Gwaro reAUDIOLOGIST RINONYANYA Kunzwa AIDS, maPSAP, NHEMA NEMAHARA.

Iyo Chikafu neDoro Administration (FDA) iri kusimudzira mirau yeoverover-the-counter (OTC) michina yekubatsira kunzwa. Zvinoenderana neFDA Reauthorization Act ya 2017, zvishandiso izvi zvichave zviripo kune mutengi kuburikidza neezvekutengesa zvinhu uye kunze kwekuita mutemesi, kungave kwekutanga-kutenga kunzwa kwekunzwa, kana kusimuka, kwakakodzera kana kusimbisa kwekuita kwechinhu ichocho. Nepo zvishandiso zveOTC zvisati zvapinda mumusika, nhungamiro iyi yakagadziridzwa kubatsira audiologistsin kunzwisisa mutsauko uripo pakati pezvigadzirwa zviripo pamwe nemidziyo yeOTC, kugadzirira kupindura mibvunzo nezvezvishandiso izvi, uye pamwe nekumbopemha pre-chinzvimbo maitiroin kutarisira kwekuwanikwa kweOTC zvishandiso. Iyi nhungamiro ichavandudzwa sezvo zviga zveOTC zvishandiso zvikave zviripo.

Muzhizha ra2017, Congress yakapa mutemo waitungamira iyo FDA kuvandudza mirawo inogadzira OTC kunzwa rubatsiro inowanikwa kuruzhinji. Izvi zvisati zvaitika, mamwe masangano emubatanidzwa, kunyanya Federal Trade Commission (FTC) uye President's Council of Advisors paSainzi neTekinoroji (PCAST), vakatanga kuongorora kugona uye kugona kwekunzwa kwekunzwa muUnited States. Panguva imwecheteyo, maNational Academies eSainzi, Injiniya neMedicine (NASEM) akaunganidzawo komiti kuti iongorore nekuzivisa mamiriro ezvekunzwa kwekuchengetwa kwekunzwa muUS The FDA, FTC, maNational Institutes of Health, Veteran's Administration, Dhipatimendi. yeDziviriro, uye Hearing Loss Association yeAmerica yakaraira iyo NASEM kudzidza.
Mhando yemakomiti aya uye ongororo dzinogona kuteverwa kune matatu ekuziva maonero uye imwe ichibuda pfungwa yehutano. Yekutanga kufunga kwekuti mutengo wekutarisirwa kwekunzwa, uye zvakanyanya mutengo we kunzwa rubatsiro, Inodzivirira vamwe vanhu kutsvaga kurapwa kwekunzwa kurasikirwa. Chechipiri, vazhinji vevatatu vanobhadhara havabhadhare kunzwa rubatsiro; kusanganisira Medicare panowanikwa zvishandiso zvekunzwa uye nemasevhisi akabatanidzwa zviri pamutemo vakasiyiwa. Pfungwa yechitatu ndeyekuti kugoverwa kwenzvimbo kwevanopa rubatsiro rwekunzwa, kusanganisira audiologists, kwakadai kuti kune nzvimbo zhinji muUS umo vanhu vasingakwanise kuwana nyore nyore rubatsiro rwekunzwa.
Pfungwa iri kubuda yehutano ndeyekuti vatengi vari kuda hutongi hwakawanda pamusoro pehutano hwavo, kusanganisira chishuvo che “kuzvitungamira” kwavo kwehutano hwekunzwa. Iko kukurudzira kunogona kuve, muchikamu, kudzora mutengo wehutano hwavo hwehutano, asi zvakare kutonga nguva uye kushanda nesimba kunoitwa kana muchiita nevashandi vehutano. Kunyange zviitiko zvakawanda zvekurapa zvisingaperi, semuenzaniso kurwadziwa kwakadzikira kumashure, kuri "kurapwa" nemishonga yekupfuura-ipapo, pakange pasina sarudzo yakadaro yekurapa kurasikirwa kwekunzwa. Pfungwa iyi iri kubuda inogona kusanganisira nzira dzingabvumidza varwere "kurapa" kurasikirwa kwavo kwekunzwa vasina kana kuona audiologist, otolaryngologist, kana disenser.
Iyi misoro yakatungamira kumasangano akati wandei achikurudzira kuwaniswa kwevatengi pamusoro-pe-kisi yekunzwa kwekutarisira kwekuteerera pasina kukosha kwekuita nyanzvi. Aya mazano aive

