Starkey Laboratories 24HALO2R312 Halo 2 RIC 312 User Manual Synergy Made for iPhone RIC Operations Manual
Starkey Laboratories Inc Halo 2 RIC 312 Synergy Made for iPhone RIC Operations Manual
user manual
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| Document ID | 3222476 |
| Application ID | qoWlK/eKEiNcCpw8pivKDQ== |
| Document Description | user manual |
| Short Term Confidential | No |
| Permanent Confidential | No |
| Supercede | No |
| Document Type | User Manual |
| Display Format | Adobe Acrobat PDF - pdf |
| Filesize | 396.96kB (4961994 bits) |
| Date Submitted | 2016-12-08 00:00:00 |
| Date Available | 2016-12-08 00:00:00 |
| Creation Date | 2016-01-15 18:36:00 |
| Producing Software | Adobe PDF Library 11.0 |
| Document Lastmod | 2016-11-22 15:13:56 |
| Document Title | Synergy Made for iPhone RIC Operations Manual |
| Document Creator | Adobe InDesign CC 2014 (Macintosh) |
Made for iPhone ® RIC (Receiver-In-Canal) O P E RAT I O N S M A N UA L Table of Contents Hearing Instrument Overview RIC 13 Overview 4 Preparation Batteries/Battery Indicators 6 Insertion and Removal 11 Operation Size 13 Battery - Orange Instrument Controls Push Button Controls p. 14 Power On & Off User Controls Volume Control Volume Control Indicators Memory Change Mute Multiflex Tinnitus Level Control Directional Settings Landline Telephone Use 14 14 15 18 18 19 20 20 21 Multiflex Tinnitus Technology 24 Adjustment Adjusting Your Hearing Instrument 26 Pairing with an iOS Device 27 Cell Phone Use 31 Hearing Instrument Care Made for iPhone RIC and TruLink are compatible with iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s, iPhone 5c, iPhone 5, iPhone 4s, iPad Air 2, iPad Air, iPad (4th generation), iPad mini 3, iPad mini with Retina display, iPad mini, iPod touch (5th generation) and Apple Watch. Use of Apple Watch requires iPhone 5 or later. Instrument Care 33 Service and Repair 36 Troubleshooting Guide 37 Tips for Better Communication 38 Safety Information 41 FDA Information 44 FCC Information 53 Made for iPhone RIC 13 Overview Made for iPhone RIC 13 Overview Features, Controls and Identification Your hearing instrument controls include: 1. Hearing Instrument 2. Cable 3. Receiver 4. Microphones 5. Push Button (user control) 6. Battery Compartment (on/off control), location of serial number 12 7. Retention Lock 8. Location of manufacturer’s name and model name 9. Location of left/right side receiver indicator 10. Instant Fit Earbud 11 10 11. Location of left/right side instrument indicator 12. Custom Earmold (optional) 13 13. RIC Custom Power Earmold (optional) Preparation Batteries Preparation RIC 13 Your hearing instrument uses a battery as its power source. This battery size can be identified by the orange (13) color code on the packaging. To insert or replace the battery: 1. Use the nail grip on the battery door. 2. Open the battery door gently and remove the old battery. 3. Remove the colored tab from the new battery. 4. Align the battery’s “+” sign (flat side of the battery) with the “+” on the battery door. 5. Close the battery door. Preparation Battery Indicators An indicator will sound when the battery voltage is low. You have approximately 30 minutes* to replace the battery. An indicator may also sound just before the battery stops working. Preparation Helpful Hints • NEVER FORCE THE BATTERY DOOR SHUT. This could result in serious damage. If the door will not close securely, check that the battery is inserted correctly. • Do not open the battery door too far or damage is likely to occur. • Dispose of used batteries immediately in the proper waste or recycling container. • Batteries vary in size and performance. Your hearing professional is your best source for lifespan estimates and verification that you are using the proper size and type. *A ctual time between low battery indicator and shutdown will vary depending on environmental noise levels and brand of battery used. Preparation Preparation WARNINGS Insertion and Removal Batteries are dangerous if swallowed. To help prevent the accidental ingestion of batteries: To insert the earbud or earmold: Keep out of reach of children and pets Check your medications before taking them – batteries have been mistaken for pills Never put batteries in your mouth, as they can easily be swallowed National Button Battery Ingestion Hotline: 202-625-3333 1. Hold the cable at the bend in front of the receiver with your thumb and forefinger. Gently insert the receiver into your ear canal. 2. Wrap the hearing instrument over the top of your ear, carefully placing it behind your ear. 3. Place the retention lock inside the bowl of your ear. To remove the earbud or earmold: • Remove the retention lock from the bowl of your ear. • Remove the hearing instrument from behind your ear. • Grasp the receiver with your thumb and forefinger. Gently pull out of your ear canal. 