MALANGIZO A AUDIOLOGIST OTIMA PAMVA KUMVETSA Edzi, PSAP, NKHANI ZOSAYENELA NDIPONSO ZOFUNIKIRA ZA OTC

Food and Drug Administration (FDA) ikupanga malamulo opangira zida zothandizira kumva. Malinga ndi FDA Reauthorization Act ya 2017, zida izi zitha kupezeka kwa ogula kudzera mu malonda ogulitsa komanso osagwiritsa ntchito audiologist, kuti iwononge chisanadze, kapena poyimitsa, koyenera kapena kutsimikizira kachitidwe ka chipangizocho. Ngakhale zida za OTC sizinalowebe pamsika, malangizo awa adapangidwa kuti athandize akatswiri owerenga kumvetsetsa komwe kulipo pakati pa zinthu zomwe zilipo ndi zida za OTC, kukhala okonzeka kuyankha mafunso okhudzana ndi zidazi, komanso mwina kupemphererabe zochita musanapemphedwere zida. Malangizowa adzasinthidwa pomwe malamulo azida za OTC apezeka.

M'chilimwe cha 2017, Congress idapereka lamulo loti FDA ipange malamulo omwe amapanga OTC zothandizira kumva kupezeka kwa anthu onse. Izi zisanachitike, mabungwe angapo aboma, makamaka Federal Trade Commission (FTC) ndi Purezidenti wa Council of Advisors on Science and Technology (PCAST), adayamba kuwunikiranso za chisamaliro chakumva ku United States. Nthawi yomweyo, National Academies of Science, Engineering and Medicine (NASEM) idayitanitsanso komiti kuti iwunikenso ndikufotokoza momwe amathandizira pakumvera ku US The FDA, FTC, National Institutes of Health, Veteran's Administration, department ya Chitetezo, ndi Hearing Loss Association of America adalamula kafukufuku wa NASEM.
Chiyambi cha makomitiwa ndi kuwunikiridwa kumatha kutsatiridwa pamalingaliro atatu odziwika ndi lingaliro limodzi lomwe likupezeka posamalira zaumoyo. Choyamba ndikulingalira kuti mtengo wa chisamaliro chakumvera, makamaka mtengo wa zothandizira kumva, Imalepheretsa anthu ena kufunafuna chithandizo kuti amve. Chachiwiri, ambiri omwe amapereka chipani chachitatu samaphimba zothandizira kumva; kuphatikizapo Medicare komwe zida zothandizira kumva ndi ntchito zina sizimasankhidwa. Lingaliro lachitatu ndikuti kugawa kwa omwe amapereka chisamaliro chakumva, kuphatikiza omvera, ndikuti kuli madera ambiri ku US komwe anthu sangathe kupeza chithandizo chamankhwala osamva.
Lingaliro lachipatala lomwe likubwera likuwonetsa kuti ogula akufuna kuwongolera chisamaliro chaumoyo wawo, kuphatikizapo kufunitsitsa "kudzilamulira" posamalira chithandizo chamankhwala. Chowonjezera chikhoza kukhala, mwa kuwongolera mtengo wa chithandizo chazachipatala, komanso kuwongolera nthawi ndi kuyesetsa komwe kumagwiritsidwa ntchito ndi othandizira azaumoyo. Ngakhale chithandizo chambiri chazovuta masiku, monga kupweteka kumbuyo, chikuthandizidwa ndi mankhwala othandizira, sipanakhale njira yotere yochizira makutu. Lingaliro lodziwikirali lingaphatikizepo njira zina zomwe zimaloleza odwala "kuchiritsa" kutaya kwawo kwa makutu popanda kuwona audiologist, otolaryngologist, kapena dispens.
Mitu iyi idatsogolera mabungwe ambiri omwe amavomereza mwayi wogwiritsa ntchito makasitomala osamalira makasitomala popanda chifukwa chothandizira akatswiri. Malangizo awa anali

