Open fitting: performance verification of receiver in the ear and receiver in the aid

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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,夽夽

Maria

Fernanda

Capoani

Garcia

Mondelli

a,∗

_,

_Tatiana

_Manfrini

_Garcia

b

_,

Fabiana

Midori

Tokuhara

Hashimoto

b

,

Andressa

Vital

Rocha

b a_Faculdade_de_Odontologia_de_Bauru,_Universidade_de_São_Paulo_(FOB/USP),_Bauru,_SP,_Brazil

b_{Phonoaudiology,}_Faculdade_de_Odontologia_de_Bauru,_Universidade_de_São_Paulo_(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.

夽 _Please_cite_this_article_as:_Mondelli_MF,_Garcia_TM,_Hashimoto_FM,_Rocha_AV._Open_ﬁtting:_performance_{veriﬁcation}_of_receiver_in_the_ear

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

夽夽_Institution:_Faculdade_de_Odontologia_de_Bauru_(FOB/USP),_Bauru,_São_Paulo,_SP,_Brazil.

∗_{Corresponding}_author.

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

Adaptaçãoaberta:verificaçãododesempenhoRITEeRITA

Resumo

Objetivo: Estudo clínico prospectivo para verificar as adaptações RITE e RITA por meio da mensuraçãoinsitudapercepçãodafalaesatisfaçãodosusuários.

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-sondaparaverificaçãodoganhoesaídadoAASIeavaliaçãodapercepçãodafalacom HearinginNoiseTest(HINT),semecomAASI.Apósumperíododeseissemanasdeusosem interrupções,oindividuoretornou paraacompanhamentoerespondeuaoquestionárioSADL (SatisfactionwithAmplificationinDailyLifeScale)erealizouoHINT.

Resultados: Osgruposapresentarammelhoresresultadosnotestedereconhecimentodafala compresenc¸aderuído.

Conclusão:Osgrupos1e2apresentaramsatisfac¸ãocomousodoAASIemelhorano reconhec-imentodefalanassituac¸õesdesilêncioeruídocomousodeAASI.

Introduction

Much has been discussed regarding the hearing aid (HA) adaptationinsubjectswithslopinghearingloss.1_The 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.9_With_this_{investigation,}_it_is_possible_to

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.13_This 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.

ThisstudyaimedtoverifytheperformanceofRITEand RITAadaptationsbymeasurementsinsitu,speech percep-tion,andusers’satisfaction.

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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 _under_four_conditions: - 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.

Intheevaluationinpresenceofnoise,thestimuluswas presented at a ﬁxed level of 65dB (A) and the level of speechwaxedandwanedaccordingtotheresponsesofthe participanttested,until alevelof 50%of speech recogni-tionwasreached.21 _The_score,_deﬁned_as_the_threshold_for

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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.

Figure2 Responsesingroup2obtainedwiththeapplication ofthehearinginnoisetest(HINT)atthreetimes:without hear-ingaid(HA),withHA,andsixweeksaftertheﬁtting(n=10).

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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.24_In 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, _{acclimatization}_refers_to_the_period 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 values13_for_both_groups._Only_the_subscale_{‘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-tionoftheparticipants wasfound, 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.32_The_study_in_question observedsimilardataforbothadaptations(RITEandRITA); however,theresponsesweresignificantlybetter,compared totheabsenceofamplification.

Based on the above considerations, this study demon-strated the relevance of the investigation of the beneﬁts provided by the ampliﬁcation for patients with sloping hearing loss,thus facilitating thedecision-making process regarding the prescription of HAin centers accredited by theBrazilianhearinghealthcarepolicy.

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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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