Digital Audiometer/Hearing Aid 3100
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K833883 FDA 510(k)
- FDA Product Code
- EWO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1050 FDA 510(k)
- Regulation Number
- 874.1050 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Digital Audiometer/Hearing Aid 3100 is an audiometer designed for objective measurement of hearing thresholds. It provides precise audiometric testing to assess auditory function across frequencies, supporting clinical evaluation and diagnosis of hearing loss in patients.
This device is intended for use in clinical settings, such as audiology clinics or ENT (ear, nose, and throat) departments. Supplied as a reusable medical instrument, it requires proper calibration and maintenance to ensure accurate results. The Digital Audiometer/Hearing Aid 3100 holds FDA 510(k) clearance (K833883) under the classification of Class II medical devices, adhering to regulatory standards for audiometric equipment.
Frequently asked questions
What clinical settings is this audiometer intended for and how does it help in diagnosis?
The Digital Audiometer/Hearing Aid 3100 is specifically designed for use in clinical settings like audiology clinics or ENT (ear, nose, and throat) departments. It provides precise audiometric testing to objectively measure hearing thresholds across different frequencies, aiding clinicians in evaluating and diagnosing hearing loss in patients. This helps in tailoring appropriate treatment or hearing aid recommendations based on accurate auditory function assessment.
Is this device single-use or reusable, and what maintenance is required to ensure accuracy?
The Digital Audiometer/Hearing Aid 3100 is a reusable medical instrument. To maintain its accuracy and reliability, it requires proper calibration and regular maintenance as outlined in the manufacturer’s guidelines. This ensures consistent performance for clinical evaluations of hearing thresholds.
How was this device’s regulatory pathway determined, and what does the FDA clearance indicate?
The Digital Audiometer/Hearing Aid 3100 received FDA clearance through a 510(k) premarket notification process, specifically under the Traditional Review pathway. The device was determined to be substantially equivalent to a legally marketed predicate audiometer, as indicated by the decision code SESE (Substantially Equivalent in Safety and Effectiveness). This clearance confirms it meets regulatory standards for audiometric equipment classified as Class II under FDA regulations.
Are there multiple models or configurations of this audiometer, and how would I identify them?
Yes, the Digital Audiometer/Hearing Aid 3100 appears to have multiple FEI (Frye Electronics, Inc.) registration numbers listed in regulatory records, suggesting variations or different configurations may exist. These identifiers (e.g., 3013557562, 3008717264) are used for tracking and compliance but do not indicate distinct clinical functions. For exact model specifications, refer to the manufacturer’s documentation or contact Frye Electronics directly.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Audiological Test Equipment, Parts and Accessories - Frye Electronics, Inc., DIGITAL AUDIOMETER/HEARING AID 3100 - Innolitics, Frye Museum - Frye Electronics, Inc., Digital Audiometer/Hearing Aid 3100 - Beudamed
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K833883 | Class II | Active |
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Manufacturer
- Manufacturer
- Frye Electronics, Inc.
Sources (1)
- FDA 510(k) K833883 24 fields · synced Sep 19, 2026