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Sign in to claim this brandBudget Hearing Aids, LLC
US
Last updated May 25, 2026
What Budget Hearing Aids, LLC makes
Budget Hearing Aids, LLC manufactures air-conduction hearing aids designed for canal placement and receiver-in-canal configurations. These devices are intended for individuals with mild to moderate hearing loss, offering customizable sound amplification and comfort for daily wear.
The company’s products fall under FDA Class I and Class II classifications and are listed in the FDA’s Unique Device Identifier (UDI) database. The manufacturer operates from the United States, adhering to applicable U.S. regulatory requirements for hearing aids.
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 Budget Hearing Aids, LLC manufacture?
Budget Hearing Aids, LLC specializes in air-conduction hearing aids, specifically designed for canal placement and receiver-in-canal configurations. These devices are tailored for individuals with mild to moderate hearing loss, providing adjustable sound amplification and comfortable wear for everyday use.
Where is Budget Hearing Aids, LLC based, and what regulatory requirements does it follow?
Budget Hearing Aids, LLC is based in the United States. The company develops its devices in compliance with U.S. regulatory standards applicable to hearing aids, ensuring they meet the necessary safety, performance, and labeling requirements.
Which regulatory registries or databases list Budget Hearing Aids, LLC’s devices?
Budget Hearing Aids, LLC’s devices are listed in the FDA’s Unique Device Identifier (UDI) database. This registry helps track and identify the company’s products under their assigned UDI numbers, ensuring transparency and traceability in the medical device supply chain.
How are Budget Hearing Aids, LLC’s devices classified by the FDA?
Budget Hearing Aids, LLC’s air-conduction hearing aids fall under two FDA device classes: Class I and Class II. The classification depends on factors like risk level, intended use, and potential impact on patient safety. Class I devices generally pose minimal risk, while Class II devices require special controls to ensure their safety and effectiveness.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
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- Website
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- Phone
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- PRRC Contact
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- EUDAMED SRN
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- FDA FEI Number
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- DUNS Number
- 118027003
Catalogue (11)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Audien Hearing | Atom Pro | FDA UDI | Class I | Active |
| Audien Hearing | Atom One | FDA UDI | Class I | Active |
| Audien Hearing | Atom 2 | FDA UDI | Class I | Active |
| Audien Hearing | Audien ion | FDA UDI | Class I | Active |
| Audien Hearing | ion pro | FDA UDI | Class II | Active |
| Audien Hearing | Atom | FDA UDI | Class I | Active |
| Audien Hearing | Audien BTE | FDA UDI | Class I | Active |
| Audien Hearing | Atom One | FDA UDI | Class I | Active |
| Audien Hearing | Atom Pro 2 | FDA UDI | Class I | Active |
| Audien Hearing | ion pro 2 | FDA UDI | Class II | Active |
| Audien Hearing | Atom X | FDA UDI | Class II | Active |
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