yakavakirwa, muchikamu, pane ese matekinoroji matekiniki (semuenzaniso ma-smartphone, zvinonzwika, nezvimwewo) izvo zvinogona kupa rubatsiro rwekunzwa uye mafungiro ekuti vanhu vari kuramba vachiwedzera hunyanzvi hwehupfumi vanogona kuve nehunyanzvi hwekukwanira uye zvirongwa zvekunzwa zvekutarisira pasina rubatsiro muteereri.
Mutemo weOTC wakapihwa neCongress (S934: FDA Reauthorization Act ya 2017) unotsanangura chishandiso cheOTC seicho: Federal Mitemo) (kana chero inotsiva mvumo) kana isina waya yemhepo marezheni ekuunzwa ekubatsira (sekutsanangurwa kuchikamu chikamu 874.3300 chezita 21, Code ye Federal Regulation) (kana chero anoteedzera mutemo); (B) yakagadzirirwa kushandiswa nevakuru vanopfuura makore gumi nemasere kubhadhara kune vanozivikanwa vanyoro kusvika pamwero kunzwa kwekukanganisa; (C) kuburikidza nezvishandiso, bvunzo, kana software, inobvumira mushandisi kudzora pamusoro-iyo-counter yekunzwa yekubatsira uye ita kuti iite kune iyo yekunzwi yemushandisi inonzwa; (D) anogona— (i) kushandisa tekinoroji isina waya; kana (ii) inosanganisira bvunzo dzekuzviongorora kwekupererwa kwekunzwa; uye (E) inowanikwa pamusoro pechibatiso, pasina kutariswa, kunyorerwa, kana kumwe kurongeka, kupindira, kana kupindira kwemunhu ane rezinesi, kune vatengi kuburikidza nekutengeserana kuri kwevanhu mukati, netsamba, kana online. " Mutemo uyu unopa mutemo wekuti FDA ivandudze uye ibudise mutemo pasati papfuura makore matatu mushure mekuitwa kwemutemo. Shanduro yekupedzisira yemutemo, yakasainwa neMutungamiriri Trump musi waNyamavhuvhu 874.3305, 21, inonyatsotarisa zvinotevera: "Secretary of Health and Human Services ... pasati papera makore matatu mushure mekugadzwa kwemutemo uyu. gadza boka rezvinhu zvinonzwisisika zvinonzwisiswa, sezvakatsanangurwa muchikamu (q) chechikamu 18 cheFederal Chikafu, Doro, uye cosmetic Act (3 USC 18j) sezvakagadziridzwa nechikamu (a), uye, kwete mushure memazuva 2017 " Iyo FDA yakatanga chirongwa chekuunganidza ruzivo uye data, kusanganisira kuisa kubva kumasangano ehunyanzvi, masangano emubatanidzwa, uye mapoka evatengi uye anogona kuburitsa mitemo yakatemerwa chero nguva mukati memakore matatu anotevera. Inosanganisirwa mumitemo yakatsanangurwa ichave nguva yeiyo FDA yekuwana mhinduro kubva kune veruzhinji pamusoro pemitemo yakatsanangurwa. Pakati peino nguva, masangano, vamiririri, kana vamwe vanhu vanogona kupa makomendi, kupa mazano ekugadzirisa, kana kupa sarudzo dzakasiyana dzemirairo yakatsanangurwa. Izvo zvakare zvinogoneka kuti FDA ichaita hurukuro yeruzhinji panguva iyo chipupuriro chemuromo chinogona kupihwa pamirairo yakatsanangurwa. Panopera nguva yekutaura, iyo FDA ichaongorora chero humbowo hwemuromo kana hwakanyorwa uye kuona kana paine shanduko mumitemo yakatsanangurwa inofanirwa. Mukati memwedzi mitanhatu (mazuva makumi mapfumbamwe nemaviri) yekuvharwa kweiyo nguva yekutaura, mitemo yekupedzisira ichaburitswa, pamwe nezuva rekunyorwa.

