CA2700628C - Methods and apparatus for transmitting vibrations - Google Patents

Abstract

Methods and apparatus for transmitting vibrations via an electronic and/or transducer assembly through a dental implant are disclosed herein.
The assembly may be attached, adhered, or otherwise embedded into or upon the implant to form a hearing assembly. The electronic and transducer assembly may receive incoming sounds either directly or through a receiver to process and amplify the signals and transmit the processed sounds via a vibrating transducer element coupled to a tooth or other bone structure, such as the maxillary, mandibular, or palatine bone structure.

Description

`
!"ANS'ti'lII I..t.NÃ:x- `:tRRA'i'IO: t;:
'V1E`I'1=iOilS AND APPARATUS FOR"~.

l.'I_f _.LD C?( THE INVENTION

100011 The present ilavclatit3n relates to i-a:ictlaotls and apparatus for transmitting vibrations, Ã17rotagh Ãeetla or boa7e structtares, in arztÃ~or arou.nda rtacauth.
BA('KGROU-ND OF f'1-1E (NV ENt`.i:C)N_ 1 00021 Hearing loss atTects over :>l million people In the United SÃa:tes (atiaut l.:>% of t:(-ze popta(aticatz}. .r#.S a chronic ccandition, the iaicicleiace of laeariai~ :ir~:~ia~gi:~.~~~er.~i .ra~~.ais t:(~a~xt of heart disease aia~.~, likc. IZcart disease, the inei~.~eiaee of hearing impaim1ent iÃZcrc:asc.s sharply wiÃb age.
100031 While the vast araajcarit.y oi='tlaose with taearilig[oss c<aal be lael~ed by a. we11-fiÃÃetl, high tILaaliÃv 1-ie<ariiig cievice_ izly 22% of tl-ie ic3tra_l hearing inzpra.ireci lac3ptilat.ioii own taeariaa, devices. C;rirreiai prodLiLts and distribution metlaoda are a7oÃ
able to satisfy or reach over 20 iaiilliaia persoii5 wiili hearing impairment in the U.S. a(unc., [00041 I-1earing loss adversely affects a persata-s quality of lite. aild psyclaologica:[ we1.1-beiiag. Individuals with hearing inalsairaa~ent often withdraw from social interactions to avoid friastrations, result.ing l;`r~oara inability to understand coa7versat.iotas, lZeceni studies have showia t[iat hearing inipairzneaat causes iaaorease~.-1 stress levels, reduced sel1=~confidence, a~~~uce(i socicabilityand reduced el:fectÃveaiess Ãn the workplcace.
tiFOÃ~~~ The hut.narz ear geaaei=a.llz comprises three regioa7s: the oLaÃ:er ear, Ã:17e m.idd:l~ e,,xz:
asxd the in:taer ear. The outer ear generally c:or~~pri.ses tlxc extcrnal auricle and the ctir ~~i-itii, wbicli is a tubular pathway t;hroudw whiclt sound reac;hes the Ãiiiti:d[e ear.
'1"1-te outer ear is separated fii-orn the niidci:le ear by the t~~~~ipaui~ ~~icrribrane (eardr aii)_ The middle car 2 5 genera11y comprises three si-aaall bones, known as the ossicles, wlaich form a meclaaai.ical eoia~.~ttctor from the tymparaic nieinbran4 tc.~ the inai4r c.ar. Finally, the inner car iiaelaados the ~oc:(ikea, wlaicla is a flaiid-f-jl:(ed structure that contains a Iame tatimber of delicate seaasozv hair cells tbat are connected to the auditorv nerve.
100061 Hearing loss can a[so be Llaasitied in terryas ol''`beia7g e~~~i-idtictive, sensoriaretiral, :T0 or a comb.ination of botta. Conductive hearing impairtzieaat izpicallz resLilts 1=rom diseases or tli,orcler-s that l.imit the transg-za.ission o1`,ound through tl:-ae mi.dd1.e car. Most cor:-gd~ict:iv~.~
iraapa:Ãrments can be treated medically or su:r4~ically. :E'urely conductive hearing loss i represents a relati~~eIy sttiall portion oi'Ãhe total hearing inipair~~~
population (estitna:ted at 1ess, than 5% ot the total }tearisY~,~ .inrtpairtci poptÃlation).
(OO071 Sensoritietiral 1~eara~-ig losses occur rnosÃiz .in the i.iiiier ear and aLcou.tit for t[ie vast 11*orit:y of [ieari~ig iiiipairment (estimated. at 90695% of the total hearing illitaaired population). Sensorineurat hearing impai~tnent {someÃinies called "nerve to5s"
) is largely ~atised by damage to the s~~~sory [iair cells inside t:~~e, cc?chlea.
;5~llsori~~eura1 hearing imi.-~airrni`nt E}cs;txrs siatural1.y as a result ofagiz~g or prolonged exposure to kaud. music azid.
noise. This ty-pe of hearing loss cannot be reversed nor can it be medically or surgically ti'uate~.~; however, the use of pi-cgperly titteti- hearing id~,~vic:es can i_i-nprcgve the intfivicit3aI's I.{.~ quaIittF of life.
[00081 Conventional hearing devices are the most cc?anmcln devices use(l to tTeat ani.1(l t-k} severe se.iisoiineural hearim)_ impairnzont. '1kese are acotistic devices tla"It amplify sottild to the t~iiipanic nieiizbrwie. 'I`hese devices are, individually etistoniiza6le to tlie paÃiont's physical and acoustical characteristics over toiir to six separate visits Ãc) z-iti audiologist or I;> hearing instrument specialist. Stick~ devices generally comprise a microplione, amplifier, battery, aiid speaker. t~ecently, hearing device rzianufaciurers i.~iave increased the sophiStiLatioti of soLit7d processing, oi~~~i using digital technoIogy, to provide ~eatLites aucb as programmability ~~-ici m.tÃlti-i~~~-ici c~~s-npression. Altho~igii these devices have ~~~~-i miniaturized and are less obtnisive: tbey are still visible and bave tn.,~jor acotistic limitation.
20 100091 YndusM, reseai-cb ha4 4bown that t(xu primary obstacles fc4r not pure.hasing a beari~~g device ;~enenal1y include: a) the sti(yassociated wit~i woarin,) a hearina cievice;
b) dissentina atÃittides on the part of the medical profession, particti1ar1v ENTpht%sieians;
c:3 product valiie i.ssueR related to perceived performance proiilems; d) 4.~enera( lack of information and edt:rcati~.~Ãi at the c:Ã~~nstainc..r and physician level;
and. e:) iiegative worci-ofv ~5 mouth from tiisyaÃisfied users.
100101 Other devic-es such as cochlear implants have, be~.sti developed for people who have severe to profound hearing loss and a~~o essentially cteaf (approxii-nately 21N", of tb ~.~
tota:l :h.ea.r:in~.?; impa::ireci popLilatiozil). -I.lte electrode of a cochlear impIatit is inserted itito the inner car inan invasiv~.s an(i non-reversible ,atrger-y.. T(xc cIet:trc4(ic electrically stimulates the auditory nerve, through ati electrode array tliattarovides audible cties to t[ie iiser, wliicit are tiot ustially interpreted by tbe brain as normal souiid. Users g~ne-rally require intensive aiid extended cÃzi~iiseiiii=;f and tra.Ãning to11Ãzwif-ig surgery to achieve tl:~~ expected k~~i-iefit.

[00111 Other devices such as electronic middle ear implants generally are surgically placed within the niiddle car ol'tlxe he4irin~,s :imi.~4sii-ed.. They are surgically implanted devices witla an externally worn Lornpor~~ent.
100121 The manufacture, fitting and dispensi~ig of'ltearititw devices remai~~
an a~~~ne.
~iid it7efficietiÃ:13i-ocess. Most 1icaritig devices are ctisÃom manufactured, fabricated by the ~~~anufacturer to fit t:lle. ear of each prospective purchaser. An impression of'th~ ear canal is taken bo, the dispesisir (either azi atit1i.oIo~,~i,t or licertsed hearing alid mailed to tl~~ manufacturer for interpretation and fabrication of the cust~~~i molded ri Lid plastic casiiig. Hand-wired ulec:ti-onie.s and t.raasclucer4 (microphone and-speaker) al-c then 1.0 placed inside the casiniw, axicl tlte final pt'~~dtieà is sliityped 13ae.k. to the dispensing pro#:e;sic?n,al a:{-ter ,or~~c periocl of #-irne, typically c?Tie to two z.i eek.s.
