the audiologist’s guide to hearing aids, … 2018. american academy of audiology. . 3 based, in...

Copyright2018.AmericanAcademyofAudiology.www.audiology.org. 1

THEAUDIOLOGIST’SGUIDETOHEARINGAIDS,PSAPs,

HEARABLESANDOTCDEVICES

AMERICANACADEMYOFAUDIOLOGYJanuary2018


INTRODUCTIONTheFoodandDrugAdministration(FDA)isdevelopingproposedregulationsforover-the-counter(OTC)hearingaiddevices.AccordingtotheFDAReauthorizationActof2017,thesedeviceswillbeavailabletotheconsumerthroughretailoutletsandwithouthavingtoengageanaudiologist,eitherforapre-purchasehearingevaluation,orfortheselection,fittingorverificationofperformanceofthedevice.WhileOTCdeviceshavenotyetenteredthemarketplace,thisguidancewasdevelopedtoassistaudiologistsinunderstandingthedifferencesbetweenexistingproductsandOTCdevices,tobereadytoanswerquestionsaboutthesedevices,andpossiblytobegintopre-positionpracticesinanticipationoftheavailabilityofOTCdevices.ThisguidancewillbeupdatedastheregulationsforOTCdevicesbecomeavailable.BACKGROUNDInthesummerof2017,CongresspassedalawthatdirectedtheFDAtodevelopregulationsthatmakeOTChearingaidsavailabletothepublic.Priortothis,anumberoffederalagencies,notablytheFederalTradeCommission(FTC)andthePresident’sCouncilofAdvisorsonScienceandTechnology(PCAST),begantoreviewtheaccessibilityandaffordabilityofhearingcareintheUnitedStates.Simultaneously,theNationalAcademiesofScience,EngineeringandMedicine(NASEM)alsoconvenedacommitteetoreviewandreportonthestatusofhearingcaredeliveryintheU.S.TheFDA,theFTC,theNationalInstitutesofHealth,theVeteran’sAdministration,theDepartmentofDefense,andtheHearingLossAssociationofAmericacommissionedtheNASEMstudy.Thegenesisofthesecommitteesandreviewscanbetracedtothreefamiliarperceptionsandoneemerginghealthcareconcept.Thefirstistheperceptionthatthecostofhearingcare,andmorespecificallythecostofhearingaids,preventssomeindividualsfromseekingtreatmentforhearingloss.Second,manythirdpartypayersdonotcoverhearingaids;includingMedicarewherehearingaiddevicesandassociatedservicesarestatutorilyexcluded.Thethirdperceptionisthatthegeographicdistributionofhearingcareproviders,includingaudiologists,issuchthattherearemanyareasintheU.S.inwhichindividualscannotreadilyaccesshearingcareservices.Theemerginghealthcareconceptisthatconsumersaredemandinggreatercontrolovertheirhealthcare,includingthedesireto“self-direct”theirhearinghealthcare.Theimpetusmaybe,inpart,tocontrolthecostoftheirhealthcare,butalsotocontrolthetimeandeffortexpendedwhenengagedwithhealthcareproviders.Whilemanycommonchronicmedicalconditions,e.g.lowbackpain,arebeing“treated”withover-the-counterremedies,therehasbeennosuchoptionforthetreatmentofhearingloss.Thisemergingconceptcouldconceivablyincludealternativesthatallowedpatientsto“treat”theirhearinglosswithouthavingtoseeanaudiologist,otolaryngologist,ordispenser.Thesethemesledtoseveralagenciesrecommendingconsumeraccessover-the-counterhearingcaredeviceswithoutthenecessitytoengagetheprofessional.Theserecommendationswere


based,inpart,onbothemergingtechnologies(e.g.smartphoneapps,hearables,etc.)thatcouldprovidehearingbenefitandtheperceptionthatanever-increasingtechnologicallysavvypopulationmighthavethecapabilitytofitandprogramhearingcaredeviceswithouttheassistanceofanaudiologist.TheOTClawpassedbyCongress(S934:FDAReauthorizationActof2017)definesanOTCdeviceasonethat:

“(A)usesthesamefundamentalscientifictechnologyasairconductionhearingaids(asdefinedinsection874.3300oftitle21,CodeofFederalRegulations)(oranysuccessorregulation)orwirelessairconductionhearingaids(asdefinedinsection874.3305oftitle21,CodeofFederalRegulations)(oranysuccessorregulation);

(B)isintendedtobeusedbyadultsovertheageof18tocompensateforperceivedmildtomoderatehearingimpairment;

(C)throughtools,tests,orsoftware,allowstheusertocontroltheover-the-counterhearingaidandcustomizeittotheuser’shearingneeds;

(D)may—(i)usewirelesstechnology;or(ii)includetestsforself-assessmentofhearingloss;and

(E)isavailableover-the-counter,withoutthesupervision,prescription,orotherorder,involvement,orinterventionofalicensedperson,toconsumersthroughin-persontransactions,bymail,oronline.”

ThislawmandatesthattheFDAdevelopandpublishrulesnolaterthan3yearsaftertheenactmentofthelaw.Thefinalversionofthelaw,signedbyPresidentTrumponAugust18,2017,specificallynotesthefollowing:

“The Secretary of Health and Human Services … not later than 3 years after the date of enactment of this Act, shall promulgate proposed regulations to establish a category of over-the-counter hearing aids, as defined in subsection (q) of section 520 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360j) as amended by subsection (a), and, not later than 180 days after the date on which the public comment period on the proposed regulations closes, shall issue such final regulations.”

TheFDAhasbeguntheprocessofcollectinginformationanddata,includinginputfromprofessionalorganizations,federalagencies,andconsumergroupsandcouldpublishproposedrulesanytimewithinthenextthreeyears.IncludedintheproposedruleswillbethetimeframefortheFDAtoreceivefeedbackfromthepublicontheproposedrules.Duringthistime,organizations,agencies,orindividualscanprovidecomments,suggestmodifications,orprovidedifferentoptionsfortheproposedrules.ItisalsopossiblethattheFDAwillholdapublichearingatwhichtimetheoraltestimonycanbeprovidedontheproposedregulations.Atthecloseofthecommentperiod,theFDAwillevaluateanyoralorwrittentestimonyanddeterminewhetheranychangesintheproposedrulesarenecessary.Withinsixmonths(180days)ofthecloseofthecommentperiod,finalruleswillbepublished,alongwithadateofenactment.


TYPESOFHEARINGDEVICESThisdocumentreviewsdevicesandtechnologiescurrentlyavailableforconsumersandpatients.Theoptionspresentedwithinthisdocumentdonotincludesurgicallyimplantabledevices(e.g.cochlearimplants,middleearimplants,etc.).Asofnow,OTCdevicesdonotexistandthereforetheirform,function,cost,performancecharacteristics,orimpactonaudiologypracticesisspeculative.HearingAid:FDAregulationsdefineahearingaidas“anywearableinstrumentordevicedesignedfor,offeredforthepurposeof,orrepresentedasaidingpersonswithorcompensatingfor,impairedhearing”(21CFR801.420).HearingaidsareregulatedbytheFDAasClassIorClassIImedicaldevicesandareonlyavailablefromlicensedproviders.Hearingaidsmayberecommendedforindividualswithmildtoprofoundhearinglossandcanbecustomizedbytheprovider.PersonalSoundAmplificationProducts(PSAP):PSAPsareover-the-counter,wearableelectronicdevicesthataredesignedtoaccentuatelisteningincertainenvironments(notfull-timeuse).TheyaregenerallydesignedtoprovidesomemodestamplificationofenvironmentalsoundsbutbecausetheyarenotregulatedbytheFDA,theycannotbemarketedasdevicesthathelpindividualswithhearingloss.TheFDAsuggeststhatexamplesofsituationsinwhichPSAPstypicallyareusedincludehunting(listeningforprey),birdwatching,listeningtolectureswithadistantspeaker,andlisteningtosoftsoundsthatwouldbedifficultfornormalhearingindividualstohear(e.g.,distantconversations)(FDADraftGuidance,2013).PSAPsarecurrentlyavailableforpurchasebytheconsumeratavarietyofretailoutlets,includingthroughon-lineretailers.AudiologistscansellPSAPs.Assistivelisteningdevices(ALD),Assistivelisteningsystems(ALS),Alertingdevices:Broadly,acategoryofdevicesthatassistthepersonwithhearinglossmanagespecificlisteningenvironmentsorsituationsinwhichconventionaldevicesareinadequateorinappropriate.ALDsorALSscanbeusedatwork,home,placesofemploymentorplacesofentertainment,andcanbeusedtoimprovethesignal-to-noiseratio,counteracttheeffectofdistance,orminimizetheeffectofpooracoustics(e.g.reverberation.)Thesedevicesmaybeforpersonaluseorforgroups(widearea).Alertingdevicestypicallyutilizelight,intensesoundorvibrationtoconnectorsignalthepersonwithhearinglossabouteventsintheirenvironment,andcanbeconnectedtophones,lights,doorbells,smokealarms,etc.TheFDAdoesnotregulateALDs,ALS,oralertingdevices,althoughsomedevices,suchascaptionedtelephones,mayhavetocomplywithFCCregulations.Thesedevicescanbepurchasedthroughretailoutlets,on-line,andaudiologypractices.Insomecircumstances,thesedevicesareavailableforreducedcostthroughgovernmentagencies.Wirelesshearingaidaccessories:Therearenumerousaccessoriesavailabletodaythataredesignedtosupplementahearingaid,enhancecommunication,orusealternativemeansofcommunicating.Accessoriesincludedevicesthatallowthelistenertodirectlystreaminformationfromaphoneorotherpersonallisteningdevice(e.g.,tablet,computer,e-reader)aswellasremoteorlapelmicrophonesthathelpthelistenertohearoverlongdistances(e.g.,in


