ISIQONDISO SE-AUDIOLOGIST SOKUZWA I-AIDS, ama-PSAP, IZIMPILO NEZIVIVINYO ZE-OTC

IFood and Drug Administration (FDA) isungula imithethonqubo ebekiwe yokwengeza amadivaysi osizo lokuzwa. Ngokomthetho we-FDA Reauthorization Act ka-2017, la mathuluzi atholakala kumthengi ngezitolo ezithengisayo futhi ngaphandle kokubandakanya i-audiologist, kungaba ukuhlolwa kokuzwa ngaphambi kokuthenga, noma ukuphakanyiswa, okufanele noma ukuqinisekiswa kokusebenza kwento. Ngenkathi amadivaysi e-OTC engakangeni emakethe, lo mhlahlandlela wathuthukiswa ukuze usize abakwa audi audiin baqonde umehluko phakathi kwemikhiqizo ekhona namadivayisi we-OTC, ukulungele ukuphendula imibuzo mayelana nalawa madivaysi, futhi mhlawumbe nokucela i-pre-position mazoe okulindelwe ukutholakala kwe-OTC amadivayisi. Lo mhlahlandlela uzovuselelwa njengoba imiyalo yamadivayisi we-OTC itholakala.

Ehlobo lika-2017, iCongress yaphasisa umthetho owawuyalela i-FDA ukuthi yakhe imithetho ebeka izinsiza kusebenza zokuzwa ze-OTC emphakathini. Ngaphambi kwalokhu, izinhlangano eziningi zamadlelandawonye, ​​ikakhulukazi i-Federal Trade Commission (FTC) kanye noMkhandlu Wabaqondisi Bezeluleko Zesayensi Nethekhinoloji (PCAST), baqala ukubukeza ukutholakala nokungeneka kokunakekelwa kwezindlebe e-United States. Ngakolunye uhlangothi, abakwaNational Academies of Science, Ubunjiniyela Nezokwelapha (i-NASEM) babuye bahlanganisa ikomidi elizobheka futhi libike ngesimo sokulethwa kwezidingo e-US The FDA, FTC, National Institutes of Health, Veteran's Administration, uMnyango. Wezokuvikela, kanye ne-Hearing Loss Association of America yathuma lolu cwaningo lweNASEM.
Uhlobo lwalamakomidi nokubuyekezwa kungalandelelwa ngemicabango emithathu ejwayelekile nomqondo owodwa osafufusa wokunakekelwa kwempilo. Owokuqala umbono wokuthi izindleko zokunakekelwa kokuzwa, futhi ikakhulukazi izindleko zezinsiza zokuzwa, zivimbela abantu abathile ekufuneni ukwelashwa kokulahlekelwa izindlebe. Okwesibili, abaningi abakhokha eceleni abazisebenzisi izinsiza zokuzwa; kufaka phakathi i-Medicare lapho amadivaysi wosizo lokuzwa nezinsizakalo ezihambisanayo ngaphandle. Umbono wesithathu ukuthi ukusatshalaliswa kwezindawo zabanakekeli bezindlebe, kufaka phakathi ababukeli, ukuthi kunezindawo eziningi e-US lapho abantu bengakwazi ukufinyelela kalula ezinsizeni zokulalela.
Umqondo osafufusa wokunakekelwa kwempilo uthi abathengi bafuna ukulawulwa okukhulu ekunakekelweni kwabo kwezempilo, kufaka phakathi isifiso “sokuziqondisa” ekunakekelweni kwabo kwezempilo. Umfutho kungenzeka ukuthi, ngakolunye uhlangothi, ulawule izindleko zokunakekelwa kwempilo yabo, kodwa futhi ulawule isikhathi nomzamo osetshenziswa lapho uhlangana nabanikezeli bezokunakekelwa kwempilo. Ngenkathi izimo eziningi zokwelapha ezingamahlalakhona, isb. Izinhlungu eziphansi emuva, zelashwa “ngamakhambi asebusondelene nabo, akubanga khona inketho enjalo yokwelashwa kokulahleka kwezindlebe. Lo mqondo ovelayo ungahlanganisa ezinye izindlela ezivumela iziguli ukuthi "zelaphe" ukulahleka kwazo kokuzwa ngaphandle kokubona i-audiologist, i-otolaryngologist, noma i-dispenser.