10 Do not pull with the hearing instrument case as this may damage the connection. 11 Preparation Preparation Helpful Hints • Minor irritation and/or inflammation may occur as your ear becomes accustomed to having an object in it; if so, please contact your hearing professional. • If an actual allergic reaction occurs, alternative earmold materials are available; contact your hearing professional. • Severe swelling, discharge from the ear, excessive wax or other unusual conditions warrant immediate consultation with a physician. 12 13 Operation Power On & Off To turn ON: Insert a battery and completely close the battery door. Your instrument has a power‑on delay which may require a few seconds. You may hear a tone indicating that your instrument is powered on. To turn OFF: Operation Your instrument is capable of having one function assigned to a short press (press and release) and one function assigned to a long press (press and hold). The options selected below indicate how your particular user control is configured. Assigned User Control Settings Open the battery door until the battery is no longer touching the battery contacts. User Controls Your hearing instrument’s user control may have been customized by your hearing professional. Ask your hearing professional how the user control on your instrument is set. Available User Control Functionality The user control on your hearing instrument can respond differently depending on how long you activate (press) the button. 14 Volume Control Memory Change Mute Multiflex Tinnitus Level Short Press (Press and Release) Long Press (Press and Hold) Volume Control Power On Volume Level Your hearing instrument has been set to a specific volume level by your hearing professional. If sounds are generally too loud or too soft, please contact your hearing 15 Operation professional for advice and adjustment. If your hearing instrument has been set up with a user adjustable volume control, temporary volume adjustments can be made. Your hearing instrument will always power-on to the same volume setting (Volume Home) determined by your hearing professional. Sprinkler Volume Control If your user control is configured as a sprinkler volume control, each time you activate the user control, the volume of your hearing instrument changes. Sprinkler volume control is configured by default to automatically decrease in volume before it increases. To make sounds louder, activate the user control. Repeat this motion until you are at the minimum setting. The next time you activate the user control, the volume will increase one step. Continue to 16 Operation activate the user control until you reach the desired loudness. NOTE: If 10 minutes or more have passed since the last volume change, the volume will automatically decrease before it increases. Up/Down Volume Control If your user control is configured as a dedicated up/down volume control, each time you activate the user control, the volume of your hearing instrument always changes in a specific direction (either up or down). For example, a short press and release may increase the volume while a long press and hold may decrease the volume in your hearing instrument. Some user controls can be set for the Right instrument to increase volume and the Left instrument to decrease volume. Ask your hearing professional if this setting would benefit you. 17 Operation Operation Volume Control Indicators Your hearing professional may enable audible indicators, which highlight the current volume position. Volume Level Volume Max Volume Step(s) Volume Home (Power on volume level) Volume Step(s) Volume Min Tone Length of Tone 5 Beeps ..... Click – 3 Beeps ... Click – Single Tone — Memory Change Your hearing professional may create multiple memories within your hearing instrument. These additional memories can be accessed by activating the user control on your hearing instrument. 18 If your user control is configured for memory changes, each time you activate the user control, the memory of your hearing instrument will increment through the available memories. Memory Indicators Your hearing professional may enable an audible indicator, which is presented while making a memory change. The indicator defaults to a voice saying “One, Two, Three or Four” to identify which memory your instrument is in. Mute Long Press Mute If your hearing instrument is configured with mute functionality, a long press and hold of the user control will mute your hearing instrument. If enabled by your hearing 19 Operation professional, you may hear an indicator prior to the hearing instrument muting. To unmute your hearing instrument, long press and hold the user control until audio is restored. Operation Landline Telephone Use Some hearing instruments can be customized with features to help you effectively communicate on the telephone. Ask your hearing professional about your telephone solution. Multiflex Tinnitus Level Control Your user control can also adjust the level of your Multiflex Tinnitus stimulus. Please refer to the section labeled Multiflex Tinnitus Technology (on page 24) for further information. Directional Settings Your hearing instrument may have a directional microphone to help improve speech understanding in noisy situations. Ask your hearing professional about your particular directional settings. 