[00131 I'he time cycle 1=or dispensing a hearing device, t:rca~~~i tke first diagnostic sessiol7 to the final fine-tuning sessioii, t~~~~icall~~ s~~wis a period over several ~~Teel~.s, s~.ic1~ as six to ei[ià weeks, and.invo[ves multiple with the dispenser.
I;? 100141 Accordititwll=, tlier~ exists a tieed for met:liods and devices which are ef'ticacious and safe in facilitating the trea:tnaerià of 1:warÃng loss in paÃ.ients.
100151 hiatiotl~er Ãret7t1, more and more dentists aiid oral surgeotis have t;
r~~ed to dental implants as a:ii. ac:c eptabi.t ~i-icl appropriate meiins to restore a tooth that has been lost because of disease or traunia. Such dental implants oBer an attractive alternative to ot:lier 20 options because with a dental implant the patiuiit realizes a restoratioii that closely ~lsprox.imates a natural toot[i witholiÃ1~aving to alte-r the striictllre or appearance of adjacent natural teeth which occurs, for example, when a pationt chooses a bridge optic?n. United State-, Patent 5,984,681 discloses ~i-i imp1ant.for insertion iiito the alveolar bc~i-ie of a patient and wherein the impl~~i-ià is provided with a generally vertically prc?jectii-ig aticliari~ig pin ~5 that extends from the iniplant itiÃ:c) the alveolar 13otie of the patient and etfective[y interconnects t:lie, implant witli t[ie alveolar bone.

SUNtNlrlRY Ol,' Tl-lE INl EN-FIO~l 1(10161 Methods antl ap1aarattts for transmitting vibrations visx an ~.nlectr~.}l-iic and/or 3 0 tr~~~sducerassembll= through an iziipl~tià are disclosed lterein. assembly may be rigid1v attached, adhered, reversibly connected, or otben,,--is~ embedded into or upt~ti t:lie, implant to form a heariii=.:~f asseÃ-ribIv. 'I'he electronic a~id tuansducer assembly i-nay reLe.i-ve Ãziccami~-ig sot~ti~.-ls eit:lie-r directly or throii-gh a receiver to process and amplif~., t:lie, signals atid transmit the processed sounds via a -vibrat:ing transducer elenierit coupled to a tooth or other bzsrae stIUc;tUte., sUc:l-I as the or pa1titisYc. bot3e stmcture.
(OO171 In oiie aspeet, the apparatus for Ãransmaiti~~g vibrations via at least botie or Ãissiic to facilitate hearing in a patient includes an implant havititw an implant head atid a threaded :? porti~~~-i adapted to be positioned below a g m litie; ~~~id a boLisa~-ig Loril3led to the imp:l~i-it head and in vibratory cor~~~~~unication witli the irtiplant head, the housing havin, ~:~~
act.uatable transducer cii.sposed within or upon the ficyLisilig.
100181 I:11 another aspect, a method ol'transinitting vibrations via at least oiie dental implant includes Placing t(xu tlental implant orY a patieiit; and positiorYnigan actuatable l.{.t transducer suc_1a that the imp:[ant and transducer remaiÃ-t in vibratory communic;ation.
~00191 Oric ~.~xample of a met1iotI f:or tTar~~s-nitting these vibrations viaat least osic too. th mav generally comprising positioni~~g a housing of the .removab[e o.ra[
appliance oiito at least oiie tooth, whereby the housing has a shape wizic-h is conformable to at least a poitiorl ol'the ioot[i, aiid maintain.ing contact between a surface of the tooth with z-iti actuatable I;> transducer stich that tlio surface and transducer renmin in vibratory communication.
BRIEF DL?SCR.IPTIONOF= IT[E:. DRAWINGS
100201 Fig. 1 illti;trates the dentition of a patient's teeth aiYd oiic embodiment ot'a hearingai~.-l implanted device.
20 100211 Fig. 2 illatstratus a detail perspective view of the oral irsi~.-~lant ap~.-~litInce positit?iied iipon the patient's teeth utilizable in comliination with a transmitting assembly external to the mouthand wearable by the pationt in another variation of'the device.
1.00221 FÃg_ 3 shows an i(lustrat-ive confi4uration of tl:~e :ii-idi-vici-L-al components iII ~
variation ot-the oral appliance devicc..har~ing an c.xternal traÃismiÃt&ng assembly with a.
~5 receiviii4.~ and transducer asser:zibiv witl7.in the mouth.
100231 Flg. 4 sliows an illtistrative configuration of aiiotber variati~~l of the ~.-1evice, in which the esitire a,semt?ly is contained by tlic c?ral appliasic~.~ within the iiser's motith.
[00241 Figs. 5A and :~B illustrate perspective and side views, respectively, of an oral applranc~.~ which may be coupled to a ;cr~.sw. or post itziplant.~.~d directly intc) t(xe underlying 3 0 bone, sucli as tl~e maxillary or mandibular botio.
02,5 ] Fl&s. :?(:: and 5D illustrate twoadditional dental implant en1bt?diments.
[00261 Fig. 6 illustrates ano#1:~er variation ir-i whicli the oral appliance ~~~ity be co-Lipled to a screw or post i~~iplante.d. directly iiito the palate of a patient.

[00271 Fitws. 7A and 7B illust-rate perspective and side vieNvs; respectively, of an oral tippliarxc;e. wiiie.h m:ay have its transducer assembly or a cot3pling member att4ic;li.ed to the (,imxival surface to coiidLiLt vibrations tl7ro~`.~la the `ii~=~i~~~:l tissue and r~tic~.~rl~~ir~~g17~~~~e.
100281 Fig. 8 illustrates an example of bow rritiltiple oral appliance }learirl,.Y aid assemblies or t-z-ansriuc:.ers may be placed wi tziiiltilale tecÃi7 throughout tlie paiiel7t's moLith.
100291 l;^itw. 9 illustrates a perspective view of'an oral appliance (siznilar to a variat:ioll showii. above) which ~~iay have a i-nic:rophone tiriit posit.ionetl a~iaierit to or tÃpE}ri the ~~iz~gi3~a 1 surl'ace to p:l~ysically separate t:lie niicrophone i~rom the transducer to iittezitrate or elimirYate fuedback, 1.0 I:00301 1=^ig, 10 illustrates another variation of a removable oral appliaraee stipported by an ~~-c.1i. and havins.~ ~~ i-tiicr-c?p1~~~~~c unit integrated within the arch.
[0{131] Fig. l 1sl:ows vet another variation ill~~stratingat least one microphonearid opÃiona.llyadditional iiiicruphone uiiits positioiie~ around tlzo user's maut:li aiid in wireless cotziriiiirzicatiorz with the electronics arzd,,'or tr~i-isdLiLer assembly.
I;? 100321 l;^itws. 1'A. 12B and 12C show various views of t~~ie, eznbotliz~~ont of an elecÃrf~~
~~~iagne#i~ based attachmetit to implants for transmission of vibrations to teetl:~.
100331 Fig5. 13A, 1313, 13C aiid l3D show various embodiments of mechanical based attachments tc? iinpl~i-its for transmission of vibrations to teet.h.
100341 Figs. 14.~~ ind 14B show variotis views of orie enibodimerit of a chemical based 20 attachr.1~.:~ent to implants for transmission of vibrations to teet(x.

DETA1LED Dl~.~SCR.flTHON Ol=^ TFi E INVENTION
[a03:31 A.ii eleczrnn.ie and transducer device may (3e attached, adhered, or otherwise eÃiitie:ddc:d into or tat.=aÃ~~i-i a. dental implant appliance to form a hearing aid. assembly. Such an 2 5 oral aplali~i-ice may be a cLisÃomrcmade tleiital imlalz-itià device. The electronic atirl transducer assenibly, may receive inc~~rning sounds either directly or tliroligkr a receiver to process and.
~s-nplit-4' the siux~ials and transmit th~.~ processed sor~~ids via a vibratins; transducer clornent coupled to a tooth o:r other bone sÃi-ucture, such as the maxillary, mandibular, or palati:rie botYc 4trricttrre.
-30 100361 As sbowti in Fig. l za pat:ieriÃ's mt?tith and deiitition 10 is illustrated skrowin(y orie possible locatioii for removably attacltin (.y hearing aid assembly 14 tilaon or against at least one Ãmplay-it .12 connected tc) bone or tissues or ~~i-ie tooth, sLiLIi as a denÃal screw 12.
