Data / Medical devices / Self-Fitting Air-Conduction Hearing Aid, Prescription
Self-Fitting Air-Conduction Hearing Aid, Prescription (QDD): 10 FDA-registered makers in 8 countries
10 establishments in 8 countries are registered with the FDA to make Self-Fitting Air-Conduction Hearing Aid, Prescription (product code QDD, Class 2, 21 CFR 874.3325). 3 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 7 510(k) clearances under this code, the latest on October 17, 2023, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- QDD
- Device class
- 2
- Regulation
- 874.3325
- Medical specialty
- Ear, Nose, Throat
Makers by country
| Country | Makers |
|---|---|
| United States | 2 |
| Malaysia | 2 |
| Denmark | 1 |
| Singapore | 1 |
| Germany | 1 |
| Mexico | 1 |
| China | 1 |
| Philippines | 1 |
Makers of Self-Fitting Air-Conduction Hearing Aid, Prescription
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| GN Hearing A/S | BALLERUP Hovedstaden, Denmark | Specification developer | 1 | January 19, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sivantos Pte Ltd | Singapore South East, Singapore | Manufacturer, Specification developer | 1 | August 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Sivantos GmbH | Erlangen Bavaria, Germany | Manufacturer, Specification developer | 1 | August 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Concha Inc. | San Mateo, CA, United States | Complaint file establishment, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Manufacturing Juarez S. DE R.L. DE C.V. | Juarez Chihuahua, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN Resound China, Ltd. | XIAMEN Fujian, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN ReSound (Malaysia) Sdn Bhd. | Kulai Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| GN ReSound (Malaysia) Sdn. Bhd | Senai Johor, Malaysia | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Integrated Micro-Electronics Inc. (imi) | Binan Laguna, Philippines | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Novidan, Inc. | Golden Valley, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated October 17, 2023. 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.