Lezi zingqikithi ziholele ezinhlanganweni eziningi ezincoma ukufinyelela kwamakhasimende ekunakekelweni kokulalela okungaphezulu kwesidingo ngaphandle kwesidingo sokubandakanya ochwepheshe. Lezi zincomo bezikhona

kususelwa, ngakolunye uhlangothi, kubuchwepheshe obusha obukhona (isib. izinhlelo zokusebenza ze-smartphone, okuzwakalayo, njll.) ezinganikeza usizo lokuzwa kanye nomcabango wokuthi inani labantu elihlala likhula njalo kwezobuchwepheshe lingaba namandla okulingana namadivayisi wokunakekelwa kokuzwa wohlelo ngaphandle kosizo udokotela wezilaleli.
Umthetho we-OTC ophasiswe yiCongress (S934: FDA Reauthorization Act ka-2017) uchaza into ye-OTC njengalena ethi: "(A) isebenzisa ubuchwepheshe obufanayo besayensi obufana nezinsizakalo zokulalelwa komoya (njengoba kuchaziwe esigabeni 874.3300 sesihloko 21, Ikhodi Imithetho Yobumbano) (noma noma yimuphi umthethonqubo wokulandela esikhundleni) noma izinsiza zokuzwa zentambo engenazingcingo (njengoba kuchaziwe esigabeni 874.3305 setayitela 21, iKhodi Yezimali Zezimali) (noma noma yimuphi umthethonqubo wokulandela); (B) kuhloswe ukuthi isetshenziswe ngabantu abadala abaneminyaka yobudala engaphezulu kwe-18 ukunxephezela ukutholwa kokulimala okubonakalayo kokuphakathi; (C) ngamathuluzi, izivivinyo, noma isoftware, ivumela umsebenzisi ukuthi alawule usizo lokuzwa lwe-over-counter futhi enze ngezifiso izidingo zokulalela zomsebenzisi; (D) inga- (i) isebenzise ubuchwepheshe obungenawaya; noma (ii) faka izivivinyo zokuzihlola kokulahleka kwezindlebe; futhi (E) itholakala ngaphezulu kwekhawuntara, ngaphandle kokugadwa, ukunikezwa umyalo, noma enye i-oda, ukubandakanyeka, noma ukungenela komuntu onelayisense, kubathengi ngokwenziselana ngabantu, ngeposi noma nge-inthanethi. ” Lo mthetho ugunyaza ukuthi i-FDA ithuthukise futhi ishicilele imithetho kungakapheli iminyaka eyi-3 ngemuva kokusebenza komthetho. Uhlobo lokugcina lomthetho, olusayinwe nguMongameli uTrump ngo-Agasti 18, 2017, lubeka ngokuqondile okulandelayo: “UNobhala Wezempilo Nezinsizakalo Zabantu… kungakapheli iminyaka emithathu ngemuva kosuku lokuqokwa kwalo mthetho, uzokwazisa ngemithetho ehlongozwayo ukuthi asungule isigaba sezinsiza zokulalelwa kwe-overthe-counter, njengoba kuchazwe kwisigatshana (q) sesigaba 3 se-Federal Food, Drug, and cosmetic Act (520 USC 21j) njengoba kuchitshiyelwe yisigatshana (a), futhi, hhayi ngaphambi kwezinsuku ezingama-360 ngemuva kosuku lapho umphakathi uphawula ngalo ngemitheshwana ehlongozwayo, uzokhipha leyo mithetho yokugcina. ” I-FDA isiqalile inqubo yokuqoqa imininingwane nemininingwane, kubandakanya ukufaka okuvela ezinhlanganweni eziqeqeshiwe, izinhlangano zombuso, namaqembu abathengi