PILOT TEST OR DETECTIVE AUDIOMETERS

K060883 · Interacoustics A/S · EWO · Jun 23, 2006 · Ear, Nose, Throat

Device Facts

• Record ID: K060883
• Device Name: PILOT TEST OR DETECTIVE AUDIOMETERS
• Applicant: Interacoustics A/S
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Jun 23, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The Pilot Test and Detective audiometers are both manual single channel pure tone air conduction audiometers used to test the hearing thresholds of children. The Pilot Test audiometer has the additional capability of using speech testing using "select picture" audiometry with Spondee word lists. The Detective audiometer has the additional capability to perform automatic pure-tone audiometry.

Device Story

Pilot Test and Detective are single-channel pure-tone air conduction audiometers; used for pediatric hearing threshold testing. Pilot Test supports speech testing via select picture audiometry using Spondee word lists; Detective supports automatic pure-tone audiometry. Devices operate in clinical settings; used by healthcare professionals to assess hearing sensitivity. Output consists of hearing threshold data; assists clinicians in identifying hearing loss and determining appropriate clinical interventions.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual single-channel pure-tone air conduction audiometers. Pilot Test features speech testing capability; Detective features automatic pure-tone audiometry capability.

Indications for Use

Indicated for testing hearing thresholds in children. Pilot Test includes speech testing via select picture audiometry with Spondee word lists. Detective includes automatic pure-tone audiometry.

Regulatory Classification

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.

Submission Summary (Full Text)

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUN 2 3 2006

Maico-Diagnostics c/o Mr. Daniel Eggan 7625 Golden Triangle Drive Eden Prairie, MN 55344

Re: K060883

Trade/Device Name: "Pilot Test" or "Detective" Audiometers Regulation Number: 21 CFR 874.1050 Regulatory Class: Class II Product Code: EWO, GWJ Dated: March 29, 2006 Received: April 03, 2006

Dear Mr. Eggan:

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 such 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); good manufacturing practice requirements as set forth in the quality systems (OS) 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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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 [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

M.B. Egelston MD

Malvina B. Eydelman, 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: Maico-Diagnostics

510(k) Number (if known):

Device Name: Pilot Test, or Detective Audiometers

Indications For Use:

The Pilot Test and Detective audiometers are both manual single channel pure tone air conduction audiometers used to test the hearing thresholds of children.

KO60883

The Pilot Test audiometer has the additional capability of using speech testing using "select picture" audiometry with Spondee word lists.

The Detective audiometer has the additional capability to perform automatic pure-tone audiometry.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE

Prescription Use
(Per 21 CFR 801.109)

(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises

KO60883 510(k) Number