MgCHAiSICAL SEMlCmCϋl..AR €ANAL STIMUtATOB

CROSS-REFERENCE TO RELATED APPLICATIONS

£«l] The press at appKe&rion εktros ihe feeκ«fit of U,S. Provisional Patent Application 6LO4JU85; filed March 31 , 2008, wfe ^' ca is hereby incorporated by reference herein, Funltcnntrtc tm$ application Ls a related to comtπooiy owned and co-pending U.S. Pateat Application entitled - ⁴ MECHANiCAl, SCALA TYMPAM STIMULATOR," fried coasurrsntly herewith iisKkrr Attorney Docket No. 22409-00499-US. This appiieatsoπ is hereby incorporated by r«femκe Issreiϊi.

BACKROUNB Fieffl &ftk$ invention

\§§Wi\ The present ts^vsntiots ss r«!«iiod to a hearisg prosthesis, and particularly so, a mechsnjcal syrtKcircubr csssai ϋ όϊsisiδlor.

Related Art

IOT1>S| He-arUsg toss _f which nsay be disc ro many ditTere«t causseSj. is geπsraiiy of two types, condacavtf &nά xesisormeural. \n soma cat^s, as iisdividual may ha%^ feesriϊϊg ImA of both types, Sn many people who arc profoundly dcrf, howuver, the j-ea.son for their deafiasss h sessorincura! hcaiitsg loss. Sensorineural hearing loss occurs wheti tkír>s is ckrø&ge to the xsmr car, or to the ϊserve pathways trors the inner car to the brahi. As such, those suffering fmt« sensorineural hcariiig b^ arc thus imahla k> derive suitable bsacfit &oxa coavcaSbaal SCOUSϊJC hearing aid, As a re.su it, hearing prQS»tisss«s tlsat deliver electrical stϊmαktion so serve ceils of the recipsssit's axiditory system Isavcr becis developed to jsovide persons having sfβτiaoπn«ural hearing toss with the ability to ]x?sv«5vs soyrtd. Such eisctneaUy-stiunjiating hearing prostheses deliver eiseirica! nes"vtϊ ceils of the rεeϊpkaϊ's auditory system. fSO-M] As yάed hcrcla,, the recϊpieaf s auditors _^ system iaciαde* ail sensory ssys»?«ϊT! exsmpotsents as«d to perceive a sotiad sigssl, sach as hearing sensation receptors, seural psϊlrw&ys,, iacludmg she sαdήory jiervc sod spiral gsmgJion, and parts of ihe braii «5ed ta sersss sounds. ElectrjcaHy- iϊMϊmbsϊng hcajϊϊig pmsthes&i include, for exampte, auditory brain stimulators and cocέEϊcar™

prostheses (commonly referred to a ⁴ ; cochlear™ pros&ctie devices, eoctϊiesr™ implants, cociϊ&ar ^iM device*, and She like; ώ.iπsjs!y "cochlear smpkϊUs" herein,)

[δδ-853 Most jsεnsorirteυε&i hearing loss is άuv to the absence or dcsϊructtotJ of the cocfeiea h&ϊr cells which irsasduce acoustic xigsais itito aerve impulses, it is for this jϊurposc tfa&t cochlear implants have beet* developed. Cochlear itspkats wse direct eisctric&l of sadJJoty aeεvc celK to byp&ss al»em or defective hair ooite th&i. aormally transduce acouisitc vibτ&tϊθiini mtύ ω«m&f actή^ty. Such devices genersiϊy «se as electrode stray irsplaitfed m the codilea so ϊhat the eϊcc∑rodes may difleϊeaϊialiy a&tivMe auditory searons that oortaaily encode diiϊerδKtia! tϊtϊcfKss of soutid.

In cc>αtra><t to srøsoriϊicursi bsssriag bss which, results. fiχ>:« damage to the fcsnsr ear, conductive hearing k>» occurs when the normal mccb^mca! pathways a.ssd io provide ®>iχnά ϊo hsir ceils 3K rhώ cockles arc impeded, for example, by damage to the ossbfutar chain or m the car oaαal. Individual* v>ho suffer fro«s conductive hqaring I&ss typically have soϊsse form of res^usl hearing because tBe h&ir cells, is the cochlea. &re yadaπiagcd. Sseh isdividuals are typicaiiy øot GSRdidstes for a cochlear implant 4us to the sreversible narure of the csochlear itiipiaa?, hsscnioft of the electrode array into a recipiersfs cochlea exposes ibc recipient scs th-≥ risk of 4estracts>a <sf the majority of the hair cells withM the cochlea, resulting in the loss of all rssidual hearing by tho .recipient.

|δδδ7l As a result, iatϊividuaϊs sufferitsg from coaduettve hearing loss typically receive aa scoϋsttc kcarmg aid. Ua&rimjsϊely, sot ai! sndividasls who suffer froαi ooπducuvc hearisg toss ;« ^• « able ^o dem^ sxdtabb bciscfit trotϊi hcarmg ziάs. For example, soπie iiidsvjdimls are prot<« to cisronic mflumtnatkjxs or infection of the ear ϋ&nal a«d canaot wear hearing aids. Similarly, hearing «ids are sypicaUy unsuitable for irvdivsduals who have Hia!5>rmc<t, damaged or absent oaicr eats, ear csssis «πd/βi ossicular chains.

SUMMARY

«| ϊπ ose aspect ofths mvetm ^' oπ, a mechanics! stimulator for evoking a hearing percept by directly generating waves of fluid motbn of fluid \n a recψseaf & semicircular canal is provided. The rπsehame&i stimulator comprises a sound ptocesssπg a«a co« figured to process a received sound signal; and &n Implantable stimulation arrangement, comprising: a stapes prosthesis hsviag a iirst end configured to be positioned abutting art βpemag is the scnacirouSar oiosl, an actuator configured to receive electrical signals representing she processed soutid signal and configured ts vibrate m rcspθ!3se to the elecsxtca? signals, &nά & co^pkr eataacctisg ths actuator to the stapes prosthesis such that vibradoa of the actuator rssaits in wβveas of liαid motion tn a rscφieϊtt'.s setϊsk'jrcular eassi thai evoke a heatiftg percept of the received sαussd sigsal

IfKRW] Is another aspect of the proses! invent ion _* a mathod for refasbiUtatssg the hearing of a rcdpiesi asbg & mcchatjical stimulator comprlsisg a $ouad input cleanest, a sotstsd piooessiag yail aad a« ifsp]as«abϊc stmmlaϊioβ arrangement is proved. Tl?e method eosnpriscs; receiving δt ϊhc souTsd iϊϊpist elfitnetst &ω acoustic i«un<i .signal; cosv«rtmg with the sound procs&s ^j ug uα ^ή lhc r«c«iv«<l soiioα signal fate encoded data sigssls tepfesetaitsg the received sound signal; pxesvidifjg the encoded data j>igBs!s to ihu kϊψiantabic stksialatios arrangemeπl; imά gesejraJissg wi_h 'he htjpisnsablε stsntaiaftαo arrangement waves of ihxiά τsotios ϊa a recipient's setnfcircalar cansi staid that cv-αke » Ksarajg porcept of the received sound sipmi iMlti] In a sH'jl oths?r a$ρεcs of the present jnvemion, a system for rehab? Ift&tbg the hearing of a recspicaf Is provided, lhe system cosBpriscs a sound processing u.n& c-ojifϊgured to proce&s a rowive4 sound signai; as actaator configured to receive electrical signals repre&emiag th<j preceded sau^d skna? and c«ft%tored io vibrate fn response to the electrical signals; a stapes proi^hssis having a flvsϊ end eotϊfxgistβd Io be po^tio&ed abuttisg an opesiπg bs a recipient's nCKiscirc«iar carte); « coupler c:<tcκdmg &oπs the aςtuaior, and a Sxadon system configured to be attached te the sduator arid conSgujrød to position the actuator sucii that the coupler connects she actuator to the stapes prosthesis so that vibϊatios of tbe actuator msaiis is. waw nωtioti io ihs rccipicnf s. *smjcirεukr canal that evoke a recc.v<κl sowad signal

BRIEF DIbSCiPHON OF TME FIGURES

PH i| ϊϋusϊr&ύve ansfeodiroesls of the preserrf mvetrtioa are described herein with ^y cfere&ee to ϊhc accoαjpaαysisg drawi&gs, in which:

