/earbud guard as needed Service and Repair Low battery Replace battery If, for any reason, your hearing aid does not operate properly, do NOT attempt to fix it yourself. Not only Blocked Clean or replace wax are you likely to violate any applicable warranties or Unclear, earmold/earbud guard as needed Distorted insurance, you could easily cause further damage. Performance Hearing aid Should your hearing aid fail or perform poorly, check needs repair/ Contact your hearing the guide on the next page for possible solutions. If professional maintenance problems continue, contact your hearing professional for advice and assistance. Many common problems Low battery Replace battery may be solved right in your hearing professional’s Dead office or clinic. Blocked Clean or replace wax earmold/earbud guard as needed

36 | Tips for Better Communication Tips for Better Communication | 37 Your hearing professional will recommend an For Your Family and Friends appropriate schedule to help you adapt to your Your family and friends are also affected by your new hearing aid. It will take practice, time and hearing loss. Request that they: patience for your brain to adapt to the new sounds that your hearing aid provides. Hearing is only • Get your full attention before beginning to speak part of how we share thoughts, ideas and feelings. • Look at you or sit face-to-face in a quiet room Reading lips, facial expressions and gestures • Speak clearly and at a normal rate and level; can help the learning process and add to what shouting can actually make understanding amplification alone may miss. more difficult Please review the following simple communication tips: • Rephrase rather than repeat the same words; different words may be easier to understand For You • Minimize distractions while speaking • Move closer to and look at the speaker • Sit face-to-face in a quiet room • Try different locations to find the best place to listen • Minimize distractions • Background noises may be frustrating at first; remember, you have not heard them for a while • Let others know what you need; keep in mind that people cannot “see” your hearing loss • Develop realistic expectations of what your hearing aids can and cannot do • Better hearing with hearing aids is a learned skill combining desire, practice and patience

38 | Regulatory Information Regulatory Information | 39 Safety Information We are required by regulations to provide the following warnings: INTENDED USE: An air conduction hearing aid is a wearable sound- WARNING: Use of wireless hearing aids directly next to other electronic amplifying device intended to compensate for impaired hearing. Hearing equipment should be avoided because it could result in improper performance. aids are available in multiple gain/output levels appropriate to treat hearing If such use is necessary, note as to whether your hearing aids and the other losses ranging from mild-to-profound. equipment are operating normally. Your hearing aids are designed to operate in public and residential WARNING: Use of accessories, components or replacement parts other than environments and are designed to comply with international Electromagnetic those provided by the manufacturer of your hearing aids could result in increased Compatibility emissions and immunity standards for medical devices. electromagnetic emissions and decreased electromagnetic immunity and could result in degradation of performance. However, it is still possible that you may experience interference caused by power line disturbances, airport metal detectors, electromagnetic fields from WARNING: If Portable Radio Frequency communications equipment is other medical devices, radio signals and electrostatic discharges. used closer than 30 cm (12 inches) from your hearing aid, degradation of the If you use other medical devices or wear implantable medical devices such as performance of your hearing aid could result. If this occurs, move away from the defibrillators or pacemakers and are concerned that your hearing aids might communications equipment. cause interference with your medical device, please contact your physician or the manufacturer of your medical device for information about the risk of disturbance. Required Hearing Aid Information Your hearing aids should not be worn during an MRI procedure or in a The following additional information is provided in compliance with U.S. Food hyperbaric chamber. and Drug Administration (FDA) regulations: Your hearing aids are classified as a Type B applied part under the IEC 60601-1 medical device standard. WARNING TO HEARING AID DISPENSERS A hearing aid dispenser should advise a prospective hearing aid user to Your hearing aids are not formally certified to operate in explosive consult promptly with a licensed physician (preferably an ear specialist) before atmospheres such as may be found in coal mines or certain dispensing a hearing aid if the hearing aid dispenser determines through inquiry, chemical factories. actual observation or review of any other available information concerning the Your hearing aids should be stored within the temperature and humidity prospective user that the prospective user has any of the following conditions: ranges of -40°C (-40°F) to +60°C (140°F) and 10%-95% relative humidity. i. Visible congenital or traumatic deformity of the ear. Your hearing aids are designed to operate beyond the range of ii. History of active drainage from the ear within the previous 90 days. temperatures comfortable to you, from very cold up to 50°C (122°F). iii. History of sudden or rapidly progressive hearing loss within the previous 90 days. Use on Aircrafts iv. Acute or chronic dizziness. The optional wireless capabilities that may be featured in your hearing aids v. Unilateral hearing loss of sudden or recent onset within the can be used on an aircraft as hearing aids are exempt from the rules applied previous 90 days. to other personal electronic devices on an aircraft. vi. Audiometric air-bone gap equal to or greater than 15 decibels International Use at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz. Your hearing aids are approved to operate at a radio frequency that is specific vii. Visible evidence of significant cerumen accumulation or a foreign to your country or region and might not be approved for use outside your body in the ear canal. country or region. Be aware that operation during international travel may cause viii. Pain or discomfort in the ear. interference to other electronic instruments, or other electronic instruments may cause interference to your hearing aids.

