AUDIOLOGIST COV LUS QHIA RAU KEV HAIS LUS AIDS, PSAPs, HEARABLES THIAB OTC DEVICES

Lub Chaw Tswj Xyuas Khoom Noj thiab Tshuaj (FDA) tab tom tsim cov cai tswjfwm kev lag luam tshuaj xyuas cov khoom lag luam (OTC) cov khoom siv sib hais. Raws li Txoj Cai Kev Tso Cai FDA Xyoo 2017, cov cuab yeej no yuav muaj rau cov neeg siv khoom los ntawm cov chaw muag khoom thiab tsis tas yuav muaj cov kws kho mob, tsis hais txog kev ntsuas lub rooj sib hais, lossis kev ua kom tau txais txiaj ntsig, haum lossis cov pov thawj ntawm kev ua tau zoo ntawm cov cuab yeej no. Thaum OTC cov khoom siv tseem tsis tau nkag mus rau hauv kiab khw, cov lus qhia no tau tsim los pab cov kws kho mob to taub qhov sib txawv ntawm cov khoom lag luam uas muaj tam sim no thiab OTC, npaj npaj los teb cov lus nug txog cov khoom siv no, thiab muaj peev xwm thov beginto pre-position kev xav tau ntawm kev muaj OTC pab kiag li lawm. Cov lus qhia no yuav raug muab kho tshiab raws li cov kev cai rau cov khoom siv hauv OTC.

Thaum lub caij ntuj sov 2017, Congress tau tshaj tawm txoj cai lij choj uas tau qhia FDA kom tsim cov kev cai uas ua rau OTC hnov pob ntseg muaj rau sawv daws. Ua ntej qhov no, ntau lub koomhaum tsoomfwv, tshwj xeeb rau Tsoomfwv Lub Tsev Haujlwm Saib Xyuas Kev Lag Luam (FTC) thiab Thawj Tswj Hwm ntawm Cov Kws Pab Tswvyim rau Kev Tshawb Fawb Txog Kev Tshawb Fawb thiab Kev Tshawb Fawb (PCAST), tau pib los saib xyuas qhov yoojyim thiab muaj peev xwm ntawm kev saib xyuas pob ntseg hauv Tebchaws Meskas. Tib lub sijhawm, Cov Kev Tshawb Fawb Kev Kawm Hauv Tebchaws, Kev Tshawb Fawb thiab Tshuaj Kho Mob (NASEM) kuj tau tsa ib pawg neeg los tshuaj xyuas thiab tshaj tawm txog cov xwm txheej ntawm kev saib xyuas kev hnov ​​lus nyob hauv Asmeskas, FDA, FTC, National Institutes of Health, Veteran's Administration, Chav Saib Xyuas ntawm Kev Tiv Thaiv, thiab Lub Koom Haum Tsis Hnov ntawm Asmeskas ua haujlwm rau txoj haujlwm NASEM.
Lub sijhawm cog qoob loo ntawm cov pawg thiab tshuaj xyuas no tuaj yeem ua rau peb qhov kev nkag siab zoo thiab ib qho kev tawm tswv yim kho mob tshiab. Thawj qhov yog kev nkag siab tias tus nqi kho pob ntseg, thiab ntau tshwj xeeb yog tus nqi ntawm hnov pob ntseg, txwv tsis pub qee tus neeg nrhiav kev kho rau qhov hnov ​​lus. Thib ob, cov neeg them nyiaj thib peb tsis them rau hnov pob ntseg; suav nrog Medicare uas cov twj pab cuam sib hais thiab cov kev pab cuam cuam tshuam raug tshem tawm. Qhov peb nkag siab thib ib yog tias qhov chaw ntawm cov chaw muab kev saib xyuas, nrog rau cov kws kho pob ntseg, yog tias muaj ntau thaj chaw hauv Teb Chaws Asmeskas uas cov tib neeg tsis tuaj yeem nkag mus tau txais kev pab ncaj ncees.