IWϊ} FlO. I A hi & partial cross-scctioaaJ view of SJJ iodividua.r.s head;

1^131 FIC IB is 3 perspective, partially cat-awsy view of a cochlea exposing the c&πalv a∑ϊd sctvs fibers of the cochlea;

\mi4} FlG. 1C ss s. cKm-seetsoKa! view of one turn of the cassis of a huajan. cochlea;

|WiS| FRJ, 2A is s pfffxpcetjvs' vk?w of a dJrecJ isecbaaicai stimulator is secwd-iace with. vnxbύάimenx% of the praseπs invoiitba shpwπ implaated as a recipient;

RKM^j RO, 2B is & perspective view of a direct mechanical stimulator w accordance w tfh ernboaimenis t>f Ae preseaJ mventioα showa implanted in a rectpietvt;

|M1?1 F-Ki, 3 ώ a partially exploded top view of a direcE mechs-πiea! stimulator, m 3ccor<k«c^ wskh e^badSωicRf is of the presort jnvcmiort; βϋiH] FIG. 4A is s perspsctive view of a arraϋgcntent, ia accordance with embcidimestis of the presc-sy invcntson; fSOS^i FlG. 48 jjs a perspective view of a fe^ compooem ofa ampler, in accor-darjee wkk Offibόdjsxcauv δf the pTCsa^; savcntioa; f8«2iJi HG. 4C is & crosS _' StJcs-toaal view ofa second component ofa coupler, in accordance with embodiπjents* of the p-rssi^i inv*t3tkm; ofa dirfect mechanics! stimulator, in accordsnce widi embodiiaenyi of the present fπventώn; fiHBtS} FlG. SS a perspective- view of & potiioa ofaa trBpIasaed conTpcmcitt ofa direct rnechassicsj «.umu!aior, Ja aewπlsnce wish aiieπjaiive embodinienis of the prescai isvesatjos;

|δø231 FIG. 5C is a perspective vbw ofa stapes prosthesis, its accordaisce -wϊlh embodiments of ϊhe pr«jssoi invention;

\Mi24i blύ. SB is s crøss-secJ icϊϊal side view ofa stapes prosthesis, in accordance with ^τnbocϊϊ3ts?ϊ3ts of the prcssεi mvcatSoa;

180251 FICi 6 is a furϊctbnai block diagram of a direct mechatiic&i stimulator, is accordance with cπϊhodirficais of ϊjhs present inveatbn; aad

|§026] FIO. 7 is a perspective view of a fixsHon system jmplctncatcd in. coajαactiαn wish a direct mcchaajeai stimulator, m accordance with embodiments of the pre&eaf mveaikm

DETAILED DESCRIPTION

|982?j λspecis of the presesi aivcation arc generally directed to a fecarsag prosthesis which simulates satnr&l hearing fey generating mechanical raotk>a ήf the fluid, wtiM» s teciptsst ^* s cochlea. Such a bearing prosthesis, referred to herein as direst mcehaiticsl stimaistor _^ bypasses ϊhc recipient^ outer and isiddls ears to directly g&eerate wa%-cs of SuM motbδ of the cochlear Hπfd, 'hereby actϊvstjreg cochlear hslr cciis and svoksng a hearing percept

{Mlfy Specifie-αUy, a ύkoci moclmmcύ siimulaior ut accordance with embodiments of the pTtSsδϊii invsmύoa compri&ss 8 stapes proslhesii. abutting &n openfeg in the recψistrt's inner car. Coupled to the ist&pes prosthesis is 4trs implanted actuator which is coafigβrod to viferaf« tfe stapes prosthesis. The vibratios of the stapes prosthesis generates the waves of fluid moibn of ihe cochlear sl^sd,

[$)J29| FIC iA is view of an isdsv£<hιaP$ head in which a direct mccbasicai stbnaiatftr sn gecoπiaπcc with embodimeats «f tfec present iavumioa may be implcmcstcd, As sfcowβ in FKi 1 λ, she individual's hearing system compns&s an outer car 101 , » iaiddls ear 105 and six itsisr e&r 107. in a fully fuαetbnai car, outer ear 101 cosϊpπses an. auricle 110 a»d ss ear caaal IG2, λs acoustic pr<assure or souod wave 103 is: collected by aαricie HQ and ekmmleά into asd through ear easai 102. Disposed across tk« distai essd of esr c&s«iei 102 is a tyπϊpatuc mcϊsbrsoc 304 which vibrates is response to souud wave 103. TMs vibraJkns is. coapisd to oval wisdom or fesssiϊa ovaiLv 1 12 tkrougfe three bones of middle ess 105, colbcdvely nsfemed to a$ the osstcka _* 106 comprising <kt mallews IM, the keys 109 asxl lhc stapes 11 L SOΏ«S K ⁾ S, 109 and s I i of ωiϊddle ear I OS serve to filter <asd amplify scnmd wav-s 103, eaussag ova! window ! 12 Jo or vibrate i« response to vfisauoa of tyrapaaic raensbranc 104. This Vibration sjots up waves of iϊiήd unotjoT! oftke perilymph withia cochljca 140. Such fluid motiOB, in tαπi, &ctή'ates uπy hah ^* cells (aot sbcn\τi) ώsidc of cochlea 140, Activatj ^' oa of the hair cells c&sses

appropriate nsrve impulses £o be generated mά transferred through the spiral g&nguoa cells (not SIKγW Ώ} ami aadήosy nerve 114 to ths bram (also not shown) wtes they are perceived as sααad. f«H>3§j A.i shows m FfG. 1 A arc canals 125. Semicircular esnals 125 are three half- circular, mtcrcoonec'.ai tubes bcated a&j&eeal coehlsa 140. The tlϊree canals are the horizontal scmkircuiar caαsl 126, the pαsterioi semicircular canal 127, aad ih<? ϋtiperfor semicircular csaai 128. The catiSjK 126, 12? sad 128 are aligned approximately orthogonally to one ssother. Specifically, horwontal caral 126 is stsgmsd roughly horixoαtaUy in the- head, while the .vapeπor 12$ and posterior canals !27 arc aligned roisgfely at & 45 degree angle to a verttctU through ihe eemcr of the sa^ividisaS's bssd.

IMBSl Each ϋϋϊiai is fiiled with a fluid called cfjdolymph and casfajss a ωrøtlors stβnsor with tby hairs fust shows*) wkjss ends arc cτnbvd4ed ia 8 gelatinous structure called the αφuia (SIJSO not shows). As the skull in any diroςπon, the enrioijrapb is fotccd too different scctions of dse canals. TKc hairs detect when ths? sadoiyjaph passes thereby, sad a signal it _* tbssn seπi to ϊh-e b»5i\, L ^τ &mg thes« haϊr cells, horteostal cans! 126 delects horkossal head maverscnts, ™\ύi& the sajperbr ' 2S &nά postariof ^27 csiials detect vertical head πκsveraeϊi ^{ &. j ^f 8§3J] The details of ςochJca 140 &re described acx? bsbw with reference to FIGS, IB and Kl FIG. IB ϊS s pβrspccsJvc vs«w of cochics 140 paitially cut-away to display Jhe canais «rød nerve fibers βfths ε«chlc*. fl<3, 1 C is & ctoxs-seenonaS view of oαs turn of the canals of cochlea ⁾ 40.

