LITATTAFAI MAI KYAUTA NA KWARAI DA JAGO A Cutar Sida, Cutar PSDs, ZUCIYA DA DARAJAR KUDI.

Hukumar Kula da Abinci da Magunguna (FDA) tana haɓaka ƙa'idojin samarda kayayyakin jin kai. Dangane da Dokar Bayar da izini ta FDA ta 2017, za a sami wadatar wayoyin ga mai amfani ta hanyar dillalai kuma ba tare da haɗaɗɗar da masanin magana ba, ko dai don ƙimar sauraron sauraro, ko ƙararraki, dacewa ko tabbatar da aikin. Duk da cewa na'urorin OTC basu shiga kasuwa ba, wannan jagorar an kirkireshi ne don taimakawa masu ilimin sauti don fahimtar bambance-bambance tsakanin samfuran da ake amfani da su da na'urorin OTC, don shirye su amsa tambayoyi game da waɗannan na'urori, kuma mai yiwuwa don fara ayyukan farko kafin farawar kasancewar OTC na'urorin. Wannan jagorar za a sabunta yayin da ka'idojin na'urori OTC ke kasancewa.

A lokacin bazara na 2017, Majalisa ta zartar da doka wacce ta umarci FDA don ƙirƙirar ƙa'idodin yin OTC jin kunne samuwa ga jama'a. Kafin wannan, wasu hukumomin gwamnatin tarayya, musamman Hukumar Kasuwanci ta Tarayya (FTC) da Majalisar Shugaban Kasa na Mashawarta kan Kimiyya da Fasaha (PCAST), sun fara yin nazarin yadda ake samun dama da kuma iya karfin kula da jin a Amurka. Lokaci guda, Cibiyar Ilimin Kimiyya, Injiniya da Magunguna ta Kasa (NASEM) ita ma ta kira wani kwamiti don yin nazari da bayar da rahoto game da matsayin bayar da kulawar ji a Amurka The FDA, da FTC, da Cibiyoyin Kiwon Lafiya na Nationalasa, da Tsohon Soja, da Sashen na Tsaro, da ossungiyar Asarar Sauraron Amurka sun ƙaddamar da binciken NASEM.
Za a iya gano asalin wadannan kwamitocin da sake dubawa zuwa fahimta guda uku da aka saba da su da kuma batun kiwon lafiya. Na farko shine tsinkaye cewa farashin kulawa da ji, kuma mafi mahimmanci farashin jin kunne, yana hana wasu mutane neman magani don rashin jin magana. Na biyu, yawancin masu biyan kuɗi ba sa rufewa jin kunne; gami da Medicare inda aka keɓance na'urorin taimakon ji da haɗin kai. Fahimta ta uku ita ce, rarraba yanki na masu ba da kulawa da jin, gami da masanan, shi ne cewa akwai yankuna da yawa a Amurka wadanda mutane ba sa iya samun damar hidimomin kulawa da jin magana cikin sauri.
Manufar kiwon lafiya da ta kunno kai ita ce, masu sayen kayayyaki suna neman babbar kulawa kan kulawar lafiyarsu, gami da muradin “bi da kai” don kula da lafiyar jinsu. Imparfafawar na iya kasancewa, a wani ɓangare, don sarrafa farashin kulawar lafiyar su, amma kuma don sarrafa lokaci da ƙoƙarin da aka kashe lokacin aiki tare da ma'aikatan kiwon lafiya. Yayinda yawancin yanayin likita na yau da kullun, misali raunin baya, ana “kulawa” tare da magungunan kan-kanta, babu wani zaɓi irin wannan don maganin asarar ji. Wannan tunanin da zai fito zai iya haɗawa da wasu hanyoyin da zasu ba marasa lafiya damar “magance” rashi na ji ba tare da ganin likitan magana ba, ko otolaryngologist, ko kuma murhu.
Wadannan jigogi sun jagoranci wasu hukumomi da yawa suna ba da shawarar mai amfani da kayan aikin kulawa da abin sawa a kunne ba tare da mahimmancin shiga cikin masu sana'a ba. Wadannan shawarwarin sun kasance

