FONIX ,MODEL 8000

K093006 · Frye Electronics, Inc. · ETW · Dec 30, 2009 · Ear, Nose, Throat

Device Facts

• Record ID: K093006
• Device Name: FONIX ,MODEL 8000
• Applicant: Frye Electronics, Inc.
• Product Code: ETW · Ear, Nose, Throat
• Decision Date: Dec 30, 2009
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 874.3310
• Device Class: Class 2

Intended Use

This device performs electro-acoustical, telecoil, and battery current measurements of hearing aids.

Device Story

FONIX 8000 Hearing Aid Test System performs electro-acoustical, telecoil, and battery current measurements on hearing aids. Device used in clinical settings by audiologists or hearing aid technicians to verify hearing aid performance. Input consists of electrical and acoustic signals from hearing aids; system processes these signals to quantify performance metrics. Output provided to clinician for assessment of device function and quality control. Benefits include ensuring hearing aid compliance with specifications and proper operation prior to patient fitting.

Clinical Evidence

No clinical data; bench testing only.

Technological Characteristics

Hearing aid calibrator and analysis system (21 CFR 874.3310). Performs electro-acoustical, telecoil, and battery current measurements. Class II device.

Indications for Use

Indicated for electro-acoustical, telecoil, and battery current measurements of hearing aids. Prescription use only.

Regulatory Classification

Identification

A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Frye Electronics. Inc. c/o Kristina Frye 9826 S.W. Tigard St Tigard, OR 97223

DEC 3 0 2009

Re: K093006

> Trade/Device Name: FONIX 8000 Hearing Aid Test System Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing aid calibrator and analysis system Regulatory Class: Class II Product Code: ETW Dated: November 19, 2009 Received: November 20, 2009

Dear Ms. Kristina Frye:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours.

Evelyn Hammon

Malvina B. Eydelman, M. Director Division of Ophthalmic, Neurological, and Ear, Nose, Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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093004

## Indications for Use

510(k) Number (if known): K093006

Device Name: FONIX 8000 Hearing Aid Test System

Indications For Use:

This device performs electro-acoustical, telecoil, and battery current measurements

of hearing aids.

Prescription Use _ x (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 807 Subpart C)

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Concurrence of CDRH Office of Device Evaluation (ODE)

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| Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices | |

| 510(k) Number | K093006 |
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