(B90/B70/B50/B30) - Phonak

14. Compliance informationEurope:Declaration of ConformityHereby Phonak AG declares that this Phonak productmeets the requirements of the Medical Devices Directive93/42/EEC as well as the Radio and TelecommunicationsTerminal Equipment Directive 1999/5/EC. The full text ofthe Declaration of Conformity can be obtained from themanufacturer or the local Phonak representative whoseaddress can be taken from the list on www.phonak.com(Phonak worldwide locations).Australia/New Zealand:Indicates a device’s compliance with applicableRadio Spectrum Management’s (RSM) andAustralian Communications and Media Authority(ACMA) regulatory arrangements for the legal salein New Zealand and Australia.The compliance label R-NZ is for radio productssupplied in the New Zealand market underconformity level A1.29

The wireless models listed on page 2 are certified under:Phonak Audéo B -10 (B90/B70/B50/B30)USAFCC ID: KWC-WHSRIC1CanadaIC: 2262A-WHSRIC1Phonak Audéo B -312 (B90/B70/B50/B30)USAFCC ID: KWC-WHSRIC2CanadaIC: 2262A-WHSRIC2Phonak Audéo B -312T (B90/B70/B50/B30)USAFCC ID: KWC-WHSRIC3CanadaIC: 2262A-WHSRIC3Phonak Audéo B -13 (B90/B70/B50/B30)USAFCC ID: KWC-WHSRIC4CanadaIC: 2262A-WHSRIC430

Notice 1:This device complies with Part 15 of the FCC Rules andwith RSS-210 of Industry Canada. Operation is subject tothe following two conditions:1) this device may not cause harmful interference, and2) this device must accept any interference received,including interference that may cause undesired operation.Notice 2:Changes or modifications made to this device notexpressly approved by Phonak may void the FCCauthorization to operate this device.Notice 3:This device has been tested and found to comply withthe limits for a Class B digital device, pursuant to Part 15of the FCC Rules and ICES-003 of Industry Canada.These limits are designed to provide reasonable protectionagainst harmful interference in a residential installation.This device generates, uses and can radiate radiofrequency energy and, if not installed and used inaccordance with the instructions, may cause harmfulinterference to radio communications. However, there is31

no guarantee that interference will not occur in aparticular installation. If this device does cause harmfulinterference to radio or television reception, which can bedetermined by turning the equipment off and on, the useris encouraged to try to correct the interference by one ormore of the following measures: Reorient or relocate the receiving antenna. Increase the separation between the deviceand receiver. Connect the device into an outlet on a circuitdifferent from that to which the receiver is connected. Consult the dealer or an experienced radio/TVtechnician for help.32

Radio information of your wireless hearing aidAntenna typeOperation frequencyOccupied bandwidth(99% BW)ModulationChannelOperating rangeUse caseMagnetic field strength@ 10 m33Integrated ferrite coilantenna (inductive)10.6 MHzapprox. 500 kHzDQPSKSingle channel radio18 cm (7”)Streaming of audio orcommand signal toreceiving hearing aid onthe other ear-25 dBµA/m

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15. Information and descriptionof symbolsWith the CE symbol, Phonak AG confirms that thisPhonak product — including accessories — meetsthe requirements of the Medical Devices Directive93/42/EEC as well as the R&TTE Directive 1999/5/EC on radio and telecommunications equipment.The numbers after the CE symbol correspond tothe code of certified institutions that wereconsulted under the above-mentioned directives.This symbol indicates that the products describedin these user instructions adhere to therequirements for an applied part of Type B of EN60601-1. The surface of the hearing aid isspecified as an applied part of Type B.Indicates the medical device manufacturer, asdefined in EU Directive 93/42/EEC.35

This symbol indicates that it is important for theuser to read and take into account the relevantinformation in these user guides.This symbol indicates that it is important for theuser to pay attention to the relevant warningnotices in these user guides.Important information for handling andproduct safety.During transportation keep dry.36