20 My hearing instruments have the following landline telephone setting(s): utomatic Telephone Memory and Automatic Telecoil. See below. anual Telephone Memory and Manual Telecoil. See next page. (Memory # _________________ ). None Automatic Telephone Memory and Automatic Telecoil These options activate the telephone memory automatically when used with a hearing instrument compatible telephone. 21 Operation To use, place the telephone receiver on your ear as you normally would and the hearing instrument will automatically select the telephone memory. It might be necessary to move the telephone receiver slightly to find the best reception. Once the telephone is removed from the ear, the hearing instrument will switch back to the last used memory. NOTE: Consult with your hearing professional if your instrument does not switch to the telephone memory automatically, if it is enabled. Manual Telephone Memory and Manual Telecoil Manual access allows you to switch the hearing instruments into a telephone or telecoil memory, as needed. Ask your hearing professional which memory you should access for manual telephone use. 22 Operation Landline Telephone Tips Some hearing instruments work best by holding the phone close to, but not fully covering your ear. In some instances, if you encounter whistling (feedback), tilt the receiver at an angle until the whistling stops. Additionally, the hearing instrument in the non-phone ear (ear opposite the phone) may switch to a telephone setting to reduce background sounds. Your hearing professional can provide instructions and techniques for your specific needs. 23 Multiflex Tinnitus Technology Introduction Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program. Multiflex Tinnitus Technology plays a tinnitus stimulus through the hearing instrument. The tinnitus stimulus is programmed according to your hearing loss, and your hearing professional can adjust the settings of the tinnitus stimulus to meet your needs. Sprinkler Tinnitus Stimulus Control If your user control is configured as a sprinkler stimulus control, each time you activate the user control, the stimulus level in your hearing instrument changes. Sprinkler stimulus control is configured by default to automatically decrease in level before it increases. To make the stimulus level louder, activate the user control. Repeat this motion until you are at the minimum setting. The next time you activate the user control, the level will increase one 24 Multiflex Tinnitus Technology step. Continue to activate the user control until you reach the desired loudness. NOTE: If 10 minutes or more have passed since the last stimulus level change, the level will automatically decrease before it increases. Up/Down Tinnitus Stimulus Control If your user control is configured as a dedicated up/down stimulus control, each time you activate the user control, the stimulus level in your hearing instrument always changes in a specific direction (either up or down). For example, a short press and release may increase the stimulus level while a long press and hold may decrease the stimulus level in your hearing instrument. Some user controls can be set for the Right instrument to increase stimulus level and the Left instrument to decrease stimulus level. Ask your hearing professional if this setting would benefit you. 25 Adjustment Adjusting Your Hearing Instrument Your Made for iPhone hearing instrument and TruLink™ are compatible with iPhone 6s Plus, iPhone 6s, iPhone 6 Plus, iPhone 6, iPhone 5s, iPhone 5c, iPhone 5, iPhone 4s, iPad Air 2, iPad Air, iPad (4th generation), iPad mini 3, iPad mini with Retina display, iPad mini, iPod touch (5th generation) and Apple Watch. Use of Apple Watch requires iPhone 5 or later. To adjust your hearing instrument with your iOS device: • For best performance, ensure that the iOS device is running iOS 9 or higher. • Download the TruLink Hearing Control app from the App Store® or use the native iOS on your device (see Pairing Your Hearing Instrument to the iOS Device section on the next page). For more detailed information on hearing instrument functionality with the app, open the app and touch the i icon. Detailed instructions are located there. 26 Adjustment Pairing Your Hearing Instrument to the iOS Device To adjust your hearing instrument with your iOS device, you must ‘pair’ the two together so they can communicate. Please follow the instructions to ‘pair’ your iOS device and your hearing instrument. IMPORTANT: Before completing the following steps, ensure Bluetooth® is enabled on your iOS device. Within the Settings menu, go to Bluetooth and toggle to On. 1. Locate then tap the Settings icon on your iOS device. 