# K012384: Ear Muffins

- Pathway: 510(k) (Traditional)
- Applicant: Bio-Logic Systems Corp.
- Decided: Oct 15, 2001 after 80 days
- Product code: HCC (Device, Biofeedback)
- Device class: 2
- Regulation: 21 CFR 882.5050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K936039 (1995). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K936039: Algo-2 Newborn Hearing Screener, Natus Medical, Inc. (1995) Summary page 1.

## Indications for use
The Bio-logic Ear Muffins® is a disposable earphone device intended to be used as an accessory to the Bio-logic ABaer / Navigator Pro auditory evoked response screening and diagnostic systems, and the Natus Medical Inc. ALGO series auditory evoked response screening systems. The Ear Muffins® device performs as the means for delivering the auditory stimulus from the auditory stimulator to the ear of the patient under test. The Bio-logic Ear Muffins® device is especially indicated for use in the auditory evoked response screening of newborn infants, because the Ear Muffins® can be placed to cover the entire ear of the infant, so nothing has to be placed into the ear canal.

Source page: https://510kreport.com/device/K012384
Methodology: https://510kreport.com/methodology