OperatingconditionsThe product is designed such that it functionswithout problems or restrictions if used asintended, unless otherwise noted in these userguides. The hearing aids are classified IP68 (depthof 1 meter for 60 minutes) and designed to beused in all daily life situations. Therefore you donot have to worry about getting the hearingaids exposed to a rain shower or sweat. However,the hearing aid is not intended to be used inwater activities that includes chlorinated water,soap, salt water or other liquids with achemical content.Indicates the manufacturer’s serial number so thata specific medical device can be identified.Indicates the manufacturer’s catalogue number sothat the medical device can be identified.37

Temperature during transportation and storage:–20 to 60 Celsius (–4 to 140 Fahrenheit).Humidity during transportation: Up to 90% (noncondensing).Humidity during storage: 0% to 70%, if not in use.See instruction in chapter 17.2 regarding dryingthe hearing aid after use.Atmospheric pressure: 200 hPA to 1500 hPaThe symbol with the crossed-out garbagebin is to make you aware that this hearingaid may not be thrown away as normal householdwaste. Please dispose of old or unused hearingaids, at waste disposal sites intended for electronicwaste, or give your hearing aid to your hearingcare professional for disposal. Proper disposalprotects the environment and health.38

16. TroubleshootingProblemHearing aid not functioningCausesDead batteryBlocked speaker/earpieceBattery not inserted correctlyHearing aid switched offHearing aid whistlesHearing aid not inserted correctlyEarwax in ear canalVolume too loudLow batterySpeaker/earpiece blockedVolume too lowHearing has changedIndication for low batteryMoisture on battery orhearing aidHearing aid not loud enoughor distortedHearing aid plays two beepsHearing aid switches on & off(intermittent)If the problem persists, contact you hearing care professionalfor assistance39

What to doChange battery (chapter 1 5)Clean speaker opening/earpieceInsert battery correctly (chapter 1 5)Switch hearing aid on by completely closing the battery door(chapter 4)Insert hearing aid correctly (chapter 6)Contact your ENT/GP or hearing care professionalDecrease volume (chapter 1 8 9)Change battery (chapter 1 5)Clean speaker opening/earpieceTurn volume up if volume control available (chapter 1 8 9)Contact you hearing care professionalChange battery within the next 30 minutes (chapter 1 5)Wipe battery and hearing aid with dry cloth40

17. Important safety informationPlease read the information on the following pages beforeusing your hearing aid.A hearing aid will not restore normal hearing and will notprevent or improve a hearing impairment resulting fromorganic conditions. Infrequent use of a hearing aid does notpermit a user to attain full benefit from it. The use of ahearing aid is only part of hearing habilitation and mayneed to be supplemented by auditory training andinstruction in lipreading.41

17.1 Hazard warningsThe intended use ofhearing aids is to amplifyand transmit sound to theears and herebycompensate for impairedhearing. The hearing aids(specially programmed foreach hearing loss) mustonly be used by theintended person. Theyshould not be used by anyother person as they coulddamage hearing.Changes or modificationsto the hearing aid thatwere not explicitlyapproved by Phonak arenot permitted. Suchchanges may damage yourear or the hearing aid.Do not use the hearingaids in explosive areas(mines or industrial areaswith danger of explosions,oxygen rich environmentsor areas where flammableanesthetics are handled).Hearing aid batteries aretoxic if they are swallowed!Keep out of the reach ofchildren, individuals withcognitive impairment, andpets. If batteries areswallowed, consult yourphysician immediately!42

If you feel pain in orbehind your ear, if it isinflamed or if skinirritation and acceleratedaccumulations of earwaxoccur, please check withyour hearing careprofessional or physician.In very rare cases, thedome can remain in yourear canal when removingthe hearing tube from theear. In the unlikely casethat the dome does getstuck in your ear canal, itis strongly recommendedto see a physician forsafe removal.Hearing programs in thedirectional microphonemode reduce backgroundnoises. Please be aware43that warning signals ornoises coming frombehind, e. g. cars, arepartially or entirelysuppressed.This hearing aid is not forchildren below 36 months.It contains small partsthat can cause choking,if swallowed by children.Keep out of the reach ofchildren, individualswith cognitive impairment,and pets. If swallowed,consult a physician orhospital immediately.Do not make a wireconnection from yourhearing aid to any externalaudio sources like radioetc. That could causeinjuries on your body(electric shock).

