Starkey Laboratories EXPSTANDARD Hearing Aid User Manual RIC Receiver In Canal Operations Manual

Starkey Laboratories Inc Hearing Aid RIC Receiver In Canal Operations Manual

Contents

User Manual

RIC(Receiver-In-Canal)OPERATIONS MANUAL
 Select Hearing InstrumentSize 10 Battery - YellowSize 312 Battery - BrownSize 312 Battery - Brown Size 13 Battery - OrangeSize 312 Battery - BrownSize 312 Battery - BrownSelect Instrument Controls  Automatic Volume Control p. 21  Adjustable Volume Control p. 22-24  Multimemory p. 24  Combined Volume and Multimemory Control p. 24-25
Table of ContentsOverview RIC 10 Overview 4 Micro RIC 312 Overview 6 RIC 312 Overview 8 RIC 13 Overview 12Preparation Batteries/Battery Indicators 14-15 Tamper Resistant Battery Compartment 16 Insertion and Removal 18Operation On & Off 21 Volume Control/Volume Settings 21-24 Multimemory 24 Telephone Use 25 Manual Switching 26 Direct Audio Input (DAI) 28 Multiflex Tinnitus 30Accessories Wireless Accessories 32Hearing System Care Instrument Care/Hear Clear 33-34 Service and Repair 35 Troubleshooting Guide 36Tips for Better Communication 37Safety Information 40FDA Information 42FCC Information 50
4Features, Controls and IdentificationYour hearing system controls include:1. Hearing Instrument2. Cable3. Receiver4. Microphones 5. Control Surface Switch6. Battery Compartment (on/off control), Location of serial number, Location of left/right side device indicator7. Retention Lock8. Location of manufacturer’s name and model name9. Location of left/right side receiver indicator10. Instant Fit Earbud11. Custom Earmold (optional)12. RIC Custom Power Earmold (optional)RIC 10 Overview
54213571068911 12RIC 10 Overview
6Features, Controls and IdentificationYour hearing system controls include:1. Hearing Instrument2. Cable3. Receiver4. Microphones*5. Push Button Switch or Rotary Volume Control6. Battery Compartment (on/off control), Location of serial number, Location of left/right side device indicator7. Retention Lock8. Location of manufacturer’s name and model name9. Location of left/right side receiver indicator10. Instant Fit Earbud11. Custom Earmold (optional)12. RIC Custom Power Earmold (optional)Micro RIC 312 Overview*Look may vary
7Micro RIC 312 OverviewIMPORTANT NOTE: The micro RIC 312 includes a Multiflex Tinnitus Technology feature that can be enabled.  Multiflex Tinnitus is turned ON in my hearing system. See page 30. 4213571068911 12
8RIC 312 OverviewFeatures, Controls and IdentificationYour hearing system controls include:1. Hearing Instrument2. Cable3. Receiver4. Microphones5. Rocker Switch6. Battery Compartment (on/off control), Location of serial number, Location of left/right side device indicator7. Retention Lock8. Location of manufacturer’s name and model name9. Location of left/right side receiver indicator10. Instant Fit Earbud11. Custom Earmold (optional)12. RIC Custom Power Earmold (optional)
9RIC 312 Overview710 6894213511 12
10RIC 312 OverviewFeatures, Controls and IdentificationYour hearing system controls include:1. Hearing Instrument2. Cable3. Receiver4. Microphones5. Push Button Switch6. Battery Compartment (on/off control), Location of serial number7. Retention Lock8. Location of manufacturer’s name and model name9. Location of left/right side receiver indicator10. Instant Fit Earbud11. Custom Earmold (optional)12. RIC Custom Power Earmold (optional)
11RIC 312 Overview42135710 68911 12
12RIC 13 OverviewFeatures, Controls and IdentificationYour hearing system controls include:1. Hearing Instrument2. Cable3. Receiver4. Microphones5. Push Button Switch6. Battery Compartment (on/off control), Location of serial number7. Retention Lock8. Location of manufacturer’s name and model name9. Location of left/right side receiver indicator10. Instant Fit Earbud11. Location of left/right side device indicator12. Custom Earmold (optional)13. RIC Custom Power Earmold (optional)
13RIC 13 Overview42135710 6891111 12
14PreparationBatteriesYour hearing system uses a battery as its power source. This battery size can be identified by the orange (13), brown (312), or yellow (10) 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 tab from the new battery.4. Line up 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 will 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.