classrooms,conferencerooms,andlecturehalls).Hearingaidaccessoriesaregenerallypurchasedthroughaudiologypractices,butarealsoavailablethroughretailoutlets.Hearables:Ahearableisanyear-leveldevicedesignedtosupplementandenhancealisteningexperience,orthatincludesfeaturessuchasmonitoringvitalsigns(e.g.heartrate,bodytemperature,bloodoxygenlevels,etc.),activitytracking(e.g.steps,caloriesburned,etc.),augmentedhearing(allowsuserstofilteroutorenhancespecificsounds),musicstreaming,languagetranslation,orimprovedface-to-facecommunication.Thecategoriesofhearablescanincludein-eardevicesorheadphones.Hearablescanbepurchasedthroughretailoutlets,includingovertheInternet,andcouldbesoldbyaudiologypractices.FuturedevicesOver-the-counterhearingaid:Overthecounterhearingaidsdonotcurrentlyexist,butproposedlegislationdescribesOTChearingaidsasdevicesthatusethesamefundamentaltechnologyasatraditionalhearingaidsbutallowstheusertocustomizethesettingstotheuser’shearingneedsandareavailablewithouttheprescriptionofalicensedperson.TheFDAwouldregulateOTChearingaidsandmanufacturerswouldbesubjecttocertainlabelingrequirementsregardingappropriateuseofthedevicesbyconsumers.UnlikePSAPs,OTChearingaidswouldbeallowedforusebyindividualswithhearinglossbutunliketraditionalhearingaids,wouldbenarrowlytargetedforusebyadultswithmildtomoderatesensorineuralhearinglossonly.ItisnotknownhowOTCdeviceswillbedistributed,theirperformancecharacteristics,theircost,ortheimpactofthesedevicesonhearingcarebroadlyoraudiologypracticesspecifically.REGULATIONOFHEARINGAIDS,OTCDEVICESANDPSAPSThepurposeoftheFDAistoassurepatientsafetyintheuseofmedicalproducts,drugs,ormedicaldevices.Theirfocusisonassuringthatthebenefitsofanyproductordeviceoutweighthepotentialharmthatmightcomefromusingthedevice(i.e.thebenefit-riskratio).AnotherkeyfactorindeterminingiftheFDAprovidesanyregulatoryoversightisthe“intendeduse”oftheproductordevice.TheFDAregulatesproductsdesignedtobeusedtoevaluateortreatamedicalcondition.Theydonotregulateproductsthatarenotintendedtobeusedformedicalintervention.Hearingaidsareintendedtobeusedfortreatingamedicalcondition(hearingloss)whilePSAPsarenotintendedtobeusedformedicalconditions.Thus,theFDAregulatescurrenthearingaids,andwillregulate,inthefuture,OTChearings,butnotPSAPs.HearingaidsareregulatedbytheFDAasClassIorClassIImedicaldevices.Inpracticalterms,thedifferencebetweenClassIandClassIIhearingaidsisthatClassIIhearingaidsarethosethatincorporatesomesortofwirelesstechnology(ear-to-eartransmission,Bluetooth,etc.).AClassImedicaldeviceisexemptfrompremarketreviewandclearancebeforemarketing(21CFR874.3300(b)(1)),whileClassIImedicaldevicestypicallyrequireapremarketreviewandclearancebeforemarketing.However,wirelessdevices(whichclassifyasaClassIIdevice)areexemptedfromtherequirement.

ThefollowingisanexcerptfromtheFDAregulationsonClassI(21CFR874.3300)andClassII(21CFR874.3305)hearingaids:


Air-conductionhearingaid.

(a)Identification.Ahearingaidiswearablesound-amplifyingdevicethatisintendedtocompensateforimpairedhearing.Thisgenerictypeofdeviceincludestheair-conductionhearingaidandthebone-conductionhearingaid,butexcludesthegrouphearingaidorgroupauditorytrainer(874.3320),masterhearingaid(874.3330),andtinnitusmasker(874.3400).

(b)Classification.(1)ClassI(generalcontrols)fortheair-conductionhearingaid.Theair-conductionhearingaidisexemptfromthepremarketnotificationproceduresinsubpartEofpart807ofthischaptersubjectto874.9.

(2)ClassIIforthebone-conductionhearingaid.

Wirelessair-conductionhearingaid.

(a)Identification.Awirelessair-conductionhearingaidisawearablesound-amplifyingdevice,intendedtocompensateforimpairedhearingthatincorporateswirelesstechnologyinitsprogrammingoruse.

(b)Classification.ClassII(specialcontrols).Thespecialcontrolsforthisdeviceare:

(1)Appropriateanalysis/testingshouldvalidateelectromagneticcompatibility(EMC)andsafetyofexposuretonon-ionizingradiation;

(2)Design,description,andperformancedatashouldvalidatewirelesstechnologyfunctions;and

(3)Labelingshouldspecifyappropriateinstructions,warnings,andinformationrelatingtoEMCandwirelesstechnologyandhumanexposuretonon-ionizingradiation.

DevicesregulatedbytheFDAaresubjecttospecificpatientandprofessionallabelingrequirements(21CFR801.420.)Thelabelingrequirementsincludethehearingaiddeviceitself(e.g.,model,serialnumber,etc.),thecontentsoftheinstructionalbrochureincludedwiththedevices,andspecificinformationorinstructionforthedispenser.

Existingregulationsforhearingaidsspecifythatthepatientmustbemedicallyevaluatedbyaphysicianpriortothepurchaseofadevice,althoughthepatientmaywaivethemedicalevaluationbysigningawaiver.TheFDArequiresthattheaudiologistretaindocumentationofthemedicalevaluationofwaiverfor3yearsfollowingthepurchase.Personsundertheageof18musthaveamedicalevaluationandcannotsignawaiver.TheFDAannouncedin2016thattherequirementforamedicalevaluationoruseofthewaiverwouldnolongerbeenforced.However,thisrequirementdoesremainapartofthefederalregulations,andasmoststatelicensingagenciesrequirecompliancewithfederalregulations,themedicalevaluationorwaivercontinuestobenecessaryinmanystates.Audiologistsshouldcheckwiththeirstatelicensingboardsforclarificationofthisrequirement.TheFDAhasstatedthattheyintendtoeliminatethisrulewhentheOTCregulationsareissued.Withtheeliminationoftherule,the


necessityforamedicalevaluationorwaiverwillcease.Again,theaudiologistshouldcheckwithstatelicensingboardstoassuretheruleisnolongerineffectintheirstate.

Hearingaidssoldthroughretailoutlets,i.e.over-the-counter,willalsobesubjecttoFDAregulatoryoversight,andthuswillhavetomeetspecificrequirementsregardingpremarketapproval,performance,and/orlabelingrules.ThebillpassedbyCongressthatdirectstheFDAtodevelopregulationsforOTCdevicesactuallybegantheprocessofimplementingtheregulatoryframeworkbyspecifyingthefollowing:

(2) REQUIREMENTS.—In promulgating the regulations under paragraph (1), the Secretary shall—

(A) include requirements that provide reasonable assurances of the safety and efficacy of over-the-counter hearing aids;

(B) include requirements that establish or adopt output limits appropriate for over-the-counter hearing aids;

(C) include requirements for appropriate labeling of the over-the-counter hearing aid, including how consumers may report adverse events, any conditions or contraindications, and any advisements to consult promptly with a licensed physician; and

(D)describetherequirementsunderwhichthesaleofover-the-counterhearingaidsispermitted,withoutthesupervision,prescription,orotherorder,involvement,orinterventionofalicensedperson,toconsumersthroughin-persontransactions,bymail,oronline.

AdditionalregulationsregardingOTCdevicecharacteristicswillbeforthcomingfromtheFDA.Asnotedpreviously,theFDAdoesnotregulatePSAPsastheyareintendedforusebynon-hearingimpairedconsumers.TheFDAwebsitesdescribesPSAPsas:

“…intendedtoaccentuatesoundsinspecificlisteningenvironments,ratherthanforeverydayuseinmultiplelisteningsituations.Theyarenotintendedtocompensateforhearingimpairmentortoaddresslisteningsituationsthataretypicallyassociatedwithandindicativeofhearingloss.ExamplesofsituationsinwhichPSAPstypicallyareusedincludehunting(listeningforprey),birdwatching,listeningtolectureswithadistantspeaker,andlisteningtosoftsoundsthatwouldbedifficultfornormalhearingindividualstohear(e.g.,distantconversations).Examplesoflisteningsituationsthataretypicallyassociatedwithandindicativeofhearinglossinclude:difficultylisteningtoanotherpersonnearby,difficultyunderstandingconversationsincrowdedrooms,difficultyunderstandingmoviedialogueinatheater,difficultylisteningtolecturesinanotherwisequietroom,difficultyhearingthephoneordoorbellring,ordifficultylisteningsituationsinwhichenvironmentalnoisemightinterferewithspeechintelligibility.ProductsmakingtheseorsimilarclaimsshouldnotbeconsideredPSAPs.Inaddition,productsthataresoldasan“overthecounter”alternativeorsubstituteforahearingaidshouldnotbeconsideredPSAPs.BecausePSAPsarenotintendedto


diagnose,treat,cureormitigatediseaseanddonotalterthestructureorfunctionofthebody,theyarenotdevicesasdefinedintheFD&CAct.Assuch,thereisnoregulatoryclassification,productcode,ordefinitionfortheseproducts.Furthermore,therearenorequirementsforregistrationofmanufacturersorlistingoftheseproductswithFDA.”

