"Uphawu loNcedo lokuva" (HAF): ISoftware yokuqala ye-OTC yokuNceda ifumana uGunyaziso lwe-FDA 

"Inkalo yoNcedo lokuva" (HAF), isoftware yokuqala ye-OTC yokuncedisa ukuva ifumene isigunyaziso sokuthengisa yi-FDA. Ii-headphones ezihambelanayo ezifakwe nale software zisebenza njengesixhobo sokuva ukukhulisa izandi kubantu abangeva kakuhle ukuya kwephakathi. Uncedo lweengcali ezingevayo ezifana ne-audiologist ayidingeki ukuba wenze ngokwezifiso isoftware/isixhobo ukuhlangabezana neemfuno zokuva.   

I-FDA igunyazise isoftware yokuqala yokuncedisa ukuva (i-OTC). Nje ukuba ifakwe kwaye yenziwe ngokwezifiso kwiimfuno zokuva zomsebenzisi, isoftware yenza ukuba ii-headsets ezihambelanayo "ze-Apple AirPods Pro" zisebenze njengesixhobo sokuva ukukhulisa izandi zabantu abangeva kakuhle ukuya kwephakathi.  

Ebizwa ngokuba “yiNgxelo yoNcedo lokuva” (HAF), sisicelo sezonyango esiphathwayo esisetwa kusetyenziswa isixhobo se-iOS (umzekelo, i-iPhone, i-iPad). Emva kokuseta isoftware kwiinguqulelo ezihambelanayo ze-AirPods Pro, abasebenzisi banokuhlengahlengisa umthamo, ithoni kunye nesetingi sokulinganisela ukusuka kwi-iOS HealthKit. Uncedo lwengcali yokuva akufunekanga ukuba wenze ngokwezifiso isoftware/isixhobo ukuhlangabezana neemfuno zokuva.     

Ugunyaziso lokuthengisa lwe-OTC "Inkalo yoNcedo lokuva" kwi-Apple Inc. yayisekelwe kuvavanyo lweklinikhi kuphononongo kwiindawo ezininzi e-USA. Uphononongo luqhathanise i-"HAF self-fitting approach" kunye nendlela yokufaneleka yobungcali. Iziphumo zibonise ukuba akukho miphumo emibi kwaye abantu abakuwo omabini amaqela bafumana izibonelelo ezifanayo ezibonwayo ngokwemigaqo yokukhulisa isandi kunye nokuqonda intetho.  

Olu phuhliso lulandela i-FDA ye-OTC yemimiselo yokuncedisa ukuva eyaqala ukusebenza ngo-2022. Lo mgaqo uxhobise abantu abanelahleko ephakathi ukuya kwephakathi ukuya kokunciphisa ukuva ukuthenga izixhobo zokuva ngokuthe ngqo kwiivenkile okanye abathengisi be-intanethi ngaphandle kwesidingo sovavanyo lwezonyango, umyalelo okanye ukubona i-audiologist. . 

Ukulahlekelwa kukuva yingxaki enkulu yezempilo yoluntu kwihlabathi liphela. E-USA kuphela, abantu abangaphezu kwezigidi ezingama-30 banengxaki yokulahlekelwa kukuva ngandlela ithile. Le meko yaziwa ngokuba inxulunyaniswa nokuncipha kokuqonda, ukudakumba kunye nezinye iimeko zempilo phakathi kwabantu abadala.

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Imithombo:  

1. Ukukhutshwa kweendaba ze-FDA-i-FDA igunyazisa iSoftware yoNcedo lokuva yokuQala ngaphezulu kwe-Counter. Ipapashwe nge-12 Septemba 2024. Ifumaneka e https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software  

2. Ukukhutshwa kwe-Apple Press - i-Apple yazisa iimpawu zezempilo ezisisiseko ukuxhasa iimeko ezichaphazela izigidigidi zabantu. Ipapashwe nge-09 Septemba 2024. Ifumaneka e https://www.apple.com/in/newsroom/2024/09/apple-introduces-groundbreaking-health-features/  

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