# K031978: Amplaid A756 Screening Admittance Meter

- Pathway: 510(k) (Special)
- Applicant: Amplaid
- Decided: Jul 21, 2003 after 25 days
- Product code: ETY (Tester, Auditory Impedance)
- Device class: 2
- Regulation: 21 CFR 874.1090
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K903066 (1990). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K992370: Amplaid A724 and A728, Amplifon S.P.A. (1999) Summary page 1.

## Indications for use
The Amplaid A756 Screening Admittance Meter can 1. Evaluate middle ear functions such as otitis media, glue ear, eardrum scar tissues, perform myringotomy status, ossicular chain discontinuity ear canal volume, otosclerosis, stapes fixation. 2. Perform Acoustic reflex test. 3. Determine acoustic reflex threshold 4. Perform reflex decay test. The unit is intended for use by a qualifiedtrained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.

Source page: https://510kreport.com/device/K031978
Methodology: https://510kreport.com/methodology