AlthoughPSAPsarenothearingaids,andthereforenotsubjecttooversightunderexistinghearingaidregulations,PSAPscanbeconsideredaconsumerelectronic,and,assucharesubjecttoapplicableprovisionsoftheRadiationControlforHealthandSafetyActof1968,underwhichFDAregulateselectronicproductsthatemitsonicvibrations,suchassoundamplificationequipment.(21CFR1000.15.)ManufacturersofPSAPsmustreportdefectsandadverseevents(21CFRPart1003)andmustcomplywiththerequirementstorepurchase,repair,orreplaceelectronicproducts(CFRPart1004.)

TheAcademydevelopedandsubmittedseveralstatementstoCongressandtheFDAtoassistintheirdeliberationsregardingOTCdevices.Thefirststatement(AppendixA)addressedfourareas:(1)accessibilitytohearingcare;(2)assessmentandidentificationofhearingloss;(3)managementofhearingloss;(4)affordabilityofhearingcaretechnologyandservices;and(5)educationfortheconsumer.SubsequenttothesigningoftheFDAReauthorizationAct,theAcademyalsosubmittedadditionalrecommendationstotheFDAforconsiderationduringtherule-makingprocess(AppendixB.)TheserecommendationsweretargetedonspecifictechnologicalorlabelingrequirementsforOTCdevices. POTENTIALIMPACTANDOPPORTUNITIESOFOTCDEVICESOTChearingaidsdonotcurrentlyexistintheU.S.,andthereforethereisonlyspeculationastotheuptakeand/orbenefitofthesedevicesbyconsumers,orthesubsequentimpactonaudiologicpractices.Therecentlypassedlawtargetsthatsegmentofthepopulationwhohasmild-to-moderatehearingloss.OTCdevicesarenotsupposedtobeavailabletopatientswithseverehearinglossorgreater.NumerousscenarioshavebeenproposedregardingtheimpactofanOTCdevicesonaudiologicpractice,rangingfromthepotentialtoincreasethenumberofindividualsseekinghearingcareduetopositivetrialswithOTCdevices,tothepotentialtoclosepracticesduetoalargeuptakebyconsumersandthesubsequentnegativeeconomicimpactonpractices.However,untilOTCdevicesbecomeavailable,thetrueimpactwillnotbeknown.MitigatingtheimpactofOTCdevicesonaudiologicpracticeshouldbedriven,inpart,bytheabilitytodifferentiatethedevicefromthecriticalservicesprovidedbytheaudiologist,bothduringtheevaluationandduringthedevelopmentofatreatmentplan.Theproceduresconductedduringtheevaluation,andtheinstructionandcounselingbeyondthedevice,arekeyelementstosuccessfuloutcomesofpatientsusingamplificationdevicesanditmaybereasonabletoexpectthatthesefactorscouldbeusedtocreateanimportantdistinctioninthemindoftheconsumer,andthereforejustifytheneedtoengageanaudiologist.


Theargumenthasbeenmadethatconsumersmaynotbeabletodifferentiatesensoryhearinglossfromthoseformsthataremedicallyorsurgicallytreatable,andthereforethereisanincreasedlikelihoodofsignificantpathologybeingmissedaspartoftheOTCprocess.PertheNASEMreport,whichincludedotolaryngologistsandaudiologistsonthewritingpanel,theincidenceofsignificantmedicalpathologyisfairlylowinthetargetpopulationforOTCdevices,andmanyofthosepathologieshaveuniquesymptoms(e.g.unilateraltinnitusintheabsenceofhearingloss,pain,drainage,etc.)andthereforethesepatientsmaycommonlyself-selectintothehealthcaresystem.Basedonthesefactors,theimpactofOTConmissingtreatableotologicpathologywasnotconsideredtobesignificantbytheNASEMreport.Inspiteofthisperspective,theAcademybelievesthatitisinthebestinterestofanypatientconsideringamplificationtohaveacomprehensivehearingevaluationbyanaudiologistpriortomakingdecisionsregardinghearingdevices.Inthisway,significantotologicpathologycanbedetected,andamplificationdevices,ifnecessary,canbeintegratedintoacomprehensivetreatmentplan.AudiologistsareadvisedtopromotetheconceptofthenecessityofconsumershavingacomprehensiveaudiologicevaluationpriortopurchasinganyamplificationsystemorPSAPs.WithintheCongressionalmandateforOTCdevicesisthatdevicesbeavailableforpersonswithmild-to-moderatehearingloss,whichisinconsistentwithresearchthatdemonstratesthatpatientscannotself-identifyeventhepresenceofahearinglossorareabletodifferentiatetheirdegreeofhearingloss(e.g.mild,moderate,severe,etc.).TherecentstudybyHumesetal.(2017)confirmsthisperspective.Thisdichotomyraisesthequestionastohowaconsumercanbeabletodifferentiatetheirdegreeofhearinglosswithoutfirstobtaininganaudiogram.Theabilitytodifferentiatebetweentypesanddegreesofhearingloss,understandingthevarietyofcommunicationneedsofeachpersonwithhearingloss,andthecontributionofindividualcharacteristicsofeachpatienthasbeenfoundtobecrucialtoassuringthebesttreatmentoutcomesforeachpatient.Asconsumerscannotdifferentiatetype,degree,configurationoretiologyofhearingloss,itfollowsthatbestoutcomeswillnotbeachievedbasedonperceptionofhearinglossalone.Thenecessitytoprovideguidancetopatientsregardingtheappropriatetechnologywouldindicatetheneedtoobtainacomprehensiveaudiologicalevaluationpriortomakingdecisionsregardingspecifictechnologiesisinthebestinterestofthepatient.Therefore,theAcademyrecommendsthatpatientsconsideringtheuseofatechnologytoovercomecommunicationorfunctionallimitationswouldbebestservediftheyobtainedacomprehensiveaudiologicassessmentpriortoacquiringanytechnology.Inthismanner,theconsumercanbeinformedastotheirneedsandtheirpossiblesolutions.Conversely,consumerperceptionregardinghearingdifficultymaynottranslatetopuretoneloss,andthereforeaudiologistsshouldbepreparedtocommunicateeffectivesolutions,includingofferingtreatments,theindividualcouldusetomitigatetheircommunicationdifficulties,inspiteofnormalpuretonethresholds.ThereisnoprohibitionagainstanaudiologistsellingaPSAP,ALDorhearables,inadditiontothetraditionalhearingaid,andthereforeaudiologistsarefreetochoosewhichofthecategoriesofdevicestomakeavailablewithintheirpractices.Anaudiologistcanselectthetechnologythatmeetsanindividual’slong-termneeds,addressestheirprimarycommunicationconcerns,and/orenhancesqualityoflife,particularlywhenprovidedwithinthecontextofacomprehensivecommunicationtreatmentplan.Identifyingdevice(s)thatfitapatient’s


lifestyle,areeasilyutilized,andmeetfinancialconstraintsarealsoimportantconsiderations.Audiologistsmayconsiderincorporatingintotheircounselingwhetherthedeviceisintendedtobeusedtoaddresshearingloss(hearingaids,OTChearingaids)ornot(PSAPs)andthereforeisanoff-labeluseofthedeviceConcernsaboutOTCdevicesareoftennarrowlyfocusedonthepotentialforadirectandnegativeimpactonapractice.Recentinvestmentreports(Bernstein,2107)suggestthattheimpactofOTCdevicesonhearingaidsaleswillbeminimal,andthatanylossesrealizedbyindustryorpracticeswillbemorethanoffsetbygrowthintheagingpopulation.Infact,theseinvestorssuggestagreaterthan5%annualgrowthinthehearingaidmarketoverthenextfewyears,inspiteoftheadventofOTCs.SELECTIONOFCURRENTDEVICESFORPATIENTSThefollowingisprovidedasgeneraldescriptiveinformationandshouldnotbeinterpretedasconstitutingdefinitiveguidanceonuseordispensingofdifferentproducts.OTCdevicesarenotincludedinthissectionasthereisnoinformationcurrentlyavailableabouttheirutilization.HEARINGAID

