Kusukela kudlula umthetho we-Over-the-Counter Hearing Aid Act ka-2017 iFood and Drug Administration (FDA) ibilokhu isebenza ukwenza imithetho mayelana nalesi sigaba esisha sedivayisi yokuzwa. Amadivayisi we-OTC ngqo kubantu abalahlekelwe izindlebe awakabi semakethe. Uma ucabanga ukuthenga ngedivayisi ethi ikulesi sigaba esisha, umthengi qaphela. Isinyathelo esilandelayo kuzoba iSaziso seProposition Rule (NPRM) esikhishwe yi-FDA, silandelwe isikhathi sokuphawula esivulekile bese kuba yimithetho yokugcina. Ngemuva kokuba imithetho yokugcina ikhona, usadinga ukuba ngumthengi ofundile: funda konke ongakwenza mayelana nedivayisi ngaphambi kokuthenga.

Ukuhunyushwa komthethosivivinywa wosizo lokuzwa we-FDA OTC-liyini ikusasa lezinsiza-kusebenza ze-OTC?

Muva nje, "Ingqungquthela Yezimboni Yezindlebe Zokuzwa Okusetshenziswayo Yama-2019", exhaswe yiBeijing Science and Technology Association futhi ihlelwe ngokubambisana yiKomidi Lezimboni Zokuzwa, iphethwe ngempumelelo eSuzhou. Balinganiselwa ngaphezu kwama-200 abafaka izinsiza zokuzwa, abasebenza ezitolo, izimenenja zabakhiqizi nabasabalalisi basekhaya nabangaphandle abasuka ezweni lonke abebehambele le ngqungquthela. Ingqungquthela yathatha izinsuku ezintathu. Le ngqungquthela ibandakanya umhlangano wamalungu amancane, isidlo sakusihlwa, isithangami sabezindaba esibalulekile, izinkundla zezindikimba ezi-3, isifundo samacala, izinkundla zamatafula ayisiyingi ezi-4, kanye nokuvakashelwa okubumbene okungu-2. Ingqikithi yezihloko ezingama-2 Izikhulumi nezivakashi eziyi-20 zesithangami setafula eliyindilinga zenze ukwabelana okuhle.

Ekuseni ngoNovemba 16th, esithangamini setimu se- "Service Concept" engqungqutheleni ye-2019 New Audience Hearing Summit, u-Adnan Shennib wabelane ngenkulumo yosuku enesihloko esithi "Lihamba kanjani ikusasa lezinsiza-kuzwa ze-OTC?"
Ngokukhethekile faka: Amakhethini nezinqubomgomo zokusiza kokuzwa kwe-US OTC / DTC, izithiyo ezinkulu ezithinta ukuthengisa kosizo lokuzwa, ukuhunyushwa koMthetho we-OTC ka-2017, isimo samanje semakethe yase-US OTC / DTC, ukuthi abalaleli / abafanelekayo baphendula kanjani emakethe ye-OTC, izinsiza zokuzwa ze-OTC ezizayo, njll.

Okokuqala uMnu. Adnan wachaza imiqondo ye-OTC ne-DTC. I-DTC: I-Direct-To-Consumer. Kungokwesigaba sezinsiza zokuzwa, futhi abasebenzisi badinga ukusayina i-medical waiver (Medical waver) ngaphambi kokuthi bathenge ngqo kwi-Intanethi, emakhemisi nakwezinye iziteshi. I-OTC: I-Over-The-Counter. Izinsiza zokuzwa ezikulesi sigaba zingathengwa ngqo kwi-Intanethi, emakhemisi nakwezinye iziteshi ngaphandle kokuxolelwa kwezokwelashwa.
Umgomo Wokusizwa Kwe-US
Izinsizakusezwa zingamadivayisi ezokwelapha alawulwa yi-FDA. Izinsizakusebenza eziningi zokuzwa zidayiswa ngababukeli / abalaleli. Abasebenzisi abafuna ukuthenga izinsiza zokuzwa ezivela kubalaleli / abahloli bama-inthanethi, emakhemisi, njll. Kudingeka basayine i-waiver yezokwelapha. Ngenxa yalolu hlobo lokuthengisa olusimboziwe, ukuthuthukiswa kweziteshi ezithengiswayo ngqo bekungathandeki.
U-Chuanpu wasayina umthethosivivinywa ohlobene ne-OTC wezinsiza zokuzwa ngo-2017, kodwa i-FDA ayizange imemezele isigaba sosizo lwe-OTC, ngakho-ke abathengisi abakakwazi ukuthengisa ngaphansi kwegama elithi "izinsiza zokuzwa ze-OTC".