40 | Regulatory Information Regulatory Information | 41 IMPORTANT NOTICE FOR PROSPECTIVE rating of 6 or greater would indicate “excellent performance”. See the Quick HEARING AID USERS Start Guide included with your hearing aid for the exact M/T rating of your hearing aid. Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes CHILDREN WITH HEARING LOSS in diseases of the ear) before purchasing a hearing aid. Licensed physicians who specialize in diseases of the ear are often referred to as otolaryngologists, In addition to seeing a physician for a medical evaluation, a child with a hearing otologists or otorhynolaringologists. The purpose of the medical evaluation loss should be directed to an audiologist for evaluation and rehabilitation since is to assure that all medically treatable conditions which may affect hearing are hearing loss may cause problems in language development and the educational identified and treated before the hearing aid is purchased. and social growth of a child. An audiologist is qualified by training and experience to assist in the evaluation and rehabilitation of a child with a hearing loss. Following the medical evaluation, the physician will give you a written statement affirming that your hearing loss has been medically evaluated and that you may be considered a candidate for a hearing aid. The physician will refer you to an audiologist or hearing aid dispenser, as appropriate, for a hearing aid evaluation. For Hearing Professionals The audiologist or hearing aid dispenser will conduct a hearing aid evaluation INDICATIONS FOR USE to assess your ability to hear with and without a hearing aid. The hearing aid The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a evaluation will enable the audiologist or dispenser to select and fit a hearing Tinnitus Management Program to relieve patients suffering from tinnitus. The aid to your individual needs. target population is primarily the adult population over 18 years of age. If you have reservations about your ability to adapt to amplification, you should The Multiflex Tinnitus Technology is targeted for healthcare professionals, which inquire about the availability of a trial-rental or purchase-option program. Many are treating patients suffering from tinnitus, as well as conventional hearing hearing aid dispensers now offer programs that permit you to wear a hearing aid disorders. The fitting of the Multiflex Tinnitus Technology must be done by a for a period of time for a nominal fee after which you may decide if you want to hearing professional participating in a Tinnitus Management Program. purchase the hearing aid. Federal law restricts the sale of hearing aids to those individuals who have INSTRUMENT DESCRIPTION obtained a medical evaluation from a licensed physician. Federal law permits a Multiflex Tinnitus Technology is a software function that generates sound which fully informed adult to sign a waiver statement declining the medical evaluation for is programmed into a hearing aid. The hearing aid may be used in one of three religious or personal beliefs that preclude consultation with a physician. The exercise modes of operation: as a hearing aid, as a tinnitus treatment instrument or as a of such a waiver is not in your best health interest and its use is strongly discouraged. hearing aid and tinnitus treatment instrument. A hearing aid will not restore normal hearing and will not prevent or improve a When enabled, the Multiflex Tinnitus Technology generates the sound and allows hearing impairment resulting from organic conditions. Use of a hearing aid is a patient’s hearing professional to design and program appropriate settings for only part of hearing habilitation and may need to be supplemented by auditory an individually prescribed sound treatment plan. The treatment plan should be training and instruction in lip reading. In most cases, infrequent use of a hearing used in a tinnitus management program for relief of tinnitus. aid does not permit a user to attain full benefit from it. Multiflex Tinnitus Technology generates a broadband white noise signal that Special care should be exercised in selecting and fitting a hearing aid whose varies in frequency and amplitude. These characteristics are adjustable by the maximum sound pressure level exceeds 132 decibels because there may be risk in hearing professional and are specific to the prescribed therapy designed by impairing the remaining hearing of the hearing aid user. the professional for the patient’s needs and comfort. Some hearing aid users have reported a buzzing sound in their hearing aid when The patient may have some control of the level or volume of the signal and they are using mobile phones, indicating that the mobile phone and hearing aid the patient should discuss this adjustment as well as his or her comfort level may not be compatible. According to the ANSI C63.19 standard (ANSI C63.19-2007 and sound of the signal with their hearing professional. American National Standard Methods of Measurement of Compatibility Between Wireless Communications Devices and Hearing Aids), the compatibility of a particular hearing aid and mobile phone can be predicted by adding the rating for the hearing aid immunity to the rating for the mobile phone emissions. For example, the sum of a hearing aid rating of 2 (M2/T2) and a telephone rating of 3 (M3/T3) would result in a combined rating that equals at least 5 would provide “normal use;” a combined