motengera mbali imodzi pamatekinoloje onse omwe akutuluka (mwachitsanzo mapulogalamu a foni yam'manja, zomvetsera, ndi zina) zomwe zitha kupereka mwayi wa kumva komanso malingaliro kuti anthu omwe akuchulukirachulukira paukadaulo atha kukhala ndi kuthekera kokwanira komanso zida zamakono zothandizira popanda kumva wolemba mawu.
Lamulo la OTC lomwe linaperekedwa ndi Congress (S934: FDA Reauthorization Act of 2017) limatanthauzira kachipangizo ka OTC kuti: "(A) imagwiritsa ntchito ukadaulo wofanana ndi zida zamakono zothandizira kumva (monga tafotokozera mu gawo la 874.3300 la mutu 21, Code of Malamulo a Federal) (kapena aliyense wolowa mmalo) kapena zothandizira kugwiritsa ntchito makina opanda waya (monga tafotokozera mu gawo la 874.3305 la mutu 21, Code of Federal Regulations) (kapena lamulo lililonse); (B) cholinga chake kugwiritsidwa ntchito ndi akulu azaka zopitilira 18 kuti alipire ndalama zomwe anthu akumva kuti ndi ofatsa komanso ochepa; (C) pogwiritsa ntchito zida, mayeso, kapena pulogalamu, imalola wogwiritsa ntchito kuti azitha kuyang'anira makutu othandizira omvera; (D) atha (i) kugwiritsa ntchito ukadaulo wopanda zingwe; kapena (ii) akuphatikiza mayeso oti adziyesa amvedwe akumva; ndipo (E) imapezeka pamalowo, popanda kuyang'aniridwa, kupatsidwa mankhwala, kapena lamulo lina, kutengapo gawo, kapena kulowererapo kwa munthu wokhala ndi zilolezo, kwa ogula kudzera mwa anthu, kudzera makalata, kapena pa intaneti. ” Lamuloli lalamula kuti FDA ipange ndikusindikiza malamulo pasanathe zaka 3 mutakhazikitsidwa lamulolo. Malamulo omaliza, omwe adasainidwa ndi Purezidenti Trump pa 18 Ogasiti 2017, akufotokoza motere: "Secretary of Health and Human Services ... pasanathe zaka 3 chitachitika lamulo lalamulo, adzakhazikitsa malamulo operekedwa kwa khazikitsani gulu la zida zothandizira kumva kwambiri, monga zimanenedwera m'gawo lachigawo 520 la Federal Food, Drug, and cosmetic Act (21 USC 360j) monga kusinthidwa ndi gawo (a), ndipo, lisanafike masiku 180 ikafika tsiku lomwe anthu adzapereke ndemanga pamalamulo omwe adzaperekedwe, adzapereke malamulo omaliza. ” FDA yayamba njira yosonkhanitsa zidziwitso ndi zidziwitso, kuphatikiza zochokera ku mabungwe aluso, mabungwe a federal, ndi magulu ogula ndipo amatha kufalitsa malamulo ovomerezeka nthawi iliyonse mkati mwa zaka zitatu zotsatira. Kuphatikizidwa m'malamulo omwe akutsimikiziridwa idzakhala nthawi yoti FDA ilandire kuchokera kwa anthu pa malamulo omwe akufuna. Munthawi imeneyi, mabungwe, mabungwe, kapena anthu amatha kupereka ndemanga, kupereka lingaliro, kapena kupereka zosankha zingapo pazomwe zaperekedwa. Ndizothekanso kuti FDA ikhazikitse chisankho pagulu panthawi yomwe umboni wapakamwa ungaperekedwe pamalamulo omwe aperekedwa. Pamapeto pa nthawi yopereka ndemanga, a FDA adzawunikira umboni uli wonse wapakamwa kapena wolembedwa ndikuwona ngati kusintha kulikonse pamalamulo ofunikirawa ndikofunikira. Pakupita miyezi isanu ndi umodzi (masiku 180) kumapeto kwa nthawi yankhani, malamulo omaliza adzasindikizidwa, komanso tsiku loti akhazikitsidwe.

