FDA product code · Ear, Nose, Throat · Class 2
QUH: Self-Fitting Air-Conduction Hearing Aid, Over The Counter
QUH is FDA's product code for "Self-Fitting Air-Conduction Hearing Aid, Over The Counter": a Class 2 device classified under 21 CFR 874.3325, reviewed by the Ear, Nose, Throat panel.
510(k) review time for QUH
Across 10 510(k) clearances under QUH decided from 2018-01-01 to 2026-10-06, the median was 175 days from FDA receipt to decision. Half took between 123 and 199 days, and 80% were decided within 214 days. These are past clearances, not a forecast for a new submission.
| Fastest | 109 |
|---|---|
| 25th percentile | 123 |
| Median | 175 |
| 75th percentile | 199 |
| 80th percentile | 214 |
| 90th percentile | 287 |
| Slowest | 532 |
Source: openFDA 510(k) records, snapshot of 2026-10-06 (openFDA data as of 2026-09-28). Compare 510(k) review times across all device types, see every code side by side in the Clearance Timeline Estimator, or browse the clearances themselves in PredicateScope.
FDA-recognized standards that cite QUH
1 FDA recognized consensus standard cite QUH, among them ANSI ASA S3.35-2025. Horizontal standards such as biocompatibility, sterilization and software standards can apply without citing the code.
- 4-352 ANSI ASA S3.35-2025 — American National Standard Method for Measurement of Performance Characteristics of Hearing Aids Under Simulated Real-Ear Working Conditions
Source: FDA Recognized Consensus Standards, snapshot of 2026-09-01. Search them all in the Consensus Standards Lookup.