Starkey Laboratories EXPSTANDARD Hearing Aid User Manual Synergy BTE Operations Manual

Starkey Laboratories Inc Hearing Aid Synergy BTE Operations Manual

Contents

Users manual

OPERATIONS MANUALBTE(Behind-The-Ear)
Hearing InstrumentInstrument Controls Push Button Controls p. 14Size 312 Battery - Brown
Table of ContentsOverview Push Button mini BTE 312 Overview . . . . . . . . . . . . . . 4Preparation Batteries/Battery Indicators . . . . . . . . . . . . . . . . . . . . . 6 Insertion and Removal . . . . . . . . . . . . . . . . . . . . . . . . 10Operation Power On & Off . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 User Controls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 Volume Control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 Volume Control Indicators . . . . . . . . . . . . . . . . . . . . . 17 Memory Change . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 Mute . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 CROS/BiCROS Balance Control . . . . . . . . . . . . . . . . 19 Multiflex Tinnitus Level Control . . . . . . . . . . . . . . . . . 19 Directional Settings . . . . . . . . . . . . . . . . . . . . . . . . . . 19 Telephone Use . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19CROS/BiCROS Technology . . . . . . . . . . . . . . . . . . . . . . . 22Multiflex Tinnitus Technology . . . . . . . . . . . . . . . . . . . . . 23Accessories Wireless Accessories � � � � � � � � � � � � � � � � � � � � � � � � � � � 25Hearing Instrument Care Instrument Care . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 26 Standard Tubing/Thin Tubing . . . . . . . . . . . . . . . . . . 27 Service and Repair . . . . . . . . . . . . . . . . . . . . . . . . . . . 29 Troubleshooting Guide . . . . . . . . . . . . . . . . . . . . . . . 30Tips for Better Communication � � � � � � � � � � � � � � � � � � � � � 31Safety Information � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 33FDA Information � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 35FCC Information � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � � 40
4Push Button mini BTE 312 OverviewFeatures, Controls and IdentificationYour hearing instrument controls include:1. Earhook2. Microphones3. Push Button (user control)4. Battery compartment (on/off control)5. Location of left/right side instrument indicator RED is for right ear, BLUE is for left earYour hearing instrument can be identified by:6. Location of serial number (inside the battery compartment) 7. Location of manufacturer’s name and model nameComfort Fit Solutions: 8. Standard Earmold with tubing9. Thin tube with Instant Fit Earbud10. Thin tube with Custom Eartip
5Push Button mini BTE 312 Overview00-000000Serial Number54213679108
6PreparationBatteriesYour hearing instrument uses a battery as its power source. This battery size can be identified by the brown (312) 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.Battery IndicatorsAn indicator will sound when the battery voltage is low. You have approximately five 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 environmental noise levels and brand of battery used.
7Preparation13245
8PreparationHelpful 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.
9Preparation WARNINGS Batteries are dangerous if swallowed. To help prevent the accidental ingestion of batteries: 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
10PreparationInsertion and Removal To insert the Custom Earmold and hearing instrument:1. Hold the Custom Earmold with your thumb and forefinger on the outer side near the tubing.2. Tilt your hand slightly forward and gently insert the canal tip of the Custom Earmold into your ear canal.3. Rotate the Custom Earmold backward.4. Softly press the Custom Earmold into place with your fingertip.5. Carefully place the BTE behind your ear wrapping the earhook over the top of your ear.To remove the hearing instrument and Custom Earmold:Take the instrument from behind your ear and gently pull the Custom Earmold outward. Pulling lightly down on the earlobe may help loosen the Custom Earmold as it is removed.
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12Preparation213Instant Fit Earbud or Custom EartipTo insert the Instant Fit Earbud or Custom Eartip:1. Insert the Instant Fit Earbud/Custom Eartip into your ear canal.2. Gently wrap the BTE over your ear until it rests securely behind your ear.3. Place the lock in the concha bowl of your ear.To remove the hearing instrument and Instant Fit Earbud or Custom Eartip:• Remove the lock from the concha bowl of your ear.• Remove the hearing instrument from behind your ear.• Gently grasp the tubing at the opening of the ear canal and pull outward.
13PreparationHelpful 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.
14OperationPower On & OffTo turn ON:Insert a battery and completely close the battery door. Your instrument has a power on delay and may require a few seconds to power on. You may hear a tone indicating that your instrument is fully powered on.To turn OFF: Open the battery door until the battery is no longer touching the battery contacts.User ControlsYour 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 FunctionalityThe user control on your hearing instrument can respond differently depending on how long you activate (press) the button. 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 on the next page indicate how your user control is configured.
15OperationVolume ControlMemory Change Mute Multiflex Tinnitus LevelShort Press (Press and Release)Long Press (Press and Hold)Assigned User Control SettingsVolume Control Power On Volume LevelYour 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 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 instrument will always power on to the same volume setting (Volume Home) determined by your hearing professional.Sprinkler Volume ControlIf 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,
16Operationthe volume will increase one step. Continue to 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 ControlIf 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.