Cov tswv yim kev noj qab haus huv uas tau tshwm sim yog cov neeg siv khoom xav tau kev tswj hwm lawv li kev saib xyuas kev noj qab haus huv, suav nrog kev xav "tswj lawv tus kheej" lawv cov kev kho mob. Kev raug mob tuaj yeem yog ib feem, los tswj tus nqi rau lawv cov kev saib xyuas kev noj qab haus huv, tab sis kuj tswj hwm lub sijhawm thiab kev rau siab siv thaum koom nrog cov kws kho mob. Txawm hais tias muaj ntau yam mob ntsig txog mob, piv txwv li mob nrob qaum, tab tom kho "kho" nrog cov tshuaj yuav tom khw, tsis muaj ib txoj kev zoo li hais txog kev kho pob ntseg. Cov tswv yim tshiab no tuaj yeem suav nrog lwm yam kev xaiv uas tso cai rau cov neeg mob "kho" lawv lub pob ntseg tsis hnov ​​yam tsis pom kws kho mob, kws kho qhov muag, lossis tso tshuaj.
Cov ntsiab lus no tau coj mus rau ntau lub chaw lis haujlwm pom zoo kom cov neeg siv khoom siv tshaj tawm-ntawm lub rooj sib hais tsis tas yuav tsum muaj kev koom nrog kev tshaj lij. Cov lus pom zoo no tau ua

raws li, ib feem, ntawm ob qhov thev naus laus zis (piv txwv li cov khoom siv smartphone, cov kev sib tw, thiab lwm yam) uas tuaj yeem muab txiaj ntsig thiab hnov ​​tias ib txwm muaj cov neeg ua haujlwm thev naus laus zis yuav muaj lub peev xwm kom haum thiab cov phiaj xwm kev saib xyuas tsis muaj kev pab los ntawm kws ntsuas suab.
Txoj cai OTC tau tshaj tawm los ntawm Congress (S934: FDA Reauthorization Act of 2017) txhais qhov OTC ntaus ntawv yog ib qho uas: “(A) siv tib qho txuj ci kev tshawb fawb zoo li huab cua kev hnov ​​suab nrov (raws li tau hais hauv tshooj 874.3300 ntawm nqe 21, Txoj Cai ntawm Tsoomfwv Txoj Cai Tswjfwm) (lossis ibqho kev ua tiav ntawm cov cai) lossis lub xov tooj cua zoo li lub ntsej muag sib luag (raws li tau txhais hauv ntu 874.3305 ntawm nqe 21, Txoj Cai Tswjfwm Tsoomfwv Txoj Cai) (lossis ibqho kev cai ntawm successor); (B) yog npaj los siv rau cov neeg muaj hnub nyoog tshaj 18 xyoo los pab them rau qhov tsis hnov ​​lus ntawm qhov tsis hnov ​​lus zoo; (C) los ntawm cov cuab yeej, kev sim, lossis software, tso cai rau tus neeg siv los tswj lub khw muag khoom sib txawv thiab kho nws kom haum rau tus neeg siv lub rooj sib hais; (D) yuav - (i) siv wireless technology; lossis (ii) suav nrog kev ntsuas tus kheej qhov tsis hnov ​​lus; thiab (E) muaj muag hauv khw, tsis muaj kev saib xyuas, tshuaj, lossis lwm yam kev txiav txim, kev koom tes, lossis kev cuam tshuam ntawm tus neeg muaj ntawv tso cai, rau cov neeg siv khoom hauv kev sib tham tus kheej, hauv kev xa ntawv, lossis online. " Txoj cai no tau cog lus tias FDA tsim thiab tshaj tawm cov kev cai tsis pub dhau 3 xyoos tom qab kev cai tau pib los ntawm txoj cai no. Txoj cai kawg ntawm kev cai lij choj, kos npe los ntawm Thawj Tswj Hwm Trump thaum Lub Yim Hli 18, 2017, tshwj xeeb sau cia cov lus hauv qab no: “Tus Secretary of Health thiab Pabcuam Tib Neeg… tsis pub dhau 3 xyoos tom qab hnub ua haujlwm ntawm tsab cai no, yuav tshaj tawm cov kev cai thov teeb tsa cov pab cuam lub rooj sib hais cov lus hais, raws li txhais hauv ntu (520) ntawm ntu 21 ntawm Tsoomfwv Khoom Noj, Tshuaj thiab Tshuaj Kom Zoo (360 USC 180j) raws li tau hloov kho los ntawm ntu (a), thiab, tsis pub dhau 180 hnub tom qab