DESCRIPTION:AClassIorClassII(wirelessandtinnitus)wearablesound-amplifyingdevicethatisintendedtocompensateforimpairedhearingandisthereforeregulatedbytheFDAasamedicaldevice.Manufacturersandprovidersmustcomplywithspecificregulationsrelatedtothedesign,dispensing,anduseofthesedevices.TARGETPOPULATION:Allageswithanydegreeofhearingloss,mostcommonlysensorytypelosses,andinsomecases,conductiveormixedhearinglossUTILIZATION:UsuallyanappropriateconsiderationforanydegreeofhearinglossWHEREPURCHASED:AudiologistDISPENSINGGUIDANCE:Followingacomprehensiveaudiologicalevaluation,adeviceisordered,fit,andprogrammedspecificallytotheindividual’sneedsbytheaudiologistaspartofacomprehensivetreatmentplan.Instructiononuseandcareofthedeviceisprovided.Additionalinstructionalorrehabilitativeservicesmaybeprovidedtoincreasecompliance,orimproveoutcomesorbenefitfromthedevice.AlthoughtheFDApreviouslyrequiredmedicalclearancefromaphysicianpriortothefittingofahearingdevice,inDecember2016,theFDAindicateditnolongerintendstoenforcethisrequirement.Dependingonyourstate,youmaynolongerberequiredtoobtainmedicalclearancebeforethehearingdevicefitting.ItisexpectedthattheFDAwillremovethemedicalevaluationrequirementwhentheregulationsforOTCdevicesarefinalized.THIRDPARTYCOVERAGE:Variesbypayer.NocoveragefromMedicarefordeviceorassociatedservices.NOTESANDCONSIDERATIONS:• Typicallyincludes,orhastheoptiontoinclude,adevicewarranty,follow-upservices,

andaccesstoaproviderforothersupplementalcare• RegulatedbytheFDA• LikelytooffermoreadvancedfeaturesandflexibilityinprogrammingthanOTCdevices


• Whencomparingcosts,itisimportanttodifferentiatebetweenthedeviceonlyandthedeviceplusassociatedtheservices(bundled).TheAmericanAcademyofAudiologyencouragesitsmemberstodistinctlydescribedeviceandprofessionalfeestosupportpatients’greaterunderstandingofcostsassociatedwiththeirtreatmentplan.

PERSONALSOUNDAMPLIFICATIONPRODUCT(PSAP)

DESCRIPTION:WearableelectronicdevicethatminimallyincreasesamplificationincertainlisteningenvironmentstoaccentuatehearingTARGETPOPULATION:Adultswithnormalhearing;cannotbemarketedasatreatmentforhearingloss.Thereisnoprohibitionforchildren,asthesedevicesarenotintendedtotreathearingloss.UTILIZATION:Patientsinneedofminimalamplification,particularlyinspecificandinfrequentlisteningsituations(e.g.hunting,restaurants,etc.)WHEREPURCHASED:Audiologists,online,retailersDISPENSINGGUIDANCE:PSAPscanbepurchasedoverthecounterorthroughanaudiologypractice.Aprescriptionfromalicensedproviderisnotnecessary.Audiologistsshouldbepreparedtodiscusstheappropriatenessofthistechnologyfortheirpatient’sneedsandprovideguidancebeforepurchase.AudiologistscansellPSAPsasalternativeproductstohearingaids.THIRDPARTYCOVERAGE:NonecurrentlyandnotexpectedNOTESANDCONSIDERATIONS:• Lowcostandeasilyaccessible• NotregulatedbytheFDA• Self-fittingwithminimalfeatures;volumecontrolcommon;somehigh-enddeviceshave

smart-phoneappsthatallowprogrammingoffrequencyresponse• Havethepotentialtooveramplifycertainsoundswhichcanbedamagingtohearing• Havethepotentialtoactlikeanearplugandthusdiminishhearingability• Couldcausecerumenimpaction• Warrantiesbasedonmanufacturer

ASSISTIVELISTENINGDEVICE(ALD)DESCRIPTION:Acategoryofdevicesthatassistthepersonwithhearinglossmanagespecificlisteningenvironmentsorsituationsinwhichconventionaldevicesareinadequateorinappropriate.TARGETPOPULATION:Anyage;withorwithouthearingloss.Thereisnoprohibitionforchildren,asthesedevicesarenotintendedtotreathearingloss.UTILIZATION:UsedinspecificlisteningsituationsorwithinspecificenvironmentstoassistthepersonwithhearinglossWHEREPURCHASED:Audiologists,Online,retailersDISPENSINGGUIDANCE:ALDscanbepurchasedoverthecounterorthroughanaudiologypractice.Aprescriptionfromalicensedproviderisnotnecessary.Audiologistsshouldbepreparedtodiscusstheappropriatenessofthistechnologyfortheirpatient’sneedsandprovideguidancebeforepurchase.AudiologistscansellALDsasanalternativeproducttohearingaids.


THIRDPARTYCOVERAGE:NonecurrentlyandnotexpectedalthoughsomeagencieswillprovidesomeALDsatlowornocostNOTESANDCONSIDERATIONS:• Lowcostandeasilyaccessible• NotregulatedbytheFDA• Warrantiesbasedonmanufacturer

HEARABLES

DESCRIPTION:Anyofanumberofdeviceswornatearlevelthatprovidethewearerwithfunctionalitywithintheauditorydomain,includingaudiocuration,musicorcommunicationstreaming,languagetranslation,improvedunderstandinginbackgroundnoise,etc.Mayincludeminimalamplificationtoaccentuatehearingincertainlisteningenvironments.TARGETPOPULATION:Adultswithnormalhearing;cannotbemarketedasatreatmentforhearingloss.Thereisnoprohibitionforchildren,asthesedevicesarenotintendedtotreathearingloss.UTILIZATION:Ifapatientneedsminimalamplification,particularlyinspecificandinfrequentlisteningsituations(e.g.hunting,restaurants,etc.),ordesiresconnectivitywithdevicessuchassmartphonesorTVsWHEREPURCHASED:Online,retailers,audiologistsDISPENSINGGUIDANCE:Hearablescanbepurchasedoverthecounterorthroughanaudiologypractice.Aprescriptionfromalicensedproviderisnotnecessary.Audiologistsshouldbepreparedtodiscusstheappropriatenessofthistechnologyfortheirpatient’sneedsandprovideguidancebeforepurchase.Audiologistscansellhearablesasalternativeproductstohearingaids.THIRDPARTYCOVERAGE:NonecurrentlyandnotexpectedNOTESANDCONSIDERATIONS:• Lowcostandeasilyaccessible• NotregulatedbytheFDA• Self-fittingwithminimalfeatures;volumecontrolcommon;somehighenddeviceshave

smart-phoneappsthatallowprogrammingoffrequencyresponse• Couldcausecerumenimpaction• Warrantiesbasedonmanufacturer

WIRELESSCONNECTIVITYANDACCESSORIESWHO:AllagesWHAT:Includesremotemicrophones,personalneckloopsystems,FMsystems,Bluetooth®phonesystems,TVstreamingsystems,andothers.WHERE:Audiologist;someonlineretailersWHEN:Ifhearingaidsworkwellinmostsituations,butadditionalhelpisneededinchallenginglisteningsituationslikeoverdistanceorinnoise,orforeasyuseofothertechnologieslikephonesandpersonalelectronicdevicesHOW:Accessoriesthatarespecificallydesignedtobeusedwithonebrandofhearingdevicemustbeorderedthroughthehearingcareprovider.Genericorgloballycompatiblesystems,suchaspersonalneckloopsworkingthroughtelecoil,areavailablefromthehearingprovideraswellasonlineproviders.


CONSIDER:• Wirelessconnectivityandaccessoriesenhancethebenefitofhearingdevicesbymaking

iteasiertousepersonalelectronicsandcommunicateinchallengingenvironments• Maybeadditionalcostabovehearingdevice;notusuallycoveredbyinsurance

BUNDLINGVERSUSUNBUNDLINGWITHINAUDIOLOGYPRACTICESWithintheaudiologydeliverysystem,thecostsofthetreatmentservices,particularlyifthoseservicesincludeamplificationdevices,maybe“bundled”togetherasasingleprice.Inadditiontothescopeofthetreatmentservices,thebundledpricealsowillincludecostsforwarranties,replacementguarantees,batteriesforthedevices,cleaningkits,earmolds(ifnecessary),andsomepredeterminedlengthoftimeduringwhichofficevisitsareprovidedatnocharge.Thus,bundledpricingincludesboththedeviceandtheservicesassociatedwiththetreatmentplan.Thisprocessissimilartothemannerinwhichsurgicalproceduresareconducted,chargedandreimbursed.Inadditiontothesurgicalprocedureitself,thesurgeon’schargealsoincludessomepre-determined,post-operativetimeperiodduringwhichtheofficevisitsandphysicianencountersareprovidedaspartofthenecessaryfollow-uptothesurgery.Patientsmayreturnasoftenasnecessaryduringthistimetoreceivecareastheofficevisitchargesarebundledwiththesurgicalcharge.Whileallpatientsgenerallyreturnonceortwice,theremaybethosethathavesmoothrecoveriesthatdonotneedadditionalcare,andthosethathavedifficultrecoveriesthatmayneedadditioncarefromthesurgeon.Similarly,whenindividualsreceivehearingaids,theyaregenerallyprovidedwithfollow-upcareforsomepre-determinedlengthoftime,andthenumberofencounterswiththeaudiologyproviderswillvarydependingontheneedsofthepatient.Theexceptiontobundledchargesforaudiologyservicesisthattheinitialdiagnosticservicesaregenerallynotincludedinabundledpricingstructure.Thirdpartypayers,includingMedicare,generallyreimbursediagnosticservicesprovidedbyaudiologists.ItisimportanttorecognizedthatMedicarerequiresaphysicianreferraltobereimburseableandanyhearingtestprovidedforthepurposeofprogramminghearingaidsisstatutorilyexcluded.AsparticipatingproviderswithMedicare,audiologistsmustchargeMedicarebeneficiariesthesamefeeasanyotherpatient,andthereforedonotofferfreehearingtests.Someinsurancecompaniesrequirebundlingofthedeviceandservices.Bundledpricinggenerallyincludesthefollowingadvantagestotheconsumer:

• Inclusionofpost-fittingservices• Cleaningandin-officerepairsatnocharge• Longtermlossanddamagewarranties• Batteriesandaccessories(e.g.waxguards)providedatnocharge• Semi-annualchecksofhearingaidsandreprogrammingofhearingaidsatnocharge.