42 | Regulatory Information Regulatory Information | 43 WARNING TO HEARING CARE PRACTITIONER PRESCRIPTION USE ONLY A hearing care practitioner should advise a prospective sound generator user to CAUTION: Federal law restricts this instrument to sale by or on the order consult promptly with a licensed physician (preferably an ear specialist) before of a doctor, audiologist or other hearing care practitioner licensed to dispense using a sound generator if the hearing care practitioner determines through hearing aids in your state. inquiry, actual observation or review or any other available information concerning the prospective user that the prospective user has any of the following conditions: The use of any sound generating tinnitus therapy instrument should be only on the advice and in consultation with your audiologist or hearing care practitioner. i. Visible congenital or traumatic deformity of the ear. Your hearing professional will properly diagnose and fit the instrument to your ii. History of active drainage from the ear within the previous 90 days. personal needs and requirements. This should include its use in a prescribed tinnitus treatment program. iii. History of sudden or rapidly progressive hearing loss within the previous 90 days. Your hearing professional will also be able to offer the appropriate follow-up care. It is important that you follow your hearing professional’s advice and direction iv. Acute or chronic dizziness. regarding such care. v. Unilateral hearing loss of sudden or recent onset within the previous 90 days. WARNING: There are some potential concerns associated with the use of any sound generating tinnitus therapy instrument. Among them are the potential for worsening of tinnitus, a possible change in hearing thresholds, and possible For the Patient skin irritation at the point of contact with the instrument. A tinnitus therapy instrument is an electronic instrument intended to generate Multiflex Tinnitus Technology has been designed to minimize these concerns. noise of sufficient intensity and bandwidth to treat ringing in the ears. It can also However, should you experience or notice any of the above conditions or any be used as an aid in hearing external sounds and speech. dizziness, nausea, headaches or heart palpitations, you should immediately Multiflex Tinnitus Technology is a tool to generate sounds. It is recommended that discontinue use of the instrument and seek a consultation with a medical, this tool be used with appropriate counseling and/or in a tinnitus management audiology or other hearing professional. program to relieve patients suffering from tinnitus. As with any instrument, misuse of the tinnitus therapy instrument could present some potentially harmful effects. Care should be taken to prevent the unauthorized TINNITUS THERAPY CONCEPTS AND BENEFITS use and to keep the instrument out of the reach of children and pets. Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program. CAUTION: If set to the maximum output level and worn for periods of time Multiflex Tinnitus Technology plays a white noise through the hearing aid. exceeding the recommendations below, your exposure to sound energy has the potential to exceed noise exposure limits. You should not use your hearing aid for Multiflex Tinnitus Technology is programmed according to your hearing loss and more than sixteen (16) hours a day if your hearing aid is set at the maximum output preference, and your hearing professional can adjust the settings of Multiflex level, nor should you use your hearing aid if your hearing professional has set the Tinnitus Technology to meet your needs. hearing aid at levels that exceed your comfort level. Multiflex Tinnitus Technology may provide temporary relief of your tinnitus. Important Notice for Prospective Sound Generator Users Good health practice requires that a person with tinnitus 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, otologists or otorhinolaryngologists. The purpose of a 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.

