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InformationYouNeedtoKnow
FDABASICSWEBINAR
May23,2012
PresentedbyShuChenPeng,Ph.D.CCCA
ScientificReviewerinAudiology
CenterforDevicesandRadiologicalHealth
Outline
Hearingloss
Basicsabouthearingaids
Whatarehearingaidsandwhoaretheyfor?
Howdoesahearingaidwork?
Stylesandcommonfeatures
Gettingthemostoutofyourhearingaids
Hearingaidfitting&care
Hearingaidbenefits&limitations
Learningtolistenwithhearingaids
HearingAidsvs.PersonalSoundAmplifyingProducts
Questions&Answers
2
FactsaboutHearingLoss
Individualswithhearinglossmaybelimitedindailyoral
communication.
Somefactsabouthearingloss&hearingaids(NIDCD/NIH)
36million(or17%)adultpopulationintheUSreportsome
degreeofhearingloss.
Lessthan20%ofthosewithhearinglosswhomightbenefit
fromtreatmentactuallyseekhelp.
Mosthearingaidusershadlivedwithhearinglossfor10+
years,andwaiteduntilitprogressedtomoderatetosevere
levelsbeforeseekingprofessionalhelpforhearingaid
fitting.
3
TypesofHearingLoss
Conductive:Middleearpathology
Sensorineural:Damageattheinnerear(cochlea)
Mixed:Bothcochleardamage&outer/middleearpathology
DegreesofHearingLoss
0 20dBHL:Withinnormallimits(WNL)
2040dBHL:Mild
4070dBHL:Moderate
7090dBHL:Severe
>90dBHL:Profound
WNL
mild
moderate
severe
profound
5
WhoareHearingAidsfor?
Soundamplifyingmedicaldevicestoaidindividualswith
hearingloss.Hearingaidsmaybeusefulfor:
Hearinglossthatmayormaynotbemedicallytreatable.
Anytypeofhearingloss,aslongastheindividualneeds
compensationforthereductioninhearing.
Selectionofhearingaidsshouldbebasedonthetypeand
severityofhearingloss,listeningneeds,andlifestyle.
HearingAids:
BasicComponents&HowTheyWork
Electroniccomponents:
Microphone
Amplifiercircuitry
Miniature
loudspeaker/receiver
Battery
Howdoesahearingaid
work?
www.fda.gov/hearingaids
7
HearingAidStyles
Behindtheear(BTE)aids:
Aplasticcasecontainingmostparts;restingbehindtheearconnectedtoan
earmold
Easytobecleanedandhandled,relativelysturdy
"Mini"BTE(or"ontheear")aids:
Averythintubeconnectstheaidtotheearcanal
Mayhaveanopenfiteartiporaregularearmold
Withopenfit Reducedocclusion("pluggedup)sensations,increased
comfort,relativelylessvisible
(SiemensHearingInstruments)
(NIDCD/NIH)
HearingAidStyles
Intheear(ITE)aids:
ITE
Allpartscontainedinashell,which
fillsintheearcanal
Relativelyeasiertohandlethan
smalleraidssuchasITC&CIC
ITC
Inthecanal(ITC)aids&
completelyinthecanal(CIC)aids:
Allpartscontainedintinycases,
whichfitspartlyorcompletelyin
theearcanal
Smallestinsize,whichmakesit
difficulttohandleandadjustfor
someusers
CIC
(SiemensHearingInstruments)
HearingAidTechnology:Analogvs.Digital
Analog
Convertingphysicalsoundwavesintoelectricalwaves
Makingthecontinuoussoundwaveslarger
Digital
Convertingsoundwavestotheirbinaryformatwhere
thesoundisrepresentedbyaseriesof1sand0s
Allowingmanipulatingsoundsinrelativelyflexibleways
toachievemoreprogrammingoptions.
10
CommonHearingAidFeatures
Directionalmicrophones
Soundfromaspecificdirectionamplifiedtoagreaterlevel
Mayhelplistenerstounderstandspeechinnoisyenvironments
Feedbacksuppression
Squealssuppressedwhenthehearingaidgetstooclosetothe
phoneorhasaloosefittingearmold
Tcoil(Telephoneswitch)
Soundpickedupfromthetelephonewhenswitchingtothe"T
coil"setting
Helptoreducethechanceofhearingaid"whistling"
Alsoworkswellinenvironments(e.g.,theaters,auditoriums,etc.)
wherethereisinductionlooporFMinstallation
11
HearingAidFitting
Getamedicalcheckupfroma
licensedphysiciantoruleoutany
medicalreasonsforhearingloss.
Insomecases,hearinglossis
medicallyorsurgicallytreatable.
Certainmedicalconditionsmay
underliethepersonshearingloss.
Seekhearingaidfittingfromalicensedhearing
healthcareprofessional.
Audiological exam,includinghearingevaluation
Providepropergainandsetting:Toomuchamplification
maycausediscomfort&additionalhearingloss.
12
HearingAidFitting(contd)
Questionstoconsider:
Whatstylesandfeatureswouldfitmydailyneeds?
Cost:
Whatisthetotalcostofthehearingaids?
Dothebenefitsofnewertechnologiesoutweighthehighercosts?
Trial/adjustmentperiod:
Isthereatrialoradjustmentperiodformetotryoutthehearingaids?
WhatfeesarenonrefundableifIdecidetoreturnthehearingaids?
Care&Warranty:
HowshouldIcareformyhearingaids?
Whatiscoveredduringtheperiodofwarranty?
Howlongisthewarranty?Canitbeextended?
13
HearingAidCare&Maintenance
Keephearingaidsawayfromanymoistureandheat,which
maycausedamagetotheinternalelectronics.
Cleanhearingaidsasinstructed.
Powerconsumption&batterysafety:
Turnoffhearingaidswhennotinuse.
Keepbatteriesandhearingaidsawayfromchildrenandpets.
Visitthehearinghealthcareprofessionalonaregularbasis
tohavehearingaidsinspected.
14
HearingAidBenefits&Limitations
Benefits
Abilitytohearsoundsthatcouldnotbeheardpreviously,
andhelporalcommunication
Abilitytohearspeechoverthetelephone
Limitations
Donot restorenormalhearing
Allsounds,includingbackgroundnoiseandundesired
sounds,aremadelouder.
Sounds,includingownvoice,mightseemtooloudatfirst.
Mayneedtobereplacedeveryseveralyears
15
LearningtoListenwithHearingAids
Understandyourhearingloss&setrealisticexpectations
Allowyourselftimetoadjustandrequestfinetuning
Involveyourfamilymemberstounderstandhearingloss
andhearingaids
Learnaboutcommunicationstrategies,includingdealing
withbackgroundnoise&utilizingvisualcues
Joinsupportgroups
LearnaboutAssistiveListeningDevices(ALDs)
16
HearingAidsvs.PersonalSound
AmplificationProducts(PSAPs)
HearingAids
Anywearablesoundamplifyingmedicaldevice
Aidingpersonswith,orcompensatingforimpairedhearing
PSAPs
NOTmedicaldevices;wearableelectronicconsumerproducts
Amplifyingenvironmentalsoundfornonhearingimpaired
consumersforuseinavarietyoflisteningsituations
Notintendedorlabeledtocompensateforhearingloss
17
Questions?
Formoreinformationabouthearingaids,
pleaserefertotheFDAwebsiteon
hearingaidsat:
http://www.fda.gov/hearingaids