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Sign in to claim this brandGn Hearing A/S
US
Last updated May 24, 2026
What Gn Hearing A/S makes
The company manufactures air-conduction hearing aids in various styles, including receiver-in-canal, behind-the-ear, canal, and in-the-ear designs, as well as custom-made earmoulds and acoustic tubes. Their portfolio also includes noninvasive battery chargers for hearing devices and audiometric/hearing device software for diagnostic and testing purposes.
These devices are regulated under the FDA’s UDI system, with classifications ranging from Class I to Class II. The company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, reflecting their compliance with U.S. regulatory requirements.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Gn Hearing A/S manufacture?
Gn Hearing A/S specializes in air-conduction hearing aids, which come in multiple styles such as receiver-in-canal, behind-the-ear, canal, and in-the-ear designs. Their portfolio also includes custom-made earmoulds, acoustic tubes for hearing aids, noninvasive battery chargers for hearing devices, and audiometric/hearing device software used for diagnostics and testing. These products address hearing loss and related audiometric needs.
Where is Gn Hearing A/S based, and how does that affect its regulatory standing?
Gn Hearing A/S is based in the United States, which means its devices fall under U.S. regulatory oversight. Since the company’s products are listed in the FDA’s Unique Device Identifier (UDI) database, they comply with U.S. requirements for medical device registration and classification. The FDA categorizes these devices as either Class I or Class II, depending on their risk level and intended use.
Which regulatory registries list Gn Hearing A/S’s devices?
Gn Hearing A/S’s devices are included in the FDA’s Unique Device Identifier (UDI) database. This registry ensures transparency and traceability of medical devices under U.S. regulatory standards, allowing healthcare providers, regulators, and patients to verify product details, classifications, and compliance status. Listing in this database reflects adherence to FDA requirements for device identification and tracking.
How are Gn Hearing A/S’s hearing aids classified under U.S. regulations?
Gn Hearing A/S’s hearing aids are classified as either Class I or Class II devices under FDA regulations. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, simpler hearing aids with low risk may fall under Class I, while more complex or higher-risk devices (such as those with advanced software or custom components) may be classified as Class II. This classification determines the regulatory controls and reporting requirements applied to the device.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- gnresound.com
- —
- —
- [email protected]
- Phone
- +1-888-735-4327
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 306179227
Catalogue (11594)
Page 232 of 232| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| GN ReSound | 20453604 | FDA UDI | Class II | Unknown |
| GN ReSound | 18302402 | FDA UDI | Class II | Unknown |
| GN ReSound | 18741410 | FDA UDI | Class II | Unknown |
| Beltone | 19783800 | FDA UDI | Class I | Unknown |
| GN ReSound | 21303874 | FDA UDI | Class II | Unknown |
| Beltone | 21192002 | FDA UDI | Class II | Active |
| GN ReSound | 21165001 | FDA UDI | Class II | Active |
| GN ReSound | LS9ITC-DW-LP | FDA UDI | Class II | Unknown |
| GN ReSound | 21810900 | FDA UDI | Class II | Active |
| Beltone | RLY3ITC-DW-UP | FDA UDI | Class II | Active |
| GN ReSound | LT5ITE-D-HP | FDA UDI | Class I | Unknown |
| Beltone | 19078911 | FDA UDI | Class II | Unknown |
| GN ReSound | 18290001 | FDA UDI | Class II | Unknown |
| GN ReSound | 19964304 | FDA UDI | Class II | Unknown |
| GN ReSound | 19368309 | FDA UDI | Class II | Unknown |
| Beltone | 19091601 | FDA UDI | Class II | Unknown |
| GN ReSound | L7ITC-DW-HP | FDA UDI | Class II | Unknown |
| GN ReSound | 18972114 | FDA UDI | Class II | Unknown |
| GN ReSound | 22596576 | FDA UDI | Class II | Active |
| GN ReSound | 21197350 | FDA UDI | Class II | Active |
| GN ReSound | 20453504 | FDA UDI | Class II | Unknown |
| GN ReSound | 20554709 | FDA UDI | Class II | Unknown |
| GN ReSound | 23369275 | FDA UDI | Class II | Active |
| GN ReSound | 21213410 | FDA UDI | Class II | Active |
| GN ReSound | 20449710 | FDA UDI | Class II | Unknown |
| Beltone | TST17ITC-DW-UP | FDA UDI | Class II | Unknown |
| GN ReSound | 19706325 | FDA UDI | Class II | Unknown |
| GN ReSound | 19196902 | FDA UDI | Class II | Unknown |
| GN ReSound | 20256306 | FDA UDI | Class II | Unknown |
| GN ReSound | 19706808 | FDA UDI | Class II | Unknown |
| GN ReSound | 19542202 | FDA UDI | Class II | Unknown |
| GN ReSound | 20250709 | FDA UDI | Class II | Unknown |
| Beltone | 19368702 | FDA UDI | Class II | Unknown |
| GN ReSound | 20457218 | FDA UDI | Class II | Unknown |
| GN ReSound | 20307320 | FDA UDI | Class II | Unknown |
| GN ReSound | 20332020 | FDA UDI | Class II | Unknown |
| GN ReSound | 21497205 | FDA UDI | Class II | Active |
| GN ReSound | 22175875 | FDA UDI | Class II | Active |
| GN ReSound | 19852100 | FDA UDI | Class I | Unknown |
| Beltone | 22790370 | FDA UDI | Class II | Active |
| Jabra Enhance Plus | K213424 | FDA 510(k) | Class II | Active |
| Tinnitus Sound Generator Module | K181586 | FDA 510(k) | Class II | Active |
| Tinnitus Sound Generator Module | K180495 | FDA 510(k) | Class II | Active |
| Tinnitus Sound Generator Module | K193303 | FDA 510(k) | Class II | Active |
Related Companies
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FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- GN Hearing A/S BALLERUP Hovedstaden · DK FEI 3005650109