HEARLAB ACA

K123701 · Frye Electronics, Inc. · GWJ · Apr 5, 2013 · Neurology

Device Facts

• Record ID: K123701
• Device Name: HEARLAB ACA
• Applicant: Frye Electronics, Inc.
• Product Code: GWJ · Neurology
• Decision Date: Apr 5, 2013
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1900
• Device Class: Class 2
• Attributes: Pediatric

Intended Use

The HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstem response device). Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential (CAEP) is absent or present in humans from infants who are 42 weeks gestational through adults when stimulated with speech tokens presented in the sound field. This test can be performed on unaided subjects wearing hearing instruments. However, it is not meant to be used on subjects with cochlear implants. These professionals can also use HEARLab to determine audibility of unaided frequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEARLab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.

Device Story

HEARLab ACA records/analyzes human electro-physiological data to aid hearing assessment. Input: auditory evoked potentials via electrodes; output: CAEP presence/absence or tone audibility. Used by trained healthcare professionals/audiologists in clinical settings. Device presents speech tokens or frequency-specific tones; records resulting cortical responses. Output assists audiologists in diagnosing hearing loss or verifying hearing aid effectiveness. Benefits: objective assessment of auditory response in infants and adults.

Clinical Evidence

No clinical data provided; device cleared based on substantial equivalence to existing auditory evoked response stimulators.

Technological Characteristics

Evoked response auditory stimulator; records electro-physiological data; presents speech tokens and frequency-specific tones in sound field; intended for use with unaided subjects or those wearing hearing instruments; excludes cochlear implant patients.

Indications for Use

Indicated for infants (from 42 weeks gestational age) through adults to assess Cortical Auditory Evoked Potential (CAEP) presence/absence using speech tokens in sound field, or to determine audibility of frequency-specific tones in adults. Contraindicated for subjects with cochlear implants.

Regulatory Classification

Identification

An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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April 5, 2013

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

Frye Electronics, Inc. % Ms. Kristina Frye ISO Coordinator 9826 S.W. Tigard Street Tigard, OR 97223

Re: K123701

Trade/Device Name: HEARLab ACA Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: February 18, 2013 Received: March 5, 2013

Dear Ms. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Kristina Frye

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.

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/Resourcesfor You/Industry/default.htm.

Sincerely yours.

## Eric ADMann

for 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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## Statement of Indications for Use

510(k) Number: K123701

Device Name: HEARLab ACA

Indications for Use:

The HEARLab device is intended for use in evoking an auditory response and recording, analyzing, and displaying the resulting human electro-physiological data as an aid for hearing assessment used in conjunction with other clinical devices (such as an audiometer or an auditory brainstem response device).

Healthcare professionals trained in auditory evoked potentials can use HEARLab in order to determine whether the Cortical Auditory Evoked Potential (CAEP) is absent or present in humans from infants who are 42 weeks gestational through adults when stimulated with speech tokens presented in the sound field. This test can be performed on unaided subjects wearing hearing instruments. However, it is not meant to be used on subjects with cochlear implants.

These professionals can also use HEARLab to determine audibility of unaided frequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEARLab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.

Prescription Use X (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)

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