15Preparation13245
16Tamper Resistant Battery Compartment To lock the battery door:Use an appropriate tool to slide the recessed switch to the left until it “clicks” and the colored mark is visible.To unlock the battery door:Slide the recessed switch to the right until it “clicks” and the colored mark disappears.Locking the door is not required for operation. My hearing instrument has a tamper resistant battery compartment. See below.Preparation
17Preparation 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: 202-625-3333Helpful 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 care professional is your best source for lifespan estimates and verification that you are using the proper size and type.
18PreparationInsertion and Removal To insert the earbud or earmold: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 (fig. 1).2. Wrap the hearing instrument over the top of your ear, carefully placing it behind your ear (fig. 2).3. Place the retention lock inside the bowl of your ear (fig. 3).To remove the earbud or earmold:1. Remove the retention lock from the bowl of your ear.2. Remove the hearing instrument from behind your ear.3. Grasp the receiver with your thumb and forefinger. Gently pull out of your ear canal.Do not pull with the hearing instrument case as this may damage the connection.
19PreparationFigure 1 Figure 2Figure 3 Figure 4
20PreparationHelpful Hints• Minor irritation and inflammation may occur as your ear becomes accustomed to having an object in it; if so, please contact your hearing care professional. • If an actual allergic reaction occurs, alternative earmold materials are available; contact your hearing care professional.• Severe swelling, discharge from the ear, excessive wax or other unusual conditions warrant immediate consultation with a physician.
21OperationOn & OffTo turn ON: Insert a battery and completely close the battery door. To turn OFF: Open the battery door until the battery is no longer touching the battery contacts.Your instrument has a Power-On delay and may require a few seconds to power on. You may hear a tone series indicating that your device is fully powered on.Volume ControlAutomatic Volume ControlYour hearing system has been set to a specific volume level by your hearing care professional. If sounds are generally too loud or too soft, please contact your hearing care professional for advice and adjustment.
22OperationAdjustable Volume Control Push Button/Control Surface Volume ControlYour hearing system uses the control surface/push button to control volume. To change volume, press then release the control surface/push button. Rocker Switch Volume ControlYour hearing system uses the rocker switch to control volume. To increase volume, press then release the top part of the switch. To decrease volume, press then release the bottom part of the switch.
23OperationRotary Volume ControlYour hearing system uses a rotary volume control to adjust volume. Turn the wheel up (higher number) to increase volume. Turn the wheel down (lower number) to decrease volume.Volume SettingsSome hearing systems can be set for the Right device to increase the volume and the Left device to decrease the volume. Ask your hearing care professional if this setting would benefit you.Push Button/Rocker Switch/ControlSurface Volume ControlVolume Level ToneLevel 5 (More volume) Five beeps plus toneLevel 4 Four beepsLevel 3 (Power on volume level) Three beepsLevel 2 Two beepsLevel 1 (Less volume) One beep plus tone
24OperationRotary Volume ControlMultimemoryYour hearing care professional may be able to set up to four hearing programs for you. These additional programs are accessed by pressing the control surface/push button/rocker switch. When you press the control surface/push button/rocker switch, you may hear an alert indicating the device has changed to the next program. Ask your hearing professional about your specific hearing programs.Combined Volume and Multimemory ControlYour hearing device is set up to adjust volume and programs. To adjust volume, press then release the switch. To change Volume Level ToneOptimal volume setting One beep
25OperationMy hearing instruments have the following telephone setting(s): Automatic Telephone. See next page. Automatic Telecoil. See next page. Telecoil and Manual Switching. (Program # ____________________ ). Noneprograms, press and hold the switch. The hearing aid will cycle through the programs and present indicators. Release the switch when you are at the desired program. Telephone UseSome hearing instruments are equipped with tools to help you effectively communicate on the telephone. Ask your hearing professional about your telephone solution.
26OperationAutomatic Telephone and Automatic TelecoilThese options activate the telephone response automatically when used with a hearing aid compatible telephone. To use, place the telephone receiver on your ear as you normally would and the hearing instrument will select the telephone setting. 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 normal listening mode.NOTE: Consult with your hearing professional if your device does not seem to switch to the telephone setting automatically.Manual SwitchingManual switching allows you to switch the devices to telephone mode when needed.Ask your hearing professional which program you should access for manual telephone use.
27OperationGeneral 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.
