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Otoport Pro Clinical+AABR

OTODYNAMICS LIMITED · Model OPRO-CLN-DA · UDI-DI 05060396173271

510(k) clearances

Adverse events

Recalls

Facilities

Description

Handheld, portable, Otoacoustic Emission [OAE] analyser for advanced hearing test applications and Automated Auditory Brainstem Response (AABR) screener. Includes Otoport Pro instrument, ear probe, system items, and DPOAE+AABR Clinical licence

Recalls

Date	Firm	Reason
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2023-09-26	PATH	Affected lots of product may experience technical distortions to a greater extent than expected.
2008-09-16	Cardinal Health, Inc	GSI Audera systems requires a system software update due to issues with the Split-Screen and the Vestibular Evoked Myogenic Potential (VEMP) functions. A. Split Screen Field Cor

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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.