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www.bjorl.org

Brazilian

Journal

of

OTORHINOLARYNGOLOGY

ORIGINAL

ARTICLE

Open

fitting:

performance

verification

of

receiver

in

the

ear

and

receiver

in

the

aid

,

夽夽

Maria

Fernanda

Capoani

Garcia

Mondelli

a,∗

,

Tatiana

Manfrini

Garcia

b

,

Fabiana

Midori

Tokuhara

Hashimoto

b

,

Andressa

Vital

Rocha

b

aFaculdadedeOdontologiadeBauru,UniversidadedeSãoPaulo(FOB/USP),Bauru,SP,Brazil

bPhonoaudiology,FaculdadedeOdontologiadeBauru,UniversidadedeSãoPaulo(FOB/USP),Bauru,SP,Brazil

Received2January2014;accepted6April2014 Availableonline7September2014

KEYWORDS Hearingaids; Hearingloss; Speechperception; Noise

Abstract

Objective:Toverifythereceiverintheearandreceiverintheaidadaptationsbymeasuring

insituthespeechperceptionandusers’levelofsatisfaction.

Methods:The study was approved by the research ethics committee (Process: 027/2011). Twentysubjectsolderthan18 yearswithaudiologicaldiagnosisofmildandmoderate bilat-eraldescendingsensorineuralhearinglosswereevaluated.Thesubjectsweredividedintotwo groups,whereG1(group1)wasfittedwithopen-fithearingaidswiththebuilt-inreceiverunit (receiverintheear)andG2(group2)wasfittedwithopen-fithearingaidswithRITE.Aprobe microphonemeasurementwasperformedtocheckthegainandoutputprovidedbythe ampli-ficationandforassessmentofspeechperceptionwithHearinginNoiseTestwithandwithout hearingaids. Afteraperiodofsixweeksofusewithoutinterruption, thesubjectsreturned forfollow-upandansweredtheSatisfactionwithAmplificationinDailyLifequestionnaire,and wereagainsubjectedtoHearinginNoiseTest.

Results:Bothgroupspresentedbettertestresultsfor speechrecognitioninthepresenceof noise.

Conclusion:Groups1and2weresatisfiedwiththeuseofhearingaidsandimprovedspeech recognitioninsilentandnoisysituationswithhearingaids.

© 2014Associac¸ãoBrasileira de Otorrinolaringologiae CirurgiaCérvico-Facial. Publishedby ElsevierEditoraLtda.Allrightsreserved.

Pleasecitethisarticleas:MondelliMF,GarciaTM,HashimotoFM,RochaAV.Openfitting:performanceverificationofreceiverintheear

(RITE)andreceiverintheaid(RITA).BrazJOtorhinolaryngol.2015;81:270---5.

夽夽Institution:FaculdadedeOdontologiadeBauru(FOB/USP),Bauru,SãoPaulo,SP,Brazil.

Correspondingauthor.

E-mail:[email protected](M.F.C.G.Mondelli). http://dx.doi.org/10.1016/j.bjorl.2014.08.013

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PALAVRAS-CHAVE Auxiliaresdeaudic¸ão; Perdaauditiva; Percepc¸ãodafala; Ruído

Adaptac¸ãoaberta:verificac¸ãododesempenhoRITEeRITA

Resumo

Objetivo: Estudo clínico prospectivo para verificar as adaptac¸ões RITE e RITA por meio da mensurac¸ãoinsitudapercepc¸ãodafalaesatisfac¸ãodosusuários.

Método: Estudo aprovado peloCEP (Processo no 027/2011). Foram avaliados 20 indivíduos

maioresde18anoscomdiagnósticoaudiológicodeperdaauditivasensorioneuraldescendente bilateraldegrausleveemoderado.Osindivíduosforamdivididosemdoisgrupos,ondeoG1 (grupo1)foiadaptadocomAASIopen-fitcomreceptornopróprioaparelho(RITA)eoG2(grupo 2)foiadaptadocomAASIopen-fitcomreceptornocanal(RITE).Foirealizadaamedidacom microfone-sondaparaverificac¸ãodoganhoesaídadoAASIeavaliac¸ãodapercepc¸ãodafalacom

HearinginNoiseTest(HINT),semecomAASI.Apósumperíododeseissemanasdeusosem interrupc¸ões,oindividuoretornou paraacompanhamentoerespondeuaoquestionárioSADL (SatisfactionwithAmplificationinDailyLifeScale)erealizouoHINT.