futhi ingashicilela imithetho ehlongozwayo nganoma yisiphi isikhathi eminyakeni emithathu ezayo. Kufakwe kwimithetho ehlongozwayo kuzoba yisikhathi sesikhathi sokuba i-FDA ithole impendulo evela emphakathini ngemithetho ehlongozwayo. Ngalesi sikhathi, izinhlangano, izinhlangano noma abantu banganikeza imibono, baphakamise ukuguqulwa, noma banikeze ngezinketho ezahlukene zemithetho ehlongozwayo. Kungenzeka futhi ukuthi i-FDA ibambe ukulalelwa komphakathi ngasikhathi lapho ubufakazi bomlomo bunganikezwa khona kwimithetho ehlongozwayo. Ekupheleni kwesikhathi sokuphawula, i-FDA izohlola noma yibuphi ubufakazi obudluliselwa ngomlomo noma obubhaliwe futhi inqume ukuthi ngabe kukhona ushintsho emithethweni ehlongozwayo luyadingeka. Zingakapheli izinyanga eziyisithupha (izinsuku ezingama-180) zokuvalwa kwesikhathi sokuphawula, kuzoshicilelwa imithetho yokugcina, kanye nosuku lokumiswa.

IMIHLA YOKUZWA IZIVIVINYO
Lo mbhalo ubukeza amadivayisi nobuchwepheshe obukhona njengamanje kubathengi neziguli. Izinketho ezethulwe kulo mbhalo azihlanganisi amadivayisi angafakelwa amandla (isib. Ukufakelwa okuhlanganisiwe, ukufakwa kwendlebe okuphakathi, njll.). Njengamanje, amadivayisi we-OTC awekho ngakho-ke ifomu lawo, umsebenzi, izindleko, izimfanelo zokusebenza, noma umthelela wazo ku-audiology.
I-Hearing Aid: Imithetho ye-FDA ichaza insiza yokuzwa njenge "noma iyiphi insimbi engahlelekile noma ithuluzi elenzelwe ukuhlinzekelwa, noma elethwe njengabantu abasizayo nabanxephezela, abalalele ukuzwa" (21 CFR 801.420). Izinsizakusezwa zilawulwa yi-FDA njengamadivayisi ezokwelapha we-Class I noma Class II futhi zitholakala kuphela kubahlinzeki abanamalayisense. Izinsizakuzwa zingahle zinconyelwe abantu abathobeke kancane ekulahlekelweni kwezindlebe okukhulu futhi kungenziwa ngezifiso umhlinzeki.
Imikhiqizo Yokukhulisa Umsindo Womuntu (i-PSAP): Ama-PSAPs angamadivayisi we-elekthroniki aphathekayo, enzelwe ukukhulisa ukulalela ezindaweni ezithile (ukungasebenzisi isikhathi esigcwele). Ngokuvamile zenzelwe ukuhlinzeka ngemisindo ethile yezemvelo kodwa ngenxa yokuthi azilawulwa yi-FDA, azikwazi ukuthengiswa njengamadivayisi asiza abantu abalahlekelwe ukuzwa. I-FDA iphakamisa ukuthi izibonelo zezimo lapho ezisetshenziswa kakhulu ama-PSAP zifaka ukuzingela (ukulalela inyamazane), ukubuka izinyoni, ukulalela izinkulumo ngesipika esikude, kanye nokulalela imisindo ethambile okungaba nzima ngayo ukuzwa ngabantu abajwayelekile (isib. izingxoxo ezikude) (FDA Draft Guidance, 2013). Ama-PSAP atholakala manje ukuthi athengwe ngumthengi ezindaweni ezithengisayo ezahlukahlukene, kufaka phakathi abathengisi abakulayini. Ama-Audiologists angathengisa ama-PSAP.