28Operation My hearing system is set up for DAI use. My hearing system is not set up for DAI use. See page 32. Direct Audio Input (DAI)Your hearing system has full direct audio input (DAI) capability. This allows you to connect your hearing system to an electronic sound source such as a wireless FM system, computer audio or an MP3 player. DAI can improve communication and sound quality when reverberation, distance and background noise compete with what you want to hear. To attach the DAI shoe:Snap the DAI shoe on the bottom of the RIC.
29OperationTo access the battery with the DAI shoe attached:Hold the RIC and DAI shoe and press the lower part of the DAI shoe, then open the battery door.To remove the DAI shoe: Turn the RIC on the side. Grasp the RIC in one hand and the DAI shoe in the other. Gently bend at the seam between the DAI shoe and the hearing aid.There are many FM systems available to help improve communication in challenging environments. Ask your hearing care professional about personal FM systems.
30Multiflex Tinnitus Technology Operation My hearing instrument uses the switch for tinnitus stimulus control. See next page. My hearing instrument has combined volume and tinnitus stimulus control. See next page. My hearing instrument has combined multimemory and tinnitus stimulus control. See next page.Introduction 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. The tinnitus stimulus is programmed according to your hearing loss, and your hearing care professional can adjust the settings of the tinnitus stimulus to meet your needs. Multifunction SwitchYour switch can be set to perform different functions. Ask your hearing aid professional how your device is set.
31Multiflex Tinnitus Technology OperationTinnitus Stimulus ControlYour hearing system uses the multifunction switch to control the tinnitus stimulus. Press then release the switch until the desired level is reached. Each press/release changes the volume one increment.Combined Volume or Multimemory and Tinnitus Stimulus ControlIf your hearing system is set up to adjust volume and tinnitus stimulus, adjust volume by pressing then releasing the switch until the desired volume level is reached. If your hearing system is set up to adjust multimemory and tinnitus stimulus, adjust memory by pressing then releasing the switch until the desired memory is reached. To adjust the tinnitus stimulus, press and hold the switch. The hearing aid will cycle through the tinnitus stimulus levels. Release the switch when you are at the desired level.
32AccessoriesWireless Accessories*There are several wireless accessories that allow you to control and maximize the full potential of your hearing system. These include a remote control as well as wireless connection to your cell phone and entertainment system. Consult with your hearing professional to determine if your hearing aids have wireless capabilities and which accessories may be best for you.* Wireless accessories are only compatible with hearing aids that have wireless technology.
33Hearing System CareInstrument CareDo your best to keep 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 switches, 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 care professional can provide further information on additional maintenance procedures for your hearing system if needed.
34Hearing System Care80Starkey offers various methods of wax protection for your hearing instruments. The following is a brief description of some of our wax protection options:WAX PROTECTION GUIDEHearClear™*The Hear Clear exclusive earwax protection system uses disposable wax guards. The innovative wax guards prevent earwax accumulation in the hearing aid receiver. The Hear Clear is incompatible with Extended Receiver Tube, Biconic Wax Guard and Canal Bell.Biconic Wax Guard (Wax Spring)The Biconic Wax Guard is a small coil basket inserted into the receiver tubing of the hearing aid to prevent wax from reaching the receiver. The wax spring is typically removed and replaced by a hearing professional.Extended Receiver TubingThe Extended Receiver Tubing increases the distance wax must travel before reaching the receiver. It potentially allows the user to visualize the presence of wax before it enters the receiver of the hearing aid. The Extended Receiver Tubing is incompatible with Waxceptor.Canal BellThe Canal Bell recesses the receiver of the hearing aid, making it more difficult for wax to reach the receiver. The Canal Bell is incompatible with the Waxceptor.Hear Clear™ Receiver Wax GuardsThe Hear Clear exclusive earwax protection system uses disposable wax guards. The innovative wax guards prevent earwax accumulation in the hearing aid receiver. Helpful Hints• When not wearing your hearing system, open the battery door to allow any moisture to evaporate.• When not in use, remove the batteries completely; place your hearing system in the storage container and store: – In a dry, safe place – Away from direct sunlight or heat to avoid extreme temperatures
35Hearing System Care – Where you can easily find them – Safely out of reach from pets and children• Do not take apart your hearing instruments or insert the cleaning tools inside them.Service and RepairIf, for any reason, your hearing system 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 system fail or perform poorly, check the guide on the next page for possible solutions. If problems continue, contact your hearing care professional for advice and assistance. Many common problems may be solved right in your hearing care professional’s office or clinic.