Resultados: Osgruposapresentarammelhoresresultadosnotestedereconhecimentodafala compresenc¸aderuído.

Conclusão:Osgrupos1e2apresentaramsatisfac¸ãocomousodoAASIemelhorano reconhec-imentodefalanassituac¸õesdesilêncioeruídocomousodeAASI.

©2014Associac¸ãoBrasileiradeOtorrinolaringologiaeCirurgiaCérvico-Facial.Publicado por ElsevierEditoraLtda.Todososdireitosreservados.

Introduction

Much has been discussed regarding the hearing aid (HA) adaptationinsubjectswithslopinghearingloss.1The

occlu-sioneffectisoneof theirmajorcomplaintsasdue tothe configurationoftheloss,whichisreportedasautophonia.

Consideringthetechnologicalevolutioninthe develop-mentofHAandtheparticularconfigurationofthehearing loss in these cases, open fit-specific mini behind-the-ear (BTE) devices provide benefits to these individuals. This model uses a shaft and a flexible adapter, and has an uniquecharacteristicof amplificationinmedium andhigh frequencies.2,3

These devices areknown asreceiver in the ear(RITE) whenthereceiverisusedintotheearcanalandconnected to the HA through a thin tube. Since the receiver is not locatedwithintheretroauriculardevice(BTE),thistypeof HAisparticularlysmallandmayhaveadvantagesregarding soundqualityandcomfort.Receiverintheaid(RITA)devices featurethereceiverintheHAitself.

Bothfittingandverificationshouldbeperceivedasa pro-cesswithamainobjective:theoptimumadaptationofthe individualtotheamplificationcharacteristics.Researchers4

havedevelopedaguidewherebytheverificationprocessby probemicrophonemeasurement ispart ofthe procedures foraproperHAfitting.Theprobemicrophonemeasurement isthepreferredmethodforverificationofHAinsitu.5

Probemicrophonemeasurementscanbeusedfor check-ingadjustmentsmadeintheHAandtoassesstheefficacyof specialcircuitssuchasnoisereducers,feedbackreducers, directionalmicrophones,andopen-fittingHA.6---8

The main aim of the adaptation of HA is to improve speech intelligibility, thus facilitating the communication process; hence the importance of testing the individual’s speechperception.9Withthisinvestigation,itispossibleto

obtainthethresholdofspeechrecognitionwithandwithout competitivenoisethroughtheHearinginNoiseTest(HINT),10

whichconsistsofaseriesof12listsof20sentenceswiththe sameextension, phoneticdistribution, and degree of dif-ficulty,which werenormatized so astopresent a natural aspectandreliability.

During the process of counseling hearing-impaired patients,thethreeprocessesof motivationrelatedtothe useofHAshould beconsidered:acceptance,benefit,and satisfaction.11 The success of the adaptation process of

amplificationdepends,amongotherfactors,onthe individ-ual’ssatisfactionwiththeresultsoftheuseofHA.12

Satisfactionistheoutcomemeasureofauditory rehabili-tationthatrepresentsthemostcomprehensivecombination of factors needed for the final result, since the variable ofinterestis thepointof viewoftheindividual,and itis not related only to the performance of HA,13 but rather

dependsexclusivelyontheperceptionsandattitudesofthe individual.14

The measurement of satisfaction with the use of HA in daily life has also been studied using the Satisfaction WithAmplificationinDailyLife(SADL)questionnaire.13This

tool wasdesigned toassess the satisfaction of HA users, quantifyingitthroughascoring processof foursubscales: positiveeffects, costs andservices, negativefactors,and self-image.15,16

Inthefieldofphonoaudiology,studiesthatcritically con-tributeto the process of HA fitting in centers accredited bythenationalpoliticsofhearinghealthcarearelacking.17

Thepresentstudyprioritizedtheevaluationofopen-fitting devicesusingobjectiveandsubjectivetoolsandfavoringthe optionsofRITEorRITA.

