aTymp

NEUROSOFT, OOO · Model aTymp · UDI-DI 04650075334003

510(k) clearances

Adverse events

Recalls

Facilities

Description

The aTymp system is a portable audiometric device intended for use in conduction of diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders with the help of acoustic impedance tests, including tympanometry, Eustachian tube function (for intact and perforated tympanic membrane), acoustic reflex and acoustic reflex decay. The target population for aTymp system includes all ages. During the Eustachian tube function tests patient should be able to understand and perform instructions to do maneuvers.

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Data compiled from public U.S. FDA sources (GUDID, 510(k)/PMA, MAUDE, recalls, establishment registration). Adverse-event reports are unverified and do not establish causation. Informational only — not medical, clinical, or regulatory advice.