The following is onlyapplicable for persons withactive implantable medicaldevices (i.e. pacemakers,defibrillators, etc.):Keep the wireless hearingaid at least 15 cm(6 inches) away from theactive implant. If youexperience any interference,do not use the wirelesshearing aids and contactthe manufacturer of theactive implant. Please, notethat interference can alsobe caused by power lines,electrostatic discharge,airport metal detectors etc.Keep magnets (i.e. batteryhandling tool, EasyPhonemagnet, etc.) at least15 cm (6 inches) awayfrom the active implant.If using a Phonak wirelessaccessory, consult thechapter “Important safetyinformation” in yourwireless accessoryuser guide.Hearing aids should not befitted with domes / waxprotection systems whenused by clients withperforated eardrums,inflamed ear canals orotherwise exposed middleear cavities. In these cases,we recommend the use ofa custom earpiece. In theunlikely case that any partof this product shouldremain in the ear canal, itis strongly recommendedto see a medical specialistfor safe removal.44

17.2 Information on product safetyPhonak hearing aids arewater resistant and notwaterproof. They aredesigned to withstandnormal activities andoccasional accidentalexposure to extremeconditions. Never immerseyour hearing aid in water!Phonak hearing aids are notspecifically designed forextended periods of watersubmersion on a continualbasis, that is worn inactivities such as swimmingor bathing. Always removeyour hearing aid beforethese activities, as thehearing aid containssensitive electronic parts.45Never wash themicrophone inputs. Doingso could cause it to lose itsspecial acoustic features.Protect your hearing aidfrom heat (never leave neara window or in the car).Never use a microwave orother heating devices todry your hearing aid. Askyour hearing careprofessional about suitabledrying methods.The dome should bechanged every threemonths or when itbecomes stiff or brittle.This is to prevent the domefrom detaching from the

tube spout during insertioninto or removal fromthe ear.When you are not usingyour hearing aid, leave thebattery door open so thatany moisture canevaporate. Make sure thatyou always completely dryyour hearing aid after use.Store the hearing aid in asafe, dry and clean place.a new one to avoid anyskin irritation. You canreturn used batteriesto your hearing careprofessional.Do not drop your hearingaid! Dropping onto a hardsurface can damage yourhearing aid.The batteries used in thesehearing aids should notexceed 1.5 Volts. Please donot use silver-zinc or Li-ion(lithium-ion) rechargeablebatteries as these maycause severe damage toyour hearing aids. The tablein chapter 5 explainsexactly which type ofbattery your particularhearing aids require.Always use new batteriesfor your hearing aid. Incase a battery is leaking,replace it immediately withRemove the battery ifyou are not using yourhearing aid for a longperiod of time.46

Special medical or dentalexamination includingradiation described below,may adversely affect thecorrect functioning of yourhearing aids. Remove andkeep them outside theexamination room/areabefore undergoing:Medical or dentalexamination with X-ray(also CT scan).Medical examinations withMRI/NMRI scans,generating magnetic fields.Hearing aids don’t need tobe removed when passingsecurity gates (airportsetc.). If X-ray is used at all,it will be in very low doses,and will not affect thehearing aids.47Do not use your hearingaid in areas whereelectronic equipmentis prohibited.

18. Important information: Cell phonesSome hearing aid users have reported a buzzing sound intheir hearing aids when they are using cell phones.According to the ANSI 63.19 (American National StandardMethods of Measurement of Compatibility betweenWireless Communications Devices and HearingInstruments) standard, the compatibility of a particularhearing aid and cell phone can be predicted by adding therating for the hearing aid immunity to the rating for thecell phone emissions. The sum of the hearing aid rating(e.g. M2/T2 2) and the telephone rating (e.g. M3/T3 3) is5, and any combination that equals 5 will provide “normaluse”; a sum of 6 or greater would indicate “excellentperformance”. The equipment performancemeasurements, categories and system classifications arebased upon the best information available but cannotguarantee that all users will be satisfied. The immunity ofthis hearing aid is at least M2/T2.48

Note: the performance of individual hearing aids may varywith individual cell phones. Therefore, please try thehearing aid with your cell phone or, if you are purchasinga new phone, be sure to try it with your hearing aid priorto purchase. For additional guidance, please ask yourhearing care professional for the booklet entitled “hearingaid compatibility with digital wireless cell phones”.49