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Methods

This was a prospective clinical study, conducted after approval by the Research Ethics Committee, process No. 027/2011.Allparticipantswereinformedaboutthe objec-tives and methodology of the proposed study, agreed to theproceduresnecessaryforconductingtheresearch,and signedaninformedconsent.

Forsamplecomposition,thefollowingeligibilitycriteria wereestablished: subjectsolder than 18years with audi-ologicaldiagnosis ofbilateralsensorineuralhearinglossat highfrequencies,ofmildtomoderatedegree,andwithno priorexperiencewithamplification.

Subjects with unilateral hearing loss or with previous experiencewiththeuse of HA;whodid notcontinue the processofadaptation;orwhodidnotagreetoparticipate inthestudywereexcluded.

The sample consistedof 20subjects, randomlydivided intotwogroups:group1(G1),usersofopen-fitHA adapta-tionwithRITE,and group2 (G2),userswithconventional open-fitHAadaptation(RITA).Bothgroupsconsistedoften subjectswithsimilarauditory characteristicsand commu-nicativeneeds.

The degree of hearing loss was classified using the audiometric thresholds at 500, 1000, 2000, and 4000Hz, rated as mild (average 26---40dB NH), moderate (average 41---60dB NH), severe (average of 61---80dB NH), and pro-found (average above 81dB NH), according to the World HealthOrganizationcriteria.18

The participants were bilaterally fitted with a Claris-Oticon HA device, with the same criteria of prescriptive method(NAL-NL1),whichhasasunderlyinglogicthe loud-ness equalization, i.e., the formula assumes that speech intelligibilitywillbe maximizedwhenall frequencybands areperceivedbytheuserashavingthesameloudness.

Attheconsultationfortheadaptationprocedure,aprobe microphonemeasurementofthegainandoutputprovided bytheamplificationwasperformed,inadditiontoan eval-uation of speech perception with and without HA. The procedurelastedapproximately90mininthisfirstphaseof thestudy.

Probemicrophonemeasurement

Probe microphone measurements were performed in a sound-proofroomwithadequatesize.Thepatientwas pos-itionedonemeterawayfromtheloudspeakerat0◦azimuth,

usingAffinity2.0(Interacustics)equipment.

Theinformationrelatedtospecifiedacoustic character-isticswith respect to the tubing type and olive size was inserted.Thefollowingmeasurementswereperformed:real earunaidedresponse(REUR),open-fitcalibration;realear occludedresponse(REOR),toverifyanypossibleocclusion oftheexternalauditorymeatus(EAM)bytheolive;andreal earaidedresponse(REAR).

The resonance response with the use of amplification (REAR)wasobtainedwithspeechnoisestimuliat50dBSPL, 65dBSPL,and80dBSPLintensities.

The values of REAR,at frequencies of 250, 500, 1000, 2000, 3000, 4000, and 6000Hz for input levels of 50, 65,and 80dB SPL,werecompared withtheNAL-NL1rule

targetsforweak,medium,andstrongsounds,respectively. The obtained responses were considered equivalentwhen thedifferencebetweenthetargettorealearinsertiongain (REIG) andthe realvalue obtained in ear didnot exceed 10dB.19

HearingInNoiseTest(HINT)

TheassessmentofspeechperceptionwasheldbytheHINT, adaptedforBrazilianPortuguese,20 underfourconditions:

- Sentences presented in silence: the HINT sentences adapted to Brazilian Portuguese were recorded at the HouseEarInstitute(LosAngeles,USA)byaBrazilian pro-fessionalactor.

- Speechwithfrontnoise(FN):20sentencesderivedfrom afrontallypositionedsoundbox(0◦)andpresented

simul-taneouslywithnoiseatafixedintensityof65dBNHinthe samefrontalbox(0◦).Acomposite-typenoisemaskerwas

used.

- Speechwithnoisetotheright(RN):20sentencesderived fromafrontallypositionedbox(0◦)withnoisepresented

atafixedintensityof65dBNHinaboxtotheright(90◦).

Acomposite-typenoisemaskerwasused.