Isithiyo esikhulu kunazo zonke ekuthengisweni kwezinsiza zokuzwa

Intengo ephakathi yokuthengisa yezinsiza zokuzwa e-United States ingama- $ 2400, kanti inani eliphansi lokufakwa kwezixhobo zokuzwa liyi-14-20% kuphela. Lezi zinto ziholele abasebenzisi ukuthi bakhethe ukuthenga ama-PSAPs asiza uqobo imikhiqizo yokulalela. (I-Personal Sound amplfication China ibhekisa kuma-PSAPs njengezikhulisi zomsindo)

Ukuhunyushwa koMthetho we-OTC wango-2017

Kusho ukuthini umthetho we-OTC Act 2017?

Izinsizakusebenza zokuzwa ezikwelashweni eziseduze zizothengiswa ngqo kubasebenzisi. I-FDA izothuthukisa ukuhlukaniswa komkhiqizo omusha bese ibeka amazinga omkhiqizo wezinsiza-kusebenza ze-OTC.

Kungani kungasayinwa umthethosivivinywa we-OTC?

Izinsiza-kuzwa ze-OTC zinganciphisa izindleko zabathengi ukuthola izinsiza-kuzwa; ukwandisa iziteshi zabathengi ukuze bathenge izinsiza-kuzwa; khuthaza ukuzalwa kwemikhiqizo nezinsizakalo ezintsha.

Uqala nini ukusebenza lo mthethosivivinywa?

Lo Mthetho wasayinwa ngo-Agasti 2017, kanti i-FDA izophothula wonke umsebenzi ofanele ukuze kusizakale izinsiza-kuzwa ze-OTC kungakapheli unyaka ka-2020. Imboni yezinsiza-kuzwa iphendule kabi kakhulu, kodwa abakwazanga ukunikeza isixazululo esingcono, ngakho-ke umthethosivivinywa wedlula ngaphandle kwezihibe.

Isimo semakethe yase-US OTC / DTC

"Izinsiza-kuzwa ze-OTC" azikavulwa emakethe yase-US, kepha abathengisi bakulangazelele ukuhamba ngokuzayo. Ngakolunye uhlangothi, abathengisi be-inthanethi basebenzela ukuthuthukisa futhi banikeze ama-PSAP aphelele. Eminye imikhiqizo isivele isekela ubuchwepheshe obudumile obuqhamukayo njengokufakwa kude. Ngakolunye uhlangothi, i-CVS, i-COSTCO - njengezilwane zasekhemisi zaseMelika sethule ukuthengiswa kwama-PSAP. Izinsiza-kuzwa ze-OTC zizokwethulwa ngokuzayo.
Abathengisi beCable / Online babika ukukhula konyaka wama-46%. Amandla ale makethi asafufusa asemakhulu, futhi kulinganiselwa ukuthi ukukhula konyaka kwamanje kungama-20-30%.

Abadlali abakhulu emakethe ye-OTC / DTC

I-CVS neBeurer, izinsiza zokuzwa ze-NANO zinganikeza ubuchwepheshe obusha obuphambili nemikhiqizo yemakethe ye-OTC / DTC. Abadlali abakhulu embonini yabathengi bama-elekthronikhi, njengeBOSE, nabo bamemezele ukungena kwabo emakethe ye-OTC / DTC.

Umthelela wemakethe ye-OTC / DTC

Imakethe ye-OTC izoba nomthelela omkhulu embonini nakubathengi, futhi ezinye izinguquko zizohambisa amandla aphelele we-OTC / DTC. Umthelela osobala kakhulu ukuthi abathengi bangathola izinsiza zokuzwa zamanani aphansi, nemikhiqizo yokusiza kakhulu esezingeni eliphakeme izogibela iziteshi ezivele nezimakethe.

UMongameli wase-US uTrump usayine Umthetho Wezokudla Nokuphathwa Kwezidakamizwa wonyaka we-2017, okubandakanya Umthetho we-OTC OTC Aid ozobandakanya izinsiza zokuzwa emikhiqizweni ye-OTC OTC. Ngemuva kokuthi umthetho uqale ukusebenza, abantu abadala abanokulahlekelwa okukuzwa okulinganiselwe okulinganiselwe bangathenga izinsiza zokuzwa ze-OTC ngqo.
Ngaphambi kwalokhu, noma yisiphi isiguli esikhubazekile ezindlebeni e-United States kufanele sikhethwe futhi sihlonyiselwe izinsiza zokuzwa ngabasebenza ukunakekela okungezwakali ochwepheshe.
Lokhu futhi kusho ukuthi izinsiza zokuzwa sezishintshile zivela konkulunkulukazi besilisa / abesifazane ababanda kakhulu abafakwa kumphakathi jikelele baba abangane abanomusa nabanobungane eduze kwalapho. Abantu abaningi ngokwengeziwe bazoba nethuba lokuthola izinsiza zokuzwa futhi bafunde ukuthi kungasiza kanjani ukuzwa abangane abalimele ukuba banqobe ukuphazamiseka empilweni futhi bathuthukise ikhwalithi yempilo!