The patient's torttwue TG atid palate, PL are also illiistm, te~:-1 tor r6erence. An electronics ;uic~/or trkiiiscitic:c:r asseml}k% 16 mciy be attached, adlaer>6:d, or otherwise embecicieci izito or -ul.on the assembly -1.4 us:Ã~~~ rnagnetic, me4han.ical, or c.hemictil attachment as deser.Ãlaed belu", in further detai1.
(00371 Fig. 2 s17ow5 a perspective view ot'the patieni's 1o-,v~~ dentition illustrating the 1~~aring aid assenibly 14 cc?ntlsrisin,.~ a r~~~~ovable. oral appliance 18and the electronics and.'or transcclLiLer assembly 16 laositic~iieccl al~~~-ig a au.rt:zice of Ãi7e assembly 14. In this variation, c?ral appliance 1.8 may be positioned oz~ orabove screw 12 iiiiplaiited. itito the patient's bone or ti~sue. Moreover, electronics and/or- traii,titicer assenibly.1.6 c:a-ii. be fitted itiside the oral a1SpIiance -18. The figures are illustrative of variations azid are riot i:tiÃerided to be lir.liiting; ae.cordingly, otber configurations anti. shapes for oral appliance 18are 1.0 iÃ-ttextcled tc) be inc:[uded herein.
[00:381 Ge7:-g~~-ally, the vo1rr~~~e of electronics and/or- transducer as,~rnbly .16 may be minimized so as to be unobtrusive aiitl as comfortable to tke iIsC.r wIiei-i p[acecl in the mutitli. Alth~uLOI the size Ã~ia~~ ~e. varied, a volume of as~~iii6l~ 16 may be less than 800 cLibic millitzieters. 'z.his volunae is, of eoLirse, illltst-rative aiid iiot lim.iti.ng as size at7d voltiziie of as~enibly 16 and may be varied accordingly between different tlsers.
100391 I.11 c~~~e variation, wit.lt assemblN, 14 positioned upon screw 12. as sl:iown in F'ig.
'?, aii extra-blicc:.al trat7srzlit-ter assei-iibly 22 located oiitsicl.e the l~atietit's motith rz-iav be attiliztd to receive atiditEgry s~~,~ri4s1, for p:roc;essii-ig a:ti.tt tr~i-ismissiosY via a wireless si~M,- a124 to t:lie, electronics and.~or Ãransdu,cer assembly .1.6 positioned within the patient's niouth, whicb r.1~.:~sty then process and transmit the processed auditory ;i;Fnstl;
via vibratory conductance to the underlying toc?tli and conseqtiently to t:he, patient's i~~tier ear.
100401 The transmitter asseiiibly, 22, as described in ttirther detail below., may contain a microphone asRe1ribl~ as well as a t~~~i-ismitter assembly ~~.tiri z~~av be configured in ~~-iv number of shapesand 1'ariiis wom by the t.iser; stich as a watch, necklac:e, lapel, p1ionc:.,.
~ 5 belt--naounted dev.ice, etc.
10041] Fig. 3 illustrates a schozriatic representation of t?n~.~ variation o1=hearing aid.
ass~.~tnbly 14 utilizing aii extr-a~~~iccal tran;rrii#-ter assemb1y 22, wI:iich rna~~ generally coniprise mucrophozie 30 for receiving sounds and which is elect-rically connected to processor 32 frgr processing the auditory signals. Processor 32 mav b~.~
coi~~iecte(i ~0 electrically to transmitter 34 for transmitting tbe processed signals to the electronics an~.-l:'or transducer assembly 16 disposed iilsc?ii or ai,~jacent to the tiser's toetb.
"i'l~e, microphone ~0 aiid processor 32 r-ziztv be configi~~~ed to detect and process aticiitorz signals in c.~llz practicable range, biit may be conl=igured in one variation to detect auditc~tv signals ranging from, e,;~..T., "?50 Hertz to 20,000 1-lert:r,.

~00 4~ With zespect to riiic.rophzsrae 30, a of ,: anc?us- microphone systems may be attilia_.ed. For instance, microphone 30 r~~ay bt a cl.igitala ~nalog, antlior t1irtctiorial type microlahone. Such varioliy types of microphones may be interchangeably configured Ãc~ ~e titilized. with tlio asseiiibly, if so desired.
[00431 Power supply 36 may be cot7tiecteccl to each of the comporzenÃs, in tra~~s-mitter assenibly 22 to provide power thereto, rF1ie transmitter sig-nals 24 may be in ~~iv wireless toz-ril. wu(izing, e.g., radio frequ ns;y, tilt-riisotint1, microwave, Blue TootltIt (BLUETOOTH
SIG, lNC'.,1=:3ellevue, WA), etc. for transmission to assembly 16. Assembly 22 ~~iay also optionally iiie.lLatle cg~ie or more input contrcgls 28 that a user may manipulate to adjust 1.0 various ac:ousti c paraÃiieter~ of the e lec_trc nic:s. and/c?r transducer assembly 16, s act~ as acoustic tocusims:, volume cc?titrc?l, filtration, t-nutin;=, frequency optianization, sounti:
~~(tiusti~~ents, and totie a4ju5tinents, etc.
(0044] 'Flie signals trwisiilittec-l 24 bv transmitter 34 may be received 6v electronics and,,'or transducer assemb[v 16 via receiver 38, which ~~~iav be coiiiiecÃed to z-iti ai-ite.riial I;> processor tor ad.ditional processing of f1ie received. sig-nals. The received signals mav l~e, ccamm-Liiiiccxte(l tt) transducer 40, wIiich tnay v.ibrafe correspondingly ~~~~inst a starfzice of t17e tooth to conduct the vibratory signals through the tooth ~iid bone ~i-id subsequently to t:lxt niidÃlle ear to facilitate hetirin.~.r Of the User. Transducer 40 nx~~~
~e contigurtd as an~.>
number of dif't'erent vibratc~ty ~~~echaiiisms. For instance, in one variation, tratisdtic-er 40 20 may- be aii electromagnetically actuated tran;tlLacer. In other variations, transducer 40 r#~ay be in t:he, form of a piezoelectric m.,stal having a range of vibratory frequencies, e.g., l:set:~~~~~~ 2-50 to 4000 Hz.
[004:31 Power RaFl_~ply 42 may also be inC( ded with aRsembly 16 to prc~-vicie power to the reeeiver, Ãransducer, and,'or processor, il'a.lsÃ~~ inelude:d. AlthÃ~~tigh power supply 42 may 2 5 be a simple batte.rz, replaceable or lae.r~~~~~~~~ent, other variatic~ii;-, may include a power supply 42 whicb is cliar(.~ed bv indticxa~ice vi==:aaa external ~harger.
Additic~~iallyz power stilapl~~ 42 may aiternatively be charged via clirec#- coupling tc.) an ait~inating ctirretit (AC) or di~~ect current (DC) sotrrce. Other vaa:iatioiis niiy- include a power supply 42 wltich is charged via c:hvtni.cal mec:hvtni.sr.zi suc(x vts MI ir.ICCrnai penkltl(t3r#i rgr;Ii{l.ab(e electrical inductance a me 30 charger as known in the art, which is actuated via, e.motions of the jaw and/or movement for translatin:.~~ tbe mechanical motion into stored. electrical onerg y for chart=ititw power siipplz 42.
100461 In another variation of asseziibly 16, raÃliez thati utilizing ata extra-buccal Ãxansnuiterõ 1ie.ir:ir-ig ard assenibly 50 may bc: configured as aii iricleper-iderit assenably r cortta.it7eci eriÃ.itely within the user's motith, as shown In l7ag. 4.
A4cord.ingIy, assenibly, 1,57tl rnay it3eltide ai3 internal mie.rophonC 1-52 in communic:ation with an on-board. processor 54.
hiternal m.icrolai7one 52 rnay comprise at7v number of different types of microphones, as described ~~ove. Processor 54 ~~~ybe tised to process ~tiv received auditorysi;.~nals t`or iilÃerir~~g ancl.:`o.r analalitying the signia:ls and transmitting them to transducer 56, which is in vibrator~., contact agaiiist t:lie, toc?tli surface. Power stipply 58, as described ab~ve.z z~~av also be included within assembly 50 for providing power to iac1i of tlic.
ioaZ~~poni`nts of asseriibly,50 as necessary.
