Type 6400 Real Ear Hearing Aid Analyzer
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K872242 FDA 510(k)
- FDA Product Code
- ETW FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.3310 FDA 510(k)
- Regulation Number
- 874.3310 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Type 6400 Real Ear Hearing Aid Analyzer is a Calibrator, Hearing Aid/Earphone and Analysis System designed for real-ear measurement of hearing aid performance. It evaluates acoustic output and fit in the ear canal, ensuring accurate verification of hearing aid prescriptive targets and patient-specific responses.
This device is intended for use in clinical audiology settings by trained professionals, providing objective assessment of hearing aid function. Supplied as a reusable instrument, it operates under FDA 510(k) clearance (K872242) and falls under regulation 874.3310 as a Class II medical device. No specific sterility or MRI safety information is provided in the data.
Frequently asked questions
What is the primary clinical purpose of the Type 6400 Real Ear Hearing Aid Analyzer, and who should use it?
The Type 6400 is designed for real-ear measurement of hearing aid performance, allowing clinicians to verify how well a hearing aid fits and functions in a patient’s ear canal. It objectively assesses acoustic output and ensures the device meets prescriptive targets tailored to the individual’s hearing loss. This tool is intended exclusively for use in clinical audiology settings by trained professionals, such as audiologists, to provide precise, patient-specific evaluations.
Is the Type 6400 Real Ear Hearing Aid Analyzer a single-use or reusable device, and what does that mean for maintenance?
The Type 6400 is supplied as a reusable instrument, meaning it is built for repeated use in clinical environments. Since it is not sterile, maintenance involves regular cleaning and calibration to ensure accuracy. The manufacturer’s instructions (not provided here) would outline specific care protocols, but generally, reusable devices require periodic servicing to maintain performance standards.
How is the Type 6400 Real Ear Hearing Aid Analyzer regulated, and what does that imply for purchasing or clinical use?
The Type 6400 is classified as a Class II medical device under FDA regulation 21 CFR 874.3310 and holds a 510(k) clearance (K872242). This means it has undergone FDA review to demonstrate substantial equivalence to a predicate device and is intended for clinical audiology use only. Purchasers should confirm compliance with facility protocols for medical devices, and clinicians should ensure proper training before operation.
Are there different models or sizes available for the Type 6400, and how might that affect selection?
The data lists multiple FEI numbers (e.g., 3010611950, 3005581270, etc.), which typically correspond to different software versions, accessories, or firmware updates rather than physical size variations. These variations may include additional probes, calibration tools, or software enhancements for specific use cases (e.g., pediatric vs. adult real-ear testing). Clinicians should verify compatibility with their practice’s needs before purchasing.
Does the Type 6400 Real Ear Hearing Aid Analyzer require any special storage conditions, and what should be considered?
While the data does not specify storage requirements, reusable medical devices like this generally need protection from dust, moisture, and extreme temperatures to prevent damage or contamination. Storage should follow the manufacturer’s guidelines (not provided here) and align with facility protocols for electronic medical equipment. Environmental controls (e.g., temperature/humidity) may be recommended to ensure longevity and accuracy.
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: TYPE 6400 REAL EAR HEARING AID ANALYZER - Innolitics, TYPE 6400 REAL EAR HEARING AID ANALYZER 510 (k) K872242 - FDA.report, Type 6400 Real Ear Hearing Aid Analyzer - Beudamed, TypeRacer - Play Typing Games and Race Friends
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K872242 | Class II | Active |
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Manufacturer
- Manufacturer
- Frye Electronics, Inc.
Sources (1)
- FDA 510(k) K872242 24 fields · synced Sep 19, 2026