17OperationVolume Level Tone Length of ToneVolume Max 5 Beeps .....Volume Step(s) Click–Volume Home(Power on volume level) 3 Beeps ...Volume Step(s) Click–Volume Min Single Tone —Volume Control IndicatorsYour hearing professional may enable audible indicators, which highlight the current volume position.Memory ChangeYour 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.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.
18OperationMemory 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.MuteLong Press MuteIf 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 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.
19OperationCROS/BiCROS Balance ControlYour user control on the transmitter can also adjust the balance between your hearing instrument and transmitter. Please refer to the section labeled CROS/BiCROS Technology (on page 22) for further information.Multiflex Tinnitus Level ControlYour user control can also adjust the level of your Multiflex Tinnitus stimulus. Please refer to the section labeled Multiflex Tinnitus Technology (on page 23) for further information.Directional SettingsYour hearing instrument may have a directional microphone to help improve speech understanding in noisy situations. Ask your hearing professional about your particular directional settings.Telephone UseYour hearing instruments can be customized with features to help you effectively communicate on the telephone. Ask your hearing professional about your telephone solution.
20OperationMy hearing instruments have the following telephone setting(s): Automatic Telephone Memory and Automatic Telecoil. See below. Manual Telephone Memory and Manual Telecoil. See below. (Memory # ________________ ). NoneAutomatic Telephone Memory and Automatic TelecoilThese options activate the telephone memory automatically when used with a hearing instrument compatible telephone. 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 TelecoilManual 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.
21OperationGeneral Telephone UseSome 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.Ear-to-Ear Phone StreamingThe telephone memory in your hearing instrument may be equipped with an ear-to-ear phone streaming Phone Streaming option. When you enter your telephone memory, the audio from your telephone will be streamed from the phone ear’s hearing instrument to the opposite ear’s hearing instrument. This allows you to hear the telephone conversation in both ears. Ask your hearing professional about your particular telephone settings.
22CROS/BiCROS TechnologyIntroductionA Contralateral Routing Of Signals (CROS) hearing system is a type of hearing instrument that is used to treat unilateral hearing loss. It takes sound from the ear with poorer hearing and transmits it to the ear with better hearing. CROS only picks up sound from the unaidable ear, while BiCROS picks up sound from both ears. This helps the patient to receive sounds from both sides of the head without the head-shadow effect.Multifunction Button Balance ControlYour hearing system uses the button to adjust the balance between the hearing instrument and the transmitter. This control adjusts the level of sound coming from the transmitter. Press and release the button until the desired level is reached. Each press and release changes the balance level one increment.NOTE: Balance Control is only applicable for BiCROS memories.CROS StreamingYour hearing system is equipped with a CROS transmitter. When you enter a memory with either CROS or BiCROS streaming enabled, audio from transmitter is streamed to your hearing instrument. When CROS streaming begins you may hear an alert tone. If for some reason the CROS stream is unexpectedly interrupted you may also hear an alert tone. Please ask your hearing professional about your particular settings.
23Multiflex Tinnitus TechnologyIntroductionMultiflex 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 ControlIf 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 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.
24Multiflex Tinnitus TechnologyUp/Down Tinnitus Stimulus ControlIf 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.
25AccessoriesWireless Accessories*There are several wireless accessories that allow you to control and maximize the full potential of your hearing instrument. Available functionality includes:• Ability to adjust your instruments using a remote control.• Ability to transmit television audio directly to your instruments.• Ability to transmit remote microphone audio directly to your instruments.• Ability to transmit your cell phone conversation directly to your instruments. Consult with your hearing professional to determine if your hearing instruments have wireless capabilities and which accessories may be best for you. * Wireless accessories are only compatible with hearing instruments that have 900 MHz wireless technology.
26Hearing Instrument CareInstrument CareKeep your hearing instrument clean at all times. 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.• 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.My hearing instrument has: Standard Tubing. See next page. Thin Tubing. See next page.
27121Hearing Instrument CareStandard Tubing1. Separate the Custom Earmold from the BTE by gently pulling the tubing away from the earhook. – Use a soft, damp cloth or a cleaning brush to clean debris from the Custom Earmold – Wash the Custom Earmold with warm soapy water – Never use solvents2. Slide the Custom Earmold tubing onto the BTE earhook when completely dry.Your hearing professional can provide further information on additional maintenance procedures for your hearing instrument, if needed.Thin Tubing1. Unscrew the tubing from the tip of the hearing instrument.2. Thread cleaner through the tubing, starting at the end just removed from the hearing instrument, until it extends from the other end of the tubing.
