FDA applicant

Intelligent Hearing Systems

Miami, FL13 decisions1991–20170 recalls

FDA records 13 decisions for Intelligent Hearing Systems (Miami, FL) from 1991 to 2017: 13 510(k) clearances. Most are in product codes GWJ (Stimulator, Auditory, Evoked Response) and GWL (Amplifier, Physiological Signal). Its devices cite 19 predicates, 10 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Intelligent Hearing Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2017

2007high 1 (2007) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Intelligent Hearing Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Intelligent Hearing Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Intelligent”

FDA records each applicant name separately; these may or may not be the same firm.

Intelligent Implant Systems, LLC 6 Intelligent Medical Devices, Inc. 4 Intelligent Medicine, Inc. 4 Intelligent Orthopaedics, Ltd. 3 Intelligent Medical Systems 2 Intelligent Ultrasound Limited 2 Intelligent Surgical Lasers, Inc. 2 Intelligent Product Limited Co. 2 Intelligent Images Srl 2 Intelligent Software Systems, Inc. 1 Intelligent Sensory Concept SA 1 Intelligent Medica Imaging, Inc. 1

Intelligent Hearing Systems

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Intelligent”