hnub uas pej xeem tawm tswv yim txog cov kab kev thov kaw no, yuav sau cov kev cai zaum kawg no. " FDA tau pib txheej txheem ntawm kev sau cov ntaub ntawv thiab cov ntaub ntawv, suav nrog cov tswv yim los ntawm cov koom haum tshaj lij, cov koomhaum tsoomfwv, thiab cov neeg siv khoom thiab tuaj yeem tshaj tawm cov kev cai tswjfwm txhua lub sijhawm nyob rau peb xyoos tom ntej no. Hauv cov cai uas tau thov yuav yog lub sijhawm rau FDA tau txais kev tawm tswv yim los ntawm pej xeem txog txoj cai thov. Nyob rau lub sijhawm no, cov koomhaum, cov koomhaum, lossis cov neeg tuaj yeem tuaj yeem tawm lus qhia, hais qhia hloov kho, lossis muab cov kev xaiv sib txawv rau cov cai thov. Nws kuj tseem tuaj yeem hais tias FDA yuav tuav lub rooj sib hais rau pej xeem thaum lub sijhawm twg los hais lus tim khawv tuaj yeem muab tau nyob rau hauv txoj cai thov. Thaum kaw lub sijhawm hais lus, FDA yuav ntsuas cov lus hais lossis sau ntawv pov thawj thiab txiav txim siab seb puas muaj kev hloov pauv hauv cov cai tau hais tseg uas tsim nyog. Hauv rau lub hlis (XNUMX hnub) ntawm lub sijhawm kaw lus pom, cov kev cai kawg yuav muab luam tawm, nrog rau hnub uas yuav tawm.

HOM HAIS TXOG KEV HAIS LUS HAIS DUA
Daim ntawv no tshuaj xyuas cov cuab yeej thiab cov thev naus laus zis tam sim no rau cov neeg siv khoom thiab cov neeg mob. Cov kev xaiv uas tau hais hauv cov ntaub ntawv no tsis suav nrog cov khoom siv phais mob phais (piv txwv li kev cog hniav cochlear, kev cog hniav hauv nruab nrab, thiab lwm yam). Raws li tam sim no, OTC cov khoom siv tsis muaj nyob thiab yog li ntawd lawv daim ntawv, kev ua haujlwm, nqi, cov yam ntxwv ntawm kev ua haujlwm, lossis qhov cuam tshuam rau cov kev coj ua lub luag haujlwm yog xam.
Tswb Hais Txog: FDA cov cai tau txhais lub pob ntseg pab yog "tej cuab yeej siv coj los hnav, tsim los rau, los yog sawv cev los pab cov tib neeg muaj lossis pab rau, hnov ​​lus tsis zoo" (21 CFR 801.420). Cov khoom siv hauv pob ntseg yog tswj hwm los ntawm FDA raws li Chav Kawm I lossis Chav Kawm II cov cuab yeej kho mob thiab tsuas yog muaj los ntawm cov kws kho mob muaj ntawv tso cai. Qhov zoo yuav hnov ​​rau cov tib neeg uas tsis hnov ​​lus me me thiab tsis hnov ​​lus zoo thiab tuaj yeem kho los ntawm tus kws kho mob.
Tus Kheej Lub Luag Haujlwm Txhawb Nqa Tus Kheej (PSAP): PSAP tau tshaj tawm, khoom siv hluav taws xob tau tsim los ua kom mloog zoo hauv qee qhov chaw ib puag ncig (tsis yog siv tag nrho). Lawv feem ntau yog tsim los muab qee qhov me me ntawm cov suab nrov hauv ib puag ncig tab sis vim tias lawv tsis tau tswj hwm los ntawm FDA, lawv tsis tuaj yeem ua lag luam ua cov khoom siv uas pab cov tib neeg tsis hnov ​​lus. FDA tau qhia tias cov piv txwv ntawm cov PSAP uas siv feem ntau suav nrog kev yos hav zoov (mloog rau cov tsiaj raug tsim txom), saib noog, mloog lus qhuab qhia nrog tus hais lus nyob deb, thiab mloog cov suab mos mos uas yuav nyuaj rau cov tib neeg hnov ​​lus zoo (xws li, cov kev sib tham deb deb) (FDA Kev Ntsuas Cov Qauv, 2013). PSAP tam sim no muaj rau kev yuav khoom los ntawm tus neeg siv khoom ntawm ntau lub khw muag khoom muag, suav nrog los ntawm cov khw muag khoom on-line. Cov kws kho mob hnov ​​tau PSAP.