100471 In order to tumsmit t(xu vibrations ~orruspond_ing to the received auditory~ sigr:fals 1.0 efficiently and wit1a mininial loss to the ÃooÃb or teeth., secure mechanical contact between the transducer and the toothis ideally rnaintain~.~ti to ensure iftici~.~nt vibratory cominunication. Accordinglyry any number ot.'meclranisms may be trtili~ed to maint.ain this vibratory communication.
[00481 In various embodimenÃs, vibrations i3~~ay be tra.asinitied directly ii-ito tlae tiiiderlying bone or tissue striiottires. As s~~~~~ti in Fig. 5A, ~ti oral appliance 240 Is illustrated positioned iipc~i-i the user's tooth, :in this ex'atnple upon amcalar Iociated along, the upper row of teeth. The electronics andr`or transducer aysemlrly 242 is shown as being located along t1Yt bUccal surface of the tooth. Rather tl~~i-i titilizing a tr~i-isdtic er in contact witb the toot[i surface, a ct~ti~.-ltiction transmissic~~i mertiber 244, siioli as a rigid or solid metallic mem1/+er, may be coL3p(eti to the transducer in assembly 242 aii(i extend fror.1~.:~ oral ,g s}~[ian~.e 240 tc~ a post or screw 246 ~~l~i~.h is ir~~piatited directly into tlio tlnderlviii(.y bt~tie 248, such as the maxillary, bone, as sk~~~~ti in the partial cross-sectional view of Fig. 513.
As the distal erid of transmission r.nerzil3e.r 244 is coupled directly to post or screw 246, the ktibnitioiis <xeiieratetl by the transdttc:er may be transmitted t1rrot:-gIl transmission illem6c..r 2 5 244 at7d directly itiÃc) post or screw 246, ~.~~hieb in t.tirii transmits the vibrations directly into atid through the bc?~~e 248 for transmission to t:l~e, user's inner ear.
100491 Figs. SC and 5D illustrate additional <~enta l. imisl.ant embodig~~ents. :1n Fig. SC, the transducer assembly 242 contains the transmissioii menibe:r ~'44. which ill ttirn is connected to a stiap fit hou,ing:2140. The snap fit hc4tasiti{F 240 is secttreiy snapped otitfa an 3 0 implant 246 which has aii exposed head that receives the snap fit housing.
717he implant bead. can be, an implatit: abutment that is threaded onto t[ie implant fixture, or directly cor:~i-ieLteci tc) the Ãmplant t:ixture as otte piece. One piece anaplants a-vca:iti the presettce of microgaps, while, multi-pi~ce, implants provide more options for various clinical needs witli i:ewer cor~~poiients. The i.mlakaiA 246 is sec re1y screNveci iiitc~ boiie through Ãlic giragiva( ?4~. T~.~~e c,L~Ãti~~~.~ end of the implant may r:.Ã~F~Ã~~i1~ c~:ittirIg ec~4es to facilit:t~ie e.:irect iniplant ~lac:e~~em `vitlxoatt pt-o-dt-ill.a:ti.;r. The tii:t'eiitis of the imi.~lant '24E~ ~~ay have constant or pro4.~ressive t[iread geometry alotig the length of the tlareadecl regiot-iy of the i~~~iplanÃ. Sharp edges can be tised to promote ctttting; and is more ~~~ect:'velv utilized towards tlie apical ~iid of the implant. Rounded square threads are more effective i.ti distributing forces and hence proiiiote osseointegration. For rotinde~:-~ square tbrea~:-~s, optimal stress distribution is obtiiiried bo, controlling the widt:hot'eas;h thread (i.e. iui~jor- diaanet.er rilisitis n$iliff diameter) to be 40-50% of the thread pitch liei4.~ht; and by cotitrolliii4.~
ttie throadheight (height of't(xu region that defines the r~~,,ij cgr diameter) to be :50% of the t(xread_ pite.b.
I.{.t Microgrooves I-t~ay promote soft tis5ue adaptation to tlae iti-tplaiit aÃid may be placed iia the implant above the ti~~~eati:s, ~~id therefore above the crestal bc3n~.~, in the r-es:i.on where the iinpl.ant traverses the gingival tis5tie. '1`1ae t-1-ar~~smucosa[ ccai-iipotiei-it. may be constricted sit#htiv to pr~duc-e ~.slattorn~ switehing- like, effectS. The surface texture (e.g. roughriess) caii dramaticallv alter broIo~xical boiie resoiise to the surface, as well as the mec:.bali.ical I;> a~:-~vanta(Ye dtie to increased surface area and increased resistaz~ce, to removal. Sand blasci~-ig, acid etching, ~~lasnaa sprayÃng, auclea#iÃzn and growth, p1asr-z-ia etching, etc., are well known.Ãti the art to proc~~ice biocompatible surfaces. 'I"i~~~~e adaptation to the implant has also been shown to be improved. with the addition of lv.iocerctmics, cell adhesion molecules, atid delivery of'cyÃol;:iiies,. driigs, genes: and growÃb fiactors, rF1i~ surface 20 modification can include altering biological boiie respe~~~se to an iniplant sL3r~ace using one of: texturina~ the iziiplaiit surface, physically anoditl{ing t[ie iniplant surface, chemically modifying the iiiip1aiit surface, and biologically modi64ng the implant surfiace. Texturing is one way to perf:orm. physical modifÃcatio.n. Other physical modification methods can iÃicIude saridtiiasting, laser, gritidi~ig, milling, anian<x attierS. Chemical Ãii~.~dific:atÃoii aftl-ie:
2 5 imp1z-itit au.rt.'c~;ce c:.at7 include vapor deposition, plasnaa etching, acid or base, or providing precursors to growth biocompatible oxides, drugs, vitamin D, among t?tliers.
Alternatively, bi.oio;=ica1 rnt3di.{icatit?ns can be clc?Tie, including providing cell adhesion molecules (fibrotlecxin, laminiti, etc.), extracellular mitrix molecules (colla4~en., figrinogen, etc.}, t:vtc4k:ines {, peptides (RGD repeats, et.c.), growth factors (BMPs, FG-Fs, VEGF, etc.), for ~~ example.Turning now to Fig. 5D, a diff'erent wav of inserting the implant itt Fig. 5C is sk~~~~ti. Whereas Fig. 5C sliows a vertically p1aced implant, siiiiilar to the ~~av natural teetb are ali~nied wÃthii-i the jaw bone. :~D shows a hÃzrizcanÃalIy place iÃ-~ipIant. `T'liciÃ-~ipIant in Fig. ~~ ~~~av be apical to the roots of the teeti.i; or placed in between the roots of the teeÃli_ Wher-i placed ap.ical to the roots, anatornical .fle:atures Us c:m~~idered to ei.~sure adequate bone-to-i.rnplant contact. llor exatriple, the maxillary s-i.nr.rs apical to the maxillary posterior teeth n~<ay precltide tlrattype of p1ace:rirerrt: 011 the i?Lrcc:al sic1e, shorivestihrrle area may also preellrtie horizontal P[acemenà above tlae roots o.l`tlae teeth.
In t[i~~~ and other cases: tbe implarit cari be placed. hr:irizonvally, in between the rcrots of the ar,~jacent teeth, wlaere the maxirzitirii aml3larit: diameter mLrst: consider the width of the periodontal 1ig~arnent space (t3.?-5-0.:.~ nim) on each adjacent teetkr. "i'lie, bottozn illustration in Fig. 5D
shows in riiE}re details relationship between the sziirp fit lrr,ausrn.~.~
240azrr;l t.l$e. implant`?~46-l'ig. 51) also shows the transznission menibe:r 1-44 lsosiÃioned. above the snap fit lr:ousi~ig 240 -itYd the (xuati. of the implant 246.
I.{.t I:00501 For a single iriiplaxit: or screw 246., the snap fit botrsing 240 is attaclied to the t-rarrsruis;io7:-g ruimber 244. For nlultiisle screw irribt?tlimerit,, only one scr-ow is T~ectled for bcarle conduction, and the snap 1:rt housing for the rer:naining screws caii tae attached to tlle respective screw heads witizur.tt 6eirig coiuiected to the transmission iiiemlrser 244.
[00511 Fig. 6 illustrates a p<irtial cross-sectional view ot an oral appliance 250 p[acer`1 trpon the user's Ãootb TH with t:lie, electronics andr'or Ãransducer assembly 252 located along the li.ngtral su.rt:itce of Ã:lte tooth. Similarly, Ã:lte vibrcxt:iotrs may be transmitted through t17e conduction trc~.rlsmissic~~i member 244 and direcÃly.ÃnÃo post or screw 246, whicl7 i.n this exarnple is irrii.-rla:ri.ted irYt:o the palatine bone PI.. Other variations may, utilize this arrangement located along the lower row of teeth for transmission to a post or scrow 246 drilled intca the mandibular bone.