Conversely,unbundlingrequiresthatthechargeforamplificationdevicesbeseparatedfromtheassociatedservices.Inthisscenario,thedevicesandaccessories(e.g.carekit,batteries,earmolds,etc.)arepricedindependentofthediagnosticservices,thedeliveryfeeforthehearing


aids,long-termwarrantiesandthelong-termpost-fittingfollow-upservices.Theunbundledmodel(alsocalled“pay-as-you-go”model)hasthefollowingadvantages:

• Allowstheconsumertoreadilydifferentiatethecostofthedevice,accessoriesandservices.

• Providestheconsumerwiththeopportunitytobeselectiveinchoosingthelevelofservices.

• Reducesthepricedifferentialbetweenlow,mid-rangeandhigh-leveltechnologiesasthecostoftheservicesarefixed,regardlessofthetechnologies.

• Allowsconsumerstopurchasedevicesthroughotherplatformsandthenreceiveonlytheservicecomponentsfromtheaudiologist

TheAcademybelievesthatpricingforamplificationdevices,accessoriesandassociatedservicesshouldbetransparenttothepatient,andhaspublishedguidance,educationalmaterials,andanumberofresourcestosupportunbundling,mostrecentlyinourstatementonAffordabilityandAccessibilityofHearingCare.Inspiteofthebenefitsofunbundling,challengesexist.Forexample,thereisalackofconsistencyamongpayersleadingtosomeservicesbeingreimbursedbyinsuranceandsomenot.Somepatientsmaybeabletoaccesstheirbenefitsmorefullywhenservicesarebundled.Thecomplexityofreimbursementdoesnotallowforthedevelopmentofasimplesolutiontotheissueofunbundling.AstheOTCapproachdevelops,unbundlingshouldprovidetheopportunityforpatientstomoredirectlycomparethecostofdevicesacrossdifferentacquisitionoutlets.Itshouldalsohighlighttheservicesassociatedwithoptimizingoutcomeswithamplificationdevices.Inthisregard,oneofthecriticalelementsforsuccessintheOTCerawillbetohighlightthecriticalroleservicesplayinachievingbenefitwithamplification.


CONSUMERFAQs:Asconsumersareintroducedtonewtechnologiesandmaybegintoinvestigateoptionsformore“self-directed”care,audiologistsshouldbepreparedtoconsiderandanswerthefollowingquestions.Whyisanaudiologicevaluationimportantpriortoacquisitionofanyamplificationdevice?

Consumersmaybeableto“self-identify”thepresenceofacommunicationproblemorafunctionallimitationorparticipationrestriction.However,thereisnoevidencethatindividualscanconsistentlycorrectlyidentifythedegree,typeorcauseofhearingloss,ortodiscriminatethosehearinglossesthatrequireaudiologicormedicalintervention.Ideally,individualswhobelievetheyhaveacommunicationproblemorfunctionallimitationarebestservedbyhavingacomprehensiveaudiologicalevaluationpriortoaccessinganytreatmentoption.Thisevaluationservestoidentifytheoptionsfortreatmentaswellasassuresthatunderlyingtreatablemedicalconditionsareidentified.Furthermore,itisimportanttorecognizethatthemanagementofhearingencompassesfarmorethanthesimplefittingofadevice.Anaudiologicevaluationallowsforathoroughunderstandingofthecapabilitiesandlimitationsofanindividualtocommunicateinavarietyofenvironments.Ahearingneedsassessmentconveystotheaudiologistwhichfeaturesandfunctionsareessentialforachievingthestatedcommunicationgoals.Realisticexpectationsforspecificsituationscanbeoutlined,andcommunicationstrategiesorassistivedevicesthatcansupplementahearingdevicecanbeidentified.Thefocusofanaudiologistisnotsimplyondispensingahearingdevice.Rather,theaudiologicevaluationiscenteredonimprovingthequalityoflifeofapatient.Withtheintroductionandincreasingavailabilityofover-the-counterdevicestothegeneralpublic,itisimportanttorecognizethatincorporationofaudiologicevaluationanddiscussionofappropriatemanagementoptionsremainsbestpractice.

Cantheaudiologistprogramadeviceacquiredthrougharetailoutlet?

ManyPSAPsthatarecurrentlyavailableonthemarkethavesomefrequencyresponseprogrammingalongwithvolumecontrolsanddirectionality.Thesedevicesarecommonlyprogrammablethroughsmartphoneapps.Audiologistscanmakeadeterminationastowhethertheywanttoprogramadirect-to-consumerdevice,aswellassetanyfeesassociatedwiththeservicedelivery.

CananaudiologistsellaPSAPor,inthefuture,anOTCdevice?

Yes,audiologistscansellPSAPsintheirpracticescurrently.Dermatologistssellskin-careproductsthatarealsoavailableatretailoutlets.Similarly,dentalhygieneproductscanbepurchasedwithindentalpracticesandretailsites.However,audiologistsshouldbeawareofseveralimportantfactorsshouldtheydecidetosellPSAPsintheirpractices.First,asthesedevicesmaynotnecessarilybeconsidered“medical”devices,theremay


beasalestaximplicationwithincertainstates.Audiologistsshouldcheckwiththeirlegalcounselorstatelicensingboardstoassuretheyarecompliantwithtaxlawsfortheseproducts.Second,asOTChearingaidswillbeavailablewithoutaprescriptionorwithoutthenecessityforprofessionalengagement,thelegalresponsibilitiesforOTCversustraditionalhearingaidsmaybedifferentwhenthedevicesaresoldside-by-sideinanaudiologypractice.WhenOTCdevicesbecomeavailable,licensingboardsshouldbeabletoofferguidanceinthisregard.

Thethirdfactoristhenecessitytodeveloppracticeguidelinesregardingthesaleofproductsthatmaycarrydifferentoutcomesorusesthantraditionalhearingaids.Warranties,dispensingfees,expectedlifespan,returnpolicies,refundablefees,andfollow-upservicesmightbedifferentwithPSAPsdevicesthantraditionalhearingaids.Theaudiologistandstaffwillhavetobeabletocommunicatethedifferencesandpatientswillhavetobemadetounderstandthedifferencesbetweenthedeviceswhenacquiredthroughanaudiologicpractice.Finally,theethicalparametersassociatedwithdevicesthatareavailablethroughretailoutletsarenotthesameasthoseassociatedwithtraditionalhearingaids.Aspreviouslynoted,dermatologistscansellskincareproductsthroughtheirpractices,andsolongasthosesameproductsareavailablethroughretailoutlets,thedermatologistcannegotiatedifferentarrangementswithsuppliersthanwouldotherwisebeinplaceforproductsnotavailablethroughretail.

Whatisthedifferencebetweenacquiringadevicethrougharetailoutletversusacquiringthedevicethroughanaudiologist?

Themostobviousdifferenceisintheexpertiseoftheaudiologistinconductingathoroughevaluation,assuringthecorrectdeviceisselected,settingrealisticexpectations,guidingapatientinutilization,andincreasingcomplianceinusingthedevicethroughcomprehensiveinstruction.Theroleoftheaudiologistinassessing,diagnosingandtreatinghearinglosscannotbeunderstated,andshouldbeapointofemphasisregardlessofthetypeoftechnologyavailable.Inaddition,theaudiologistcanprovideanyadditionaltreatmentoptions,includingaudiologicrehabilitation.

HowdoIdecidewhethertorecommenddevicesotherthanahearingaid?

Treatmentforhearinglossmayincludedevelopingalternativecommunicationstrategies,counselingofbothpatientandtheirsignificantothers,acquisitionofassistivelisteningdevices,provisionofamplificationdevices,orsomecombinationoftheabove.Twoindividualswithidenticalhearinglossesmayhavecompletelydifferentcommunicationneeds,andthereforedecisionsregardingtreatmentplansarebasedonindividualpatientcharacteristics,includinglifestylevariations,employmentstatus,orsocializationrequirements.Themannerinwhichtreatmentisdeliveredwillvarybasedontheaccessofthepatienttohearingcareservices,physicalcharacteristicssuchasdexterityandcognitivefunction,andthefamilysupportstatusofthepatient.Thus,thecomplexityofthecharacteristicsofthepatient,beyondthehearingloss,willdictatethescopeofatreatmentplan.Decisionsregardingthedevicetorecommendtoapatientwillbebasedonalloftheabovefactors,includingsocioeconomicstatus.


