Otoport

Full name

Otodynamics Otoport

510(k) Number

K072033 ↗

FDA Product Code

EWO

Device Class

Class II

Regulation

21 CFR Part 874.1050

Advisory Committee

Ear, Nose, Throat

FDA Decision

SESE Substantially Equivalent

• Otodynamics

  Class IIa

  CE/MDD

• ILO2088 Enchocheck or ILO2088 Otocheck

  Class II

  FDA 510(k) K983352 Active Cleared 11 Dec 1998

• ILO88. Otodynamic Analyser, Kit System for Pc

  Class II

  FDA 510(k) K962995 Active Cleared 10 Jan 1997

• Otoport Pro

  Class II

  FDA 510(k) K240430 Active Cleared 15 Mar 2024

• ILO292 Dp Echoport Plus Oae System

  Class II

  FDA 510(k) K983350 Active Cleared 11 Dec 1998

• Otoport OAE +ABR Advance, Otoport OAE+ABR DP+TE, Otoport OAE+ABR Screener-Otocheck OAE+ABR, Otocheck OAE+ABR LE, Otocheck ABR Screener-Otodynamics ABR Upgrade Kit

  Class II

  CE/MDD FDA 510(k) K143395 Active Cleared 23 Feb 2015

See all devices from Otodynamics, Ltd. →

• What types of hearing assessments can the Otoport perform, and how does it differ from traditional audiometry?

  The Otoport measures otoacoustic emissions (OAEs), specifically distortion product OAEs (DPOAE) and transient evoked OAEs (TEOAE), to objectively evaluate cochlear function. Unlike traditional audiometry, which relies on patient response (e.g., button-pressing or raising a hand), the Otoport provides non-invasive, quantitative data on auditory health without requiring active participation from the patient. This makes it ideal for screening infants, young children, or patients with cognitive impairments who cannot follow verbal instructions.

• Is the Otoport designed for single-use or reusable clinical environments, and what are the sterility requirements?

  The Otoport itself is a reusable clinical instrument, intended for use in controlled settings like audiology clinics and ENT departments. Sterility is maintained through disposable probes and accessories, ensuring compliance with sterile conditions during use. The device’s design adheres to FDA 510(k) clearance and EU Medical Device Directive (MDD) standards, emphasizing infection control in clinical applications.

• What model variants or registration numbers should I look for when purchasing the Otoport, and how do they relate to functionality?

  The Otoport is available in multiple model variants, each identified by unique FDA registration numbers (e.g., 3013557562, 3008717264, etc.). These variants are not functionally distinct in terms of core capabilities (measuring DPOAE/TEOAE) but may reflect software updates, firmware revisions, or minor hardware adjustments over time. Always verify the specific registration number against the OpenFDA database or manufacturer documentation to confirm compatibility with your needs.

• Can the Otoport be used in an MRI environment, and what safety precautions should be considered?

  The Otoport is not MRI-compatible, meaning it should never be used or stored near MRI machines. This is explicitly noted in the device documentation, as electromagnetic interference from MRI systems could compromise the device’s functionality or pose safety risks. Clinicians should ensure the device remains in a non-MRI zone at all times.

• What regulatory pathways does the Otoport follow, and how does its classification as a Class II device impact its use?

  The Otoport follows FDA 510(k) clearance (traditional pathway under the Ear, Nose, and Throat advisory committee) and EU Medical Device Directive (MDD) compliance. As a Class II device (product code EWO, regulation number 874.1050), it undergoes premarket review to ensure safety and effectiveness for measuring OAEs. This classification means it is subject to additional manufacturing controls (e.g., design validation, risk management) but does not restrict its use—clinicians can rely on its substantially equivalent status to established audiometers for clinical and screening applications.