{"id":13804,"date":"2018-07-03T07:29:35","date_gmt":"2018-07-03T05:29:35","guid":{"rendered":"https:\/\/www.onacustica.net\/audifonos-versus-amplificadores-de-sonido\/"},"modified":"2023-11-09T12:15:29","modified_gmt":"2023-11-09T11:15:29","slug":"audifonos-versus-amplificadores-de-sonido","status":"publish","type":"post","link":"https:\/\/www.onacustica.net\/ca\/audifonos-versus-amplificadores-de-sonido\/","title":{"rendered":"Audi\u00f2fons versus amplificadors de so"},"content":{"rendered":"

L’ AEMPS informa de les difer\u00e8ncies entre audi\u00f2fons i aparells amplificadors de so. Els AUDI\u00d2FONS<\/strong> s\u00f3n productes sanitaris que amplifiquen i processen sons i que estan destinats a compensar defici\u00e8ncies auditives. En canvi, els AMPLIFICADORS<\/strong> de so s\u00f3n dispositius electr\u00f2nics destinats simplement a amplificar el so ambiental per a persones sense defici\u00e8ncies auditives. Tant audi\u00f2fons com amplificadors de so, afecten la capacitat de percebre sons, per\u00f2 tenen diferents indicacions i estan subjectes a diferents controls legislatius.<\/p>\n

L’Ag\u00e8ncia Espanyola de Medicaments i Productes Sanitaris (AEMPS), ha rebut diverses den\u00fancies relatives a la venda d’aparells amplificadors de so la finalitat dels quals \u00e9s amplificar el so ambiental, per\u00f2 que s’ofereixen i publiciten sota el terme \u00abaudi\u00f2fon\u00bb. Per aix\u00f2, resulta necessari aclarir la difer\u00e8ncia entre ambd\u00f3s productes.<\/p>\n

El consumidor no ha de confondre els audi\u00f2fons amb els productes d’ amplificaci\u00f3 de so. Encara que la tecnologia i l’ aparen\u00e7a d’ alguns aparells amplificadors siguin similars a les d’ un audi\u00f2fon, nom\u00e9s aquests \u00faltims estan dissenyats i indicats per compensar les defici\u00e8ncies auditives. Un amplificador de so, per contra, est\u00e0 destinat a ser utilitzat per persones amb audici\u00f3 normal que tenen el desig o la necessitat d’ amplificar els sons en certes situacions.<\/p>\n

Els audi\u00f2fons i els amplificadors de so, degut a la seva diferent finalitat d’ \u00fas, es troben sotmesos a diferents normatives, per la qual cosa els requisits de seguretat, efic\u00e0cia, qualitat i informaci\u00f3 i els procediments d’ avaluaci\u00f3 i control que s’ apliquen a ambd\u00f3s productes s\u00f3n diferents.<\/p>\n

AUDI\u00d2FONS VERSUS AMPLIFICADORS DE SO<\/h3>\n

1. Els audi\u00f2fons es consideren productes sanitaris perqu\u00e8 es destinen a la compensaci\u00f3 de les defici\u00e8ncies auditives, essent, en general, la compensaci\u00f3 de defici\u00e8ncies una de les funcions previstes en la definici\u00f3 de productes sanitaris.<\/p>\n

Aquests productes posseeixen sistemes electr\u00f2nics, normalment programables, que permeten processar de forma espec\u00edfica les diferents freq\u00fc\u00e8ncies de l’ espectre sonor, per compensar les diferents p\u00e8rdues auditives. A m\u00e9s, requereixen una adaptaci\u00f3 individualitzada, duta a terme per un professional sanitari, per optimitzar el seu funcionament d’ acord amb les caracter\u00edstiques audiol\u00f2giques i anat\u00f2miques de cada pacient.<\/p>\n

Els audi\u00f2fons, igual que els establiments on es venen i adapten, es troben subjectes al Reial decret 1591\/2009 de 16 d’octubre, pel qual es regulen els productes sanitaris, transposici\u00f3 de la Directiva europea 93\/42\/CEE. Els productes han d’ estar conformes amb aquesta reglamentaci\u00f3 i els establiments posseir la corresponent autoritzaci\u00f3 de les autoritats sanit\u00e0ries de les comunitats aut\u00f2nomes.<\/p>\n

D’altra banda, els establiments d’audiopr\u00f2tesis tenen el car\u00e0cter d’establiments sanitaris i estan regulats pel Reial decret 1277\/2003, de 10 d’octubre, pel qual s’estableixen les bases generals sobre autoritzaci\u00f3 de centres, serveis i establiments sanitaris.<\/p>\n