2. Within the Settings menu go to General > Accessibility > Hearing Aids. 3. While the iOS device searches for the hearing instrument, open and close the battery door on your hearing instrument (this puts the hearing instrument into ‘pairing’ mode). 27 Adjustment Adjustment 5. Tap on the Hearing Aid Name to connect the hearing instrument to the iOS device. 4a. If your name does not appear in the “Devices List” within 5-7 seconds, tap Accessibility in the upper left corner, then tap Hearing Aids. 6. You will see two pairing requests (one for each hearing instrument). Select Pair for each request. These requests may be several seconds apart. 4b. You will see your first name and hearing aid (e.g. “Matt Hearing Aids” or “Matthew H/As” depending on the length of the first name) when the iOS device first discovers the hearing instrument. 7. Pairing is complete. 28 29 Adjustment You are now ready to use your iOS device to adjust your hearing instrument. You can adjust either with the native iOS controls or with the TruLink app. To access the native iOS hearing instrument controls, triple-click the Home button on your iOS device. From this screen you can adjust the volume, select memory or use your iOS device as a remote microphone. Select Start Live Listen to stream the iOS device microphone input directly into your hearing instrument. Point the iOS device microphone toward the audio source. To minimize background noise and provide the best signal, place the iOS device as close to the source as possible. Adjustment Turn off Adjust Independently to make changes to both hearing instruments simultaneously. Normal indicates the name of a memory setting in the hearing instrument. You can select from any memories shown in the list to change the hearing instrument to that memory setting. Cell Phone Use Your hearing instrument is designed to work with iPhone. When the hearing instrument is paired and powered on, incoming phone calls will route automatically to your hearing instrument. When your hearing instrument is not powered on, incoming calls route only to iPhone. Right Volume/Left Volume allows you to increase and decrease volume for each hearing instrument individually. 30 31 Adjustment iOS allows you to select a preference for how audio (call audio and media audio) is routed from iPhone to your hearing instruments. Hearing Instrument Care Instrument Care Keep your hearing instrument 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 or eartip, and wax guard regularly. • Never use water, solvents, cleaning fluids or oil to clean your instrument. Your hearing professional can provide further information on additional maintenance procedures for your hearing instrument, if needed. 32 33 Hearing Instrument Care Hear Clear™ Receiver Wax Guards The hearing instrument integrates disposable Hear Clear earwax protection. The innovative wax guards prevent earwax accumulation in the hearing instrument receiver. Hearing Instrument Care Helpful Hints • When not wearing your hearing instrument, open the battery door to allow any moisture to evaporate. • Do not take apart your hearing instruments or insert the cleaning tools inside them. • When not in use, remove the batteries completely; place your hearing instrument in the storage container and store: – In a dry, safe place – A way from direct sunlight or heat to avoid extreme temperatures – Where you can easily find them – S afely out of reach from pets and children 34 35 Hearing Instrument Care Service and Repair If, for any reason, your hearing instrument does not operate properly, do NOT attempt to fix it yourself. Not only are you likely to violate any applicable warranties or insurance, you could easily cause further damage. Should your hearing instrument fail or perform poorly, check the guide on the next page for possible solutions. If problems continue, contact your hearing professional for advice and assistance. Many common problems may be solved right in your hearing professional’s office or clinic. Hearing Instrument Care Troubleshooting Guide SYMPTOM Not Loud Enough Inconsistent Performance Unclear, Distorted Performance Dead 36 POSSIBLE CAUSES SOLUTIONS Low battery Replace battery Blocked earmold/earbud Clean or replace wax guard as needed Hearing change Contact your hearing professional Debris buildup Clean both microphone and receiver with brush Low battery Replace battery Blocked earmold/earbud Clean or replace wax guard as needed Low battery Replace battery Blocked earmold/earbud Clean or replace wax guard as needed Defective hearing instrument Contact your hearing professional Low battery Replace battery Blocked earmold/earbud