Kubva pakapfuura chikamu cheOperation the Hearing Aid Act ye 2017 iyo Chikafu uye Dhigavhu Administration (FDA) yanga ichishanda kugadzira mirau zvine chekuita neiyi nyowani nyowani yekushandisa kunzwa. OTC zvishandiso zvakanangana nevanhu vane kunzwa kuderera havasati vari pamusika. Kana iwe uri kufunga nezvekutenga chishandiso icho chinonzi chiri muchikamu ichi chitsva, mutengi chenjera. Nhanho inotevera ichave Chiziviso cheProposed Rule Kuita (NPRM) chakaburitswa neFDA, ichiteverwa nenguva yakajeka yekutaura uye ipapo yekupedzisira mitemo. Mushure mekunge mitemo yekupedzisira yavapo, iwe uchiri kuda kuve mutengi anodzidziswa: dzidza zvese zvaunogona nezve mudziyo usati watenga icho.

Kududzirwa kweiyo FDA OTC bumbiro rekubatsira bhiri-iri ramangwana rei OTC yekubatsira?

Munguva pfupi yapfuura, iyo "2019 New Audiovisual Hearing Industry Summit", inotsigirwa neBeijing Science uye Technology Association uye yakabatanidzwa neKunzwa Services Industry Committee, yakabudirira kupedza muSuzhou. Vanopfuura mazana maviri vanogamuchira rubatsiro rwekunzwa, vashandisi vezvitoro, mamaneja evanogadzira epamba uye vekunze nevashambadziri vanobva kumatunhu ese enyika vakapinda musangano uyu. Musangano uyu wakatora mazuva matatu. Musangano uyu waisanganisira musangano mudiki wenhengo, chisvusvuro, musangano wakakosha wenhau, maforamu mana ezvinyorwa, nyaya yekudzidza, 200 maforamu etafura eround, uye 3 kushanya kwemakambani. Yakazara yemisoro makumi maviri Vatauri nevashanyi gumi veforamu yetafura yekutenderera vakaita kugovana kunoshamisa.

Mangwanani aNovember 16th, mumusangano wenyaya we "Service Concept" ku2019 New Audience Hearing Industry Summit, Adnan Shennib akagovana hurukuro yekutaura yakanzi "Ko ramangwana reOTC kunzwa rubatsiro enda? ”
Kunyanya sanganisira: US OTC / DTC yekunzwa rubatsiro maitiro uye marongero, zvipingamupinyi zvikuru zvine chekuita nekutengesa rubatsiro rwekunzwa, kududzirwa kwe2017 OTC Act, mamiriro azvino emusika weUS OTC / DTC, ma audiologists / fitters anopindura sei kumusika weOTC, chinotevera-chizvarwa OTC kunzwa rubatsiro, nezvimwe. .

Kutanga Mr. Adnan akatsanangura pfungwa dzeOTC uye DTC. DTC: Direct-Ku-Mutengi. Iyo ndeyechikamu che kunzwa rubatsiro, uye vashandisi vanofanirwa kusaina waiver yekurapa (Medical waver) vasati vatenga zvakananga paInternet, ma pharmist uye dzimwe nzira. OTC: Pamusoro-Iyo-Counter. Kunzwa zvinobatsira muchikamu ichi zvinogona kutengwa zvakanangana kubva paInternet, mafarmacy uye dzimwe nzira pasina kuregererwa kwekurapa.
US Kunzwa Rubatsiro
Kunzwa zvinhu zvinoshandiswa pakurapa zvinodzorwa neFDA. Mazhinji anobatsira ekutengesa anotengeswa nevateereri / audiologists. Vashandisi vanoda kutenga zvinobatsira zvinzwiwa kubva kuvateereri / vaongorori pamhepo, mishonga yemishonga, nezvimwewo vanoda kusaina waiver yekurapa. Nekuda kweiyi nzira yakafukidzwa yekutengesa, kuvandudzwa kwenzira dzekutengesa zvakatwasanudza.
Iye Chuanpu akasaina bhiri rine chekuita nerubatsiro rweOTC muna2017, asi FDA haina kuzivisa chikamu cheOTC chekunzwa rubatsiro, saka vatengesi havasati vakwanisa kutengesa pasi pezita rekuti "OTC kunzwa rubatsiro".

Icho chipinganidzo chikuru kune kutengesa kwekubatsira

Wepakati mutengo wekutengesa zvinhu zvinobatsira muUnited States unosvika zviuru makumi maviri nezvishanu zvemadhora, uye yakaderera mari yekupinda pazvinhu zvekunzwa zvinongova 2400-14%. Izvi zvinhu zvakakonzera vashandisi kusarudza kusarudza PSAPs ivo pachavo vakabatsira kuteerera zvigadzirwa. (Somunhu inzwi amplfication China inoreva kuPSAPs seanonzvesa amplifiers)

Dudziro yeiyo 2017 OTC Act

Zvinoreva sei OTC Act 2017?