19. For the US market only, complieswith the FDA regulationsWarning to Hearing Aid DispensersA hearing aid dispenser should advise a prospective hearingaid user to consult promptly with a licensed physician(preferably an ear specialist) before dispensing a hearing aidif the hearing aid dispenser determines through inquiry,actual observation, or review of any other availableinformation concerning the prospective user, that theprospective 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 theprevious 90 days.(iii) History of sudden or rapidly progressive hearing losswithin the previous 90 days.(iv) Acute or chronic dizziness.(v) Unilateral hearing loss of sudden or recent onsetwithin the previous 90 days.50

(vi) Audiometric air-bone gap equal to or greater than15 decibels at 500 hertz (Hz), 1,000 Hz, and 2,000 Hz.(vii) Visible evidence of significant cerumen accumulationor a foreign body in the ear canal.(viii) Pain or discomfort in the ear. Special care should beexercised in selecting and fitting a hearing aid whosemaximum sound pressure level exceeds 132 decibelsbecause there may be risk of impairing the remaininghearing of the hearing aid user. (This provision isrequired only for those hearing aids with a maximumsound pressure capability greater than 132 decibels (dB).Important Notice for Prospective Hearing Aid UsersGood health practice requires that a person with ahearing loss have a medical evaluation by a licensedphysician (preferably a physician who specializes indiseases of the ear) before purchasing a hearing aid.Licensed physicians who specialize in diseases of the earare often referred to as otolaryngologists, otologists orotorhinolaryngologists. The purpose of medical evaluationis to assure that all medically treatable conditions that51

may affect hearing are identified and treated before thehearing aid is purchased.Following the medical evaluation, the physician will giveyou a written statement that states that your hearing losshas been medically evaluated and that you may beconsidered a candidate for a hearing aid. The physicianwill refer you to an audiologist or a hearing aid dispenser,as appropriate, for a hearing aid evaluation.The audiologist or hearing aid dispenser will conduct ahearing aid evaluation to assess your ability to hear withand without a hearing aid. The hearing aid evaluation willenable the audiologist or dispenser to select and fit ahearing aid to your individual needs.If you have reservations about your ability to adapt toamplification, you should inquire about the availability ofa trial-rental or purchase-option program. Many hearingaid dispensers now offer programs that permit you towear a hearing aid for a period of time for a nominal feeafter which you may decide if you want to purchase thehearing aid.52

Federal law restricts the sale of hearing aids to thoseindividuals who have obtained a medical evaluation froma licensed physician. Federal law permits a fully informedadult to sign a waiver statement declining the medicalevaluation for religious or personal beliefs that precludeconsultation with a physician. The exercise of such awaiver is not in your best health interest and its use isstrongly discouraged.Children with Hearing LossIn addition to seeing a physician for a medical evaluation,a child with a hearing loss should be directed to anaudiologist for evaluation and rehabilitation since hearingloss may cause problems in language development andthe educational and social growth of a child. Anaudiologist is qualified by training and experience to assistin the evaluation and rehabilitation of a child with ahearing loss.53

20. Important notice for ProspectiveNoise Generator usersThe Tinnitus Balance noise generator is a broadbandsound Generator which may have been enabled in yourhearing aid. It provides a means of sound enrichment thatcan be used as part of a personalized tinnitusmanagement program to provide temporary relief fromtinnitus. It should always be used as prescribed by youraudiologist. The underlying principle of sound enrichmentis to provide supplementary noise stimulation which canhelp defocus your attention from your tinnitus and avoidnegative reactions. Sound enrichment, coupled withinstructional counseling, is an established approach tomanaging tinnitus.Good health practice requires that a person reportingtinnitus have a medical evalua

4 Your hearing aid details Model c Audéo B-10 (B90/B70/B50/B30) c Audéo B-312 (B90/B70/B50/B30) c Audéo B-312T (B90/B70/B50/B30) c Audéo B-13 (B90/B70/B50/B30) Earpiece c Dome c SlimTip c cShell Battery type 10 312 312 13 Your hearing care professional: If no box is checked and you do not know the