190:~2] In vet another variat:i~t.i: rather utilizing a post or screw drilled.
irito the underlying bone itself, a Ãransdtic-er rnay be attached, cotrpler.-l, or r:itheri.vise, adbered cii.rectlv to tl:re 9ii-m:i-val t-issurr srr.rf:zice ad . acerià to the teeth.
As shown i.n l:'iwR. %Aancl 7B, an oral appliance 260 may have ar-i electronics assembly 262 positiÃ~~Ãie:d along its side witli ?5 at7 electrical ~.~~i.re 2(4 extenr`Iim~x therefrom to a transducer assembly 266 attached to the gingival tissue surface 268 next to tlio Ãootb TH. Transducer asseilibly 266 may be < att-aclietl ttl tb~.~ tissue sur:{-ar;:e 268 4 iaarr adhesive, str-trctriral st~pportartrr extending #:rorr-i oral alypliarice 260, a dent:al se:rew or post, or any other structural mechanism. Iti iise, the Crarrsdt:rc~.~r rriav vibrat~.~ arr(l transmit directly into the xrnderlyin~>
giri{Fival t:is,trc, wliit:lr may ~0 contltrct t[ie signals to t:l~e, underlying bt?rie.
100531 For any of tbe variatioris described above, they may be utilized as a single device or in conabi.naÃ:ion witli artv cYtlrer var.iiatiÃzn herein, as practicable, to achieve the desired hear irig level in the user, .Moreover, ziiore than one oral appliance devi~e and elec.Ãxanic:s and/or t:r>ursducer assemblies rnay be uÃ.ili.recl at any one ii.me. For exarnple, F=ig. 8 illust.rates otie exatripl~ where -n-rultiple transducer ~~~~nibIies 270., *72, 274, 276 i-r~av. be pl4ic;eii ori rnultiple dental implants. Although Shown. on the lo~.ver row of tectll, nw[Ãilale assemblies may a[Ãernatively be laositic~i-ieti atirl located along the upper row of teeth or botb rows ~s well. Moreover, each of tkteassemblies may l~e, configured to transmit vibrations within a u-nit:orni frequency range. Alternatively in other tianations, differeat ~~~enibli~s may be configured to vibrate ovithi~i nort-overlappi~~g ftec-ltiencv ra~ig~s bew,-eert each a;Sia-rik?ly. As anent:ioned. abc?ve, eacli. transducer 270, 272, 274, 276 can be programmed or preset for a different tieqt~~~icv response such t:liat each transducer may be optimized ~ora di~~erent frequency response and/or transmission to deliver a relatively 1.0 high-tidelitv sound to the user.
~00541 Mtlretlver-, iacli of the different transducers 270, 272, 274, 276 can also be p.ro;~rf1r~~~~~~~ed to vibrate in ~~~~~~~iltier wkich indicates tlic directionality Of SOUncl received by tizo microphone worn by t:lie, tiser. For example, different transdticers ~.susitiailed. at different loLatac~~~s withai-i the uyer's mouth La~i vibrate in a specified naanner bv larovid.ing I5 st?t~ti~.-l or vibrational qtieties to infbrzn tl~c user wbieli direction a sot~ti~.-l was detected relative to an orienuatiÃzn ca.f'the tise.r. I'or Ãtistatice; a first traiisciLacer located, e.g., on a user'y left toot[i, Lati be prograninied to vibrate for soLincl detected origmating from the atser"s left sid.e. Sirzii.larlv, a sec:onci transducer located, e-g.a osx a user's right tootha can be programmed to vibrate for sound detected originating) from the user's right si& Otlier 20 variatioiis and. c1L3eLaes may, be. utilized as t(xu;e examples are intentletl to be illustrative of potetit:ial variat:iolls.
05,5 ] In variations wlie-re tlle one or iiior.e microphones are positioned in intra-buccal locations, the rziierophone r.nay be integrat~d directly ii-ito the electronics and/or transducer asSembly, a.S describc..d above. However, in additiOnal variation, the Ãiiicra~.=ah~.~Ãie ti:tiit ~~~ay 2 5 be laositi~~i-ied at a distance from the transtiucer assetzibliea to mai-iimize f~edback. Ii-i c~ii~
example, similar to a variation shown above, ziiicropkt~~~e, tinit 282 may be separated ftom electronics and: t3r transtit3cir- a irribly 280, as shown M 1='iux, 9. :fn sticli a variation, tb ~.~
inicrophone unit 282 positioned upon or a4ja:cent to tlie gingival surface 268 inay be eI~.se.trically- cotYn~.se.te(l via wire(s) 264.
-30 100561 Alt[iotigli the variatioii illustrates the mic~~opbone unit 282 placed adjacent to the gingival tissue 268, unit 282 may be positioned upon another ~.-1~tital iz~iplant, screw implant or aiiotber location witlii.ii the mouth. For instance, F:ig. 10 illLastrates anotl:ier variation 290 whicb utilizes a~tarch 19 connecting ~~ie, or niore dental implant retairting portions 21, 23, >is ciescr.ibed above. flowever, in this v>iraat.iori, tlio microphone unit 294 ~~iav be inte-;rated ll within or upon the arch 1.9 separated t'ron-i i:lic i:ratisduc~~~ ~~~emb1y 292. One ur ri-tore wires 296 rotÃted through arc13 19 may electrically con.nect t13e. microphone tai3it 294 toa tlic asser:zibiv 292. Altert7ative[~~, rather tl~~~t7 l~ti[i:ri~~4.~a wire 2'~6.
~~t~icrc~l~l~c~t~ze unit 294 at~c.
assenibly, 292 may be wirelessly ctattpled to one anotberz as desc-ri~ed above.
[00571 Iti yet another variation for separating the microphone from the transducer assenibly. Fig. I l illustrates atit?tl~er variation where at least one microphone 302 (or opt.ioziitlh, any ritimk?er of atiditiona1 microphones 304, 306) may be i.-~ositi.oried within the mot,tth ot'Ãhe user while physically separated. from tlic electronics and:`or transducer as4er.1~.:~b1y. 300. In this mai~~ier; t(xu one or optionally more.
micropbones 302, 304. 306 may 1.0 be wire[e5sly, coupled to t1ae electronics aÃ-td,"Or transducer assembly 300 in a manner wliic~i attenuates or etiminates feed-back, it'present, ftom the transducer.
[00581 Fi.t)& 12A, 1.213 and 12C' show various views o1`one embodiment of aii eleetro-magt1etic based attaeluiieiit to a tleiital iiiiplaiià for trwisiiiissiot1 of'vtbrations to teeth. The tienia[ imp[~i-it it7ellities c~.ti tippet= porÃaoti (imp[~i-it bead) z-itid [o~.~~e.t- portion (tlarearled I5 portion) withat least tlie, lower portion assuming a generally tapered and conical shape.
While various mater.iials can be taseci to Lonsir~ict the .implartt., it is widely reLogt-lized that one ol'the more suiÃable materials for dental implants is titanium. I hiy is due, in part at least, to t1Yt fact that titari.unx is a very strong and light metal and is highly res:istar~t to corrosit?ti and ~.-1e4.yradatit~~~ eveti though w[ieti i~~~alaz~t~~ the implant assuznes a ist?sitioti 20 embet.ltiet.l within the alveolar bone strtic:tui-e of a pationt, 100591 In otie embo~.~imetit; tbe implant can be provided withan atichoriti4.y lsiii or screw that functions to secttrely anchor the implant wiÃbin the alveolar b~~ie, of the patietiÃ. The anchot -i.t1~.~ pÃzl pr~-vel-its the impiant from rotatiii- or becorziiii-loose w1-icii tl:te :impla.tit iS
eÃiitie:t.ldc:t.l uitliin the alveolar bone afthe paticiit. The anchoring pii-i is ot'Ãhe se.lt'atal?pii-ig ?5 Ã-y-1~e arLil .includ~s a screw head 310, a smoot[i slac~iik portion 321, atirl a Ã:17reatied self-. portion 308. 7I'he anchoring lsiii is inserted downwardly through an access opening tapping ~~id into the throughbore. Onceirt the throughbore, tb~.~ scr-etii=1"teati 310 is ens;a;=etl witb a turning too l strch as a: screw driver or Allen Narrench Ãba.t extends through. the access opening., and the anchoring pin is tttr-ne(l cat3sitYg the self-tapping threads 308 to be ptillet.l 3 0 wiÃbin botio structure ad jaceiit to the iniplant. anchoring pin ftirtl'ter anchors and secures tlie, inilslant in place atid is particularly designed to lsreveiit the implant from rcyicxt.Ãtt.. or becoming loose t.irtcler stress or load.