Clean or replace wax guard as needed 37 Tips for Better Communication Tips for Better Communication Your hearing professional will recommend an appropriate schedule to help you adapt to your new hearing instrument. It will take practice, time and patience for your brain to adapt to the new sounds that your hearing instrument provides. Hearing is only part of how we share thoughts, ideas and feelings. Reading lips, facial expressions and gestures can help the learning process and add to what amplification alone may miss. • Background noises may be frustrating at first; remember, you have not heard them for a while Please review the following simple communication tips: • Better hearing with hearing instruments is a learned skill combining desire, practice and patience For You • Let others know what you need; keep in mind that people cannot “see” your hearing loss • Develop realistic expectations of what your hearing instruments can and cannot do • 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 38 39 Tips for Better Communication Safety Information For Your Family and Friends Safety Information Your family and friends are also affected by your hearing loss. Request that they: INTENDED USE: An air conduction hearing • Get your full attention before beginning to speak • Look at you or sit face-to-face in a quiet room • Speak clearly and at a normal rate and level; shouting can actually make understanding more difficult • Rephrase rather than repeat the same words; different words may be easier to understand • Minimize distractions while speaking instrument is a wearable sound-amplifying device intended to compensate for impaired hearing. Hearing instruments are available in multiple gain/output levels appropriate to treat hearing losses ranging from mild-to-profound. Your hearing instruments are designed to comply with the most stringent Standards of International Electromagnetic Compatibility. However, it is still possible that you may experience interference caused by power line disturbances, airport metal detectors, electromagnetic fields from other medical devices, radio signals and electrostatic discharges. If you use other medical devices or wear implantable medical devices such as defibrillators or pacemakers and are concerned that your hearing instruments might cause interference with your medical 40 41 Safety Information device, please contact your physician or the manufacturer of your medical device for information about the risk of disturbance. Your hearing instruments should not be worn during an MRI procedure or in a hyperbaric chamber. Your hearing instruments are classified as a Type B applied part under the IEC 60601-1 medical device standard. Your hearing instruments are not formally certified to operate in explosive atmospheres such as may be found in coal mines or certain chemical factories. Your hearing instruments should be stored within the temperature and humidity ranges of -40°C (-40°F) to +60°C (140°F) and 10%-95% relative humidity. Safety Information Use on Aircrafts The wireless capabilities that may be featured in your hearing instruments can be used on an aircraft as hearing instruments are exempt from the rules applied to other personal electronic instruments on an aircraft. Your iOS device should be put into Airplane Mode or turned off. International Use Be aware that operation during international travel may cause interference to other electronic devices, or other electronic devices may cause interference to your hearing instruments. Your hearing instruments are designed to operate beyond the range of temperatures comfortable to you, from very cold up to 50°C (122°F). 42 43 FDA Information Required Information The following additional information is provided in compliance with U.S. Food and Drug Administration (FDA) regulations: WARNING TO HEARING AID DISPENSERS. A hearing aid dispenser should advise a prospective hearing aid user to consult promptly with a licensed physician (preferably an ear specialist) before dispensing a hearing aid if the hearing aid dispenser determines through inquiry, actual observation, or review of any other available information concerning the prospective user, that the prospective user has any of the following conditions: i. Visible congenital or traumatic deformity of the ear. ii. History of active drainage from the ear within the previous 90 days. iii. History of sudden or rapidly progressive hearing loss within the previous 90 days. iv. Acute or chronic dizziness. v. Unilateral hearing loss of sudden or recent onset within the previous 90 days. vi. Audiometric air-bone gap equal to or greater than 15 decibels at 500 Hertz (Hz), 1,000 Hz and 2,000 Hz. vii. Visible evidence of significant cerumen accumulation or a foreign body in the ear canal. viii. Pain or discomfort in the ear. 44 FDA Information IMPORTANT NOTICE FOR PROSPECTIVE HEARING AID USERS. Good health practice requires that a person with a hearing loss have a medical evaluation by a licensed physician (preferably a physician who specializes 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, otologists or otorhinolaryngologists. The purpose of the medical evaluation is to assure that all medically treatable conditions which may affect hearing are identified and treated before the hearing aid is purchased. 