Kurapa-giredhi yekunzwa zvinobatsira zvinotengeswa zvakananga kune vanopedza vashandisi. Iyo FDA inovandudza chigadzirwa chitsva nekugadzika zvigadzirwa zviyero zveOTC zvinonzwika zvinobatsira.

Nei bhiri reOTC richisainwa?

Kubatsira kwekunzwa kweOTC kunogona kudzora mutengo wevatengi kuti vawane zvekunzwa; kuwedzera nzira dzevatengi kuti vatenge rubatsiro rwekunzwa; kukurudzira kuberekwa kwezvigadzirwa zvitsva nemasevhisi.

Bhiri rinotanga riini kushanda?

Mutemo wakasainwa muna Nyamavhuvhu 2017, uye iyo FDA ichapedzisa basa rose rakakodzera kuti zvibudirire zveOTC zvinonzwa mukati me2020. Indasitiri yekubatsira kunzwa yakadaira zvakashata, asi vakatadza kupa mhinduro iri nani, saka bhiri rakapfuura mushe.

US OTC / DTC mamiriro emusika

"OTC kunzwa rubatsiro”Haisati yavhurwa mumusika weUS, asi vatengesi vane shungu dzekutama mune ramangwana. Kune rimwe divi, vatengesi vepamhepo vari kushanda kusimudzira uye nekupa yakazara yakazara maPSAP. Mimwe michina inogona kutotsigira matekinoroji anozivikanwa senge ekumira kure. Kune rimwe divi, CVS, COSTCO - senge American pharmacy zvikara zvakaunza kutengesa kwePSAPs. OTC kunzwa rubatsiro ichaunzwa munguva inotevera.
Cable / Pamhepo vatengesi vanotaura kukura kwegore negore kwe 46%. Iko kugona kwemusika uyu unobuda uchiri wakakura, uye zvinofungidzirwa kuti iko kungokura kwegore rino kuri 20-30%.

Vatambi vakuru mumusika weOTC / DTC

CVS uye Beurer, NANO kunzwa rubatsiro inogona kupa matekinoroji epamusoro uye zvigadzirwa kumusika weOTC / DTC. Vatambi vakuru mumhizha yevatengi yemagetsi, senge BOSE, vakazivisawo kupinda kwavo mumusika weOTC / DTC.

Iko kukanganisa kweiyo OTC / DTC musika

Musika weOTC uchave nemhedzisiro yakakura paindasitiri nevatengi, uye dzimwe shanduko dzinotyaira kugona kuzere kweOTC / DTC. Mhedzisiro yakajeka ndeyekuti vatengi vanogona kuwana mutengo wakaderera kunzwa rubatsiro, uye zvimwe zvigadzirwa zvemhando yepamusoro zvekunzwa zvinofashamira muzviteshi zvinobuda nemisika.

Mutungamiri weU.S.Trump asayina Chikafu neDrug Administration Reauthorization Act ya2017, inosanganisira OTC OTC Hearing Aid Act iyo inosanganisira kunzwa rubatsiro mune OTC OTC zvigadzirwa. Mushure mekunge mutemo watanga kushanda, vakuru vane hunyoro kusvika pakati nepakati kurasikirwa kwekunzwa vanogona kutenga OTC kunzwa rubatsiro zvakananga.
Izvi zvisati zvaitika, chero murwere anonzwa akaremara muUnited States anofanirwa kusarudzwa uye nekurongedzwa nemidziyo yekunzwa nehunyanzvi hwekutarisa kwekunzwa nyanzvi.
Izvi zvinoreva zvakare kuti zvinobatsira zvekuzwa zvachinja kubva kune yepamusoro-inotonhora vanhurume / vakadzi vechikadzi vakaiswa kubva kuruzhinji kuenda kune vane hushamwari uye hushamwari shamwari yepedyo. Vazhinji vanhuwo zvavo vanozove nemukana wekuwana rubatsiro rwekunzwa uye vadzidze kuti zvinogona kubatsira sei kunzwa kushaya shamwari kuti vakunde kusagadzikana muhupenyu uye kuvandudza kunaka kwehupenyu!