bisa tsarin, a wani bangare, akan dukkanin fasahohin da ke fitowa (misali, wayoyin salula na zamani, kayan kwance, da dai sauransu) wanda zai iya samar da fa'idar ji da tsinkaye cewa karuwar yawan masu fasaha ta zamani na iya samun damar dacewa da na'urorin kula da ji ba tare da taimakon ta ba. wani masanin sauti.
Dokar OTC da majalisar ta zartas (S934: FDA Reauthorization dokar ta 2017) ta bayyana na'urar OTC a matsayin wacce ta ce: “(A) tana amfani da fasahar kimiyya guda ɗaya kamar ta jiyo iska (kamar yadda aka ayyana a sashi na 874.3300 na taken 21, Code of Dokokin Tarayya) (ko kowane ƙa'ida na maye) ko abubuwan sauraron iska mara amfani da iska (kamar yadda aka ayyana a sashi na 874.3305 na take 21, Lambar Ka'idojin Tarayya) (ko kuma duk wani magabacin maye); (B) an yi niyya ne don amfani da tsofaffi sama da shekaru 18 don rama don tsinkaye mai tsinkaye zuwa raunin ji a cikin matsakaici; (C) ta kayan aiki, gwaje-gwaje, ko software, yana bawa mai amfani damar sarrafa kayan saƙo na kan-kan-da-kan-da-sa da kuma sanya shi cikin bukatun saurarar mai amfani; (D) may-- (i) amfani da fasaha mara waya; ko (ii) sun hada da gwaje-gwaje na gwajin kai na asarar ji; kuma (E) ana samunsa ta-sama-sama, ba tare da dubawa ba, ba kwaya, ko wani tsari, sanya hannu, ko sanya hannun wani mai lasisi, ga masu cinikin ta hanyar ma'amala na mutum, ta hanyar wasiku, ko kan layi. ” Wannan doka ta ba da izini cewa FDA ta haɗu kuma ta fitar da dokoki ba daga shekaru 3 ba bayan aiwatar da dokar. Arshe na ƙarshe na dokar, wanda Shugaba Trump ya sanya hannu a ranar 18 ga Agusta 2017, 3, ya lura da takamaiman abubuwa kamar haka: “Sakataren Kiwan lafiya da Ayyukan Jama'a… ba a bayan shekaru 520 bayan ranar da aka kafa wannan Dokar, za su ba da sanarwar ƙa'idodin. kafa wani ɓangare na kayan jin magana marasa amfani, kamar yadda aka ayyana a sashi (q) na sashi na 21 na Dokar Abinci, Drug, da Cosmetic dokar (360 USC 180j) kamar yadda aka gyara ta (a), kuma, ba a wuce kwanaki 180 ba. bayan ranar da aka gabatar da jawabin ra'ayoyin jama'a game da ka'idojin da aka gabatar, aka fitar da irin wannan ka’idodin karshe. ” FDA ta fara aiwatar da tattara bayanai da bayanai, gami da shigar da kara daga kungiyoyin kwararru, hukumomin tarayya, da kungiyoyin mabukata kuma suna iya buga sharuddan da aka gabatar a kowane lokaci cikin shekaru uku masu zuwa. Kunshe a cikin ka'idojin da aka gabatar za su kasance lokacin tsara FDA don karɓar ra'ayi daga jama'a game da ka'idodin da aka gabatar. A wannan lokacin, ƙungiyoyi, hukumomi, ko daidaikun mutane na iya ba da ra'ayi, ba da shawara ga gyare-gyare, ko samar da zaɓuɓɓuka daban-daban don ƙa'idodin da aka gabatar. Hakanan yana yiwuwa FDA za ta gudanar da sauraron jama'a a lokacin da za a iya bayar da shaidar baka game da ka'idodin da aka gabatar. A ƙarshen lokacin sanarwa, FDA za ta kimanta duk wata magana ta baki ko rubutacciyar sanarwa kuma ta ƙayyade ko wasu canje-canje a cikin ƙa'idodin da aka gabatar sun zama dole. A tsakanin watanni shida (kwanaki XNUMX) na ƙarshen lokacin yin sharhi, za a buga sharudda na ƙarshe, tare da ranar aiwatarwa.