Theaudiologistwillhavetodeterminewhichdevicetousebasedonthespecificcomplaintofapatient,incombinationwiththeresultsofanaudiologicalevaluation.TherehasbeennospecificguidancedevelopedonutilizationofPSAPswithinaudiologicpractices,and,asOTCdevicesdonotcurrentlyexist,thereisalsonoguidanceondispensingthesedevices.Whenamplificationisincludedaspartoftheoveralltreatmentplan,theamplificationserviceshavehistoricallyincludedcomprehensivefollow-upservicestoassurethepatientisappropriatelyfitaswellasachievingtherequiredbenefit.Thisincludesadjustmentofthedevicesovertimeasthebrainacclimatizestothechangedauditoryinput.Inthisregardthetreatmentplanmayalsoincludecounselingregardingexpectationsofbenefit,developmentandimplementationofaninstructionalplanforincreasingcommunicativecompetence,coordinationofcarewithotherprovidersinthecasesofexistingcomorbidities,andmeasurementofprogressandoutcomesassociatedwiththedevices.Inaddition,decisionsregardingalternativeoptionsforovercomingfunctionallimitations(e.g.FMsystems,directaudioinput,streamingcapabilities,cochlearimplants,etc.)arealsoincludedinthepostfittingservicesforamplification.

WhatarethecontraindicationsforPSAPsorothernon-traditionalhearingaids?

TherearefourprimaryconcernswithcompletelyunsuperviseduseofaPSAP:(1)providingmoreamplificationthanisnecessaryandpotentiallycausinggreaterhearingloss;(2)providinglessamplificationthanisnecessaryandsufferingconsequencesofundertreatedhearingloss;(3)providinggainwithoutregardtothetypeofhearinglossandtheassociatedprocessingabilitiesofthepatientcanactuallymakethemhearworseratherthanbetter,eveniftheamountofgainisappropriate;or(4)failingtoidentifyanunderlyingmedicalconditiontothehearingloss.Thisoversightmaybeassimpleasfailingtorecognizetheearcanalcontainsimpactedearwaxorasseriousasfailingtorecognizethehearinglossistheresultofatumor.TheAmericanAcademyofAudiologyrecognizesthatbestpracticeswouldsuggestthesedeviceswouldbestserveindividualswithnomorethanmildhearinglossforwhomthebenefitsofamplificationwiththedeviceoutweightherisksthatareinherenttoself-diagnosisandself-directedtreatment.Inotherwords,whenconsumersselectahearingdevice,withouttheevaluationofanaudiologist,thereisariskthatfurtherharmmaybedonebyselectinganinappropriatedeviceorusingitineffectively.ConsumersshouldbeawareoftheserisksandusePSAPdevicescautiously.TheAmericanAcademyofAudiologyrecommendsthatconsumerscompleteacomprehensivehearingevaluationbeforeselectinganOTCdevice,andthattheychoosetousethesetechnologiesonlyupontheadviceofanaudiologist.


APPENDIX1

StatementoftheAmericanAcademyofAudiologywithrespecttoaccessibilityandaffordabilityofhearingcareforadultconsumers

January26,2017TheAmericanAcademyofAudiologysupportsconsumerautonomywithrespecttocontrolovertheirhealthcaredecisions,includingaccesstosafeandaffordablehearingcare.Inthiscontext,hearingcaredescribesabroadrangeofservices,includingtheassessmentofhearingfunction,determinationofthetypeandextentofthehearinglossorlossoffunction,diagnosisofthecauseofthehearinglossorlossoffunction,determinationoftheoptionsavailablefortreatmentormanagementoftheloss,andtheprovisionofthoseservicesortechnologiestomitigatethehearinglossorminimizethecommunicativeimpairment.Theincreasingneedforhearingservicesamongtheagingpopulation,includingmanagementofhearinglosswithhearingdevices,coupledwithadvancementsintechnologythatmayofferconsumersmoreopportunitytoself-directtheircare,haverecentlygarneredtheattentionoffederalregulatoryagenciesandadvisoryboards.Itiswelldocumentedthathearingaidadoptionbyindividualswithhearinglossislow.Studieshavesuggestedthatbarrierstoadoptionincludemildhearinglossornoperceptionofactivitylimitationsorparticipationrestrictions,youngerage,perceivedstigma,lackofencouragementtoseekinterventionfromprimarycareproviderorsignificantothers,andperceptionofmoreobstaclesthanbenefittoamplification(Jenstad&Moon,2011;Meyer&Hickson,2012).TheAcademyrecognizesthataccessibility,appropriateassessmentandmanagement,andaffordabilityoftreatmentoptionsmaybecriticalcomponentstoencouragingappropriateadoptionofhearingtechnologies.Assuch,theAcademyseekstoofferguidancethatwilloptimizethequalityofcareforpatientswithhearinglossinlightofrecentproposalsthatsuggestchangesintheestablishedhearingcaredeliverymodel.Recommendation#1:AccessibilitySeveralfactorsmaymakeaccesstoappropriatehearingcarechallengingforconsumers.Theseincludeseveralclassesofhearingdevices,variousprovidersofservices,geographicdistributionofprovidersandheterogeneityamongindustrymanufacturersanddevices.TheAmericanAcademyofAudiologyrecommendsimprovingaccesstohearinghealthcareforconsumersthroughthedevelopmentofthefollowing:

a.) Acommonlanguageandterminologytobeusedacrosshearinghealthcarevenuesandprovidersthattheconsumercaneasilyunderstand.Thislanguageshouldapplytoprofessionalpractices,providers,andhearingdevices,regardlessofpointofserviceorsale.

b.) Acleardifferentiationofthecostofservicesfromthecostofproductswhenpurchasinghearingdevices.Continuedbundlingofthecostofproductswiththecostofservicesdoesnotprovidethetransparencythatallowsconsumerstomakeinformeddecisionsnordoesitencourageconsumerstoappreciatetheroletheaudiologistplaysinassuringoptimaloutcomeswhentreatmentisindicated.Bundlingproductsandservicesisthereforenotin


thebestinterestoftheconsumernorthemembersoftheAcademy,northeaudiologycommunityatlarge.

c.) Regulatoryorstatutoryrequirementsthatallowdirectandcost-effectiveaccesstoaudiologicservices,includingeliminationoftherequirementforMedicarebeneficiariestoobtainaphysician’sorderforaudiologicevaluationandtheeliminationoftheFDArequirementformedicalclearanceorwaiverpriortofittingahearingdevice(asopposedtonon-enforcementofthecurrentregulation).

d.) Increasingaccesstoaudiologyservicesthroughthesupportfortelehealthinitiativesthatallowconsumersinunderservedmarketstoreceivehearingcareservices.

Recommendation#2:IdentificationandAssessmentTheAcademyendorsestherightsofindividualstoself-directtheirhearingcareprovidedthatcareissafeandeffective.TheAcademysupportstheconceptthatconsumersmaybeableto“self-identify”thepresenceofacommunicationproblemorafunctionallimitationorparticipationrestriction.However,nostudiessuggestthatconsumerscandifferentiatedegree,typeoretiologyofhearingloss,ortodiscriminatethosehearinglossesthatrequireaudiologicormedicalintervention.Theconceptofself-diagnosisimpliesthecapabilitytodeterminetheetiology,thetype,andthedegreeoftheloss,whichisnotpossiblewithoutacomprehensiveaudiologicevaluation.Therefore,theAcademydoesnotsupporttheconceptof“self-diagnosis”withrespecttoself-directedhearingcare,andinsteadrecommendsthattheterm“self-identification”beusedtoidentifytheconsumer’sabilitytodeterminetheneedforhearingcare.Ideally,individualswhobelievetheyhaveacommunicationproblemorfunctionallimitationhearinglossarebestservedbyhavingacomprehensiveaudiologicalevaluationpriortotheiraccessinganytreatmentoption.Thereareagrowingnumberoftools(e.g.smartphoneapps,on-linetests,homehearingtests)availableforpatientstoassesstheirhearingwithouttheneedforaprofessionalevaluation.Intheirpresentform,however,thesetoolsonlyprovidegeneralclassificationsoflossorfunction,butcannotprovidecomprehensivedataondegree,configuration,typeoretiologyofloss,norquantifycommunicationability.Assuch,theAcademyrecommendsthatanydevicesorapplicationsthatclaimtoevaluatehearingorauditoryfunction,andaremadeavailabletotheconsumerforself-evaluation,clearlydescribetheiruseasascreeningtoolratherthanadiagnostichearingtest,andthatlabelingofdevicesindicatesthatthesedevicesareusedsolelytoscreencommunicativefunctionratherthanhearinglossperse.Furthermore,theAcademyendorsestheneedforincreasedawarenessofhearinglossanditscomorbiditiesaspartofannualprimarycareexaminations,andencouragesincreasedreferralforacomprehensiveevaluationwiththeunderstandingthatthereisno“normal”age-relatedhearingloss,andanydegreeofhearinglossshouldbeappropriatelyevaluated.Recommendation#3:ManagementofHearingLossThesymptomofhearinglossislossofcommunicativefunction,andthereforeindividualsmayseektoself-managetheircommunicationdeficits,butthisshouldnotbeconstruedastreatmentforhearinglossoramedicalcondition.Self-treatmentcannotoccurintheabsenceofanaccuratediagnosis.TheAcademybelievesindividualswhohaveself-identifiedwithahearinglossor


communicativeimpairmentarebestservedwhendiagnosisleadstothedevelopmentofacomprehensivetreatmentplanthatmayincludeinstruction,counseling,rehabilitativeservicesand/oramplificationproducts.Itiscriticaltorecognizethatanyselecteddeviceisonlyoneaspectofthesuccessfulmanagementofhearinglossandcannotbeconsideredinisolationastheonlynecessarytreatment.Furthermore,theAcademyremainsconcernedthatconsumersmaynotunderstandtheramificationsofunder-fitoruntreatedhearinglosses,whichmayinclude,butarenotlimitedto,negativeimpactoncognitivefunctionanddiminishedsuccesswithappropriatebutlate-fithearingdevices.TheAcademyrecommendsahearingcaredeliverymodelthatoptimizessafeandeffectivemanagementofhearingloss,andisfirminitspositionthatsuchamodelincludesthefollowing:

a. determinationofappropriatemanagementoptionbasedonacomprehensiveevaluationandindividualhearingneedsassessmentperformedbyanaudiologist;

b. considerationofaspectrumofhearingmanagementoptionsthatmaybeappropriateincluding,butnotlimitedto,hearingaids,assistivelisteningdevices,implantabletechnologies,communicationstrategies,andauditory-basedtherapy;

c. recommendationformedicalassessmentandinterventionwhenappropriate;andd. counselingandrecommendationsthatiscognizantofindividualfactorsthatmaylimit

accesstoappropriatehearinghealthcare,includingbutnotlimitedtogeographicconstraintsandfinanciallimitations.

