Identifiers
- 510(k) Number
- K133012 FDA 510(k)
- FDA Product Code
- EWO FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 874.1050 FDA 510(k)
- Regulation Number
- 874.1050 FDA 510(k)
- Advisory Committee
- Ear, Nose, Throat FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sentiero Advanced is a diagnostic audiometer designed for audiological testing, including auditory brainstem response (ABR), auditory steady-state response (ASSR), and otoacoustic emissions (OAE) assessments. It supports both screening and diagnostic evaluations, enabling clinicians to measure hearing function across various frequencies and conditions. The device integrates multiple testing modalities to provide comprehensive auditory assessments, aiding in the diagnosis and monitoring of hearing disorders.
Supplied as a complete system, the Sentiero Advanced includes binaural ABR capabilities, interchangeable insert earphones or headphones, an electrode cable, a set of 30 electrodes, user manual, charger, USB cable, and a carrying case. It is paired with MIRA PC software for data analysis and management. The device is classified under FDA regulation 874.1050 and is intended for use in clinical settings, though regulatory status and sterility requirements are not specified in the provided data. It is not classified as single-use or reusable, nor is MRI safety information provided.
Frequently asked questions
What types of auditory assessments can the Sentiero Advanced perform?
The Sentiero Advanced audiometer is designed to perform three key diagnostic tests: auditory brainstem response (ABR), auditory steady-state response (ASSR), and otoacoustic emissions (OAE). These modalities enable clinicians to evaluate hearing function across a range of frequencies and conditions, supporting both screening and detailed diagnostic evaluations for hearing disorders.
What components are included in the Sentiero Advanced system?
The Sentiero Advanced is supplied as a complete system, including binaural ABR capabilities, interchangeable insert earphones or headphones, an electrode cable, a set of 30 electrodes, a user manual, charger, USB cable, and a carrying case. It also pairs with MIRA PC software for data analysis and management, ensuring all necessary tools for comprehensive testing are provided.
Is the Sentiero Advanced intended for single-use or reusable applications?
The Sentiero Advanced audiometer is not classified as single-use or reusable in the provided data. Its design and components, such as electrodes and earphones, suggest it is intended for repeated use in clinical settings, though specific cleaning or sterilization instructions are not detailed in the description.
What software is required to operate the Sentiero Advanced?
The Sentiero Advanced audiometer is paired with MIRA PC software, which is used for data analysis and management. This software integrates with the device to facilitate comprehensive auditory assessments, enabling clinicians to interpret results and monitor hearing function effectively.
What regulatory classification does the Sentiero Advanced fall under?
The Sentiero Advanced audiometer is classified under FDA regulation 874.1050 and is intended for use in clinical settings. It was granted a 510(k) clearance through a traditional review process by the FDA’s Ear, Nose, and Throat (ENT) advisory committee, with a decision date of June 9, 2014.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: SENTIERO ADVANCED - PATH MEDICAL - Audiology | Diagnostic | Screening ..., PATH MEDICAL - Audiology | Diagnostic | Screening | Tracking, Sentiero Advanced, Path Medical ‹ INVENTIS, PDF Sentiero Brochure REVC FInal V2 - pathkorea.com
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K133012 | Class II | Active |
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Manufacturer
- Manufacturer
- PATH medical GmbH
Sources (1)
- FDA 510(k) K133012 24 fields · synced Oct 1, 2026