- Speechwithnoisetotheleft(LN):20sentencesderived fromafrontallypositionedbox(0◦),withnoisepresented

atafixedintensityof65dBNHinaboxtotheleft(90◦).

Acomposite-typenoisemaskerwasused.

TheevaluationwasperformedwithoutHA,withHA,and six weeks after the adaptation. The acoustically-treated room andthe space allowed for theproper placement of theparticipant,examiner,andequipment.

After calibration of the system, the participant was instructed to remainin the same position throughout the test, ensuringthattheintensity that wouldreachtheear wouldbethesameasindicatedonthecomputerscreen.

Foreachcondition,alistof20sentenceswaspresented, andthelistwaschosenrandomlybytheHINTPROsoftware. Theparticipantswereinstructedverbally,accordingtothe guidelinescontainedintheHINToperatingmanual.

The sentence was considered correct by the examiner when all essential words were repeatedcorrectly. In this case,theexaminerpressedthe‘Yes’buttononthesoftware screen.When‘Yes’wasselectedafterthefirstpresentation, thesecondsentencewaspresented4dBbelowtheintensity ofthefirstsentence.

Forthetestconductedinsilence,thespeechlevelwas initiallysetat60dB.Therewasvariationinintensity accord-ing tothe responses of the participant--- if he/shefailed tocorrectlyrepeatthesentence,thelevelofpresentation wouldbeprogressivelyincreasedby4dB,untilthe partici-pantcouldrepeatthesentencecorrectly.

Thescoringforthetestconductedinsilence,definedas thethreshold ofrecognition of50% ofthesentences, was expressedindBNH.

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signal-to-noise ratio after application of a list of 20 sentences,wasexpressedindB.Thus,thelowerthe signal-to-noise ratio, the better the speech perception of the participantinthiscondition.

Afteraperiodofsixweeksofuninterrupteduse,the par-ticipantreturnedtotheclinicforfollow-up.Atthisstage, he/she answered the SADL questionnaire administeredby theresearcher, in ordertoverifythe satisfactionlevelof theindividualwiththeuseofamplification.Uninterrupted useofHAwasdefinedastheuseforlongerthan8h/day.

The second stage of the study, with the realization of HINTand application of SADL questionnaire, lastedfor approximately1h.

SatisfactionwithAmplificationinDailyLife

Scale---SADL

TheSADLquestionnaireisaninstrumentdesignedtoassess users’satisfactionwithHA.Thisquestionnairecontains 15 questionsdivided intofoursubscales: positiveeffects (six itemsassociated withacousticand psychologicalbenefit), servicesandcosts(threeitemsassociatedwithprofessional competence,productpriceandnumberofrepairs),negative factors(threeitemsrelatedtoenvironmentalnoise ampli-fication,presence offeedback andtheuse oftelephone), andself-image(threeitemsrelatedtoestheticfactorsand tothestigmaofusingHA).13

Considering the 15 items of SADL, in 11 the score attributed by the participants coincided with the scoring scale,andintheotherfouritems(questions2,4,7,and13) therewasaninverserelationshipbetweenthescoreandthe scale(i.e.,inthesequestionsthescore1receives7points, expressinggreater satisfaction).The higherthe numerical results obtained by averaging the responses of each sub-scale,thegreatertheindividual’ssatisfaction.Questions1, 3,5,6,9,and10arerelatedtopositiveeffectsofthe sub-scale;questions2,7,and11arerelatedtonegativefactors ofthe subscale;questions4,8,and13 arerelatedtothe subscale‘self-image’;andquestions12,14,and15referto thesubscale‘servicesandcosts’.14

Results

The results of the probe microphonemeasurements were defined asexpected (target) responses, and asresponses obtainedofsoundpressurelevelwiththeuseof amplifica-tion(REAR),intheintensityof50,65,and80dBSPL.

Forgroups 1and2,amaximumdifferenceof10dBwas observedbetweentheexpectedresultsandthoseobtained inthewholefrequencyrangeinthethreeinput levels.No discrepanciesbetweentheresultsobtainedatall frequen-ciesforthewholesamplewerenoted,andnoresponsewas obtained exceedingthe expectedanswers,respecting the establishedprescriptionrules.