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. The audiologist or hearing aid dispenser will conduct a hearing aid evaluation to assess your ability to hear with and without a hearing aid. The hearing aid evaluation will enable the audiologist or dispenser to select and fit a hearing aid to your individual needs. If you have reservations about your ability to adapt to amplification, you should inquire about the availability of a trial-rental or purchase-option program. Many hearing aid dispensers now offer programs that permit you to wear a hearing aid for a period of time for a nominal fee after which you may decide if you want to purchase the hearing aid. 45 FDA Information Federal law restricts the sale of hearing aids to those individuals who have obtained a medical evaluation from a licensed physician. Federal law permits a fully informed adult to sign a waiver statement declining the medical evaluation for religious or personal beliefs that preclude consultation with a physician. The exercise of such a waiver is not in your best health interest and its use is strongly discouraged. A hearing aid will not restore normal hearing and will not prevent or improve a hearing impairment resulting from organic conditions. Use of a hearing aid is only part of hearing habilitation and may need to be supplemented by auditory training and instruction in lip reading. In most cases, infrequent use of a hearing aid does not permit a user to attain full benefit from it. CHILDREN WITH HEARING LOSS. In addition to seeing a physician for a medical evaluation, a child with a hearing loss should be directed to an audiologist for evaluation and rehabilitation since hearing loss may cause problems in language development and the educational 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. FDA Information For hearing professionals INDICATIONS FOR USE The Multiflex Tinnitus Technology is a tool to generate sounds to be used in a Tinnitus Management Program to relieve patients suffering from tinnitus. The target population is primarily the adult population over 18 years of age. The Multiflex Tinnitus Technology is targeted for healthcare professionals, which are treating patients suffering from tinnitus, as well as conventional hearing disorders. The fitting of the Multiflex Tinnitus Technology must be done by a hearing professional participating in a Tinnitus Management Program. INSTRUMENT DESCRIPTION Multiflex Tinnitus Technology is a software function that generates sound which is programmed into a hearing aid. The hearing aid may be used in one of three modes of operation: as a hearing aid, as a tinnitus treatment instrument or as a hearing aid and tinnitus treatment instrument. When enabled, the Multiflex Tinnitus Technology generates the sound and allows a patient’s hearing professional to design and program appropriate settings for an individually prescribed sound treatment plan. The treatment plan should be used in a tinnitus management program for relief of tinnitus. 46 47 FDA Information FDA Information Multiflex Tinnitus Technology generates a broadband white noise signal that varies in frequency and amplitude. These characteristics are adjustable by the hearing professional and are specific to the prescribed therapy designed by the professional for the patient’s needs and comfort. CAUTION: If set to the maximum output level and The patient may have some control of the level or volume of the signal and the patient should discuss this adjustment as well as his or her comfort level and sound of the signal with their hearing professional. For the patient WARNING TO HEARING CARE PRACTITIONER A hearing care practitioner should advise a prospective sound generator user to consult promptly with a licensed physician (preferably an ear specialist) before using a sound generator if the hearing care practitioner determines through inquiry, actual observation or review or any other available information concerning the prospective user that the prospective user has any of the following conditions: i. Visible congenital or traumatic deformity of the ear. ii. History of active drainage from the ear within the previous 90 days. iii. History of sudden or rapidly progressive hearing loss within the previous 90 days. iv. Acute or chronic dizziness. v. Unilateral hearing loss of sudden or recent onset within the previous 90 days. 48 worn for periods of time exceeding the following recommendations, the patient’s