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 "Likanjani ikusasa le-OTC izinsiza zokuzwa hamba? ”
Ngokukhethekile faka: Amathrendi nezinqubomgomo zosizo lokuzwa zase-US OTC / DTC, izithiyo ezinkulu ezithinta ukuthengiswa kosizo lokuzwa, ukutolikwa koMthetho we-2017 OTC, isimo samanje semakethe yase-US OTC / DTC, ukuthi abaphenduli bezwi / abafaki baphendula kanjani emakethe ye-OTC, isizukulwane esilandelayo i-OTC izinsiza zokuzwa, njll. .

Okokuqala uMnu u-Adnan uchaze imiqondo ye-OTC ne-DTC. I-DTC: Qondisa-Kumthengi. Kungokwesigaba se izinsiza zokuzwa, futhi abasebenzisi badinga ukusayina i-waiver yezokwelapha (Medical waver) ngaphambi kokuthi bakwazi ukuthenga ngqo kwi-Intanethi, emakhemisi nakwezinye iziteshi. I-OTC: Ngaphezulu kwe-The Counter. Izinsiza-kuzwa kulesi sigaba zingathengwa ngqo kwi-Intanethi, emakhemisi nakwezinye iziteshi ngaphandle kokuxolelwa kwezokwelapha.
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

"I-OTC izinsiza zokuzwa”Azikavulwa emakethe yase-US, kodwa abathengisi bakulangazelele ukuhamba ngokuzayo. Ngakolunye uhlangothi, abathengisi abakwi-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. OTC izinsiza zokuzwa izokwethulwa 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 ne-Beurer, i-NANO izinsiza zokuzwa ingahlinzeka ngobuchwepheshe obusha kanye nemikhiqizo emakethe ye-OTC / DTC. Abadlali abakhulu embonini ye-electronics yomthengi, njenge-BOSE, nabo bamemezele ukungena kwabo emakethe ye-OTC / DTC.

Umthelela wemakethe ye-OTC / DTC

Imakethe ye-OTC izoba nomthelela omkhulu embonini nakubathengi, kanti ezinye izinguquko zizoqhuba amandla aphelele we-OTC / DTC. Umthelela osobala kakhulu ukuthi abathengi bangathola intengo ephansi izinsiza zokuzwa, kanye nemikhiqizo yezinsizakuzwa esezingeni eliphakeme izogcwala iziteshi nezimakethe ezivelayo.

UMongameli Trump wase-US usayine i-Food and Drug Administration Reauthorization Act ka-2017, efaka i-OTC OTC Hearing Aid Act ezobandakanya izinsiza zokuzwa kumikhiqizo ye-OTC OTC. Ngemuva kokuthi umthetho uqale ukusebenza, abantu abadala abanokulahleka kokuzwa okuphakathi kuya kokulingene bangathenga i-OTC izinsiza zokuzwa 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

Izintandokazi. Ngoba i-OTC izinsiza zokuzwa babe nesiteshi esibanzi sokuthengisa, lokhu kusho ukuthi abathengi abaningi abangaba khona bazobona ukulahleka kwezindlebe, futhi ngokungaqondile, kuzophinde kuqhube nombono wezinsiza zokuzwa / zokuzwa. Futhi ukuzwa ochwepheshe / usizo lokuzwa lufanele ochwepheshe abanezizinda 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 zokuzenzisa zomphakathi mayelana izinsiza zokuzwa. Abasebenzisi bosizo lokuzwa bachazwa njengokuguga nokungezwa kahle, okunciphisa kakhulu ukukhula kwangaphandle kwe izinsiza zokuzwa. 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 balangazelele ubunini kubaluleke kakhulu kunokuba ngumnikazi. Indlela yokwenza izinsiza zokuzwa lahla izinkolelo-ze futhi ube “ubuchwepheshe obuphakeme” futhi ube “nempilo” kufanelekile ukucatshangelwa ngemikhiqizo yosizo lokuzwa.

Kungenzeka ukuthi kuthuthukiswe usizo losizo lokuzwa kwesizukulwane esilandelayo

Ubuchwepheshe obukhona obukhona be- izinsiza zokuzwa okwamanje ayikwazi ukuxhasa izidingo zokuthuthukiswa kwe-OTC entsha izinsiza zokuzwa; ubuchwepheshe obukhona buxazulula "isidingo sokuzwa" futhi buzibe "ukuzwa kokuzwa"; ukungeza eminye imisebenzi (njengokuqapha ezempilo)) Kungashintsha ngempumelelo izinkolelo-ze zabathengi mayelana izinsiza zokuzwa.

Umhlinzeki osiza kakhulu wezindlebe we-OTC eChina

I-Huizhou Jinghao Medical Technology CO., LTD. nguyena kuphela obhalwe ohlwini izinsiza zokuzwa/ umkhiqizi wesikhulisi sokuzwa eChina, adume ngokuhlinzeka ngekhwalithi enhle nentengo enhle izinsiza zokuzwa/ i-amplifier yokuzwa.
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.
I-OTC ejwayelekile Izinsizakuzwa 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.

搜索结果 10:

Khombisa ibha eseceleni