!§φ33| R«%τiiig ϊø FIG. IB, cockles 140 vs a conical s-pira! sl?«cturc comprising three parallel Oiiid-fiOed CAQSSS or ducts, collecsively and generally referred to iiema a$ ςan&te 132» Canals 132 comprise tϊic tys^mak cssaϊ 13Jl, also referred Io as she scala tympam 138, Uw vestibular cϊmsl 134, also referred to as iN? soak ysstsbuϋ 134, md the medxsn cat5al 136, also referred, to as the cochlear duct 136. Cochkϋ I4d has & ςofttcal sb&pcci ccstel axis, the modiolus 154;. that form* the maer wa.ll of scala s^cstibuli 134 sad scala tynspant 138. The base of seals vost£b«li 134 comprises oval wmdow 1 1S (FlG. IA), %-hiic the base of SC&& sympaai J 38 tertnmstcs in round wimio*- i2i (HO. iA). Tympanic sad vcsaibuiar canals 138, IM traasrais pressure waves received at oval window H2, while medial canal 136 coπsains ?he orgaa of Coiti 150 wliich dcU-sSs pressure KΏ|J«1*CS< and respoaάs with electrical impyises which (ravel along auditory nerve 1 14 so die br&ia (a-ot sljswπ),

\m34\ Cochlea 140 spirals about nsodialus 154 sevens! røτsss &«d terminates &i cochlea 3p«x ]4£, Modiolus 154 is largest scsr us base where Jt corresponds to first tøτi 151 of cochlea 140. The Sϊ2S of ssodblas 154 decreases is the regioas coireijpoudnjg to medial 152 and apical turns 156 sf cochlea 140. f$03$| Referring siow Io PRl 1C, jsepar&ttsg canst* 132 of cochlear 140 arc various mesabmus^ and otϊtcr -Jssu?. The Os&scou^ j»pirai l&ssaja 1 S2 projects from modiolus 154 to separate scak veMsMH 134 from scala ijinpani 138- Toward lateral Side 172 of soak tyπipam 13S, a basilar mcinbntae 158 separate* seaia tympasi 138 lrom median caaai 136. Similarly, toward kicrai side 172 of sc&k vessiboii 134, & vεstibuiar mcnibraae 166, also referred to &s the Reissster's raenibraiiB 16δ, separates seats vestitjuU 134 lrom 8ϊ$djaa &as$al 5Jδ, poδl PornoDS of cochlea 140 arc encased ύi 8 bony capsyk i"0. Bony capsule- 170 resides oa lsiicrai hide s ?2 (the right ssdt- as; diawa is FIG. 1C), βf cochlea 140. Spiml gaaglfon o;!is ISO reside osi the opposing medial side 174 (the left side *s draw-i ia FIG. 1C) of cochlea HO. A spiral ligamcm sncaibfsne 164 is located bβtwesa ktcrai side 172 of spiral tympani 138 and bony a»κl betwcca ktεrs! side S 72 of median canal 136 &ad bony aφsnlz 170. Spirit h'g&!r _: cftt 164 also typically extends SXOUSKI at least a portion of lateral side 172 of soak vεasibuii 134. tmyi] The fluid m tympanic and ve^tibulsr c-tftalά 13^, 134, referred to as peril yinph, has differed properties th&n that of the fl^s ^' d which fύls rnediao canal 136 a»d which sι»τownd-j orgsfs of €ortj 15<3, referred to as Souad esϊtcrlag auricle I IO causes- pressure is cocklώd 140 to travel through the O«id-ftU«<i -ympaajc &»d vestibuias casmb 13 S, 134. As assail αr'gass o? Cotti ϊS0 Ls situated on basilar membrane 158 Eϊ sHcdiats cans! 136, ϊt coϊ∑Uαas rows of 1^,000-20,000 liait cells (aor showa) which protrisde Som Its s&r&ecr. Above them is rhe tectoral ϊωcmbraπs 362 which moves is respoose to pressure varu^soRi in the Ousd- fslled rytnpaait ami vestibular canals 138, 134. SaiaU rclaHvc movemeiUs of the layers of ϊ»cτϊibτ&fis 162 arc sulϊlcia« to cause the hair cells to svud it voltage p«?$e or sctios poisstiai down the a»sodat<jd nerve fiber 178. Nerv<s iibcrs I?B, embedded withia spiral k»Una !82, coiϊnccf the hair cells wish the spϊraS gaisglion ccik ISO wbsch fi>ran aαduory «crvc U 4. λutlilory nerve 114 relays the impulses to the auditory areas of the brain (jioi rfxnva) far nfGcosshig.

|MM| As described above -with referen.ee to FlG. IA ₅ sseπiieireiύar cabals 125 ars nhυ- filled with cndolyropk The ] 2 ⁴ > (FlG, IA) provides Quiά comraufiiaaioa between the eiidoSymph m sβsxsjdrcukr canals 125 ami the smlolymph in tsodkc casal 136. f8&rø| PϊG. 2λ i* a perspective view of a direct iscchanseal stimulator 200A 5s accordance witα ώmbudirøeBts of the psr-sserat iπvenuon having Direct mcshatϊieal stimulator 20 ⁽ IA is shovsj have

ξδMδf Direct mschask&l stimulator 20DA conjprtses &n external component- 242 wbica is direαiy csr mUtrεcUy attached to the body of the rccspirøt, asd &λ jstcrssJ eoκϊ|>anoτit 244A which U '.orsψorarϋy ør pcmiascntly iαjpismed m the tedpkm. External eompsneπt 242 sypkslK' cotϊψrisesi os< or asore sonnd iapαt elemejsJ*, such as iaicrophoacs 224 Jot delecting sound, s so-υtϊd ptocessmg mm 22f>, s pov,-«r source (sot shown), »nά an exlera&i tr&ssmkrer υnjt (also sot s _* "5s5%v5i>, TIx; cxsersal traasraittcr ®nϊt is disposed oκ the cxterle-r surface of soυπd proci^sssg uait 226 aisd coi»pm«<s aa external coil (not sho ^{^} wss). SouaU prøecssing unn 226 ϊ>roe≤xses the ouφu? of sascrophooes 224 mά generates encoded signals, λometjinijs rε-fen'od to herein as encoded das^ signals, which me pr&vjdsd to the external Sransmitter unit. For «ase of llkstfsfi&n, soursd processύig τmii 226 b sknvs detached from the r«cipjent.

|δδ4i| ltstarnst comporitSQt 244A &>mprkss an mteroal receiver unit 232, a stirmiiutαr Mnh 220, .s:sd a. $titsxaiatk>κ »rπ«agssm«at 250A _* Infernal receiver unit 232 sad ssiisuLator unis 220 ^β rs bcπrsetϊcaily sealed wϊύύn ά bbcompatibio Isousϊog _t sorscϊiiftδs eoiksαively Kfforrod JO herein as & sta«u!s5or/rcc??ϊvcr usii . fSβ42] Mteπiai receiver s«it 232 comprises an srtaaai coil (aot sho^tϊ), and prefcmbly, a magnet (»b» xs>ϊ shows) Iked relative to ths interns! coil The external csoii transmits e!eϊ ^; iricai {i.J ¹ ,, po«,'or anά stbximhttoa ante) to the hjremsl coil via a radio frequency (RF) lϊak. The istcrtKil ccii h typically JJ wire asteαns coil comprised of multiple turns of okαπeaiiy iasslated siϊsgtc-.styatsd or πi«lti-&κ-atxt piannυm or gold wire. The electrical insulation of ϊbc imemal coil is prøvkfcd by a flexible stlicoov molding (oot shown). M «se, implantable receiver ^aIt 132 may be j*os«ύ>fκ*>i is3 a r&eess of IIJS tetrφoral bone adjacent auricle 1 10 of the recϊpϊeat,

I9S43S embodiment, atknuiatkss λrrangcnsejϊi 250A is implanted is tπiddk ear J05, For ease of iliustratba, ossicle 106 have been omirtδd &ox& FfG. 2A. liowcvc?, it should

ho appreciated that etirmshtfos βrrangemcαt 250λ may be implanted without disturbing ossicles. 106.