Regarding theresults of HINT,Figs.1 and2 depict the dataobtainedinpatientswithRITEandRITAfittings, respec-tively.TheresultsfromSADLquestionnairearedescribedin

Fig.3.

ConsideringtheresultsofHINTbetweengroups1and2, analysisofvariance(ANOVA)revealedastatistically signif-icantdifference(p=0.01)betweenthefactor‘withoutHA’

60

50

40

30

Response/dB

20

10

0

–10

Silence F.N. N.R. N.L.

Noise position

RITE pre-RITE post-RITE post-6wk.

Figure1 Responsesingroup1obtainedwiththeapplication ofthehearinginnoisetest(HINT)atthreetimes:without hear-ingaid(HA),withHA,andsixweeksafterthefitting(n=10).

and‘with HA’ in a silence condition. Evaluating such sig-nificance,theTukeytestrevealednosignificantdifference betweenthegroupsofRITEandRITAHAusers.

As for the results in the presence of noise, there was no significant difference between RITA and RITE users, regardingtothetimeofuseofHAandtonoisepositioning.

Fig.1indicatesthat,inthenoisepositions‘infront’,‘tothe right’,and‘totheleft’,group1patientsshowed improve-ment in speechperception, according tothe time of use ofHA.

InFig.2,thegroupofRITAusersshowedbetterresultsin speechperceptiontestinthepresenceofnoisetotheleft andtotheright,withalongeruseoftheHAtest.

When the degree of satisfaction of participants from both groups wascompared using ANOVA for two criteria, nostatistically significant difference wasobserved in any subscale.

60

50

40

30

Response/dB

20

10

0

–10

Silence F.N. N.R. N.L.

Noise position

RITE pre-RITE post-RITE post-6wk.

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8.00

5.90 5.92 5.886.22

7.006.70

5.42 4.80

5.605.88

RITE RITA 7.00

6.00

5.00

Scor

ing

4.00

3.00

2.00

1.00

0.00

Global Positive Effect

Service and cost

Negative factors

Subescalas

Self-image

Figure3 Meanscoreofsatisfactionlevelofreceiverinthe ear(RITE)andreceiverintheaid(RITA)hearingaidusersinthe foursubscalesoftheSatisfactionwithAmplificationinDailyLife (SADL)questionnaire(n=20).

Discussion

The probe microphone measures consist of an objective andaccuratetechniquetocheckwhethertheperformance of the HAin the ear of the user is equivalent toa given curve(orasetofcurves)of gainor outputperprescribed frequency. These measures are considered to be a good practiceinthefittingprocedureofthesedevices.4,5,8,19,22,23

In this study, these measurements were performed, sug-gesting that the adequacy of HA settings to the target canprovidebetterspeechrecognitionand,inconsequence, greaterusers’satisfactionwiththedevice.Thegroupshad theirHAadjustedaccordingtoprescriptivemethods,andall participantsreachedthetarget,beingconsidereda differ-enceof10dB.19

Regardingthespeechrecognitiontests,itisknownthat theycanbeusedtopredictthedifficultiesthatpeoplewill haveincertainenvironmentswhenusingHA.Furthermore, thesetestsfacilitatethespeechtherapist’sdecision-making processregarding the need for specific training or use of otherdevices.19

Thespeechtestsinnoiseconditionsweredevelopedinan attempttohampertheidentificationofaspeechsignaland tosimulatereal-lifesituationsexperiencedbypatients.24In

addition,theinformationobtainedfromspeechperception in noise tests can be usedto accomplish the therapeutic planningforagivenpatient.25

Inthisstudy,theresultsofHINTobtainedbyanalysisof variance(Figs.1and2)indicatedastatisticallysignificant difference(p=0.01)betweentheresponseswithand with-outHAinconditionofsilence.TheTukeytest revealedno significantdifferencebetweenthegroupsofRITEandRITA HAusers.ThisresultdemonstratesthatHAprovidesa sig-nificantimprovementinspeechrecognitioninconditionof silenceforbothgroupsofsubjects;however,whenthis vari-ablewascomparedaftersixweeks,therewasnosignificant difference.