Maindasitiri kupindura kune OTC zvekubatsira kunzwa

Inofadza. Nekuti OTC kunzwa rubatsiro kuve neyakafara yekutengesa chiteshi, izvi zvinoreva kuti vazhinji vangangove vatengi vanozoona kurasikirwa kwekunzwa, uye zvisina kunangana, ichaitisawo pfungwa yekunzwa / yekunzwa rubatsiro vanokodzera. Uye vanonzwa nyanzvi / rubatsiro rwekunzwa rwakakodzera nyanzvi dzine hunyanzvi hwemamiriro ekunze dzichava nezwi guru mukugadzirwa kwezvigadzirwa zvitsva muCTC chiteshi.

Maitiro ekuita sei nemusika weOTC?

Kuputika kwemusika weOTC kunoreva kuti audiologists / fitter vanogona kushandisa ruzivo rwavo rwehunyanzvi uye ruzivo rwehupfumi kutora chikamu mukuvandudza uye kugadzira zvigadzirwa zveOTC, panguva imwechete kutora chikamu mumusika wepamberi wekiriniki wekutsvaga, kana kupa zvigadzirwa zveOTC zvehunyanzvi. Kunzwa Services Kurovera.


Kutarisana nemusika weOTC, mavara ekubatsira anonzwa haasati agadzirira. Izvo zvigadzirwa zviripo hazvina kukodzera zvakakwana kumusika weOTC. Kunyangwe zvigadzirwa zvakasiyana siyana zvabuda muindasitiri yekubatsira kunzwa mumakore mashanu apfuura, izvi zvigadzirwa zvehunyanzvi hazvina kukwanisa kukurudzira kuputika kweindasitiri yekubatsira kunzwa. Vatengi vanoda zvigadzirwa zvitsva uye zvitsva.
Izvo hazvina chekuita nemutengo, chiteshi uye tekinoroji, asi zvinouya kubva mukufungidzira kweruzhinji nezve kunzwa rubatsiro. Kunzwa vashandisi vekubatsira vanotsanangurwa sekuchembera uye kunzwa kutadza, izvo zvinokanganisa zvakanyanya kukura kwekunze kwe kunzwa rubatsiro. Naizvozvo, varidzi vemakambani vanofanira kutanga nezvinodiwa nevashandisi uye nekuunza zvigadzirwa zvitsva, akasiyana magadzirirwo, kana kupa mamwe mabasa kupfuura "kuteerera."
VaAdnan, vachishandisa zvigadzirwa zvinopfeka semuenzaniso, vakatsanangura kuti kuita kuti vashandisi vashuve kuve kwakakosha pane kuva nazvo. Kugadzira kunzwa rubatsiro bvisa maratidziro uye uwedzere "hunyanzvi hwepamusoro" uye "hutano" zvakakodzera kuti utarise nekunzwa maronda erubatsiro.

Kutya kweanotevera-chizvarwa OTC rubatsiro rubatsiro kusimudzira

Iyo iripo yemhando yepamusoro tekinoroji ye kunzwa rubatsiro haikwanise kutsigira izvo zvinodiwa zvekuvandudza zveOTC itsva kunzwa rubatsiro; iyo tekinoroji iripo inogadzirisa "kukosha kwekunzwa" uye inofuratira "kunzwa kwekunzwa"; kuwedzera mamwe mabasa (senge hutano hwekuongorora)) Inogona kunyatso shandura zvisungo zvevatengi nezve kunzwa rubatsiro.

Wakanakisa OTC rubatsiro rubatsiro rubatsiro muChina

Huizhou Jinghao Medical Technology CO, LTD. ndiye oga akanyorwa kunzwa rubatsiro/ yekunzwa gudzazwi gadziri muChina, ive inozivikanwa nekupa mhando yakanaka uye mutengo wakanaka kunzwa rubatsiro/ kunzwa gudzazwi.
Jinghao Chiremba akapfuura BSCI, ISO13485, ISO9001, C-TPAT, SQP, CVS HEALTH nezvimwe kuongorora, uye zvese zvigadzirwa zvine CE, RoHS, FDA zvitupa. Iine vanopfuura makumi matatu vane ruzivo mainjiniya eR & D department, Jinghao anokwanisa kuita ODM & OEM chirongwa.
Yakajairwa OTC Kunzwa rubatsiro Vatengi vanosanganisira CVS Hutano, BEURER, AEON (JAPAN), nezvimwe.

Kunyora zvese

Iko kugona kweiyo OTC / DTC musika yakakura. Iyo yekubatsira yekunzwa yekugadzira indasitiri haisati yawana chigadzirwa chinonyatso kupindura. Kugadzirisa matanho evatengi chinhu chekutanga pakukura kwemusika. Kupararira chete muhunyanzvi hwetekinoroji kunogona kugadzira zvigadzirwa zvitsva uye kusunungura musika weOTC.

Achiratidza zvose 9 zvawanikwa

Ratidza mativi