18844} Stimulation arrangesssBi 2SQA comprises &« actuator 241), a stapes prosthesis 252 sad a coiipUtϊg demons: 251. As ds&cπbed ia greater de&il btϊow with reference to FIGS, 4A and 4B, k ibis CHϊbodϊuvss! j,iim«3ittion arrangement 250A is iinpksied sad/or εoεϋguredϊ such that a poϊibβ of stapes prøsthtsjk 252 abut* sa opening m oae of the semieireiiiβr canals 225, Ia the ilϊustrstrvs embodiπictii, stapes prosthesis 252 abais as opesfeg is horizontal semicircular cstiai !2<V It would be spprociated that in akeniativc embodimeaϊs, stitatiϊstion arrangement 250A xmy be implanted such that stapes pmsthcsis 252 abaj$ as. opεnsrsg in posterior semicircular <K3&sl 12? sr supcrbr c&nal 12§,

|$«I4?1 As nosed s-bovfc, & søiiXiά signal is received by one or π>αre jnicrppbou&f ^; 224, processed by souδd processing issist 226, mά traasiritfcd a* encoded άs£& signals to mtcπsaϊ receiver 232. 8a$ed o;5 ώ«$c received sigaais, stimulator 220 generates drive sigasls whscb cause actuation of actuator 240. Th& actuatioa is traasiefred io siapes prosthesis 252 such that a w&ve of fluid ωXJtioϊi ss gsricr&ted in horizoma! scmkϊrcalar canal \2& _r Because, as nored above, vesϋbuts 129 provides fluk! «oinmy«i<5sϊtiois between iJjc semkiteuSar c&nafe 125 sad ihc πrøiiau oaftisl T 36 (FIG, I B) _* the wsYB of Cϊutd inoϊioo coMinues fato mediate canai 136, ifeαreby activating she lsair ceils of ths organ of Cord 150 (FIG, 1C). Activation of the hair cells causes spprcpnasc serve impulses ϊo be generated &nά tsami&ε∞ά throu^x the $pkal gasglioo edis (not shows) mά aυdst-ory sssrvc I I 4 to the brain (also uat shown) where they ere perceived as sound.

|8S46| F-IO. 28 is a pcrspfislsvc view of a direct nsschantcsϊ stitπαktør 200S in accotdaricc with farther «mhαdtm«sis of the j»rcsc«t (tivention having Simikr to the embod3m*«t$ described above, -direct nsce&aaicai ssϊismkiot 20OS is ^bowπ have compoπems ϊmpkated k a recipient,

J804?] IHrscs. mechadcal stiϊrsυktor 200B comprises &a exreraal Goaijiβπent 242 which si direct Jy or indsreetly attached to the body of the recipieat, sad an isacraai 244Fi Vcbich ϊ-v ϊcrøpo«frily or pcmiaacatly iispisiϊtcd in .he rceipioat. As <!ese«fec4 above wύ ^' h rcfereisce ϊo FlG, 2A, external cotnpoTscnt 242 typically eonipϊises o&s or more sound input such as πn-cropho-oes 224, a seαad processing ami 226, a power soaxcc (not shown), ssd ^a external tmiSωiitryr unit (also tκ>t ϋhown). Also as described above, internal cOBψαπeωt

2448 cαmpiives csπ iiScrsal receiver vinft 231, a snamkSor unit 220, and a Ntiraulaϊkjn arr&sgemest 250B,

[0848! Is ihe illustrative εmbcKHmst-t- stimulation arraagesie∑tf 250E is implanted In middle car 105, For sasc of illustration-, o^sieks !(K5 have bees omitted ftomFϊG. 2B. However, it should be appreciate ύut siinjuiation arrangement 250B may be implanted wishout d&'Uirbs ^' xsg o,v _* .'eks 306.

IM49] Stkv.'alMioω arraagemsBi 2508 comprises &o aciuaior 240. a stapes prosthesis 254 asd a couphng eiemem 253 connecting the aciostør w the »«φcs prosKlsssfe. A$ described in greater cks&H hciow with rcfercijcc ro FIGS. SA-SC, in ibis vmboάsnam atkmxhiimi amssgcasotit 2S0B is ii&pl&BtcU ssd'ur coa%ui«d *»<;h that a portjoa of stapes pro^h«>b 254 abuts røus<i window 12J (FIG, !A).

|iRW; A^ aoied akrn^ s. s.oimd signal Ls received by arse or mote mkϊophmtss 224, pjm:«s»sed by sound prøcc^mg unit 226, and sransmrtted as encoded ama signals to tntersal reeesv-er 232. Based <m ϊ^aύ received signsbv stimuiatsor 220 geoeralcs drive ssgnals which cause ήctaatsαn of sctujstOE 24δ. This actyatsoji is tramierred to stapes prosthesis 254 such thiύ a wave of H»id πκϊtκ?π is g«ncπited is th<? p^rϊlympa in aa&U tytnpmi 138 (FKI IB). Such fluid atjotioπ, in tum, activate* tlse hair cell>< of the organ of Corti ^! 50 (FIG. IC). Acth'&tion of the fesir cells causes appropriate, nerve iπspαSses to be g«tϊemted ®aά traasferred through the spiral gaagtios eeϊis (sot shown) imά auditory nerve 1 14 to tηe hr&in (also ix)t shown) where they are perceived as soaπd.

|§85!| FIG, J Is s nartsally exploded top view of a direct snscfaasicsl stimulator 300» in accordsace with cjnbodtjscsts of ώ-e present fevβiuiofi. < ^■ % discussed above, direct nsedsauscs? stiwukUoT J^)C) ςoϊ5ipri?Cis sst external oompo&sπi 342 and sn intemal co?«ρoa«!iϊ 344. Externa! coϊϊφotscm 342 comprises ss sound processiag unit 326. Disposed in or o» sound ικat 326 are one or rαore sαurd iaput elements cotiSgαrβd to receive an ϊnpui sound signal In tisc iHustrative etϊ\hodimeRt of FIG. 3, sound processing unit $2{> h&& micropho^es λ24 dϊspαsed therein to reocjvc sa acoiwSic sctsnd signal, Soijs.4 procsssiag uxάi 326 iurther cwaψrbcs. aa ciertricsl c*sϊo<;ctor 33-1, Ebctxica! csonsisctor 33-^ us configured to coπaeeϊ mechanics! SttmuLaϊoϊ 300 io cxtcπssϊ equipment, sad to receive an electrical sigrcaK *»«ch as at? ciectrkβ! xvvmά ϊ,iganL directly there from. Electrical connector 334 provides the ability iϋ cotuiec; d?r«ct meeb&rsjc<i! stimui&Sor 300 to, lbr example, FM hearing systems, MF3 pkyers, televisions.

siiobile pliotsas, etc. Direct ϊsechasicai stimulator 300 further includes a sound iapat eiemera in the farm of s. tciccoii 3δf>. Tesecsϋ 306 provides She ability to receive iαpin sound signals ffcuB, far t'xsmpic, a telephone or other similar device.

|80S2| Sound processing amx 326 Includes a sousd piocessor 310 which processes sousid ssgfish received by ihe sound mp«i elements. Souad processor 310 generates βacoded data signals based o& thess received sound signals. To provide coπmii over the SOϊKKϊ proees^ssg asd other functJoJia^ity of direct tscch&mcal stimulator 300. souftd proce-ssiβg unit 326 mcludes one or xsore user controls 322. Integral in sound processing tarit 326 is a batter)' 308 which provides power u> the other coasponcδϊs of direct mcchaascal stimulator 300. Sound processing unit 326 further i&dudc _* . λ printed circuit board (PCEi) 312 as sKchaakaϊiv support &u<! electrically i.\HϊaocJ the above as« other fuacifenal compoaesU. Disposed on the exterior surface of >oυsd pϊoccss^g urύϊ 326 ss aa external irasisrninef unit (not s&øwn),

|ø8SJ| Fo? ease of iUustmtims, so^ad processing unit 326 has bees, showa wish cover 302 rersøved. Covw 502 further hits oae or more openings 321 thcrcta wlsicfe receive user coβtrøϊs 322, micropHoωeϋ 304 mύ cosinector 334. Cove? 302 is cotsSg«τ«d io seal sound preceding ami 12(> so as so prcvsst She hsgress of water, dust aad oέher debris, particularly through openings

32 K f§S54| iateroal compoϊsent 344 comprises, mi miemal receiver u»« 332, & stimulator unit J20, and a stitiiukuio?3 srrangeπiem 350. As shov/n, receiver ami 232 comprises aa is>terBsi coil 314, imύ prefcrgbSy, a magnet 320 CSxed relative to ike iat«πml coil. The otlsrosl t««« in ext«rκal coϊπpoiic-at 344 uaavmits electrical signals (i,«., power a«d stteuiatfeft data) to interml coil 314 via a radio frequency (RF) Hak. Signals receive ar interna] csosl 354 may be provided to sdmakϊor uaii 320. A<* "wo^ld be appreciated, interna! receiver xmh 332 mά stimukior xa-ύt 320 would be hcnn«ica)iy seated withiti a biocompatible bossixsg. This feo«sϊ»g has been omitted from FIO. 3 for eass of iliystratios.

