Search Results

hearOAE is intended to be used by hearing healthcare professionals in the audiologic evaluation and documentation of ear function and ear disorders using Transient Evoked Otoacoustic Emissions (TEOAEs) and Distortion Product Otoacoustic Emissions (DPOAEs). The target population for the hearOAE includes all ages.

Per 21 CFR 874.1050, the hearOAE (otoacoustic emission device) is a portable, handheld, battery-operated device that can detect hearing loss using Otoacoustic Emission technologies. The hearOAE device may be configured to support one or any combination of TEOAE or DPOAE. Otoacoustic Emission devices are class II medical devices. hearOAE consists of three main components listed below: - hearOAE Application (available on supported Android devices supplied by i hearX) - hearOAE Codec - hearOAE Probe The hearOAE Application: - is operated on an Android smart device that uses Bluetooth connectivity to communicate with the hearOAE Codec. - enables the user to choose and set up testing protocols for both TEOAE and DPOAE. - enables the checking of the probe functionality, namely "Probe Check". - controls the start and stop of a TEOAE and DPOAE test including pre-test functions such as Probe Check and in-ear calibration. - provides feedback during and after the test in the form of tables, figures, and graphs. The hearOAE Codec: - consists of hardware and software for generating the test signals and measuring the responses. - has the ability to generate, measure and process signals. - contains a rechargeable lithium-ion battery to power the device. - uses three light indicators to provide a visual display of the status of the hearOAE Codec to the user. A push button (signified by a Power symbol) is located on the case of the hearOAE Codec to allow the user to switch it on or off. - communicates the test results via Bluetooth to the hearOAE smart device which will be displayed on the Smart device screen to the user within the application. The hearOAE Probe: - houses the speakers (drivers), and a microphone that produces the test stimuli and measures the sound pressure level (SPL) present in the ear canal. - has a removable probe coupler with ear tips which fit onto the probe coupler.

The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting air-conduction hearing aid, intended to amplify sound for individuals 18 years of age or older with perceived mild to moderate hearing impairment. The device is adjusted by the user to meet the user's hearing needs. The device is intended for use without the assistance of a hearing care professional.

The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a self-fitting, air conduction hearing aid consisting of the IntriCon hardware, Lexie Software, Lexie Application and accessories supplied in the carton. The Lexie App is available on Android and iOS. The Lumen self-fitting OTC hearing aid is the only model applicable to this 510(k). The Lexie Lumen Self-Fitting OTC Hearing Aid(s) with Lexie Application is a behind the ear device that includes self-adjustable coupling by means of a slim tube and ear tip/dome. The hearing aids can be fine-tuned remotely by trained hearing experts, at the request of the user, in the Lexie contact center. The Lexie app receives custom remote settings as performed through the Lexie adjustment wizard and fitting portal (internet service).