exposure to sound energy has the potential to exceed noise exposure limits. This instrument is intended for use for a maximum of sixteen (16) hours a day when set at the maximum output level. A tinnitus therapy instrument is an electronic instrument intended to generate noise of sufficient intensity and bandwidth to treat ringing in the ears. It can also be used as an aid in hearing external sounds and speech. Multiflex Tinnitus Technology is a tool to generate sounds. It is recommended that this tool be used with appropriate counseling and/or in a tinnitus management program to relieve patients suffering from tinnitus. TINNITUS THERAPY CONCEPTS AND BENEFITS Multiflex Tinnitus Technology can be used as a part of a tinnitus treatment program. Multiflex Tinnitus Technology plays a white noise through the hearing aid. Multiflex Tinnitus Technology is programmed according to your hearing loss and preference, and your hearing professional can adjust the settings of Multiflex Tinnitus Technology to meet your needs. Multiflex Tinnitus Technology may provide temporary relief of your tinnitus. 49 FDA Information PRESCRIPTION USE ONLY CAUTION: Federal law restricts this instrument to sale by or on the order of a doctor, audiologist or other hearing care practitioner licensed to dispense hearing instruments in your state. 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. Your hearing professional will properly diagnose and fit the instrument to your personal needs and requirements. This should include its use in a prescribed tinnitus treatment program. 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 regarding such care. FDA Information As with any instrument, misuse of the tinnitus therapy instrument could present some potentially harmful effects. Care should be taken to prevent the unauthorized use and to keep the instrument out of the reach of children and pets. CAUTION: If set to the maximum output level and worn for periods of time exceeding the following recommendations, your exposure to sound energy has the potential to exceed noise exposure limits. You should not use your hearing instrument for more than sixteen (16) hours a day if your instrument is set at the maximum output level, nor should you use your instrument if your hearing professional has set the instrument at levels that exceed your comfort level. Important notice for prospective sound generator users WARNING: There are some potential concerns 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. Multiflex Tinnitus Technology has been designed to minimize these concerns. However, should you experience or notice any of the above conditions or any dizziness, nausea, headaches or heart palpitations, you should immediately discontinue use of the instrument and seek a consultation with a medical, audiology or other hearing professional. 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. 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 skin irritation at the point of contact with the instrument. 50 51 FDA Inform ation FCC Information TECHNICAL DATA REGULATORY NOTICES Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when m easured in a 2cc coupler per ANSI S3.22 or IEC 60118-7. RIC 13 FCC ID: EOA-24HALO2R13 IC: 6903A-24HALO2R13 RIC 312 FCC ID: EOA-24HALO2R312 IC: 6903A-24HALO2R312 FCC Notice 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 interference, and (2) this device must accept any interference received, including interference that may cause undesired operation of the device. Note: The manufacturer is not responsible for any radio or TV interference caused by unauthorized modifications to this equipment. Such modifications could void the user’s authority to operate the equipment. Hereby, Starkey® Hearing Technologies declares that the products listed above are in compliance with the essential requirements and other relevant provisions of Directive 1999/5/EC. A copy of the Declaration of Conformity can be obtained from the addresses on the following page. 52 53 FCC Information Notes Starkey Hearing Technologies 6700 Washington Ave. South Eden Prairie, MN 55344 USA Wm. F. Austin House, Bramhall Technology Park Pepper Road, Hazel Grove, Stockport SK7 5BX United Kingdom Waste from electronic equipment must be handled according to local regulations. 54 55 0086 “Made for iPod,” “Made for iPhone,” and “Made for iPad” mean that an electronic accessory has been designed to connect specifically to iPod, iPhone, or iPad, respectively, 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. Please note that the use of this accessory with iPod, iPhone, or iPad may affect wireless performance. © 2016 Starkey Hearing Technologies. All Rights Reserved. 81960-007 1/16 BKLT2839-00-EE-XX 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.
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Page Count : 29EXIF Metadata provided by EXIF.tools