# K133012: Sentiero

- Pathway: 510(k) (Traditional)
- Applicant: Path Medical GmbH
- Decided: Jun 9, 2014 after 257 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K902540 (1990). 25 ancestors in all.
4 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K061744: Cochlea-Scan / Cochlea-Scan Plus, Bio-Logic Systems Corp. (2006) Summary page 1.
- K122067: Type 1077 Accuscreen, Gn Otometrics (2012) Summary page 1.
- K092373: Ics Chartr EP 200, Gn Otometrics (2009) Summary page 1.
- K083861: Titan, Titan Shoulder Box, Titan Cradle, Titan Printer, Titan IMP440, IMP440 Module, Titan Suite, Interacoustics AS (2009) Summary page 1.
- K070696: Interacoustics Assr, Eclipse System (Cabinet Name), Interacoustics A/S (2007) Summary page 1.

## Most influential descendants
- K171038: Hearing Healthcare Pro (2017), 1 descendant of its own
- K220139: QScreen (2022), 0 descendants of its own
- K213345: Sentiero, AuDX, AuDX PRO, Sentiero Desktop, AuDX PRO Flex, Sentiero Advanced, NavPRO ONE (2022), 0 descendants of its own
- K183201: Hearing Healthcare Pro (2019), 0 descendants of its own

## Recalls of this device
- Sep 26, 2023 · Class II · Z-0401-2024: Affected lots of product may experience technical distortions to a greater extent than expected.
- Sep 26, 2023 · Class II · Z-0402-2024: Affected lots of product may experience technical distortions to a greater extent than expected.
- Sep 26, 2023 · Class II · Z-0403-2024: Affected lots of product may experience technical distortions to a greater extent than expected.
- Sep 26, 2023 · Class II · Z-0404-2024: Affected lots of product may experience technical distortions to a greater extent than expected.

## Indications for use
Sentiero is a portable instrument to diagnose all ages for hearing loss. The instrument offers different test methods which can be configured to fit the professional's needs for screening or diagnostic purposes. It offers physiological test methods such as: * Distortion Product Otoacoustic Emissions (DPOAE) * Transient Evoked Otoacoustic Emissions (TEOAE) * Auditory Brainstem Response (ABR) * Auditory Steady State Response (ASSR) * Auditory Impedance and acoustic reflex (TYMP) Additionally it offers standard audiometry (psycho-acoustical). All physiological test methods are especially indicated for use in defining the type and configuration of hearing loss particularly for individuals whose behavioral audiometric results are deemed unreliable or to assist in the diagnosis of otologic disorders. Estimation of cochlear hearing thresholds (DPTHRESH) is possible at various frequencies without the need of cooperative interaction with the patient. Acoustic reflex and tympanometry (TYMP) are featured to evaluate the functional condition of the middle and outer ear. For each method, several protocols can be configured. The results are to be used to make further recommendations regarding appropriate intervention strategies. Therefore, Sentiero is intended for use by trained personnel such as audiologists, pediatricians, ENT doctors and other health care professionals. In the United States of America, Federal law restricts this device to sale by or on the order of a licensed physician. Available psycho-acoustical methods on Sentiero are especially indicated for use with cooperative patients starting at the age of 2 years or adequate development age, which enables them to do play/interactive audiometry. All other modules are suitable to be used for all ages. Sentiero is designed for: 1. Diagnostics, monitoring and follow-up after newborn hearing screening 2. Pre-school, school, and adult hearing screening 3. ENT diagnostics based on measurement of * Otoacoustic emissions * Tympanometry and acoustic reflex * Auditory Brainstem Responses * Auditory Steady State Responses Sentiero must not be used in cases of external otitis (outer ear canal infection) or in any case which yields to pain when inserting the ear probe or applying any other transducer.

Source page: https://510kreport.com/device/K133012
Methodology: https://510kreport.com/methodology