# K132957: Madsen Accuscreen Type 1077

- Pathway: 510(k) (Traditional)
- Applicant: Gn Otometrics
- Decided: Feb 27, 2014 after 160 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: 5 generations back to K902540 (1990). 12 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013977: Echo-Screen T, TA, TD, Tda, TC, Fischer-Zoth Audiologic Systems, Inc. (2002) Summary page 1.
- K122067: Type 1077 Accuscreen, Gn Otometrics (2012) Summary page 1.

## Most influential descendants
- K143395: 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 (2015), 2 descendants of its own
- K234095: OtoNova/OtoNova Pro (2024), 0 descendants of its own
- K240430: Otoport Pro (2024), 0 descendants of its own

## Indications for use
The Type 1077 device is indicated for use in the recording and automated analysis of human physiological data (screening auditory brainstem responses and/or otoacoustic emissions) necessary for the diagnosis of auditory and hearing-related disorders. Distortion Product Otoacoustic Emissions and Transient Evoked Otoacoustic Emissions: The Type 1077 DPOAE module and TEOAE module can be used for patients of all ages, from children to adults, including infants and geriatric patients. It is especially indicated for use in testing individuals for whom behavioral audiometric results are deemed unreliable, such as infants, young children, and cognitively impaired adults. Auditory Brainstemn Response: The Type 1077 ABR module is especially intended for infants from 34 weeks (gestational age) up to 6 months of age. When the device is used to screen infants, they should be asleep or in a quiet state at the time of screening. The device is intended for use by audiologists, ENT's and other healthcare professionals.

Source page: https://510kreport.com/device/K132957
Methodology: https://510kreport.com/methodology