AFFINITY (CABINET NAME), AC440, HIT440, OR THE COMBINATION OF SYSTEMS by INTERACOUSTICS AS

The HIT440 system is intended to be used as a means to get an objective indication of the characteristics of a hearing aid and as a help for making the adjustments of the hearing aid to the patient. It is used by manufacturers of hearing aids and in clinics for hearing aid fitting. These two devices can either be sold individually or together in the same housing. The HIT440 system may also be used with other approved Hearing aid test chambers

Device Description

Not Found

AI/ML Overview

This is an FDA 510(k) clearance letter for an audiometer and hearing aid calibrator system. As such, it does not contain the detailed study information typically found in a clinical trial report or a comprehensive regulatory submission. The document focuses on the regulatory determination of substantial equivalence to a predicate device, rather than detailed acceptance criteria and performance data from a specific study.

Therefore, I cannot provide the requested information from this document. To answer your questions, I would need access to the actual 510(k) summary or the full regulatory submission, which would contain the performance data and methodology used to demonstrate substantial equivalence.

Summary

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features an abstract image of an eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB - 4 2005

Interacoustics AS c/o Daniel Eggan 7625 Golden Triangle Drive Eden Prarie, MN 55344

Re: K043219

K043219
Trade/Device Name: Affinity (cabinet name), AC440, HIT44, or the combination of systems
Trade/Device Name: Affinity (cabinet name), AC CER 2019 Trade/Device Namer 21 CFR 874.1050; 21 CFR 874.3310 Regulation Name: Audiometer; Hearing aid calibrator and analysis system Regulatory Class: Class II Product Code: EWO; ETW Dated: January 19, 2005 Received: January 21, 2005

Dear Mr. Eggan:

We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 310(x) premained is substantially equivalent (for the indications
referenced above and have determined the device and success marketed in inters referenced above and have decembed the arrested predicate devices marketed in interstate for use stated in the enclosure) to regally manced promised Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1776, the chance with the provisions of the Federal Food. Drug, devices that have been reciassified in accordance while approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a provisions of the Act . The and Cosmetic Act (Act) that do not require upproval or werels controls provisions of the Act. The You may, merelore, market the device, because in a general controls provisions of the frective request required in the branding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classified (sec above) in the existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation E may be subject to such adultional controlis. Existing increase of to 898. In addition, FDA may
be found in the Code of Federal Regulations, Title 21, Parts Forester be found in the Code of Poderal Registering your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that I DA s issualled of a but other requirements of the Act
that FDA has made a determination that your device and of a fealers and one must that FDA nas made a delerinmanon that your as res be other Federal agencies. You must as and listing and listing or any Federal statutes and regulations administered of end limited to: registration and listing (21 l comply with all the Act STEquiltenes, more and manufacturing practice requirements as setting CFR Part 807); labering (21 CFR Part 800); good and if applicable, the electronic
forth in the quality systems (QS) regulation (21 CFR Pat 1000 1050 forth in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 - Daniel Eggan

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 827-8910. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

A. Ralph Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section A

Indications for Use Statement

Applicant: Interacoustics A/S

510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________

Device Name: AFFINITY (Cabinet name), AC440, HIT440, Or the combination of systems

Indications For Use:

The AC440 system is intended to be used for the detection and diagnosis of suspected hearing loss.

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Per 21 CFR 801.109)

Oohthalmic Ear.

510(k) Number

Prescription Use (Per 21 CFR 801.109)

se and Throat Devises
K043219
0(k) Number

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.