Recommendation#4:AffordabilityTheAcademyappreciatesthatconsumersareconcernedaboutthecostofhearingcare,particularlyasmanyinsuranceplans,includingMedicare,provideinadequatepaymentfordiagnosticservices,andlimitedcoveragefornon-surgicaltreatmentsforhearingloss,includinghearingaids.Moreover,unlikedentalcareoroptometriccare,therearefewsupplementalinsuranceplansavailablethatcoverthecostofhearingcare.Improvedreimbursementforhearingcareserviceswouldservetoreducetheburdenofconsumerstoaccessaffordablehearingcare.Additionally,requirementssuchastheneedforaphysicianreferralforaudiologyservicesbyMedicarecanaddfurthercoststohearingcarebycompellingprerequisitephysicianvisitstoacquirethatreferral.TheAcademyrecommendsremovalofstatutoryandregulatoryrequirementsthatplaceadditionalfinancialburdensonindividualswhoseekhearingcare,particularlyforthosewithmildhearinglossesorcommunicativeimpairments.Removalofregulationssuchasthatrequiringphysicianreferralwillresultinreducingthecostofhearingcaretotheconsumer.TheAcademyalsosupportsaccessofindividualswithhearinglossorcommunicativeimpairmenttolow-costalternativesfortreatment,includinglow-costamplificationtechnologies.Assuch,theAcademyrecommendsthataudiologicpracticesincludeabroadrangeofamplificationtreatmentoptionsforpatients,andthatmembersendeavortoprovidebothservicesandproductsthatmeetthecommunicativeandfinancialneedsofpatients.Inthissameregard,theAcademysupportsthedevelopmentofapurchasingmodelfordevicesthatbenefitsboththepracticeandtheconsumer.TheAcademyrecognizesthatforsomeconsumers,theremaybeadiscrepancybetweentheirperceivedcommunicationlimitationandtherelativevalueofhearingdevices.Asaresultitispossiblethatover-the-counter(OTC)hearingaidsmayrepresentanintroductorypathtohearing


healthcarethatseemsmorepalatableforthoseconsumerswithmildhearinglossormildcommunicativeimpairment.WhiletheAcademyappreciatesthattheremaybepotentialbenefitsofover-the-counter(OTC)hearingaids,theirsafetyandefficacyhavenotbeenestablished.ThenumberofindividualswhogainbenefitfromOTCdevices,themagnitudeofthatbenefit,andthepatientperspectiveaboutthebenefitscanonlybeestablishedoncethedevicesbecomeavailabletothepublic.Similarly,theriskassociatedwithOTCdevicesintheU.S.hasnotbeendetermined.Thelikelihoodofrisk,theseverityofharm,thenumberofpatientswhofailtoreceivenecessarymedicaltreatment,theuseofdevicesbypopulationsotherthanthatintended,andthepatienttoleranceofriskwillbedeterminedifandwhenthedevicesareavailable,andtheshort-termandlong-termoutcomesbecomeevident.UntilsuchtimethatthesafetyandefficacyofOTCdeviceshasbeenestablished,theAmericanAcademyofAudiologybelievestheconsumerofhearingcareproductsmustcontinuetobeprotectedfromaccessingproductsthatputthematriskforgreaterhearingoreconomicloss,orfailstoprovidebenefitfortheircommunicationimpairment.However,theAcademyalsorecognizesthathearingdevicesarecurrentlyunder-utilizedbyappropriatecandidatesandrecognizesthatidentifyingtherootcauseofthissituationaswellasappropriatecountermeasuresshouldbeahighpriorityfocusorprofessionalorganizationsandgovernmentagencies.Recommendation5:EducationTheAcademyrecognizesthatregulatoryorstatutorychangestothehearingcaredeliverysystemorproductsrequireacomprehensiveandcollaborativeeducationprocessfortheconsumer,primarycarephysicians,theaudiologycommunity,otherhearingcareproviders,andgovernmentandnon-governmentagencies.TheAcademyrecommendsacollaborativeapproachwithkeystakeholderstodevelopthemessage,materialsanddeliverysystemtosupportthiseducationalendeavor.Summary:TheAcademyrecognizesthatexistingservicedeliverymodelsforhearingcaremayneedtobereconsideredinordertooptimizehearinghealthcareforagreaternumberofconsumersimpactedbyhearingloss.Improvingaccessibility,encouragingappropriateassessmentandmanagementofhearingloss,andrecognizingtheimpactofaffordabilityonamplificationusageareallprioritiesfortheAcademy.Tothisend,theAcademypresentsthispositionstatementontheaccessibilityandaffordabilityofhearingcareforadultconsumers.


APPENDIX2

ProductsAmericanAcademyofAudiologyRegulatoryRecommendationsforOver-the-

CounterHearingAidDevicesandPersonalSoundAmplificationProductsTheAmericanAcademyofAudiology(the“Academy”)istheworld'slargestprofessionalorganizationof,by,andforaudiologists,representingover12,000members.TheAcademypromotesqualityhearingandbalancecarebyadvancingtheprofessionofaudiologythroughleadership,advocacy,education,publicawareness,andsupportofresearch.Inanticipationofformalrulemakingrelatedtothedevelopmentofacategoryofover-the-counter(OTC)hearingaidsandthefinalizationofdraftguidancerelatedtopersonalsoundamplificationproducts(PSAPs),theAcademyrespectfullysubmitsthefollowingrecommendationsforconsiderationbytheU.S.FoodandDrugAdministration(FDA).Theserecommendationsarebeingofferedtoensurethattheaudiologist’sexpertiseinmanagingapatient’shearinghealthoutcomesaretakenintoconsiderationasFDAlookstocreateanewcategoryofOTChearingaids.TheAcademylooksforwardtoworkingwiththeFDAasregulationsarefinalizedthroughtherulemakingprocess.

• Recommendation1:LabelingforOTCdevicesshouldincludelanguagethatadvisestheuserthatbetteroutcomesareachievedwhenacomprehensiveaudiologicalexaminationisconductedpriortotheacquisitionofanOTCdevice.

TheAcademyendorsestherightsofindividualstoself-directtheirhearingcareprovidedthatcareissafeandeffective.TheAcademysupportstheconceptthatconsumersmaybeableto"self-identify"thepresenceofacommunicationproblemorafunctionallimitationorparticipationrestriction.However,nostudiessuggestthatconsumerscandifferentiatedegree,typeoretiologyofhearingloss,ortodiscriminatethosehearinglossesthatrequireaudiologicormedicalintervention.Therefore,theAcademydoesnotsupporttheconceptof"self-diagnosis"withrespecttoself-directedhearingcare,andinsteadrecommendsthattheterm"self-identification"beusedtoidentifytheconsumer'sabilitytodeterminetheneedforhearingcare.Ideally,individualswhobelievetheyhaveacommunicationproblemorfunctionallimitationhearinglossarebestservedbyhavingacomprehensiveaudiologicalevaluationpriortotheiraccessinganytreatmentoption.TheAcademyadvocatesforinclusionoflabelinglanguagethatadvisestheconsumerthatbetteroutcomesareachievedwhenacomprehensiveaudiologicalexaminationisconductedpriortotheacquisitionofanOTCdevice.

• Recommendation2:LabelingshouldaddressutilizationofOTCdevices,includingbothhearingaidsand/orPSAPs,byindividualsundertheageof18.SpecificlanguageshouldbeincludednotingthatuseofOTCdevicesbyindividualslessthan18yearsofageshouldonlyoccurunderthedirectionofalicensedaudiologist.

