# K123701: Hearlab Aca

- Pathway: 510(k) (Traditional)
- Applicant: Frye Electronics, Inc.
- Decided: Apr 5, 2013 after 123 days
- Product code: GWJ (Stimulator, Auditory, Evoked Response)
- Device class: 2
- Regulation: 21 CFR 882.1900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## 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 brainstemt 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 and 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 firequency-specific tones presented to adults using CAEP. Only audiologists should use information acquired by HEAR~ab in diagnosing a hearing loss or in verifying the effectiveness of a hearing aid.

Source page: https://510kreport.com/device/K123701
Methodology: https://510kreport.com/methodology