Data / Medical devices / Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Self-Fitting Air-Conduction Hearing Aid, Over The Counter (QUH): 24 FDA-registered makers in 13 countries

24 establishments in 13 countries are registered with the FDA to make Self-Fitting Air-Conduction Hearing Aid, Over The Counter (product code QUH, Class 2, 21 CFR 874.3325). 16 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 10 510(k) clearances under this code, the latest on June 25, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

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Product code

QUH

Device class

2

Regulation

874.3325

Medical specialty

Ear, Nose, Throat

Makers by country

Makers of Self-Fitting Air-Conduction Hearing Aid, Over The Counter

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Updated June 25, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.