100601 The iziiplatià cati be tltilized witbout ati anchoring pit~ and. can be inserCed. an~.-1 st.ati.onc:ci within tl:-walveolar bmit: o#'>t laaÃ.ient by simply screw:ir-ig the i.rzilal.uit iiito thtr.

alveolar botie: In certain cases, the utilization of ati anchor-i.nt; pin gÃiay assÃ;t:in stabil:~r.i.rig and pr~~~erÃti:Ãi.~,s the iniplasYt: ftoÃn rotating urider load or stress.
(00611 Fig. 12A shows a top view o1'an.imp1anà tÃaviÃ~~g ati iÃ:riplant laead or a screw bead. 31.0 an~.-~ a. vibratory transdÃ.ecer 3:12. The vibratory transducer 312 caÃi itic-llÃ~.-~e a :? iaroteLt:i~~e bousiÃig, or simply can inLl rIe the elecÃrol7ic components that are covered by a protective, seal or coating. T1ic screw head 310 is c-kÃarge~.-~ in a pred.etermined.iaolarit:y (either ziorth or soÃ3th polarity). The vibratory Ãrari,ducer 312 is shaped to eri;xiÃgi the screw bead. 310 at opening 314. T1ie vibraÃo:R= transducer 312 contains a magaiet 316 having the end fac.i.m-> the screw head 310 charged in an opposite polarity to the screw head's polaritv, 1.0 In this manner, t1ae tn'InsclÃ:Ãc;er 31.2 aÃid the screw 1aeac1310 are sÃz-on;AlyattÃ-acted to each other tosect3re the tdvc? to;=etb~.~r. Sticliti~.rlit phy;ic,,cil cc3tÃp1irÃux n$i.iirmizo; r~.`sor.ia7:-gÃ:e vibrations tkaà cÃccÃtr if the transducer 312 and Ãlic screw head 310 3~~eTe iiot attracted to each other.
[00621 Fig.. I?B shows aiioÃher meatis of a;ttachinent to the screw head. A
screw head I;? 326 is sectÃred to the boÃ~e, portic?Ãi 320 w[ieÃi a threaded. portion 321 is screwed into tbe bt~iie portion 320. I~lie screw head 326 supports ia base plate 332 through a p:i-vcat tab 328 t:l7at .is secLited to the screw bead 326 u5.ing a rod 330. .1Ãop plate 334 .is positioned above tlxt base plate 332 iÃnd extends btyonci the base plate 332 to engage a pair oi'arnis 340-342 positioned on t.~~e, bottozn of the vibratory transducer 31.2. Additionally, a ball 344 is 20 positioned on the traÃYsciÃ3cer 312 and is spring lcgattuel. (not shown) so t(xat t(xu trwYscit3cer 312and the ball 344 are adapted to locate a spherical indentation 346 on the top ialate 334.
During insertion of'the transducer 312 into t[ie screw head 310, the ball 344 engages t[l~
spherical indentation 346 to prnperlv oriciit the transducer 312. The magrÃet 316 encircles the ball spriÃ~~ 344 and opposiÃ~g magnetic forces sec:t.-rc: the screw head 310 ÃÃ~~ the ?5 transducer 312 c~~aÃ~~i~.i~7iÃig the Ã.~~~a.~neà 316. Duri.n.~
.inserÃ:aoÃi, the ba[l 344 drops i.ÃiÃo the spherical orientation 346 to allow the transducer 3:12 to ~~e. properly positioned over the screw head 310, [00631 The vibritory transducer 312 may pner:alIy i~icltÃde a. rtiiGrophone for receÃviÃig scgtÃrÃ(is and which is el~.sctrically connected toa processor for proc~.
ssilig th~.a auditory '0 si;.ynals. 'I'he iaroc-essor may be electrical1v connected to an antenna for receivi~~, wireless CommiÃnication signals, inptÃt control sigaIs f'rc?maÃi external remote control atidr'or otl:ÃeÃ~ external sÃzÃiÃid =.:.,feneratiag devices, e.4.~., cell pitoiies, te:Ieijhcaties, stereos, MP3 players, and other ziie~.-~ia p~aylers. The ii~ierc?phone and processor may be conf'igiÃred to detc:et aÃad process aridit.ory signÃiIs in Ãitiv practicable range, but Ãn,Ãy bc: cozi.iigÃarcd m one variatioti Ãff detect atirlitcyry sigi3ti1s ranging tt~-on-i, e.g., ?50 l`_lerÃz to 20,00Ã3 Hertx. `fhe detected and p:tocessetl,i:~,~iia1; inay be ami.~lifietl via as-nplifier, wliich in:creases the otttpttt levels for vibrational transmission by trc~.tisdticer 312 it7to t[ie ailja~~i-it, or ot[ier >ise coupled, bone struett~re, 322 st~~h as a patient's tooth or teeth.
:? [00641 Wit:li respect to i-nicrophorze., a variety of varioiis i-nicrophorze systems may be titilized. For instatice: micropkt~~~e, may bea ~:-li;.~ital, analog, piezoelectric, and/or d.irict.ioiial type ztiicrop1iE}ric.. Sttcli various types ot'mis;rophortes n$<iy be interchangeably configured to be utilized with the assembly, it'so desired.
100(5] The signals transmitted may be t-uceive~.l by electronics and/or transducer 1.0 assembly via a rec_eiver, which may be connected t~) an internal priwessoz-for addiÃioxial processing o#`ti~~ received si~.r~ials. The received si~.r~ials tnay be cor~$n-ittnicated to transducer 312, which may vibrate co.r.respot:7ding1y against a surface of the tcaoth to conduct the vibratorv signals t.lirut.it#h t:lie, toutiz and bone aird.
subsec.~ttentlv to t.lie, mitldl~
ear to facilit:aie hearim, of the user. Transducer 312 rnav be configured as any nunaber of 15 different vibratory mechanisms. For instance, in one variat:i~t.i;
transdt.tcer 31.2 may 1,~e, an elect.romagtteticallv ac-ttiaÃ:eci Ãraz~sdrFcer. In cYiher variiatiÃzns, tx-ar:tsducer 312 r-zlay be in the t:orni of a piezoelectric crystal having a range of vil=.rnatory frequencies, e._.~_ betweet7 250 to 20,000 Hz.
100661 The implant process starts after a t:ootli extraction Gavity has healed and closed.
20 The first step is to determine the t.~src4laer size i.i-npl:irat frt.}in a st.antlaid kit or standard g.c3trp of iiiiplatits. Si~ice t:l~~ extraction cavity has now become c-losed and lioaled, the particttlar implant is so-lected based on the size, and c~~idition of the izlipl~tià site.
in any event, after the proper i.Ã11plant (aaR been selected, the nextstep er-itails clrillÃtiw a receiviii- caviÃv through the g~~~i antl alktc..olar baiie ot'the patient at tlie implant sitc, The partic:t.-lar drill is 25 selected based oti the opÃiniurti size .imlalanà selected from the siandard-rou13 of aml3lailts.
Bttà in ativ event, a drill guide. is utilized atid the selected drill bit is directed dowtiwart.-llv throug ~h the ctri1.1 gauge itito the alveolar bone of'tl:te patient Ã:~~eati.7:-gs;
an implant cavity.
(~~ice the borehas been created tllefi the tiext step is to utilize a selected ~eanier aga:in based on th~.s implant selectirgii. This also oe.t:tars .tft~.~r .t tooth has be~.~tY etitracte(i and it is the 3 0 intent of the deiitist or oral surgeon to immediately set the implant. In eitber case, a select reamer is c-ktosen based. oti the optimum size of the iniplant to be used. A
reamer guide cati be sectared abo-Lii Ã:lte extraction cavity or the cavity torty-ied by the drill. "I"l:te reanaer is preferably of a conical or tapered shape atid wottld g~ne-rally conforzn to the shape of'the o.riwiiial rot~ÃsÃxtat:iatrc: of the eitx'acÃeci tooth. T.he cavity is reamed atid the eitx'aneoats niaterial re4ttltin~ frc~tn the reaming is renxo-,,,ed. Therea.fier, as discussed herei~.1 be#zsre. the imi.~1ant is inserted within the rea:tiied cavity ai3ci arft,horeci \,vithin.
the iilveolar k?one. Ncx:t.a t17e anchoring p.in or screw is extended through t17e throughbore z-ilid screwed it7io the alveolar bone ai,~jacent tbe, implant. This couples the implant to tbe alveolar boz~e and laz~e-,-,enis rotation aiiccl loosening.