Amadivayisi okulalela ayisizayo (i-ALD), Amasistimu wokulalela awusizo (i-ALS), amadivayisi wokuqwashisa: Ngokubanzi, isigaba samadivayisi asiza umuntu ekulahlekelweni kokuzwa ukuphatha izindawo ezithile zokulalela noma izimo lapho amadivaysi evamile enganele noma engafanele. Ama-ALD noma ama-ALS angasetshenziswa emsebenzini, ekhaya, ezindaweni okuqashwa kuzo noma ezindaweni zokuzijabulisa, futhi singasetshenziselwa ukuthuthukisa isilinganiso somsindo, ukuphikisana nomphumela webanga, noma sinciphise umphumela we-acoustics emnyama (isib. Ukuphindiselwa emuva. ) Lawa madivayisi angasebenza owomuntu siqu noma amaqembu (indawo ebanzi). Amadivayisi wokwazisa ngokuvamile asebenzisa ukukhanya, umsindo omkhulu noma ukudlidliza ukuxhuma noma ukusayina umuntu olahlekelwe ngokuzwa mayelana nezehlakalo ezenzeka endaweni yabo, futhi kungaxhunywa ngocingo, amalambu, izingqongqo zomnyango, ama-alamu omusi, njll. I-FDA ayilawuli i-ALDs, ALS, noma ukuqwashisa amadivaysi, noma amanye amadivaysi, njengezingcingo ezifakiwe, kungadingeka ukuthi athobele imithetho ye-FCC. Lawa madivayisi angathengwa ngezitolo ezithengisa izinto ezitolo, on-line, kanye nemikhuba ye-audiology. Kwezinye izimo, lawa madivayisi atholakala ngezindleko ezincishisiwe ngokusebenzisa izinhlaka zikahulumeni.
Izesekeli zokuzwa ezingenazintambo: Kukhona izesekeli eziningi ezikhona namuhla eziklanyelwe ukuxhasa usizo lokuzwa, ukuthuthukisa ukuxhumana, noma ukusebenzisa ezinye izindlela zokuxhumana. Izesekeli zifaka amadivaysi avumela izilaleli ukuthi zisakaze ngokuqondile imininingwane kusuka ocingweni noma kwenye insiza yokulalela yomuntu (isb. Ithebhulethi, ikhompyutha, isifundi se-efa) kanye nemakrofoni eqhelile noma ye-lapel esiza isilaleli ukuzwa amabanga amade (isib.
I-copyright 2018. I-American Academy of Audiology. www.audiology.org. 5
amagumbi okufundela, amakamelo ezinkomfa kanye namahholo ezinkulumo). Izesekeli zosizo lokuzwa ngokuvamile zithengwa ngemikhuba ye-audiology, kepha futhi iyatholakala ngezitolo ezithengisayo.
Okuzwakalayo: Okuzwakalayo yinoma yiliphi idivaysi elenziwa izindlebe elenzelwe ukungeza nokuthuthukisa isipiliyoni sokulalela, noma okubandakanya izici ezifana nokubheka izimpawu ezibalulekile (isb. Ukushaya kwenhliziyo, izinga lokushisa lomzimba, amazinga we-oksijini wegazi, njll.), Ukulandelela umsebenzi (isib. Izinyathelo, amakhalori ashiswa, njll.), ukuzwa okungathandiswanga (kuvumela abasebenzisi ukuthi bahlunge noma bengeze imisindo ethile), ukusakazwa komculo, ukuhumusha ulimi, noma ukuxhumana okubonakalayo kobuso.

I-copyright 2018. I-American Academy of Audiology. www.audiology.org. 4

Landa ISIQONDISO SE-AUDIOLOGIST SOKUZWA I-AIDS, ama-PSAP, IZIMPILO NEZIVIVINYO ZE-OTC [PDF]