Description of Event or Problem · 0
FDA OFFICE OF REGULATORY AFFAIRS (ORA) / CDRH (CENTER FOR DEVICES AND RADIOLOGICAL HEALTH) THE DEVICE CANNOT INPUT SPECIFIC AUDIOGRAM PARAMETERS AS ADVERTISED, AND IT IS NOT EVEN AN OTC HEARING AID. AFTER ADJUSTMENTS AND WEARING IT FOR ONE DAY, MY HEARING CONDITION WORSENED. PRODUCT AND REGULATORY VIOLATIONS UNAPPROVED DEVICE: VIVTONE'S "XPURE" HEARING AIDS CLAIM TO PERFORM FREQUENCY-DEPENDENT ADJUSTMENTS BASED ON AUDIOGRAMS, IMPLYING MEDICAL FUNCTIONALITY. HOWEVER: NO 510(K) CLEARANCE (PER FDA DATABASE SEARCH: PCD CLASSIFICATION ID=QUH). MISREPRESENTED AS OTC HEARING AIDS DESPITE FAILING TO MEET FDA'S OTC FINAL RULE (21 CFR 800.30). EVIDENCE OF MISLEADING CLAIMS AMAZON PRODUCT PAGES (DIRECT LINKS): HTTPS://WWW.AMAZON.COM/DP/B0D4VKT271 HTTPS://WWW.AMAZON.COM/DP/B0DBLV63LJ B0D4VKT271 / B0DBLV63LJ KEY VIOLATIONS: CLAIMS OF "AUDIOGRAM-BASED ADJUSTMENT" AND "SELF-FITTING" (IMPLIED MEDICAL FUNCTIONALITY). MARKETED AS "OTC HEARING AIDS" WITHOUT COMPLIANCE. SUPPORTING DOCUMENTS (REFERENCED): AMAZON ORDER #(B)(6) (PROOF OF PURCHASE). PRODUCT MANUAL ("USER_MANUAL_VIVTONE_XPURE_2024") ¿ HIGHLIGHTS UNAPPROVED MEDICAL CLAIMS. APP SCREENSHOTS ("APP SELF-FITTING") ¿ SHOWS ATTEMPTED AUDIOGRAM INPUT FAILURE. CONSUMER HARM FUNCTIONAL FAILURE: THE DEVICE CANNOT PROCESS AUDIOGRAM DATA AS ADVERTISED, UNLIKE PRESCRIPTION HEARING AIDS. DECEPTIVE MARKETING: TARGETS SENIORS/ADULTS SEEKING FDACOMPLIANT OTC SOLUTIONS. REQUESTED ACTION INVESTIGATE VIVTONE FOR: SELLING UNCLASSIFIED/UNAPPROVED MEDICAL DEVICES. MISBRANDING UNDER 21 U.S.C. § 352. REVIEW AMAZON'S ROLE IN DISTRIBUTING NON-COMPLIANT DEVICES.