36 | Regulatory Information Regulatory Information | 37 TECHNICAL DATA NOTE: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when modifications could void the user’s authority to operate the equipment. measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7. Note FCC/IC Cet appareil est conforme à la partie 15 des règles de la FCC et avec les normes WIRELESS TECHNICAL DESCRIPTION RSS de licence d’ISDE Canada. Le fonctionnement est soumis à deux Your hearing aids contain a radio transceiver utilizing Bluetooth® Low Energy conditions: (1) Cet appareil ne doit pas causer d’interférences nuisibles et (2) cet wireless technology operating in the 2.4-2.4835 GHz frequency band with a appareil doit accepter toute interference reçue, y compris les interférences qui maximum effective radiated power of -13 dBm using GFSK transmission peuvent causer des fonctionnements du dispositif. modulation. The receiver section of the radio has a bandwidth of 1.5 MHz. The NOTE: Le manufacturier n’est pas responsable de l’interférence créée par la rocker switch RIC 312 also contains a radio transceiver utilizing Near Field modification de cet équipement lors de l’écoute du téléviseur ou de la radio. Magnetic Induction operating on 10.281 MHz with maximum induced magnetic De telles modifications pourraient entrainer la révocation de l’autorité de field strength of -5 dBuA/m at a measurement distance of 10 meters with 8- l’utilisateur à opérer cet équipement. DPSK transmission modulation. The receiver section of the NFMI radio has a Hereby, Starkey Hearing Technologies declares that the products listed above are in bandwidth of 400 kHz. compliance with the essential requirements and other relevant provisions of This hearing aid model has been tested to, and has passed, the following Directive 2014/53/EU. A copy of the Declaration of Conformity can be obtained emissions and immunity tests: from the addresses on the following page or docs.starkeyhearingtechnologies.com • IEC 60601-1-2 radiated emissions requirements for a Group 1 Class B device as stated in CISPR 11. • RF radiated immunity at a field level of 10 V/m between 80 MHz and 2.7 GHz Starkey Hearing Technologies as well as higher field levels from communication devices as stated in Table 9 of IEC 60601-1-2. 6700 Washington Ave. South • Immunity to power frequency magnetic fields at a field level of 30 A/m. Eden Prairie, MN 55344 USA • Immunity to ESD levels of +/- 8 kV conducted discharge and +/- 15 kV air discharge. WIRELESS NOTICES FCC ID: EOA-24LIVIOR312 (Rocker Switch RIC 312) W m. F. Austin House, Bramhall Technology Park IC: 6903A-24LIVIOR312 (Livio RIC 312, Via RIC 312, AGXsliv RIC 312, Circa RIC Pepper Road, Hazel Grove, Stockport SK7 5BX 312, Esentia RIC 312, Livio AI RIC 312, Via AI RIC 312, AGXsliv AI RIC 312, Circa AI RIC 312, Esentia AI RIC 312) United Kingdom FCC ID: EOA-24LIVIOM312 (Push button micro RIC 312) IC: 6903A-24LIVIOM312 (Livio micro RIC 312, Via micro RIC 312, AGXsliv micro Waste from electronic equipment must RIC 312, Esentia micro RIC 312, Livio AI micro RIC 312, Via AI micro RIC 312, be handled according to local regulations AGXsliv AI micro RIC 312, Esentia AI micro RIC 312, Livio mRIC 312, Via mRIC 312, AGXsliv mRIC 312, Esentia mRIC 312, Livio AI mRIC 312, Via AI mRIC 312, AGXsliv AI mRIC 312, Esentia AI mRIC 312) FCC NOTICE Consult Operations Manual This device complies with part 15 of the FCC rules and with ISED Canada license- exempt RSS standards. Operation is subject to the following two conditions: (1) This device may not cause harmful interference, and (2) this device must accept any interference received, including interference that may cause undesired operation.

Notes Notes

Use of the Made for Apple badge means that an accessory has been designed to connect specifically to the Apple product(s) identified in the badge, and has been certified by the developer to meet Apple performance standards. Apple is not responsible for the operation of this device or its compliance with safety and regulatory standards. Apple, the Apple logo, iPhone, iPad, iPod touch, Apple Watch and App Store are trademarks of Apple Inc., registered in the U.S. and other countries. App Store is a registered service mark of Apple Inc. © 2018 Starkey Hearing Technologies. All Rights Reserved. 86158-007 10/18 BKLT3005-01-EE-XX


Document Created: 2018-11-27 08:49:52
Document Modified: 2018-11-27 08:49:52
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