KALMOMI NA SIFFOFIN GWAMNATI
Wannan takaddar tana nazarin na'urori da fasaha a halin yanzu don masu amfani da marasa lafiya. Zaɓuɓɓukan da aka gabatar a cikin wannan takaddun basu haɗa da na'urorin da ke cikin jijiyoyin jini ba (misali. Cochlear implants, implants ear ear, da sauransu). Kamar yadda a yanzu, na'urorin OTC basu wanzu kuma saboda haka nau'in su, aikin su, farashin su, halayen su, ko tasirin al'adar sauraren magana ce.
Taimakon jin kai: Ka'idodin FDA sun ayyana kayan jin kai kamar "kowane kayan aiki na yau da kullun ko naúrar da aka ƙera shi, an bayar da shi don dalilin, ko wakilci a matsayin taimakon mutane tare da ko diyya don, ji mai rauni" (21 CFR 801.420). Ka'idodin ji na ji ne ta hanyar FDA azaman na'urorin likitancin na Class ko na Class II kuma ana samun su ne kawai daga masu ba da lasisi. Mai yiwuwa a bada shawarar taimakon sauraron ga mutane da ke da rauni zuwa babban rashi jin magana kuma mai bada tallafi zai iya tsara shi.
Samfuran Amplification na sirri (PSAP): PSAPs sune kan-kan-kanta, na'urorin lantarki masu kayatarwa waɗanda aka tsara don haɗa sauraro a wasu mahalli (ba amfani da cikakken lokaci). An tsara su gaba ɗaya don samar da ɗan ƙara sauti na sauti na muhalli amma saboda FDA ba ta kayyade su ba, ba za'a iya kasuwarsu azaman na'urorin da ke taimaka wa mutane rashin jin magana ba. FDA ta ba da misalin cewa misalai na yanayi waɗanda ake amfani da PSAPs galibi sun hada da farauta (sauraron abin farauta), kallon tsuntsu, sauraron laccoci tare da mai magana mai nisa, da sauraron sautuka masu taushi waɗanda zasu zama da wahala ga mutane masu ji na al'ada su ji (misali,. tattaunawa mai nisa) (Jagorar Gudanar da FDA, 2013). Ana amfani da PSAPs a yanzu don siye ta siyar da mai siyarwa a fannoni daban daban na otel, hade da ta kan layi. Masu ilimin sauti na iya siyar da PSAPs.
Na'urorin sauraro mai taimakawa (ALD), Tsarin sauraro mai taimako (ALS), Na'urorin fadakarwa: Ballantana, rukuni na kayan aikin da ke taimakawa mutum da rashi sauraran takamaiman wurin sauraro ko yanayi wanda na'urorin al'ada basu dace ba ko basu dace ba. Ana iya amfani da ALDs ko ALSs a wurin aiki, gida, wuraren aiki ko wuraren nishaɗi, kuma ana iya amfani dashi don inganta siginar-zuwa-amo, rage tasirin nesa, ko rage tasirin rashin hankalin mara kyau (misali maimaitawa. ) Waɗannan na'urorin na iya zama na amfanin mutum ko na ƙungiyoyi (yanki mai faɗi). Na'urar faɗakarwa yawanci suna amfani da haske, sauti mai ƙarfi ko rawar jiki don haɗawa ko siginar mutum tare da asarar ji game da abin da ya faru a cikin mahallinsu, kuma ana iya haɗa shi zuwa wayoyi, fitilu, ƙwanƙwasa ƙorafi, ƙararrawa, haya da sauransu FDA baya tsara ALDs, ALS, ko na'urorin faɗakarwa, kodayake wasu na'urori, irin su wayoyin tarho, basu dace da dokokin FCC ba. Waɗannan na'urorin za'a iya siyan su ta hanyar hanyoyin siyarwa, kan layi, da kuma ayyukan jin magana. A wasu yanayi, ana samun waɗannan na'urori don rage farashin ta hanyar hukumomin gwamnati.
Kayayyakin aikin ji na marasa amfani da mara waya: Akwai wadatattun na'urori da yawa a yau waɗanda aka ƙera su don inganta taimakon ji, inganta sadarwa, ko amfani da wata hanyar sadarwa. Na'urorin haɗi sun haɗa da na'urori waɗanda ke ba wa mai sauraro damar watsa bayanai kai tsaye daga waya ko wata naúrar sauraro na sirri (misali, kwamfutar hannu, kwamfuta, e-Reader) da kuma wayoyin hannu na nesa ko na cinya wanda ke taimaka wa mai sauraron sauraron nesa mai nisa (misali, a cikin
Hakkin mallaka 2018. Cibiyar Nazarin Muryar Amurka. www.audiology.org. 5
dakunan karatu, dakunan taro, da kuma dakunan karatu na karatu). An sayi kayan haɗin ji na jika gabaɗayan ta hanyar tsarin magana, amma ana samun su ta hanyoyin kantuna.
Zazzagewa: Mai warke shine kowace naúrar-kunnuwa da aka tsara don haɓakawa da haɓaka kwarewar sauraro, ko wanda ya haɗa da abubuwa kamar saka idanu mahimman alamomi (misali ƙyallin zuciya, zafin jiki, matakan oxygen, da sauransu), bin diddigin aiki (misali matakai, adadin kuzari ya ƙone, da dai sauransu), sauraren sauraro (yana ba masu amfani damar tace ko haɓaka takamaiman sautikan), waƙar kiɗa, fassarar harshe, ko haɓaka sadarwar fuska.

Hakkin mallaka 2018. Cibiyar Nazarin Muryar Amurka. www.audiology.org. 4

Zazzage jagorar mai sauraro game da KARANTA Cutar kanjamau, PSAPs, ZUCIYA DA JAGORAN halittun jiki [PDF]