J8SS5] Coδsecsod m slϊrauϊator 320 vis a. cable 328 Ls a stimuJalkjn arraagcmcni 350. StjRssktbπ arrasgetncnt 350 oon^risci &a actuator 340, a stapes prosthesis 354 atϊd a coupling sfemersi 355. A second c«d of shapes prosthesis 354 is coatϊgiired to be posiifoned abutfing an opemrtg m & redpseist's mssr ear. A second end of &iapes prosthesis 354 is cosasctcd to &n aciuator 340 via a coupling 353. As described above, acfcuaSioti of actuator vibraies s _* apc&

prosthesis 354. The vibration of stapes prosthesis 354 generates *arø of fluid motion of the eoehic&r 8uki thereby activating the hair ecils of the orgais pi ^" Card 130 (FIG. .1C). Aetivxπon of tb. bak cells causes appropriate sicrve impulses to be gescr^ted &nά transferred through ths spiral ganglion cells i not shows) mά auditory nerve H 4 to the braiti (also KOϊ shown) where rhcy

IMSb] FIG. 4 A ϋlusirstes a stimulation, srrattgemssl 450 ύi accordance with embodiments of the prsssra srwsnitoπ. In the ϊiiaswative embodiment of MG. 4λ, sdrtuibtsart atrsif5gem«!>t 450 Ls configured to g« aerate llaid ϊaσtbs of the <isdoiymj>b. contained in a recipient's semicircular canal 126- Because, as noted above, vestibule 129 (FiG. .I A) provides fluid communkatSou betwoca she casal 126 aad the median casal 136 (FlG, IB), the w&v« of fluid motioa contβjucs JπSo tτmάϊns. εanai 136, thereby aαivatiπg the hsir cells of the organ of Corti 150 (FIG. 5C). ActivaiioTs of the hair cells c&tsses apprαpriate ocrve impulses to be generated and transferred through the sp'Val gaogifcπ cells (FKJ. 1C) and auditory nem: (FTG. IA) to the rccspi^r^ brajf) where they an? perceived aSύ.o««d.

|MS7| In ϊi5& jlkmtrative embodiment, stitsoiatjots arrangemeta 450 eoroprise-x an aςtusSør 440 CQuple<l us s &jiiϊjulaiyr αnii (nol showa) by one or more cables 42fS, Actuator 440 πsay be positb&ed ssϊd secured to the r«ctpseftt by a fixsϊi>t> system. Details of an exetsipiary fixatsorj system are provided below with rsfereπβe to FIG, 7. Stimuiatba arrangement 450 farther comprises a stjφes prosthesis 452, is the iHuslraϋve embodiment, stapes prosthesis 452 is a sαbsiaπtiaϋy cyimdriosl member h&vmg a first end 460 abutiiαg ait opening 405 i» the recipient's

£§0585 CojKKtctiog setuarat 440 sod stapes prosthesis 452 is a coupler 409, CoapSer 409 csoαipmes a first elongate eoinporient 404 extsndjβg tongitadmβlly &om ^4O. Dkpεssed &; the ύsst&l pottsss of ilrst compossest 404 is a second commonest 406. Second component 406 3$ orϊcϊiS cd such that the eotttpoactit cxresjdn away first compoacur 404 ar so angle and cø&aecLs to stapes pr»srt3«sis 452. Is other words, aa axis 41 ) extending thrcsugh the ccmer of S,C«>JK! 406 &!ø&g the directiojϊ oforleatatios ?5 at sa angle from She longitudinal sxss 407 of first coiϊspαacnt 404. is certain coiϊ^oBCtϊt 406 is oriented suck that axis, Al l is positioned at an angle of apprøxfeatcly 125 degrees ftoπi longitudiaal axis 407,

ps»*>] As wottsd be appreciated, there is iimiied space withsn a recipient's sku.il in which stsmtiUtior: m&ngeroent 450 may be trapJsnied psri ieulariy if the recipients middle car i* left uadisiurbeU. As such, due to these siae constπώrts the orkmiatioa of second component 406 relative to first component 404 may faciik&te ihe proper or desitrεd positioning of stapes prosthesis 4S2 so opsϊm&Hy tttcchaaically stimulate tjjc recipient. To impJam stimulation. arcangerosm 450 iHusiraied in FlG. -&A, s surgeon may drill or fern a passageway in the mastoid of the skaU. This passageway Js preferably conjsJructed asd arranged sacb that it provides άmzet access to rise cochsca, Is this ύinbodάπont. I he surgeon (hen drills or fornis srs opeafog in ήctnicircubr c&nal 126 of the τaπpi«nt. Siimalaϊ ion ϋrrsngemeat 450 may be inψlaatcri sV: the lbimcii pvissagcw&y stsxi'or the recipient's middle ear caylty, aad the ssxsngcmcm is ooaSgαrcd so that ^ta|K"s prosthesis 452 is posiii»ned abutting the opcairsg ia the semicircular caπsl 126. is ϊhc t!f&<vtf&dv« ersbodsjicat of FIG. 4A, this opαύng « crcsι£t:-d ύi hørizoma? xemiesxiular aunt 126. IJ w&αid l>e apprccisacd ihat aa opening creased ά, pø5j|<sisr scmscstsuiar canal 127 (FiG. IA) o? sypsnor s-etjiicir-cular αaal 128 (FlG. IA) way also bo used. j$8«δj Ia embodimems &f the pt?8«eτϊt mvcatbλ, first consposent 404 conψfm&ϊ aa elongate md 404, FiG. 48 iiluinTsfcs one cxcπ^siary eβnβguraiiøα for s rod 404. Aά S-høwa m FKI 4& _t rod 404 ccsi3pns«js a plumUty of tsbj>c»pϊβg .vjctjons 420 c*nftg»r§d to bs slkiably cagaged with OϊI<? asotber. A& yscji lϊcrcώ, *oak>si» jrcfer to sections (hit c&a &H4e i«%vδi'd or outward with reflect to each otfe, Tise ϊclcscopiϊig sections 420 have mcrcjtskg cax^-seetiøπa? sχϋ ^N b Oat each telescoping section, stay Ix; received within as larger teiϊ&eornag *odtssa. _< -Vs ϊtoϊδd duo to size εossixϊύ&ts, tte? may be limited locations ia whkh ssasssor 440 may be implaπSsd. Tekseapsng seαtons 420 enhauojs the adjustment espahiliHe* wihta the limited space provided Us a t«eij>tc«t's sku.ll ma that the shapes pros^csLs Hssy be properly ppsitksiβά &f the op-^oiag s ^' n senacircutar canal ϊ26,

|θ»$i| In the specme embodiment sjf FiG, 4B ₅ rod 404 comprises tares sections 420. first ssctbs 4J0λ has the laxgei? eross-secifonal dkmctcr sM settbrss 42ϋB imά 420C &&ve bi?tvai>big sraaSbf cxoδ.vsectk»sal diaBieters, ϊ<yd 404 is con&trueted and arr&ftgsd $ϋeh that each scctkjs 420 may bώ mdspendtntiy retracted or extended so as to permit v srϊoυ^ of rod 404. For cxampk, ii ^" a shorter rød 4t}4 is de&trtxf in cxie e»n%.uriitk?n, seetiorss 420B aad 420C tsay Lx ^> both retracted into sedton 420A. hi other eπitjodsisiems.. seαiosi 420B msy be extended SO® section 420A, while section 4ZϋC rcmainsi in a retracted positioned within 420B. Secrfoas

420 snchsde srucπocking meclmmsrns which iBdepeαde&tiy lock th& sectkms m a desired retraced or cxtcsdcd coKfiguratkm.