2. Els amplificadors de so s\u00f3n aparells electr\u00f2nics destinats a augmentar el so, per\u00f2 en cap cas a compensar defici\u00e8ncies auditives. Normalment, tenen menor complexitat tecnol\u00f2gica i menors funcionalitats que els audi\u00f2fons. Estan dissenyats per accentuar sons en certes situacions, com quan el soroll ambiental pot interferir, o per veure la televisi\u00f3 mentre una altra persona dorm, o en certs entorns, per captar sons que poden ser dif\u00edcils de percebre, com en activitats de ca\u00e7a o observaci\u00f3 d’ aus.<\/p>\n

Aquests productes estan dissenyats per ser utilitzats durant un temps breu, per la qual cosa el seu \u00fas prolongat pot provocar danys en l’ o\u00efda.<\/p>\n

Es troben subjectes a la normativa sobre aparells electr\u00f2nics.<\/p>\n

Per tant, la finalitat d’ \u00fas de cada producte determina si es tracta d’ un producte sanitari o un aparell electr\u00f2nic. Aquesta finalitat ha d’ estar indicada clarament en l’ etiquetatge o material promocional.<\/p>\n

Els productes que s’ ofereixen al consumidor sense esmentar la necessitat d’ una avaluaci\u00f3 audiol\u00f2gica pr\u00e8via i d’ una adaptaci\u00f3 individualitzada per un professional sanitari, no s’ han de presentar com a audi\u00f2fons, sin\u00f3 com a amplificadors de so, i no han d’ estar indicats per compensar defici\u00e8ncies auditives.<\/p>\n

RECOMANACIONS<\/h3>\n

El consumidor ha de ser conscient que qualsevol senyal de p\u00e8rdua d’ audici\u00f3 necessita un diagn\u00f2stic m\u00e8dic. No realitzar un adequat diagn\u00f2stic pot impedir la detecci\u00f3 d’una s\u00e8rie de patologies potencials de diferent grau de gravetat (des d’un tap de cera, fins a un tumor), amb les oportunes conseq\u00fc\u00e8ncies.<\/p>\n

A m\u00e9s, l’ avaluaci\u00f3 audiol\u00f2gica per un professional sanitari especialitzat \u00e9s essencial abans de triar l’ audi\u00f2fon m\u00e9s adequat per a cada pacient. La manca d’ una correcta avaluaci\u00f3 audiol\u00f2gica i adaptaci\u00f3 de l’ audi\u00f2fon a les caracter\u00edstiques del pacient pot produir un trauma ac\u00fastic en l’ o\u00efda.<\/p>\n

L’ AEMPS recomana que:<\/p>\n

    \n
  1. En el cas de detectar dificultats per escoltar, acudeixi a un especialista en otorrinolaringologia (ORL), perqu\u00e8 li realitzin un diagn\u00f2stic m\u00e8dic de la seva p\u00e8rdua auditiva.<\/li>\n
  2. Acuda a Gabinets d’ Audiopr\u00f2tesis autoritzats per a l’ adquisici\u00f3 de l’ audi\u00f2fon, en els quals l’ audi\u00f2leg-audioprotesista, com a professional sanitari especialitzat, li realitzar\u00e0 l’ avaluaci\u00f3 audiol\u00f2gica i l’ adaptaci\u00f3 del producte, aix\u00ed com el seguiment adequat.<\/li>\n
  3. Si t\u00e9 audici\u00f3 normal, i desitja o necessita utilitzar amplificadors de so en certes situacions, llegeixi i segueixi atentament tant les indicacions com les precaucions d’ \u00fas de l’ aparell, evitant un \u00fas prolongat.<\/li>\n
  4. L’ AEMPS desaconsella l’ adquisici\u00f3 d’ amplificadors de so per tal de compensar p\u00e8rdues auditives.<\/li>\n<\/ol>\n","protected":false},"excerpt":{"rendered":"

    L’ AEMPS informa de les difer\u00e8ncies entre audi\u00f2fons i aparells amplificadors de so. Els AUDI\u00d2FONS s\u00f3n productes sanitaris que amplifiquen i processen sons i que estan destinats a compensar defici\u00e8ncies auditives. En canvi, els AMPLIFICADORS de so s\u00f3n dispositius electr\u00f2nics destinats simplement a amplificar el so ambiental per a persones sense defici\u00e8ncies auditives. Tant audi\u00f2fons […]<\/p>\n","protected":false},"author":1,"featured_media":13687,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[110],"tags":[],"class_list":["post-13804","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-audiofons-ca"],"acf":[],"yoast_head":"\nAudi\u00f2fons versus amplificadors de so - Onac\u00fastica<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/www.onacustica.net\/ca\/audifonos-versus-amplificadores-de-sonido\/\" \/>\n<meta property=\"og:locale\" content=\"ca_ES\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Audi\u00f2fons versus amplificadors de so - Onac\u00fastica\" \/>\n<meta property=\"og:description\" content=\"L’ AEMPS informa de les difer\u00e8ncies entre audi\u00f2fons i aparells amplificadors de so. 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