Impendulo yezimboni ezinsizeni zokuzwa ze-OTC

Kuyathandeka. Ngenxa yokuthi izinsiza zokuzwa ze-OTC zinesiteshi esibanzi sokuthengisa, lokhu kusho ukuthi abathengi abaningi abazobe bekubona ukulahleka kokuzwa, futhi ngokungaqondile, kuzophinda kuholele ekuqondeni kwezikezi zokuzwa / zokuzwa. Futhi ochwepheshe bokuzwa / abafundela usizo lokuzwa abalungele izizinda eziqeqeshiwe bazoba nezwi eliyinhloko ekwakhiweni kwemikhiqizo emisha esiteshini se-OTC.

Ungabhekana kanjani nemakethe ye-OTC?

Ukuqhuma kwemakethe ye-OTC kusho ukuthi ama-audiologists / fitters angasebenzisa ulwazi lwabo lochwepheshe kanye nesipiliyoni esicebile sokubamba iqhaza ekwakhiweni nasekukhiqizweni kwemikhiqizo ye-OTC, ngasikhathi sinye babambe iqhaza ocwaningweni lokuhlolwa kwasemtholampilo lwangaphambi kwemakethe, noma bahlinzeke ngemikhiqizo ye-OTC yobungcweti. Ukuzwa Ngezinsizakalo Zokuzwa.


Ukubhekana nemakethe ye-OTC, imikhiqizo yosizo lokuzwa ayikakulungeli. Imikhiqizo ekhona ayifanele ngokuphelele emakethe ye-OTC. Yize sekuqhamuke amasu ahlukahlukene embonini yosizo lokuzwa eminyakeni eyisi-5 eyedlule, lobu buchwepheshe abukwazanga ukukhuthaza ukukhula okuqhamukayo komkhakha wosizo lokuzwa. Abathengi bafuna imikhiqizo emisha nezinto ezintsha.
Akuhlangene namanani, iziteshi kanye nobuchwepheshe, kepha kuvela ezinqubweni zomqondo zomphakathi mayelana nezinsiza-kuzwa. Abasebenzisi bosizo lokuzwa bachazwa njengokuguga nokungezwa kahle, okubeka umkhawulo omkhulu ekukhuleni kwangaphandle kwezinsiza-kuzwa. Ngakho-ke, abanikazi bomkhiqizo kufanele baqale ngezidingo zomsebenzisi futhi bethule amadizayini amasha, amadizayini ahlukahlukene asebenzayo, noma banikeze imisebenzi eyengeziwe ngaphezu "kokulalela."
UMnu Adnan, esebenzisa imikhiqizo egqokekayo njengesibonelo, uchaze ukuthi ukwenza abasebenzisi ukuthi balangazelele ubunini kubaluleke kakhulu kunokuba ngumnikazi. Ungazenza kanjani izinsiza-kuzwa zisuse izinkolelo-ze futhi ube “ubuchwepheshe obuphezulu” futhi ube “nempilo” kufanelekile ukucatshangelwa ngemikhiqizo yosizo lokuzwa.

Kungenzeka ukuthi kuthuthukiswe usizo losizo lokuzwa kwesizukulwane esilandelayo

Ubuchwepheshe obukhona obukhona bezinsiza zokuzwa abukakwazi okwamanje ukuxhasa izidingo zokuthuthuka zezinsiza zokuzwa ze-OTC ezintsha; ubuchwepheshe obukhona buxazulula "isidingo sokuzwa" futhi buzibe "ukuzwa kokuzwa"; ukungeza eminye imisebenzi (njengokuqapha ezempilo)) Kungashintsha ngempumelelo imibono eyeqisayo yabathengi mayelana nezinsiza-kuzwa.

Umhlinzeki osiza kakhulu wezindlebe we-OTC eChina

I-Huizhou Jinghao Medical Technology CO., LTD. iyona kuphela ebhalwe uhlu lwezinsiza zokuzwa / yokuphakamisa izindlebe eChina, idume ngokuhlinzeka ngezinsizakalo ezinhle nezinsizakalo ezinhle zokuzwa.
I-Jinghao Medical idlule i-BSCI, i-ISO13485, i-ISO9001, i-C-TPAT, i-SQP, i-CVS HEALTH njll audit, nayo yonke imikhiqizo enezitifiketi ze-CE, RoHS, FDA. Ngabanjiniyela abangaphezu kuka-30 abanolwazi ngomnyango we-R & D, uJinghao unamandla okwenza iphrojekthi ye-ODM ne-OEM.
Amakhasimende Asejwayelekile Ozwela Usizo Amakhasimende afaka i-CVS HEALTH, BEURER, AEON (JAPAN), njll.

Ngamafuphi

Amandla emakethe ye-OTC / DTC makhulu. Umkhakha wokukhiqiza izinsiza zokuzwa awutholi ukuthola umkhiqizo ophendula ngempela. Ukuxazulula izingqinamba zabathengi kuyisidingo sokukhula kwemakethe ephezulu. Ukuphumelela kuphela kubuchwepheshe obukhulu kungadala imikhiqizo emisha futhi kuvule imakethe ye-OTC.

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