C§s«2| Although FlCi. 4B has hsen dise&ssed herek with reference to three telescoping secifpπs 420, it would W apprecssued that the u»c of greater or lesser numbers of sections b- within the Mxsps of the presctrt isivessisoa. Furthermore _* although telescoping sections. 420 are illustrated as. havbg j. <;ylitκkk&l shtape, it should be υadmtood shat m other embodiments the idssεøpisg sections may have dHYεren∑ αross-xeciioaa! sfvapc.% such as. for example, rectasgsJar, trLtaguϊar, L-'&λ

C#8fc3f A* tsotcd above, second cotrtfKisent ^Oo is attached to & άxst&l portion of first component 404 asd ex.tejj.ds ϊherc frotr? at asi asjgie In embodiments of the present aivcωtksa, second eompδiϊcπ! 406 is attached to First αmφo&e&t 4CM so as to cjstsnd there from a? & prsdcseπnsπeci ϋϋgle Is other eπjbo&ts&ems. sce»ad corrφoneni 40§ is attached Sa first compoacm 404 by a pivot join! winch percnhs adjustment of ibe angie of oπentattoπ of lbs scώosd Hd. 4C is a cross-^ectiosai view of an exemplary second coisposeia 406 cotinectcd to fest coTfsponcnl 404 by a ptvxst joint 456. h \ ?hc itlusnr&tivc pivot joint 436 ootnjMiscs a baH ^3 ¹ I S.EK! a socket 43θ, collectively refcrrcd to ss ball aad socket jomt 436 Wrώin. BsIl 434 j& at she distal end of ilr>s component 434 asci Ls contigxsrcd to be isceivsd i« sackcϊ 430 of scco^d ccsjϊxpencst 406, λs show a, the ceater of bail 434 is positioned at bag:«u^ioal axis* 40? <?f fet wrtipoaesit 404. B«ϋ aad socket Joint 436 is constructed sad arrasigcd sack that socket 4?δ m&y be rotated about ioagiiiidi&ai axis 404 or tengitudsπal axis 4M, Tins provide* πvo degrees of feedoss in the adjustineat of ώs asgk ofsccotsd coxiipoaetit 406. p&4ij As sho>rø, bail snά socket jo mi 436 may further comprises a bckmg airangcmcnt 442, Once s desired angle of^ccosd coraponεtit 406 has boon s.et, bckiag amaigemcm 442 tmay be eogagsd to rctjϊiπ ib$ ^ccosd conspoaeiit m tsc desired configuration.

|«iias| As rsotcsi sbovy, supys prosthesis 452 is connected to second eoπ^onent 406. FlG, 4C lor cotauxiing stapes nrosxhssi* 452 to second sompoa-est 40$, Ai> .second cotapo«ctrt comprises » receiving member 432 therem. Art elβmeat disposed aϊ th<; proximal end of stapes prosthesis 452 is configured m m&Jc with receiving member ^3S, Is certain ciabodimetits, stapes pro&iheib 452 is detachable ϋrøαt ;>cc<js<i comporastii 4Qh. Far cxajsptc, in one embodiment, the proximal clement of stapes prosthesis 452

is tesifestly tlεsjbie atid b configured io snap into receiving member 4.32, lit outer zϋxbaάi∞s&ta, receiving member 432 has iliresds therein whicb are configured m βmo wish threads on the proxkn&l ©lemeisi of stapes prosthesis. It should be appreciated that other eos-sncetsorss may also be used is alternative erabodrroeπfcs. In all embodiments, the connection, wcxuld be ca^s&ycicd a&d srrangerπeri so as mi w> interfere with the- trsnsϊsissios of vibration sh>;τs setu&tor 440 to stapes prosthesis 452. imwi Aϊ _> rsoied above, dae to i.iκc con^raints., ibcre may be limited locations IΏ which actuator 441) s&ty be mtpl&ated within the recipionϊ. Connecting flirf ssnd second components 4CH, 406 m a ro&traer whici peπϊdfs a<!ja«Rieat of the orksitatioa and/or positbπ of stapes prosthesis 452 i ^' acstϊtstφs opsiisaϊ poxirionisg of the- prosthesis S>r sUmuiatsan,

^W-f] FIG. 5A ilkjKtrates & stiimjiation aϊ?aiigem«αt 550 is sccorsJasee %vah cmbadiaicsts of the prevscot mvcmios. In the illustrative eπibodimeαi of BG. 5A, stimu'siion am ^y igcmeat 550 is coKδgyrcd io gerøaic Sussi iftαiioa ofώc »eri.!> ^r Dripb. contained in a recipient's, se&k fym|»asi 13h (FIG, I B). As di»cu^so-d shove, fluid motion of the r»crilymph activates the hair cdfc of die of Corn ISO (FIO, SC>, Activatkm of the hair ceOs c&tssos appropriate nvnx impulses to be gsnerased asx. tfaaderred tkrøiigh the spiral gajϊgiiosi ceJis <FϊO. 1C) and aυditory serve (HG. 1 A) to the recspieafs fe"ain where they are pstro≥Jvcd a* /sound. SErniuMbα arraKgeiaeiit 550 comprises an actuator 540, Actuator 540 πsay fov possrkmed srsd secured to the recipient by a fixation system. Deaails of ss excrapϊ&rj- flx&Hos system are provided below with reia'Ofiec to FIG. ?. Stim«iatioo -αTάKfcKαieftt 5S0 further cαmpri^es a .stapes prosthesis 554. λ$ shown in FϊG. 5C, jϋapcs prosthesis 554 is a substantially cyljodrtcal member having a first end 560 a«d a ,seco«c end 514, Aa s,knvϊκ first aad second ends 560 &xιά 514 h&vo cross-scctiøβaϊ dismeters which exceed fh<r di _< jfn«?i<?r of ώe remainder of prosthesis 554, Retiming IQ FlO, 5A ₁ di&ta! es>d 560 k coiiBgiiϊ-ed io be positioned abutting the membrane ofrousd window 321 in the recipient ^' s cochkt&. 554 is a coupler 509. Due to s«se coiϊstraύrts, iherv sϊsay h& Isou ^' ted ioestioas in. which actuator 540 may be iinplaπied witfem the recsptersl. parriculaily If fbc rccipieat'si maer ear is io remain oadiϋjtuibed. FIG, 5A illustrates ctnlxϊdiϊϊseots m whkh aciyator 340 i* pxsidααcd substantia! Iy m line v?ith rousd wiadow 121.

13

Thai is, actuator 540 ss positioned siotsg or parallel to an axis extcaditig through the geometric center of roiisd window 12 ! . As such, is Shis exemplary coα%aratba coupler 509 comprises as ekmgstv ¹ vød sxteadisg bsgitudmaOy from aetaatsjr 540 along axis SUl, The distal portion of rod 50$ is connected to starves prostheses 554, Ia the illustrative embodiment of FlG. 5A, stapes prosthesis 554 y, aligned along, sad is substantially symmetrica! about axis 507. In other words, lbs surface of nrst cad 580 is pøsiύosed orthogonal m axis 507.

|Sδ70j FICi. 5D :s crc-ss-sectionai view of one qrabαdπnextf of stapes 554 tϋustrattng one ώx&mplarv s;τartgemeδt rbr comccring the stapes prosthesis to rod S09. in the illystπstive embodiment, stapes pfOAihcsis 534 has. sa slongaic chaancl 555 exresding at kxtst psrik^iy there ϊkrougli. As siκ>w} _\ c^πnd 555 has a cylindrical sisspe which is symmetrica! about axLv 507. More j*pcciflcsl33% channel 555 is shaped so a& to receive at least th« disjfeai portion of rod 509 therein. A^ wou'-d be &pfκed&κsL the distajscc between acmator 540 and secosd «ad SI 4 of stapes pa. _* sϊhcsis 554 aiiiy !>e iπcrsased Of decs-cased, bending oa the extent to which rod 509 is inserted i'Jt© ch&rs&el. Once a desired disεaace between second eod 514 and acϊaarø? 540 is reached, rεsa 509 tmy he secured within channel 555. The adjustment m. the kmgth prot^ded by ϊ^is corJlguraύos allows stimalatϊoa attangcmcnt 55(1 to he adjusted for use m. & particular reelpk-at, without having to rammlccters different tegth rods 509 «βd &ta|κ:^ prosthesis 554. i& oϊhc? ctrkbcfdimcists, rod S09 xmy cos^rise a plurality of tclcsεopssg seαioas, such as described «bov« with jyicκ-.s?ce to BG. 48 to provide adjus.racst m. the lcagth. For example, in «ae embodiment md SQ9 has $ breads rhereos. la this catbodimeat, channel 555 has threads therein configured io tϊϊste wkh the threads of rod 5 ^Q θ. f80?i] Its alktnvithT, embediments, cfeasnsl 555 is configured to coastrictabiy engage τaά 509, channel 553 is lined with a πmtsrkl which exerts a compressive force ofj rod 509 w&eti it is JTissϊted iaϊcs cb-uaicl 555, This coαψf«$sive ib-rce i& &xdfκkm to coiφie sfspcs prosthesis 554 to n>ά 509, but nay !>e low enou^i tfeat the mά aod prosthesis may be majtaalϊy .separated. i^?2) As aotsd, the inψlasicd pos^ioa of actuator 540 may depend upo« the size coes^aists of s paiUrybx skull. As such, is alicfaβtivc cxnbodimcats of the present iavssitioB, aclu&sftx 540 tϊ«ιv swt be positioned aloDg or parulk! to an ;sxis extcadhig fhrough she geoisetrk censer of routse wmdbw 121, Therefere, in cortaia eτalx><!imcλts, coupler 509 way fee

iropiaϊngnϊed rø ose of lhs cotsflguraiiotts described above with refcrersee ks FICr. ^A, Fer example, in certsis ctnhodimeats, coxspJcr 309 may tOrcψrøe Jdbscoptng sections, a bail asd socket joins, <jtc.