TYPES Yokunzwa DEVICES
Gwaro iri rinoongorora michina uye matekinoroji aripo kune vatengi nevarwere. Idzo sarudzo dzakaunzwa mukati megwaro idzi hadzigadzire maturakiti ekushandisa (semuenzaniso cochlear implants, yepakati nzeve implants, nezvimwewo). Sezvo pari zvino, zvishandiso zveOTC hazviripo saka chimiro chavo, basa, mutengo, maitiro ekuita, kana kukanganisa maitiro e audiology zvinofungidzirwa.
Kunzwa Rubatsiro: Mitemo yeFDA inotsanangura rubatsiro rwekunzwa se "chero chinhu chinogona kusimba kana chishandiso chakagadzirirwa, chakapihwa nechinangwa che, kana chinomiririrwa sevanhu vanobatsira kana kudzorera, kunzwa kusanzwa" (21 CFR 801.420). Kunzwa zvinobatsira zvinodzorwa neFDA seClass I kana Kirasi II michina yekurapa uye zvinowanikwa chete kubva kune vanopa marezinesi. Kunzwa rubatsiro kunogona kukurudzirwa kune vanhu vane hunyoro kune hwakadzama kurasikirwa kwekunzwa uye vanogona kuve yakagadziriswa neanopa.
Zvemunhu Zvinoremekedzwa zveMapureti Zvigadzirwa (PSAP): maPSAP anopfuura-the-counter, anogona kupfeka zvigadzirwa zvemagetsi zvinogadzirwa kuti zviwedzere kuteerera mune dzimwe nharaunda (kusashandiswa-nguva yakazara). Izvo zvinowanzogadzirwa kuti zvipe kudzikisira kwakanyanya kwemanzwi ekunze asi nekuda kwekuti haisi kurongeka neFDA, haigoni kutengeswa semidziyo inobatsira vanhu vane kutadza kunzwa. Iyo FDA inoratidza kuti mienzaniso yemamiriro ezvinhu umo maPSAP anowanzo shandiswa anosanganisira kuvhima (kuteerera mhuka), kutarisa shiri, kuteerera hurukuro nemutauri ari kure, uye kuteerera kurira kwakapfava izvo zvingaomera vanhuwo zvavo kunzwa (semuenzaniso, kure hurukuro) (FDA Draft Guidance, 2013). MaPSAP aripo pari kutengwa nemutengi kunzvimbo dzakasiyana siyana dzekutengesa, kusanganisira kuburikidza nevanozvitengesa. Audiologists vanogona kutengesa maPSAP.
Anobatsira ekuteerera michina (ALD), Assistive kuteerera masisitimu (ALS), zvekuzivisa Nyevero: Zvakawanda, chikamu chemidziyo chinobatsira munhu ane kurasikirwa kwekunzwa anobata nharaunda dzakateererwa dzekuteerera kana mamiriro ezvinhu umo zvigadzirwa zvegungano zvisina kukwana kana zvisina kukodzera. ALDs kana ALSs inogona kushandiswa kubasa, kumba, nzvimbo dzevashandi kana nzvimbo dzevaraidzo, uye inogona kushandiswa kugadzirisa chiratidzo-kune-ruzha chiyero, kurwisa mhedzisiro yemudhara, kana kuderedza mhedzisiro yekusagadzikana acoustics (eg reverberation. ) Izvi zvishandiso zvinogona kuve zvekushandisa pachako kana zvemapoka (nzvimbo yakakura). Ziviso zvekuzivisa zvinowanzoita kushandisa kujeka, kurira kwakanyanya kana kudedera kubatanidza kana kusaina munhu nekukanganisika kwekunzwa nezvezviitiko munharaunda yavo, uye zvinogona kubatana nemafoni, magetsi, mabhero pamusuwo, alarm yekuputa, nezvimwe .. Iyo FDA haidzore ALDs, ALS, kana kuchenjerera zvishandiso, kunyangwe mamwe madivaysi, akadai sekufonerwa manzwi, angatofanirwa kutevedzera mutemo weFCC. Midziyo iyi inogona kutengwa kuburikidza nezvitoro zvinotengesa, on-line, uye audiology maitiro. Mune mamwe mamiriro ezvinhu, zvishandiso izvi zviripo pamutengo wakaderedzwa kuburikidza nemasangano ehurumende.
Zvishandiso zvekunzwa pasina waya: Pane zvakawanda zvinowanikwa nhasi zvakagadzirirwa kuwedzera rubatsiro rwekunzwa, kusimudzira kutaurirana, kana kushandisa imwe nzira yekutaurirana. Zvishongedzo zvinosanganisira zvishandiso zvinobvumidza muteereri kutarisisa zvakananga kubva pafoni kana chimwewo chinhu chekuteerera (semuenzaniso, piritsi, komputa, e-muverengi) pamwe nemaikorofoni ari kure kana lapel anobatsira muteereri kunzwa pamusoro pemakiromita akareba (semuenzaniso, mu
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makirasi, makamuri emusangano, uye dzimba dzehurukuro). Kunzwa zvinhu zvekubatsira zvinowanzotengwa kuburikidza nevevhiology maitiro, asi zvinowanikwawo kuburikidza nezvitoro zvinotengesa.
Zvinonzwika: Zvinonzwika ndezvese chero-danho remhete rakagadzirirwa kuwedzeredza uye kuwedzera chiitiko chekuteerera, kana izvo zvinosanganisira zvinhu zvakaita sekutarisa zviratidzo zvakakosha (semuenzaniso moyo, kupisa kwemuviri, huwandu hwe oksijeni yeropa, nezvimwewo), chiitiko chekuteedzera (semuenzaniso nhanho, makoriyori akapiswa, nezvimwewo), yakanzwika kunzwa (inobvumira vashandisi kuchera kunze kana kuwedzera mamwe manzwi), mumhanzi kufambiswa, kushandurwa kwemitauro, kana kunatsiridza kutaurirana kumeso.

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Dhawunirodha Muongorori weAUDIOLOGIST KUTI unzwe AIDS, maPSAP, NHEMA NEMOYO DEVICES [PDF]