TheAcademyfirmlybelievesthatOTCdevicesshouldbelabeledasintendedforusebyadultsovertheageof18.Everyeffortshouldbemadetoensurethesedevicesarenotacquiredorusedbyindividualsundertheageof18yearsexceptwhendispensedorprescribedbyalicensedaudiologist.Inadditiontoregulatorylanguageandlabeling


requirementsthatreinforcethisprinciplecodifiedinSection709(a)(q)(1)(A)(ii)oftheFDAReauthorizationAct,theAcademyrequeststhatlabelingrequirementsforOTChearingdevicesincludethefollowingstatement:“UseofOTCdevicesbyindividualslessthan18yearsofageshouldonlyoccurunderthedirectionofalicensedaudiologist.”Infantsandchildrenidentifiedwithhearinglossaregenerallymanagedbyaudiologistsfromthepointofidentificationforward,whichmayincludetheuseofamplificationdevicesasapartofthetreatmentprocess.Throughoutthecourseofthistreatmentprocess,theremaybeinfantsandchildrenwhohaveshort-termortemporaryhearinglossesforwhomtraditionalhearingaidsmaynotbenecessary.Insuchcases,theaudiologistmaydeterminethatanOTCtypedeviceorPSAPmaybethemostsuitabletreatmentoptionforchildrenduetothenatureofthelossandotherfactors.Forexample,childrenwhohaveamildconductivehearinglosswho,formedicalreasons,mustwaitforsurgicalcorrectionandthereforemightbenefitfromalowercostalternativetoatraditionalhearingaid.Similarly,OTCorPSAPdevicesmaybebeneficialforspecificsituationalneedsforchildren,suchasifachildhasminimalhearingloss,oranauditoryprocessingdisorderwithouthearingloss.Inthesesituations,asimpleamplifiercouldprovidetheneededacousticboostwhenthechildisintheeducationalenvironment.Withinthiscontext,theremaybeinstanceswhereanOTCdevice,oraPSAP,maybeasuitablealternativeforchildren.TheAcademydoesnotadvocatethattheintendedagelimitbechangedtoallowopenaccesstoOTCdevicesbyparents.Duetotheroleoftheaudiologistastheprimarycaregiverforchildrenwithhearingloss,wesuggestthelabelingrequirementsincludethequalifierofallowingchildrentoaccessthedeviceonlyunderthedirectionoftheiraudiologist.

• Recommendation3:LabelingofOTCdevicesshouldadviseconsumerstoseekanevaluationbyanaudiologistiftheyarenotreceivingsatisfactoryresultswithanOTCdevice.

ManyviewtheemergenceofOTCdevicesasacatalystforimprovingaccessibilityandaffordabilityofhearingcare.TheybelievetheavailabilityofOTCdevicesexpandsthemarkettoincludeindividualswithperceivedmildtomoderatehearinglosswhomaynothavepreviouslysoughttreatmentforhearinglossthroughmoretraditionalchannels.UtilizationofOTCdevicesmayprovetobeanotherentrypointintothehearinghealthcaresystemandleadtoconsumersseekinghearinghealthcarefromanaudiologistashearingneedsincreaseorchangeovertime.Conversely,thereareconcernsthataconsumermaypurchaseanOTCdevicewhichdoesnotmeettheirhearingorcommunicationneeds,especiallyasOTCdevicesarenotintendedforusebyallindividualswithhearingloss.Thepotentiallydetrimentaleffectsofundertreatedhearinglossarewell-documentedandcouldnegativelyimpactlong-termhearingabilityjustasmuchasover-amplification.Furthermore,ifaconsumerdoesnotreceivesatisfactoryresultsfromtheOTCdevice,theymaybediscouragedfromseekingfurthertreatment.TheAcademyencouragestheFDAtoincludelabelinginformationdirectingconsumerstoseekanevaluationbyanaudiologistiftheydonotreceivetheresultstheyhopeforwhenpurchasinganOTCdevice.


• Recommendation4:LabelingofOTCdevicesshouldspecifythattheoutputmayexceedlevelsthatcouldcauseeitheradditionalhearinglossorinitialhearinglossinthosewithnormalhearing.Standardsfortheacousticalcharacteristicsofthesedevicesshouldbesettolimittheserisks.ThecategoryofOTCdeviceshasbeenestablishedtoincludetargetinglistenerswithuptomoderatehearingloss.Consequently,appropriategainandoutputlevels(asdefinedbycurrentprescriptivegainmethods),willprovideoutputlevelsthatexceedNIOSHandOSHArecommendationsinhighergainandoutputdevices,withconsistentexposuretomoderatelyhigh(orgreater)soundlevelsthroughouttheday.Therefore,utilizinglabelingtoacknowledgesuchariskisimportant.Inaddition,gainandoutputlevelsshouldbelimitedtothelowestpossiblelevelsthatremainappropriateforthesedegreesofhearinglossasspecifiedbycurrentlyacceptedandvalidatedprescriptivegainmethods.Sincemanydeviceswillincludeamplitudecompression,gainlimitsshouldbeconsideredasafunctionofinputlevel.ThoughtheFDAReauthorizationActpassedbyCongressonAugust3directstheFDAtocreateacategoryofOTChearingaidsforadultswithperceivedmildtomoderatehearingloss,theAcademymaintainsitspositionthatOTCdevicesbelabeledasintendedforusebyadultswithmildhearinglossandwithmildcommunicativeimpairments.Asstated,theAcademybelievestheFDAshouldtakestepstocautionconsumersabouttheeffectsofpotentialover-amplification,butalsorecognizestheneedforsettingacousticalcharacteristicstandardsforthesedevicesinordertolimitsuchrisk.Conversely,forthoseconsumersexperiencingmoderatehearinglosswithmoderatecommunicativeimpairmentsmayfindthatthedevicesprovidelessthanoptimalamplification.TheAcademybelievesthatprofessionalintervention,eitherthroughdeviceadjustmentorthroughprescriptiverecommendationsfordeviceswithspecificgainconfigurations,maybenecessaryforOTCdevicestoprovideappropriateamplificationforthosewithmoderatehearingloss.

• Recommendation5:LabelingofOTCdevicesshouldadviseconsumerstoseekanevaluationbyanaudiologistwhentheynoticeanychangeintheirhearing,includingtemporarychanges,assustainedlong-termexposuretomoderatetohighoutputlevelsmayhaveanegativeeffectonhearing.Dependingontheagreedupongainandoutputlimitations,OTCdeviceshavethepotentialtoleadtohearinglossinsomeindividualsduetolongtermexposuretosoundlevelsexceedingOSHAandNIOSHrecommendations.Listenerswithnormalhearingmaybeparticularlyatrisk.Asnotedpreviously,thereisnodatasupportingtheconceptthatindividualscandifferentiatedegree,typeoretiologyofhearingloss.Indeed,somedatahavesuggestedlistenerswithnormalhearingmaymistakenlyself-identifyashavingpoorhearingthresholdsandthereforemaypurchaseanduseanOTCdevice.TheAcademyrecommendsthatconsumersbeadvisedtoseekimmediateattentionfromanaudiologistshouldtheynoticeanychangeintheirhearingorcommunicativefunctionresultingfromtheuseofanOTCproduct.


• Recommendation6:TheAcademyrecommendsthattheFDAregulationsrelatedto

thesaleandpurchaseofOTCdevicesspecifythatOTCdevicesaremedicaldevicesandnotconsumerelectronics.

TheAcademyrecommendsthattheFDAcreateregulationsrelatedtothesaleandpurchaseofOTCdevicestoensureconsumersunderstandthatthesearetobeusedtoimprovecommunicativeimpairmentand,assuch,aremedicaldevicesandnotconsumerelectronicproducts.Certaintypesofhearinglossmayrequireaudiologicormedicalintervention.Redflagwarningsignsshouldbeincludedwithalllabelingforproductsintendedtomanagehearinglossorcommunicationdeficits,andthatindicationsforreferralforanaudiologicorotologicevaluationshouldbeclearlynoted.Retailersanddistributorsshouldberequiredtoimplementmeasurestoprovideconsumerswithaccesstoclear,easytounderstandsafetyinformationforOTCdevices.OnesuchmeasurecouldincludehavingtheconsumersignanacknowledgmentthattheyhavereadandunderstoodthesafetyandlabelinginformationrelatedtotheOTCdevicepriortopurchase.TheAcademyalsoencouragestheFDAtodevelopregulationsestablishingaformalizedtrialperiodtoallowconsumers,whohavepurchasedanOTCdevice,tohavetheoptiontoreturnthatdevice.

• Recommendation7:TheFDAshouldtakestepstomitigateconsumerconfusionregardingthedifferencebetweenPSAPsandOTChearingaiddevices.

Hearingaids,includingOTChearingaids,andPSAPsarenotinterchangeablefromthestandpointofintendeduse,butmayoverlapgreatlyintermsoftheamplificationandprocessingstrategiesapplied.Giventhetwodistinctintendedusesofeachclassificationofproduct,andtherelatedlevelofregulatoryoversight,marketingforthesedevicesshouldappropriatelyandclearlyconveytoconsumerstheintendeduseoftheproduct.TheAcademyisconcernedabouttheabilityoftheconsumertodifferentiatebetweenOTChearingaidsandPSAPs.WeapplaudeffortstoprotectconsumerswhouseOTCdeviceswithappropriatelabelinganddevicegainandoutputlimitation.Thesesameprotectionsare,however,currentlynotappliedtoPSAPdevices.Therefore,assupportedbypublisheddata,usersofcurrentPSAPdevicesmayactuallybeexposedtohighersoundlevelsthanusersofappropriatelyregulatedOTCdevices.TheAcademyurgestheFDAtodefineandregulatethesedevicesinsuchawayastominimizeconsumerconfusionandmaximizeconsumersatisfactionandprotection.WeencouragetheuseofappropriatelabelingtoallowtheconsumertodifferentiatebetweenOTChearingaidsandPSAPsandwouldalsoadvocatethatgainandoutputlimitationsbeappliedtobothOTChearingaidsandPSAPstoensurepropersafeguardsexistforconsumerspurchasingsuchdevices.

the audiologist’s guide to hearing aids, … 2018. american academy of audiology. . 3 based, in...

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