\W!3\ FIG. SS illustrates, an alternative coafiguranoa for sffamihaioii arrangement SS6. hi this erαboόiaϊsnt, stønul&tiαrt arrangcsasiii 550 b configured to generate Bind naotba of the eϊκk>ly"αip,h eojitaiasd JϊS a rocipicist's ses^icircular caaal 126. Because, 8& aot«l above, vesisbitk 129 (FϊG. I A) provides fluid cosnnstnsostkjn bery _s ^" eet3 the scraicirculsr esssu 126 asd the πsc<Haϊϊ cam! 136 (FIG. IB), rhe wave of tXuiά motk>a coctiaaes Mo mediae c*«al 136, thereby sedvsHng the hair cells of the organ of Oorti 150 (FTG. 1C). Activstion of the hair ceils causes, appropnsic ftcrrvC- impafeεs to be gs&erate-d soά trasϋferred throogh the spars! g&sϊgijøs cells (FlG. IC> sad audiϊory scτ>-c {FϊG. I A) to the reeφicstV feraisi λvfeerQ ihcy are perceived as λO and

[0<J74j As discussc4 above, re these c;mbodimcωt$, sdmuktioa arrangement 550 comprises as actosϊ^r 540. Actuator 540 may be positioned asd secured to the recipient by a fixation system. Uetaϊb of &n es,£j«!pi&ry ϋxa5to$i system are provided below with reference to FIG. 7 Sϊimsis.m>ω ammgemem 550 ilim∑er eompπ5«s a stapes prosthc? ^" is 554. As siiowrt in FlG, S€, stapcβt prosthesis 554 is $ $uhs4*mial!y cylfedricai metjifccr havujg a first end S6ϋ and a secoad «sd 514, As shows, first «πd second ends 560 a.m1 514 have crøss-seciio»a! which sxcced the CT»s*-.xoetsraal dism«ier of the remaiadβr of prosthesis 554. Reteraing to FTG. SA, distal v&ti 560 ks αssfs^ured to be positioned abuttirig ati opcaiisg iti scmiciicαkr CΆϊϊ&I 126.

19875] €oimec&ig sctuator 540 mά stapes, pmsibcsi^ 554 is a eoupfer 509. Due to ssfee constraints, there may be limited Socatioxts in wkicb actuator 540 may be impiajired withia the rήCijήcaϊ, ρartsc«lariy if the rccφie«t"s> mn&: ear is IQ remain asicnstuϊ'bcd- FϊO. 5A iUusfrates cmbodimt-xas» ia which actuaior 544) is positioned along or parallel to «ϊ* axis exSending through έhc gcojωeifiα csmcr of the opening m scmCcircBkf Cfeϊieύ 126. As such, in this exemplary cs>n(%i?suo8 coxφJα' 509 cota|>dse$ &n ekmgate rod extending bngttudiaaUy from actuator 540 along axiv 507. The disiaS portio of rod 508 is connected to stapes prosthesis 554, Is the jiiwjtfrstive emtsodfrocm of MG. 5A, st&pcs prosthesis 554 is MIgacd aiøsg, mά is substsstially about axis 50?. Ia other words, the surface βf first crsd 560 is positioned oπhogoTssi

U) axis 507. S^apss prosthesis 554 may be contiect&d to coupler 509 as described above with reference so SA.

I&876J As nαted, the hrφsamsd position of actuator 540 may depend upas the size constraints of a paπicuJsr rsdpserst's slα∑il Aθ such, ta alternative embodiments of εδs pre&em investioa, actuator 540 msy τsoi be positioned ateβg or parallel to an sods «steodiog ihrough. the geometric easier of ihs opening m seiaidrcukr caaai 126 ^" , Exemplary such embodiments sre illustrated In FIG. 4A.

|&87?) FlG. 6 is a fbtjetioυaJ block diagram of a direct mechanical sfimuiator 600 i« sccordance widi ecnbodi-Ksrots «f ihs present s ^' avcstsoπ. λs shouis, direct mechanics! sϊέrmsiator 600 aa extcπial coisijose.it 642 aaά &ω iaterasl compoaeat 644. External coioporteni 642 comprises ^ee or taore sousd inpui elemetsts 624, a soaod processing uaiϊ 62<x a power source 620, and as cx∑cmsi trsatsmittcr unit 631.

Soua<l itφu! skπicst 624 receives a &<»υπd 603 ausi osnputsi ajs electrical sigsal 66! t«pr«sentms the so^iπ.d to a sound processor 610 it? soutKϊ proc&sstg uait 626. Sound processor 610 gsrsraie* encoded signals 662 which are provided io external transmitter uolt 646. As should be sp|>ϊ«ciatsϊd, SQIπKJ processor 610 yscs one Oi more of a phimlity of tcehsiqucs to selectively aod'ot fiker dectήcal signal 661 to generate encoded signals 662. Is CAfrfsia estbodirscats, souad j>rQcessor 610 eomprise-s substaatiaUy tlis? satnc sound pme«ssor a, ¹ ?, is used in ao sir oβndyeHøω hear fag asd. 1s> δirther embodiments, sound processor 610 eoπspnscs a dtgitsL sigω^l proccss-or, lW/$i External traasmiuer atsit 64ή is conβgyred to tr^assait the encoded data signals to iϋtfrorrusϊ cORψOϊtefit 644, ϊ« eett3.m ≤mbodinseftts, exteπjaJ rrsasraitter uns 646 comprises &n cxfemsl coil ^isick (oms& part of 4 rβdio frequency (RF) Hπk with contpotscnts e-f internal coinpotietst 644.

|68&δ] Internal eom{K>ns8t 644 comprises an isterøal receiver unit 648, a stimulator imk 620, &x\ύ a stimαkuos a∑τ&ageπ5«nt which iaekiάes aα acfuator 640. Internal receiver umi 64U comprises ^n ϊatsπial coil which receives power &n4 encoded signals from the cxtcrπ&i coil ia exicpisl 646. The eiscodcd signals 662 received by internal receiver unit 633 arc provided io stlnsuiator nail 620. .Biϊλe-ά oa the received signals, stimulator unit 621) is configured to deliver an efoctrkal dnv<; signs! 664 to actuator 64Q, Based ofj drive signal f>6-4 _f actuator 640

IZ

γφτa?ws & component sbϋtHπg dii opening hi a recipient's inxssr ear to generate fluid πKstson of the eαchio&r jiuicl. fβ§8i] As xhwrs ϊϊ3 FIG. ύ, sound processing unit 626 further comprises a user interface f>52 and control ckcirooies 654. These compαacnts may function together to psstni. s recψicai or csJlicr u<>eτ of dsrcct mscbsmcat stuαulaJor όϋO to control or adjust tae operation of the sismut&tør. For e>iκHϊplCv HI esmsfes erobødmssϊrUs of the present invention, ^" based on inputs received by a s&er interface 652, control eieαmm ^' es 654 may provide isstmetbrbs to, or rcquesϊ iαferøϋksn ottiSM swiϊφϋrtc-Rts of direct tacchanical stiir^ktor 600. U^cr iater&cε 652 m&y comprise one or ose or buUoriSi or iaputs which allow rhe- rβcipicat to adjyst she volume, alter she s.|κech processing strategies, power oti-OlTthc device, etc.

