"Hearing Aid Feature" (HAF), yekutanga OTC yekubatsira kunzwa software yakagamuchira mvumo yekushambadzira neFDA. Mahedhifoni anowirirana akaiswa nesoftware iyi anoshanda seyamuro yekunzwa kukwidziridza manzwi kune vanhu vane hunyoro kusvika pakati nepakati kusanzwa. Rubatsiro rwenyanzvi yekunzwa senge audiologist haidiwi kugadzirisa software/mudziyo kuti usangane nezvido zvekunzwa.
FDA yakabvumidza yekutanga-over-the-counter (OTC) yekubatsira kunzwa software. Kana yangoiswa uye yagadziridzwa kune zvinodiwa pakunzwa kwemushandisi, software inogonesa shanduro dzinoenderana dze "Apple AirPods Pro" mahedhifoni kuti ashande seyamuro yekunzwa kukwidziridza ruzha rwevanhu vane hunyoro kusvika pakati nepakati kusanzwa.
Inonzi "Hearing Aid Feature" (HAF), isoftware-chete mobile medical application iyo inomisikidzwa uchishandisa iOS mudziyo (semuenzaniso, iPhone, iPad). Mushure mekugadzira software pane inowirirana shanduro yeAirPods Pro, vashandisi vanogona kugadzirisa vhoriyamu, toni uye chiyero marongero kubva kuIOS HealthKit. Kubatsira kwenyanzvi yekunzwa hakudiwi kugadzirisa software/mudziyo kuti usangane nezvido zvekunzwa.
Mvumo yekushambadzira yeOTC "Hearing Aid Feature" software kuApple Inc. yaive yakavakirwa pakuongorora kwayo kwekiriniki muongororo munzvimbo dzakawanda muUSA. Chidzidzo ichi chakaenzanisa "HAF self-fitting approach" nenyanzvi yekukodzera maitiro. Zvakawanikwa hazvina mhedzisiro yakaipa uye vanhu vari mumapoka maviri aya vakawana mabhenefiti akafanana maererano nekusimudzira inzwi uye kunzwisisa kwekutaura.
Kubudirira uku kunotevera mitemo yeFDA's OTC yerubatsiro yakatanga kushanda muna 2022. Mutemo uyu wakapa simba kuvanhu vane pfungwa dzakapfava kusvika pakati pekurasikirwa kwekunzwa kuti vatenge zvinoyamura kunzwa zvakananga kubva kuzvitoro kana vatengesi vepamhepo pasina chikonzero chekuongororwa kwechiremba, kunyorerwa kana kuona chiremba wezvekunzwa. .
Kurasika kwekunzwa idambudziko guru rehutano hweveruzhinji pasi rese. MuUSA chete, vanhu vanopfuura mamirioni makumi matatu vanotambura nekutadza kunzwa. Ichi chiitiko chinozivikanwa kuve chakabatana nekuderera kwekuziva, kushushikana uye mamwe mamiriro ehutano pakati vakwegura vanhu.
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Sources:
- FDA Nhau kuburitswa - FDA Inobvumidza Chekutanga Pamusoro-the-Counter Hearing Aid Software. Yakabudiswa 12 September 2024. Inowanikwa pa https://www.fda.gov/news-events/press-announcements/fda-authorizes-first-over-counter-hearing-aid-software
- Apple Press kuburitswa - Apple inoburitsa zvinokatyamadza hutano maficha kutsigira mamiriro ari kukanganisa mabhiriyoni evanhu. Rakabudiswa musi wa09 Gunyana 2024. Inowanikwa pa https://www.apple.com/in/newsroom/2024/09/apple-introduces-groundbreaking-health-features/
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