Cov cuab yeej pab kom zoo mloog (ALD), Cov kev pab mloog kom zoo (ALS), Cov lus ceeb toom: Hais kom dav, ib pawg ntawm cov cuab yeej uas pab tus neeg hnov ​​lus tsis zoo tswj cov chaw mloog tshwj xeeb lossis cov xwm txheej uas cov cuab yeej siv tsis txaus lossis tsis tsim nyog. ALDs lossis ALSs tuaj yeem siv rau tom chaw ua haujlwm, hauv tsev, thaj chaw ua haujlwm lossis chaw lom ze, thiab tuaj yeem siv los txhim kho cov teeb liab-rau-lub suab nrov, rov ua dua qhov cuam tshuam ntawm qhov deb, lossis txo qhov cuam tshuam ntawm cov suab lus tsis zoo (piv txwv li kev thim rov qab). ) Cov khoom siv no tuaj yeem siv rau tus kheej lossis rau pab pawg (thaj chaw dav). Ceebtoom cov khoom siv feem ntau siv lub teeb, lub suab nrov lossis lub suab nrov los txuas lossis teeb liab tus neeg tsis hnov ​​lus txog cov xwm txheej hauv lawv ib puag ncig, thiab tuaj yeem txuas rau cov xov tooj, teeb, lub qhov rooj, pa hluav taws, thiab lwm yam zoo li FDA tsis tswj hwm ALDs, ALS, lossis cov cuab yeej ceeb toom, txawm hais tias qee cov khoom siv, xws li cov xov tooj hu npe, yuav tsum tau ua raws li FCC cov cai. Cov khoom siv no tuaj yeem muas tau los ntawm cov khw muag khoom tawm sab nrauv, on-line, thiab kev kaw suab. Qee qhov xwm txheej, cov cuab yeej siv no muaj rau tus nqi txo los ntawm tsoomfwv cov chaw haujlwm.
Wireless lub tswb pob ntseg khoom siv: Muaj ntau cov khoom siv niaj hnub no tau tsim los ntxiv cov cuab yeej sib pab, txhim kho kev sib txuas lus, lossis siv lwm txoj hauv kev sib txuas lus. Cov khoom siv ntxiv muaj cov khoom siv uas tso cai rau cov mloog kom ncaj qha xa xov xwm los ntawm lub xov tooj lossis lwm yam khoom siv mloog ntawm tus kheej (piv txwv li, ntsiav tshuaj, khoos phis tawm, e-nyeem ntawv) nrog rau cov chaw taws teeb lossis cov lapel microphones uas pab kom tus mloog tau hnov ​​ntev dhau los (piv txwv, hauv
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cov chav kawm, chav sib tham, thiab chav qhuab qhia). Cov khoom siv hauv pob ntseg yog feem ntau yuav khoom los ntawm kev kaw suab, tab sis kuj tseem muaj los ntawm cov khw muag khoom muag.
Hearables: Ib qho hnav tau yog txhua lub pob ntseg uas tau tsim los ntxiv thiab txhim kho kev mloog, lossis uas muaj cov yam ntxwv xws li saib xyuas cov cim tseem ceeb (piv txwv li lub plawv dhia, lub cev kub, ntshav qib oxygen, thiab lwm yam), kev ua ub no (piv txwv li cov kauj ruam, cov calories uas raug hlawv, thiab lwm yam), lub rooj sib hais ntxiv (tso cai rau cov neeg siv los lim tawm lossis txhim kho lub suab tshwj xeeb), tso suab paj nruag, txhais lus, lossis txhim kho kev sib txuas lus tim ntsej tim muag.

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