|0δH2l λttlsøugh the embodkttc^ts of FϊG. 6 have foeea described with refereticc to as cxtcmai coispon.eϊE. it should be appreciated that in βitcroaSivc csubodimem^ direςέ mechatjical xiiϊϊmlsior Sθϋtκ! pfαee&sϊtsg mx ^' a 626 is tmpi&5t?eci its u recipient ia >JϊS mastoid botw. Ta such embodiments, sound |ϊrøccssor may cθπ»«υϊiϊcstt dirsetϊy with stirsulator unst 620 and the transmitter and rsecivsr may be eHrαmsted, fθSS^i RG. 7 is ϋ perspective view of a fixation system B88 implemented in conjaEKSkm with a direct mcchaj3ϊθϋ3 ^tsmaiator m accordiiaco with smbodEmesis of the present iaveatiofi, Fiisarba .system S??S ;s configured to be implanted, for example, in the middle eat cavity of the recipierJ is io rdain a stύϊialstiαo &rraBgc;mc«t ^" m a de&srcd positioned. M aytcd, the sϊzc «oκstϊsmts of a parlscυiar rccipseat's sksϋ saay lhmi haw compQwsnU of a taechaaical ϋtimsl-ϊϊor m&y he pos>tion«4 vi'ithiω a ϋccipicnt. λs descried bebw, fϊxaύon jtysistn 8B8 provides a flexible system tkst permss βsstbn of an actuator in & mmih^r af positions vHidsia a recipient. Suelt 4 fi&s έhk .vystεra provides ϊhe ability to cavtoraks the Sftiraϋβtiott arrstsgemsaϊt for optimal cochkar fluid dtspiac«t3icat wiέhis the gcoxnetrk size coπ^traint-s of the middle ear. ps«4f As .vhowa, Sxation system 88B fet comprises 8 first c»s.v-,<;hapod co^nposcat 860. First coraponest 850 cortiprbcs a Srxt elongate and substaiit-ally pkn*$r member 862 posϋkϊned is s pbac t<50 Hxisnding laterally iroia first mcrabcsr 860 is plam: 850 are $ymsie?Ti«aI :ncmόcr» 8 ?0. First snetnbcr 860 and lateral members 8?0 each have one or more sp«rture.s H92 thcrem used to secure the fssation system to the recipients; KkulK SpecificaHy, during

iϊiψhntatϊoϊϊ of fixation, system 8^K, one ør mtsre bone screws (not shown) are drUi-ed jato the κxiρs&m\* &kuil through aperture 892, The screws cxett a fores on eomposc&t 860 which sKxtjrcs the COSSpGBCiH kϊ a .selected pø&Itkmed. f«ϊOS5| Cmspk-d to first composes! 860 is a second component 872, Second cossponeat 872 comprises first &nά second |>ka&r portioits E?4 positioned substantially parsHsi to pisae 850. Portions 874 are separated fey an orthogoasi aajisber 8?6 positioned eπisogosal to p.tet 850, As shown m FϊO. 7, portion $74 A is pα&itioscd adjacent to- first member 860 atϊd secured thereto by a screw $90. Portion 874 is spaced fro-tπ fir&t tπembef S60 by s spacer 8?fi. i»0S6j SHKSISγ to per! toα S74A, pottioa 874S is posάibscd paraiiei to a portion 882 of first HK-sBber ${ ^• >&, ?ortba S?4B is spaced ϊroro portbo BS2 by spacer 878 and orthogosal member 876. As A)wn in FKJ. ?„ portions B74B mά 882 each contpos^ an agertise 88<1 dimensioned to receive a ^phcricsl d<?mcBt S80, refcrrøi so herein smcylating ball 8SO ₅ theresa. Tiss disasters of sφertures B84 are sssaiier tfeas the diamdsr of articulstkig ball 880 suck that only a jsorttoa of the h&\l h received therest. As. discussed above, screw 890 secαces fϊrst coπφonest 862 as second component $72. Screw $9ϋ serves a second puspose of securing the posnksn of artHMϊ&tϊng !>;-:!! 880. Specificaliy, as screw 890 is tightened, portwrjs 882 and 874S are forced together, THs yxert$ a coasprassiVc ferce o-s articulating ball 88S vvMcb pre^ai$ a»y romsiou of the ball v-ishm apϋrfures SB4,

[MS?! Affixed to sxsd sxtendttig from aitkisktmg baS! SSO is SIR L-shapod eSoisgato r»embef 880. Disposed «t she distsi easd of ctesgme member 880 is an actuator rctcatiosi elcraent 864. retention eϊ«κϊent 864 conipriacs a hαϋow t&hv which is coϊiiϊguxcd to receive asd retain ths boάy øf an actuator fherei«. Reieatbu elemeat S64 Is configured ^; to securdy hold sa acksasyr therein during mcchaoicai wimulatson of a rβcipiesa's ϊ»κer ear. Aλ would be appreciated, other types of r<;S««kni cteneπts are within the scope of iM present inwESion. For csasipϊc, in osss embodiment, the acta&tor comprises a met&iKe outer body, I& such aa cmbociJraent, ret can bis δϊcsϊicst 864 may comprise & ra&gset coafiguped to create a magnetic eojsncction wήsi the outer body of the actuator.

IδϋSSj As r«>ted aδovcj during implantation of a of fixation system Js88, oaβ or more ixH'.e screws sre drsiled into the rccspicn^s ^fcull tbotigh apedureϋ 892 to secure the jsyfciona to lbs nscϊ ^' pism. Prfes' or subsequsEit to impisss!afiotx _t screw 890 is adjusted So such that &ftk:ut&Hag baϊl

&S0 is free u* a>utc itϊ aperture* 884. By proving freedom of movement of artieuteig ball BSO, u surges^ ;usy adjust Use iocstiβs, posies sad'or oricntatios of retsπiikm element Ss64 in say άxh. This £k;sκk>∑«. of raovcnsjns provides the sargeoa wMs the ability to precisely fsøfciiioπ rctsstkm clement Hδ4 sack thai &•? actuator received therem will bs properly positicmed fe ir&nsfer vibra-bn JO S stapes prosthesis positioned as varioss is the iancr ear.

[StS^ Is eϊϊ5lχ>Jhi?eats of the present invention, ekmgste member E8δ may have sa adjustable lengi>s. i ^: &? example, k <>rse stsch embodiment, ebngme member 880 may ccnsiprise a pisπiliiy of telescoping sceriøns oøsilgurøi to be sKdafaly engtsged with esc ssaotfeer, As jjsscd henjm. the tcrπϊ ««lc«copis>g sections refers: Io sedbii& thai can Slide inward or outward wirfe respect to each other. TH« K'k-≤copiag sectxsss have increasHig cross-seetioail diamesm., such that each ϊdescoping seciioa may be reoϊn*ed wύhin as adjacent krger tciescopi»g section,

|8-β§δ| Ia other eϊϊiboditncωts, the location, of reioitwii elcmest SCJ4 is sdju&table. For j« ose retcatbn cbmest Sθ4 is πsmaieό on a rail s>st«m, Ia $uch an embodiment, retentkjϊs e-iesnesi S64 would he eaaSpired to slide afoπg the rail into * desired loc-atioti. The mil Nyststn wβuki be conSgured so bεk rctcBtioa element 864 isto the desired Sacatioti.

Itø9i\ Wlύk variouϋ emboditneots of tht present mv^artoa have been described abov^, it should bt ϊitiά&f&isoά dmt they have b«e« presented by way of «?x<smpie only, and, not Hroitadon. It will be apfpsrcat to person* skiMed m the relevant art that various obsasges tα iόita SJM detail ^■ ύan be mads thereiss without departi«g from the spirit and scope of the iκve«tϊθii. Thus, the breadth &nά scope of the pjrøssms iavctitwa should u»t be ϊisaitcd by assy of the above-describsd exemplary sτnbodϊmeβ£$, but ϋhemfci be defined only ϊa a«cordancs with the foilowsng cMtas sscf rhcir equivaiesits. AH patesas and publications di$ca*«cd berein arc s ^" κ their entirety by refcren.ee rh-crcSo.

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