36Hearing System CareTroubleshooting GuideSYMPTOM POSSIBLE CAUSESSOLUTIONSNot Loud EnoughLow battery Replace batteryBlocked earmold/tubing/earbudClean or replace wax guard as neededHearing change Contact your hearing care 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 care professionalDeadLow battery Replace batteryBlocked earmold/tubingClean or replace wax guard as neededCrimped tubing Contact your hearing care professional
37Tips for Better CommunicationYour hearing care professional will recommend an appropriate schedule to help you adapt to your new hearing system. It will take practice, time and patience for your brain to adapt to the new sounds that your hearing system 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
38Tips for Better Communication• 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 patienceFor 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
39Tips for Better Communication• Rephrase rather than repeat the same words; different words may be easier to understand• Minimize distractions while speaking
40Safety InformationSafety InformationINTENDED USE: An air conduction hearing aid is a wearable sound-amplifying device that is intended to compensate for impaired hearing. Hearing aids 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 not formally certified to operate in explosive atmospheres such as may be found in coal mines or certain chemical factories. Your hearing instruments are classified as a Type B applied part under the IEC 60601-1 medical device standard.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% rH.
41Safety Information*Applies to wireless hearing instruments onlyYour hearing instruments are designed to operate beyond the range of temperatures comfortable to you, from very cold up to 50°C (122°F).Use on Aircrafts*The optional wireless capabilities that may be featured in your hearing instruments should not be used on an aircraft unless specifically permitted by the flight personnel. Your hearing care professional can enable a special program that allows your hearing aids to work without wireless functionality.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 devices, or other electronic devices may cause interference to your hearing instruments.
42FDA 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.
43FDA InformationIMPORTANT 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.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.
44FDA InformationFederal 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.
45FDA InformationFor hearing care 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.DEVICE 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 device, or as a hearing aid and tinnitus treatment device. When enabled, the Multiflex Tinnitus Technology generates the sound and allows a patient’s hearing care 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.
46FDA InformationThese characteristics are adjustable by the hearing care 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 care 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.
47FDA 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 device 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 device is an electronic device 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 care professional can adjust the settings of Multiflex Tinnitus Technology to meet your needs. Multiflex Tinnitus Technology may provide temporary relief of your tinnitus.
48FDA InformationPRESCRIPTION USE ONLY CAUTION: Federal law restricts this device 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 device should be only on the advice and in consultation with your audiologist or hearing care practitioner. Your hearing care professional will properly diagnose and fit the device to your personal needs and requirements. This should include its use in a prescribed tinnitus treatment program. Your hearing care professional will also be able to offer the appropriate follow-up care. It is important that you follow your hearing care professional’s advice and direction regarding such care. WARNING: There are some potential concerns associated with the use of any sound generating tinnitus therapy device. 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 device. 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 device and seek a consultation with a medical, audiology, or other hearing care professional.As with any device, misuse of the tinnitus therapy device
49FDA Informationcould present some potentially harmful effects. Care should be taken to prevent the unauthorized use and to keep the device 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 device for more than sixteen (16) hours a day if your device is set at the maximum output level, nor should you use your device if your hearing care professional has set the device 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.
FCC/IC/EU Information REGULATORY NOTICES FCC ID: EOA-ZSERIES-HI IC:6903A-ZSERIESHI Model: Zseries R312d A3 R312d Start R312d Zseries mR312d A3 mR312d Start mR312d FCC ID: EOA-EXPSTANDARD IC: 6903A-EXPSTANDARD Model: ExP R312 A4 R312 Start 1200 R312 Start 1000 R312 FCC ID: EOA-3SER312 IC:6903A-3SER312 Model: 3 series R312d tour R312d A2 R312d Start 8 R312d Start 7 R312d FCC ID: EOA-IRIS-HA IC:6903A-3SER312 Model: Xino mR312d A2 mR312d Start 8 mR312d Start 7 mR312d FCC NOTICE This device complies with part 15 of the FCC rules and with RSS-210. 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. INDUSTRY CANADA NOTICE This device complies with Industry Canada licence-exempt RSS standard(s). Operation is subject to the following two conditions: (1) this device may not cause interference, and (2) this device must accept any interference, including interference that may cause undesired operation of the device. 50
FCC/IC/EU Information Le présent appareil est conforme aux CNR d'Industrie Canada applicables aux appareils radio exempts de licence. L'exploitation est autorisée aux deux conditions suivantes : (1) l'appareil ne doit pas produire de brouillage, et (2) l'appareil doit accepter tout brouillage radioélectrique subi, même si le brouillage est susceptible d'en compromettre le fonctionnement.. 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. EU NOTICE 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 below addresses. 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 51
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