SMARTOAE

K964426 · Intelligent Hearing Systems · EWO · Feb 3, 1997 · Ear, Nose, Throat

Device Facts

• Record ID: K964426
• Device Name: SMARTOAE
• Applicant: Intelligent Hearing Systems
• Product Code: EWO · Ear, Nose, Throat
• Decision Date: Feb 3, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1050
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.

Device Story

SmartOAE is an audiometric device for assessing cochlear function via distortion product otoacoustic emissions (DPOAE). Device delivers sound signals into the outer ear and records resulting acoustic emissions produced by the cochlea. It simultaneously measures ambient noise levels near the distortion product frequency to validate test conditions. Operated by hearing health professionals in clinical settings; requires no behavioral response from the patient. Output provides clinicians with objective data on cochlear response, aiding in the evaluation of hearing health.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Audiometer (21 CFR 874.1050). System delivers acoustic stimuli and records otoacoustic emissions. Includes signal processing for distortion product frequency analysis and noise floor estimation. Form factor is a clinical diagnostic system.

Indications for Use

Indicated for use by hearing health professionals to assess cochlear function in patients of all ages. No patient behavioral response required.

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)

{0}

DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
10903 New Hampshire Avenue
Document Control Room -WO66-G609
Silver Spring, MD 20993-0002

Intelligent Hearing Systems
c/o Edward Miskiel, Ph.D.
President
10689 N. Kendall Drive, Suite 315
Miami, FL 33176

Re: K964426
Trade/Device Name: SmartOAE
Regulation Number: 21 CFR 874.1050
Regulation Name: Audiometer
Regulatory Class: II
Product Code: EWO
Dated: November 18, 1996
Received: November 20, 1996

JUN - 1 2012

Dear Dr. Miskiel:

This letter corrects our substantially equivalent letter of February 3, 1997.

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 (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

{1}

Page 2 - Edward Miskiel, Ph.D.

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.

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,


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

Enclosure

{2}

K964426

510(k) Number (if known): K964426

Device Name: **SmartOAE**

## Indications for Use:

The SmartOAE device is intended to be used for the purpose of determining the distortion product response of the human cochlea. The device is intended to be used by hearing health professionals to determine cochlear function. The test administered by the device does not require any patient behavioral response, such as pushing a button switch. The device delivers sound signals into the outer ear and subsequently records the sound in the outer ear which contain sounds produced by normal cochleas. The device also measures the level of sound near the distortion product frequency to estimate the noise level present while the test was performed.

Prescription Use ☑ OR Over-the-Counter Use ☐
(Per 21 CFR 801.109)

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

Concurrence of CDRH, Office of Device Evaluation


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

Prescription Use ☑
(Per 21 CFR 801.109)

510(k) Number K964426