← Back to catalogue

Fonix, Model 7000

FDA 510(k)

Class II (US FDA 510(k))

510(k) K022510

by Frye Electronics, Inc.

Identifiers

510(k) Number
K022510 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 Fonix Model 7000 is a Hearing Aid / Earphone and Analysis System designed for evaluating hearing aid performance. It measures key acoustic parameters, including frequency response, harmonic distortion, equivalent input noise, battery current drain, and compression characteristics, ensuring compliance with audiological standards.

This system is intended for use in clinical and manufacturing settings to assess hearing aid functionality through coupler and optional real-ear measurements. Supplied as a reusable device, it adheres to FDA 510(k) clearance (K022510) under the Ear, Nose, and Throat specialty classification. Storage and handling follow manufacturer guidelines to maintain calibration and accuracy.

Frequently asked questions

What clinical or manufacturing environments is the Fonix Model 7000 intended for use in, and what does it measure?

The Fonix Model 7000 is designed for use in both clinical and manufacturing settings to evaluate hearing aid performance. It measures key acoustic parameters such as frequency response, harmonic distortion, equivalent input noise, battery current drain, and compression characteristics. These measurements help ensure hearing aids meet audiological standards before being used by patients.

Is the Fonix Model 7000 a single-use or reusable device, and how should it be stored?

The Fonix Model 7000 is a reusable device, not intended for single-use. To maintain its calibration and accuracy, it must be stored and handled according to the manufacturer’s guidelines, which are provided by Frye Electronics, Inc. Proper storage ensures reliable performance for ongoing use in testing environments.

What types of measurements can be performed with the Fonix Model 7000, and does it support real-ear testing?

The Fonix Model 7000 measures coupler-based acoustic parameters like frequency response, distortion, and noise levels. It also supports optional real-ear measurements, allowing for more comprehensive evaluations of hearing aid performance in the ear canal itself, beyond just coupler-based testing.

How is the regulatory status of the Fonix Model 7000 determined, and what classification does it fall under?

The Fonix Model 7000 holds FDA 510(k) clearance (K022510) under the Ear, Nose, and Throat specialty classification, with a decision described as substantially equivalent. This classification is based on its intended use as a calibrator for hearing aid/earphone analysis systems, falling under product code ETW and device class II.

What manufacturer provides support or maintenance for the Fonix Model 7000, and where is it located?

Frye Electronics, Inc., the manufacturer of the Fonix Model 7000, is based in Tigard, Oregon (9826 SW Tigard St., Tigard, OR 97223). For support, maintenance, or calibration-related inquiries, contact information is available through the listed address or via the provided contact, Kristina Frye.

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: PDF FONIX 7000 - Frye, FONIX 7000 Hearing Aid Analyzer - Frye Electronics, Inc., FRYE FONIX 7000 OPERATOR'S MANUAL Pdf Download | ManualsLib, FONIX 7000 Hearing Aid Test System Operator's Manual | Manualzz, Frye FONIX 7000 : Hearing Aid User Manual - ManualShelf

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Frye Electronics, Inc.

Sources (1)

  • FDA 510(k) K022510 24 fields · synced Sep 19, 2026