100671 Coznlslete osseointegration, i.e, tbe rlytiamic. ititG,ractioji of hivir.tg iaotio with a bic~coanpat.ibli itaiplarit withotÃt an interc, enint* ,olt tisstie laver, is pret~ i-i=ed kytit ii.ot essential in all cases. Wben the l}t~~~~ quality is sufficient (abundant bone volume and high bone densitv), i.r#~~-nediate loading or cielayeti. loading (weeks) may be consitlurecl. 4ince the fcgrcu 1.0 paraÃiieter~ involvedfor this applicatioti are very low, `I'1iere may be t;[ic possibilit~',, that selected force parat-neter, can proti-iote the i~~~iie healing.
[00681 Wbeii tke iaoiie qLialiÃ-y is insufficient (inadequate bone voluir~e or density), then iizore, healiiig time may be required for esm, blislziiig implant stabilitti'.
In such cases, after the imlalanÃ:has'beeti placed, Ã17e implant site is closed in order tlaat t[ie same can laeal for a period of time. A temporary cap can be used., or the gingival flap may be ret~irtied. across Ã:lte top ca.f'the inap1aziÃ: so as to close the sianae. 1Ã:~~~~~ever, it is also possible to leave tl-zc implant head exposed duri.tig the:[icalirzg period, sitzlilar to the I'f I
dental implai-zt cc~~icelat.
T1Ytreafter, osseointegration OCCLU,, 4int1 bEg~-ie structure rts-nodels and heals iri intimat~
contact wit[i tbe implant wit.liout an intervening soft tisstic laver. The tizne, for complete osseointegration can van, f-rc4m approximately 3 to 12 r~ior:fths depending on the ~ge. of tbe.
pati~tit and otber factc?rs. H~~~~ever; due to tbe force parameters of this application, th. e implant z~~av be tised withoiit complete osseointetwm, tion. It is likely that 1-3 nionths z~~ay iie adequate for many cases. l.f'a.f-1ap was placed ~~.tirl liealiii- waR
allowed tc) occur iznder the mucosal tissuc..s, thenafter the appropriate heali~ig tÃine the tlei-iÃist or oral sur ge:Ã~~~-i can 2 5 retLirti to the implarzt site and surgically opetis the gingival flap z-itid aÃtac17 a Ãrimsmucosa[
abutment for the vibratory t:~~ansdticer 3 1.2 to be motinted.
100691 Figs. 1:3A., .1:313, 1:3C and 13D show various embodirn~.~Tits c?:{'n$ech'anical basicl attachments to i:iiiplatits for transmission of vibrations to teeth. A dental implant in Fig.
13A inclti(ics a Chreacieel portion 308 tl-tat isa:pit:al to the >um line 320 and an inip1atYt head '30 or screw head 326 that extends above the botio re(yic?ii 320. A vibratory transducer 340 engages the screw bead 326 to transtrilt or condii,ct sound through t[ie botio re,.yit~ti 320.
'I'I~~c vibrafory transducer 340 has a plurality ca.f'sprÃng; 356 that provide spring-loaded forces to catise balls or tabs 358 to securely engage t:lie, screw head 326.
In one t~

enibodiniez3t; the screw head 326 has a plurality o1'recesses 327 t:o engage the balls or ttibs 358.
(00701 Referring tio~.~~ to Fig. 1 3:[3, another ertibt3dimeni: to inecIxanic:.a1Ãy. attach the vibr,itc~tvtr~tisd.ucer 34tt iss[iown, in this embociiment.. t:~ie. ia~i plant tioad or screw bead 326 has z-iti opening tlaereÃ17rougla Ãc) receive one arm oi`a clip 352. 'I'he clip 352 bas a suplaortiii(.~ surface 334 that en4#ages a Ãol) plate 346. In one eziibodiiiient, the top plate 346 has a ball 344 that cooperates wit:li a spherical indentation osi t~ic top place 334 to prop i~riv position the transducer 340 ozi the top plate 346. The implant head or sc-rew head 326 sL3pports a base plate 364 throug(x a pivot tab 360 that is ~ecLire~.~ to t(xu screw head 326 1.0 u5iiliw a 5ecoiid screw or rod 362. A top plate 368 is positiailed above the base plate 364 and exteiicis beyond the base plate 364 to ~.~ngauxe a pair of'arri-is 378-380 positioned on tb ~.~
bottom o1`t1.7e vibratory transducer 376. Adtlitionallyry a baI"[ 372 is positioned on the vibr atatv transducer 376 wZd is spri~ig loaded through Spriiit# 374 so that tlle vibr atatv transducer 376 at7d the bal1,3'72 aread.alateccl to locate a spherical indentation 370 on the top plate 368. During insertion or installation of tbe vibratc~tv transducer 376 itito the screw bea(l 326, the ba.I1 372 engag-es #1:w sp1:wrica1:incieniatican 370 to properIv orief-it the vibratory transducer 376.
100711 In sLitzi, the base plate 322 has a rod 352 or 330 attached to the base plate 321.
'I`he rod 352 or 330 slides itito t[ie hole in the screw hea~:~ 312 or 326.
The. transducer portion t.henatt.aches to that base plate either witli a magnet as in Fig. l 2B aiiti Fig. l 2C or niechanically as in Fig. 13B or 1~'ig. 13C. l,igs. 14A atid 14B sbow tA.vo chemical embodiments for attachititw the vibrational traiisdiicer to t[ie screw head 312 or 326.
1.00721 Figs. 14A ~i-icl 14B show varÃouR views o#'one em13ocii.rzient oCa c(aem.ieal based attachment to iinplanÃs for transiiiissl~.~Ãi of vibratiÃ~~iis ÃÃ~~ tee:t1i.
Fig. 14A shows tlle ?5 vibratorv transducer 382 prior to mounting ot7 t[ie itnp1ant laead or screw head 326, while Fig. 14B shows the completed transd.iieer atid impiatit head or screw head assembly. An irnplant head or screw i~~iplant in Fig. 32A inchiti:es a threaded portion 308 that is below the ~~im l:ifie 320 itid asc:rew beit13?'(i that extends above the bozie region 320. A vibritory t'ansdtic~.~r 382 ~.stYga{Fes the screw heat1326 to transmit or conduct Sc3unti thrc3tig(x the bon~.s ~0 region 320. Tk~e vibratory Ãransdiicer 382 has a recess 383 that ~~~~ages the screw head 326. '-I'o sec~~re, the Ãransdtic-er 382 to the screw }iea~:~ 326, anadhosi~~~
Ia1{er 384 is provided at ar-i inter-ffiie between the transducer 382 aiid the screw l:~ccxd 326.
100731 The iziiplatit caii be ~~se-d to treat Ãitinittis or stiitterititw. For stuttering; tbe implktiià ckiii play frequency s1iifteci kiiid delayed version of tLiesound ffirectc:d'at the paÃ.ic:nt and t1i.is dela;~erl ~~la~~ba~.~:. stops the l~aÃie~~t s st-r~Ãte~~i~~~~.
ll'or e~.t~t~~l~le, the sound is i::t=eq~iet3t:.y si3i:fted by about 500tlz 4ir-ic1 the auditory feedback can be cleiayetl by about Orris. "['he yeltre~~~i-itai~~ed tienial impl~i-it assists those wl7o aÃut-te.r. With t[ie device in place, sttitteri~ig is redticed and speecb prt?dticed is judged to be more, natural than witltotit the device.
100741 The iiiip1~tit caii treat tinnitus, whic-li is ki con~,~lition, iit whicb sound is}?erc.eived in E}rie or both oais or iri the head wh n. zio extorn.a1 soL3nd is i.-~r-eserit. Stic:h a c:E}ritlit.ioii. may tl=picaIIv be treated 6v masking tlic tinnitus via a unerated zioise or soti:tid. III oz~e variation, the f'requency or frequencies of't(xu tiii-iYitL3s may' be determined tli_l-cgat~h mY
I.{.t audiology ~xamiÃ-tatiail tc) piilpoixtt the range(s) iÃ-t which the timiitus twcuz-s in the patiextt.
