# K070696: Interacoustics Assr, Eclipse System (Cabinet Name)

- Pathway: 510(k) (Traditional)
- Applicant: Interacoustics A/S
- Decided: Jun 29, 2007 after 108 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
Longest line of descent: 4 generations back to K930328 (1993). 4 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K021895: Bio-Logic Master Evoked Response System, Bio-Logic Systems Corp. (2002) Summary page 1.

## Most influential descendants
- K133012: Sentiero (2014), 4 descendants of its own
- 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

## Indications for use
The Interacoustics ASSR is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. The Interacoustics ASSR can be used as either simple screening device, or a diagnostic device if used as part of a group of audiometric tests. It is exceptionally useful in testing individuals for whom behavioural audiometric results are deemed unreliable; this would include infants, young children, cognitively impaired or uncooperative adults. It allows for the estimation of hearing threshold at various frequencies, through the use of ASSR (Auditory Steady-State Response) test protocols. It is designed to be used by individuals who are trained in the performance and interpretation of evoked potentials such as audiologists and physicians. The results of the test will be used by trained hearing health care professionals to make recommendations regarding appropriate intervention strategies.

Source page: https://510kreport.com/device/K070696
Methodology: https://510kreport.com/methodology