NJIRA ZAKUMVA ZAMVA
Chikalatachi chimawunikira zida ndi matekinoloje omwe alipo tsopano kwa ogula ndi odwala. Zosankha zomwe zalembedwazi siziphatikiza ndi zida zothandizidwa (mwachitsanzo, zovekera zolumikizira, zodzikhira pakatikati, ndi zina). Monga pano, zida za OTC zilibe chifukwa chake mawonekedwe, ntchito, mtengo, magwiridwe antchito, kapena momwe amathandizira pakumvera kwa audiology ndikulingalira.
Kumva Thandizo: Malangizo a FDA amatanthauzira chothandizira kumva ngati "chida chilichonse chovala kapena chida chopangidwira, choperekedwa, kapena chothandizira monga kuthandiza kapena kubwezera, kusamva kwakumva" (21 CFR 801.420). Zothandizira kumva zimayendetsedwa ndi FDA ngati zida zamakono za Class I kapena Class II ndipo zimangopezeka kuchokera kwa omwe ali ndi zilolezo. Zothandizira kumva zimatha kulimbikitsidwa kwa anthu omwe ali ndi vuto losamva kwambiri ndipo amatha kuthandizanso ndi omwe amapereka.
Zinthu Zomvera Zazikulu Zomwini (PSAP): MaPSAP ndi zida zogwiritsa ntchito zamagetsi, zomwe zimapangidwira kuti zimveketse kumvetsera m'malo ena (osagwiritsa ntchito nthawi yonse). Zopangidwira kuti zizipereka phokoso laling'ono koma chifukwa sizikulamulidwa ndi FDA, sizingagulitsidwe ngati zida zomwe zimathandiza anthu omwe amamva. FDA ikuwonetsa kuti zitsanzo za zochitika zomwe PSAPs zimagwiritsidwa ntchito nthawi zambiri zimaphatikizapo kusaka (kumvetsera nyama), kuyang'ana mbalame, kumvetsera zokambirana ndi wokamba kwakutali, komanso kumvetsera nyimbo zomwe zimakhala zovuta kwa anthu akumva wamba. zokambirana zazitali) (FDA Draft Guidance, 2013). Ma PSAP pano akupezeka kuti ogula azigulitsa m'malo ogulitsa osiyanasiyana, kuphatikiza ogulitsa pa intaneti. Audiologists amatha kugulitsa ma PSAP.
Zipangizo zothandizira kumvetsera (ALD), makina othandizira omvera (ALS), zida zokuthandizira: Pofalikira, gulu la zida zomwe zimathandiza munthu amene amamva kumayang'anira malo omvera kapena zochitika zina zomwe zida zachilendo sizili zokwanira kapena zosayenera. Ma ALD kapena ALS angagwiritsidwe ntchito kuntchito, kunyumba, malo ogwirira ntchito kapena malo achisangalalo, ndipo angagwiritsidwe ntchito kukonza chiwonetsero chaphokoso-chaphokoso, kuthana ndi zotsatira za mtunda, kapena kuchepetsa zomwe amabwera chifukwa chosagwirizana bwino (mwachitsanzo kubwezeretsa. ) Zipangizozi zimatha kukhala zogwiritsa ntchito patokha kapena zamagulu (m'dera lalikulu). Zipangizo zodziwitsa anthu zimagwiritsa ntchito kuwala, phokoso lalikulu kapena kugwedeza kolumikizira kapena kuunikira munthu yemwe amva kutayika pazomwe zikuchitika mdera lawo, ndipo amatha kulumikizana ndi mafoni, magetsi, mabatani am'makomo, ma alarm alamu, etc. A FDA samayendetsa ALD, ALS, kapena kuchenjeza zida, ngakhale zida zina, monga ma telefoni osemedwa, zitha kutsatira malamulo a FCC. Zipangizozi zitha kugulidwa kudzera mumisika yogulitsa, pa intaneti, komanso machitidwe azomvera. Nthawi zina, zidazi zimapezeka kuti zichepetse ndalama kudzera mabungwe aboma.
Chalk chothandizira makutu othandizira opanda zingwe: Pali zinthu zambiri zomwe zilipo lero zomwe zimapangidwa kuti zithandizire othandizira, othandizira kulankhulana, kapena kugwiritsa ntchito njira zina polumikizirana. Zomwe muli zimaphatikizapo zida zomwe zimathandizira womvera kuti azitha kutulutsa chidziwitso kuchokera pafoni kapena chida china chomvetsera (mwachitsanzo, piritsi, kompyuta, e-owerenga) komanso maikolofoni akutali kapena lapel omwe amathandizira omvera kuti azimva kutalika kwakutali (mwachitsanzo, mu
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makalasi, zipinda zamisonkhano, ndi maholo omvera). Zothandizira pazothandizira zimagulidwa nthawi zambiri kudzera machitidwe a audiology, komanso zimapezeka mu malonda ogulitsa.
Zomvera: Zomveka ndi chida chilichonse chamakutu chomwe chimapangidwira kuti chithandizire komanso kumvetsera zowonjezera, kapena chomwe chimaphatikizapo zinthu monga kuwunikira zizindikiro zofunika (monga kugunda kwa mtima, kutentha kwa thupi, kuchuluka kwa okosijeni wamagazi, ndi zina zotere), kutsata zochitika (mwachitsanzo masitepe, zopatsa mphamvu zopsereza, ndi zina zotere, makutu olimbikitsidwa (amalola ogwiritsa ntchito kusefa kapena kupititsa mawu ena), kusinthana ndi nyimbo, kumasulira kwachilankhulo, kapena kulankhulana pamaso ndi nkhope.

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Tsitsani MLANGIZO WA AUDIOLOGIST WOPANDA KUKHALA NDI IMFA, ATSOGOLO, MITU YA NKHANI NDI ZOTHANDIZA ZA OTC [PDF]