Regardingtheresultsinthepresenceofnoise,therewas no significant difference between RITE and RITA users in

relation to the timeof use of HA andthe noise position.

Fig.1 shows thatin front,right, andleft positionsof the noise,subjectsingroup1(RITEusers)showedimprovement in speech perception regarding the timeof HAfitting. In

Fig.2,thegroupofRITAusers,aftersixweeksusingtheHA device,showedimprovementinthespeechperceptiontest withpresenceofnoiseinfrontandrightpositions.

For both groups, when the situation without HA and aftersix weeksof adaptationwascompared,asignificant improvementinspeechperceptioninpresenceofnoisewas observed.Inastudyofopen-fitusers,itwasfoundthatthe effectofacclimatizationthatoccurswithHAusersresults inimprovementinthespeechrecognitionskills,andhence inthecommunicationandusersatisfaction.26

Theuseofsoundamplificationcanimprovethespeech recognitionovertime,afteraperiodofsixto12weeksof amplification.27 Thus, acclimatizationreferstotheperiod

followingtheHAfitting,whenaprogressiveimprovementof listeningskillsandspeechrecognitionoccurs,asaresultof thenewcluesofspeechavailableforamplificationusers.28

ConsideringthatasuccessfulHAfittinginvolvesmultiple aspects,thebenefits ofacclimatizationcannot belimited onlytotheimprovementinspeechrecognition,butalsoto matters involving allaspects ofthe user’ communication, andthatprovidesalevelofsatisfaction,thankstohis/her newconditionoflistener.29

Regardingthe satisfactionwith theuse of HA (Fig.3), the results of the SADL questionnaire subscales (positive effect,serviceandcost,negativefactors,andself-image) werehigherthantheresultsinthenormalization,withlower values13forbothgroups.Onlythesubscale‘self-image’for

RITE amplificationusers confirmed the normative data. A high level of satisfaction in the subscale‘positive effect’ wasnotedfor thegroups ---aresultsimilartodatafroma nationalsurvey.30

Ingeneral,theparticipantsweresatisfiedinallsubscales withtheuseofHA,regardlessofthelocationofthereceiver. Nosignificantrelationshipbetweenthedegreeof satisfac-tionofthe participantswasfound, whentheresponses of thegroupsinthequestionnaireasawholewerecompared. The data obtained are consistent with a study emphasizingthattheexperiencewiththeaudiological ser-vice/support influences on the satisfaction with HA use; subjects whoreported their satisfactionwiththe support receivedalsotendedtoreportgreatersatisfactionwiththe device.31

In a study of 25 adult open-fit users, the Abbreviate Profile of Hearing Aid Benefit (APHAB) questionnaire was applied to measure the individual benefit with the dif-ferentpositions of the receiver,with nosignificant result betweenRITEandRITA.However,greaterusersatisfaction wasobservedwithRITE,duetotheappearance,comfort, retention,andspeechintelligibility.32Thestudyinquestion

observedsimilardataforbothadaptations(RITEandRITA); however,theresponsesweresignificantlybetter,compared totheabsenceofamplification.

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Conclusion

Individualswithslopinghearinglossusinganopen-fitsystem showed improvement in auditory performance, according toobjectiveandsubjectivemeasurements,consideringthe high-levelsatisfactionwiththeuseofamplificationandthe improvementinspeechrecognitionin situationsofsilence andnoise.Therewasnodifferenceinperformancebetween RITEandRITAusers.

Funding

ThisstudywassupportedbyFundac¸ãodeAmparoàPesquisa doEstadodeSãoPaulo(FAPESP).Processn.2011/01454-0.

Conflicts

of

interest

Theauthorsdeclarenoconflictsofinterest.

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Figure 1 Responses in group 1 obtained with the application of the hearing in noise test (HINT) at three times: without  hear-ing aid (HA), with HA, and six weeks after the fitting (n = 10).
Figure 3 Mean score of satisfaction level of receiver in the ear (RITE) and receiver in the aid (RITA) hearing aid users in the four subscales of the Satisfaction with Amplification in Daily Life (SADL) questionnaire (n = 20).

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