# K141524: Neuro-Audio

- Pathway: 510(k) (Traditional)
- Applicant: Teleemg, LLC USA
- Decided: Mar 12, 2015 after 276 days
- Product code: EWO (Audiometer)
- Device class: 2
- Regulation: 21 CFR 874.1050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K930328 (1993). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052562: Eclipse (Cabinet Name), TEOAE25, EP15, or the Combination of Systems., Interacoustics AS (2005) Summary page 4.
- K030016: TEOAE25, Interacoustics A/S, Assens (2003) Summary page 4.
- K060539: DPOAE20 , Eclipse, Interacoustics A/S, Assens (2006) Summary page 4.
- K070696: Interacoustics Assr, Eclipse System (Cabinet Name), Interacoustics A/S (2007) Summary page 4.
- K043219: Affinity (Cabinet Name), AC440, HIT440, or the Combination of Systems, Interacoustics AS (2005) Summary page 4.
- K011135: Gsi Audera, Nicolet Biomedical (2001) Summary page 4.

## Indications for use
The Neuro-Audio system is indicated for use in the recording and analysis of human physiological data used for the diagnosis of auditory and hearing-related functions. It is intended as an aid to healthcare professionals trained and skilled in audiology. The system assists in the evaluation, documentation and diagnosis of ear disorders in humans using evoked potentials (EP), electrocochleography (ECochG), auditory brainstem response (ABR), auditory steady-state response (ASSR), otoacoustic emission (OAE) and pure tone audiometry (PTA). The device is intended for use in the patient care institutions, diagnostics centers, neurosurgical hospitals and experimental laboratories. The patient group includes all ages and genders.

Source page: https://510kreport.com/device/K141524
Methodology: https://510kreport.com/methodology