This freqtiericy or frequencies may theii b~.~ prt?gramrrietl into a removab1~~ oral device w1~ic:1l. is confioi~~~ed to generate SOUncls w17ieki are conducted via tkae User's t.caot:h. or bone5 to niask tlie tiiuiituS. Oi1e method for treating tiiiriitÃis niay generally Comprise masldr1g the tinnitus where at least oiie l`~~equency of sol~i-id (e.g., ~iiy toiie, m sic, or ÃTeat:~~~~i-it using a wide-ba~id or narrow-band iioise) is generated via an actuatable transducer positioned against at least ~~i-ie tooth stich that the sou.iicl .is transmitted via vibratory ccanducÃ~iance to aii n7ner ear ol'the laaiier7t, whereby the ~~~~~i.id cotripletely or at least partially maa:l,i.s the tin-iiittis perceived. bv the patient. Ii~ generatisxa a wicie-i~~i-iti sYEgise, the sot~~-ici level mav-bt raised to be at or above the tinnitus level to znask not only tbe perceived tinnitus but also ot}ier sotiiitls. Alternatively, in generati~~ga narrow-band noise, the sot3nd level r#iay be narrowed to the slaecit-ic frequency of tlio titinittis stech that oiily the perceived Ãitinittis i'S
masked and other treqi~encies of sound. may still be perceived by the user.
Another znoth. od rnay treat the patiezit by l-iabitL-atÃziw the patient to their tinnitus where the actuatable transducer may be vibrated withi~i a wide-band or narrow-band iiÃ~~ise targeted t~.~ thc:.
2 5 tantiitus treql~~iiLy perceived by the pa:tietiÃ: overla~~ed upoti a ~.~~iccle-t:reqi~~~~cy apectr~im sound. This wide-frequencyspectrum souti~.-l, e.g.z ziitisicz z~~~~~ exten~
over a rati~e which allows the patient #-t3 periodicall.r, hear their tinnitus through thesour~~~
~~iitl thus defocus their attetition to flie tin.aitus. In enhancing the treatniezit for t:.inil:itus, a: techzi:iciaii.

:It1i:IC)lo~:iSC, physician, t'LC:., E3"lay, first it'LÃ.'1'm]:Flt'= the {4#1e or more fr~.'ql_l~.'t1c]C'.4 of t.l:F3Ii9C1.14 ~0 perceived by the patient. ~~tice t[i~ ~~ie, or znore freqtiencies 1~ave beeii deterznine~.-l, the audiologist or physician z~~av determine the type of treatz~~ent to be iiiip1emeiite~.-l, e.g., naa;kingorhabituatÃon. 'I'1.~~i-i th.is informiatiÃzii z~~ayl~e utilized to develop tl:icapprÃzpriaie treat:ment and. to c-oziipile the electr~~~ic treatment program file whicb may be, transmitted, e.,-_, wirelessly, to a processor coupled to the actuatable transducer such that the transducer is prc~grarnmed to vibrate ia~ ~icc:ort1anck- with the trcatment program.
(00751 In se, z-iti inal3lant coniain.ing t[ie transducer may be p[aeeccl against one or more toeÃb of the patient ~~id t:lie, transducer z~~av be actuated by the user w~~ii tinnitus is :? perceived to ~enenate the one or more ti-equencies against the tooth or teeth. `T'1ie generated v ~bratic?~~ i~~av be transmitted ti=ia vibratory coiiductance through the tooth or teeth and to the iiiiier car o:{'t.l$e. patient gtich that c~ich of the frequencies ol'the perceived t.iziiiittis is masked c~onipletely or at least partially. The oral implant niay be pro.gramnied witli a tiniiitLas treatment ,ahgorit.hm which titilizes the one or t1iore ti-uquuncies fc4r treatment. This 1.0 tinnitus treatment ah>orithm may be uploaded to the oral appliance wireless[yF by ati external prt3~-rarnmi.7:-gs; device #-t3 ~~iabl~.~ the actuator to vibrate aÃ:cortii~ig to tb ~~ algol-ithm for t~~eating tlzc ti1111it s. MMOver, the oral appliance may be tisetl alcaile for treati.ng tiiiriittis or Ãn conibiiiatiori with uiie or niore hearing aid devices for treating patieiiÃs wlia tfer tiot onlyii=om ti~~iiiÃtis but also t:rorii i7earing[oss.
I;? 100761 The ap-plicat:~ons of't[ie devices and iiietlic?ds disctlssed above are, not limited Ãc?
Ã:lte tz~~'atulenÃ: oi'hear:ing loss bLaÃ: i-nay include any.nur-ziber ca.f'iiFriher treatment appl.icaÃ.i011s.
:,doreover, sLiLh devices atirl meÃbods tz-iav be applied tc) other t-reaÃmetià sites withill the body. Moditication. oi'the above-described assemblies iinil methods fEgr carrying otit the inventic?ii, combinations betA.veen diff'orent variatic?iis as practicable, and variations of 20 aspects of the invention that are c~bviotis to those of skill in the art are. intend.ed to be. within tlle sc-ope of tbe claims.

Claims (25)

1. An apparatus for transmitting vibrations via bone or tissue to facilitate hearing in a patient, comprising:
an implant having an implant head and a threaded portion adapted to be positioned below a gum line; and a housing which is sized for placement within a mouth of the patient; and, an actuatable transducer disposed within or upon the housing and which is removable therefrom, wherein the transducer is removably coupled to the implant head such that when connected the transducer is in vibratory communication with the implant head and when removed the transducer is not in communication with the implant head.

2. The apparatus of claim I wherein the housing is coupled the implant head through one of: an electro-magnetic coupling to the implant head, a mechanical coupling to the implant head, a chemical coupling to the implant head.

3. The apparatus of claim 1 further comprising an electronic assembly disposed within or upon the housing and which is in communication with the transducer.

4. The apparatus of claim 3 wherein the electronic assembly is encapsulated within the housing.

5. The apparatus of claim 3 wherein the electronic assembly further comprises a power supply, in electrical communication with transducer.

6. The apparatus of claim 3 wherein the electronic assembly further comprises a processor in electrical communication with the transducer.

7. The apparatus of claim 6 wherein the electronic assembly further comprises a microphone for receiving auditory signals and which is in electrical communication with the processor.

8. The apparatus of claim 3 wherein the electronic assembly further comprises a receiver in wireless communication with an externally located transmitter assembly.

9. The apparatus of claim 1 wherein the actuatable transducer is in vibratory communication with the surface via an adhesive layer for maintaining the transducer in contact with the surface.

10. The apparatus of claim 2, wherein the housing comprises a ball adapted to be seated in an indentation above the implant head.

11. The apparatus of claim 2, wherein the implant head is charged with a first magnetic polarity and the housing is charged with an opposite magnetic polarity.

12. The apparatus of claim 11 further comprising at least one biasing element positioned adjacent to the transducer such that the biasing element maintains the transducer against the implant head via a biasing force.

13. The apparatus of claim 12 wherein the at least one biasing element comprises a spring.

14. The apparatus of claim 2 wherein the housing is inserted into the implant head.

15. The apparatus of claim 14, comprising a U-shaped clip to mount the housing to the implant head.

16. The apparatus of claim 2, wherein the housing is secured to the implant head using a screw.

17. The apparatus of claim 2 further comprising an interface layer between the transducer and the implant head through which vibratory communication is maintained.

18. The apparatus of claim 17 wherein the interface layer comprises a plastic or paste material.

19. A method of transmitting vibrations via one or more dental implants, comprising:
placing a threaded portion of the one or more dental implants below a gum line of a patient; and positioning an actuatable transducer which is sized for placement within a mouth of the patient, wherein the transducer is removable from the one or more dental implants such that when connected the transducer is in vibratory communication with the implant and when removed the transducer is not in communication with the implant.

20. The method of claim 19 comprising magnetically securing the dental implant to the actuatable transducer.

21. The method of claim 19 comprising mechanically securing the dental implant to the actuatable transducer.

22. The method of claim 19 comprising chemically securing the dental implant to the actuatable transducer.

23. The method of claim 19 wherein the implant comprises an exposed head to receive a snap fit housing.

24. The method of claim 19 comprising using the one or more dental implants to treat tinnitus or stuttering.

25. The method of claim 19 comprising using the dental implant to treat stuttering by providing a frequency shift and a delayed auditory feedback.