28Hearing Instrument Care3. Brush the debris off prior to removing cleaner.4. Clean the Earbud/Eartip with a dry cloth or brush.5. If necessary, the Earbud/Eartip may be washed in warm, soapy water. Remove the Earbud/Eartip from the tubing prior to washing. Allow the Earbud/Eartip to dry overnight.6. When completely dry, reassemble the Thin Tubing to the hearing instrument.Helpful Hints• Make sure the Custom Earmold/Earbud/Eartip and tubing are completely dry before reconnecting to your hearing instrument earhook.• 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 – Away from direct sunlight or heat to avoid extreme temperatures – Where you can easily find them – Safely out of reach of pets and children
29Hearing Instrument CareService and RepairIf, 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.
30Hearing Instrument CareTroubleshooting GuideSYMPTOM POSSIBLE CAUSESSOLUTIONSNot Loud EnoughLow battery Replace batteryBlocked earmold/tubing/earbudClean or replace wax guard as neededHearing change Contact your hearing professionalDebris buildup Clean both microphone and receiver with brushInconsistent PerformanceLow battery Replace batteryBlocked earmold/tubing/earbudClean or replace wax guard as neededUnclear, Distorted PerformanceLow battery Replace batteryBlocked earmold/tubing/earbudClean or replace wax guard as neededDefective hearing instrument Contact your hearing professionalDeadLow battery Replace batteryBlocked earmold/tubing Clean or replace wax guard as neededCrimped tubing Contact your hearing professional
31Tips for Better CommunicationYour 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.Please review the following simple communication tips:For You• 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 instruments can and cannot do• Better hearing with hearing instruments is a learned skill combining desire, practice and patience
32Tips for Better CommunicationFor Your Family and FriendsYour family and friends are also affected by your hearing loss. Request that they:• 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
33Safety InformationSafety InformationINTENDED USE: An air conduction hearing 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 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 fully certified to operate in explosive atmospheres that may be found in coal mines or certain chemical factories.
34*Applies to wireless hearing instruments onlySafety InformationYour hearing instruments should be stored within the temperature and humidity ranges of -40oC (-40oF) to +60oC (140oF) and 10%-95% rH.Your hearing instruments are designed to operate beyond the range of temperatures comfortable to you, from very cold up to 50oC (122oF).Use on Aircrafts*The optional 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. International Use*Your hearing instruments are approved to operate at a radio frequency that is specific to your country or region and might not be approved for use outside your country or region. Be aware that operation during international travel may cause interference to other electronic instruments, or other electronic instruments may cause interference to your hearing instruments.
35FDA InformationRequired InformationThe 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.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 otorhynolaringologists. The purpose of the medical evaluation is to assure that all medically treatable conditions that 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 that states 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.
36FDA InformationThe 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.Federal law restricts the sale of hearing instruments 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. Special care should be exercised in selecting and fitting a hearing aid whose maximum sound pressure level exceeds 132 decibels because there may be risk in impairing the remaining hearing of the hearing aid user.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.
37FDA InformationFor 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. 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. 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. 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.
38FDA InformationCAUTION: If set to the maximum output level and worn for periods of time exceeding the recommendations below, 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. For the patient 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.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. 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 skin irritation at the point of contact with the instrument. Multiflex Tinnitus Technology has been designed to minimize these concerns. However, should you experience or notice any of the above
39FDA Informationconditions 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.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 recommendations below, 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 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. TECHNICAL DATA Multiflex Tinnitus Technology Maximum Output = 87 dB SPL (typical) when measured in a 2cc coupler per ANSI S3.22 or IEC 60118-7.
40FCC InformationREGULATORY NOTICESFCC ID: EOA-EXPSTANDARDIC ID: 6903A-EXPSTANDARDFCC NOTICEThis instrument complies with part 15 of the FCC rules and with RSS-210. Operation is subject to the following two conditions: (1) This instrument may not cause harmful interference, and (2) this instrument must accept any interference received, including interference that may cause undesired operation of the instrument.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 BTE is 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 below addresses.
41FCC Information Waste from electronic equipment must be handled according to local regulationsStarkey Hearing Technologies 6700 Washington Ave. South Eden Prairie, MN 55344 USAWm. F. Austin House, Bramhall Technology Park Pepper Road, Hazel Grove, Stockport SK7 5BX United Kingdom
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0086© 2015 Starkey Hearing Technologies. All Rights Reserved. 81872-007 10/15 BKLT2811-01-EE-XX

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