I-“Hearing Aid Feature” (HAF), isofthiwe yosizo lokuzwa yokuqala ye-OTC ithole ukugunyazwa kokumaketha yi-FDA. Ama-headphone ahambisanayo afakwe nale softhiwe asebenza njengensiza yokuzwa ukuze akhulise imisindo kubantu abanenkinga yokuzwa emaphakathi kuya kophakathi. Usizo lwengcweti yokuzwa efana ne-audioologist ayidingekile ukwenza isofthiwe/idivayisi ngokwezifiso ukuze ihlangabezane nezidingo zokuzwa.
I-FDA igunyaze isofthiwe yokuqala yosizo lokuzwa (i-OTC). Uma isifakiwe futhi senziwe ngendlela oyifisayo izidingo zokuzwa zomsebenzisi, isofthiwe yenza izinguqulo ezihambisanayo zamahedfoni e-“Apple AirPods Pro” asebenze njengesizo sokuzwa ukuze akhulise imisindo yabantu abanenkinga yokuzwa emaphakathi kuya kophakathi.
Ibizwa ngokuthi “Isici Sosizo Lokuzwa” (HAF), iwuhlelo lokusebenza lwezokwelapha oluphathwayo lwesofthiwe kuphela olusethwa kusetshenziswa idivayisi ye-iOS (isb, i-iPhone, i-iPad). Ngemva kokusetha isofthiwe ezinguqulweni ezihambisanayo ze-AirPods Pro, abasebenzisi bangalungisa ivolumu, ithoni nezilungiselelo zebhalansi ku-iOS HealthKit. Usizo lwengcweti yokulalela aludingeki ukuze wenze ngendlela oyifisayo isofthiwe/idivayisi ukuze ihlangabezane nezidingo zokulalela.
Ukugunyazwa kokumaketha kwesofthiwe ye-OTC "Yesici Sosizo Lokuzwa" eya ku-Apple Inc. kwakusekelwe ekuhlolweni kwayo komtholampilo ocwaningweni olusezindaweni eziningi e-USA. Ucwaningo luqhathanise “indlela ye-HAF yokuzilinganisa” nendlela yokufaka umsebenzi. Okutholakele akuzange kubonise imiphumela emibi futhi abantu kuwo womabili amaqembu bathola izinzuzo ezifanayo ezicatshangwayo mayelana nokukhulisa umsindo nokuqonda inkulumo.
Lokhu kuthuthukiswa kulandela imithetho ye-FDA ye-OTC yosizo lokuzwa eyaqala ukusebenza ngo-2022. Lo mthetho unike amandla abantu abanokulahlekelwa ukuzwa okucatshangwayo okumaphakathi kuya kokuphakathi ukuze bathenge izinsiza-kuzwa ngokuqondile ezitolo noma ezitolo eziku-inthanethi ngaphandle kwesidingo sokuhlolwa kwezokwelapha, incwadi kadokotela noma ukubona udokotela wokuzwa. .
Ukulahlekelwa ukuzwa kuyinkinga enkulu yezempilo yomphakathi emhlabeni wonke. E-USA kuphela, abantu abangaphezu kwezigidi ezingu-30 bahlushwa izinga elithile lokungezwa. Lesi simo kwaziwa ukuthi sihlotshaniswa nokwehla kokuqonda, ukudangala kanye nezinye izimo zempilo phakathi asebekhulile abantu.
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Imithombo:
- Ukukhishwa kwezindaba ze-FDA - I-FDA Igunyaza Isofthiwe Yokusiza Ukuzwa Yokuqala Ngaphezu Kwe-Counter. Ishicilelwe ngomhla ka-12 Septhemba 2024. Itholakala e- https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software
- Ukukhishwa kwe-Apple Press - I-Apple yethula izici zezempilo ezihamba phambili ukusekela izimo ezithinta izigidigidi zabantu. Ishicilelwe ngomhla ka-09 Septhemba 2024. Itholakala e- https://www.apple.com/in/newsroom/2024/09/apple-introduces-groundbreaking-health-features/
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